007.05.02 Ark. Code R. § 001 - Rules for Hospitals and Related Institutions in Arkansas ("Hospital Rules")

SECTION 1: AUTHORITY. The following Rules and Regulations for Hospitals and Related Institutions in Arkansas are duly adopted and promulgated by the Arkansas State Board of Health pursuant to the authority expressly conferred by the laws of the State of Arkansas in Act 414 of 1961, as amended by Act 258 of 1971, Act 190 of 1975, Act 536 of 1977, Act 273 of 1983, Act 980 of 1985, and Act 516 of 1987, along with Acts 143 of 1987, 348 of 1987, and 399 of 1987 covered under these regulations.

SECTION 2: PURPOSE. These rules and regulations have been prepared for the purpose of establishing a criterion for minimum standards for licensure, operation and maintenance of hospitals and related institutions in Arkansas that is consistent with current trends in patient care practices. By necessity they are of a regulatory nature but are considered to be practical minimum design and operational standards for these facilities. These standards are not static and are subject to periodic revisions in the future as new knowledge and changes in patient care trends become apparent. However, it is expected that facilities will exceed these minimum requirements and that they shall not be dependent upon future revisions in these standards as a necessary prerequisite for improved services. Hospitals and related institutions have a strong moral responsibility for providing optimum patient care and treatment for the populations they serve.

SECTION 3: DEFINITIONS. The word shall as used in these regulations means mandatory.

A. Administrator means the person responsible for the management of any facility requiring licensure under these regulations.

B. Department means the Arkansas Department of Health.

C. Director means the Chief Administrative Officer in the Division of Health Facility Services.

D. Division means the Division of Health Facility Services.

E. Licensee means the person to whom a license is issued for the purpose of operating the institution described in the application for licensure, who shall be responsible for maintaining approved standards for the institution of any state, county, or local government unit and any division, board, or agency thereof.

F. State Health Officer means the Secretary of the State Board of Health.

The following categories of facilities (G.-Q.), as defined herein, established for the purpose of providing inpatient diagnostic care and treatment for more than twenty-four (24) hours for two (2) or more persons not related to the proprietor, may not be conducted or maintained in this state without being licensed:

G. Alcohol/Drug Abuse Inpatient Treatment Centers means a facility, or distinct part of a facility, in which services are provided for the diagnosis, treatment and rehabilitation of alcohol and drug abuse; a facility which provides only counseling and room and board is not included in this definition.

1. For the purpose of these regulations an alcohol/drug abuse treatment center is a facility (either licensed as a hospital or an established diagnostic unit of an acute psychiatric or rehabilitation hospital) or a free-standing unit in which services are provided over a continuous period, exceeding twenty-four (24) hours for two (2) or more persons not related to the proprietor for the diagnosis, treatment and rehabilitation of alcohol and drug abuse.

2. Alcohol and drug abuse inpatient center regulations are to be applied in conjunction with the Rules and Regulations for Hospitals and Related Institutions in Arkansas where applicable. (See Section 45, Alcohol/Drug Abuse Inpatient Treatment Centers.)

3. The requirements established for alcohol/drug abuse inpatient treatment centers shall not be construed as changes in the requirements already established for licensing of any health care facility as delineated in these regulations.

H. Critical Access Hospital means a hospital that meets the following statutory requirements in Arkansas:

1. Classified as a nonprofit or public hospital located in a rural area that is:

a. Located more than a thirty-five (35) mile drive (or, in the case of mountainous terrain or in areas with only secondary roads available, a fifteen (15) mile drive) from a hospital, or;

b. Certified by the state as being a Necessary Provider of Health Care Services to residents in the area;

2. Provides twenty-four (24) hour emergency care services as determined necessary for ensuring access to emergency care in each area served by a Critical Access Hospital;

3. Provides not more than fifteen (15) beds for acute inpatient care with the exception for swing-bed facilities which are allowed to have up to twenty-five (25) inpatient beds that can be used interchangeable for acute or SNF-level care, provided that not more than fifteen (15) beds are used at any one (1) time for acute care;

4. Provides acute inpatient care for a period not to exceed ninety-six (96) hours unless a longer period is required because transfer to a hospital is precluded due to inclement weather, or other emergency conditions or a peer review organization or equivalent entity, upon request, waives the ninety-six (96) hour restriction on a case-by-case basis;

5. Provides staffing according to Rules and Regulations for Hospitals in Arkansas;

6. Has membership in a rural health network; and

7. Has an agreement with at least one (1) hospital that is a member of the network for;

a. Patient referral and transfer;

b. Development and use of communications systems;

c. Provision of emergency and non-emergency transportation;

d. Credentialing and quality assurance; and

8. Meets Health Care Financing Administration (HCFA) Conditions of Participation for Critical Access Hospitals;

9. When a hospital converts to a Critical Access Hospital (CAH) and then at a later date decides to return to a full service with no limits on bed or length of stay, the hospital would be surveyed using the Life Safety Code under which the hospital entered into the CAH program. The hospital shall be able to show that it has continued to be licensed and complied consistently with the life safety code as a CAH.

I. Emergency Services Facility means a facility that is licensed only for emergency services as provided for in Act 516 of 1987. The Department is empowered to license under Act 414 of 1961, as amended, hospitals which have discontinued inpatient services to continue to provide emergency services if there is no other hospital emergency service in the community.

J. General Hospital means any facility used for the purpose of providing short-term inpatient diagnostic care and treatment, including general medical care, surgical care, obstetrical care, and specialized services or specialized treatment.

K. Infirmary means any facility used for the purpose of offering temporary medical care and/or treatment exclusively for persons residing on a designated premise, e.g., schools, reformatories, prisons, etc. and where the persons are kept for twenty-four (24) hours or more.

L. Institution means, for the purpose of these regulations, a facility which requires a license.

M. Maternity and General Medical Care Hospital means any facility limited to providing short-term inpatient obstetrical and general medical diagnostic care and treatment.

N. Maternity Hospital means any facility limited to providing short-term inpatient obstetrical diagnostic care and treatment.

O. Psychiatric Hospital means any facility, or a distinct part of a facility, used for the purpose of providing inpatient diagnostic care and treatment for persons having mental disorders.

P. Recuperation Center means any facility or distinct part of a facility, which includes inpatient beds with an organized Medical Staff, and with medical services that include physician services and continuous nursing services to provide treatment for patients who are not in an acute phase of illness but who currently require primarily convalescent or restorative services (usually post-acute hospital care of relatively short duration). A facility that furnishes primarily domiciliary care is not within this definition.

Q. Rehabilitation Facility means, for the purpose of these regulations, an inpatient care facility, or a distinct part of a facility, which provides rehabilitation services for two (2) or more disabled persons not related to the proprietor, for more than twenty-four (24) hours through an integrated program of medical and other restorative services. A disabled person shall be considered to be an individual who has a physical or mental condition which, if not treated, will probably result in limiting the performance or activity of the person to the extent of constituting a substantial physical, mental, or vocational handicap.

R. Surgery and General Medical Care Hospital means any facility limited to providing short-term inpatient surgical and general medical diagnostic care and treatment.

The following categories (S-T) of outpatient facilities may not be conducted or maintained in this state without being licensed:

S. Outpatient Psychiatric Center means a facility in which psychiatric services are offered for a period of four (4) to sixteen (16) hours a day, and where, in the opinion of the attending psychiatrist, hospitalization as defined in the present licensure law is not necessary. This definition shall not include Community Mental Health Clinics and Centers, as they now exist. The requirements established for outpatient psychiatric centers shall not be construed as changes in the requirements already established for the licensing of any health care facility, as delineated in these Regulations.

T. Outpatient Surgery Center (Ambulatory Surgery Center) means any facility in which surgical services, other than minor dental surgery, are offered which require the use of general or intravenous anesthetics and/or render the patient incapable of taking actions for self-preservation under emergency conditions without assistance from others, and where, in the opinion of the attending physician, hospitalization is not necessary.

SECTION 4: LICENSURE AND CODES.

A. Necessity for License. No hospital or distinct part, recuperation center or distinct part, infirmary, rehabilitation facility or distinct part, outpatient surgery center, or alcohol/drug abuse inpatient treatment center or distinct part, outpatient psychiatric center or emergency services facility, as defined in Section 3, Definitions, may be established, conducted, or maintained in the State without first obtaining a license, with the exception of the following:

1. A facility operated by the Federal Government.

2. A First Aid Station.

B. Application for License.

1. An applicant shall file applications under oath with the Department upon forms provided by the Division and shall pay annual license fee as indicated by Act 574 of 1997.

2. These fees shall be paid into the State Treasury or refunded to the applicant if a license is denied. The application shall be signed by the owner, if an individual or partnership, or in the case of a corporation, by two (2) of its officers, or in the case of a governmental unit, by the head of the governmental department having jurisdiction over it. The application shall set forth the full name and address of the institution for which license is sought and such additional information as the Department may require, including affirmative evidence of ability to comply with such reasonable standards, rules, and regulations as may be lawfully prescribed hereunder. The application for annual license renewal shall be postmarked no later than January 2 of the year for which the license is issued. The license applicant for an existing institution postmarked after the date shall be subject to a penalty of one dollar ($1.00) per day for each day and every day after January 2.

3. A license issued hereunder shall be effective on a calendar year basis and shall expire on December 31 of each calendar year. A license shall be issued only for the premises and persons in the application, and shall not be transferable. If the facility changes ownership the license shall expire. The license shall be posted in a conspicuous place on the licensed premises. A license issued under previous regulations shall be effective through the period for which it was issued. The adequacy of cooperative agreements between hospitals in terms of service provided by each hospital and the type of licenses issued to each hospital shall be determined by the Arkansas Department of Health. In no event shall a cooperative agreement be accepted by theArkansas Department of Health that provides for the transfer of surgical patients back to the facility from which they were transferred.

C. Facility Change of Ownership.

1. It shall be the responsibility of the licensed entity to notify the Division in writing at least thirty (30) days prior to the effective date of change of ownership.

2. The following information shall be submitted to the Division for review and approval:

a. License application;

b. Request for Medicare Certification (where applicable);

c. Legal documents, ownership agreements, the license previously issued to the facility, and other information to support relicensure requirements; and d. Licensure fee as indicated by Act 574 of 1997.

3. For the purpose of these regulations the licensed entity is the party ultimately responsible for operating the facility. The same entity also bears the final responsibility in decisions made in the capacity of a Governing Body, and for the consequences of these decisions.

D. Facility Name Change and/or Address.

1. The facility shall notify the Division of any name and/or address change;

2. The previously issued license shall be returned to the Division; and

3. A fee, as indicated in Act 574 of 1997, shall be submitted to the Division for issuance of a new license.

E. Management Contract.

1. It shall be the responsibility of the licensed entity to notify the Division in writing at least thirty (30) days prior to entering into a management contract or agreement with an organization or firm. A copy of the contract or agreement shall also be submitted to the Division for review to assure the arrangement does not materially affect the license status.

2. An organization or firm who contracts with the licensed entity to manage the health care facility, subject to Governing Body approval of operational decisions, is generally considered an agent rather than an owner. In such instances a licensure change is not required.

F. Separate License. An individual license shall be required for an institution maintained on separate premises even though it is operated under the same management, except in cases where the hospital management of a general hospital operates a detached building which can be utilized in a limited way for general medical care. Separate licenses are not required for separate buildings on the same grounds.

G. Temporary Licenses. This license shall be for less than one (1) year and for a time specified on the temporary license by the Department.

H. Revocation of License. The Department is empowered to deny, suspend, or revoke a license on any of the following grounds:

1. Violation of any of the provisions of Act 414 of 1961, as amended by Act 258 of 1971, or Act 190 of 1975, Act 536 of 1977, or Act 273 of 1983, Act 980 of 1985, or Act 516 of 1987; Act 143 of 1987, Act 399 of 1987, or Act 348 of 1987, or the Rules and Regulations lawfully promulgated hereunder; or

2. Permitting, aiding, or abetting the commission of any unlawful act in connection with the operation of the institution. (Section 22, Act 414 of 1961, as amended).

3. The right of appeal of any revocation shall be as specified in the appeal procedure of the Arkansas Department of Health.

NOTE: If services are to be temporarily suspended, a narrative, with plans and specifications as applicable, shall be submitted to the Division of Health Facility Services for approval prior to such suspension.

I. Inspection. Any authorized representative of the Department shall have the right to enter the premises of any institution at any time in order to make whatever inspection necessary in accordance with the minimum standards and regulations prescribed herein.

J. Penalties.

1. Any person, partnership, association, or corporation which establishes, conducts, manages, or operates any institution within the meaning of Act 414 of 1961, as amended by Act 258 of 1971, Act 190 of 1975, Act 536 of 1977, Act 273 of 1983, Act 980 of 1985, And Act 516 of 1987; and Act 143 of 1987, Act 348 of 1987, and Act 399 of 1987, without first obtaining a license therefore as herein provided, or who violates any portion of this act or regulations lawfully promulgated hereunder, shall be guilty of a misdemeanor, and upon conviction thereof shall be liable to a fine of not less than Twenty-five Dollars ($25.00) nor more than One Hundred Dollars ($100.00) for the first offense and not less than One Hundred Dollars $100.00) , nor more than Five Hundred Dollars ($500.00) for each subsequent offense, and each daysuch institution operates after a first conviction shall be considered a subsequent offense. (Section 27, Act 414 of 1961, as amended.)

2. Any institution licensed by the authority of these regulations that has received damage due to fire, tornado, earthquake, man-made or natural disaster shall notify the Department by telephone immediately and follow with a written report within forty-eight (48) hours. The submitted report shall include, but not be limited to, damage to the building, damage estimates, injuries to patients, staff and the public, etc. If the Department is not notified, the institution shall be assessed a fine in the amount of Fifty Dollars ($50.00) for each day, or portion thereof, the incident is not reported or Five Hundred Dollars ($500.00) maximum.

K. Codes. See Section 47, Physical Facilities, K. List of Referenced Publications.

SECTION 5: GOVERNING BODY. An institution shall have an organized Governing Body which shall be legally responsible for maintaining quality patient care and establishing policies for the facility. The Governing Body shall be legally responsible for the conduct of the institution.

A. Governing Body Bylaws. The Governing Body shall adopt written bylaws which shall be available to all members of the Governing Body. The bylaws shall ensure:

1. Maintenance of proper standards of professional work in the hospital;

2. The Medical Staff functions in conformity with reasonable standards of competency;

3. The method of selecting members and officers with terms and responsibilities delineated;

4. The selection of an Administrator or Chief Executive Officer with responsibilities for operation and maintenance of the facility delineated. In the absence of the Administrator, an alternate with authority to act shall be designated;

5. Methods for establishing Governing Body committees with the duties of each committee delineated;

6. Coordination of activities and general policies of the departments and special committees;

7. Liaison between the Governing Body and Medical Staff with quarterly documentation;

8. Quarterly Governing Body meetings with maintenance of minutes signed by an officer;

9. Provision for formal approval of the organization, bylaws, rules and regulations of the Medical Staff and their services;

10. Admission of patients by a physician, patient choice of physician and/or dentist and emergency care by a physician. All institutions governed by these standards shall arrange for one (l) or more persons duly licensed to practice medicine to be called in an emergency. All individuals, who are not hospital employees, who make entries into the medical record, shall be credentialed through the Medical Staff;

11. A method of credentialing or appointing members to the Medical Staff and other authorized staff;

12. Methods by which Quality Improvement (QI) is established; and

13. Establishment of a quorum to be met in order to conduct business.

B. Governing Body Minutes. The Governing Body minutes shall include at least the following information:

1. Review, approval and revision of the Governing Body bylaws and the Medical Staff bylaws, Rules and Regulations;

2. Election of officers, as indicated in the bylaws;

3. Documentation that the liaison between the Governing Body and Medical Staff is maintained;

4. Appointment and reappointment of the Medical Staff and other authorized staff as indicated in the bylaws;

5. Review and approval of the hospital's annual operating budget and capital expenditure plan;

6. Review and approval of reports received from the Medical Staff and Administration; and

7. Review and approval of the Quality Improvement plan of the facility, at least annually, also documentation of the quarterly Quality Improvement summaries.

SECTION 6: MEDICAL STAFF. In institutions where two (2) or more physicians are allowed to practice there shall be an organized Medical Staff. Members of the staff shall be qualified legally and professionally for the positions to which they are appointed. Individuals who are not hospital employees, who work in the hospital shall be credentialed through the Medical Staff with approval from the Governing Body. (Refer to Section 36, Specialized Services: Emergency Services.)

A. Credential Files of the Medical Staff and Other Authorized Staff. An individual file shall be maintained for each physician/other authorized staff practicing in the hospital and shall include at least the following:

1. Verification of age, year, and school of graduation; date of licensure statement of postgraduate or special training and experience; statement of the type of medicine the applicant desires to practice; a pledge that if appointed the applicant shall comply with the rules and regulations of the hospital insofar as they affect the applicant and the applicant's membership on the Medical Staff; and verification of special qualifications;

2. Specific delineation of privileges requested and granted;

3. A detailed application signed by the applicant, the Chairman of the Credentials Committee and an officer of the Governing Body;

4. Documentation of the applicant's agreement to abide by the Medical Staff Bylaws, and/or Rules and Regulations;

5. Verification of current Arkansas license.

6. Verification of each applicable physician's Drug Enforcement Agency (DEA) registration;

7. Verification of at least three (3) references;

8. Documentation of all actions taken by the Medical Staff and Governing Board indicating the type of privileges granted, approval of appointment/reappointment, and other related data;

9. Evaluation of members' professional activities at the time of reappointment; and

10. Non-employee practitioners may be screened through the Human Resources Department of another hospital designee. The requested privileges and credentialing shall be approved by the Medical Staff.

NOTE: Hospitals shall report to the Arkansas State Medical Board the names of physicians whose hospital privileges have been terminated or revoked for cause.

B. Medical Staff Bylaws. The Medical Staff bylaws shall include at least the following information:

1. A provision stating the Medical Staff shall be responsible to the Governing Body of the facility for the quality of medical care provided for patients in the hospital and for the ethical and professional practices of members;

2. A provision stating the requirements for medical and other authorized staff membership, including allied health professionals;

3. A provision stating the division of the Medical Staff and clinical departments;

4. A provision stating the election of officers, responsibilities and terms;

5. A provision establishing Medical Staff committees, functions, frequency of meetings and composition (quorum);

6. A provision establishing frequency of general Medical Staff meetings, specifying attendance requirements;

7. A provision establishing that written minutes be maintained of all Medical Staff meetings and that minutes shall be signed by the physician chairman;

8. A provision for an appeals process which delineates the procedures for a physician or other authorized staff to follow in challenging staff, that if ratified by the Governing Body, adversely affects his/her appointment or reappointment to the Medical Staff;

9. A provision establishing the designation of a specific physician who shall direct each clinical/diagnostic service;

10. A provision delineating requirements for maintaining accurate and complete medical records. (See Health Information Services, Section 14.);

11. A provision for approval of the bylaws and amendments by the Medical Staff and the Governing Body; and

12. Documentation of appointments, reappointments, and approval of requested privileges to the medical and other authorized staff as specified in the bylaws, but at least every two (2) years.

C. Medical Staff Minutes. Medical Staff minutes shall include at least the following:

1. Documentation of review of committee reports including quarterly Quality Improvement (QI);

2. Review, approval and revision of the Medical Staff bylaws and Rules and Regulations;

3. Election of officers as specified by the bylaws; and

4. Documentation of physicians designated as chairmen of the committees to direct the services defined in the Medical Staff bylaws.

D. Quality Improvement (QI).

1. The organization shall develop, implement, and maintain an ongoing program to assess and improve the quality of care and services provided. A multidisciplinary committee shall meet at least quarterly to provide oversight and direction for the program; the hospital shall maintain minutes of these meetings. A Quality Improvement Plan shall be developed and maintained to describe the manner in which QI activities shall be conducted in the hospital. The QI plan shall be reviewed and approved by the Chief Executive Officer, Medical Staff, and Governing Body annually.

a. All hospital and Medical Staff programs, services, departments and functions, including contracted services related to patient care, shall participate in ongoing quality improvement activities.

b. The hospital shall collect and assess data on the functional activities identified as priorities in the QI plan.

c. Data collected shall be benchmarked against past performance and/or national or local standards.

d. Improvement strategies shall be developed for programs, services, departments and functions identified with opportunities for improvement.

e. The effectiveness of improvement strategies and actions taken hall be monitored and evaluated, with documentation of conclusions regarding effectiveness.

2. Scope of QI Program. The QI program shall include, but not be limited to, ongoing assessment and improvement activities regarding the following:

a. Access to care, processes of care, outcomes of care and hospital-specific clinical data, including applicable Peer Review Organization (PRO) data;

b. Customer satisfaction (patients and families, physicians, and employees);

c. Staff performance as it relates to the staff as a whole when reviewing aspects of care;

d. Complaint resolution;

e. Utilization and discharge planning data; and

f. Organizational performance.

3. Program Responsibilities. The Governing Body shall assume overall responsibility and accountability for the organization-wide QI program. The Governing Body, Chief Executive Officer, and Medical Staff shall ensure QI activities, address identified priorities and be responsible for the development, implementation, monitoring, and documentation of improvement activities.

4. Reporting. QI activities shall be reported to the Governing Body on at least a quarterly basis and shall be documented in the Governing Body meeting minutes.

5. Policies and Procedures. Policies and procedures pertaining to the QI program which are not contained within the QI plan shall be maintained in a manual, reviewed, and approved annually.

6. Program Evaluation. An evaluation of the QI program shall be conducted by the hospital and reported to the Governing Body annually. The evaluation shall be based upon objective data and shall include programs, services, departments, and functions targeted by the hospital for improvement, as well as those conducting ongoing QI activities. Changes in the QI program and QI plan shall be made in response to the evaluation.

E. Discharge Planning. There shall be an ongoing plan, consistent with available community and hospital resources, to provide or make available social work, psychological, and educational services to meet the medically-related needs of the patients and to facilitate the provision of follow-up care.

1. Discharge planning shall be initiated at the time of the patient's admission.

2. The patients, along with necessary medical information, shall be transferred or referred to appropriate facilities, agencies, or outpatient services, as needed, for follow-up or ancillary care.

3. There shall be a policy and procedure developed for discharge planning.

F. Organ and Tissue Donation. The Governing Body of each Acute Care Hospital shall cause to be developed appropriate policies, procedures, and protocols for identifying and referring potential organ and tissue donors. The written policies and procedures shall include but not be limited to the following subjects:

1. Determination and declaration of brain death;

2. Organ procurement procedures:

a. Identifying potential donors;

b. Referring potential donors;

c. Obtaining consent;

3. Role of attending physician;

4. Role of the procurement coordinator (employee of procurement agencies);

5. Reimbursement for cost of donation;

6. Liabilities associated with donation;

7. Agreement with organ procurement agency designated by Health Care Financing Administration (HCFA);

8. A consent procedure which encourages reasonable discretion and sensitivity to the family circumstances in all decisions regarding organ and tissue donations;

9. Determination by a transplant physician (MD) in conjunction with the organ procurement agency personnel of the suitability of the organs and/or tissues for transplantation;

10. Establishment of an Organ and Tissue Donor Committee (O & TD Committee). The Committee shall be composed of, but not limited to the following: appointed member of the Medical Staff, representative of Administration, and Nursing Services. The Committee shall meet quarterly, at a minimum, to coordinate the duties and responsibilities of departments and persons involved with implementation of protocols for identifying organ and tissue donors. Committee meeting minutes shall be documented and made available to the Medical Staff and Governing Body for review and action. The function of the O & TD Committee may be assigned to an existing Medical Staff Committee; and

11. Requirements for documentation in the patient's medical record that the family of a potential organ donor has been advised of their right to donate or decline to donate.

SECTION 7: GENERAL ADMINISTRATION.

A. Each institution shall have an Administrator responsible for the management of the institution. In the absence of the Administrator, an alternate with authority to act shall be designated. The responsibilities of the Administrator shall include:

1. Keeping the Governing Body fully informed of the conduct of the hospital by submitting periodic written reports or by attending meetings of the Governing Body;

2. Conducting interdepartmental meetings at regular intervals and maintaining minutes of the meetings;

3. Preparing an annual operating budget of anticipated income and expected expenditures; and

4. Preparing a capital expenditure plan for at least a three (3) year period.

B. Policies and procedures shall be provided for the general administration of the institution and for each department, section or service in the facility. All policies and procedures for departments or services shall have evidence of ongoing review and/or revision. The first page of each manual shall have the annual review date signature of the department supervisor and/or person(s) conducting the review.

C. All medical, surgical, dental, or obstetric care rendered in an institution licensed by the Arkansas Department of Health shall conform to standards acceptable to the American Medical Association and American Dental Association.

D. An accurate daily patient census sheet as of midnight shall be available to the Department at all times.

E. The facility shall have visitation policies determined by the Medical Staff, Governing Body and Administration which shall include:

1. Limitation when patient care is hindered or disrupted;

2. Exclusion in the nursery areas, except as provided for in the Pediatric Sibling Visitation Policy in the Appendix; and

3. Development by the Governing Body with advice from the Medical Staff and Infection Control Committee regarding persons under the age of twelve (12) who visit critical care areas of the hospital.

F. Provisions shall be made for safe storage of patients' valuables.

G. Animals such as cats, dogs, birds and fish and aquatic animals shall not be permitted in health care facilities. Exceptions shall be made for service animals, animals that participate in pet therapy and fish and aquatic animals in approved aquariums. (See Section 25, Pet Therapy Program.) All exceptions shall be approved by the Division of Health Facility Services.

1. Service animals shall be permitted only under the following guidelines:

a. Only animals specifically trained as service animals shall be allowed into the facility;

b. Service animals shall not be allowed into the facility if they are unhealthy, feverish, or suffer from gastroenteritis, fleas or skin lesions;

c. Healthy, well-groomed animals shall be allowed to enter the facility into areas that are generally accessible to the public (i.e., lobbies, cafeteria, and nurses stations on unrestricted wards). The owner of the animal shall be directed to inquire about the possibility of a visit before entering a patient's room. Authorization to visit shall be given by a unit supervisor;

d. Service animals shall be walked before entering the facility or shall be diapered in a manner to prevent contamination of the facility environment with excreta. Service animals shall not be fed within the facility;

e. Petting or playing with service animals by hospital personnel or patients shall be prohibited;

f. Owners of service animals shall be instructed to wash their hands before having patient contact;

g. Visiting with service animals shall be restricted in the following circumstances:

1) The patient is in isolation for respiratory, enteric, or infectious diseases or is in protective isolation;

2) The patient, although not in protective isolation, is immunocompromised or has a roommate that is;

3) The patient is in an intensive care unit, burn unit, or restricted access unit of the hospital;

4) The patient or roommate is allergic to animals or has a severe phobia;

5) The patient or roommate is psychotic, hallucinating or confused or has an altered perception of reality and is not amenable to rational explanation;

h. Animals which become loud, aggressive or agitated shall be removed from the facility immediately.

2. Fish and aquatic animals shall not be permitted in health care facilities without prior written approval by the Division of Health Facility Services. Aquariums shall be approved by the Medical Staff and Infection Control Committee. (Turtles will not be considered for approval.)

a. Aquariums shall meet the following requirements:

1) Aquariums shall be self-contained, shock proof, break proof and quiet in operation;

2) Aquariums shall be constructed or positioned in such a manner as to be leak-proof, spill proof and to preclude patients or staff from having direct contact with the animals or water in the aquarium;

3) Aquariums and associated equipment shall be cleaned frequently by appropriately trained personnel who do not have direct contact with patients or patient care items;

4) Aquariums shall be placed only in areas which are accessed by the general public. Aquariums shall not be placed in critical care areas (i.e., nursing stations, surgery, patient rooms, ICU, etc.);

5) Aquariums shall be kept in a state of good repair at all times.

b. There shall be written procedures for cleaning and caring for the aquarium.

c. There shall be written procedures for dealing with clean up in the event there is a major accident concerning the aquarium.

d. Fish or aquatic animals shall be of varieties that do not bite, sting, and are considered non-toxic or non-poisonous.

H. Each facility shall develop and maintain a written disaster plan which includes provisions for complete evacuation of the facility and care of mass casualties. The plan shall provide for widespread disasters as well as for a disaster occurring within the local community and hospital facility. The disaster plan shall be rehearsed at least twice a year, preferably as part of a coordinated drill in which other community emergency agencies participate. One (1) drill shall simulate a disaster of internal nature and the other external. Written reports and evaluation of all drills shall be maintained.

I. There shall be a posted list of names, telephone numbers, and addresses available for emergency use. The list shall include the key hospital personnel and staff, the local police department, the fire department, ambulance service, Red Cross, and other available emergency units. The list shall be reviewed and updated at least every six (6) months.

J. There shall be rules and regulations governing the routine methods of handling and storing flammable and explosive agents, particularly in operating rooms, delivery rooms, laundries and in areas where oxygen therapy is administered.

K. All refrigerated areas, including freezers, shall be provided with thermometers, and records maintained to document the temperatures checked on a daily or weekly basis, as required.

L. The facility shall provide appropriate library service to meet the professional and technical needs of hospital personnel including current books, periodicals, and other pertinent materials.

M. A safety committee shall develop written procedures for the reporting and prevention of safety hazards. The committee shall meet at least quarterly or more frequently if necessary to fulfill safety objectives. Minutes of the meeting shall be maintained.

N. All Departments and/or Services shall be required to conduct annual inservices on safety, fire safety, back safety, infection control, universal precautions, disaster preparedness and confidential information.

O. Any hospital or related institution that closes shall meet the requirements for new construction in order to be eligible for relicensure. Once a facility closes, it is no longer licensed. The license shall be immediately returned to Health Facility Services. To be eligible for licensure all the latest life safety and health regulations shall be met. Refer to Section 4, Licensure and Codes, item B., Application for License, and item H., Revocation of Licenses.

P. The facility Administrator shall develop policies and procedures in accordance with Act 348 of 1987 that, upon request of the patient, an itemized statement of all services shall be provided within thirty (30) days after discharge or thirty (30) days after request, whichever is later. The policy shall include a statement advising the patient in writing of his/her right to receive the itemized statement of all services.

Q. A general consent for medical treatment and care shall be signed by the patient or legal guardian. Written or verbal consent shall not release the hospital or its personnel from upholding the rights of it's patients including but not limited to the right to privacy, dignity, security, confidentiality, and freedom from abuse or neglect.

R. A physician shall pronounce the patient dead and document the date, time and cause of death. An exception to this requirement is found in Arkansas Code Ann. Section 20-18.601(c)(1)(2)(3)(2) which states "A registered nurse employed by the attending hospice may complete and sign the medical certificate of death for a patient who is terminally ill, whose death is anticipated, who is receiving services from a hospice program certified under 20-7-117, and who dies in a hospice inpatient program or as a hospice patient in a nursing home."

SECTION 8: PERSONNEL ADMINISTRATION.

A. Medical Attendance. All persons admitted to any institution governed by these standards shall be under the care of a person duly licensed to practice medicine in Arkansas (hereafter called physician). The name, address, and telephone number of the physician(s) attending each patient shall be recorded for ready reference.

B. Qualified Personnel. The hospital shall maintain a sufficient number of qualified personnel to provide effective patient care and all other related services. There shall be personnel policies and procedures available. Provisions shall be made for orientation and continuing education.

C. Minimum Age. Personnel who care for patients shall be a minimum of sixteen (16) years of age. For any exceptions, see Subpart C of Part 570 of Title 29 of the Code of Federal Regulations, Child Labor Regulations No. 3.

D. Employee Health. It shall be the responsibility of Administration, with advice and guidance from the Medical Staff and/or Infection Control Committee, to establish and enforce policies concerning pre-employment physicals and employee health. The policies shall include but are not limited to:

1. Requirements for an up-to-date health file for each employee;

2. Annual testing of each employee for tuberculosis. Each employee, regardless of whether the employee is a reactor, non-reactor, or converter, shall be tested or evaluated in accordance with the applicable section of the Tuberculosis Manual of the Arkansas Department of Health; and

3. Work restrictions placed on hospital personnel who are known to be affected with any disease in a communicable stage or to be a carrier of such disease, to be afflicted with boils, jaundice, infected wounds, diarrhea or acute respiratory infections. Such individuals shall not work in any area in any capacity in which there is the likelihood of transmitting disease to patients, hospital personnel or other individuals within the hospital or a potential of contaminating food, food contact surfaces, supplies or any surface with pathogenic organisms.

E. The licensure rules and regulations promulgated by the Arkansas Department of Health for hospitals and other related institutions shall be available to all personnel. All personnel shall be instructed in the requirements of the regulations pertaining to their respective duties.

F. Job descriptions shall be developed for each employee and shall include the responsibilities or actual work to be performed. The job descriptions shall include physical, educational and licensing or certification requirements for each job.

G. Personnel records shall be maintained for each employee and shall include current and background information covering qualifications for employment, records of all required health examinations, evidence of current registration, certification, or licensure of personnel subject to statutory regulation and an annual job specific performance evaluation.

SECTION 9: ADMINISTRATION REPORTS.

A. All communicable diseases shall be immediately reported to the Arkansas Department of Health. The institution shall furnish pertinent required information related to the disease to the local health unit or Arkansas Department of Health.

B. Occurrences which threaten the welfare, safety, or health of the public such as epidemic outbreaks, poisoning, etc., shall be reported either by phone or facsimile to the local or State Health Officer. The institution shall furnish other pertinent required information related to the occurrence to the local health unit or Arkansas Department of Health.

SECTION 10: PATIENT IDENTIFICATION. Each patient admitted to the hospital shall have an identification bracelet applied during the admission process.

SECTION 11: PATIENT CARE SERVICE.

A. Organization. Nursing Services shall be directed by a nurse executive who is a Registered Nurse qualified by advanced education and management experience. The nurse executive's education and experience shall be directly related to the facility's stated mission and to the nursing care needs of the patient population.

1. The nurse executive shall have overall authority for the development of organization-wide nursing standards and policies and procedures that describe how patient care needs are assessed, evaluated and met.

2. Development and implementation of the organization's plans for providing nursing care to the patient shall be approved by the nurse executive.

3. Policies, procedures and standards shall be defined, documented and accessible to the nursing staff in a written or electronic format. Each element shall be approved by the nurse executive or designee prior to implementation.

4. The nurse executive and nursing staff shall collaborate with appropriate Governing Body, Medical Staff, management and other clinical leaders in developing, implementing, revising and monitoring patient care improvement activities.

5. The nurse executive or designee shall be responsible for orienting and maintaining adequate numbers of qualified staff for patient care.

6. Staff meetings shall be conducted at least monthly for the purpose of reviewing the quality of nursing care provided. Meeting minutes and attendance shall be maintained.

7. Registered Nurses and Licensed Practical Nurses not employed by the hospital, who are involved in direct patient care, shall follow hospital policies and procedures and shall be supervised by the designee of nursing services.

8. If the organization provides clinical facilities for nursing students, there shall be a written agreement that defines:

a. The facility's responsibilities; and

b. Responsibilities of the educational institution, including supervision of students and responsibilities of the instructor.

9. Clinically relevant inservice educational programs shall be conducted at regularly scheduled intervals with not less than twelve (12) per year. There shall be documentation which includes program content, presenter, date and time presented and signatures of attendees.

10. There shall be a continuous QI program that is specific to the patient care administered. The program shall reflect nursing staff participation including reports to appropriate hospital committees.

B. Qualifications.

1. A current, valid license to practice nursing in Arkansas shall be held by all nurses hired in the facility as well as private duty and contract/pool nurses. There shall be a procedure to assure all licenses are current.

2. Licensed nursing personnel shall practice under the Nurse Practice Act of the State of Arkansas and current Arkansas State Board of Nursing Rules and Regulations.

3. The qualifications required for each category of nursing staff shall be in written policy. Job descriptions shall be available for review.

4. There shall be documented evidence of appropriate training for all nonlicensed staff who are assigned patient care duties.

5. The nurse executive or designee(s) participates with administration in decisions relative to the selection and promotion of nursing personnel based on qualifications and capabilities and recommends the termination of employment when necessary.

6. All licensed nursing personnel shall be competent in life support measures.

C. Staffing.

There shall be an adequate number of Registered Nurses on duty at all times and available for bedside care of any patient when needed on a twenty-four (24) hour basis. In addition, there shall be sufficient Registered Nurses to staff all patient care units. A Registered Nurse shall assign the nursing care of each patient to other nursing personnel in accordance with the patient's needs and the preparation and competence of the nursing staff. There shall be written criteria to substantiate the assignments.

D. Evaluation and Review of Patient Care Services.

1. There shall be established working relationships with other services of the hospital, both administrative and professional. The factors explaining the standard are as follows:

a. Registered Nurses confer with the physicians relative to patient care;

b. Interdepartmental policies affecting patient care are made jointly with the nurse executive or designee(s);

c. Procedures are established for scheduling laboratory and X-ray examinations, for ordering, securing, and maintaining supplies and equipment needed for patient care, and for ordering diets, etc.

2. There shall be on-going review and evaluation of nursing care provided for patients.

a. A Registered Nurse plans, supervises, and evaluates the nursing care for each patient in all settings where nursing care is provided.

b. Each patient shall have a plan for provision of care. Each patient plan of care shall be current. Plans indicate patient care required, how it is to be accomplished, and the methods, approaches, goals, and modifications necessary to ensure best results for the patient. The patient's plan of care shall be initiated upon admission.

c. There shall be documentation of the nursing care provided. The following information shall be documented:

1) The initial patient assessment;

2) Date and time of treatments and/or dressing changes;

3) Medication Administration Record (MAR) including the date, time, dosage and manner of administration and the initials of the nurse administering the medication. When personnel other than nursing administer medication and the MAR is not utilized, a record of that ancillary department shall comply with this requirement and be included in the medical record;

4) Date, time, dosage and manner of administration of all PRN medications to include reason for administration and results;

5) Bedtime and between meal snacks or feedings and the percentage of therapeutic diets consumed;

6) Change in patient's appearance and/or condition;

7) Patient complaints; and

8) Mode of discharge and to whom the patient was discharged. If a patient expires, the time the physician was called, time arrived, the time the patient was pronounced dead and the fact that relatives were present shall be recorded. (If relatives were not present, a note shall be made regarding their notification and disposition of the patient's belongings).

d. A Registered Nurse shall observe each patient at least once per shift and the observations shall be documented in the patient's medical record.

NOTE: Block charting and cosignatures are not acceptable.

E. Patient Care Facilities and Equipment.

1. There shall be no more beds maintained in the building than the number of beds for which the hospital is licensed except in the case of a public disaster or national emergency and then only as a temporary measure. Licensable hospital bed means every patient care bed with the exception of bassinets and labor beds.

2. No beds shall be made up in the hallway or on the floor except in case of emergency.

3. Children under the age of sixteen (16) years shall not be cared for in a room with an unrelated adult patient.

4. Provisions shall be made for safe storage of patients' valuables.

5. All facilities for cleaning and storage of patient care supplies and equipment shall be used only for the purpose for which they are designed.

6. Thermometers shall not come in contact with more than one (1) patient without disinfection or proper covers. The type of thermometer being used shall be identified.

7. All single-use equipment used by a patient shall either be sent home with the patient at the time of discharge or destroyed. Single-use equipment shall not be reused.

8. Only currently dated equipment and supplies shall be available for patient care. All equipment shall be kept clean and in good condition.

9. Observation is a designated patient status as opposed to a designated area. Patients in observation status are those patients requiring periodic monitoring and assessment necessary to evaluate the patient's condition or to determine the need for possible admission to the hospital in an inpatient status. Usually observation status shall be for forty-eight (48) hours or less.

Patients in observation status may be accommodated within the facility:

a. In private, semi-private or multi-patient rooms. Furniture is to be arranged to provide adequate room for patient care procedures and to prevent the transmission of infection;

b. Cubicle curtains, privacy screens, or an approved equivalent shall be provided for patient privacy in all multi-patient rooms. The utilization of such curtains or screens shall be such that each patient may have complete privacy;

c. Each room or cubicle shall be provided with oxygen, vacuum and a nurse call button;

d. Handwashing facilities shall be available within the area;

e. Hospital grade furniture shall be provided. Beds rails shall be provided on beds;

f. For each area in which a patient bed is utilized, a reading light shall be provided for each bed. The location and design shall be such that the light is not annoying to other patients;

g. Patient toilets shall be provided and accessible to all patients;

h. Adequate space shall be provided for medical supplies.

Patients that remain in observation status for a period of twenty-four (24) hours or more, shall have provided to them accommodations equivalent to the accommodations they would have if they were admitted as an inpatient.

SECTION 12: MEDICATIONS.

A. All medical orders (medications and treatments) shall be in writing and signed by the prescriber. Telephone/verbal orders should be used infrequently. When used they shall be given only to licensed nurses and signed by the prescriber.

B. No medication shall be dispensed or administered without a written order signed by a licensed prescriber. A pharmacist may receive telephone or verbal orders for medications from a prescriber and record them on the medical record.

C. Medications shall be administered by licensed nursing personnel in accordance with the current Arkansas Nurse Practice Act. Other personnel may administer medications only in accordance with their current Practice Act (e.g., Respiratory, Physical Therapy).

D. Blood transfusions and intravenous medications administered by licensed nursing personnel shall be in accordance with State law. If not administered by a Registered Nurse, only licensed nursing personnel who have documentation of training shall be permitted to administer blood transfusions and intravenous medications.

E. There shall be an effective hospital procedure for reporting transfusion reactions and adverse medication reactions.

F. All medications shall be properly labeled and stored in a specifically designated medication cabinet, cart or room. At nursing stations, medications shall only be accessible to licensed nursing personnel and pharmacists. In specialty units and treatment areas, medications shall only be accessible to licensed nursing personnel, pharmacists, and designated licensed personnel consistent with that unit (e.g., Respiratory, Physical Therapy).

G. Refrigeration shall be provided for the proper storage of biologicals and other medications. Medications shall be stored in a separate compartment or area from food. Employee foods and/or medications shall be stored in a separate refrigeration area. An internal thermometer shall be provided and checked daily (or at least weekly when the unit is closed) with documentation to assure temperatures between thirty-six and forty-six degrees (36º-46º) Fahrenheit (two to eight degrees (2º-8º) Centigrade). Refrigerated medications may be stored in a locked box inside the refrigerator. Refrigerated controlled substances shall meet the requirement for double-lock security.

H. Unused or damaged medications shall be returned to the pharmacy. All medications with incorrect or soiled labels shall be returned to the pharmacy for relabeling.

I. In addition to patients' medical records, a record of the procurement and disposition of each controlled substance shall be maintained at each nursing and speciality unit. Each entry on the disposition record shall reflect the actual dosage administered to the patient, the patient's name, the date, time, and signature of the licensed person administering the medication. (Licensed personnel who may legally administer controlled substances shall include only those personnel authorized by their current Practice Act and licensed by the Arkansas State Medical Board, Arkansas State Board of Dental Examiners, Arkansas State Nursing Board, and the Arkansas State Podiatry Examining Board.) Any error of entry on the disposition record shall follow a policy for correction of errors and accurate accountability. If the licensed person who procures the medication from the double-lock security is not the licensed person who administers the medication, then both persons shall sign the disposition record.

J. When breakage or wastage of a controlled substance occurs, the amount given and the amount wasted shall be recorded by the licensed person who wasted the medication and verified by the signature of a licensed person who witnessed the wastage. Documentation shall include how the medication was wasted. In addition to the above referenced licensed personnel (see I), licensed Pharmacists shall be allowed to witness wastage of controlled substances. When a licensed person is not available to witness wastage, the partial dose shall be sent to the Arkansas Department of Health, Division of Pharmacy Services and Drug Control for destruction.

K. There shall be an audit each shift change of all controlled substances stocked on the unit. At nursing stations such counts shall be recorded by the oncoming nurse and witnessed by the off-going nurse. At other units, audits shall be performed by two (2) licensed personnel. In each case, both licensed personnel shall sign the record with notation made as to date and time of the audit. If discrepancies are noted, the Director of Nursing, the Department Director, as applicable, and the Director of Pharmacy shall be notified. As with the witnessing of wastage, licensed Pharmacists shall be allowed to witness controlled substance audits.

L. If specialty units are not staffed on every shift, controlled substances shall be audited by two (2) licensed personnel on each shift that is covered by licensed personnel.

M. Controlled substances in areas that are covered only by on-call personnel shall be audited each shift the area is used and at least weekly; whichever time frame is less.

N. Solutions and medications for "external use only" shall be kept separate from other medications.

O. When a patient is discharged, the unused portion of the patient's medication may be sent home with the patient on direct written order of the attending physician; and only after the medication has been relabeled by the pharmacy. Documentation shall include the amount dispensed to the patient and quantities shall be consistent with the immediate needs of the patient.

P. Policies and procedures shall be developed and implemented for the handling of medications brought into the facility by the patient.

Q. All medication errors and controlled drug discrepancies shall be reported to the attending physician and a notification of error or discrepancy shall be sent to the Director of Nursing or designee and when appropriate, to the Director of Pharmacy.

R. Records generated by Automatic Medication Distribution Devices shall comply with these regulations. Policies and Procedures for the usage of Automatic Medication Distribution Devices shall be approved administratively by the Division of Health Facility Services prior to their usage.

S. Drug Security.

1. The pharmacist, with support from the Pharmacy and Therapeutics (P&T) Committee, is ultimately responsible for drug security throughout the facility; applicable licensed personnel at nursing and specialty units shall maintain the daily security of medications at their respective units.

2. Access to medications shall be limited to designated licensed personnel at all times.

3. Medications dispensed to nursing and specialty units shall be kept locked in accordance with all Federal and State regulations.

4. Emergency-type medications (crash cart, crash kit), as approved by the P&T Committee, shall be secured with a breakaway seal under the following conditions:

a. The quantities of medication are limited;

b. A list of medications stocked with quantities listed is posted on the emergency cart or container;

c. The breakage of the seal clearly indicates that entry has occurred (and said broken seal cannot be repaired without obvious evidence);

d. Any remaining medications shall be secured and accessible only to licensed personnel whenever the seal has been broken and before a new seal is installed;

e. Applicable personnel shall check the cart for the integrity of the seal each shift. Documentation shall reflect that the seal is intact. The emergency cart shall be stored in an area observable by licensed personnel;

f. The quantities of a controlled substance stocked in a cart or container shall be limited to a maximum of two (2) single doses of Schedule III, IV, or V drugs. No Schedule II drugs shall be included in this stock; and

g. Pharmacy Services shall check the condition of the carts or containers as part of the monthly inspections of nursing and specialty units.

5. Controlled substances maintained as floor stock at nursing and specialty units shall be stored separately from other medication under double-lock security.

6. For patient safety, Schedule III, IV, and V controlled substances in unit dose packages and dispensed in quantities limited to a maximum of a two (2) day supply, may be stored with that patient's other medication.

7. All medications shall be locked in the absence of immediate visual supervision by licensed personnel.

8. When a hospital operates an outpatient pharmacy that stocks medications in various clinical areas, stock lists, records, and security measures shall be in compliance with the requirements for nursing and specialty units.

9. Distribution of sample legend medications shall not be permitted by hospitals. Samples are defined as any prescription only medication which is not intended to be sold and is intended to promote the sale of the medication.

10. Medication security as provided by Automatic Medication Distribution Devices shall comply with these regulations. Policies and procedures for security provisions shall be approved administratively by the Division of Health Facility Services prior to usage of Automatic Medication Distribution Devices.

SECTION 13: RESTRAINTS.

A. Restraints should be applied only after less restrictive measures have failed. Restraints shall not be used as a matter of convenience for the staff or as a tool for disciplining the patient. When the use of a restraint is clinically indicated, it shall be used only after a written and signed order is obtained from the physician, except in a case of emergency (i.e., patient is a danger to self or others). In this event, the signature of the physician shall be obtained within twenty-four (24) hours.

B. Documentation of a comprehensive assessment and plan of care shall include the less restrictive measures attempted, justification for the continued need of restraint, the use of the least restrictive device, and that the patient and/or significant other has been informed of the risks.

C. Documentation in the patient's record regarding any type of restraint shall include the times the restraint was applied, released, and discontinued, as well as the patient's condition while in restraints.

D. Patient Protective Device. Protocols that specifically address protecting patients from removing IVs, NG tubes, E/T tubes and other lines may be utilized after approval of the Medical Staff and Governing Body. The attending physician shall specifically order the protocols to be followed.

E. When a patient is restrained for any reason, including the use of restraints as part of a protocol, documentation shall reflect observation of the patient's condition and the provision for activities of daily living.

F. Each physician's order for the application of restraints shall be time limited and shall include the type of restraint to be used. Restraints shall not be ordered for PRN use.

G. Patients in leather or locked restraints shall be under constant observation.

SECTION 14: HEALTH INFORMATION SERVICES.

A. General Requirements.

1. A medical record shall be maintained for each patient admitted for care in the hospital. The patient shall have the right to see the information maintained in the medical record unless the physician determines it would be harmful to the patient's health and the physician documents this in the patient's medical record.

2. The original or a copy of the original (when the original is not available) of all reports shall be filed in the medical record.

3. The record shall be permanent and shall be either typewritten or legibly written in blue or black ink.

4. All typewritten reports shall include the date of dictation and the date of transcription.

5. All dictated records shall be transcribed within forty-eight (48) hours.

6. Errors shall be corrected by drawing a single line through the incorrect data, labeling it as "Error," initialing, and dating the entry.

7. Additional patient records room requirements are provided in Section 65, Physical Facilities, Health Information Unit.

8. Disease, operation, and physicians indices shall be maintained (manual, abstract, or computer). Records shall be indexed within one (1) month following discharge. Indices maintained on computer shall be retrievable at any time for research or quality improvement monitoring.

9. Records of discharged patients shall be coded in accordance to accepted coding practices. Records shall be coded within one (1) month of the patient's dictated discharge summary.

10. Relevant inservice educational programs shall be conducted at regularly scheduled intervals with no less than twelve (12) per year. There shall be written documentation with employee signatures, program title/subject, presenter, date, and outlines or narrative of presented program.

11. A Master Patient Index shall be maintained by the Health Information Services. Index information shall include at least the full name, address, birth date, and the medical record number of the patient. The index may be maintained manually or on computer and shall contain the dates of all patient visits to the facility. If the Index is maintained on computer, there shall be a policy and procedure on permanent maintenance.

12. Birth certificates shall be completed according to the current rules and regulations of the Division of Vital Records, Arkansas Department of Health.

13 A unit record system shall be maintained. A unit record is defined as all inpatient and outpatient visits for each patient being filed together in one (1) unit.

14. A policy and procedure manual for the Health Information Management Department shall be developed. The manual shall have evidence of ongoing review and/or revision. The first page of each manual shall have the annual review date, signature of the department supervisor and/or person(s) conducting the review.

15. A qualified individual shall be employed to direct the Health Information Department. If a Registered Record Administrator (RRA) or an Accredited Record Technician (ART) is not employed as Director on a full-time basis by the facility, a consultant shall make periodic visits to evaluate functions of the Department and train personnel.

16. All patient records, whether stored within the Health Information Management Department or other areas, either within the facility or away from the facility, shall be protected from destruction by fire, water, vermin, dust, etc.

17. Medical records shall be considered confidential. Only authorized personnel shall have access to the medical records. All medical ecords (including those filed outside the department) shall be secured at all times. If authorized personnel are not available, the department shall be locked. Records shall be available to authorized personnel from the Arkansas Department of Health.

18. Written consent of the patient or legal guardian shall be presented as authority for release of medical information. There shall be policies and procedures developed concerning all phases of release of information.

19. Original medical records shall not be removed from the hospital except upon receipt of a subpoena duces tecum by a court having authority for issuing such an order.

20. All medical records shall be retained in either the original or microfilm or other acceptable methods for ten (10) years after the last discharge. After ten (10) years a medical record may be destroyed provided the facility permanently maintains the information contained in the Master Patient Index. Complete medical records of minors shall be retained for a period of two (2) years after the age of majority.

21. Procedures shall be developed for the retention and accessibility of the patients' medical records if the hospital or other facility closes. The medical records shall be stored for the required retention period and shall be accessible for patient use. Medical records stored outside the State of Arkansas shall comply with the Rules and Regulations for the State of Arkansas.

22. All entries into the medical record shall be legible. There shall be no erasures or obliterations of the original information contained in a medical record.

23. Medical records shall be complete and contain all required signed documentation (including physician reports) no later than thirty (30) days following the patient's discharge date.

24. Patient records shall be destroyed by burning or shredding. Patient records shall not be disposed of in landfills or other refuse collection sites.

25. A QI program shall be continuous and specific to the services.

B. Authentication of Medical Record Entries.

1. Each entry into the medical record shall be authenticated by the individual who is the source of the information. Entries shall include all documents, observations, notes, and any other information included in the record.

2. Signatures shall be at least, the first initial, last name and title. Computerized signatures may be either by code, number, initials, or the method developed by the facility.

3. The hospital's Medical Staff and Governing Body shall adopt a policy regarding dictation that permits authentication by electronic or computer generated signature. The policy shall identify those categories of the staff within the hospital who are authorized to authenticate patient records using electronic or computer generated signatures.

4. At a minimum, the policy shall include adequate safeguards to ensure confidentiality.

a. Each user shall be assigned a unique identifier which is generated through a confidential code.

b. The policy shall include penalties for inappropriate use of the identifier.

c. The user shall certify, in writing, that he or she is the only person authorized to use the signature code.

d. The hospital shall periodically monitor the use of identifiers, the process by which the monitoring shall be conducted shall be described in the policy.

5. The system shall make an opportunity available to the user to verify that the document is accurate and the signature has been properly recorded.

6. Each report generated by a user shall be separately authenticated.

7. A user may terminate authorization for use of electronic or computer generated signature upon written notice to the Director of Health Information Services.

8. Rubber stamp signatures shall be acceptable if a letter from the physician is on file explaining that the physician shall be the only person using the stamp and the stamp shall remain in his/her possession at all times. The signature stamp shall be the full legal name of the physician with his/her professional title.

9. Transcribed reports dictated by other than the attending physician shall be signed by the credentialed individual dictating the report and the attending physician. Dictation of reports by other than the attending physician is limited to history, physical, discharge summary and progress notes.

C. Computerized Medical Record.

1. Policies and procedures governing the use of computerized medical records shall be adopted by the Governing Body. The policies and procedures shall include:

a. Access controls (including system logs or audit trails);

b. Access to information (including levels of access and access to other employees' files);

c. Access to information by patients and their family;

d. Access to information by physicians and their office staff;

e. Access to information for research;

f. Acquisition of software;

g. Acquisition of hardware;

h. Anti-viral software use;

i. Audit trails;

j. Back-up procedures;

k. Procurement of diskettes from outside the organization;

l. Dictation and transcription of patient reports;

m. Disaster recovery;

n. Disposal of printed reports;

o. Electronic data interchange;

p. Encryption of files and electronic mail;

q. Home use of organization hardware or software;

r. Internet access;

s. Malicious code;

t. Passwords and other access control measures;

u. Privacy rights (including patients, employees, and caregivers);

v. Protection of confidential/proprietary information;

w. Remote access to information systems;

x. Retention, archiving, and destruction of electronic and paper-based information;

y. Security breaches;

z. Staff responsibility for data accuracy and integrity;

aa. Staff responsibility for data confidentiality and penalities for violation;

bb. Use and monitoring of security alarms;

cc. Use of electronic mail (including the level of privacy users may expect);

dd. Unauthorized software; and

ee. Vendor access to information systems.

D. Record Content.

1. Identification data shall include at least the following:

a. Patient's full name - maiden name if applicable;

b. Patient's address, telephone number, and occupation;

c. Date of birth;

d. Age;

e. Sex;

f. Marital status (M.S.D.W.);

g. Dates and times of admission and discharge;

h. Full name of physician;

i. Name and address of nearest relative or person or agency responsible for patient and occupation of responsible party;

j. Name, address, and telephone number of person(s) to notify in case of emergency;

k. Medical record number; and

l. A general consent for medical treatment and care. This shall be signed by the patient or guardian. Written or verbal consent shall not release the hospital or its personnel from upholding the rights of its patients including but not limited to the right to privacy, dignity, security, confidentiality, and freedom from abuse or neglect.

2. Clinical reports shall include the following and shall comply with listed requirements:

a. History and Physical Examination (HPE) shall be in the patient's medical record within forty-eight (48) hours of the patient's admission to the facility. The HPE shall be documented by the attending physician and shall contain the following:

1) Family (medical) history and review of systems - if noncontributory, the record shall reflect such;

2) Past medical history;

3) Chief complaint(s) - a brief statement of nature and duration of the symptoms that caused the patient to seek medical attention as stated in the patient's own words;

4) Present illness with dates or approximate dates of onset;

5) Physical examination;

6) Provisional or admitting diagnosis(es); and

7) History and physical examinations may be completed up to thirty (30) days prior to admission if the physician updates the examination at the time of admission.

b. Progress notes shall be recorded, dated and signed by the physician. The patient's condition shall determine the frequency of the notes. Dictated progress notes are acceptable, if they are dictated by the attending physician, transcribed by the transcriptionist, and placed on the patient's medical record within forty-eight (48) hours.

c. Orders shall be authenticated with a legible and dated signature in a timely manner as defined by Medical Staff by-laws. Telephone/verbal orders are acceptable, if they are recorded by the appropriate personnel and cosigned by the physician . Other professionals such as Physical Therapists may take telephone/verbal orders for patient treatments when nursing personnel are not available to coordinate services as they pertain to their field.

d. A discharge summary shall recapitulate the significant findings and events of the patient's hospitalization and his/her condition on discharge. This shall be documented by the attending physician within thirty (30) days of the patient's discharge. The final diagnosis shall be stated in the discharge summary.

e. Autopsy findings shall be documented in complete protocol within sixty (60) days and the provisional anatomical diagnosis shall be recorded within seventy-two (72) hours. A signed authorization for autopsy shall be obtained from the next of kin and documented in the medical record before an autopsy is performed.

f. Original, signed diagnostic reports (laboratory, X-rays, CATs, EKGs, fetal monitoring, EEGs) shall be filed in the patient's medical record. Physicians' orders shall accompany all treatment procedures. Fetal monitor and EEG tracings, may be filed separately from the medical record if accessible when needed.

g. Reports of ancillary services (Dietary, Physical Therapy, Respiratory Care, Social Services, etc.) shall be included in the patient's medical record.

h. Reports of Medical Consultation, if ordered by the attending physician, shall be included in the patient's medical record within time frames established by the Medical Staff.

E. Records of Complementary Departments. In addition to the general record content requirements stated above, parts F., G. and H. are required, as applicable.

F. Surgery Records.

1. A specific consent for surgery shall be documented prior to the surgery/procedure to be performed, except in cases of emergency, and shall include the date, time and signatures of the patient and witness. Informed consent from the patient or next of kin for any operative procedure shall be obtained by the surgeon and documented in the patient's medical record. (Abbreviations are not acceptable.)

2. A History and Physical Examination on admission containing medical history and physical findings shall be documented by the attending physician on the patient's medical record prior to surgery. In cases of emergency surgery, an abbreviated physical examination, and a brief description of why the surgery is necessary shall be written by the physician. (See Section 14, Health Information Services, Record Content.)

3. An anesthesia report, including preoperative evaluation and postoperative assessment, shall be documented by the Anesthesiologist and/or Certified Registered Nurse Anesthetist (CRNA). The pre-evaluation and post assessment shall be dated and timed.

a. Preoperative anesthesia evaluation shall be completed prior to the patient's surgery.

b. Report of Anesthesia. A CRNA who has not been granted authority by a DEA registrant to order the administration of controlled substances shall give all orders as verbal orders from the supervising physician, dentist, or other person lawfully entitled to order an anesthetic.

c. Postanesthesia assessment shall be documented in the medical record prior to the patient's discharge, not to exceed forty-eight (48) hours after the patient's surgery. If the patient is in need of continued observation, the anesthetist must be readily available. Discharge criteria shall be established and approved by the Medical Staff and Governing Body. If the patient meets the discharge criteria within a three (3) hour period postoperatively, a postanesthesia assessment is not required.

4. An individualized operative report shall be written or dictated by the physician immediately following surgery and shall be signed within seventy-two (72) hours. The report shall describe (in detail) techniques, findings, pre and postoperative diagnosis, and tissues removed.

5. A signed pathological report shall be maintained in the medical record of all tissue surgicallyremoved. A specific list of tissues exempt from pathological examination shall be developed by the Medical Staff.

G. Obstetrical Records

1. A pertinent prenatal record shall be updated upon admission, or history and physical examination signed by the physician shall be available upon the patient's admission and be maintained in the patient's medical record.

2. A Labor and Delivery record, documented by the physician, shall be maintained for every Obstetrical patient.

3. Documentation of the patient's recovery from delivery shall be maintained.

4. Nurses' postpartum record, graphics and nurses' notes shall be maintained.

H. Newborn Records.

1. A newborn history and physical examination shall be completed by the physician within twenty-four (24) hours of birth. The following additional data shall be required:

a. History of the newborn delivery (sex, date of birth, type of delivery, and anesthesia given the mother during labor and delivery); and

b. Physical examination (weight, date, time of birth, and condition of infant after birth).

2. There shall be a consent for circumcision (if applicable).

3. A procedure note for circumcision shall be documented by the physician.

4. A discharge note or summary shall be documented by the physician describing the condition of the newborn at discharge, and follow-up instructions given to the mother.

5. Hospitals shall comply with Arkansas Statutes (Act 192 of 1967 as amended by Act 481 of 1981, the same being Ark. Code Ann. §§ 20-l5-302et304), which require newborn infants to be tested for phenylketonuria, congenital hypothyroidism and galactosemia.

6. Birth certificates shall be completed on all infants born in the hospital, or admitted as a result of birth in accordance with the requirements of the Division of Vital Records, Arkansas Department of Health.

SECTION 15: MEDICAL RECORD REQUIREMENTS FOR OUTPATIENT SERVICES, EMERGENCY ROOM, OBSERVATION SERVICES AND PSYCHIATRIC RECORDS.

A. Outpatient Records. An Outpatient Record shall be completed for each outpatient and shall include the following:

1. History and physical examination of the patient (not applicable if for diagnostic services and/or outpatient therapy services);

2. Orders and reports of diagnostic services and outpatient therapy services;

3. Patient's diagnosis and summary of treatment received recorded by the attending physician;

4. Documentation of any medications administered;

5. Progress notes for subsequent clinic visits recorded by applicable disciplines (practitioners);

6. Outpatient Surgery record requirements (See also item F. of Section 14, Health Information Services.); and

7. Discharge instructions.

B. Emergency Room Records. An Emergency Room Record shall be completed for each patient who presents for treatment at the Emergency Room and shall include the following:

1. Patient identification;

2. Date and the following times:

a. Admission;

b. Time physician was notified of patient's presence in the Emergency Room;

c. Time of physician's arrival to treat the patient;

d. Discharge.

3. History (when the injury or onset of symptoms occurred);

4. Vital signs;

5. Nurses' assessment and physical findings;

6. Diagnosis (as stated by the physician);

7. Record of treatment including documentation of verbal orders and of medication quantities administered with the initials of person(s) administering the medications. Also, type and amount of local anesthetic, if administered;

8. Diagnostic reports with specific orders noted;

9. Instructions to patients for follow-up care (e.g., do not drive after receiving sedatives, return to physician's office for removal of sutures in one (1) week);

10 Disposition of case (how the patient left, condition of the patient on discharge and if patient was accompanied);

11. Signature of patient or his/her representative;

12. Physician's signature and date; and

13. A discharge order signed by the physician on the Emergency Room record.

14. The ambulance record shall be transferred with the patient.

NOTE: Emergency Room Records shall be completed within twenty-four (24) hours of the patient's visit.

C. Observation Records. A record of every patient admitted to an observation status shall be maintained. The Observation record shall include, at a minimum:

1. Patient identification data;

2. Physician's diagnosis and therapeutic orders dated and timed;

3. History and physical;

4. Physician's progress notes, including results of treatment;

5. Nursing assessment by a Registered Nurse;

6. Nursing observations;

7. Results of all diagnostic testing;

8. Medication Administration Record;

9. Allergies;

10. Patient education;

11. Plan for follow-up treatment; and

12. Referrals.

NOTE: Observation records are to be completed on patients who stay less than twenty-four (24) hours.

D. Psychiatric Records. The basic medical record requirements for psychiatric patients shall be the same as for other patient records, with the following additions:

1. The identification data shall include the patient's legal status (on the face sheet);

2. A proper consent or authority for admission shall be included;

3. A psychiatric evaluation shall be completed by the attending physician within sixty (60) hours of admission which includes the following:

a. The patient's chief complaints and/or reaction to hospitalization, recorded in patient's own words, if possible;

b. History of present illness including onset, and reasons for current admission;

c. Past history of any psychiatric problems and treatment, including a record of patient's activities (social, education, vocational, interpersonal, and family relationships);

d. Past psychiatric history of patient's family;

e. Mental status which includes at least attitude and general behavior, affect, stream of mental activity, presence or absence of delusions and hallucinations, estimate of intellectual functions, judgment, and an assessment of orientation and memory;

f. Strengths such as knowledge, interests, skills, aptitudes, experience, education and employment status written in descriptive terms to be used in developing the Master Treatment Plan; and

g. Diagnostic impressions and recommendations.

4. A history and physical examination shall be documented by a physician and shall include a neurological examination within twenty-four (24) hours of admission.

5. Social service records, including report of interviews with patient, family members and others shall be included for each admission. Social assessment and plan of care shall be completed within forty-eight (48) hours of admission.

6. Reports of consultation, psychological evaluations, reports of electroencephalograms, dental records and reports of special studies shall be included in the records when applicable.

7. An Interdisciplinary Master Treatment Plan shall be developed for each patient and included in the medical record, within sixty (60) hours of admission. The treatment plan shall involve all staff who have contact with the patient and shall include (as a minimum):

a. Problems and needs relevant to admission and discharge as identified in the various assessments, expressed in behavioral and descriptive terms;

b. Strengths (assets) including skills and interests:

c. Problems, both physical and mental, that require therapeutic management;

d. Long and short term goals describing the desired action or behavior to be achieved. Goals shall be relevant, observable and measurable;

e. Treatment modalities individualized in relation to patient's needs;

f. Evidence of patient's involvement in formulation of the plan;

g. Realistic discharge and aftercare plans;

h. Nursing assessment and progress notes integrated into the Master Treatment Plan. Reviews and revisions of the Nursing Plan of Care shall be as required under the Section 11, Patient Care Service;

i. Signatures of all staff involved;

j. Date Master Treatment Plan was implemented; and

k. Staff responsibilities.

8. The treatment received by the patient shall be documented in such a manner and with such frequency as to assure that all active therapeutic efforts such as individual and group psychotherapy, medication therapy, milieu therapy, occupational therapy, industrial or work therapy, nursing care and other therapeutic interventions are included.

9. Progress notes shall be recorded by the physician, social worker, and others involved in active treatment modalities at least as often as the patient is seen. The notes shall contain recommendations for revisions in the treatment plan.

10. Nursing notes shall be written as required under the Section 11, Patient Care Service.

11. The discharge summary shall include a recapitulation of the patient's hospitalization and recommendations from appropriate services concerning follow-up of aftercare, as well as a brief summary of the patient's condition on discharge.

12. The psychiatric diagnosis contained in the final diagnosis and included in the discharge summary shall be written in the terminology of the current American Psychiatric Association's Diagnostic and Statistical Manual.

SECTION 16: PHARMACY. All hospitals shall have adequate provision for pharmaceutical services regarding the procurement, storage, distribution and control of all medications. There shall be compliance with all federal and state regulations.

A. Definitions.

1. Hospital Pharmacy means the place or places in which drugs, chemicals, medicines, prescriptions or poisons are prepared for distribution and administration for the use and/or benefit of patients in a hospital licensed by the Arkansas Department of Health. The Hospital Pharmacy shall also mean the place or places in which drugs, chemicals, medicines, prescriptions or poisons are compounded for the dispensing to hospital employees, members of the immediate families of hospital employees, patients being discharged, and other persons in emergency situations. Hospital Pharmacy shall also mean the provision of pharmaceutical services as defined in the Pharmacy Practice Act by a pharmacist to a patient of the hospital.

2. Hospital Employee means any individual employed by the hospital whose compensation for services or labor actually performed for a hospital is reflected on the payroll records of a hospital.

3. Qualified Hospital Personnel means persons other than Licensed Pharmacists who perform duties in conjunction with the overall hospital pharmaceutical services for inpatients.

4. Licensed Pharmacist means any person licensed to practice pharmacy by the Arkansas State Board of Pharmacy who provides pharmaceutical services as defined in the Pharmacy Practice Act to patients of the hospital.

5. Unit Dose Distribution System is a pharmacy-coordinated method of dispensing and controlling medications in hospitals in which medications are dispensed in single unit packages for a specific patient on orders of a physician where not more than a twenty-four (24) hour supply of said medication is dispensed, delivered, or available to the patient.

6. Modified Unit Dose Distribution System is a system that meets the requirement of a "Unit Dose Distribution System," provided that up to a seventy-two (72) hour supply may be sent to the floor once a week if the system has been reviewed and approved administratively by the Arkansas State Board of Pharmacy.

B. Hospitals maintaining and using mechanical storage and delivery machines for legend drugs shall have such machines stocked only by Pharmacy Services. Drugs may be obtained from such machines only by licensed personnel in accordance with their Practice Act acting under the prescribed rules of safety procedures as promulgated by the individual hospital using said machine.

Limited amounts of Schedule II-V controlled substances may be stocked in the machines, provided the following requirements are met:

1. Pharmacy Services possesses the only key necessary to stock the machine;

2. Policies and Procedures specify the licensed personnel having access and responsibility for the medications.

The person removing a medication for administration shall record at least the patient's name and the name, strength, and amount of medication on a record that is maintained by the Pharmacy Department. The record shall also be signed by the person removing the medication. The removal of controlled substances shall comply with the record keeping requirements of Section 12, Medications. Pharmacy Services shall audit stock levels as needed to replace medications. Use of the machines shall not be to circumvent adequate pharmaceutical services.

C. Compounding, Dispensing and Distributing.

1. Compounding. The act of selecting, mixing, combining, measuring, counting, or otherwise preparing a drug or medication.

2. Dispensing. A function restricted to licensed pharmacists, which involves the issuance of:

a. One (1) or more doses of a medication in containers other than the original, with such new containers being properly labeled by the dispenser as to content and/or directions for use as directed by the prescriber;

b. Medication in its original container with a pharmacy prepared label that carries to the patient the directions of the prescriber as well as other vital information; and/or

c. A package carrying a label prepared for nursing station use. The contents of the container may be for one (1) patient (individual prescription) or for several patients (such as a nursing station medication container).

3. Distributing. Distributing, in the context of this regulation, refers to the movement of a medication from a central point to a nursing station medication center. The medication must be in the originally labeled manufacturer's container or in a prepackaged container labeled according to federal and state laws and regulations, by a pharmacist or under his direct and immediate supervision.

D. Administering. An act, restricted to nursing personnel as defined in the Arkansas Nurse Practice Act 43 of 1971, in which a single dose of a prescribed drug or biological is given to a patient. This activity includes the removal of the dose from a previously dispensed, properly labeled container, verifying it with the prescriber's orders, giving the individual dose to the proper patient and recording the time and dose given.

E. Pharmacy and Therapeutics Committee. There is a committee of the Medical Staff to confer with the pharmacist in the formulation of policies, explained as follows:

1. A Pharmacy and Therapeutics (P&T) Committee, composed of at least one physician, the Administrator or representative, the director of nursing service or representative, and the pharmacist is established in the hospital. It represents the organizational line of communication and the liaison between the Medical Staff and the pharmacist;

2. The Committee assists in the formulation of broad, professional policies regarding the evaluation, appraisal, selection, procurement, storage, distribution, use, and safety procedures in conformance with Food and Drug Administration and manufacturers' bulletins on the safe administration of drugs and all other matters relating to drugs in hospitals;

3. The Committee performs the following specific functions:

a. Serves as an advisory group to the hospital Medical Staff and pharmacist on matters pertaining to the choice of drugs;

b. Develops and reviews periodically a formulary or drug list for use in the hospital;

c. Establishes standards concerning the use and control of investigational drugs and research in the use of recognized drugs;

d. Evaluates clinical data concerning new drugs or preparations requested for use in the hospital;

e. Makes recommendations concerning drugs to be stocked on the nursing unit floors and emergency drug stocks;

f. Prevents unnecessary duplication in stocking drugs and drugs in combination having identical amounts of the same therapeutic ingredients;

g. Reviews and approves drug-related policies and procedures; and

h. Approves the drug formulary and all drug lists on an annual basis and makes interim revisions as needed;

4. The Committee develops and approves policies and procedures for all nursing personnel assigned the responsibility of preparing and administering intravenous (IV) admixtures. The pharmacist shall be involved in the review of the drug order, calculations, and preparation whenever possible. The Committee should consider the appropriate category of personnel (Registered Nurse or LPN) and degree of training necessary to make judgments and calculations involved in IV admixture programs;

5. The Committee assures that medications dispensed to outpatients, Emergency Room patients and discharged patients comply with all federal and state laws and regulations.

6. The Committee meets at least quarterly and reports to the Medical Staff by written report.

F. Pharmacy Operations. The hospital has a pharmacy directed by a licensed pharmacist. The pharmacy is administered in accordance with accepted professional principles.

1. Pharmacy supervision. There is a pharmacy directed by a licensed pharmacist defined as follows:

a. The Director of Pharmacy is trained in the specialized functions of hospital pharmacy;

b. The Director of Pharmacy is responsible to the administration of the hospital and Board of Pharmacy for developing, supervising, and coordinating all the activities of the Pharmacy Department and all pharmacists providing professional services in the hospital; and

c. All licensed pharmacists who provide pharmaceutical services as defined by the Pharmacy Practice Act shall practice under policies, procedures, and protocols approved by the Director of Pharmacy. These policies, procedures, and protocols shall be subject to review and approval by the Board of Pharmacy.

G. Physical Facilities. Facilities are provided for the storage, safeguarding, preparation, and dispensing of drugs, defined as follows:

1. Drugs are issued to floor units in accordance with approved policies and procedures;

2. Drug cabinets on the nursing units are routinely checked by the pharmacist. All floor stocks are properly controlled;

3. A careful determination of the functions of a department will regulate the space to be allocated, the equipment necessary to carry out the functions, and the number of personnel required to utilize the equipment and to render a given volume of service, as these functions relate to the frequency or intensity of each function or activity. Adequate equipment shall specifically relate to services rendered and functions performed by the hospital pharmacy. Equipment lists will relate to the following services and functions:

a. Medication preparation;

b. Library reference facilities;

c. Record and office procedures;

d. Sterile product manufacturing;

e. Bulk compounding (manufacturing);

f. Product control (assay, sterility testing, etc.);

g. Product development and special formulations for medical staff;

4. Equipment and supplies necessary to the hospital pharmacy's safe, efficient, and economical operation shall include, but not be limited to:

a. Graduates capable of measuring from 0.1 ml up to at least 500 ml;

b. Mortars and pestles;

c. Hot and cold running water;

d. Spatulas (steel and non-metallic);

e. Funnels;

f. Stirring rods;

g. Class A balance and appropriate weights;

h. Typewriter or other label printer;

i. Suitable apparatus for production of small-volume sterile solutions;

j. Suitable containers and labels;

k. Adequate reference library to include at least the following:

1) American Hospital Formulary Service;

2) Pharmacology text;

3) Each hospital pharmacy shall have available for personal and patient use a current copy of:

The U.S.P. DI, three (3) book set including "Drug Information for the Healthcare Professional" (two (2) volumes) and "Advice for the Patient" (one (1) volume)

Or the two (2) volume set "Facts and Comparisons" (one (1) volume) and "Patient Drug Facts" (one (1) volume);

4) Text on compatibility of parenteral products;

5) Current professional journals, such as:

a) Drug Intelligence and Clinical Pharmacy;

b) Hospital Pharmacy;

c) Journal of ASHP;

5. Special locked storage space is provided to meet legal requirements for storage of controlled drugs, alcohol, and other prescribed drugs.

H. Personnel. Personnel competent in their respective duties are provided in keeping with the size and activity of the department explained as follows:

1. The Director of Pharmacy is assisted by an adequate number of additional licensed pharmacists and other such personnel as the activities of the pharmacy may require to ensure quality pharmaceutical services;

2. The pharmacy, depending upon the size and scope of its operations, is staffed by the following categories of personnel:

a. Chief Pharmacist (Director of Pharmacy);

b. One (1) or more assistant chief pharmacists (Assistant Director of Pharmacy);

c. Staff pharmacists;

d. Pharmacy residents (where program has been activated);

e. Trained non-professional pharmacy helpers (qualified hospital personnel);

f. Clerical help.

I. Emergency Pharmaceutical Services. Through the Administrator of the hospital, the P&T Committee shall establish policies and procedures that include, but are not limited to, the following:

1. Upon admission to the Emergency Room on an outpatient basis and when examined by the physician where medications are prescribed to be administered, a record must be kept on file in the Emergency Room admission book or a copy of the Emergency Room medication order must be kept by the pharmacist to be readily accessible, for control and other purposes, as required by these regulations;

2. If the physician wishes the patient to have medication to be taken with them from the emergency room supplies, the amounts to be taken shall be sufficient to last until medication may be obtained from local pharmacies, in any case not to exceed a forty-eight (48) hour supply. All state and federal laws must be observed concerning all records, labeling, and outpatient dispensing requirements;

3. Take home prescriptions for anti-infectives issued to patients at the time of discharge from the Emergency Room, dispensed by a pharmacist shall be quantities consistent with the medical needs of the patient.

J. Pharmacy Records and Labeling. Records are kept of the transactions of the pharmacy and correlated with other hospital records where indicated. All medication shall be properly labeled. Such record and labeling requirements are as follows:

1. The pharmacy establishes and maintains, in cooperation with the accounting department, a satisfactory system of records and bookkeeping in accordance with the policies of the hospital for:

a. Maintaining adequate control over the requisitioning and dispensing of all drugs and pharmaceutical supplies; and

b. Charging patients for drugs and pharmaceutical supplies;

2. A record of procurement and disbursement of all controlled drugs is maintained in such a manner that the disposition of any particular item may be readily traced;

3. The pharmacist shall receive and provide service pursuant to the perusal of the physician's original order or a direct copy thereof, except in emergency situations wherein the pharmacist may provide service pursuant to a verbal order or to an oral or written transcription of the physician's order provided that the pharmacist shall receive and review the original or direct copy within twenty-four (24) hours of the time the service is provided;

4. A record shall be maintained by the pharmacy and stored separately from other hospital records for each patient (inpatient or outpatient) containing the name of the patient, the prescribing physician, the name and strength of the drugs prescribed, the name and manufacturer (or trademark), the quantity and the pharmacist's initials for all medications dispensed;

5. The label of each medication container prepared for administration to inpatients, shall bear the name and strength of the medication, the expiration date, and the lot or control number. The label on the medication or the container into which the labeled medication is placed must bear the name of the patient and room number;

6. The label of each outpatient's individual prescription medication container bears the name of the patient, prescribing physician, directions for use, and the name and strength of the medication dispensed (unless directed otherwise by the physician) and the date of dispensing.

K. Control of Toxic or Dangerous Drugs. Policies are established to control the administration of toxic or dangerous drugs with specific reference to the duration of the order and the dosage, explained as follows:

1. The Medical Staff has established a written policy that all toxic or dangerous medications not specifically prescribed as to the time or number of doses, will be automatically stopped after a reasonable time limit set by the staff;

2. The classifications ordinarily thought of as toxic or dangerous drugs are controlled substances, anticoagulants, antibiotics, oxytocics, and cortisone products;

3. All deteriorated non-sterile, non-labeled, or damaged medication shall be destroyed by the pharmacist, with the exception of controlled substances, as defined below:

a. All controlled drugs (Schedule II, III, IV and V) shall be listed and a copy sent, along with drugs to the Arkansas Department of Health by registered mail or delivered in person for disposition.

L. Drugs to be Dispensed. Therapeutic ingredients of medications dispensed are included (or approved for inclusion) in the United States Pharmacopoeia, N.F. and U.S. Homeopathic Pharmacopoeia, or Accepted Dental Remedies (except for any drugs unfavorably evaluated therein) and drugs approved by provisions of the Arkansas Act 436 of 1975, or are approved for use by the P&T Committee of the hospital staff, explained as follows:

1. The pharmacist, with the advice and guidance of the P&T Committee, is responsible for the specifications as to quality, quantity, and source of supply of all drugs;

2. There is available a formulary or list of drugs accepted for use in the hospital which is developed and amended at regular intervals by the P&T Committee with the cooperation of the pharmacist and the Administrator.

M. Policy and Procedure Manual.

1. A Policy and Procedure Manual pertaining to the operations of the hospital pharmacy, with updated revisions adopted by the P&T Committee of each hospital shall be prepared and maintained at the hospital.

2. The Policy and Procedure Manual shall include at a minimum, the following:

a. Provisions for procurement, storage, distribution, and drug control for all aspects of pharmaceutical services in the hospital;

b. Specialized areas such as Surgery, Delivery, ICU and CCU units and Emergency Room stock and usage of medication shall be specifically outlined;

c. A system of requisitioning supplies and medications for nurses' stations stock shall be in written procedural form as to limits of medications to be stocked in each nursing unit;

d. Detailed job descriptions and duties of each employee by job title working in the Pharmacy Department shall be developed and made a part of these policies and procedures;

e. The Pharmacy Policy and Procedure Manual shall be subject to review and approval by the Board of Pharmacy on request from the Board.

N. Employee Prescription Medication.

1. There will be a prescription on file for all prescription drugs dispensed to hospital employees and their immediate families. These records will be kept separate from all inpatient records.

2. The only person(s) entitled to have employee prescriptions filled will be the employee listed on the hospital payroll and members of their immediate family.

O. Patient Discharge Medication. Any take-home prescription dispensed to patients at time of discharge from the hospital shall be for drugs and quantities consistent with the immediate needs of the patient.

P. Licensed Pharmacist Personnel Requirements.

1. The minimum requirements for licensed pharmacists in hospitals are:

a. A general hospital, surgery and general medical care, maternal and general medical care hospital, chronic disease hospital, psychiatric hospital, and rehabilitative facility with average annual occupied beds greater than seventy-five (75) as determined by the institution's patient occupancy record, shall require the services of one (1) pharmacist on the basis of forty (40) hours per week with such additional pharmacists as are necessary, in the opinion of the Arkansas State Board of Pharmacy, to perform required pharmacy duties as are necessary in keeping with the size and scope of the services of the hospital pharmacy's safe, efficient, and economical operation;

b. The above classified hospitals, with average annual occupied beds less than seventy-five (75), as determined by the institution's patient occupancy records, shall require the services of a pharmacist such hours as, in the opinion of the Arkansas State Board of Pharmacy and the Arkansas State Board of Health, are necessary to perform required pharmacy duties in keeping with the size and scope of the services of the hospital pharmacy's safe, efficient, and economical operation;

c. Recuperation Centers, Outpatient Surgery Centers and Infirmaries:

1) If the infirmary, recuperation center, or outpatient surgery center has a pharmacy department, a licensed pharmacist shall be employed to administer the pharmacy in accordance with all state and federal laws regarding drugs and drug control;

2) If the infirmary, recuperation center, or outpatient surgery center does not have a pharmacy department, it has provisions for promptly and conveniently obtaining prescribed drugs and biologicals from a community or institutional pharmacy;

3) If the infirmary, recuperation center, or outpatient surgery center does not have a pharmacy department but does maintain a supply of drugs, a licensed pharmacist shall be responsible for the control of all bulk drugs and maintain records of their receipt and disposition. The pharmacist shall dispense drugs from the drug supply, properly labeled, and make them available to appropriate nursing personnel;

4) All medication for patients shall be on individual prescription basis.

Q. Responsibility of a Pharmacist in Hospital Pharmacy.

1. The pharmacist is responsible for the control of all medications distributed in the hospital where he practices and for the proper provision of all pharmaceutical services.

2. The following aspects of medication distribution and pharmaceutical service are functions involving professional evaluations or judgments and may not be performed by supportive personnel:

a. Selection of the brand and supplies of medication;

b. Interpretation and certification of the medication ordered. This involves a number of professional responsibilities such as the determination of:

1) Accuracy and appropriateness of dose and dosage schedule;

2) Such items as possible drug interactions, medication sensitivities of the patient, and chemical and therapeutic incompatibilities;

3) Accuracy of entry of medication order to patient's medication profile;

c. Final certification of the prepared medication.

R. Pharmacy Technicians.

1. Pharmacy technician refers to those individuals identified as Pharmacist Assistants in Arkansas Code 17-92-801. Pharmacy technicians are those pharmacy personnel, exclusive of pharmacy interns, who are regular paid employees of the hospital and assist the pharmacist in pharmaceutical services.

2. Supervision means that the responsible pharmacist must be physically present to observe, direct, and supervise the pharmacy technician at all times when the pharmacy technician performs acts specified in this regulation. The supervising pharmacist is totally and absolutely responsible for the actions of the pharmacy technician.

3. The pharmacist and pharmacy technician(s) shall comply with all applicable sections of Regulation 60 of Laws and Regulations of the Arkansas State Board of Pharmacy with regards to tasks, responsibilities, duties, ratios, and supervision in the hospital setting.

4. There shall be documentation by each technician of all duties and tasks performed in the preparation and processing of medication. The pharmacist shall be responsible for the final check and verification of all technician duties and tasks. The performance, check, and verification shall be recorded on a record maintained by the department which shall include the signature, initial(s), or other identifying mark of each person.

S. Operation of Pharmacy Department When Pharmacist is Not Present.

1. A limited supply of backup medications may be utilized for patient needs only at times when the pharmacist is not present. This stock shall be accessible only to approved licensed personnel. A record shall be maintained which identifies the medication obtained and the personnel obtaining it. The pharmacist shall then review this record when he returns to the facility to assure compliance with the physician's orders. Medications shall be replaced to stock as needed.

2. At no time will the hospital pharmacy be open and in operation unless a licensed pharmacist is physically present except:

a. Entrance may be obtained for emergency medication as set forth in the Pharmacy Policy and Procedure Manual when the pharmacy is closed outside its normal operation hours. Nursing personnel may remove only one (1) dose if the drug is not of the unit dose packaging type; if the medication is unit dosed, enough medication to last until the pharmacist returns can be removed. A record listing all medications obtained should be maintained, and the pharmacist shall check for compliance with the physician's orders when he returns to the facility. Controlled substances shall not be accessible unless daily counts are performed and documented;

b. When the pharmacist is summoned away from the pharmacy and there are other qualified personnel left in the pharmacy, the personnel left in the pharmacy shall perform only those functions authorized within this regulation.

3. A pharmacist shall be available to provide medication consultation.

T. Medication Utilization. The pharmacist, with the advice and guidance of the P&T Committee, shall participate in:

1. Discussions of reports of medication errors, with trends noted, conclusions made, and recommendations suggested. If there are no errors to report, this shall be stated;

2. Discussions of adverse drug reactions with trends noted, conclusions made, and recommendations suggested. Proper reports of appropriate reactions shall be reported to the full medical staff and/or the FDA reporting system. If there are no adverse reactions to report, this shall be stated;

3. Reviews of results of monitoring conducted according to approved criteria for antibiotics prescribed for prophylactic and therapeutic reasons;

4. Reviews of other drug utilization in the facility, as appropriate;

5. Formulation of an official record of each meeting maintained as minutes. The written report shall be forwarded to the P&T Committee, QI Committee, and/or the Medical Staff for review and consideration, with at least a quarterly frequency.

U. Electronic Data Processing in Hospital Pharmacies. All hospitals utilizing electronic data processing systems shall comply with Regulation 34 of Laws and Regulations of the Arkansas State Board of Pharmacy.

V. Maintenance and Retention of Drug Records. All drug records, including but not limited to, purchase invoices, official dispensing records, prescription and inventory records shall be kept in such a manner that all data is readily retrievable, and shall be retained as a matter of record by the pharmacist for at least two (2) years.

W. The American Society of Health-System Pharmacists Guidelines. The American Society of Health-System Pharmacists' most recent statement on hospital drug control systems and Guidelines for Institutional Use of Controlled Substances shall be required reading by hospital pharmacists.

SECTION 17: FOOD AND NUTRITION SERVICES.

A. Administration.

1. The Food and Nutrition Services shall be under the daily, including weekends, onsite supervision of a qualified individual. The individual shall be at a minimum a certified dietary manager and:

a. Be responsible for the daily management of clinical and administrative dietetic aspects of the service by formulating, reviewing, and revising policies and procedures for all Food and Nutrition Services practices;

b. Ensure that all personnel in the service are oriented in their respective duties;

c. Implement a maintenance program to ensure food service facilities, equipment, and utensils are maintained in a safe, clean, sanitary manner, and are replaced at specific intervals, or as needed;

d. Implement a continuous QI Program, specific to both clinical and administrative components of the service;

e. Participate on hospital-wide departmental committees as required;

f. Ensure that trained staff are maintained for daily administrative and clinical nutrition practices. A minimum of a two (2) week current work schedule shall be posted and reflect all positions, including the department director; and

g. Develop, implement, and maintain a system for record keeping relating to all department functions dependent on the department's scope of services, e.g., patient assessments, counseling, diet instructions, temperatures, inservices, etc.

2. Policies and procedures shall have evidence of ongoing review and/or revision. The first page of each manual shall have the annual review date, signature of the department supervisor and/or person(s) conducting the review.

3. Policies and procedures shall include:

a. Job descriptions and performance evaluations;

b. Orientation;

c. Preventive maintenance;

d. Infection control measures;

e. Safety practices; and

f. Cleaning of equipment and applicable areas.

4. Clinically relevant inservice educational programs shall be conducted at regularly scheduled intervals with not less than twelve (12) per year. There shall be written documentation with employee signature, program title/subject, presenter, date and outline or narrative of presented program.

5. Nutrition Services shall have an ongoing QI Program. There shall be documentation of monitoring, plans of corrective action/corrective action taken and follow-up.

6. Time and duty schedules for all hourly employees shall be maintained.

7. Documentation of actual downtime and remedial action taken of equipment shall be maintained.

8. Diet Manual shall be authorized by the Medical Staff, reviewed and revised, as needed, to reflect current recognized dietary practices. A cover page shall be affixed with the date of review and appropriate signatures and a copy of the manual shall be located on each patient unit. Use of electronic diet manuals is acceptable.

9. Menus shall:

a. Be planned/approved by the registered dietitian and meet the nutritional needs of the patients in accordance with the current recommended dietary guidelines of the Food and Nutrition Board, National Research Council, and the currently approved facility diet manual in accordance with the physician's written diet order.

b. Be dated at least one (1) week in advance. The current week's menus shall be posted and available in the kitchen. The meals prepared and served shall correspond with the posted menu, or physician's written diet orders.

c. Not be restrictive in nature (e.g., seasoning, fat, sodium, sugar content) unless required by a modified/therapeutic diet order.

d. Be of equivalent nutritional value when substitutions/changes are made. Menus/production schedules, showing all changes, shall be retained for at least thirty (30) days.

10. Diets shall be in writing and signed by a physician or a mid-level practitioner if privileged by the Medical Staff and Governing Body. Notification according to facility policy shall be made to the Nutrition Services Department on a timely basis, kept current, and include current date, the patient's name, room number, and diet order.

B. Food Services.

1. At least three (3) meal equivalents shall be served daily at regular intervals, approximately five (5) hours apart. No more than fifteen (15) hours shall elapse between the serving of the evening meal and the morning meal. The meals shall be served at approximately the same hour each day.

2. Food shall be prepared in accordance with approved menus and standardized recipes and in a manner to conserve nutritive value, flavor and appearance.

3. Food shall be attractive, palatable, and served at proper temperatures and meet individual needs.

4. An identification system shall be implemented for patient trays to ensure that each patient receives the appropriate diet as ordered.

5. Nourishing bedtime snacks, appropriate to the patient's needs, shall be made available. If nourishments are a nutritional component of the plan of care, the time and date offered, the types and amounts of food offered, the amounts or percentage of foods consumed or refused shall be recorded by authorized personnel in the patient's medical record.

6. Only foods prepared and stored under the direction of Nutrition Services, in accordance with the Rules and Regulations Pertaining to Retail Food Establishments of the Arkansas Department of Health shall be served in a hospital.

7. All individuals who assist patients in the preparation, heating, reheating, or consumption of food, sanitation of food ware and kitchen equipment, etc., while in the facility or on the facility grounds, shall be under the direction of Nutrition Services and in compliance with the Rules and Regulations Pertaining to Retail Food Establishments of the Arkansas Department of Health. Documentation of inservices on food preparation, safety and sanitation shall be performed for all applicable personnel (e.g., Occupational Therapy, Nursing) by Nutrition Services at least annually.

8. Nutrition Services shall follow a physician's order for any special food item.

9. Food shall not be consumed in the kitchen.

10. Food shall be transported in a manner that maintains safe food temperatures and prevents contamination. Food carts shall not block corridors/exits, emergency equipment, or patient doorways.

11. All storage containers/foodstuffs shall be stored a minimum of six (6) inches above the floor on non-porous, easily cleaned racks, dollies or shelving, in a manner that protects the food (or food contact surfaces) from splash and other contamination and that permits easy cleaning of the storage area.

12. Plastic milk crates shall not be permitted for storing of food or equipment, except for the intended use for milk storage.

13. Temperature documentation of all food refrigerators/freezers in the kitchen and cafeteria shall be performed a minimum of three (3) times per day at opening, mid-operation, and closing of the department.

14. Temperature documentation of all nourishment refrigerators/freezers in patient care areas shall be performed at least daily. Electronic devices equipped with audible alarm systems may be installed on the refrigerator/freezers for the purpose of continuous monitoring of temperatures.

15. Proper temperatures of vending machines containing potentially hazardous foods shall be ensured daily by the facility. Vending machines shall be equipped with a thermometer, easily visible to food service personnel for the purposes of monitoring the temperature of the internal environment. These machines shall have the capacity to render themselves inoperable if temperatures in excess of forty (40) degrees Fahrenheit are maintained for more than two (2) hours. Documentation of such downtime shall be maintained to include remedial action taken.

16. If, for any reason, the refrigeration equipment does not maintain the appropriate temperature, action shall be taken and a record of remedial action and downtime shall be recorded and maintained by the facility.

17. Temperature documentation of the dishmachine shall be recorded with each meal and these records shall be maintained by the facility. If the temperatures (and, if applicable, dwell times) are not maintained properly, action shall be taken and a record of remedial action, back-up procedures used, and downtime shall be maintained by the facility.

18. If the facility uses a chemical method for sanitizing food preparation and serving ware, a record of the chemical used and appropriate parts per million (ppm) measured with chemical strips, shall be maintained by the facility at each use.

19. The temperature of the food, maintained on the steam table, or other adequate hot-holding system, and cold-holding system during meal/patient tray service, shall be at a minimum, recorded at the beginning and end of each service.

20 Documentation of the testing/calibration of food/refrigeration/freezer thermometers shall be performed according to manufacturer's recommendations.

21. Food thermometers shall be sanitized after each use and stored in a manner that prevents contamination.

22. Only dietary and authorized personnel shall be allowed in the kitchen.

23. Sanitation shall be in accordance with the Food Services Establishment Regulations.

C. Food Safety/Sanitation.

1. Whole eggs and raw meat shall be stored separately and in a way that prevents contamination of other food items in refrigerated units.

2. Reheated food shall attain a temperature above one-hundred-sixty-five degrees (165º) Fahrenheit prior to placement in steam tables, warmers, or other hot food storage units. Steam tables, warmers, or other food storage units shall not be used for the rapid heating of potentially hazardous food.

3. Disposable gloves shall be worn to eliminate direct handling of food. Gloves shall be properly discarded after being used, torn or contaminated.

4. Ground beef or ground beef products shall be cooked to an internal temperature of one-hundred-sixty degrees (160º) Fahrenheit or higher.

5. Potentially hazardous food shall be tempered or thawed only:

a. In designated tempering units at a temperature not to exceed forty-five degrees (45º) Fahrenheit;

b. In general refrigeration units at a temperature not to exceed forty degrees (40º) Fahrenheit;

c. As part of the conventional cooking process; or

d. In a microwave, provided the food is immediately transferred to conventional cooking process.

6. Potentially hazardous food that is left over shall be labeled as such with the date and time it was removed from service.

7. Potentially hazardous food shall be retained for no longer than forty-eight (48) hours, chilled to a temperature below forty degrees (40º) Fahrenheit.

8. Food contact surfaces, i.e., cutting boards, of all equipment and utensils, shall be sanitized by immersion for at least one-half (1/2) minute in clean, hot water at a temperature of at least one-hundred-eighty degrees (180º) Fahrenheit or by any other method approved by Health Facility Services. Counter tops and other huge industrial equipment shall be washed down with concentrated solutions.

9. Clean linens, mopheads, and cloths shall be stored in a manner to prevent contamination prior to use.

10. Soiled linens, etc., shall be stored covered, separately from clean linen, food storage, preparation and serving areas. Containers for holding such items shall be made of non-absorbent materials. Soiled linens shall be removed daily.

11. Food inventory shall be handled on a first-in, first-out basis. A system for labeling and dating canned, dry and potentially hazardous foods shall be implemented.

12. Potentially hazardous frozen foods removed from freezer storage to be thawed shall be labeled with the date of pull from the freezer for thawing.

13. Supplies and perishable foods for a twenty-four (24) hour period and nonperishable foods for a three (3) day period shall be on the premises to meet the requirements of the planned menus.

NOTE: These regulations are referenced to the "Rules and Regulations Pertaining to Food Service Establishments," of the Arkansas Department of Health.

D. Clinical Services.

1. Clinical Dietitian/Nutritionist.

a. Shall be a registered dietitian, or registry eligible, and evaluate and oversee the delivery of effective nutritional care based on current, recognized nutritional practices. If not full-time, make regularly scheduled visits to accomplish the following:

1) Review, revise and approve a current diet manual for facility use;

2) Review, revise, approve and implement nutritional care policy and procedures, standards of nutritional care, nutritional care protocols, and the Nutritional Services QI Program;

3) Coordinate nutritional care through communication with other patient care services;

4) Provide for the initiation of nutrition screening of all patients upon admission and periodic screening of patients during their hospital stay;

5) Provide for the nutritional evaluation of patients at nutritional risk, as defined by the Medical Staff, and collaborate with the physician on the findings of the evaluation;

6) Ensure competency of all nutritional services personnel who perform assessments, counseling, develop care plans and participate in discharge planning;

7) Provide to the facility evidence of continuing education hours;

8) Perform orientation, preceptorship, and ongoing training/inservices for staff and/or students;

9) Review and revise nutrition counseling/diet education practices that are individualized to patient needs;

10) Monitor the enforcement of all policies and procedures and practices relating to food safety and sanitation;

11) Develop, implement and maintain a system for recording data related to patient care;

12) Collaborate with Nursing and Pharmacy to provide food/drug interaction counseling; and

13) If the dietitian is a consultant, submit reports to the facility Administrator reflecting services performed at each regularly scheduled visit.

2. Nutritional Screening and Documentation.

a. Nutritional Screening shall be initiated within twenty-four (24) hours of admission on all patients to determine nutritional risk and notify the physician and dietitian of any patients that are at nutritional risk.

b. Psychiatric, Alcohol and Drug, and Rehabilitation patients shall be rescreened seven (7) days from the initial screen and, at least every fourteen (14) days thereafter.

3. Nutritional Evaluations and Care Plans.

a. A nutritional evaluation of patients at nutritional risk, as reflected in the medical record, shall include as appropriate:

1) The patient's percentage of goal body weight range;

2) Abnormal pertinent laboratory values;

3) The patient's caloric and protein needs;

4) The percentage of food intake since admission;

5) Determination of abnormal intake or recent weight loss/gain prior to admission;

6) An objective evaluation of the patient's compliance with a physician ordered diet prior to admission;

7) Pertinent food/drug interactions;

8) An evaluation of the patient's special feeding/nutrient/fluid needs;

9) Patient's food preferences, dislikes, allergies or intolerances.

b. The patient care plan on all patients found to be at nutritional risk shall include the following nutritional components, as appropriate:

1) The need for individualized nutritional counseling;

2) Need for discharge planning;

3) Need for comprehensive nutritional assessments to include further clinical, laboratory, social, or nutritional data to assist with the ongoing evaluation;

4) Need for follow-up care to evaluate the effectiveness of the nutritional regimen; and

5) Any requests to the physician for alterations or modifications to the ordered diet's nutrient content, consistency, administration route/method, or meal pattern as served in the hospital in order to meet the nutritional needs and/or special feeding needs of the patient.

4. Nutritional Counseling. Nutritional counseling, to include food/drug interactions, shall be performed as ordered by the physician. Documentation of such counseling shall include:

a. Description of the individualized nutritional counseling;

b. Objective evaluation of the patient's and/or significant other's understanding and ability to carry out the diet order;

c. Plans for continued counseling and/or recommendations to the physician for post-discharge counseling and evaluation of patient diet compliance.

5. Follow-up Nutritional Care:

a. Shall be performed at a minimum of every seventy-two (72) hours with documentation in the patient's medical record when the patient is at nutritional risk. If the patient's nutritional status is stable, follow-up should be at least every seven (7) days;

b. Shall be documented in the patient's medical record by a qualified designated Nutritional Services representative on all patients at nutritional risk; and c. Shall be documented to include an evaluation of the effectiveness of the prescribed nutrition regimen, changing nutritional status/needs, nutritional counseling, and/or recommendations to improve patient nutritional care;

SECTION 18: INFECTION CONTROL.

A. General.

1. The facility shall develop and use a coordinated process that effectively reduces the risk of endemic and epidemic nosocomial infections in patients, health care workers and visitors.

2. There shall be a comprehensive list of communicable diseases for which patients must be isolated and for which there are visitation restrictions. The list, and other policies and procedures for isolation, shall conform to the latest edition of the Centers for Disease Control and Prevention, Atlanta, Georgia (CDC) Guidelines.

3. It shall be the duty of the Administrator or his/her designee to report all infectious or communicable diseases in the facility as required by Act 96 of 1913 (Ark. Statute 1947 82-110) to the Arkansas Department of Health, Division of Epidemiology.

4. The Administrator shall designate a qualified individual (Registered Nurse or Laboratorian) who shall:

a. Coordinate the activities of the Infection Control Committee;

b. Direct surveillance activities;

c. Ensure policies established by the Committee are carried out; and

d. Gather and report data regarding the hospital's nosocomial infections.

5. There shall be policies and procedures establishing and defining the Infection Control program to include:

a. Definitions of nosocomial infections and communicable diseases which conform to the current CDC definitions;

b. Measures for identifying, investigating and reporting nosocomial infections and communicable diseases and a system of evaluating and maintaining records of infection among both patients and health care workers which specify the type of infection from the following site categories:

1) Respiratory;

2) Gastrointestinal;

3) Surgical wounds;

4) Skin;

5) Urinary tract;

6) Septicemias; and

7) Use of intravascular catheters.

NOTE: The facility's system for surveillance, calculation and evaluation of the incidence of nosocomial infections within the facility shall conform to CDC's National Nosocomial Infections Surveillance System (NNIS) and CDC publications.

c. Method(s) for calculating nosocomial infection attack rates;

d. Measures for assessing and identifying patients and health care workers at risk for nosocomial infections and communicable diseases;

e. Methods for obtaining reports of infections and communicable diseases in patients and health care workers in a manner and time sufficient to limit the spread of infection;

f. A plan for monitoring and evaluating at least the following areas or departments to ensure policies and procedures are followed:

1) Inpatient and outpatient surgery;

2) Delivery;

3) Nursery;

4) Central sterilization and supply;

5) Housekeeping;

6) Laundry;

7) Dietary;

8) Laboratory;

9) Nursing;

10) Maintenance;

11) Invasive speciality laboratories (special procedures);

12) Radiology; and

13) End-Stage Renal Disease.

g. Measures for prevention of infections, at least those associated ith the following:

1) Intravascular therapy;

2) Indwelling urinary catheters;

3) Tracheostomy;

4) Respiratory care;

5) Burns;

6) Immunosuppressed patients; and

7) Other factors which compromise a patient's resistance to infection.

h. Measures for prevention of communicable disease outbreaks, especially Mycobacterium tuberculosis (TB). All plans for the prevention of transmission of TB shall conform to the most current CDC Guidelines for Preventing the Transmission of Mycobacterium Tuberculosis in Health Care Facilities.

i. Isolation procedures and requirements for infected, immunosuppressed patients and patients colonized or infected with resistant organisms. Procedures shall conform to the most current CDC Guidelines.

j. Provisions for education of patients and their families concerning infections and communicable diseases;

k. A plan for monitoring and evaluating all aseptic, isolation and sanitation techniques employed in the facility to ensure that approved infection control procedures are followed;

l. Techniques for:

1) Handwashing;

2) Respiratory protection;

3) Asepsis;

4) Sterilization;

5) Sanitary food preparation;

6) Disinfection;

7) Housekeeping;

8) Linen care:

9) Liquid and solid waste disposal of both infectious and regular waste. Disposal of infectious waste shall conform to the latest edition of the Rules and Regulations Pertaining to the Management of Medical Waste from Generators and Health Care Related Facilities;

10) Needle disposal;

RULES AND REGULATIONS FOR HOSPITALS AND RELATED INSTITUTIONS IN ARKANSAS

11) Separation of clean from dirty process; and

12) Other means of limiting the spread of contagion.

m. Authority and indications for obtaining microbiological cultures from patients;

n. A requirement that disinfectants, antiseptics and germicides be used in accordance with the manufacturer's directions;

o. Employee health;

p. Visitation rules, especially for patients in isolation, critical care, pediatrics and other special care units, including postpartum care.

6. There shall be an orientation program for all new health care workers concerning the importance of infection control and each health care worker's responsibility in the hospital's infection control program.

7. There shall be a plan for each employee to receive annual inservices and educational programs as indicated based on assessments of the infection control process.

8. The infection control officer shall maintain a log of infectious and communicable diseases.

9. No items shall be used past the expiration date.

10. One (1) time patient care items shall not be reused.

B. Infection Control Committee.

1. There shall be a multidisciplinary committee appointed by the Administrator to monitor and provide direction for the Infection Control program. There shall be at least one (1) representative from each of the following departments:

a. Administration;

b. Dietary;

c. Housekeeping;

d. Laboratory;

e. Nursing/Surgical;

f. Pharmacy;

g. Radiology;

h. Respiratory Care; and

i Maintenance.

Additional members may be appointed or consulted from any department of the hospital.

2. The Medical Staff shall appoint a physician to serve as chairperson of the Infection Control Committee. Additional physician members may be appointed.

3. The Infection Control Committee shall meet at least every two (2) months. Minutes of the meetings shall reflect the committee's actions in monitoring and directing the hospital's Infection Control program.

4. The Infection Control Committee shall fulfill the following responsibilities:

a. Assist in the development of and approval of all infection control policies and procedures within the facility;

b. Annually review and approve all infection control policies and procedures within the facility;

c. Direct all departments relative to the purchase of equipment and/or supplies used for disinfection, decontamination, sanitation and/or sterilization;

d. Annually review and approve all products used throughout the facility relative to disinfection, decontamination, sanitation and/or sterilization and approve all interim changes;

e. Annually review and approve the list of communicable diseases for which patients must be isolated;

f. At each meeting review the results of the biological spore tests on all the facility's sterilizers;

g. Ensure that an antibiogram is prepared at least annually and compared to the previous one to identify trends;

h. Monitor any contractual services relative to infection control (e.g. waste management and laundry) to ensure compliance with all applicable regulations;

i. Review any special infection control studies conducted within the facility.

C. Employee Health.

1. There shall be policies and procedures for screening health care workers for communicable diseases and monitoring for health care workers exposed to patients with any communicable diseases.

2. There shall be employee health policies regarding infectious diseases in the following categories:

a. Health care workers affected with any disease in the communicable stage;

b. A carrier of any communicable disease;

c. Health care workers affected with boils, jaundice, infected wounds, diarrhea or acute respiratory infections.

3. There shall be policies which clearly state when health care workers shall not render direct patient care.

4. There shall be a plan for ensuring that each health care worker has an annual TB skin test or is evaluated in accordance with guidelines approved by the Arkansas Department of Health (Rules and Regulations Pertaining to Communicable Disease; Section 1, Section 13 - Arkansas Department of Health Tuberculosis Program Amendment 22394 Adopted in February, 1994).

5. There shall be a plan for ensuring that all health care workers who are frequently exposed to blood and other potentially infectious body fluids are offered immunizations for Hepatitis B.

SECTION 19: LABORATORY.

A. General.

1. Each hospital shall provide laboratory services onsite commensurate with the needs of patients that are admitted. Provision shall be made for the performance of laboratory examinations in the following categories:

a. Chemistry;

b. Hematology;

c. Microbiology;

d. Immunology;

e. Immunohematology;

f. Urinalysis; and

g. Pathology.

2. The requirements of the most current rule of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) shall be met.

3. All laboratory testing that is performed at any site owned and/or operated by the facility shall be approved, in writing, by the Governing Body. The Governing Body shall authorize the director of the hospital laboratory to provide oversight of all testing to ensure the quality of the laboratory services provided. A comprehensive list of all testing sites shall be made available to the Medical Staff.

4. A laboratory shall refer specimens for testing only to a laboratory possessing a valid Clinical Laboratory Improvement Amendments (CLIA) certificate authorizing the performance of testing in the specialty or subspecialty of service for the level of complexity in which the referred test is categorized.

5. Only results from the hospital laboratory or from other approved laboratories, as determined by hospital policy, shall be placed in the patient's medical record.

6. Laboratory tests shall be authorized by a physician, dentist, or other person authorized by the Medical Staff and the Governing Body to order laboratory examinations.

7. The laboratory shall maintain accurate counts of total patient procedures for each specialty in which tests are performed.

8. Current reference material, such as textbooks, shall be available for every laboratory category in which tests are performed.

9. The laboratory shall make available to the Medical Staff a list of all tests performed onsite, including the reference range for each test.

B. Personnel.

1. A member of the Medical Staff shall be appointed to act as a liaison between the laboratory and the Medical Staff.

2. The laboratory shall be under the oversight of a pathologist who is board certified or eligible. A pathologist who is not based at the hospital shall make at least a monthly visit and submit a monthly written report to the Hospital Administrator.

NOTE: A hospital which provides only limited laboratory services (e.g., blood gas laboratory only) shall not be subject to the requirement of oversight of a pathologist.

3. The laboratory director, as defined by CLIA 88, shall be responsible for the overall operation of the laboratory but may delegate specific responsibilities to supervisory personnel. However, the director remains responsible for ensuring that all duties are properly performed and documented. The laboratory director shall be responsible for the following:

a. Ensuring that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the pre-analytic, analytic and post-analytic phases of testing;

b. Ensuring that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed and provide a safe environment in which employees are protected from physical, chemical and biological hazards;

c. Ensuring that:

1) The test methodologies selected have the capability of providing the quality of results required for patient care;

2) Verification procedures used are adequate to determine the accuracy, precision and other pertinent performance characteristics of the method;

3) Laboratory personnel are performing the test methods as required for accurate and reliable results;

d. Ensuring that the laboratory is enrolled in a proficiency testing program approved by Health and Human Services (HHS) for the testing performed and that:

1) The proficiency testing samples are tested in the same manner as the patient samples;

2) The results are returned within the timeframes established by the proficiency testing program;

3) All proficiency testing reports are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require corrective action;

4) An approved corrective action plan is followed when any proficiency testing result is found to be unacceptable or unsatisfactory;

e. Ensuring that the quality control and quality improvement programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur;

f. Ensuring the establishment and maintenance of acceptable levels of analytical performance for each test system;

g. Ensuring that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory's established performance characteristics are identified and that patient test results are reported only when the system is functioning properly;

h. Ensuring that reports of test results include pertinent information required for interpretation;

i. Ensuring that consultation is available to the laboratory's clients and to the Medical Staff on matters relating to the quality of the test results reported and interpretation concerning specific patient conditions;

j. Ensuring there is a sufficient number of laboratory personnel with the appropriate education and either training or experience to provide appropriate consultation, properly supervise and accurately perform tests and report test results;

k. Ensuring all personnel have the appropriate education and experience, receive the appropriate training for the type of services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results;

l. Ensuring there is documentation of training for laboratory personnel who perform special procedures such as arterial punctures and therapeutic phlebotomies;

m. Ensuring that qualified testing personnel are on duty or on call at all times;

n. Ensuring that policies and procedures are established for monitoring individuals who conduct pre-analytical, analytical and post-analytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. The procedures for evaluation of the competency of the staff shall include, but are not limited to the following:

1) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing;

2) Monitoring the recording and reporting of test results;

3) Review of intermediate test results or worksheets, quality control records, proficiency testing results and preventive maintenance records;

4) Direct observation of performance of instrument maintenance and function checks;

5) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples;

6) Assessment of problem solving skills;

7) Evaluation and documentation of the performance of all personnel with at least the following frequency:

a) Semiannually during the first year of employment in the laboratory;

b) Annually after the first year;

c) Prior to reporting patient test results if test methodology or instrumentation changes;

o. Ensuring that an approved procedure manual is available to all personnel responsible for any aspect of the testing process;

p. Ensuring there is a plan for providing continuing education for the laboratory staff and there is documentation of each employee's participation.

q. Specifying the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the pre-analytic, analytic and post-analytic phases of testing;

r. Specifying the examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results;

4. There shall be a supervisor accessible at all times when testing is performed.

5. Personnel responsible for day-to-day supervision of the laboratory shall meet at least one of the following qualifications:

a. A bachelor's degree in medical technology from an accredited institution and at least one (1) year of clinical laboratory training or experience relative to the specialties being supervised;

b. A bachelor's degree in a chemical, physical, biological or clinical laboratory science from an accredited institution with at least two (2) years of clinical laboratory training or experience relative to the specialties being supervised;

c. An associate degree in a laboratory science or medical laboratory technology from an accredited institution with at least two (2) years of clinical laboratory training or experience relative to the specialties being supervised;

d. A passing score on the Clinical Laboratory Technology Proficiency examination approved by HHS (HEW) and at least six (6) years of clinical laboratory experience with at least two (2) years of experience relative to the specialties being supervised;

e. Employment as a laboratory supervisor prior to January 1, 1995, in a hospital licensed by the Arkansas Department of Health.

6. Testing personnel shall meet at least the following qualifications:

a. Have earned a high school diploma or equivalent;

b. Have documentation of training appropriate for the testing performed prior to analyzing patient specimens. Such training shall ensure that the individual has the following:

1) Skills required for proper patient preparation and specimen collection, to include the following:

a) Labeling;

b) Handling;

c) Preservation or fixation;

d) Processing or preparation;

e) Transportation and storage.

2) The skills required for implementing all standard laboratory procedures;

3) The skills required for performing each test method and for proper instrument use;

4) The skills required for performing preventive maintenance, trouble-shooting and calibration procedures related to each test performed;

5) A working knowledge of reagent stability and storage;

6) The skills required to implement the quality control policies and procedures of the laboratory;

7) An awareness of the factors that influence test results;

8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control sample values prior to reporting test results.

C. Procedure Manual.

1. There shall be a procedure manual for the performance of all analytical methods used by the laboratory readily available and followed by laboratory personnel. Textbooks may be used as supplements but shall not be used in lieu of the laboratory's written procedures for testing or examining specimens. The procedure manual shall include, when applicable to the test procedure, the following:

a. Requirements for patient preparation, specimen collection and processing, labeling, preservation and transportation, including criteria for specimen rejection;

b. Procedures for microscopic examinations, including the detection of inadequately prepared slides;

c. Step-by-step performance of the procedure, including test calculations and interpretation of results;

d. Preparation of slides, solutions, calibrators, controls, reagents, stains and other materials used in testing;

e. Calibration and calibration verification procedures;

f. The reportable range for patient test results as verified by the laboratory;

g. Quality control procedures for each test to include the following:

1) Type of control;

2) Identity of control;

3) Number of controls;

4) Frequency of testing controls;

5) Criteria for determining acceptability of control results.

h. Remedial actions to be taken when any of the following occur:

1) Calibration results are unacceptable;

2) Control results are unacceptable;

3) Equipment or test methodologies fail;

4) Patient test values are outside the laboratory's reportable range of patient test results;

5) The laboratory cannot report patient test results within its established time frames;

6) Errors in reported patient test results are detected.

i. Limitations in methodologies, including interfering substances;

j. Reference ranges (normal values);

k. A list of "panic values" with written instructions for reporting such values;

l. Pertinent literature references;

m. Appropriate criteria for specimen storage and preservation to ensure specimen integrity until testing is completed;

n. The laboratory's system for reporting patient test results;

o. Description of the course of action to be taken in the event that a test system becomes inoperable;

p. Criteria for the referral of specimens, including procedures for specimen submission and handling and for record keeping.

2. The procedure manual shall be reviewed, approved, signed and dated by the current director of the laboratory or by an individual designated by the director in compliance with the CLIA 88 requirements.

3. Each revision or addition to the procedure manual shall be reviewed, approved, signed and dated by the current director of the laboratory or by an individual designated by the director in compliance with the CLIA 88 requirements.

4. The laboratory shall maintain a copy of each discontinued procedure for two (2) years, with the dates of initial use and discontinuance.

D. Record System.

1. The laboratory shall have policies and procedures for a record system which shall assure positive identification of patient specimens from the time of specimen collection until the time of test completion and results reporting. The record system shall include provisions for test requisitions, test records and test reports. The configuration of the system may be established by the laboratory, provided all of the required information is readily retrievable for at least two (2) years.

2. The laboratory shall perform tests at the written or electronic request of an authorized person.

3. Records of test requisitions or test authorizations shall be retained for a minimum of two (2) years.

4. The test requisition shall include:

a. Identification of the patient;

b. The name of the authorized person who ordered the test;

c. The test(s) requested;

d. The date the test is to be performed;

e. For Pap smears, the patient's last menstrual period, age or date of birth and indication of whether the patient had a previous abnormal report, treatment or biopsy;

f. Any additional information relevant and necessary to a specific test to assure accurate and timely testing and reporting of results (Examples: age, sex, current medications, time of specimen collection, diagnosis, type of specimen, fasting).

5. Records of patient testing, including instrument printouts, shall be retained for at least two (2) years. Immunohematology records and transfusion records shall be retained for at least five (5) years. (Exception: If an instrument is interfaced with a computer, and the electronic data cannot be edited, the instrument printouts do not have to be retained.)

6. Test records shall provide documentation of the information required for test requisitions as well as the following information:

a. Unique identification of the patient specimen;

b. The date and time of specimen receipt into the laboratory;

c. The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability;

d. The tests and date of performance of each;

e. The time of completion of testing;

f. The identity of the person who performs each test.

7. The laboratory report shall be sent promptly to the authorized person who requested the test.

8. A duplicate of each test report, including both preliminary and final reports, shall be retained for at least two (2) years. The duplicate may be retained electronically as long as it contains the exact information sent to the individual ordering the test and utilizing the test results. For test reports requiring an authorized signature or containing personnel identifiers, the exact duplicate must include the signature or identifiers. Immunohematology reports shall be retained for at least five (5) years, and pathology reports shall be retained for at least ten (10) years.

9. The test report shall include the following:

a. Identification of the patient;

b. Date of specimen collection;

c. The test(s) performed;

d. Test results and, if applicable, the units of measurement;

e. Date results were reported;

f. The condition and disposition of specimens that do not meet the laboratory's criteria for acceptability;

g. Any additional information relevant and necessary for the interpretation of the results of a specific test (Examples: Type of specimen, time of specimen collection, fasting).

10. The laboratory shall have policies and procedures for referring patient specimens to reference laboratories, to include:

a. Current list of reference laboratories, with the following information:

1) CLIA number;

2) Specialties and subspecialties in which the laboratory is certified;

3) Expiration date of CLIA certificate;

b. Specimen submission and handling;

c. Record keeping system.

11. The laboratory shall not revise results or information directly related to the interpretation of results provided by a reference laboratory.

12. The laboratory shall retain an exact duplicate of each reference laboratory report, including each preliminary and corrected report, for at least two (2) years. Pathology reports from reference laboratories shall be retained for ten (10) years, and immunohematology reports shall be retained for five (5) years.

13. The laboratory's report shall indicate the test(s) performed by a reference laboratory and the name and address of each laboratory location at which a test was performed.

E. General Quality Control.

1. The laboratory shall be constructed, arranged and maintained to ensure the space, ventilation and utilities necessary for conducting all phases of testing.

2. The laboratory shall have appropriate and sufficient equipment, instruments, reagents, materials and supplies for the type and volume of testing performed and for the maintenance of quality during all phases of testing.

3. The manufacturer's instructions shall be followed when using an instrument, kit or test system.

4. Components of reagent kits of different lot numbers shall not be interchanged unless otherwise specified by the manufacturer.

5. The laboratory shall define criteria for those conditions that are essential for proper storage of reagents and specimens and for accurate and reliable test system operation and test result reporting. These conditions shall include if applicable water quality, temperature, humidity and protection of equipment and instrumentation from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. There shall be documentation of the remedial actions taken to correct problems with these conditions.

6. Reagents, solutions, culture media, control materials, calibration materials and other supplies, as appropriate, shall be labeled to indicate the following:

a. Identity and, when significant, titer, strength or concentration;

b. Recommended storage requirements;

c. Preparation and expiration dates;

d. Other pertinent information required for proper use.

7. Reagents, solutions, culture media, control materials, calibration materials and other supplies shall be prepared, stored and handled in a manner to ensure that they are not used when the expiration date has been exceeded or when they have deteriorated or are of substandard quality.

8. The laboratory shall comply with the Food and Drug Administration (FDA) product dating requirements of 21 CFR 610.53 for blood, blood products and other biologicals and with labeling requirements in 21 FR 809.10 for all other in vitro diagnostics. Any exception to the product dating requirements in 21 CFR 610.53 shall be granted by the FDA in the form of an amendment of the product license, in accordance with 21 CFR 610.53(d). All exceptions shall be documented by the laboratory.

9. Test methodologies and equipment shall be selected and testing performed in a manner that provides test results within the laboratory's stated performance specifications for each test.

10. Before the laboratory reports patient test values using a new method or device, it shall first verify or establish for each method the performance specifications for the following performance characteristics, as applicable:

a. Accuracy;

b. Precision;

c. Analytical sensitivity and specificity, to include interfering substances;

d. Reportable range of patient test results;

e. Reference range (normal values);

f. Any other performance characteristics required for test performance;

The laboratory shall have documentation of the verification or establishment of all applicable test performance specifications and shall establish control and calibration procedures based upon those specifications.

11. The laboratory shall perform maintenance and function checks for all equipment, instruments and test systems according to the manufacturers' instructions. If the manufacturer does not define maintenance or function checks, the laboratory shall establish protocols ensuring equipment, instruments or test systems perform accurately and reliably. Maintenance and function checks shall be performed with at least the frequency of the manufacturer's instructions.

12. All function checks and maintenance activities shall be documented. The function checks shall be within the laboratory's or manufacturer's established limits before patient testing is conducted.

13. For each method or device the laboratory shall perform calibration procedures:

a. At a minimum, in accordance with manufacturer's instructions, if provided, using calibration materials provided as specified, as appropriate, and with at least the frequency recommended by the manufacturer; and

b. In accordance with established laboratory criteria to include:

1) The number, type and concentration of calibration materials, acceptable limits for calibration and the frequency of calibration; and

2) Using calibration materials appropriate for the methodology and, if possible, traceable to a reference method or reference material of known value; and c. Whenever calibration verification fails to meet the laboratory's established acceptable limits for calibration verification.

14. For each method or device the laboratory shall perform calibration verification procedures:

a. At a minimum, in accordance with the manufacturer's instructions, if provided; and

b. In accordance with established laboratory criteria to include:

1) The number, type and concentration of calibration materials, acceptable limits for calibration verification, and frequency of calibration verification;

2) Calibration materials appropriate for the methodology and, if possible, traceable to a reference method or reference material of known value;

3) Verification of the laboratory's established reportable range of patient test results, which shall include at least a minimal (or zero ) value, a mid-point value, and a maximum value at the upper limit of that range;

4) Performance of calibration verification at least every six (6) months or when the following occur:

a) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results and control values are not adversely affected by reagent lot number changes;

b) There is a major preventive maintenance or replacement of critical parts that may influence test performance;

c) Controls reflect an unusual trend or shift or are outside the laboratory's acceptable limits and other means of assessing and correcting unacceptable control values have failed to identify and correct the problem;

d) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification than specified by the manufacturer.

15. All calibration and calibration verification activities shall be documented.

16. Control Procedures - (Controls shall be performed as defined or as otherwise defined under a specific category heading.)

a. For each device the laboratory shall evaluate instrument and reagent stability and operator variance in determining the number, type and frequency of testing calibration or control materials and establish criteria for acceptability used to monitor test performance during a run of patient specimen(s). A run is an interval within which the accuracy and precision of a testing system is expected to be stable, but it cannot be greater than twenty-four (24) hours or less than the frequency recommended by the manufacturer. For each procedure, the laboratory shall monitor test performance using calibration materials or control materials or a combination thereof. Controls shall be performed as follows:

1) For qualitative tests, the laboratory shall include a positive and a negative control with each run of patient specimens. Internal procedural controls (both positive and negative) may be used to satisfy this requirement.

2) For quantitative tests, the laboratory shall include at least two (2) samples of different concentrations of either calibration materials, control materials, or a combination thereof with the frequency not less than two (2) levels per twenty-four (24) hours of operation.

3) If calibration and control materials are not available, the laboratory shall have an alternative mechanism to assure the validity of patient test results.

4) Control samples shall be tested in the same manner as patient test specimens.

5) When calibration or control materials are used, statistical parameters (e.g., mean and standard deviation) for each lot number of calibration or control material shall be determined through repetitive testing. Levy-Jennings plots or other visual representation methods shall be used to evaluate statistical data for trends and shifts. Weekly supervisory review is required. Control values shall be evaluated as follows:

a) The stated values of assayed control material may be used as the target values provided the stated values correspond to the methodology and instrumentation employed by the laboratory and are verified by the laboratory;

b) Statistical parameters for unassayed materials shall be established over time by the laboratory through concurrent testing with calibration materials or control materials having previously determined statistical parameters; and

c) Control results shall meet the laboratory's criteria for acceptability prior to reporting patient test results.

17. The laboratory shall document all control activities. Documentation shall be retained for a period of two (2) years. Immunohematology quality control records shall be retained for a period of five (5) years. Cytology and histopathology quality control records shall be retained for a period of ten (10) years.

F. Chemistry.

1. The following requirements apply only to blood gas analysis, regardless of the testing site:

a. Follow the manufacturer's instructions regarding calibration of the blood gas analyzer;

b. Test at least one (1) level of control material each eight (8) hours of patient testing;

c. Rotate the order in which the controls are performed so that normal, alkalosis and acidosis levels are tested; and

d. Test one (1) sample of calibration material or control material each time patients are tested if the instrument does not internally verify calibration at least every thirty (30) minutes.

2. For electrophoretic determinations:

a. At least one (1) control sample shall be used in each electrophoretic cell;

b. The control sample shall contain fractions representative of those routinely reported in the patient specimens.

G. Hematology.

1. There shall be at least two (2) levels of controls for non-manual hematology testing systems each eight (8) hours in which patient testing is performed.

2. There shall be at least one (1) level of control for manual cell counts each eight (8) hours in which patient testing is performed.

3. Manual cell counts shall be performed in duplicate with documentation of both counts. The laboratory shall establish criteria for the acceptable difference between duplicate counts.

4. There shall be two (2) levels of controls for non-manual coagulation testing systems each eight (8) hours in which patient testing is performed and each time a change in reagents occurs.

5. Each individual shall test two (2) levels of controls before performing manual coagulation testing on patient samples and each time a change in reagents occurs.

6. Manual coagulation tests on both patient and control specimens shall be performed in duplicate with documentation of both times. The laboratory shall establish criteria for the acceptable difference between duplicate times.

7. Background counts of diluents shall be performed daily and results recorded.

8. If the microhematocrit centrifuge is used, the maximum packing time shall be determined at least every six (6) months.

9. The laboratory director shall establish written criteria for abnormal cell morphology requiring review by a qualified physician who is board-certified or board-eligible in either pathology or hematology.

10 The laboratory shall maintain a file of unusual hematology slides to be used in the orientation, training and continuing education of laboratory personnel.

H. Immunology.

1. The equipment, glassware, reagents, controls and techniques for tests for syphilis shall conform to manufacturers' specifications.

2. The laboratory shall run serologic tests on patient specimens concurrently with a positive serum control of known titer or controls of graded reactivity plus a negative control. (If patient results are reported in terms of graded reactivity, controls of graded reactivity shall be used; if patient results are reported as a titer, controls of known titer shall be used with results reported as a titer.)

3. The laboratory shall employ controls that evaluate all phases of the test system to ensure reactivity and uniform dosages when positive and negative controls alone are not sufficient.

4. A facility manufacturing blood and blood products for transfusion or serving as a referral laboratory for such a facility shall meet the following:

a. Syphilis serology testing requirements of 21 CFR 606.65 (c&e) and 640.5(a);

b. HIV testing requirements of 21 CFR 610.45; and

c. Hepatitis testing requirements of 21 CFR 610.40.

I. Immunohematology.

1. There shall be provision for prompt ABO blood grouping, D(Rho) typing, unexpected antibody detection, compatibility testing and laboratory investigation of transfusion reactions, either through the or under arrangement with an approved facility that is certified in Immunohematology and Transfusion Services and Blood Banking under the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88).

2. If the facility does not provide immunohematological or blood banking services onsite, there shall be a written agreement with an outside laboratory or blood bank that governs the procurement, transfer and availability of blood and blood products. The agreement shall be reviewed and approved by the laboratory director.

3. The laboratory shall perform and document ABO group and D(Rho) typing on all donor red cells received from outside sources prior to transfusing.

4. The laboratory shall perform ABO group and D(Rho) typing, unexpected antibody detection, antibody identification and compatibility testing in accordance with manufacturers' instructions, if provided, and as applicable, with 21 CFR Part 606 (with the exception of 21 CFR 606.20.a, Personnel) and 21 CFR 640 et seq.

5. The laboratory shall perform ABO group by concurrently testing unknown red cells with anti-A and anti-B grouping reagents. For confirmation of ABO group, the unknown serum shall be tested with known A1 and B red cells. All reactions shall be documented.

6. The laboratory shall determine the D(Rho) type by testing and documenting the reaction of unknown red cells with anti-D(Rho) blood grouping reagent.

7. If required in the manufacturer's package insert for anti-D(Rho) reagents, the laboratory shall employ a control system (Rh-hr control) capable of detecting false positive D(Rho) test results.

8. Each day of use the laboratory shall perform and document the following quality control checks for each vial of antisera and reagent red cells:

a. Positive control only for ABO antisera, ABO reagent red cells and antibody screening cells (at least one known antibody); and

b. Positive and negative controls for D(Rho) antisera, other antisera and anti-human globulin (Coombs serum).

9. Records shall identify the source and lot number of each reagent on each day of use.

10. Policies and procedures to ensure positive identification of a blood or blood product recipient shall be established and followed.

11. Donor blood and blood products shall be stored or maintained for transfusion under conditions required to prevent deterioration and to ensure optimum integrity, whether in the blood bank or in a remote storage refrigerator.

12. Donor blood shall be stored in a refrigerator which meets the following criteria:

a. The refrigerator shall be connected to an emergency power source;

b. An audible alarm system shall monitor proper storage temperature and shall sound at a location that is staffed twenty-four (24) hours per day;

c. The refrigerator shall not be used for the storage of hazardous or contaminated items;

d. The refrigerator shall have adequate space to provide for segregated storage of the following:

1) Donor blood prior to completion of tests;

2) Donor blood not suitable for use; and

3) Autologous units;

e. A temperature recorder shall be connected to the refrigerator.

13. The high and low activation temperatures of the alarm system shall be checked and documented at least quarterly. The response to the activated alarm shall be documented.

14. The temperature recorder shall be compared daily to a thermometer in the refrigerator. Results of the temperature checks shall be documented.

15. The temperature recorder chart shall be changed weekly, and the individual who changes the chart shall initial and date it.

16. Written criteria shall be established for daily inspection of the blood storage unit for:

a. Outdated blood;

b. Hemolysis;

c. Bacterial contamination; and

d. Unit integrity.

Blood shall be visually inspected at the time of issue. Results of all inspections shall be recorded.

17. Records shall be maintained of all blood or blood components received, crossmatched, transfused, expired or returned to the supplier.

18. Patient's serum less than seventy-two (72) hours old shall be used in the compatibility procedure.

19. All blood for transfusions, except for autologous transfusions, shall be tested for hepatitis and for HIV antibodies before it is transfused. The tests for hepatitis and/or HIV antibodies may be performed by the supplier or by the institution in which the blood is transfused.

20. Samples of both patient and donor blood shall be retained at least seven (7) days following transfusion.

21. Procedures shall be established for the prompt investigation of all suspected transfusion reactions. The laboratory director shall review all suspected transfusion reactions, and a report shall be given to a committee of the Medical Staff.

22. Criteria shall be established for the reissuing of donor blood to ensure that the blood has been maintained under conditions required to ensure the safety of individuals being transfused within the facility.

23. Records of therapeutic phlebotomies shall be maintained, detailing the patient name, date, time, amount drawn, phlebotomist and disposition of the blood. Blood drawn as a therapeutic phlebotomy shall not be used for transfusion.

24. A committee of the Medical Staff shall fulfill the following responsibilities:

a. Establish criteria for the proper use of blood and its components;

b. Monitor the transfusion of blood and its components to ensure the established criteria for proper use are met;

c. Review the reports of suspected transfusion reactions;

d. Establish criteria for therapeutic phlebotomies.

25. Blood banking policies and procedures shall conform to the current Standards for Blood Banks and Transfusion Services of the American Association of Blood Banks.

J. Urinalysis.

1. Routine urinalysis shall be performed within two (2) hours of collection of the specimen unless the specimen is refrigerated.

2. Manufacturers' instructions shall be followed for all tests.

3. Two (2) levels of controls shall be performed and documented each day of patient testing utilizing an automated strip reader.

4. A refractometer for measuring urine specific gravity shall be checked each day of use with a low (1.000) and upper level standard or control.

K. Microbiology.

1. Each day of use, the laboratory shall evaluate the detection phase of direct antigen systems using an appropriate positive and negative control organism or antigen extract. When direct antigen systems include an extraction phase, the system shall be checked, each day of use, using a positive organism.

2. The laboratory shall check each batch or shipment of reagents, discs, stains, antisera and identification systems (systems using two (2) or more substrates) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable.

3. Unless otherwise specified, each day of use the laboratory shall test staining materials for intended reactivity to ensure predictable staining characteristics.

4. The laboratory shall check fluorescent stains for positive and negative reactivity each time of use (unless otherwise specified).

5. The laboratory shall check each batch or shipment of media for sterility, if it is intended to be sterile and sterility is required for testing. Media shall be checked for its ability to support growth and, as appropriate, selectivity/inhibition and/or biochemical response.

6. The laboratory may use the manufacturer's control checks of media provided the manufacturers' product insert specifies that the manufacturer's quality control checks meet the National Committee for Clinical Laboratory Standards (NCCLS) for media quality control. The laboratory shall document that the physical characteristics of the media are not compromised and report any deterioration of the media to the manufacturer.

7. The laboratory shall follow the manufacturer's specifications for using the media and be responsible for the test results.

8. The following media shall be retested using NCCLS standards for growth, inhibition and selectivity, as applicable:

a. Campylobacter agar;

b. Media for the selective isolation of pathogenic Neisseria;

c. Media used to isolate parasites, viruses, Mycoplasma, Chlamydia;

d. Mueller-Hinton media used for antimicrobial susceptibility tests; and

e. Media commercially prepared and packaged as a unit or system consisting of two (2) or more different substrates, primarily used for microbial identification.

9. The laboratory shall check positive and negative reactivity with control organisms as follows:

a. Each day of use for catalase, coagulase, beta-lactamase, and oxidase reagents and DNA probes;

b. Each week of use for Gram and acid-fast stains and for bacitracin, optochin, ONPG, X and V discs or strips;

c. Each month of use for antisera;

d. Each week of use the laboratory shall check XV discs or strips with a positive control;

e. For antimicrobial susceptibility tests, the laboratory shall check each new batch of media and each lot of antimicrobial discs or wells before or concurrent with initial use using approved reference organisms:

1) The laboratory's zone sizes or minimum inhibitory concentrations (MIC) for reference organisms shall be within established limits before reporting patient test results;

2) Each day tests are performed the laboratory shall use the appropriate control organisms to check the procedure unless adequate precision can be demonstrated. Once adequate precision is demonstrated, the controls may be performed each week of use. Documentation of precision studies is required.

10. Antibiotic sensitivities shall be performed using a recognized method. If the Kirby-Bauer method is utilized:

a. Proper sized petri dishes shall be used;

b. Dick zone sizes shall be measured and recorded, or a template shall be used; and

c. A standardized inoculum shall be used.

11. Records shall reflect all tests used to isolate and identify organisms.

12. For laboratories performing mycobacteriological testing, the laboratory shall:

a. Each day of use check the iron uptake test with at least one (1) positive and one (1) negative acid-fast control organism. Check all other reagents or test procedures used for identification with at least a positive acid-fast control organism.

b. Each week of use check the fluorochrome acid-fast stain's reactivity with a positive and a negative control organism;

c. Each week of use check the acid-fast stain's reactivity with a positive control organism; and d. Each week of use, check the procedure for susceptibility tests performed on Mycobacterium tuberculosis isolated with a strain of Mycobacterium tuberculosis susceptible to all antimycobacterial agents tested.

13. For laboratories conducting mycological testing, the laboratory shall:

a. Each day of use, if using the auxanographic medium for nitrate assimilation, check the nitrate reagents with a peptone control;

b. Each week of use check the acid-fast stain's reactivity with a positive and a negative control organism; and c. Each day of use test each drug for susceptibility tests with at least one (1) control strain that is susceptible to the drug and ensure that patient test results are reported only when control results are within the laboratory's established control limits.

14. For laboratories performing parasitology tests, the laboratory shall:

a. Have available a reference collection of slides or photographs and, if available, gross specimens for identification of parasites and use these references in the laboratory for appropriate comparison with diagnostic specimens;

b. Calibrate and use the calibrated ocular micrometer for determining the size of ova and parasites, if size is a critical parameter. Calibration of the micrometer shall be checked annually or after microscope repair or major maintenance. Documentation of the calibration is required; and

c. Check permanent stains each month of use using a fecal sample control that will demonstrate staining characteristics.

15. For laboratories performing virology tests, the laboratory shall:

a. Have available host systems for the isolation of viruses and identification methods that cover the entire range of viruses that are etiologically related to clinical diseases for which services are offered;

b. Maintain records that reflect the systems used and the reactions observed; and

c. Simultaneously culture, for identification tests, uninoculated cells or cell substrate controls as a negative control to detect erroneous identification results.

16. A microbiological safety cabinet shall be used when mycobacteriology or mycology cultures are manipulated. The cabinet shall meet the following special requirements:

a. Have a face velocity of at least seventy-five (75) feet per minute;

b. Be connected to an independent exhaust system;

c. Have filters with 99.97 percent efficiency (based on the dioctylphthalate (DOP) test method) in the exhaust system;

d. Be designed and equipped to permit the safe removal, disposal and replacement of contaminated filters; and

e. Be provided with a means of disinfection.

17. Mycology, mycobacteriology or virology cultures shall be disinfected prior to leaving the control of the laboratory.

L. Pathology (Histopathology and Cytology).

1. The ventilation system shall be adequate to properly remove vapors, fumes and excessive heat.

2. Staining dishes shall be properly labeled and covered when not in use.

3. Flow charts that reflect the staining procedure used shall be available.

4. A control slide of known reactivity shall be included with each slide or group of slides for differential or special stains. Reaction of the control slide with each special stain shall be documented.

5. For cytology stains:

a. All gynecologic smears shall be stained using a Papanicolaou (PAP) or modified PAP staining method;

b. Effective measures shall be taken to prevent cross-contamination between gynecologic and non-gynecologic specimens during the staining process;

c. Non-gynecologic specimens that have a high potential for cross-contamination shall be stained separately from other non-gynecologic specimens, and the stains shall be filtered or changed following staining.

6. All cytology slide preparations shall be retained for five (5) years.

7. For histopathology:

a. All stained slides shall be retained at least ten (10) years;

b. All specimen blocks shall be retained at least two (2) years; and

c. All remnants of tissue specimens shall be retained in a manner that assures proper preservation of the tissue specimens until the portions submitted for microscopic examination have been examined and a diagnosis has been made.

8. An exact duplicate of each test report shall be retained for at least ten (10) years.

9. The following reports shall be signed to reflect the review of a board-certified pathologist, or, as applicable, another individual meeting the qualifications specified in the CLIA requirements:

a. All tissue pathology reports;

b. All non-gynecologic cytology reports;

c. All gynecologic cytology reports on smears containing cells exhibiting reactive or reparative changes, atypical squamous/glandular cells, premalignant or malignant condition.

NOTE: If an electronic signature is used, the laboratory shall ensure that only the authorized person can release the signature. Refer to Section 14, Health Information Services.

10. The laboratory shall compare clinical information, when available, with cytology reports and shall compare each malignant and premalignant gynecology report with the histopathology report, if available, and determine the causes of any discrepancies.

11. All tissues surgically removed shall be examined by an anatomic pathologist. The Medical Staff shall develop a list of tissues that need not be examined.

12. A frozen section diagnosis, as reported to the surgeon, shall be documented and signed by the pathologist at the time the frozen section is performed. The documentation may be on the requisition, a patient test log, or a report form.

13. Autopsy services shall be under the supervision of a board-certified pathologist.

14. Autopsy findings in a complete protocol shall be filed in the patient's medical record within sixty (60) days of the autopsy. A provisional anatomical diagnosis shall be recorded within seventy-two (72) hours after autopsy. A duplicate copy of the autopsy report shall be maintained in the laboratory autopsy file.

M. Radiobioassay.

1. Background checks shall be performed each day at the proper window setting for each type of isotope being used, as applicable.

2. Criteria for unacceptable changes in background levels shall be established.

3. Safety precautions shall be written and appropriately displayed. Film badges and/or rings shall be worn, as applicable.

4. There shall be written procedures to assure reliability of testing and safety of patients and personnel.

5. All procedures for safety and disposal of radioactive waste shall conform to the most current Rules and Regulations for Control of Sources of Ionizing Radiation adopted and promulgated by the Arkansas State Board of Health.

N. Quality Improvement.

1. Each laboratory shall establish a Quality Improvement plan. The plan shall follow written policies and procedures for a comprehensive program which monitors and evaluates the ongoing and overall quality of the total testing process. The plan shall evaluate the effectiveness of the laboratory's policies and procedures, identify and correct problems, assure the accurate, reliable and prompt reporting of test results, and assure the adequacy and competency of the staff. As necessary, the laboratory shall revise policies and procedures based upon the results of those evaluations.

2. All Quality Improvement activities shall be documented.

3. The laboratory shall have an ongoing mechanism for monitoring and evaluating the following:

a. The criteria established for patient preparation, specimen collection, labeling, preservation and transportation;

b. The information solicited and obtained on the laboratory requisition for its completeness, relevance and necessity for testing patient specimens;

c. The use and appropriateness of criteria established for specimen rejection;

d. The completeness, usefulness and accuracy of the test report information necessary for the interpretation or utilization of test results;

e. The timely reporting of test results based on testing priorities (STAT, routine, manufacturer's instructions, etc.);

f. The accuracy and reliability of test reporting and record storage and retrieval;

g. The effectiveness of corrective actions taken for:

1) Problems identified during the evaluation of calibration and control data for each test method;

2) Problems identified during the evaluation of patient test values for the purpose of verifying the reference range of a test method;

3) Errors detected in previously reported test results.

h. The effectiveness of corrective actions taken for any unacceptable, unsatisfactory or unsuccessful proficiency testing results.

4. Laboratories that perform the same testing using different methodologies or instruments, or perform the same test at multiple testing sites, shall have a system that twice a year evaluates and defines the relationship between test results using different methodologies, instruments or test sites.

5. Laboratories that perform tests that are not challenged with a proficiency testing program shall have a system for verifying the accuracy and reliability of its test results at least twice per year.

6. The laboratory shall have a mechanism to identify and evaluate patient test results that appear inconsistent with relevant criteria such as patient age, sex, diagnosis or pertinent clinical data, when provided; distribution of patient test results, when available; and relationship with other test parameters, when available.

7. The laboratory shall have an ongoing mechanism to evaluate the effectiveness of its policies and procedures for assuring employee competence.

8. The laboratory shall have a system in place to document problems that occur as a result of breakdowns in communication between the laboratory and the authorized individual who orders or receives the results of test procedures or examinations. Corrective actions shall be taken, as necessary, to resolve the problems and minimize communication breakdowns.

9. The laboratory shall have a system in place to assure that all complaints and problems reported to the laboratory are documented. Investigations of complaints shall be made, when appropriate, and, as necessary, corrective actions shall be instituted.

10. The laboratory shall have a mechanism for documenting and assessing problems identified during quality improvement reviews and discussing them with the staff. The laboratory shall take corrective actions that prevent reoccurrences.

11. The laboratory shall maintain documentation of all quality improvement activities, including problems identified and corrective actions taken. All quality improvement records shall be available and maintained for a period of two (2) years.

O. Safety.

1. The physical plant and environmental conditions of the laboratory shall provide a safe environment in which employees, as well as all other individuals, are protected from physical, chemical and biological hazards.

2. Safety precautions shall be established, posted and observed to ensure protection from physical, chemical, biochemical and electrical hazards as well as biohazardous materials.

P. Point of Care Testing.

1. The requirements under this section apply only to the following tests which employ simple and accurate methodologies, as defined by the Centers for Disease Control and Prevention (CDC):

a. Dipstick or tablet reagent urinalysis;

b. Fecal occult blood;

c. Urine pregnancy tests (visual color comparison);

d. Hemoglobin by single analyte instrument with self-contained or component features to perform specimen/reagent interaction, providing direct measurement and readout;

e. Whole blood glucose by devices approved for home use;

f. Spun microhematocrit;

g. Whole blood immunoassay for Helicobacter pylori;

h. Rapid test for Group A streptococcal antigen from throat swabs; and

i. Glycosylated hemoglobin (Hgb Alc).

2. All testing personnel shall have earned a high school diploma or equivalent.

3. There shall be documentation that prior to testing patients' specimens each individual has received training for each test to be performed and has demonstrated the ability to perform all testing operations reliably.

4. Manufacturer's instructions for each of the tests shall be available in each area in which the specific test is performed and shall be followed by all testing personnel.

5. Components of reagent kits of different lot numbers shall not be interchanged unless otherwise specified by the manufacturer.

6. Reagents, control and calibration materials and other supplies shall be stored and handled in a manner to ensure that they are not used when the expiration date has been exceeded or when they have deteriorated or are of substandard quality.

7. Quality control procedures shall be performed in accordance with the manufacturer's instructions, at a minimum. Additional quality control procedures shall be performed as determined by the director of the hospital laboratory.

8. Maximum packing time of the microhematocrit centrifuge shall be determined at least every six (6) months.

9. The test record system shall include at least the following:

a. Identification of the patient;

b. Name of the authorized person who ordered the test;

c. Test performed;

d. Date and time of test performance;

e. Identity of the person who performed the test;

f. Test results; and g. Any additional information relevant and necessary for the interpretation of the results of a specific test.

10. The configuration of the test system shall be determined by the facility.

11. All required records shall be readily retrievable for at least two (2) years.

12. Point of Care Testing shall be included in the hospital laboratory's Quality Improvement program.

13. Any tests other than those specified in P(1) above shall be subject to all of the requirements of Section 19.

SECTION 20: RADIOLOGICAL SERVICES.

A. Radiology.

1. Each hospital shall have shock-proof diagnostic X-ray facilities.

2. Radiological Services shall be under the supervision of a physician, who is a member of the Medical Staff.

a. The physician director shall be certified (or eligible for examination) by the American Board of Radiology.

b. At a minimum, a board certified radiologist shall be available on a consultative basis. Documentation of the radiologist's visits shall be required.

3. Radiological Services shall be supervised by a technologist who is qualified by experience or education and has at least two (2) years technical experience.

4. A radiologic technologist with at least two (2) years training shall be on duty twenty-four (24) hours or on call at all times.

5. Radiologic staff who use the radiologic equipment and administer procedures shall have written verification of training and shall have approval in writing by the physician director and Medical Staff.

6. Radiologic technologists shall not independently perform fluoroscopic procedures.

7. Radiologic staff who administer agents for diagnostic purposes shall have written verification of training and approval by the physician director and individual(s) supervising the training.

8. Radiology personnel who participate in direct patient care shall have current Cardiopulmonary Resuscitation (CPR) certification or the equivalent.

9. Clinically relevant inservice educational programs shall be conducted at regularly scheduled intervals with not less than twelve (12) per year. There shall be written documentation with employee signatures, program title/subject, presenter, date, and outline or narrative of presented program.

10. Policies and procedures for the department shall have evidence of ongoing review and/or revision. The first page of each manual shall have the annual review date, signature of the department and/or person(s) conducting the review. Policies and procedures shall include:

a. Job descriptions for every type employee;

b. A written list of all tests/procedures performed by the Radiology Department and the list shall be available to the Medical Staff;

c. Infection control measures;

d. The holding of patients;

e. Orientation practices for new employees;

f. Operation of equipment;

g. Management of an adverse reaction;

h. Cleaning and disinfecting procedures; and

i. Posting of signs.

11. Radiology personnel shall receive yearly instruction in:

a. Safety precautions;

b. Managing emergency radiation hazards and accidents.

12. A documented preventive maintenance and quality control program shall include:

a. Radiology personnel shall wear a whole body monitoring device if they are likely to receive a radiation dose greater than ten (10) percent of the annual total effective dose equivalent limit of five (5) rem. Monitoring of radiology personnel for exposure to radiation with integration over a period not to exceed one (1) month;

b. Preventive maintenance for all diagnostic and therapeutic radiologic equipment to assure a safe working condition. Safety and calibration checks shall be made according to manufacturer's directions, not exceeding one (1) year intervals;

c. Annual inspection of all leaded gloves, aprons and similar protective devices at least once a year with documentation to include: the name of the examiner, identification of the protective device examined and the results plus corrective action taken;

d. Documentation of safety, calibration, and inspection checks maintained for the life of the equipment;

e. Remedial and corrective action recorded in response to equipment "down time," with documentation to include: the piece of equipment involved, time/date malfunction occurred, action taken, time/date when the equipment became operational.

13. X-ray films shall not be stored in radiologic examination rooms.

14. X-ray films shall be filed according to a recognized filing system.

15. X-ray prescription/work requests shall be authorized by a written and signed physician's order and shall include the following:

a. Identification of the patient;

b. Date the test was ordered;

c. Physician's name;

d. Concise statement as to the reason why the x-ray/test was ordered; and

e. Originator's signature.

16. The radiologic report shall be signed by a credentialed physician and shall be placed in the medical record.

17. The Radiological Services shall have an ongoing QI program that addresses patient care issues. A mechanism for reporting results of audits shall be provided, to include: indicators monitored, thresholds/standards, results, corrective plan/corrective action taken, and follow-up.

18. This section establishes requirements for radiology that are in addition to, not in substitution of the Arkansas State Board of Health Rules and Regulations for Control of Sources of Ionizing Radiation.

19. Actual X-ray film shall be retained for five (5) years.

20. X-ray films and reports shall be stored in a room that is equipped with a smoke detection system. An extinguishing system shall be made available.

21. Locked security shall be ensured for the written reports maintained in the X-ray file when the storage area is not under the direct supervision of radiology personnel.

B. Nuclear Medicine Services.

1. Nuclear Medicine procedures shall be under the direction of a physician, qualified in Nuclear Medicine, who is a member of the Medical Staff.

2. Nuclear Medicine services shall be supervised by a nuclear medicine technologist who has completed certification requirements and has at least two (2) years technical experience.

3. Nuclear Medicine staff who use the equipment and administer procedures shall have written verification of training and shall have approval in writing by the physician director and Medical Staff.

4. All radioactive materials shall be purchased, stored, administered, and disposed of in a manner consistent with the requirements of the Rules and Regulations for Control of Sources of Ionizing Radiation or with the specific condition of a Radioactive Material License issued pursuant to these regulations.

5. The policy and procedure manual shall be reviewed annually and revised as necessary. Included in the manual shall be a cover page with signatures of those reviewing the manual and a month/day/year of review. The policies and procedures shall include:

a. Job description for each employee;

b. A list of tests/procedures performed by Nuclear Medicine;

c. Safety practices;

d. Management of an adverse reaction;

e. Orientation for new employees;

f. Operation of equipment;

g. Cleaning and disinfecting procedures;

h. Posting of signs;

i. Quality control;

j. Quality Improvement;

k. Clean up of spills;

l. Receipt/disposal of radioactive materials; and

m. Radiation safety plan.

6. All nuclear medicine personnel who participate in direct patient care shall maintain competency in life support measures.

7. There shall be a documented preventive maintenance and quality control program:

a. Monitoring of nuclear medicine personnel for exposure to radiation shall be integrated over a period not to exceed one (1) month;

b. Nuclear medicine personnel shall wear a whole body monitoring device if they are likely to receive a radiation dose greater than ten (10) percent of the annual total effective dose equivalent limit of five (5) rem. They shall also wear an extremity monitoring device if they are likely to receive a radiation dose to the extremity or skin greater than ten (10) percent of the skin or extremity dose limit of fifty (50) rem;

c. All nuclear medicine equipment shall be maintained in safe working condition. Preventive maintenance, safety and calibration checks shall be made according to manufacturer's directions, not to exceed one (1) year interval;

d. Documentation of all safety, calibration, and inspection checks shall be maintained for the life of the equipment;

e. Remedial and corrective action shall be recorded in response to equipment "down time." Documentation shall include: the piece of equipment involved, time/date malfunction occurred, action taken, time/date when equipment became operational again.

8. The nuclear medicine "hot lab" shall be kept locked when not under the direct supervision of authorized personnel.

9. There shall be an emergency eye wash available in the nuclear medicine "hot lab".

10. All nuclear medicine staff who administer agents for diagnostic purposes shall have written verification of training and approval by the physician director and individual(s) supervising the training.

11. Clinically relevant inservice educational programs shall be conducted on a regularly scheduled intervals at not less than twelve (12) per year. There shall be written documentation with employee signature, program title/subject, presenter, date and outline or narrative of presented program.

12. All nuclear medicine requests shall be authorized by a written and signed physician's order and shall include the following:

a. Identification of the patient;

b. Date;

c. Physician's name;

d. Originator's signature; and

e. Reason/justification for the test.

13. The nuclear medicine report shall be signed by a credentialed physician. The original shall be placed in the medical record.

14. Films shall not be stored in radiologic or nuclear medicine examination rooms.

15. The storage of nuclear medicine films shall comply with the guidelines under Section 20, Radiological Services.

C. Guidelines for Mobile Services. The Governing Body and Medical Staff shall approve the provisions for establishing services in accordance with the following criteria:

1. General Considerations.

a. The installation is governed by the following Arkansas Department of Health publications:

1) Rules and Regulations for Hospitals and Related Institutions, Section 20, Radiological Services; and

2) Rules and Regulations for Control of Source of Ionizing Radiation.

b. Approvals shall be granted by the Arkansas Department of Health:

1) Health Facility Services; and

2) Radiation Control and Emergency Management.

c. The mobile service provider shall maintain fire, theft, general and professional liability insurance.

2. Operating Policies.

a. All examinations shall be authorized by a written and signed physician's order;

b. Examinations shall be performed under the direction of and interpreted by a qualified physician, with documented training or experience, who is a member of the hospital's Medical Staff;

c. Examinations shall be performed by a radiologic technician with documented training and experience;

d. The Radiology Department shall maintain current policies and procedures for use of the mobile units to include infection control and safety.

e. All personnel who administer agents for diagnostic purposes shall have written verification of training and approval by the physician director and individual(s) supervising the training;

f. Hospital personnel shall transport patients to and from the mobile unit according to hospital safety policies;

g. Oxygen and emergency medical supplies shall be maintained within the suite or mobile unit or readily available;

h. The hospital Pharmacy may provide necessary medical supplies including contrast media, but proper handling and control of dated items shall be ensured;

i. A log of all patients shall be maintained;

j. Films shall be maintained in the same manner as X-ray films;

k. Technicians who participate in direct patient care shall be competent in life support measures; and

l. Contracted services shall be under current agreement and the contractor shall fulfill all requirements of this section.

3. Refer to Section 56, Physical Facilities, Imaging Suite.

SECTION 21: PHYSICAL THERAPY. Licensed physical therapist means any person licensed to practice physical therapy by the Arkansas State Board of Physical Therapy.

The practice of licensed physical therapy assistants shall be performed under the supervision of the licensed physical therapist. The supervising therapist shall be readily available for consultations, evaluations, and establishment of each program prior to delegation of any treatments and determination of patient discharge.

If physical therapy services are rendered by an individual who does not meet at least the assistant-level qualifications (aide/technician), a qualified physical therapist shall be on the premises and immediately available to provide assistance and direction throughout the time the services are rendered.

A. Physical therapy services shall be provided under the direction of a physician member of the Medical Staff.

B. Physical therapy services shall be supervised by a physical therapist licensed by the Arkansas State Board of Physical Therapy. Physical therapy assistants and aides shall comply with all state licensure requirements.

C. A policy and procedure manual for Physical Therapy shall be developed. The manual shall have evidence of ongoing review and/or revision. The first page of each manual shall have the annual review date, signature of the department supervisor and/or person(s) conducting the review.

D. There shall be written policies and procedures which shall include:

1. Job descriptions for each type of employee;

2. Infection control measures;

3. Standards of care;

4. Criteria for assuring continuous communication of the patient's therapy and progress to the physician;

5. Assembly and operation of equipment;

6. Physical therapy services provided and a list of services made available to the Medical Staff;

7. Documentation specifying who may perform special procedures and give patient instruction; this shall be verified by the physician director;

8. Safety practices;

9. Orientation practices for new employees; and 10. Cleaning, disinfecting and sterilizing procedures.

E. There shall be an adequate supply of reference material for the physical therapist which shall include current literature.

F. All physical therapy prescriptions/work requests shall be authorized by a written and signed physician's order.

G. Equipment shall be adequate for the services offered and maintained in good repair.

1. Equipment shall be serviced, calibrated, and operated according to the manufacturer's directions.

2. All physical therapy equipment shall be under the control of the physical therapy supervisor.

3. A preventive maintenance program shall be implemented with periodic inspection of all equipment and appropriate records maintained for the life of each piece of equipment.

4. All temperature-dependent patient use equipment shall have the temperature checked and recorded before each patient use or at least daily, if used, to ensure patient safety.

H. Physical therapy records for each patient shall include:

1. Current written plan of care;

2. Statement of treatment objectives;

3. Statement of patient's short-term and long-term rehabilitation potential;

4. Functional limitations;

5. Justification of continued rehabilitative care; and

6. Documentation of daily treatments.

I. Clinically relevant inservice educational programs shall be conducted on a regularly scheduled interval not less than twelve (12) times per year. There shall be written documentation with employee signature, program title/subject, presenter, date and outline or narrative of presented program.

J. All physical therapy personnel shall maintain competency in CPR.

K. There shall be an ongoing QI program.

L. Hospitals which have swimming pools shall comply with applicable sections of Rules and Regulations Pertaining to Swimming Pools and Other Related Facilities.

M. Contracted physical therapy services shall be under current agreement and the contractor shall fulfill all requirements of this Section.

SECTION 22: OCCUPATIONAL THERAPY. In facilities with an organized Occupational Therapy Department, the following shall apply:

A. Occupational Therapy Services shall be under the direction of a physician member of the Medical Staff.

B. Occupational Therapy Services shall be supervised by a currently licensed therapist in the field of rehabilitation services.

C. There shall be sufficient occupational therapy supportive technical staff to provide authorized Occupational Therapy Services.

D. The policy and procedure manual shall have evidence of ongoing review and/or revision. The first page of each manual shall have the annual review date, signature of the department supervisor and/or person(s) conducting the review.

E. There shall be written policies and procedures which shall include:

1. Job descriptions for every type of employee;

2. Documentation specifying who may perform special procedures and give patient instructions. This shall be verified by the physician director;

3. Orientation practices for new employees;

4. Occupational therapy services provided and a list of services provided to the Medical Staff; and

5. Safety practices.

F. Current reference material shall be available for the occupational therapist.

G. All occupational therapy prescriptions/work requests shall be authorized by a written and signed physician's order.

H. Equipment shall be adequate for the services offered and maintained in good repair.

1. Equipment shall be serviced, calibrated, and operated according to the manufacturer's directions.

2. All occupational therapy equipment shall be under the control of the occupational therapy supervisor.

3. A preventive maintenance program shall be implemented with periodic inspection of all equipment and appropriate records maintained for the life of each piece of equipment.

4. All temperature-dependent patient use equipment shall have the temperature checked and recorded before each patient use.

When appropriate elements are planned and arranged for shared use by physical therapy patients and staff, one (1) or both services shall be responsible for the preventive maintenance program and the retention of records.

I. Occupational therapy records for each patient shall include:

1. Current written plan of care;

2. Statement of treatment objectives;

3. Statement of patient's short-term and long-term rehabilitation potential;

4. Justification of any continued rehabilitation care; and

5. Documentation of the patient's condition and response to treatments.

J. Clinically relevant inservice educational programs shall be conducted on a regularly scheduled basis at not less than twelve (12) per year. There shall be written documentation with employee signature, program title/subject, presenter, date and outline or narrative of presented program.

K. All occupational therapy personnel shall maintain competency in life support measures.

L. There shall be an ongoing QI program.

M. Contracted occupational therapy services shall be under current agreement and the contractor shall fulfill all requirements of this Section.

SECTION 23: SPEECH PATHOLOGY/AUDIOLOGY SERVICES. In facilities with an organized Speech Language Pathology/Audiology Services Department, the following shall apply:

A. Speech Pathology/Audiology Services shall be under the direction of a physician member of the Medical Staff.

B. Speech Pathology/Audiology Services shall be supervised by a therapist who is currently licensed.

C. There shall be sufficient supportive personnel to provide authorized speech pathology/audiology services.

D. There shall be documentation, verified by the physician director, of who may perform special procedures and give patient instructions.

E. Policies and procedures shall have evidence of ongoing review and/or revision. The first page of each manual shall have the annual review date, signature of the department supervisor and/or person(s) conducting the review.

F. There shall be written policies and procedures which shall include:

1. Job descriptions for every type of employee;

2. Orientation procedures for new employees;

3. Infection control measures;

4. A listing of services/treatments available to the Medical Staff; and

5. Safety practices.

G. Equipment shall be in good repair and under the control of the therapist supervisor. Documentation of preventive maintenance shall be maintained for the life of each piece of equipment.

H. Current reference material shall be available for the department.

I. Clinically relevant inservice educational programs shall be conducted on a regularly scheduled basis at not less than twelve (12) per year. There shall be written documentation with employee signature, program title/subject, presenter, date and outline or narrative of presented program.

J. All speech pathology/audiology prescriptions/work requests shall be authorized by a written and signed physician's order.

K. Speech Pathology/Audiology Services records for each patient shall include:

1. Current written plan of care;

2. Statement of treatment objectives;

3. Statement of patient's short-term and long-term rehabilitation potential;

4. Justification of any continued rehabilitation care; and

5. Documentation of progress notes following treatment given to patients.

L. All Speech Pathology/Audiology personnel shall maintain competency in CPR;

M. There shall be an ongoing QI program.

N. Contracted Speech Pathology/Audiology Services shall be under current agreement and the contractor shall fulfill all requirements of this Section.

SECTION 24: RECREATIONAL THERAPY. In facilities with organized Recreational Therapy Services, the following shall apply:

A. Recreational Therapy Services shall be under the direction of a physician member of the Medical Staff;

B. Recreational Therapy Services shall be supervised by a therapist with current certification;

C. There shall be sufficient Recreational Therapy supportive staff to provide authorized Recreational Therapy Services;

D. There shall be documentation, verified by the physician director, of who may perform special procedures and give patient instructions;

E. The policy and procedure manual shall have evidence of ongoing review and/or revision. The first page of the manual shall have the annual review date, signature of the department supervisor and/or person(s) conducting the review;

F. There shall be written policies and procedures which shall include:

1. Job descriptions;

2. Infection control measures;

3. Recreational Therapy Services provided and a list of services shall be made available to the Medical Staff;

4. Orientation practices for new employees and volunteer personnel;

5. Assembly, operation and maintenance of all equipment;

6. Safety practices;

7. Security of supplies and tools; and

8. Activities off-campus.

G. All equipment, tools, and machines shall be in good repair and under the control of the therapist supervisor. Documentation of preventive maintenance shall be maintained for the life of each piece of equipment;

H. Current reference material shall be available for the department;

I. Clinically relevant inservice educational programs shall be conducted on a regularly scheduled basis at not less than twelve (12) per year. There shall be written documentation with employee signature, program title/subject, presenter, date and outline or narrative of presented program;

J. All recreational therapy prescriptions/work requests shall be authorized by a written and signed physician's order and shall include:

1. Identification of the patient;

2. Date;

3. Physician's name;

4. Type, frequency, and duration of treatment; and

5. Originating signature.

K. Recreational Therapy Services records for each patient shall include:

1. Current written plan of care;

2. Documentation of attendance by the therapist in team meetings and the contribution by the therapist to the treatment plan;

3. Statement of treatment objectives;

4. Statement of patient's short-term and long-term rehabilitation potential;

5. Record of daily activity participation;

6. Justification of any continued rehabilitation care; and

7. Progress notes.

L. All Recreational Therapy personnel shall maintain competency in life support measures;

M. There shall be an ongoing QI program;

N. If food and/or nutritional service functions are offered, infection control, storage, and supervision shall be coordinated with the Dietary Department of the facility;

O. Contracted Recreational Therapy Services shall be under current agreement and the contractor shall fulfill all requirements of this Section.

SECTION 25: PET THERAPY PROGRAM.

A. The Pet Therapy Program shall be approved by the Governing Body, Medical Staff and the Infection Control Officer.

B. Only dogs shall be used in Pet Therapy. Potential pet volunteers and their dogs shall be screened by a local animal protection society or veterinarian using the health and behavior tools listed in tables in the Appendix (Table 7, Dog History and Table 6, Behavioral Screening Exam). The dog shall pass a behavioral and medical screen before participating in a Pet Therapy Program. Records of the examinations shall be maintained by the Pet Therapy Program.

1. The behavioral screen shall be performed semiannually and shall include assessment of the dog's response to a new environment, the approach of physical contact and interaction with a stranger, response to an unexpected loud noise, response to painful stimulation and reaction to an unexpected event. See Table 6 in the Appendix (Behavioral Screening Exam).

2. The medical screening examination shall include proof of up-to-date immunizations (distemper, parainfluenza, hepatitis, parvovirus, and rabies), fecal and nasal cultures every four (4) months, routine medication for the prevention of heartworms and a flea prevention routine. See Table 7 of the Appendix, (Volunteer Dog History). Animals culturing positive for Giardia, group A streptococcus, Shigella Salmonella and Campylobacter shall be excluded from the program until the animal is treated and one (1) negative culture is obtained. Reports of all organisms isolated shall be forwarded to the Infection Control Office for review.

C. Volunteers shall attend the hospital's volunteer orientation program and meet with members of the hospital's Recreation Therapy Team.

D. The dog shall be bathed at least weekly with a flea shampoo and receive anti-flea dip according to a veterinary's schedule. The dog shall be brushed and groomed before each hospital visit.

E. While in the hospital the dog shall be on a leash and be under the direct supervision of the handler at all times. The dog and pet volunteer shall be escorted through the hospital. If an elevator must be used, only the escort, dog and handler shall be the occupants. The dog shall not traverse acute patient care corridors.

F. Dogs on antibiotic therapy for an infection, with skin or ear infections, wearing a bandage, experiencing any gastrointestinal upset, or who are in "heat" shall be excluded from hospital visits.

G. Animals shall be allowed only in designated areas, such as recreational therapy rooms, day rooms, or group therapy rooms and never into critical areas such as patient rooms, ICU or physical therapy areas.

H. Dogs shall be walked fifteen (15) minutes prior to admission to the designated pet therapy care area. There shall be procedures for immediate clean up in case the dog has an accident.

I. The attending physician shall write an order in the medical record for the patient to participate in pet therapy. Parents shall sign a consent form for children to participate in pet therapy.

J. There shall be procedures for handwashing and cleaning of the patient after pet therapy.

K. Hospitalized patients with the following shall be excluded from pet visitation program:

1. Open sores or exposed areas of skin;

2. Aggressive behavior;

3. Neutropenia (WBC<1000);

4. HIV-infection;

5. Immunoglobulin deficiencies;

6. An immunocompromised state (and not in protective isolation) or who have an immunocompromised roommate;

7. Patients whose roommate has an allergy to dogs;

8. Psychoses, hallucinations or confusion or an altered perception of reality that is not amenable to rational explanations; and

9. Functional asplenia.

L. Animals shall not be allowed to play with children's toys.

SECTION 26: SPECIALIZED SERVICES: SURGICAL SERVICES.

A. Organization and Supervision.

1. An organizational plan shall be developed.

2. Surgical Services shall be under the medical direction of a qualified physician or a physician committee.

3. A Surgical Services Registered Nurse supervisor shall be accountable and responsible for patient care.

4. Surgical Services shall have written policies and procedures that include:

a. Operative and special consents;

b. Fire and disaster plans;

c. Environmental control;

d. Visitor and traffic control to include allowance for no one other than staff or professionals without the expressed consent of the physician and operating room supervisor;

e. Safety practices;

f. Infection control measures;

g. Care and disposition of surgical specimens, cultures, and foreign bodies;

h. Care of special equipment including preventive maintenance contracts and records;

i. Emergency management;

j. Orientation of all personnel; and

k. Medication accountability. (Refer to Section 11, Patient Care Service and Section 16, Pharmacy.)

5. Clinically relevant inservice educational programs shall be conducted on a regularly scheduled basis not less than twelve (12) per year. There shall be written documentation with employee signature, program title/subject, presenter, date and outline or narrative of presented program.

6. A surgery schedule shall be maintained in the surgery suite.

7. There shall be a continuous QI program that is specific to the patient care administered.

8. A current roster of physicians and dentists with a delineation of each physician's and dentist's surgical privileges shall be accessible and available in the confidential files of the Surgical Services Registered Nurse and in the files of the hospital administrator.

9. The following information shall be maintained in the surgery services log:

a. Patient's full name;

b. Hospital number;

c. Surgeon;

d. Assistant surgeon;

e. Type of anesthetic and person administering;

f. Pre and postoperative diagnoses;

g. Circulating nurse;

h. Scrub nurse(s);

i. Procedures;

j. Complications;

k. Sponge, needle, and instrument count;

l. Time of beginning and ending of case; and

m. Other persons present.

B. Environment, Equipment and Supplies.

1. A safe operating room environment shall be established, controlled and consistently monitored.

2. At a minimum, the following general equipment and supplies shall be in the surgical suite:

a. Call-in system;

b. Crash cart;

c. Cardiac monitor

d. Defibrillator;

e. Resuscitating equipment;

f. Suction equipment;

g. Thoracotomy set.

3. Equipment and supplies necessary to meet the requirements of the services provided:

a. Stretcher;

b. Anesthetic equipment and supplies;

c. Adjustable operating table with waterproof pad;

d. Side tables;

e. Approved surgical light;

f. Medical gases;

g. Twenty-four (24) hour supply of sterile linen;

h. Wall clock; and

i. Equipment and supplies for timed scrubbing technique.

C. Staffing.

1. Surgical personnel including a Registered Nurse shall be available to provide emergency surgical services on a twenty-four (24) hour basis.

2. A Registered Nurse shall be present in the operating room for the duration of the surgical procedure. Additional auxiliary personnel shall be available as necessary.

3. Only qualified Registered Nurses may perform circulating duties in the operating room.

4. There shall be documentation of training and/or experience for all operating room personnel assigned to surgical procedures.

SECTION 27: SPECIALIZED SERVICES: POSTANESTHESIA CARE UNIT.

A. Postanesthesia Care Unit (PACU) Services shall be provided in a well organized manner under the direction of a qualified physician and under the supervision of a Registered Nurse.

B. Policies and procedures shall have evidence of ongoing review and/or revision. The first page of each manual shall have the annual review date, signature of the department supervisor and/or person(s) conducting the review. Policies and procedures shall include:

1. Lines of authority and nursing supervision;

2. Transfer of patients from the Operating Room to Postanesthesia Care Unit;

3. Criteria for discharge of patients from the Postanesthesia Care Unit; and

4. The care of patients in the event the Postanesthesia Care Unit closes (including provisions of adequate nursing staff).

C. There shall be adequate nursing staff in attendance with every patient during anesthesia recovery.

D. A physician shall order the discharge of the patient from the Postanesthesia Care Unit.

E. Equipment shall be available in accordance with services provided.

F. The Registered Nurse shall assess and document assessment of each PACU patient.

G. Clinically relevant inservice educational programs shall be conducted on a regularly scheduled basis not less than twelve (12) per year. There shall be documentation which includes program content, presenter, date, time presented and signatures of attendees.

H. There shall be an ongoing QI program that is specific to the patient care administered.

SECTION 28: SPECIALIZED SERVICES: AMBULATORY SURGERY SERVICES.

A. There shall be policies and procedures specific to Ambulatory Surgery Services. Policies and procedures for the department shall have evidence of ongoing review and/or revision. The first page of each manual shall have the annual review date, signature of the department supervisor and/or person(s) conducting the review.

B. Policies and procedures shall include:

1. Scheduling of patients for surgery;

2. Admission and discharge criteria;

3. Perioperative patient care;

4. Operative and special consents;

5. Obtaining a documented history and physical on the patient's medical record prior to the procedure. Refer to Health Information Services, Section 14;

6. Preoperative assessment procedures required by the Medical Staff; and

7. Medication accountability. (Refer to Section 11, Patient Care Service, Section 12, Medications and Section 16, Pharmacy.)

C. A physician shall order the discharge of the patient from the facility.

D. For additional requirements refer to Patient Care Service, Section 11, Specialized Services: Surgical Services, Section 26 and SpecializedServices: Postanesthesia Care Unit, Section 27.

SECTION 29: SPECIALIZED SERVICES: ANESTHESIA SERVICES.

A. Organization and Staffing. Anesthesia Services shall be provided in a well organized manner under the direction of a qualified physician. The service is responsible for all anesthesia administered.

B. Those administering anesthesia shall be credentialed by Medical Staff and approved by the Governing Body. A current roster, with delineation of privileges for those administering anesthesia, shall be maintained and readily available.

C. Anesthesia shall be administered by the following:

1. Anesthesiologist;

2. Physician qualified to administer anesthesia; or

3. Certified Registered Nurse Anesthetist (CRNA) under the supervision of a physician.

D. Written policies and procedures specific to Anesthesia Services shall have evidence of ongoing review and/or revision. The first page of the manual shall have the annual review date, signature of the department supervisor and/or person(s) conducting the review.

E. Policies and procedures shall include:

1. Preanesthesia evaluation;

2. Approved anesthesia agents;

3. Methods of delivery of anesthesia;

4. Intraoperative anesthesia record;

5. Postanesthesia follow-up report;

6. Mechanism for routine checking and maintenance of anesthesia machines and equipment for safe use;

7. Medication accountability. See Section 16, Pharmacy, Section 11, Patient Care Service, and Section 12, Medications;

8. Responsibilities in the discharge of patients from the Postanesthesia Care Unit. See Section 27, Postanesthesia Care Unit; and

9. Infection control measures.

F. All medications and anesthesic agents administered to the patient shall be ordered by the prescriber and/or anesthesia provider. This includes preoperative as well as intraoperative and postoperative medications.

G. There shall be an ongoing QI program that is specific to the patient care administered.

SECTION 30: SPECIALIZED SERVICES: LABOR, DELIVERY, LABOR DELIVERY RECOVERY (LDR), LABOR DELIVERY RECOVERY POST PARTUM (LDRP), POST PARTUM AND MATERNAL-CHILD EDUCATION.

A. Labor Room and/or LDR, LDRP Room.

1. Provisions shall be made for patients in labor in either a designated labor room and/or birthing room. Rooms used only for labor shall be in close proximity to the delivery room. Furniture, washable wallpaper, pictures, radio, television, and other items may be used as long as the needs of the mother and baby are not compromised. Items selected shall be made of durable materials, with a smooth, impervious surface which can be easily cleaned and disinfected.

2. All beds used for labor shall be equipped with side rails.

3. There shall be equipment and supplies available for the examination and preparation of patients in labor, which shall consist of the following:

a. Precipitous delivery tray;

b. Stethoscope;

c. Suction equipment;

d. Sterile gloves;

e. Emergency medications as approved by the Pharmacy and Therapeutics Committee and supplies to include laryngoscopes, airways, endotracheal tubes and infant ambu bags; and

f. Fetal monitoring device.

4. Oxytocin when administered a physician shall be immediately available. "Immediately available" shall be determined by the hospital's administrative staff, Medical Staff and Governing Body.

5. Father or support persons may be allowed with the patient during labor unless medically contraindicated.

B. Delivery Areas.

1. Hospitals offering delivery and maternity services shall comply with the requirements of this Section. (See Section 14, Health Information Services and Section 11, Patient Care Service.)

2. General operating rooms may not be used for deliveries, except for major surgical deliveries. Delivery rooms shall be separate from operating rooms and shall not be used for any other purpose, with the exception of a tubal ligation immediately following a delivery. Delivery rooms may be used for Caesarean sections provided the usual operating room equipment is used, and surgical policies and procedures related to the delivery are made a part of the labor and delivery manual.

3. The following equipment and supplies shall be provided:

a. Supply of medications as approved by the Pharmacy and Therapeutics Committee;

b. Infant identification and supplies. Identification shall be done in the delivery room at the time of birth and shall remain in place during the entire period of hospitalization. Identification information shall be sufficient to identify the infant(s) with one (1) mother. Identification bands shall be waterproof plastic with tag inserts written in waterproof ink;

c. Heated bassinet, crib, or incubator;

d. Supply of prophylaxis medication for the prevention of infant blindness. The medication shall be administered within one and one-half (1-1/2) hours of the time of birth per written order of the physician;

e. Commercially manufactured delivery table/birthing bed with a waterproof non-conductive table pad;

f. Side tables for instruments and other necessary equipment;

g. Approved surgical light;

h. Wall clock;

i. Equipment and supplies for timed scrub technique and an approved disinfectant soap;

j. Apgar score chart;

k. Suction equipment (infant and adult);

l. Sphygmomanometer; and

m. Fetal monitoring device.

C. Organization.

1. Delivery services shall be under the direction of a qualified physician and under the supervision of a Registered Nurse. A Registered Nurse shall be present during labor, delivery and postdelivery of each patient. The birth shall be attended by a licensed physician or a certified nurse midwife with hospital privileges.

2. Patients shall be provided with direct care by a Registered Nurse during labor, delivery, recovery and postpartum.

a. All patients in active labor shall be attended and/or monitored.

b. Qualified nurses, in adequate numbers shall be provided to meet the needs of each patient.

3. An on-call schedule shall be provided to ensure that a physician with obstetrical privileges is readily available to perform obstetrical services at all times.

4. Qualified Registered Nurses shall always be available in-house for labor and delivery patients. When there are no patients, on-call staff may be utilized if approved by the Medical Staff and Governing Body.

5. Procedures for obtaining the mother's Rh factor shall be provided by the facility or documented by the mother's attending physician upon admission.

6. When a patient presents to the hospital for evaluation, the physician shall be notified.

7. Policies and procedures shall include:

a. Immediate delivery;

b. Obstetrical emergencies;

c. Setting up and cleaning the delivery room, LDR or LDRP room, and C-section room;

d. Equipment requirements;

e. Visitation;

f. Climate control (physical);

g. Infection control measures;

h. Aseptic techniques;

i. Intermittent rooming in;

j. Anesthesia;

k. Deliveries occurring outside the delivery area;

l. Infectious patients; and

m. Infant security.

8. A permanent record of all deliveries shall be maintained. There shall be a reasonable attempt to collect current information to include the following:

a. Mother's name, date of birth, maiden name, father's name if available, hospital number, gravida-para, ABO type, Rh factor, and length of gestational period;

b. Baby's sex, race, date of birth, time of birth, weight, apgar score, and baby identification band number;

D. Anesthesia.

1. Only a physician, anesthesiologist or Certified Registered Nurse Anesthetist (CRNA) shall be permitted to initiate and reinject continual epidural or caudal anesthesia and to initiate or continue general or regional anesthesia.

2. A physician shall be immediately available if CRNAs are administering anesthesia.

3. The permanent record shall contain the names of the physician, anesthesiologist, anesthetist or CRNA.

E. Postpartum Care.

1. Policies and procedures shall be developed specific to the care of maternity patients.

2. Maternity patients shall not be routinely cared for in rooms with patients admitted for diagnosis other than maternity.

3. After an observation period, the infant may stay in the room with the mother for the duration of the hospital stay.

4. Mothers with infection, fever or other condition that could adversely affect the safety and welfare of others shall be immediately segregated and isolated in a separate room.

F. Maternal-Child Education. The hospital shall develop an educational program for the care of the obstetrical patient and infant. Policies and procedures shall include:

1. Personal hygiene;

2. Dietary instruction;

3. Care of episiotomy and perineum;

4. Care of incision;

5. Breast care;

6. Exercise program;

7. Car seat safety (Arkansas State Law);

8. Preventive health;

9. Referral services; and

10. Infant care.

SECTION 31: NURSERY SERVICES. The newborn nursery shall be under the direct supervision of a Registered Nurse with clinical skills in newborn nursing. The newborn nursery shall be located within or adjacent to the postpartum unit. The following requirements shall apply to all nurseries:

A. Nurseries shall not be used for any other purpose and shall never be left unattended when occupied.

B. Infants born outside the hospital or with proven or potential infections shall be isolated from other infants in the Nursery. Infants with infections, skin rash, or diarrhea shall be immediately separated and isolated.

C. Isolettes shall not serve as a sole means of isolation. Provisions for isolation shall be provided.

D. The following equipment shall be provided in nurseries:

1. Individual approved type hospital bassinets. Wicker or woven type bassinets shall not be used;

2. Metal or approved plastic diaper and waste containers. The lids on these containers shall be operated by a foot control or equivalent device;

3. Accurate scales;

4. Blankets and linen;

5. Suction equipment;

6. Incubators suitable for the care of premature infants provided in the ratio of at least one (1) incubator to twenty (20) bassinets;

E. Infant emergency supplies:

1. Emergency medications approved by the Pharmacy and Therapeutics Committee;

2. Infant laryngoscope;

3. Suction catheters;

4. Endotracheal tubes;

5. Stylets; and

6. Infant airways and IV supplies.

F. Strict handwashing techniques shall be maintained by the physicians and the nurses. A clean barrier shall be used by anyone handling the infant.

G. Infant clothing shall be furnished by the hospital; however, if the mother wishes to provide clothing for the infant, hospital personnel shall examine the clothing to make sure it meets hospital requirements. Diapers shall be available in necessary quantities.

H. Formula Feedings.

1. Any individually packaged, presterilized formula delivered by an outside source shall be approved by the facility.

2. There shall be an adequate supply of sterile disposable ready-to-use formula bottles available.

3. Formulas shall be stored in enclosed cabinets.

4. The expiration date shall be checked on each bottle prior to infant feeding.

5. Policies and procedures shall be developed in conjunction with the Infection Control Committee regarding the handling, labeling and storing (separately) of breast milk.

6. Individual nipple shields and breast pumps used in infant feeding shall be cleaned according to hospital infection control policies and procedures.

7. If the facility has a breast milk bank the policies and procedures shall be submitted to and approved by the Arkansas Department of Health and hospital Infection Control Committee.

I. Rooming-In Service. Hospitals providing a newborn nursery may provide rooming in for infants on an intermittent or twenty-four (24) hour basis based on the mother's request.

SECTION 32: SPECIALIZED SERVICES: CRITICAL CARE. A Critical Care Unit is a section of the hospital where intensive care nursing, necessary monitoring and treatment equipment and supplies are provided to those patients who, in the opinion of the attending physician, require such specialized services.

A. Staffing.

1. Critical Care Units shall be staffed with a Registered Nurse each shift.

2. All critical care nursing staff shall be oriented and trained in life support measures, interpretation of dysrhythmias and shall demonstrate competency in critical care nursing specific to patient types. Competency in the specific areas shall be maintained.

B. Policies and Procedures. Procedures shall include:

1. Admission and continuing stay criteria;

2. Discharge criteria;

3. Triage/transfer;

4. Use of protocols; and

5. Definition of the clinical scope of the hospital's critical care service.

C. Equipment. Equipment shall include:

1. Suction;

2. Diagnostic monitoring equipment to include electrocardiographic monitoring;

3. "Crash Cart" containing emergency medications and supplies;

4. Defibrillator;

5. Wall clock;

6. Accommodations to maintain privacy; and

7. Weighing device for bed patients.

D. Isolation. An isolation room shall be available for the treatment of potentially infectious or immunosuppressed critical care patients.

E. Pediatric Critical Care. If the facility offers critical care for the pediatric patient there shall be:

1. Policies, procedures and equipment specific to the needs of pediatric patients; and

2. The requirement for all the nursing staff to be oriented and trained in life support measures, interpretation of dysrhythmias and shall demonstrate competency in critical care nursing specific to patient types.

SECTION 33: SPECIALIZED SERVICES: DENTAL SERVICES.

A. Dental Services shall comply with the requirements of this section. (See Section 14, Health Information Services, Section 11, Patient Care Services, Section 16, Pharmacy and all applicable sections.)

B. Patients admitted to the hospital for dental care shall be given the same medical appraisal as those admitted to other services. The care of dental patients shall be the dual responsibility of the dentist and a physician on the hospital staff.

C. Dental services shall be under the direction of a dentist.

D. Policies and procedures shall be provided.

SECTION 34: SPECIALIZED SERVICES: CENTRAL STERILIZATION AND SUPPLY.

A. Each hospital shall provide central medical and surgical supply services with facilities that are responsible for processing, sterilizing, storing, distributing supplies and equipment to all units of the hospital. (Refer to Section 66, Physical Facilities, Central Medical and Surgical Supply Department, for space and equipment requirements.)

B. The central sterilization and supply service shall be under the direct supervision of a Registered Nurse or other qualified person who is trained in management, aseptic procedures, supply processing, and control methods which are applicable to central sterilization and supply service.

C. Policies and procedures shall have evidence of ongoing review and/or revision. The first page of each manual shall have the annual review date, signature of the department and/or person(s) conducting the review.

Policies and procedures shall include:

1. Job descriptions;

2. Infection control measures;

3. Assembly and operation of equipment;

4. Safety practices;

5. Orientation for new employees;

6. Care and cleaning of equipment;

7. Evaluation of:

a. Cleaning effectiveness;

b. Sterilizing effectiveness;

8. Receiving, decontaminating, cleaning, preparing, disinfecting, and sterilizing reusable items;

9. Assembling and wrapping of packs (to include the double-wrapped techniques);

10. Storage and distribution of sterile equipment/medical supplies;

11. Use of chemical indicators and biological spore tests for sterilizers;

12. Recalling and disposing/reprocessing of outdated sterile supplies;

13. Cleaning and disinfecting of surfaces, utensils, and equipment;

14. Specifications for cold-liquid sterilization and gas sterilization (if used); and

15. Collection and disposal of supplies recalled by the manufacturer.

16. Ongoing QI program.

D. Precautions shall be exercised to prevent the mixing of sterile and unsterile supplies and equipment. The precautions shall be set forth in written policies.

E. Procedures shall be developed for unloading and transporting flash sterilized items. The procedures shall be developed with the assistance of the Infection Control Committee and shall provide for the aseptic transfer within the physical constraints of the facility.

F. Relevant inservice educational programs shall be conducted on a regularly scheduled basis not less than twelve (12) per year. There shall be written documentation with employee signature, program title/subject, presenter, date and outline or narrative of presented program.

G. A liaison with the Infection Control Committee shall be maintained.

H. Records shall be maintained of all autoclave loads, both routine and "flash," which shall include the date, time, lot number (on routine loads), the time at temperature (where a recorder is not available), item(s) sterilized and shall identify the person performing the task.

I. Autoclaves shall meet the following requirements:

1. The efficacy of autoclaves, both for routine and "flash" use, shall be determined weekly through the use of biological spore monitors;

2. The results of all biological spore monitoring shall be reported to the Infection Control Committee;

3. Failures of the biological spore test shall be brought to the attention of the Infection Control Officer or designee immediately so the appropriate surveillance measures can be initiated;

NOTE: All materials sterilized from the date of the biological spore monitor failure to the last successful biological spore monitor shall be resterilized before use.

J. All autoclaves within the facility shall be maintained in accordance with the manufacturer's written directions. Records shall be maintained of all maintenance and repairs for the life of the equipment.

K. Chemical indicators for sterility shall be used with each cycle.

L. Facility must validate compliance and efficacy of sterilization policy through quality review process. Facility sterization policy must describe the mechanism used to determine shelf life of sterilized packages. Sterilization policy must:

1. Sterilization policy must be consistent with published industry standards (AAMI and APIC).

2. Sterilization policy must stress that sterility is related to integrity of pack regardless of whether expiration dating or event-related expiration is utilized.

M. Recommendations for common packaging and functioning of sterilization process.

Double-wrapped Muslin, Paper or Polypropylene	Use for rapid turn-around items only in well controlled environment, < 30 days
Double-wrapped Muslin, Paper or Polypropylene Placed in a Plastic Dust Cover Then Heat Sealed or Bonded	Indefinite
Peel Pack (Paper, Plastic or Tyvek/Mylar)	Indefinite
Rigid Containers, Caskets, Etc.	Per Manufacturer=s Instructions

NOTE:

1. Stock rotation shall be based on the "first in-first out" principle.

2. Sterile storage areas shall maintain a temperature range of 18°-22°C (64°-72°F) and a relative humidity of 35-75%. Ventilation shall be ten (10) air changes per hour and shall follow clean to dirty flow.

3. The interior of the dust cover shall not be considered sterile.

4. Indefinitely dated items shall be labeled with the date of sterilization and state "contents sterile unless package is damaged." Packages that are wet, dropped on the floor, compressed, or torn shall be rejected.

5. The lot number or control number and expiration statement shall be visible through the package or another tag shall be placed on the outside.

6. Containers for sterilization systems must be scientifically proven suitable for the specific sterilization cycle used; the container system shall be verified as the correct one for the cycle. (Manufacturer's instructions shall be followed.)

7. Double-wrapped shall mean the end results of the wrapping technique will yield an envelope within an envelope.

8. The date of sterilization and load control number shall be placed on each sterilized pack.

N. Flash (autoclaving) shall be restricted to unplanned or emergency situations. Flash sterilization shall never be used as a convenience to compensate for inadequate inventories of instruments or implantables. Flash sterilization of implantables shall be restricted to the direst circumstances.

O. Items which are to be flash sterilized shall be cleaned and decontaminated before the sterilization process.

P. Traffic areas in which flash sterilization is carried out shall be restricted to authorized personnel wearing surgical attire consisting of surgical scrubs, shoe covers, masks, and hair covers. The sterilizer shall not be located adjacent to any potential sources of contamination such as scrub sinks, clinical sinks or hoppers, wash sinks, linen or trash disposal areas.

Q. For flash sterilization, minimal time at effective temperature shall conform to the following:

Gravity	Nonporous (Simple Metal Instruments)	3 minutes at 132°C (270°F)
Gravity	Porous (Towels, Rubber, Plastic) Nonporous Mix	10 minutes at 132°C (270°F)
Gravity	Nonporous with Lumens, Deep Grooves, Sliding Parts	10 minutes at 132°C (270°F)
Gravity/Prevacuum	Complex Devices, Air-powered Drills	Per Manufacturer's Instructions
Prevacuum	Nonporous	3 minutes at 132°C (270°F)
Prevacuum	Porous/Nonporous	4 minutes at 132°C (270°F)

R. Items that previously have been packaged, sterilized, and issued, but not used may be returned to the sterile storage area if the integrity of the packaging has not been compromised and there is no evidence of contamination; such items may be dispensed when needed.

Items that previously have been packaged, sterilized and issued to the patient care units or other areas where the environment is not controlled must be discarded if they are single use items, or unwrapped, and reprocessed through decontamination if they are reusable.

S. Sterile materials must be stored eight (8) to ten (10) inches from the floor and at least eighteen (18)

inches from the ceiling and at least two (2) inches from outside walls. Items must be positioned so that packages are not crushed, bent, compressed, or punctured and sterility is not compromised.

T. All sterilization techniques other than steam (plasma, ethylene oxide, chemical, etc.) shall follow the manufacturer's directions and meet all state and federal regulations.

SECTION 35: SPECIALIZED SERVICES: RESPIRATORY CARE.

A. Respiratory Care Services shall be under the direction of a physician member of the Medical Staff.

B. Respiratory Care Services, including equipment, shall be supervised by a qualified and trained respiratory therapist.

C. There shall be sufficient personnel qualified and trained in respiratory care to provide respiratory care services.

1. Services may be performed by an assistant only when a qualified and trained respiratory therapist is readily available for consultation;

2. Personnel qualified and trained in respiratory care shall be on the premises whenever continuous ventilatory support is provided to patients.

D. All respiratory care personnel shall maintain competency in:

1. Life support measures;

2. Isolation techniques; and

3. Safety techniques for oxygen and oxygen equipment;

E. The policy and procedure manual shall have evidence of ongoing review and/or revision. The first page of the manual shall have the annual review date and signature of the department supervisor and/or person(s) conducting the review.

F. Policies and procedures shall include:

1. Job descriptions;

2. Documentation, verified by the physician director, of who may perform special procedures and give patient instructions.

3. Safety practices;

4. Handling, storage and dispensing of therapeutic gases;

5. Infection control measures;

6. Assembly and operation of equipment;

7. Posting of "no smoking," "oxygen in use," or "oxygen precautions" signs;

8. Respiratory care services provided and a list of services shall be available to the Medical Staff;

9. Steps to take in the event of an adverse reaction;

10. Cleaning, disinfecting, and sterilizing procedures; and

11. Orientation policies for new employees.

G. Clinically relevant inservice educational programs shall be conducted on a regularly scheduled basis not less than twelve (12) per year. There shall be written documentation with employee signature, program title/subject, presenter, date and outline or narrative of presented program.

H. If arterial blood gases are performed the Respiratory Care department shall subscribe to a nationally recognized proficiency testing program for blood gases and meet the quality control requirements for clinical laboratories.

I. The Respiratory Care Service shall have sufficient equipment and adequate facilities appropriate for safety and effective provision of care.

1. Equipment shall be serviced, calibrated, and operated according to manufacturers' directions.

2. An approved safety system shall be used with therapeutic gases.

3. Resuscitation, ventilatory, and oxygenation support equipment shall be available for patients of all sizes.

4. Ventilators for continuous assistance or controlled breathing shall be equipped with alarm systems.

5. A preventive maintenance program shall be implemented and records maintained for the life of the apparatus.

J. All Respiratory Care prescription/work requests shall specify the type, frequency, and duration of each treatment, and, as required, the type and dose of medication, the type of diluent and oxygen or medical air.

K. Respiratory Care reports of blood gas results shall be prepared in duplicate and signed by the therapist responsible for the procedure/test. The original shall be placed in the patient's medical record and the copy retained in the department file.

L. Accurate records shall be maintained regarding the type and duration of each treatment given. These records shall be correlated with the patient's medical record.

M. Respiratory Care documentation for each patient shall include:

1. Current written plan of care to include goals and objectives;

2. Instructions to patient or patient's family; and

3. Type and duration of the treatment given.

N. When oxygen is being administered to a patient:

1. "No Smoking," "oxygen in use," or "oxygen precautions" signs shall be posted;

2. Visitors and personnel shall be apprised of the fire hazard; and

3. If the patient is in a tent, alcohol or rub-on lotion shall not be used.

O. Oxygen shall be humidified in accordance with physicians orders.

P. If reusable reservoirs are used to humidify the oxygen, the reservoirs shall be cleaned and disinfected to a high-level of disinfection. (A high-level disinfection can be expected to kill all microorganisms with the exception of high numbers of bacterial endospores. Only sterile solutions and diluents shall be used in humidification and nebulizing equipment. Nebulizers (in-line and hand-held), between treatments on the same patient, shall be disinfected to a high level and rinsed in sterile water or, if a small volume medication nebulizer, air dried. All other semicritical equipment shall be cleaned and disinfected in accordance with the Center for Disease Control and Prevention's Guidelines.

Q. After use, all equipment shall be returned to a central location for thorough cleaning, servicing and disinfecting before use on another patient.

R. There shall be an ongoing QI program.

S. Contracted Respiratory Care Services shall be under current agreement and the contractor shall fulfill all requirements of this section.

NOTE: The National Fire Protection Association Book 99, Health Care Facilities, is a mandatory reference for developing safety regulations for Respiratory Care Services.

SECTION 36: SPECIALIZED SERVICE: EMERGENCY SERVICES.

A. Emergency Services shall be available within the community or local area served by the hospital.

B. The hospital's emergency department shall have organized services and procedures for any emergency.

C. Diagnostic and treatment equipment, medications, supplies, and space shall be adequate in terms of the size and scope of services provided.

D. An inventory list of all supplies and equipment including all items on the crash cart, shall be checked each shift and after each use.

E. The location and telephone number of the nearest poison control center and a list of poison antidotes shall be posted in the emergency department.

F. Staffing.

1. Arrangements shall be provided, such as a duty or on-call roster, to ensure that all emergency patients are seen by a physician. Arrangements shall be made for obtaining specialized medical services.

2. The Emergency Service shall be under the supervision of a Registered Nurse. All patient care personnel assigned to the emergency department shall receive orientation and be competent in life support measures.

3. A Registered Nurse or physician shall assess each patient who presents to the emergency department. The assessment shall be completely documented. If a physician is not present, a Registered Nurse shall contact the physician requested by the patient or the physician on call to discuss the assessment findings. The physician shall determine the patient's condition.

4. The Registered Nurse shall assume the responsibility for the nursing functions of the Emergency Services. This includes:

a. Supervision;

b. Evaluation of the patient's emergency nursing care needs;

c. The assignment of nursing care for each patient to other nursing personnel in accordance with the patient's needs and the preparation and competence of the nursing staff;

d. Supplies and equipment;

e. The emergency department record (See Sections 7, General Administration and 15, Medical Record Requirements for Outpatient Services, Emergency Room and Observation Services for policy and procedure.); and

f. Maintenance of an emergency department log.

5. Physicians' Assistants (PA's) shall not see patients, in lieu of a physician, in the emergency department.

6. Emergency Medical Technician (EMT). Pursuant to Act 293 of 1981, if a hospital allows an Arkansas Certified Emergency Medical Technician to perform specified procedures within the Emergency Room or be a member of a hospital code team the following action shall be taken:

a. The Medical Staff shall approve the privileges granted to the individual EMT with concurrence of the hospital's Governing Body. Specific policies governing the supervision and the procedures to be performed by an EMT shall be developed by the Medical Staff and approved by the hospital's Governing Body. In no event shall an EMT perform a procedure that he/she is not certified to do by the Office of Emergency Services of the Arkansas Department of Health;

b. Approved EMT's shall function in accordance with physician's orders and under the direct supervision of either the physician or Registered Nurse responsible for Emergency Services;

c. Students in EMT training programs approved by the Office of Emergency Medical Services of the Arkansas Department of Health shall be trained by qualified instructors within the hospital under guidelines established by the Medical Staff and approved by the Governing Body; and

d. A roster with the delineation of privileges shall be maintained and readily available.

G. Medications. See Section 16, Pharmacy and Section 12, Medications.

H. Emergency Services Facility. The Arkansas Department of Health is hereby empowered to license under Act 414 of 1961, as amended by Act 516 of 1987, hospitals which have discontinued inpatient services to continue to provide emergency services if there is no other hospital Emergency Service in the community.

1. The Emergency Services Facility shall be subject to inspection and to all other provisions of Act 414 of 1961, as amended.

2. The Emergency Services Facility shall have agreements with licensed hospitals to accept patients who are in need of inpatient hospital services.

3. An emergency facility shall not have licensed inpatient beds, however, at least one (1) holding/observation bed shall be provided for patient use not to exceed twenty-four (24) hours.

4. Emergency Service Facilities shall provide, or contract to provide emergency ambulance services licensed by the Arkansas Department of Health, that include radio communication and patient telemetry. It is further required that contractual agreements be made for patient air transport services.

5. Policies and procedures shall be developed and approved by the Division of Health Facility Services of the Arkansas Department of Health, prior to issuance of a license, and the facility may not provide services without a license.

6. Clinically relevant inservice educational program shall be conducted on a regularly scheduled basis not less than twelve (12) per year. There shall be documentation which includes program content, presenter, date and time presented and signatures of attendees.

7. There shall be an ongoing QI program that is specific to the patient care administered.

SECTION 37: SPECIALIZED SERVICE: PSYCHIATRIC SERVICES.

A. Psychiatric care units in general hospitals shall meet the construction requirements of Section 52, Psychiatric Nursing Unit, and shall in all respects comply with the requirements of Section 48, Physical Facilities, Patient Accommodations (Adult Medical, Surgical, Communicable or Pulmonary Disease) except furniture, equipment, and supplies may be modified by the attending physician on an individual patient basis as verified by signed orders.

B. General Requirements.

1. Each psychiatric care unit shall have a written plan describing the organization of services or the arrangement for the provision of such services to meet patient needs.

2. The services shall include, but not be limited to, diagnostic evaluation, individual or group therapy, consultation, and rehabilitation.

3. The unit shall be under the direction and management of a psychiatrist who is qualified by training and experience for examination by the American Board of Psychiatry and Neurology or the American Osteopathic Board of Neurology and Psychiatry and licensed in the State of Arkansas.

4. The Program Director of the unit shall be an individual with at least two (2) years administrative experience.

5. The unit shall furnish, through the use of qualified personnel, psychological services, social work services, occupational therapy, recreational therapy, and psychiatric nursing.

6. The unit shall have a qualified Director of Nursing (Master's Degree) or be qualified by education and experience in the care of the mentally ill. If the director does not meet the qualifications, there shall be regular documented consultation by a qualified Registered Nurse.

7. Staffing for the unit shall ensure the presence in the unit of a Registered Nurse at all times. There shall be adequate numbers of Registered Nurses, Licensed Practical Nurses, and mental health workers to provide the care necessary under each patient's active treatment program.

8. The unit shall provide or have available, psychological services to meet the needs of the patients.

9. There shall be a social service staff to provide services in accordance with accepted standards of practice and established policies and procedures.

10. The unit shall provide a therapeutic activities program. The program shall be appropriate to the needs and interests of the patients and be directed toward restoring and maintaining optimal levels of physical and psychosocial functioning.

11. There shall be a procedure for referrals for needed services.

12. There shall be adequate space, equipment, and supplies for services to be provided effectively and efficiently in functional surroundings that are readily accessible to the patients. All space, equipment, and facilities, both within the psychiatric facility and those utilized outside the facility, shall be well maintained and shall meet applicable federal, state, and local requirements for safety, fire, health, and sanitation.

13. Policies and procedures shall have evidence of ongoing review and/or revision. The first page of each manual shall have the annual review date, signature of the department director and/or person(s) conducting the review.

14. Clinically relevant inservice educational program shall be conducted on a regularly scheduled basis not less than twelve (12) per year. There shall be written documentation with employee signature, program title/subject, presenter, date and outline or narrative of the presented program.

15. Staff meetings shall be held at least monthly. Dated minutes of each meeting shall be kept in writing.

16. There shall be an ongoing program for orientation of staff.

17. All psychiatric services personnel shall maintain competency in life support measures.

18. There shall be an ongoing QI program.

C. Medical records shall include at least:

1. Identification data including patient's legal status;

2. Admitting psychiatric diagnosis as well as diagnoses of medical problems;

3. The reasons for the patient's admission;

4. Social service records including reports of interviews with patients, family members, and others and a social history and assessment;

5. Psychiatric evaluation (See Section 15, Medical Record Requirements for Outpatient Services, Emergency Room, Observation Services and Psychiatric Records); and

6. Treatment plan (See Section 15, Medical Record Requirements for Outpatient Services, Emergency Room, Observation Services and Psychiatric Records).

D. Medications. Shall fulfill the requirements in Section 16, Pharmacy.

E. Food and Nutritional Services shall meet requirements of Section 17.

F. Organization of psychiatric nursing units and services in general hospitals:

1. Medical direction shall be provided by a qualified psychiatrist and under the supervision of a Registered Nurse, qualified by training and experience in psychiatric nursing.

2. In addition to the requirements set forth for Nursing Services in Section 11, Patient Care Service, policies and procedures shall be developed specific to the care of the psychiatric patient.

G. Supplies and equipment shall be commensurate with the type of services offered.

H. Medical Records (See Section 15, Medical Record Requirements for Outpatient Services, Emergency Room, Observation Services and Psychiatric Records).

SECTION 38: SPECIALIZED SERVICE: CARE OF PATIENTS WITH PULMONARY DISEASE IN GENERAL HOSPITALS.

A. In addition to the Patient Care Services requirements set forth in Section11, the policies and procedures shall include specialized procedures specific to respiratory disease patients and shall include:

1. Collection of sputum;

2. Utilization of respiratory care;

3. Skin test procedures;

4. Tuberculosis control program for personnel;

5. Follow-up service for patients after discharge from the hospital; and

6. Provision for individual patient's plan of care.

SECTION 39: AMBULATORY SURGERY CENTERS.

A. General. Any facility in which surgical services, other than minor dental surgery, are offered which require the use of general or intravenous anesthetics, that renders the patient unable to be responsible for their actions, and where, in the opinion of the attending physician, hospitalization is unnecessary, shall be considered ambulatory surgery centers and shall conform with the following sections:

1. Section 3, Definitions;

2. Section 4, Licensure and Codes;

3. Section 5, Governing Body;

4. Section 6, Medical Staff;

5. Section 7, General Administration;

6. Section 11, Patient Care Service (Nursing);

7. Section 12, Medications;

8. Section 14, Health Information Services;

9. Section 16, Pharmacy.

10. Section 18, Infection Control;

11. Section 19, Laboratory;

12. Section 20, Radiological Services;

13. Section 26, Specialized Services: Surgical Services;

14. Section 28, Specialized Services: Outpatient Surgical Services;

15. Section 29, Specialized Services: Anesthesia Services;

16. Section 34, Specialized Services: Central Sterilization and Supply; Exclude Sections:

17. Section 14, Health Information Services, Obstetrical Records;

18. Section 14, Health Information Services, Newborn Records;

19. Section 15, Medical Record Requirements for Outpatient Services, Emergency Room, Observation Services and Psychiatric Records;

20. Section 40, Outpatient Psychiatric Centers;

21. Section 41, Rehabilitation Hospitals and Units;

22. Section 43, Psychiatric Hospitals; and

23. Section 44, Infirmaries.

B. Staffing. There shall be an adequate number of Registered Nurses on duty at all times and available for bedside care of any patient when needed. There shall be Registered Nurses to staff all patient care areas. A Registered Nurse shall assign the nursing care of each patient to other nursing personnel in accordance with the patient's needs and the preparation and competence of the nursing staff. There shall be written criteria to substantiate the assignment.

C. Discharge criteria shall be established and approved by the Medical Staff and Governing Body.

D. Surgical records shall include documentation stating the patient meets discharge criteria and is discharged from the facility accompanied by a responsible adult.

E. Diagnostic and treatment services provided through contract shall be from a source approved by the Department. Such services shall be monitored by the Ambulatory Surgery Center.

F. Surgical procedures performed in the Ambulatory Surgery Center shall be those which are:

1. Commonly performed on an inpatient basis in hospitals, but may be safely performed in an Ambulatory Surgery Center;

2. Not of a type which are commonly performed, or which may be safely performed, in physicians' offices; and

3. Limited to those requiring a dedicated operating room (or suite), and generally requiring a postoperative recovery room or short term (not overnight) rooms.

G. Surgical procedures shall be limited to those that do not exceed a total of ninety (90) minutes operating time and a total of four (4) hours recovery time.

H. If the surgical procedures require anesthesia, the anesthesia shall be local or regional, or if a general anesthesia is required it shall be of ninety (90) minutes or less duration.

I. Surgical procedures shall not be of a type that generally result in extensive blood loss; require major or prolonged invasion of body cavities; directly involve major blood vessels; or generally emergency or life threatening in nature.

J. The Ambulatory Surgery Center shall have a written agreement with a local hospital for transfer of a patient in a medical emergency of a nature which cannot be handled in the Ambulatory Surgery Center.

K. The Ambulatory Surgery Center shall comply with Section 78, Physical Facilities, Freestanding Ambulatory Surgery Centers.

L. The Ambulatory Surgery Center shall comply with Section 46, Physical Environment.

M. Extended Recovery Time

1. Scope/Limitations of Services

a. The extended recovery time service shall be approved by the Health Facility Services Division prior to implementation of the service.

b. Ambulatory Surgery Centers shall have the capability to provide care for post-surgical patients requiring continued nursing or medical treatment, but whose condition does not warrant acute hospitalization. The extended recovery period shall not exceed 23 hours and 59 minutes. The extended recovery period shall be limited to:

1) Observation;

2) Control of nausea/vomiting;

3) Replacement of fluids; and

4) Pain management.

c. Patients shall be screened prior to surgery and prior to admission to the overnight area to ascertain that established admission criteria is met.

d. Services shall not include intensive nursing care, continuous monitoring due to the instability of vital signs, administration of IV cardiac or anti-hypertensive drugs, or treatment of any unstable underlying medical condition.

e. If question arises as to whether or not a patient is an appropriate candidate for extended stay, the decision shall be made by the Medical Director or Administrator.

2. Admission Criteria

a. Physician's order shall be obtained for transfer to extended stay;

b. Stable vital signs and 0₂ saturation level;

c. Oriented to person, place, and time (a return to preoperative mentation);

d. Presence of satisfactory airway;

e. Absence of significant bleeding;

f. Stabilized or resolution of any acute problem;

g. Movement of extremities following regional anesthetic;

h. Level of consciousness which permits patient to call for nurse;

i. Recovery will require 23 hours 59 minutes or less prior to discharge;

j. The surgeon and anesthesia provider (or their designee of similar training and expertise) shall be present or immediately available; and k. Patient assessment and orientation shall be recorded in the medical record.

3. Discharge Criteria

a. Discharge shall be done in keeping with the same criteria established for the discharge of any patient from the Ambulatory Surgery Center.

b. The patient shall be discharged within 23 hours and 59 minutes of his/her admission to extended recovery by the surgeon or anesthesiologist or his/her designee.

c. If the patient's condition is such that discharge is deemed inappropriate, arrangements shall be made for hospital transfer.

d. Postoperative prescription orders and instructions shall be given to the patient and responsible adult with an understanding of instructions verbally by the person(s) receiving them and a copy retained in the medical record.

4. Transfer Requirements to Acute Care Facility

a. Patients who require continuous monitoring due to the instability of vital signs;

b. Patients who require administration of IV cardiac or anti-hypertensive drugs;

c. Patients who require treatment of any unstable underlying medical condition;

d. Patients whose pain management or observation requires longer than 23 hours and 59 minutes;

e. Patients who have a lowered level of consciousness than their preoperative status; and

f. Patients who exhibit current or potential airway complications.

5. Supervision of Extended Recovery Care

a. Ambulatory Surgery Centers shall provide adequate supervision of extended stay area to assure quality patient care and safety.

b. The extended stay area shall be staffed with a minimum of two caregivers at all times.

1) At least one of the caregivers shall be a Registered Nurse.

2) All caregivers shall be Basic Cardiac Life Support (BCLS) certified.

3) At least one Registered Nurse on duty at all times shall be Advanced Cardiac Life Support (ACLS) certified.

4) The anesthesiologist (or designee) and the surgeon (or designee) shall be present or immediately available.

6. Emergency Procedures

a. Any emergency or life-threatening situation shall be handled in a manner that provides the most appropriate and rapid care to best meet the patient needs.

b. Local Emergency Medical Services (EMS) shall be notified that regular hours are being extended on the days patients required extended recovery care.

c. Appropriate drugs, supplies and equipment shall be immediately available to the area, including a fully stocked crash cart with defibrillator and oxygen tank.

d. Transfer agreements to a local acute care hospital and ambulance transportation covering the Ambulatory Surgery Center shall include the extended stay area.

7. Medications

The Ambulaory Surger Center shall have provisions for obtaining prescribed drugs and biologicals to meet the needs of the population served. In addition, policies and procedures shall be developed and implemented for the handling of medications brought into the facility by patients. Should it be necessary to administer a patient's own medications, a signed physician's order shall be in the medical record identifying the medications(s) along with the route and directions for use.

8. Medical Records

a. Ambulatory Surgery Centers shall have an expanded medical record for patients in extended stay.

b. The same medical record shall be utilized that was initiated upon admission for surgery.

c. A discharge note shall be written upon discharge from acute recovery care.

d. An admission note, to include a patient assessment by a Registered Nurse, shall be included when the patient is received in the extended care area.

e. Pertinent observations, treatments, and medications shall be documented in the nurses' notes.

f. A closing entry or discharge summary shall include information/observations regarding the patient's condition and the care provided throughout the extended care.

g. Patient food allergies and preferences shall be documented. Meal intake and toleration of diet shall be documented by nursing personnel in the nurses' notes.

9. Patient Nutrition

a. If meals are prepared onsite, the Food and Nutrition Services shall be supervised by a qualified individual on the days the facility is open. A qualified individual shall be at a minimum a certified dietary manager.

b. The food preparation area shall included at a minimum:

1) Refrigerator/freezer;

2) Microwave oven;

3) Handwashing sink with towel and soap dispensers;

4) Counter space;

5) Garbage cans with cover;

6) Storage area for food, food preparation equipment and tableware; and

7) A three (3) compartment sink, if disposables are not utilized at all times.

c. If meals are not prepared onsite, the food served to the patient shall be obtained from a food service establishment that operates in accordance with the Arkansas Department of Health Rules and Regulations Pertaining to Food Service Establishments.

d. Leftover foods shall not be stored for future patient use.

10. Physical Facilities

Extended stay may permit patient sleeping accommodations in the post-anesthesia recovery area.

11. Staffing

a. At least one (1) registered nurse shall be on duty at all times while the center is in operation, with supportive personnel as needed.

b. Non-nursing personnel, i.e., aides, housekeeping, etc. shall be assigned in sufficient numbers and with sufficient training to meet the patient's needs.

12. Security Procedures

a. Measures shall be employed to ensure the security of patients, families, physicians, and employees while at the center after normal working hours.

b. The parking lot shall be well-lit, with frequent checks made for light bulbs needing replacement.

c. At least two employees shall be be present inside the facility when patients are present.

13. Quality Improvement/Risk Management Plan

a. Ambulatory Surgery Centers shall assure the same QI plan is followed for extended recovery care patients as general patients.

b. Each extended recovery patient shall receive the same Patient Satisfaction Questionnaire as general surgical patients upon discharge from the facility.

c. Each extended recovery care patient shall receive a postoperative call if they are discharged to home. If they are discharged to an alternate health care facility (i.e., rehab) a discharge summary shall be obtained upon discharge from that facility.

d. During the firs year of extended recovery services a quarterly report of the plan review shall be sent to the Health Facility Services Division of the Department.

SECTION 40: OUTPATIENT PSYCHIATRIC CENTERS. Any facility in which psychiatric services are offered for a period of four (4) to sixteen (16) hours a day, and where, in the opinion of the attending psychiatrist, hospitalization, as defined in the present licensure law, is not necessary, is considered an Outpatient Psychiatric Facility. This definition does not include Community Mental Health Clinics and Centers as they now exist. Such facilities shall conform with applicable sections if those services are provided within the facility. Such facilities shall conform with applicable sections of Section 79, Physical Facilities, Outpatient Care Facilities.

A. General Requirements.

1. Each psychiatric facility shall have a written plan describing the organization of outpatient services or the arrangement for the provision of such services to meet patient needs.

2. The outpatient services shall include, but not be limited to, diagnostic evaluation, individual or group therapy, consultation, and rehabilitation.

3. The center shall be under the direction and management of a psychiatrist who is qualified by training and experience requirements for examination by the American Board of Psychiatry and Neurology or the American Osteopathic Board of Neurology and Psychiatry and licensed in the State of Arkansas.

4. The Program Director of the Outpatient Center shall be an individual with at least two (2) years of administrative experience.

5. The center shall furnish, through the use of qualified personnel, psychological services, social work services, occupational therapy, recreational therapy, and psychiatric nursing.

6. The center shall have a qualified Director of Nursing (Master's Degree) or be qualified by education and experience in the care of the mentally ill. If the director does not meet the qualifications, there shall be regular documented consultation by a qualified Registered Nurse.

7. Staffing for the center shall insure the presence in the center of a Registered Nurse during the hours the unit is open. There shall be adequate numbers of Registered Nurses, Licensed Practical Nurses, and mental health workers to provide the care necessary under each patient's active treatment program.

8. The center shall provide or have available, psychological services to meet the needs of the patients.

9. There shall be a social service staff to provide services in accordance with accepted standards of practice and established policies and procedures.

10. The center shall provide a therapeutic activities program. The program shall be appropriate to the needs and interests of the patients and be directed toward restoring and maintaining optimal levels of physical and psychosocial functioning.

11. There shall be a procedure for referrals for needed services that are not provided directly by the facility.

12. There shall be adequate space, equipment, and supplies for outpatient services to be provided effectively and efficiently in functional surroundings that are readily accessible and acceptable to the patients and community services. All space, equipment, and facilities, both within the psychiatric facility and those utilized outside the facility, shall be well maintained and shall meet applicable federal, state, and local requirements for safety, fire, health, and sanitation.

13. Policies and procedures shall have evidence on ongoing review and/or revision. The first page of each manual shall have the annual review date, signature of the department supervisor and/or person(s) conducting the review.

14. Clinically relevant inservice educational program shall be conducted on a regularly scheduled basis not less than twelve (12) per year. There shall be written documentation with employee signature, program title/subject, presenter, date and outline or narrative of the presented program.

15. Regular staff meetings shall be held at least monthly. Dated minutes of easch meeting shall be kept in writing.

16. There shall be an ongoing program for orientation of staff.

17. There shall be an ongoing QI program.

B. Medical records shall include at least:

1. Identification data including patient's legal status;

2. Admitting psychiatric diagnosis as well as diagnoses of medical problems;

3. The reasons for the patient's admission to this level of care;

4. Social service records including reports of interviews with patients, family members, and others and a social history and assessment;

5. Psychiatric evaluation (See Section 37, Specialized Services: Psychiatric Services.);

6. Treatment plan (See Section 37, Specialized Services: Psychiatric Services.); and

C. Medications. Outpatient Services utilizing medications in therapeutic programs shall fulfill the requirements in Section 16, Pharmacy.

D. Food and Nutritional Services shall meet requirements of Section 17.

E. Physical Facilities. The Outpatient Psychiatric Centers shall comply with Section 79, Physical Facilities, Outpatient Care Facilities.

SECTION 41: REHABILITATION HOSPITALS AND UNITS.

A. General Requirements.

1. Rehabilitation Hospital means a hospital or a distinct part of a hospital as designated in Section 3, Definitions, of these regulations which is used for the primary purpose of providing rehabilitative services as so defined and shall comply with Sections 1, Authority, through Section 38, Specialized Services: Care of Patients with Pulmonary Disease in General Hospitals. Each hospital or unit shall have the capability of providing or arranging for emergency services twenty-four (24) hours per day, seven (7) days per week.

2. Any comprehensive physical rehabilitative program shall provide through the use of qualified professional personnel, at a minimum, the following clinical services:

a. Physical therapy;

b. Occupational therapy;

c. Speech therapy; and d. Social services or psychological services.

NOTE: May be provided under contract or arrangement on an as needed basis.

3. A physician qualified by training, experience and knowledge of rehabilitative medicine shall be appointed as the Medical Director.

4. Nursing Services shall be under the direct supervision of a Registered Nurse who has a Masters Degree or be qualified by education and experience in Rehabilitative Nursing. If the Registered Nurse does not have the required credentials, a Masters prepared Registered Nurse shall be available as a consultant. The number of Registered Nurses, Licensed Practical Nurses, and other nursing personnel shall be adequate to formulate and carry out the nursing components of the individual treatment plan for each patient. There shall be a Registered Nurse on duty twenty-four (24) hours per day, seven (7) days per week, to plan, assign, supervise, and evaluate nursing care and to provide for the delivery of nursing care to patients.

5. A physician licensed in the State of Arkansas shall be responsible for each patient's general medical condition. Medical services shall be provided twenty-four (24) hours per day, seven (7) days per week. Upon admission there shall be written orders for the immediate care of the patient.

6. Policies and procedures shall be developed. The manual shall have evidence of ongoing review and/or revision. The first page of the manual shall have the annual review date, signature of the department supervisor and/or person(s) conducting the review.

7. Clinically relevant inservice educational programs shall be conducted on a regularly scheduled basis not less than twelve (12) per year. There shall be written documentation with employee signature, program title/subject, presenter, date and outline or narrative of the presented program.

8. Regular staff meetings shall be held at least monthly. Dated minutes of each meeting shall be kept in writing.

9. There shall be an ongoing QI program.

B. Special Medical Record Requirements. (Refer also to Section 14, Health Information Services.) The medical record shall include:

1. Reason for referral to physical rehabilitation services or admission to the comprehensive physical rehabilitation program;

2. History and physical examination including patient's clinical condition, functional strengths and limitations, indications and contra-indications for specific physical rehabilitative services and prognosis;

3. Goals of treatment and the treatment plan, including any problem that may affect the outcome of physical rehabilitation services, and criteria for the discontinuation of services;

4. Interdisciplinary treatment plans to include measurable goals of treatment and criteria for discharge. The plan shall include ongoing assessments as required by the patient's medical condition. Documentation of patient and family in the development of the treatment plan and resolution of problems and rehabilitation potential;

5. A discharge summary that includes recommendations for further care;

6. Patient evaluation procedures, including treatment plan for each patient based on the functional assessment and evaluation. The initial treatment plan shall be developed within twenty-four (24) hours, and a comprehensive individualized plan developed no later than one (1) week after admission and updated at least monthly. The plan shall state the rehabilitative problem, goals, and required therapeutic services, as well as prognosis, anticipated length of stay, and discharge disposition;

C. Physical Environment. The Rehabilitation Facility shall comply with Section 46, Physical Environment.

D. Physical Facilities. The Rehabilitation Facility shall comply with Section 80, Physical Facilities, Rehabilitation Facilities.

SECTION 42: RECUPERATION CENTERS. Any facility which includes inpatient beds with an organized Medical Staff, and with medical services including physician services and continuous nursing services to provide treatment for patients who are not in an acute phase of illness but who currently require primarily convalescent or restorative services, shall be considered a recuperation center and shall comply with applicable Sections 1, Authority, through 76, Physical Facilities, Electrical Standards.

A. Quality Improvement, Infection Control, Pharmacy and Therapeutics, and Utilization Review.

1. The Recuperation Center shall maintain a Quality Improvement Committee consisting of the Nurse Manager, Medical Director, and at least three (3) other members of the center's staff, which shall meet at least quarterly to provide oversight and direction for the center's quality improvement activities. Minutes of the Quality Improvement Committee shall be maintained.

2. QI activities shall include ongoing monitoring, with identification of opportunities for improvement, actions taken, and evaluation of the results of actions. QI activities shall be reported at least quarterly to the Medical Staff and Governing Body through the hospital-wide QI program.

3. Reporting of all infection control, medication and utilization review issues specific to the center shall be evident in the minutes of the hospital-wide Infection Control, Pharmacy and Therapeutics and Utilization Review Committees. Frequency of reporting shall be defined in policies and procedures consistent with State laws.

B. Restraints. See Section 13, Restraints.

C. Documentation Requirements.

1. An assessment of the patient's needs shall be completed by a Registered Nurse on admission.

2. Each assessment shall be coordinated with all health professionals.

3. The interdisciplinary team shall develop a comprehensive care plan based on the patient's identified needs, measurable goals of treatment, methods of intervention, and documentation of resolution or continuance. There shall be documentation of the patient and family's participation in the development of the care plan.

4. Verbal/telephone orders shall be reduced to writing and countersigned by the physician.

D. Physical Environment. The requirements in Section 48, Physical Facilities, Patient Accommodations (Adult Medical, Surgical, Communicable or Pulmonary Disease) shall apply to recuperation centers with the following exceptions:

1. The patient dining, recreation, and day room(s) may be in separate or adjoining rooms and shall have a total of thirty-five (35) square feet per patient bed.

2. Patient corridors shall have handrails on both sides of the corridors. A clear distance of one and one-half (1-1/2) inches shall be provided between the handrail and the wall. The top of the gripping surface of handrails shall be thirty-two (32) inches minimum and thirty-six (36) inches maximum above the finish floor. Ends of handrails and grab bars shall be constructed to prevent snagging the clothes of patients. Exception, special care areas such as those serving children.

E. Health Information Services. Applicable parts of item D. of Section 14, Health Information Services and Section 15, Medical Record Requirements for Outpatient Services, Emergency Room, Observation Services and Psychiatric Records.

F. Nursing Services. A Registered Nurse shall observe each patient at least once per shift and the observations shall be documented in the patient's medical record.

SECTION 43: PSYCHIATRIC HOSPITALS.

A. General. Any facility used for the primary purpose of providing inpatient diagnostic care and treatment of persons having mental disorders shall be considered a psychiatric hospital and shall conform with Sections 1, Authority, through 24, Recreational Therapy and applicable portions of Section 81, Physical Facilities, Psychiatric Hospitals and Alcohol/Drug Abuse Inpatient Treatment Centers of these regulations.

B. Personnel. The hospital shall furnish, through the use of qualified personnel, psychological services, social work services, occupational therapy, recreational therapy and psychiatric nursing. Provisions shall be made for speciality medical requirements, i.e., neurologist, internist, etc. Each hospital or unit shall have the capability of providing or arranging emergency services twenty-four (24) hours per day, seven (7) days per week.

1. A board-certified psychiatrist shall be the Medical Director. The Medical Director shall coordinate the Psychiatric Services in conjunction with other medical, nursing, therapy, and hospital administration.

2. The diagnosis, care and treatment for patients shall be under the direction of a psychiatrist.

3. The unit shall have a qualified Director of Nursing (Master's Degree) or be qualified by education and experience in the care of the mentally ill. If the director does not meet the qualifications, there shall be regular documented consultation by a qualified Registered Nurse.

4. All personnel working within an area of psychiatric patients shall be trained in psychiatric patient care.

5. Policies and procedures shall be developed specifically for Psychiatric Services.

C. Seclusion and Restraints.

1. Seclusion. Patients shall be placed in seclusion only on the written order of the physician. Documentation shall reflect time in seclusion, frequency of observation and frequency of re-evaluation for continued seclusion.

2. Restraints (Mechanical).

a. The Medical Staff shall establish criteria for use.

b. If locked restraints are used a designated staff member shall have possession of the key and keep the patient under constant observation.

c. A schedule shall be developed for releasing the restraints.

d. Restraints shall be used only as a last resort for prevention of harm self-inflicted or to others.

3. Patients shall be grouped according to age (children, adolescents and adults), sex and treatment needs. Patients with communicable diseases shall be isolated.

D. Health Information Services. See Section 14, Health Information Services.

E. Special Precautions.

1. Special precautions shall be taken so that medications and controlled substances are not accessible to patients.

2. Sharp instruments, knives, ice picks, or other objects which could be used for homicidal or suicidal purposes, shall not be available to patients.

F. Patient Identification.

If the facility does not choose to follow Section 10, Patient Identification, they shall take three (3) pictures of the patient at the time of admission. Pictures shall be attached:

1. To the medication sheet;

2. To the face sheet of the patient's medical record; and

3. In the dietary department.

G. Physical Environment. A Psychiatric hospital shall comply with Section 46, Physical Environment.

H. Clinically relevant inservice educational programs shall be conducted on a regularly scheduled basis not less than twelve (12) per year. There shall be documentation which includes program content, presenter, date and time presented and signatures of attendees.

I. There shall be an ongoing QI program that is specific to patient care.

J. Physical Facilities. A psychiatric hospital shall comply with Section 81, Physical Facilities, Psychiatric Hospitals and Alcohol/Drug Abuse Inpatient Treatment Centers.

SECTION 44: INFIRMARIES. An infirmary shall be considered a facility established for the purpose of offering temporary medical care and/or treatment exclusively for persons residing on a designated premise, e.g., schools, reformatories, correctional institutions, etc.

A. Compliance. Infirmaries shall comply with applicable parts of Sections 10, Patient Care Service, through 13, Restraints. Infirmaries shall comply with all applicable parts of:

1. Section 5, Governing Body and Section 6, Medical Staff. The infirmary shall have an organized Governing Body or in its absence, a person shall be legally responsible for maintaining quality patient care, establishing policies for the infirmary and shall be legally responsible for the conduct of the infirmary;

2. Section 6, Medical Staff. The infirmary shall be under the direction of a qualified physician who shall be responsible for the medical care and treatment rendered;

3. Item A of Section 11, Patient Care Service. The infirmary shall be under the supervision of a Registered Nurse on the day tour of duty. Evening and night tours shall be staffed with licensed nursing personnel. The medical record for each patient admitted to the infirmary during the day tour of duty shall document the admission and observation of patient acuity by a Registered Nurse. The admission must be performed by the Director of Nursing or the Registered Nurse on call when such admission occurs on a weekend day;

4. Section 14, Health Information Services and Section 15, Medical Record Requirements for Outpatient Services, Emergency Room, Observation Services and Psychiatric Records;

5. Applicable parts of Sections 19 Laboratory and 20, Radiological Services. The infirmary need not comply unless the services are offered in the infirmary. Where laboratory and/or radiology services are not offered in the infirmary, the infirmary shall obtain a written agreement to provide any such services, as appropriate in the scope of the infirmary setting from a source approved by the Arkansas Department of Health;

6. Section 17, Food and Nutrition Services. Kitchen sanitation and food preparation areas shall meet the requirements for public eating establishments set forth by the Arkansas Department of Health;

7. Section 16, Pharmacy;

8. Section 82, Physical Facilities, Infirmaries;

9. Section 18, Infection Control.

B. Pharmacy Services. All infirmaries shall have adequate provisions for pharmaceutical services regarding the procurement, storage, distribution, and control of all medications. All federal and state regulations shall be followed. See Section 16, Pharmacy.

C. Administration of Pharmaceutical Services.

1. The infirmary shall provide policies and procedures for obtaining, dispensing, and administering of drugs and biologicals developed with the advice of a physician or pharmacist.

a. Definition of Dispensing. A function restricted to licensed pharmacists which involves the issuance of:

1) One (1) or more doses of a medication in containers other than the original, with such new containers being properly labeled by the dispenser as to content and/or directions for use as directed by the prescriber;

2) Medication in its original container with a pharmacy prepared label that carries to the patient the directions of the prescriber as well as other vital information;

3) A package carrying a label prepared for nursing station use. The contents of the container may be for one (1) patient (individual prescription) or for several patients (such as a nursing station medication container).

b. Definition of Administering. An act restricted to nursing personnel as defined in The Nurse Practice Act, in which a single dose of a prescribed drug or biological is given to a patient. This activity includes the removal of the dose from a previously dispensed, properly labeled container, verifying it with the prescriber's orders, giving the individual dose to the proper patient and recording the time and dose given.

2. The infirmary shall provide for the procurement of drugs and pharmaceutical supplies as follows:

a. If the infirmary has a pharmacy department, a licensed pharmacist shall be employed to administer the pharmacy in accordance with all state and federal laws and regulations regarding drugs and drug control;

b. If the infirmary does not have a pharmacy department, the Infirmary shall provide for prompt, convenient availability of prescribed drugs and biologicals from a community pharmacy;

c. If the infirmary does not have a pharmacy department but does maintain a supply of medications, a licensed pharmacist shall be responsible for the control of all bulk drugs and maintain records of receipt and disposition. The pharmacist shall dispense medications from the drug supply, properly labeled, and available to appropriate nursing personnel;

d. If a physician maintains his own stock of drugs in the infirmary, he shall dispense all drugs and maintain control as required of a pharmacist.

D. Conformance with Physician's Orders.

1. All medications administered to patients shall be ordered in writing by the physician. Verbal orders shall be given only to a licensed nurse or a licensed pharmacist, immediately reduced in writing, signed by the nurse or pharmacist, and countersigned by the physician within seventy-two (72) hours.

2. Medications are released to patients on discharge only on the written authorization of the physician.

E. Administration of Medication.

1. All medications administered by licensed personnel shall be in accordance with the Arkansas Practice Acts.

2. Medications prescribed for one (1) patient shall not be administered to any other patient.

3. Medication errors and adverse drug reactions shall be reported to the patient's physician and the pharmacist.

4. All medications administered shall be recorded in the medical record.

F. Labeling.

1. Medication kept as general floor stock in the facility shall be labeled with the trade name (or generic name with the name of the manufacturer), strength, lot number, and expiration date.

2. The label of each patient's individual medication container shall clearly indicate the patient's full name, physician's name, prescription number, name and strength of the medication, date of issue, and name, address and telephone number of issuing pharmacy.

3. Medication containers having soiled, damaged, incomplete, illegible, or makeshift labels are returned to the issuing pharmacist or pharmacy for re-labeling or disposal.

G. Storage and Security of Medications.

1. All medications shall be locked to limit access to licensed personnel.

2. Each patient medication shall be kept and stored in original containers. There shall be no transferring between containers.

3. Medication cabinets shall be of sufficient size to permit storage of medication.

4. Refrigeration shall be provided for the proper storage of biologicals and other medications. Medications shall be stored in a separate compartment or area from food. Employee foods and/or medications shall be stored in a separate refrigeration area. An internal thermometer shall be provided and checked to assure temperatures between thirty-six and forty-six degrees (36°-46°) Fahrenheit (two to eight degrees (2°-8°) Centigrade). Daily documentation of temperatures shall be maintained. Refrigerated medications may be stored in a locked box inside the refrigerator.

5. Poisons and external medications shall be separated from other medications.

6. Applicable medications shall be removed from usage in the event of a drug recall or upon expiration.

H. Pharmacy Records.

1. The infirmary shall comply with all federal and state laws and regulations relating to the procurement, storage, dispensing, administering, and disposal of medications.

2. A controlled substance record is maintained which lists the following information on a separate sheet for each type and strength of controlled substance: date, time administered, name of patient, dose, physician's name, signature of the person administering the dose, and remaining drug balance.

3. All controlled substances shall be counted by two (2) licensed personnel at the opening and closing of each staffed shift to ensure compliance between the listed drug balances and the actual amounts in stock.

4. All pharmacy records shall be maintained for two (2) years.

5. The pharmacy shall either maintain copies of the doctor's order or a prescription for every medication dispensed.

6. Policies and procedures shall be provided.

7. Clinically relevant inservice educational programs shall be conducted on a regularly scheduled basis not less than twelve (12) per year. There shall be documentation which includes program content, presenter, date and time presented and signatures of attendees.

8. There shall be an ongoing QI program that is specific to the patient care administered.

I. Physical Facilities. Infirmary shall comply with Section 82, Physical Facilities, Infirmaries.

SECTION 45: ALCOHOL/DRUG ABUSE INPATIENT TREATMENT CENTER. Alcohol/Drug Abuse Inpatient Treatment Center means a facility or distinct part of a facility in which services are provided for the diagnosis, treatment and rehabilitation of alcohol and/or drug abuse; a facility which provides counseling only (room and board are not included in this definition). Participating hospitals shall designate a distinct part and a specific number of beds for the unit. The distinct part unit shall be at least ten (10) beds, with a maximum of ten percent (10%) of the total hospital licensed capacity recommended. Free-standing facilities shall not be larger than seventy (70) beds or smaller than thirty-five (35) beds. Each facility or unit shall have the capability of providing for emergency services twenty-four (24) hours per day, seven (7) days per week. Detoxification beds - alcohol/drug abuse treatment beds which are engaged during that period in which the patient is being physically withdrawn from chemical substances in order that they may be able to participate in rehabilitative activities. Active treatment beds - alcohol/drug abuse treatment beds which are used in providing a highly structured rehabilitative treatment program.

A. Administrative Requirements. A facility or unit shall develop policies and procedures for the alcohol/drug program that shall include, but be not limited to, the following:

1. Staffing. Clinical staff shall be licensed or certified by appropriate state licensure or certification boards;

2. Admission procedures, including a procedure for accepting emergency admissions;

3. Patient evaluation procedures, including preliminary evaluation and establishment of an individual treatment plan;

4. Treatment procedures and services that are consistent with accepted standards of treatment for alcohol/drug abuse illness;

5. Procedures for referral and follow-up of patients' outside services;

6. Procedures for involvement of family in counseling process;

7. Provision for after-care plan;

8. Program Quality Improvement;

9. Provision for an education program acceptable to local school officials for patients of school age that would also include suitable recreational needs of adolescents;

10. Provision for coordination of services with community mental health centers, substance abuse treatment programs, and other appropriate facilities or programs.

11. Clinically relevant inservice educational programs shall be conducted on a regularly scheduled basis not less than twelve (12) per year.

B. Medical Services. A physician licensed in the State of Arkansas shall be responsible for diagnosis and all medical care and treatment. Medical services shall be provided directly or on call twenty-four (24) hours per day, seven (7) days per week. Upon admission, there shall be written orders for the immediate care of the patient.

C. Nursing Services. Nursing services shall be under the direct supervision of a Registered Nurse who has had at least one (1) year experience in psychiatric or mental health nursing or has had previous work experience in chemical dependency units. The number of Registered Nurses, Licensed Practical Nurses, and other personnel shall be adequate to formulate and carry out the nursing components of the individual treatment plan for each patient. There shall be a Registered Nurse on duty twenty-four (24) hours per day, seven (7) days per week to plan, assign, supervise and evaluate nursing care, and to provide for the delivery of nursing care to patients.

D. Psychiatric Services. Patients shall be provided with psychiatric services in accordance with their needs by a psychiatrist licensed in the State of Arkansas. Services to patients include evaluations, consultations, therapy and program development.

E. Psychological Services. Patients shall be provided with psychological services in accordance with their needs by a qualified psychologist. Services to patients include evaluations, consultation, therapy and program development. A qualified psychologist is an individual licensed by the State Board of Psychological Examiners with a specialty area in clinical or counseling psychology.

F. Social Services. Social work services are under the supervision of a qualified social worker. The director of the service or department shall be a licensed social worker in the State of Arkansas. If the director does not have a Masters Degree from an accredited School of Social Work or has not been certified by the Academy of Certified Social Workers, there shall be documented monthly supervisory consultation by such a qualified social worker.

G. Social Work Staff. Social work staff is qualified and numerically adequate to provide the following services:

1. Psychosocial data for diagnosis and treatment planning;

2. Direct therapeutic services to individual patients, patient groups or families;

3. Develop community resources;

4. Participate in interdisciplinary conferences and meetings concerning treatment planning, including identification and utilization of other facilities and alternative forms of care and treatment.

H. Activity Services. Activity services staff shall be sufficient in number and skills to meet the needs of patients and achieve the goals of the service. The activity service shall be supervised by a qualified Activity Director. A qualified Activity Director is an individual with a Bachelor's Degree who has at least one (1) year of experience in assessing, planning and coordinating activity services in a health care setting. In the absence of such a qualified Activity Director, this requirement may be met with a documented monthly supervisory consultation visit by a qualified Activity Therapist.

I. Substance Abuse Counselor. There shall be at least one (1) Certified Substance Abuse Counselor on the treatment staff (as certified by the Arkansas Substance Abuse Certification Board). Substance Abuse Counselor staff is qualified and numerically adequate to provide the following services:

1. Direct counseling services to individual patients, patient groups and families;

2. Participate in interdisciplinary conferences and meetings concerning treatment planning, including alternative forms of care and treatment;

3. Develop treatment resources;

4. Participate in casework processes.

J. Facility and Program Evaluation. Program evaluation is a management tool primarily utilized by the facility's Administrator to assess and monitor, on a priority basis, a variety of facility services and programmatic activities which shall be a component of the Quality Improvement Program. The facility shall have a written statement of goals and objectives, established as a result of a planning process, and provided to the Governing Body for approval. There shall be documentation that the goals and objectives of facility services and programmatic activities are evaluated at least annually and revised as necessary.

K. Individualized Comprehensive Treatment Planning.

1. Intake. Written policies and procedures governing the intake process shall specify the following:

a. The information to be obtained on all applicants or referrals for admission;

b. The records to be kept on all applicants;

c. The statistical data to be kept on the intake process; and

d. The procedures to be followed when an applicant or a referral is found ineligible for admission.

2. Criteria for determining the eligibility of individuals for admission shall be clearly stated in writing.

3. The intake procedure shall include an initial assessment of the patient by professional staff.

4. Acceptance of a patient for treatment shall be based on an intake procedure that results in the following conclusions:

a. The treatment required by the patient is appropriate to the intensity and restrictions of care provided by the facility or program component; and/or

b. The treatment required can be appropriately provided by the facility or program component; and c. The alternatives for less intensive and restricted treatment are not available.

5. The patient record shall contain the source of any referral.

6. During the intake process, every effort shall be made to assure that applicants understand the following:

a. The nature and goals of the treatment program;

b. The treatment costs to be borne by the patient, if any; and

c. The rights and responsibilities of patients, including the rules governing patient conduct and the types of infractions that can result in disciplinary action or discharge from the facility or program component.

7. Facilities shall have policies and procedures that adequately address the following items for each patient:

a. Responsibility for medical and dental care, including consents for medical or surgical care and treatment;

b. When appropriate, arrangements for family participation in the treatment program;

c. Arrangements for clothing, allowances, and gifts;

d. Arrangements regarding the patient's departure from the facility or program; and e. Arrangements regarding the patient's departure from the facility or program against medical advice.

8. When a patient is admitted on court order, the rights and responsibilities of the patient and the patient's family shall be explained to them. This explanation of the rights and responsibilities of the patient and the patient's family shall be documented in the patient's record.

9. Sufficient information shall be collected during the intake process to develop a preliminary treatment plan.

10. Staff members who shall be working with the patient but who did not participate in the initial assessment shall be informed about the patient prior to the meeting.

L. Assessments.

1. Within seventy-two (72) hours of admission, the staff shall conduct a complete assessment of each patient's needs. The assessment shall include, but shall not necessarily be limited to, physical, emotional, behavioral, social, recreational, and nutritional needs.

2. A licensed physician shall be responsible for assessing each patient's physical health. The health assessment shall include a medical, alcohol and medication history; a physical examination; neurological examination when indicated; and a laboratory workup. The physical examination shall be completed within forty-eight (48) hours after admission.

3. In facilities serving children and adolescents, each patient's physical health assessment shall also include evaluations of the following: Motor development and functioning; sensorimotor functioning; speech, hearing, and language function, visual functioning; and immunization status. Facilities serving children and adolescents shall have all necessary diagnostic tools and personnel available to perform physical health assessments.

4. A Registered Nurse shall be responsible for obtaining a nursing history and assessment at the time of admission.

5. An emotional and behavioral assessment of each patient shall be completed and entered in the patient's record. The assessment shall include, but not be limited to, the following items:

a. A history of previous emotional, behavioral, and substance abuse problem and treatment;

b. The patient's current emotional and behavioral functioning;

c. When indicated, psychological assessments, including intellectual and personality testing.

6. A social assessment of each patient shall be completed by the qualified social worker and entered in the patient's record. The assessment shall include information relating to the following areas, as necessary:

a. Environment and home;

b. Religion;

c. Childhood history;

d. Military service history;

e. Financial status;

f. The social, peer group, and environmental setting from which the patient comes; and g. The patient's family circumstances, including the constellation of the family group, the current living situation; and social, ethnic, cultural, emotional, and health factors, including drug and alcohol use.

7. When appropriate, an activities assessment of each patient shall be completed by the qualified Activity Director and shall include information relating to the individual's current skills, talents, aptitudes, and interest.

8. A nutritional assessment shall be conducted by the food service supervisor or Registered Dietitian and shall be documented in the patient's record.

9. An educational assessment shall be performed by personnel approved by the Arkansas Department of Education.

M. Treatment Plans.

1. Each patient shall have a written individual treatment plan that is based on assessments of their clinical needs.

2. Overall development and implementation of the treatment plan shall be assigned to an appropriate member of the professional staff.

3. The treatment plan shall be developed as soon as possible after the patient's admission. Appropriate therapeutic efforts may begin before a fully developed treatment plan is finalized.

4. Upon admission, a preliminary treatment plan shall be formulated on the basis of the intake assessment.

5. Within seventy-two (72) hours following admission, a designated member of the treatment team shall develop an initial treatment plan based on at least an assessment of the patient's presenting problems, physical health, emotional status, and behavioral status. This initial treatment plan shall be utilized to implement immediate treatment objectives. If a patient's stay in a facility is ten (10) days or less, only a discharge summary shall be required in addition to the initial treatment plan. If a patient's stay in a facility exceeds ten (10) days, the interdisciplinary team shall develop a master treatment plan that is based on a comprehensive assessment of the patient's needs. The master treatment plan shall contain objectives and methods for achieving them.

6. The treatment plan shall reflect the facility's philosophy of treatment and the participation of staff from appropriate disciplines.

7. The treatment plan shall specify the services necessary to meet the patient's needs.

8. The treatment plan shall include referrals for needed services that are not provided directly by the facility.

9. The treatment plan shall contain specific goals the patient shall achieve to attain, maintain, and/or reestablish emotional and/or physical health as well as maximum growth and adaptive capabilities. These goals shall be based on assessments of the patient and, as appropriate, the patient's family.

10. The treatment plan shall contain specific objectives that relate to the goals, written in measurable terms, and include expected achievement dates.

11. The treatment plan shall describe the services, activities, and programs planned for the patient, and shall specify the staff members assigned to work with the patient.

12. The treatment plan shall specify the frequency of treatment procedures.

13. The treatment plan shall delineate the specific criteria to be met for termination of treatment. Such criteria shall be a part of the initial treatment plan.

14. When appropriate, the patient shall participate in the development of his or her treatment plan, and such participation shall be documented in the patient's record.

15. A specific plan for involving the family or significant others shall be included in the treatment plan when indicated.

N. Progress Notes.

1. Progress notes shall be recorded by the physician, nurse, social worker and, when appropriate, others significantly involved in treatment. The frequency of progress notes is determined by the condition of the patient but shall be recorded at least weekly for the first two (2) months and at least monthly thereafter.

2. Progress notes shall be entered in the patient's record and shall include the following:

a. Documentation of implementation of the treatment plan;

b. Documentation of all treatment rendered to the patient;

c. Description of change in the patient's condition; and

d. Descriptions of the response of the patient to treatment, the outcome of treatment, and the response of significant others to important intercurrent events.

3. Progress notes shall be dated and signed by the individual making the entry.

4. All entries involving subjective interpretation of the patient's progress shall be supplemented with a description of the actual behavioral observation.

O. Treatment Plan Review.

1. Interdisciplinary case conferences shall be documented, and the results of the review and evaluation shall be recorded in the patient's treatment plan and his or her progress in attaining the stated treatment goals and objectives.

2. Interdisciplinary case conferences shall be documented, and the results of the review and evaluation shall be recorded in the patient's record. The review and update shall be completed no later than thirty (30) days following the first ten (10) days of treatment, and at least sixty (60) days thereafter.

P. Discharge Planning/After-care.

1. The facility shall maintain a centralized coordinated program to ensure that each patient has a planned program of continuing care which meets his postdischarge needs.

2. Each patient shall have an individualized discharge plan which reflects input from all disciplines involved in his/her care. The patient, patient's family, and/or significant others shall be involved in the discharge planning process.

3. Discharge planning data shall be collected at the time of admission or within seven (7) days thereafter.

4. The Chief Executive Officer shall delegate the responsibility for discharge planning, in writing, to one (1) or more staff members.

5. The facility shall maintain written discharge planning policies and procedures which describe:

a. How the discharge coordinator shall function, and his authority and relationships with the facility's staff;

b. The time period in which each patient's need for discharge planning is determined (within seven (7) days after admission);

c. The maximum time period after which reevaluation of each patient's discharge plan is made;

d. Local resources available to the facility and the patient to assist in developing and implementing individual discharge plans; and

e. Provisions for period review and reevaluation of the facility's discharge planning program (at least annually).

6. An interdisciplinary case conference shall be held prior to the patient's discharge. The discharge/after-care plan shall be reviewed with the patient, patient's family, and/or significant others.

7. The facility shall have documentation of follow-ups to assure referrals to appropriate community agencies.

Q. Discharge Summary. A discharge summary shall be entered in the patient's record within thirty (30) days following discharge. The discharge summary shall include, but not be limited to:

1. Reason for admission;

2. Brief summary of treatment;

3. Reason for discharge;

4. Assessment of treatment plan goals and objectives; and

5. Recommendations and arrangements for further treatment, including prescribed medications and after-care.

R. Additional Requirements. In addition to the requirements contained in this section, Alcohol/Drug Inpatient Treatment Centers shall comply with the following sections of the Rules and Regulations for Hospitals and Related Institutions in Arkansas:

1. Sections 3 through 11.G.

2. Applicable parts of Section 14, Health Information Services.

3. Section 19, Laboratory. (If services are not provided by the facility, an arrangement for diagnostic services shall be made with another licensed hospital or Medicare certified independent laboratory for such services.)

4. Section 36, Specialized Services: Emergency Services. (If not provided, services shall be made available through arrangement with a licensed hospital.)

5. Applicable parts of Section 18, Infection Control.

6. Section 17, Food and Nutrition Services.

7. Section 46, Physical Environment.

8. Applicable parts of Section 16, Pharmacy.

9. Section 81, Physical Facilities, Psychiatric Hospitals and Alcohol/Drug Abuse Inpatient Treatment Centers.

A minimum of ten percent (10%) of the facility's bedrooms shall be equipped with a nurse call system. These rooms shall be located adjacent to the nurses station, and shall be used for initial detoxification or special treatment.

SECTION 46: PHYSICAL ENVIRONMENT.

A. Building and Grounds.

1. The building and equipment shall be maintained in a state of good repair at all times.

2. Facilities and their premises shall be kept clean, neat and free of litter, rubbish.

3. All openings to attics and to spaces between ceilings and roof decks shall be closed.

4. Rooms for gas fired equipment shall not be used for storage except for noncombustible materials.

5. Portable equipment shall be supervised by the department having control of such equipment and shall be stored in areas which are not accessible to patients, visitors, or untrained personnel.

6. Corridors, attics, and passageways shall be free of storage. Exits shall not be blocked by storage of furniture or equipment at any time.

7. Emergency wireless communication shall be provided and maintained in a state of good repair.

8. Each hospital shall develop a written preventive maintenance plan. This plan shall be available to the Department for review at any time. Such plans shall provide for maintenance as recommended by manufacturer, applicable codes, or designer.

9. The handwashing facilities in vistors' rest rooms and the handwashing facilities used by staff personnel shall be equipped with a soap dispenser, and a towel dispenser.

10. Vertical and horizontal transport systems shall be operated and maintained in a manner to provide for safe transport.

11. Doors located on exit access corridors and those for entry to patient care areas shall be labeled as to their intended use for convenience and emergency purposes. All patient rooms shall be labeled numerically and hazardous rooms labeled as to classification.

12. Refer to Sections 8, Personnel Administration and 71, Physical Facilities, Waste Processing Services, for the requirements for sharps containers.

13. Fire safety and other safety systems shall be operated and maintained in a manner to protect patients, personnel, visitors, and property from fire and the products of combustion.

14. A supply of hot water for patient use shall be available at all times. A weekly hot water temperature log shall be maintained.

15. Heating, ventilating and air-conditioning (HVAC) systems shall be operated, and maintained in a manner to provide a comfortable and safe environment for patients, personnel, and visitors. An air filter change out log shall be maintained.

16. Plumbing systems, including equipment and systems for the supply and distribution of potable, non-potable, and/or high purity (such as deionized and sterilized) water, equipment and systems for the complete and safe removal or dispersion of storm water and waste water, shall be operated and maintained in a manner to be adequate, safe and reliable for all required hospital operations.

17. Boiler systems shall be operated, and maintained in a manner to provide a safe supply of steam and/or hot water for all required facility operations.

18. In accordance with NFPA, Volume 99, medical gas and medical/surgical vacuum systems shall be operated and maintained in a manner to provide an adequate and safe supply for all required hospital operations.

19. Exit lights shall be illuminated per NFPA 101 Life Safety Code requirements at all times.

20. Facilities shall have lighting levels that are conducive to efficient work, safety, and patient comfort.

21. The essential power system including emergency generators and uninterrupted power supplies shall be exercised under load conditions monthly for thirty (30) minutes. An equipment log shall be maintained of all tests, malfunctions and the immediate corrective actions. Preventive maintenance work or repairs shall be noted. Refer to current NFPA 101.

22. Communication systems, including telephone, nurse call, and internal/external paging shall operate effectively and reliably at all times.

23. The electrical distribution system shall be operated and maintained in a manner to provide safe electrical power for all required operations.

B. Maintenance and Engineering.

1. The physical plant and equipment maintenance programs shall be under the direction of a person qualified by training and/or experience and licensed where required.

2. Equipment Management Program (EMP). There shall be a preventive maintenance program designed to assure the electrically powered patient care equipment used to monitor, diagnose, or provide therapy, performs properly and safely. This program shall be administered by individuals qualified through training and/or experience or by procuring a contractual maintenance agreement. The following are minimum program elements:

a. A current list of electrically powered patient care equipment shall be maintained regardless of location or ownership;

b. Each device, or identical group of devices, shall have a procedure establishing minimum criteria against which performance and safety are measured. The elements of these procedures shall be based on the manufacturer's directions;

c. Each device shall be tested at intervals of not more than six (6) months unless there is documented evidence that less frequent testing is justified;

d. Historical records documenting acceptable performance as established by the procedures shall be maintained;

e. A program to identify and repair equipment failures shall be maintained;

f. User or owner departments shall be notified of the status of their equipment when it will be out of service more than twenty-four (24) hours;

g. There are operator and maintenance instructions for each device, or group of similar devices on the electrically powered patient care equipment list;

h. Individuals shall be trained to operate and maintain equipment used in the performance of their duties. This training shall be documented.

3. Utilities Management Program (UMP). There shall be a preventive maintenance program designed to assure that the physical plant equipment and building systems perform properly and safely. This program shall be administered by individuals qualified through training and/or experience or by procuring a contractual agreement. This program shall consist of at least the following minimum elements:

a. A list of physical plant equipment and/or building system(s) shall be maintained regardless of location or ownership;

b. Equipment and/or building system(s), shall have a procedure establishing minimum criteria against which performance and safety are measured. The elements of these procedures shall be based on the manufacturer's directions and/or the experience of the repair technician or operator;

c. Equipment and/or building system(s), shall be tested, serviced, or inspected at intervals of not more than twelve (12) months unless there is documented evidence that less frequent service is justified;

d. Historical records documenting acceptable performance as established by the procedures shall be maintained;

e. A program to identify and repair equipment failures shall be maintained;

f. User or owner departments shall be notified of the status of their equipment or system when it will be out of service for more than twenty-four (24) hours;

g. There shall be operator and/or maintenance instructions for each piece of equipment or building system on the list;

h. Individuals shall be trained to operate and maintain physical plant equipment and/or building systems. This training shall be documented.

4. Life Safety Management Program (LSM). There shall be a preventive maintenance program designed to assure that all circuits of fire alarm and detection systems are tested on a quarterly basis and all components receive annual preventive maintenance. Analog detection devices that provide automatic self testing are exempt from the quarterly testing requirement. This program shall be administered by individuals qualified through training and/or experience or by procuring a contractual maintenance agreement. This program shall consist of the following minimum elements:

a. A list of all fire protection equipment or component groups shall be maintained;

b. Equipment and/or component groups, shall have a procedure establishing minimum criteria against which performance and safety are measured. The elements of these procedures shall be based on the manufacturer's recommendations and/or the experience of the repair technician or operator;

c. Fans or dampers in air handling and smoke management systems shall be reliable and functional at all times;

d. Automatic fire extinguishing systems shall be inspected and tested annually; actual discharge of the fire extinguishing system is not required. Records documenting acceptable performance as established by the procedures shall be maintained;

e. A program to identify and repair equipment and/or component group failures shall be maintained;

f. Systems for transmitting fire alarms to the local fire department shall be reliable and functional at all times;

g. There shall be operator and maintenance instructions for each piece of equipment and/or component group on the list;

h. Individuals shall be trained to operate and maintain all equipment and/or component group on the list;

i. Portable fire extinguishers shall be clearly identified.

5. Emergency Procedures Program (EPP). There shall be written emergency procedures or a disaster management plan for utility system disruptions or failures which address the specific and concise procedures to follow in the event of a utility system malfunction or failure of the water supply, hot water system, medical gas system, sewer system, bulk waste disposal system, natural gas system, commercial power system, communication system, boiler or steam delivery system. These procedures shall be kept separate from all other policy and procedure manuals as to facilitate their rapid implementation. These procedures shall contain but are not limited to the following information:

a. A method of obtaining alternative sources of essential utilities;

b. A method of shutoff and location of valves for malfunctioning systems;

c. A method of notification of hospital staff in affected areas;

d. A method of obtaining repair services.

6. Policies and procedures shall include job descriptions and orientation practices for employees.

7. Policies and procedures shall have evidence of ongoing review and/or revision. The first page of each manual shall have the annual review date, signature of the department supervisor and/or person(s) conducting the review.

8. Relevant inservice educational programs shall be conducted on a regularly scheduled basis not less than six (6) per year. There shall be written documentation with employee signature, program title/subject, presenter, date and outline or narrative of presented program.

9. The department director shall ensure that all employees annually attend mandatory inservices on the fire safety, back safety, infection control, universal precautions, emergency procedures and disaster preparedness or make provisions to conduct these departmentally.

10. There shall be sufficient supervisory and support personnel to provide maintenance services in relation to the size and complexity of the facility and the services that are provided.

11. An ongoing QI program with a liaison with the Infection Control and Safety Committee.

C. Environmental Services.

1. The environmental services shall be under the direction of a person qualified by training and/or experience and licensed where required.

2. There shall be written policies and procedures which include:

a. Cleaning of the physical plant;

b. The use, care, and cleaning of equipment;

c. Specific cleaning methods used for:

1) Operating rooms;

2) Delivery rooms;

3) Nurseries/infant care units;

4) Emergency rooms;

5) Isolation areas; and

6) Other units as appropriate.

d. Job descriptions;

e. Orientation practices;

f. Safety practices;

g. Infection control measures;

h. Methods used for evaluation of cleaning effectiveness;

i. Personal hygiene;

j. The selection of housekeeping and cleaning supplies; and

k. The proper use of housekeeping and cleaning supplies.

3. The policy and procedure manual shall have evidence of ongoing review and/or revision. The first page of each manual shall have the annual review date, signature of the department and/or person(s) conducting the review.

4. Relevant inservice educational programs shall be conducted on a regularly scheduled basis not less than six (6) per year. There shall be written documentation with employee signatures, program title/subject, presenter, date, and outline or narrative of presented program.

5. Expendable supplies (i.e., soap, paper products, etc.) shall be stored in a manner that shall prevent their contamination prior to use.

6. Solutions, cleaning compounds, disinfectants, vermin control chemicals, and all other potentially hazardous substances that are used in connection with environmental services shall be:

a. Kept in containers which accurately reflect at least the following:

1) Content name;

2) Concentration of solution;

3) Expiration date and lot number;

b. Stored in a secured area. Under no circumstances shall these substances be stored in or near food storage or food preparation areas;

c. Selected by the director of environmental services or other appointed qualified person. The Infection Control Committee shall initially approve the list of chemicals used in the facility and thereafter, any additions or deletions to the list.

7. A designee from this department shall be a member of the Infection Control Committee.

8. The use of common towels and common drinking utensils shall be prohibited.

9. Dry, or untreated dusting, sweeping, or mopping, except vacuum type cleaning shall be prohibited within the facility.

10. There shall be an ongoing QI Program with a mechanism for reporting results.

D. Laundry Services.

1. Laundry services shall be under the direction of a person qualified by training and/or experience and licensed where required.

2. There shall be sufficient support personnel to provide laundry services in relation to the size and complexity of the facility and the services that are provided.

3. There shall be written policies and procedures which include:

a. Collection of soiled, wet, and contaminated linen;

b. Transporting of soiled, wet, and contaminated linen to the laundry service or to a designated area for commercial pick-up;

c. Storage of soiled, wet, and contaminated linen until laundering or being picked up by the commercial laundry;

d. Storage of clean linen;

e. Specific laundry requirements (type detergent, sours, bleach, time and temperatures used) for washing:

1) New linen;

2) Diapers;

3) Soiled, wet, and contaminated linen;

f. Personal hygiene;

g. Evaluation of washing/cleaning effectiveness;

h. Job descriptions;

i. Orientation practices for new employees;

j. Safety practices;

k. Infection control measures.

4. Policies and procedures for Laundry Services shall have evidence of ongoing review and/or revision. The first page of the manual shall have the annual review date, signature of the department supervisor and/or person(s) conducting the review.

5. Relevant inservice educational programs shall be conducted on a regularly scheduled basis not less than six (6) per year. There shall be written documentation with employee signature, program title/subject, presenter, date and outline or narrative of presented program.

6. Facility laundry service:

a. Sorting of soiled laundry shall be done in a designated area;

b. Tables or bins shall be provided for sorting of soiled laundry;

c. Lint traps shall be provided on dryers and shall be cleaned regularly;

d. Prerinsing shall be done in the laundry service not in showers, bathtubs or lavatories;

e. Removal of solid soil shall be done in soiled utility rooms or rooms that are designated for this purpose;

f. Patient clothing may be washed in the patient area if a separate equipped laundry room is available;

g. A rinsing sink shall be provided in the soiled linen area of the laundry;

h. Hot water supplied to laundry areas shall be in accordance with Table 9 of the Appendix;

i. Linen contained in hot water soluble plastic bags (identified as being contaminated) shall be placed directly into the washing machine without being removed from the bag for sorting;

j. A lavatory equipped with wrist action controls, a soap dispenser and a towel dispenser shall be provided in the laundry for use by the personnel;

k. Personnel with infectious disease or open wounds shall not be permitted in the laundry;

l. Personnel assigned to laundry duties shall wash their hands:

1) After handling wet or soiled laundry;

2) Before leaving the laundry;

3) After using the toilet;

4) As often as is necessary to maintain good hygiene.

NOTE: Laundry equipment and installation requirements are set forth in Section 68, Physical Facilities, Laundry Service.

7. Soiled linen from isolation areas, surgical cases, etc., shall be placed into impervious bags and, if leakage occurs, bagged into a second bag with proper identification. Suitable precautions shall be taken in transport, handling, and processing.

8. Soiled, wet, and contaminated linens shall be transported in a closed container.

9. Soiled, wet, and contaminated linens shall be stored in closed containers or impervious bags in designated areas off the floor. Areas for storage of soiled, wet, and contaminated linens shall have forced ventilation to the outside of the building.

10. All new clothing, linen and diapers shall be laundered before being used.

11. There shall be a designated area for the storage of clean linens.

12. The laundry service within the facility shall have a capacity sufficient to process a continuous supply of clean laundry ready for use.

13. Temperature used in the dryer will depend on the type fabric. An employee shall be present at all times when the dryer is in operation.

14. There shall be an ongoing QI Program with a mechanism for reporting results.

15. Laundry Service shall include a written contingency plan indicating an alternative provision that may be followed in the event the laundry is unable to meet the production demand of the facility.

16. Separate containers for the disposal of infectious waste and sharps shall be located in the soiled linen sorting area.

17. Laundry workers handling infectious linens shall wear protective equipment, including but not limited to waterproof, puncture-resistant gloves, protective over-clothing, and where necessary, face shields or goggles.

18. Facilities which do not have laundry services:

a. The facility shall designate a person to determine that all launderable items processed in a commercial laundry shall be in accordance with standards set forth in this section. Hospital personnel shall conduct annual onsite inspections of the commercial laundry;

b. Soiled, wet, and contaminated laundry shall be stored in a designated area until pick up by the commercial laundry;

c. A designated clean area shall be provided for receiving clean laundry and shall be separate from the soiled laundry area;

d. Clean linen shall be packaged and protected from contamination during transportation and storage.

19. Refer to Section 18, Infection Control, for additional requirements.

E. Safety Services.

1. There shall be an effective program to enhance safety within the facility and grounds. The program shall be monitored by a Safety Committee appointed by the Administrator. Committee members shall be selected from Administration, Nursing, Maintenance, Housekeeping, Laboratory, Respiratory Care, Rehabilitation Services, the Medical Staff and others as appropriate.

2. The Safety Committee shall meet a minimum four (4) times per year to fulfill safety objectives. Minutes of each meeting shall be recorded and kept in the facility.

3. The Administrator shall designate a specific individual to carry out policies established by the committee and to gather data for the committee to study safety related incidents.

4. Safety policies and procedures shall have evidence of ongoing review and/or revision. The first page of each manual shall have the annual review date, signature of the department supervisor and/or person(s) conducting the review. Safety policies and procedures shall include:

a. Facility wide hazard surveillance program;

b. Response to medical-device recalls and hazard notices;

c. Safety education;

d. Reporting of all accidents, injuries, and safety hazards;

e. External and internal disaster plans;

f. Fire safety; and

g. Safety devices and operational practices.

5. The orientation program for the facility shall include the importance of general safety, fire safety and the responsibility of each individual to the program.

6. The Safety Committee shall have the following functions:

a. Investigation and evaluation of each accident, injury or safety hazard report;

b. Provision for safety-related information to use in orientation and education programs;

c. Monitoring the results of the safety program and analyzing the effectiveness of the program annually;

d. Conducting fire drills and disaster drills at required intervals;

e. Reporting conclusions, recommendations, and actions of Committee at east quarterly to Administration;

f. Ensuring each department or service shall have a safety policy and procedure manual within their own area that is a part of the overall facility safety manual and establishes safety policies and procedures specific to each area.

7. Fire extinguishers shall be provided in adequate numbers, of the correct type, and shall be properly located and installed. Personnel shall be trained in the proper use of fire extinguishers and equipment. Personnel shall follow procedures in fire containment and evacuating patients in case of fire or explosion. There shall be an annual check of all fire extinguishers by qualified persons in accordance with the applicable sections of the National Fire Protection Association's Standard 10 (NFPA 10). The date the check was made and the initials of the inspector shall be recorded on the fire extinguisher or on a tag attached to the extinguisher.

8. A plan shall be available for the protection of patients, visitors, and employees for evacuation in the event of an emergency. A simple floor plan (graphic display) showing the evacuation routes shall be posted in prominent locations on all floors and in all departments. Any fire or disaster event at the facility shall be reported immediately to the Arkansas Department of Health by telephone 661-2201 during regular working hours or to 1-800-554 -5738 or 661-2136 after normal working hours, holidays and weekends. If any fire(s) or disaster is not reported to the Department, the facility is subject to a fine, refer to item J. of Section 4, Licensure and Codes.

9. "No Smoking" signs shall be posted in any room or compartment where flammable Liquids, combustible gases, or oxygen is used or stored, and in any other hazardous locations. Smoking shall be prohibited by patients classified as not responsible, except when the patient is under the direct supervision of the staff. Ash trays shall be provided of noncombustible material and safe design in areas where smoking is permitted.

10. There shall be rules and regulations governing the routine methods of handling and storing flammable and explosive agents, particularly in operating rooms, delivery rooms, laundries and in areas where oxygen therapy is administered.

11. There shall be keys available to assure prompt access to all locked areas. All doors shall be devised so they can be opened from the inside of the locked area. Special door locking devices are acceptable in limited areas. Usage is subject to all codes and regulations.

12. All containers used in the institution shall be legibly and accurately labeled as to content.

13. All required exit doors shall remain unlocked per NFPA requirements.

14. A list of Material Safety Data Sheets (MSDS) for solutions, cleaning compounds, disinfectants, vermin control chemicals, and other potentially hazardous substances used in connection with the facility shall be readily available to the Safety Committee, Emergency Room, Environmental Services and as directed by facility policy and procedures;

SECTION 47: PHYSICAL FACILITIES.

A. Definitions.

1. Accessible - having access to but which first may require the removal of a panel, door or similar covering of the item described.

2. Addition - an extension or increase in floor area, height of a building, or structure.

3. Alter or Alteration - any change(s) or modification in construction or occupancy or the installation or the assembly of any new structural components, or any change(s) to the existing structural component, in a system, building, and structure.

4. And/Or (in a choice of two (2) code provisions) - signifies that use of both provisions shall satisfy the code requirements and use of either provision is acceptable, also. The most restrictive provision shall govern. Where there is a conflict between a general requirement and a specific requirement the specific or restrictive requirement shall be applicable.

5. Architect - a duly registered architect and licensed by the State of Arkansas.

6. Corridor - a passage way into which compartments or rooms open and which is enclosed by partitions and/or walls and a ceiling, or a floor/roof deck above.

7. Dead end - a hallway, corridor or space open to a corridor so arranged that it can be entered, from an exit access corridor without passage through a door, but does not lead to an exit.

8. Engineer - a duly registered engineer and licensed by the State of Arkansas.

9. Licensing agency - Arkansas Department of Health, Division of Health Facility Services or current name.

10. Listed - equipment or materials included in a list published by a nationally recognized testing laboratory, inspection agency or other organization concerned with products evaluation that maintains periodic inspection of production of listed equipment or materials, and whose listing states either that the equipment or materials meets nationally recognized standards or has been tested and found suitable for use in a specific manner.

11. Narrative program - the narrative program describes the functional and utilizational information related to fulfillment of the institution's objectives. The description reflects those services necessary for complete operation of the facility. Some common elements which shall be included address policies and procedures; intent or purpose; space requirements; staff patterns, quantities, and credentials.

12. New construction - these regulations establish health, safety and welfare requirements for the design of all new hospitals and related institutions. Where new work is done within the state, all portions of the work shall comply with applicable sections of these regulations.

13. Partition - an interior wall, other than folding or portable, that subdivides spaces within any story, attic or basement of a building.

14. Patient care area - any portion of a health care facility wherein patients are intended to be examined or treated. Typical areas include delivery, nursery, recovery, patient bedrooms, therapy suites, patient occupiable diagnostic spaces, and areas in which patients are intended to be subjected to invasive procedures. Non-patient care areas may include business offices, corridors, lounges, day rooms, dining rooms or similar areas in which only occasional use occurs and no patient care takes place in the patient's vicinity during transient periods.

15. Plenum - an air compartment or chamber to which one (1) or more ducts are connected and which forms part of air distribution system.

16. Readily accessible - having direct access without the need of removing any panel, door or similar covering of the item described, and without requiring the use of portable ladders, chairs, etc.

17. Renovation - where renovation or replacement work is done within an existing facility, all new work or additions, or both, shall comply, insofar as practical, with applicable sections of these regulations, Section 46, Physical Environment, and with appropriate parts of NFPA 101, covering new health care occupancies. Those existing portions of the facility which are not included in the renovation but which are essential to the functioning of the complete facility, as well as existing building areas that receive less than substantial amounts of new work shall at a minimum, comply with that section of NFPA 101 for existing health care occupancies and the prior edition of the state regulations. Renovations, including new additions, shall not diminish the safety level that existed prior to the start of the work; however, safety in excess of that required for new facilities is not required. Approval for the renovation work shall be based on the written narrative program construction document and other information submitted to the Division for final approval or disapproval.

18. Repair - the reconstruction or renewal of any part of an existing building for the purpose of its' maintenance.

19. Room - a separate, enclosed space, with doorway(s), for the one (1) named function.

20. Special care units - include, but are not limited to: coronary care unit or cardiovascular unit; intensive care unit, burn unit, neonatal care unit, post obstetric and postoperative recovery unit, renal dialysis unit, pulmonary care units, and surgical and trauma unit.

21. Through Penetration Protection - a system installed to resist, for a prescribed time period, the passage of flame, heat, and hot gases through openings which penetrate an entire fire resistant assembly in order to accommodate cables, cable trays, conduits, tubing, pipes, ductwork or similar terms.

22. Toilet - one (1) or more of the following items shall be contained in the Room: a water closet, lavatory, tub or shower.

B. General Considerations.

1. The requirements set forth herein have been established by the Department and constitute minimum requirements for new construction, new addition(s), and/or major renovations(s) in facilities requiring licensure under these regulations. These requirements are considered necessary to ensure properly planned and well constructed health care facilities which can be efficiently maintained and operated to furnish adequate services. In many instances, these minimum requirements shall need to be exceeded for the facility to function as programmed.

2. Facilities shall be accessible to the public, staff, and patients with physical disabilities. Minimum requirements shall be those set forth by the Arkansas State Building Services, Minimum Standards and Criteria - Accessibility for the Physically Disabled Standards.

3. Projects involving renovation, and additions to existing facilities shall be programmed and phased to minimize disruption of the existing functions. Access, exits and fire protection shall be maintained for the occupant's and the facility's safety.

4. Codes and Standards. Nothing stated herein shall relieve the owner from compliance with building codes, ordinances, and regulations which are enforced by city, county, or other State jurisdictions. Where such codes, ordinances, and regulations are not in effect, the owner shall consult the state building codes for all components of the building type which are not specifically covered by these minimum requirements. In location where there is a history of tornadoes, floods, earthquakes or other regional disasters, planning and design shall consider the need to protect the occupants and the facility.

5. No new mechanical, electrical, plumbing, fire protection, or medical gas system shall be installed, nor any such existing system materially altered or extended, until complete plans and specifications for installation, alteration, or extensions have been submitted to the licensing agency for review and approval.

C. Plan Review. The following list illustrates the process flow which shall be used for all new construction, remodeling, and/or alterations and shall include:

1. Narrative program;

2. Site location;

3. Preliminary plans;

4. Submission of plan review fee;

5. Final construction documents;

6. Letter of approval for construction documents;

7. Site inspections during construction;

8. Final site inspection.

D. Narrative Program.

1. The facility shall supply for each project (whether new construction, addition, modernization, and renovation) a narrative program that describes the purpose of the project, the projected demand or utilization, staffing patterns, departmental relationships, space requirements, and other basic information relating to the fulfillment of the institution's objectives.

2. The facility's narrative program and/or construction documents shall be approved by all applicable Departments prior to starting construction.

E. Site Location.

1. Location.

a. The site of any medical facility shall be easily accessible to the community and to service vehicles such as fire protection apparatus.

b. Facilities shall be located with due regard to the accessibility by public transportation for patients, staff, and visitors, and availability of competent medical and surgical consultation.

c. The facility shall have security measures for patients, personnel, and the public consistent with the conditions and risks inherent in the location of the facility. These measures shall include a program designed to protect human and capital resources.

d. The facility shall be located to provide reliable utilities (water, natural gas, sewer and electricity). The water supply shall have the capacity to provide normal usage plus fire fighting requirements. The electricity shall be of stable voltage and frequency.

e. The site shall afford good drainage and shall not be subject to flooding nor be located near insect breeding areas, noise, nor other nuisance producing locations, nor near airports, railways, nor highway producing noise, nor air pollution, nor near penal institutions (except prison infirmaries), nor near a cemetery.

2. Roads and Parking.

a. Paved roads and walks shall be provided within the lot lines to provide access to the main entrance and service entrance, including loading and unloading docks for delivery trucks. Hospitals having an organized emergency services department shall have the emergency entrance well marked to facilitate entry from the public roads or streets serving the site. Access to the emergency entrance shall not conflict with other vehicular traffic or pedestrian traffic. Paved walkways shall be provided for necessary pedestrian traffic.

b. Each facility shall have parking spaces to satisfy the minimum needs of patients, employees, staff, and visitors. In the absence of a formal parking study, each facility shall provide not less than one (1) space for each day shift staff member and employee plus one (1) space for each patient bed. This ratio may be reduced in an area convenient to a public transportation system or to a public parking facility if proper justification is given and provided that approval of any reduction is obtained from the Department. Additional parking shall be required to accommodate outpatient and other services when they are provided. Space shall be provided for emergency and delivery vehicles.

3. Subsoil Investigation. Subsoil investigation shall be made to determine the subsurface soil and water conditions. The investigation shall include a sufficient number of test pits or test borings to determine, in the judgment of the architect and the structural engineer, the true subsurface conditions. Results of the investigation shall be available in the form of a soil investigation report or a foundation engineering report. The investigation shall be made in close cooperation with the architect and structural engineer and shall contain detailed recommendations for foundation design and gradings. The following is a general outline of the suggested scope of soil investigation:

a. The borings or test pits shall extend into stable soils well below the bottom of any proposed foundations. A field log of the borings shall be made and the thickness, consistency, and character of each layer recorded;

b. The amount and elevation of groundwater encountered in each pit or boring and its probable variation with the seasons and effect on the subsoil shall be determined. High or low water levels of nearby bodies of water affecting the ground level shall also be determined;

c. Laboratory tests shall be performed to determine the safebearing value and compressibility characteristics of the various strata encountered in each pit or boring;

d. Maximum depth of frost penetration below surface of the ground shall be recorded;

e. Tests shall be made to determine whether the soil contains alkali in sufficient quantities to affect concrete foundations;

4. Approval. The new building site shall be inspected and approved by the Department before construction begins.

F. Preliminary Plans and Design Development. A preliminary plan which shall include scales, single line drawings of each floor (basement area considered a floor), showing the relationship of various departments and services to each other and the room arrangement in each department. It shall also show room and corridor dimensions. The name of each room shall be noted. Design development plans shall include the following: room names (note new and existing, if applicable); required fire safety and exiting criteria; building construction type; compartmentation showing fire and smoke barriers. An existing floor plan showing existing spaces and exits and their relationship to the new construction shall be submitted on all renovation or additions to an existing facility. A building section(s) shall be required to establish construction type and fire rating. Section(s) shall be drawn at a scale sufficiently large to clearly present the proposed construction system. Smoke compartments and exit requirements shall also be shown. Proposed roads, walks, service and entrance courts, parking, and orientation may be shown either on a small plot plan or on the first floor plan. Simple vertical space diagrams shall be submitted with this plan. This plan shall also include single line schematics of mechanical, electrical, etc.systems, and a plan for ensuring that the contractor provides adequate "as built" drawings. An existing floor plan showing existing spaces and exits and their relationship to the new construction shall be submitted on all renovation or additions to an existing facility.

G. Submission of Plan Review Fee.

A plan review fee in the amount of one (1) percent of the total cost of construction or five-hundred dollars ($500.00), whichever is less, shall be paid for the review of plans and specifications. The plan review fee check is to be made payable to the Division of Accounting, Arkansas Department of Health. A detailed estimate must accompany the plans unless them maximum fee of five-hundred ($500.00) is paid. This office will coordinate review of plans for all Arkansas Department of Health offices.

H. Final Construction Documents.

1. Requirements for plans and specifications shall be prepared by an architect and/or professional engineer licensed by the State of Arkansas. The licensed Architect and the licensed Engineer shall prepare and submit construction documents with the respective seals for each professional discipline. Architectural construction documents shall be prepared by an Architect and engineering (mechanical, electrical, civil and structural) construction documents shall be prepared by an (mechanical, electrical, civil and structural) Engineer. Periodic observations of construction shall be provided and documented by each design professional to assure that the plans and specifications are followed by the contractor, and that "as built" prints are kept current. The construction contract shall contain a provision to withhold progress payments to the contractor until "as is" prints are current. The interval for periodic observation shall be determined and approved by the licensing agency prior to beginning construction. Progress reports shall be submitted as required by the licensing agency to monitor the construction work.

2. Working drawings and specifications shall be well prepared so that clear and distinct prints may be obtained. Accurate dimensions including all necessary explanatory notes, schedules, and legends shall be legible. Working drawings and specifications shall be complete for contract purposes. Separate drawings shall be prepared for each of the following branches of work: architectural, structural, mechanical, electrical, life safety and fire protection; and shall include the following:

a. Architectural.

1) Approved plan showing all new topography, newly established levels and grades, existing structures on the site (if any), new buildings and structures, roadways, walks, and the extent of the areas to be planted. All structures and improvements removed under the construction contract. A print of the survey included with the working drawings.

2) Plan of each floor, roof, and all intermediate levels.

3) Elevations of each exterior wall.

4) Sections through building.

5) Scale details as necessary to properly indicate portions of the work.

6) Schedule of finishes.

b. Equipment.

1) Large scale drawings of typical and special rooms indicating all fixed equipment and major items of furniture and movable equipment.

2) The furniture and movable equipment not included in the construction contract shall be indicated by dotted lines.

c. Structural.

1) Plans of foundations, floors, roofs, and all intermediate levels shall show a complete design with sizes, sections, and the relative location of the various members and schedule of beams, girders, and columns.

2) Dimensional floor levels, column centers and offsets.

3) Special openings.

4) Details of all special connections, assemblies, and expansion joints.

5) Name of the governing building code.

d. Mechanical.

1) Heating, piping, and air-conditioning systems:

a) Steam heated equipment, such as sterilizers, warmers, and steam tables;

b) Heating and steam mains and branches with pipe sizes;

c) Diagram of heating and steam risers with pipe sizes;

d) Sizes, types, and heating surfaces of boilers and oil burners, if any;

e) Pumps, tanks, boiler breeching and piping, and boiler room accessories;

f) Air-conditioning systems with required equipment, water refrigerant piping, and ductwork showing required fire smoke/dampers;

g) Exhaust, return, and supply ventilating systems with piping and required fire/smoke dampers;

h) Air quantities for all room supply, return, and exhaust ventilating duct openings;

i) A ventilation schedule specifying the following information: room number, room name, room volume (ft3), required room air changes, required outside air changes, required air movement relative to adjacent area, required air filtration (% efficiency), required room total supply air quantity (cubic feet per minute (CFM), required outside air quantity (CFM), required room exhaust air quantity (CFM), design room total supply air quantity (CFM), design room return air quantity (CFM), design outside air quantity (CFM), design room exhaust air quantity (CFM), design room air filtration (% efficiency), room design summer (ºF) dry bulb/wet bulb (DB/WB), room design winter (ºF) DB/WB, outside air design summer (ºF) DB/WB, and outside air design winter (ºF) DB/WB.

j) Air filter design pressure drop both clean and dirty.

2) Plumbing, drainage, and standpipe systems:

a) Size and elevation of street sewer, house sewer, house drains, and street water main;

b) Locations and size of soil, waste, and vent stacks with connections to house drains, clean outs, fixtures and equipment;

c) Size and location of hot and cold circulating mains, branches, and risers from the service entrance and tanks;

d) Riser diagram to show all plumbing stacks with vents, water risers, and fixture connections;

e) Gas, oxygen, and special connections;

f) Standpipe and sprinkler systems;

g) Plumbing fixtures and equipment which require water and drain connections;

3) Elevators and dumbwaiters: Details and dimensions of shaft, pit and machine room, pit sumps with alarms when required, sizes of car platform and doors.

4) Kitchens, laundry, refrigeration, and laboratories detailed at a satisfactory scale (1/4 inch scale) to show the location, size, and connection of all fixed and moveable equipment.

e. Electrical.

1) All electrical wiring, outlets, smoke detectors, and equipment which require electrical connections.

2) Electrical service entrance with switches, and feeders to the public service feeders, characteristics of the light and power current and transformers and their connections, if located in the building.

3) Plan and diagram showing main switchboard power panels, light panels and equipment. Diagram of feeder and conduit sizes with a schedule of feeder breakers or switches.

4) Light outlets, receptacles, switches, power outlets, and circuits.

5) Telephone layout showing service entrance, telephone switchboard, terminal boxes, and telephone outlets.

6) Nurses' call systems with outlets for beds, nurses stations, door signal lights, annunciators, and wiring diagrams.

7) Staff paging and doctor's in-and-out registry systems with all equipment wiring, if provided.

8) Fire alarm and/or security system with stations, signal devices, control board, and wiring diagrams.

9) Emergency electrical system with outlets, transfer switch, source of supply, feeders, and circuits.

10) Medical gas alarm systems.

11) All other electrically operated systems and equipment.

f. Life Safety and Fire Protection.

1) Limits of each smoke compartment.

2) Location of each smoke barrier wall.

3) Dimensions and gross areas of each smoke compartment.

4) Location of each fire rated wall or partition, fire separation wall and horizontal exit.

5) Location of each exit sign, fire pull station, and extinguisher cabinet and extinguisher.

6) Travel distance(s) from the most remote location(s) in the building to an exit as defined by NFPA 101 (i.e., horizontal exit, exit passageway, enclosed exit stair, exterior exit door).

g. Specifications.

1) Specifications shall supplement the drawings to fully describe types, sizes, capacities, workmanships, finishes, and other characteristics of all materials and equipment and shall include the following:

a) Cover or title sheet with architectural seal;

b) Index;

c) General conditions;

d) General requirements;

e) Sections describing material and workmanship in detail for each class of work.

h. All construction documents and specifications shall be approved by the Department prior to the beginning of construction and a letter shall be issued from the licensing agency granting approval to commence with construction. The Department shall have a minimum of six (6) weeks to review construction documents and specifications. The Division of Health Facility Services shall coordinate the plan review with other Divisions in the Department. Penalities for starting construction without Department approval see Section 4.I, Licensure and Codes.

I. Site Inspection During Construction. The new building site shall be inspected and approved by the Department before construction begins. The construction of the new building and/or addition shall be inspected during the construction phases and before occupying the building and/or addition.

1. This Department is to be notified when construction begins and a construction schedule shall be submitted to determine inspection dates.

2. Representatives from the Department shall have access to the construction premises and the construction project for purposes of making whatever inspections deemed necessary throughout the course of construction.

3. Any deviation from the accepted construction documents shall not be permitted during construction, until the written request for change(s) in the construction is approved by this Department.

J. Final Site Inspection.

1. Upon completion of construction and prior to the approval by the Department to occupy and use the facility, the owner shall be furnished a complete set of reproducible drawings, and one (1) legible set of prints showing all construction, fixed equipment, and mechanical and electrical systems as installed or built. The Department shall be provided as built plans. In addition, the owner shall be furnished a complete set of installation, operation, and maintenance manuals and parts lists for the installed equipment at the time as built prints are provided.

2. No facility shall occupy any new structure or major addition or renovation space until the appropriate permission has been received from the local building and fire authorities and licensing agency.

3. A list of final site inspection items has been provided in the Table 5 of the Appendix.

K. List of Referenced Publications.

Codes and standards which have been referenced in whole or in part in the various sections of this document are listed below. The most current codes and standards adopted at the time of this publication are used. Later issues will normally be acceptable where requirements for function and safety are not reduced; however, editions of different dates may have portions renumbered or re-titled. Care shall be taken to ensure that appropriate sections are used. Names and addresses of originators are also included for information.

1. American National Standards Institute (ANSI) Standard A17.1, "American National Standard Safety Code for Elevators, Dumbwaiters, Escalators and Moving Stairs."

2. American Society of Civil Engineers, (ASCE), "Minimum Design Loads for Buildings and Other Structures."

3. American Society of Heating, Refrigerating and Air Conditioning Engineers (ASHRAE), "Handbook of Fundamentals" and "Handbook of Applications."

4. American Society of Heating, Refrigerating and Air Conditioning Engineers (ASHRAE), Standard 52, "Method of Testing Air Cleaning Devices Used in General Ventilation for Removing Particulate Matter."

5. Arkansas State Building Services, Minimum Standards and Criteria - Accessibility for the Physically Disabled Standards.

6. International Fire Prevention Code, - International Building Construction .

7. Arkansas State Mechanical Code, Arkansas Department of Health.

8. Arkansas State Plumbing code, Arkansas Department of Health.

9. DOP Penetration Test Method, MIL STD No. 282, "Filter Unites, Protective Clothing, Gas Mask Components and Related Products: Performance Test Methods."

10. Illuminating Engineering Society of North America, IESNA Publication CP29, "Lighting for Health Care Facilities."

11. Laws, Rules, and Regulations Governing Boiler Inspection, Arkansas Department of Labor.

12. National Council on Radiation Protection (NCRP), Report No. 33, "Medical X-ray and Gamma Ray Protection for Energies Up to 10 MeV Equipment Design and Use, 1986."

13. National Council on Radiation Protection (NCRP), Report No. 49, "Medical X-ray and Gamma Ray Protection for Energies up to 10 MeV Structural Shielding Design and Evaluation, 1976."

14. National Council on Radiation Protection (NCRP), Radiation Protection Design Guidelines for 0.1pi29100, MeV Particle Accelerator Facilities.

15. National Fire Codes - 2001.

16. Rules and Regulations Pertaining to the Management of Regulated Waste from Health Care Related Facilities, Arkansas Department of Health.

17. Rules and Regulations Pertaining to Swimming Pools and Other Related Facilities -Arkansas Department of Health.

L. Availability of Codes and Standards. The codes and standards referenced in various sections throughout this document can be ordered, if they are Government publications, from the Superintendent of Documents, U.S. Government Printing Office (GPO), Washington, DC 20402. Copies of non-government publications can be obtained at the addresses listed below.

1. Air Conditioning and Refrigeration Institute, 1501 Wilson Boulevard, Arlington, VA 22209.

2. American National Standards Institute, 1430 Broadway, New York, NY 10018.

3. American Society of Civil Engineers, 345 East 47th Street, New York, NY 10017

4. American Society for Testing and Materials, 1916 Race Street, Philadelphia, PA 19103.

5. American Society of Heating, Refrigerating, and Air Conditioning, 1741 Tullie Circle, NE, Atlanta GA 30329.

6. Arkansas State Building Services, 1515 West 7th Street, Suite 700, Little Rock, AR 72201.

7. Arkansas Department of Labor, 10421 West Markham, Little Rock, AR 72205.

8. Illuminating Engineering Society of North America (IESNA), 120 Wall Street, 17th Floor, New York, NY 10005.

9. National Council on Radiation Protection and Measurement, 7910 Woodmont Avenue, Suite 1016, Bethesda, MD 20814.

10. National Fire Protection Association, 1 Batterymarch Park, Post Office Box 9101, Quincy, MA 02269-9101.

11. National Technical Information System (NTIS), 5285 Port Royal Road, Springfield, VA 22161.

12. Defense Printing Service, 700 Robbins Avenue, Building 4D, Philadelphia, PA 19111 (for DOP Penetration Test Method).

13. International Building Code Congress International, Inc., 900 Montclair Road, Birmingham, AL 35213.

14. Underwriters' Laboratories, Inc. 333 Princeton Road, Northbrook, IL 60062.

SECTION 48: PHYSICAL FACILITIES, PATIENT ACCOMMODATIONS (ADULT MEDICAL, SURGICAL, COMMUNICABLE OR PULMONARY DISEASE). NOTE: See other sections of this document for Special-Care area units such as Postanesthesia Care Unit, Critical Care Units, Rehabilitation Units, Pediatric Units, Postpartum Care Units, and/or other speciality units.

A. Patient Rooms. Each patient room shall meet the following requirements.

1. Maximum room capacity shall be two (2) patients.

2. In new construction, patient rooms shall have a minimum of one-hundred (100) square feet of clear floor area per bed in semi-private rooms and one-hundred-twenty (120) square feet of clear floor area for single-bed rooms, exclusive of toilet rooms, closets, lockers, wardrobes, alcoves or vestibules. The dimensions and arrangement of rooms shall be such that there is a minimum of three (3) feet between the sides and foot of the bed and any wall, other fixed obstruction, or another bed. In semi-private bed rooms, a clearance of four (4) feet shall be available at the foot of each bed to permit the passage of equipment and beds.

Minor encroachments, including columns and lavatories, that do not interfere with functions may be ignored when determining space requirements for patient rooms. Where renovation work is undertaken, every effort shall be made to meet the above minimum standards.

3. Each patient room shall have a window with outside exposure and where the operation of windows or vents requires the use of tools or keys, such devices shall be on the same floor and easily accessible to staff. The windowsills shall not be higher than three (3) feet above the floor and shall be above the grade. Patient rooms in new construction intended for twenty-four (24) hour occupancy shall have windows. If operable windows are installed, such devices shall be restricted to inhibit possible escape or suicide.

4. Nurse patient communication station shall be provided in accordance with item G. of Section 76, Physical Facilities, Electrical Standards.

5. Handwashing facilities shall be provided to serve each patient room. These handwashing facilities shall be located in the toilet room.

6. Each patient shall have access to a toilet room without having to enter the general corridor area. One (1) toilet room shall serve no more than four (4) patient beds and no more than two (2) patient rooms. In new construction, an additional handwashing facility shall be placed in the patient room where the toilet room serves more than two (2) beds. The toilet room shall contain a water closet and a handwashing facility and the door shall swing outward or be double acting.

7. Each patient shall have within the room a separate wardrobe or closet that is suitable for hanging full length garments and for storing personal items.

8. Visual privacy from casual observation by other patients and visitors shall be provided for each patient in semi-private rooms with cubicle curtains or equivalent built-in or movable dividers. Provisions for privacy is not required within psychiatric or alcohol and drug units. The method for providing privacy shall not obstruct passage of other patients either to the entrance, toilet, or lavatory. All curtains shall have a flame spread of zero (0) to twenty-five (25) and shall comply with NFPA 13 requirements for clear space below sprinklers.

9. Each room shall communicate directly with a corridor without passage through another patient's room.

10. Rooms existing partially below grade level shall not be used for patients unless they are dry, well ventilated, and are otherwise suitable for occupancy.

11. Beds shall be arranged to provide adequate room for all patient care procedures and to prevent the transmission of infections.

12. Individual approved hospital type beds shall be provided. Bed rails shall be provided on beds for children.

13. A reading light shall be provided for each patient bed. The location and design shall be such that the light is not annoying to other patients.

14. A bedside table with drawer shall be provided for each bed. The lower portion of the table and/or enclosed shelves shall be provided for individual nursing care equipment.

B. Service Areas. Each services area may be arranged and located to serve more than one (1) nursing unit but at least one (1) such service area shall be provided on each nursing floor. Some of the service areas may be combined in a single space. The following service areas shall be located in or readily available to each nursing unit:

1. Nursing Station. Facilities for charting, clinical records, work counter, communication system, space for supplies and convenient access to handwashing facilities shall be provided. It may be combined with or include centers for reception and communication;

2. Dictation area shall be provided. This area shall be adjacent to but separate from the nurses' station;

3. Toilet room(s) for staff convenient to nurses' station (may be unisex);

4. Lounge facilities for staff. These facilities may be on another floor;

5. Individual closets or compartments for the safekeeping of coats and personal effects of nursing personnel. These shall be located convenient to the nurses' station of personnel or in a central location;

6. Multi-purpose room(s) for staff, patients, patients' families for patient conferences, reports, education, training sessions, and consultation. The rooms must be accessible to each nursing unit. One (1) such room may serve several nursing units and/or departments;

7. Examination/treatment room(s). Such rooms may be omitted if all patient rooms are single-bed rooms. It shall have a minimum floor area of one-hundred-twenty (120) square feet excluding space for vestibule, toilet, closets, and work counters (whether fixed or movable). Centrally located examination and treatment room(s) may serve more than one (1) nursing unit on the same floor. The room shall contain a lavatory or sink equipped for handwashing, work counter, storage facilities, and a desk, counter, or shelf space for writing. The emergency treatment room may be used for this purpose if it is conveniently located to the patient rooms;

8. Clean workroom or clean supply room. If the room is used for preparing patient care items, it shall contain a work counter, a handwashing fixture, and storage facilities for clean and sterile supplies. If the room is used only for storage and holding as part of a system for distribution of clean and sterile materials, the work counter and handwashing fixture may be omitted. Soiled and clean workrooms or holding rooms shall be separated and have no direct connection;

9. Soiled workroom or soiled holding room. This room shall be separate from the clean workroom. The soiled workroom shall contain a clinical sink (or equivalent flushing-rim fixture). The room shall contain a lavatory (or handwashing fixture). The above fixtures shall both have a hot and cold mixing faucet. The room shall have a work counter and space for separate covered containers for soiled linen and waste. Rooms used only for temporary holding of soiled material may omit the clinical sink and work counter. If the flushing-rim clinical sink is eliminated, facilities for cleaning bedpans shall be provided elsewhere;

10. Medication Station. Provisions shall be made for distribution of medications. This may be done from a medicine preparation room or unit, from a self-contained medicine dispensing unit, or by another approved system;

a. Medicine preparation room. This room shall be designed to allow for visual supervision by the nursing staff. It shall contain a work counter, a sink adequate for handwashing, refrigerator, and locked storage for controlled drugs. When a medicine preparation room is to be used to store one (1) or more self-contained medicine dispensing units, the room shall be designed with adequate space to prepare medicines with the self-contained medicine dispensing unit(s) present.

b. Self-contained medicine dispensing unit. A self-contained medicine dispensing unit may be located at the nurses' station, in the clean workroom, or in an alcove, provided the unit has adequate security for controlled drugs and adequate lighting to easily identify drugs. Convenient access to handwashing facilities shall be provided. (Standard cup-sinks provided in many self-contained units are not adequate for handwashing.)

11. Clean Linen Storage. A separate closet or a designated area within the clean workroom shall be provided. If a closed cart system is used, storage may be in an alcove. Carts must be out of the path of traffic;

12. Nourishment Station. This shall contain a sink equipped for handwashing, equipment for serving nourishment between scheduled and unscheduled meals, refrigerator, storage cabinets, and ice maker units to provide ice for patients' service and treatment. Ice for human consumption shall be from self-dispensing units. Handwashing facilities shall be in or immediately accessible to the nourishment station;

13. Equipment Storage Room. This shall be for equipment such as I.V. stands, inhalators, air mattresses, and walkers;

14. Parking for stretchers and wheelchairs. This shall be located out of path normal traffic;

15. Patients' Bathing Facilities. For new construction, at least one (1) bathing facility on a floor or per unit containing a tub and/or shower shall have space for a wheelchair and an attendant;

16. Emergency Equipment Storage. Space for emergency equipment such as a "crash cart" shall be provided and shall be under control of the nursing staff;

17. Environmental Services Closet. See Section 69, Physical Facilities, Cleaning and Sanitizing Carts and Environmental Services, for detailed requirements.

C. Airborne Infection Isolation Room(s). Rooms for patients who are suffering from infections shall be provided at the rate of one (1) for each thirty (30) beds or fraction thereof. These may be located within each nursing unit or placed together in a separate unit. Anterooms are not required for those isolation rooms exceeding the minimum ratio. See also Section 49, Physical Facilities, Critical Care Unit for the requirements of Critical Care Units. Psychiatric and Alcohol/Drug Unit(s) beds need not be included in the bed count ratio to establish the number of rooms. Each isolation room shall be a single-bed room and planned as required for a normal patient room except as follows:

1. Each airborne infection isolation room shall have an anteroom for handwashing, gowning, and storage of clean and soiled materials located directly outside the entry door to the patient room.

2. Airborne infection isolation room perimeter walls, ceiling, and floors, including penetrations, shall be sealed tightly so that air does not infiltrate the environment from the outside or from other spaces.

3. Airborne infection isolation room(s) shall have self-closing devices on all room exit doors.

4. Separate toilet, bathtub (or shower), and handwashing facilities are required for each airborne infection isolation room.

5. Airborne infection isolation rooms may be used for noninfectious patients when not needed for patients with airborne infectious disease.

6. Windows shall not be operable without the use of a key or tool controlled by the nursing staff.

7. Airborne infectious isolation rooms not requiring an anteroom shall have an area for handwashing, gowning, and storage of clean and soiled materials located directly outside or immediately inside the entry door to the patient room.

D. Protective Isolation Rooms. In facilities where procedures such as organ transplants, burn therapy, and immunosuppressive treatments are performed, special design provisions, including special ventilation, may be necessary to meet the needs of the narrative program. Refer to Table 4 of the Appendix for air pressure and ventilation. Each protective isolation room shall be a single-bed room and planned as required for a normal patient room except as follows:

1. Each protective isolation room shall have an anteroom for handwashing, gowning, and storage of clean and soiled materials located directly outside the entry door to the patient room.

2. Protective isolation room perimeter walls, ceiling, and floors, including penetrations, shall be sealed tightly so that air does not infiltrate the environment from the outside or from other spaces.

3. Protective isolation room(s) shall have self-closing devices on all room exit doors.

4. Separate toilet, bathtub (or shower), and handwashing facilities are required for each protective isolation room.

5. Protective isolation rooms may be used for nonimmunosuppressed patients, except airborne infectious patients are prohibited.

6. Windows shall not be operable without the use of a key or tool controlled by the nursing staff.

E. Seclusion Rooms. Each hospital shall provide one (1) or more single-bed rooms for patients needing close supervision if suitable psychiatric facilities are not available elsewhere in the community. Such rooms shall comply with the applicable requirements in Section 52, Physical Facilities, Psychiatric Nursing Unit.

SECTION 49: PHYSICAL FACILITIES, CRITICAL CARE UNIT. The Critical care units require special space and equipment considerations for effective staff functions. In addition, space arrangement shall include provisions for immediate access of emergency equipment from other departments. Critical care units shall comply in size, number, and type with these standards and with the narrative program. The following standards are intended for the more common types of critical care services and shall be appropriate to needs defined in narrative programs. Where specialized services are required, additions and/or modifications shall be made as necessary for efficient, safe, and effective patient care.

A. Critical Care (General). The following shall apply to all types of critical care units unless otherwise noted. Each unit shall comply with the following provisions:

1. The location shall offer direct access by the emergency, respiratory care, laboratory, radiology, surgery, and other essential departments and services as defined by the narrative program. It shall be located so that the medical emergency resuscitation teams may be able to respond promptly to emergency calls within minimum travel time. The location shall be arranged to eliminate the need for through traffic.

2. In new construction, where elevator transport is required for critically ill patients, the size of the cab and mechanisms and controls shall meet the specialized needs.

3. In new construction, each patient room (or multiple bed space for neonatal or pediatric units) shall have a minimum of one-hundred-fifty (150) square feet of clear floor area with a minimum headwall width of twelve (12) feet per bed, exclusive of anterooms, vestibules, toilet rooms, closets, lockers, wardrobes, and/or alcoves.

In renovation of existing critical care units, every effort shall be made to meet the above minimum standards. If it is not possible to meet the above square foot standards, the Division having jurisdiction may grant approval to deviate from this requirement. In such cases, rooms shall be no less than one-hundred-thirty (130) square feet.

4. View panels to the corridor shall be required and shall have drapes or curtains which may be closed. Where only one (1) door is provided to a bed space, it shall be at least four (4) feet wide and arranged to minimize interference with movement of beds and large equipment. Sliding doors shall not have floor tracks and shall have hardware that minimizes jamming possibilities. Where sliding doors are used for access to cubicles within a suite, a three (3) foot wide swinging door may also be provided for personnel communication. The sliding doors shall swing out.

5. Each patient bed area shall have space at each bedside for visitors and provisions for visual privacy from casual observation by other patients and visitors. For both adult and pediatric units, there shall be a minimum of eight (8) feet between beds.

6. Each patient bed shall have visual access, other than skylights, to the outside environment with not less than one (1) outside window in each patient bed area. In renovation projects, clerestory windows with windowsills above the heights of adjacent ceilings may be used, provided they afford patients a view of the exterior and are equipped with appropriate forms of glare and sun control. Distance from the patient bed to the outside window shall not exceed fifty (50) feet. When partitioned cubicles are used, patients' view to outside windows may be through no more than two (2) separate clear vision panels.

7. Nurse/patient communication shall be provided in accordance with item G. of Section 76, Physical Facilities, Electrical Standards. The communication station for the unit shall include provisions for an emergency code resuscitation alarm to summon assistance from outside the critical care unit.

8. Handwashing fixtures shall be convenient to nurse stations and patient bed areas. There shall be at least one (1) handwashing fixture for every three (3) beds in open plan areas, and one (1) in each patient room. The handwashing fixture shall be located near the entrance to the patient cubicle or room, shall be sized to minimize splashing water onto the floor, and shall be equipped with hands-free operable controls.

9. Nurses' station shall have space for counters and storage. It may be combined with or include centers for reception and communication. There shall be direct or remote visual observation between the nurses' station and all patient beds in the critical care unit.

10. Each unit shall contain equipment for continuous monitoring, with visual displays for each patient at the bedside and at the nurses' station. Monitors shall be located to permit easy viewing and access but not interfere with access to the patient.

11. Emergency equipment storage space that is easily accessible to the staff shall be provided for emergency equipment such as an emergency cart.

12. Medication Station. Provisions shall be made for distribution of medications. This may be done from a medicine preparation room or unit, from a self-contained medicine dispensing unit, or by another approved system;

a. Medicine preparation room. This room shall be designed to allow for visual supervision by the nursing staff. It shall contain a work counter, a sink adequate for handwashing, refrigerator, and locked storage for controlled drugs. When a medicine preparation room is to be used to store one (1) or more self-contained medicine dispensing units, the room shall be designed with adequate space to prepare medicines with the self-contained medicine dispensing unit(s) present.

b. Self-contained medicine dispensing unit. A self-contained medicine dispensing unit may be located at the nurses' station, in the clean workroom, or in an alcove, provided the unit has adequate security for controlled drugs and adequate lighting to easily identify drugs. Convenient access to handwashing facilities shall be provided. (Standard cup-sinks provided in many self-contained units are not adequate for handwashing.)

13. The electrical, medical gas, heating, and air conditioning shall support the needs of the patients and critical care team members under normal and emergency situations.

14. At least one (1) airborne infection isolation room with anteroom shall be provided. The number of airborne infection isolation rooms shall be determined based on an infection control risk assessment; as per the primary catchment area by the facility. Each room shall contain only one (1) bed and shall comply with the requirements of item C. of Section 48, Physical Facilities, Patient Accommodations (Adult Medical, Surgical, Communicable or Pulmonary Disease).

15. The following additional service spaces shall be immediately available within each critical care area (Note: These additional spaces may be shared by more than one (1) critical care unit provided that direct access is available from each unit.):

a. Securable closets or cabinet compartments for the unit personnel;

b. Clean workroom or clean supply room. If the room is used for preparing patient care items, it shall contain a work counter, a handwashing fixture, and storage facilities for clean and sterile supplies. If the room is used only for storage and holding as part of a system for distribution of clean and sterile supply materials, the work counter and handwashing fixture may be omitted. Soiled and clean workrooms or holding rooms shall be separated and have no direct connection;

c. Clean linen storage. There shall be a designated area for clean linen storage. This may be within the clean workroom, a separate closet, or an approved distribution system on each floor. If a closed cart system is used, storage may be in an alcove. It must be out of the path of normal traffic and under staff control;

d. Soiled workroom or soiled holding room. This room shall be separate from the clean workroom. The soiled workroom shall contain a clinical sink or equivalent flushing-rim fixture. The room shall contain a lavatory or handwashing fixture. The above fixtures shall have a hot and cold mixing faucet. The room shall have a work counter and space for separate covered containers for soiled linen and a variety of waste types. Rooms used only for temporary holding of soiled material may omit the clinical sink and work counter. If the flushing-rim clinical sink is eliminated, facilities for cleaning bedpans shall be provided elsewhere;

e. Nourishment Station. There shall be a nourishment station with sink, work counter, refrigerator, storage cabinets, and equipment for hot and cold nourishments between scheduled meals. The nourishment station shall include space for trays and dishes used for nonscheduled meal service. Provisions and space shall be included for separate temporary storage of unused and soiled dietary trays not picked up at meal time. Handwashing facilities shall be in or immediately accessible from the nourishment station;

f. Ice machine. There shall be available equipment to provide ice for treatments and nourishment. Ice-making equipment may be in the clean work room or at the nourishment station. Ice intended for human consumption shall be from self-dispensing ice makers;

g. Equipment storage room or alcove. Appropriate room(s) or alcove(s) shall be provided for storage of large items of equipment necessary for patient care and as required by the narrative program. Its location shall not interfere with the flow of traffic;

h. An X-ray viewing facility.

16. The following shall be provided and may be located outside the unit if conveniently accessible.

a. A visitors' waiting room shall be provided with access to telephones and toilets. One (1) waiting room may serve several critical care units.

b. Staff lounge(s) and toilet(s) shall be located so that staff may be recalled quickly to the patient area in emergencies. The lounge shall have telephone or intercom and emergency code alarm connections to the critical care unit it serves. One (1) lounge may serve adjacent critical care areas.

c. A special procedures room shall be provided if required by the narrative program.

d. Multipurpose room(s) for staff, patients, and patients' families for patient conferences, reports, education, training sessions, and consultation shall be provided. These rooms must be accessible to each nursing unit.

e. A housekeeping room shall be provided within or immediately adjacent to the critical care unit. It shall not be shared with other nursing units or departments. It shall contain a service sink or floor receptor and provisions for storage of supplies and housekeeping equipment.

f. Storage space for stretchers and wheelchairs shall be provided in a strategic location, without restricting normal traffic.

g. Laboratory, radiology, respiratory care, and pharmacy services shall be available. These services may be provided from the central departments or from satellite facilities as required by the narrative program.

B. Coronary Critical Care Unit. In addition to the standards set forth in Section 49, Physical Facilities, Critical Care Unit, the following standards apply to the coronary critical care unit:

1. Each coronary patient shall have a separate room for acoustical and visual privacy.

2. Each coronary patient shall have access to a toilet in the room. (Portable commodes may be used in lieu of individual toilets, but provisions must be made for their storage, servicing, and odor control.)

C. Pediatric Critical Care. If a facility has a specific pediatric critical care unit, the narrative program must include consideration for staffing, isolation, and the safe transportation of critically ill pediatric patients, along with life support and environmental systems, from other areas. In addition to the standards previously listed for critical care units, each pediatric critical care unit shall include:

1. Space at each bedside for parents;

2. In new construction, each patient space (whether separate rooms, cubicles, or multiple bed space) shall have a minimum of one-hundred-fifty (150) square feet of clear floor area with a minimum headwall width of twelve (12) feet per bed, exclusive of anterooms, vestibules, toilet rooms, closets, lockers, wardrobes, and/or alcoves;

3. Consultation/demonstration room within, or convenient to, the pediatric critical care unit for private discussions;

4. Provisions for formula storage. These may be outside the pediatric critical care unit but must be available for use at all times;

5. Separate storage cabinets or closets for toys and games for use by the pediatric patients;

6. Examination and treatment room(s).

D. Newborn Intensive Care Units. Each Newborn Intensive Care Unit (NICU) shall include or comply with the following:

1. The NICU shall have a clearly identified entrance and reception area for families. The area shall permit visual observation and contact with all traffic entering the unit. A scrub area shall be provided at each public entrance to the patient care area(s) of the NICU. All sinks shall be hands-free operable and large enough to contain splashing;

2. At least one (1) door (forty-four (44) inches minimum) to each room in the unit to accommodate portable X-ray equipment;

3. There shall be controlled access systems to the unit from the Labor and Delivery area, the Emergency Room, or other referral entry points;

4. When viewing windows are provided, provision shall be made to control casual viewing of infants;

5. Noise control shall be a design factor;

6. Provisions shall be made for indirect lighting in all nurseries. Provisions shall be made for multiple lighting levels;

7. A central area shall serve as a nurses' station, shall have space for counters and storage, and shall have convenient access to handwashing facilities. It may be combined with or include centers for reception and communication and patient monitoring;

8. Each patient care space shall contain a minimum of one-hundred (100) square feet excluding sinks and aisles. There shall be an aisle for circulation adjacent to each patient care space with a minimum width of three (3) feet;

9. An airborne infection isolation room is required in at least one (1) level of nursery care. The room shall be enclosed and separated from the nursery unit with provisions for observation of the infant from adjacent nurseries or control area(s);

10. Blood gas lab facilities shall be immediately accessible.

11. A respiratory care work area and storage room shall be provided;

12. A consultation/demonstration/breast feeding room shall be provided convenient to the unit;

13. Charting and dictation space for physicians shall be provided;

14. Medication station shall be provided;

15. Clean workroom or clean supply room shall be provided. See Section 48 B.8, Physical Facilities, Patient Accommodations (Adult Medical, Surgical, Communicable or Pulmonary Disease);

16. Soiled workroom or soiled holding room shall be provided. See Section 48 B.9, Physical Facilities, Patient Accommodations (Adult Medical, Surgical, Communicable or Pulmonary Disease);

17. A lounge, locker room, and staff toilet within or adjacent to the unit suite for staff use shall be provided;

18. Space shall be provided for emergency equipment that is under direct control of the nursing staff, such as an emergency cart. This space shall be located in an area appropriate to the functional program, but out of normal traffic;

19. One (1) environmental services closet shall be provided for the unit. It shall be directly accessible from the unit and be dedicated for the exclusive use of the neonatal critical care unit. It shall contain a service sink or floor receptor and provisions for storage of supplies and housekeeping equipment.

20. Space shall be provided for the following:

a. A visitors' waiting room;

b. Nurses' station;

c. Multipurpose room(s) for staff, patients and patients' families for patient conferences, reports, education, training sessions, and consultation. These rooms must be accessible to each nursing unit. They may be on other floors if convenient for regular use. One (1) such room may serve several nursing units and/or departments.

SECTION 50: PHYSICAL FACILITIES, NEWBORN NURSERY UNITS. Hospitals having twenty-five (25) or more postpartum beds shall have a separate nursery that provides continuing care for infants requiring close observation (for example, those with low birth weight). The minimum floor areas per infant shall be fifty (50) square feet, exclusive of auxiliary work areas, with provisions for at least four (4) feet between and at all sides of bassinets.

NOTE: Normal newborn infants shall be housed in nurseries that comply with the standards below.

Location shall be convenient to the postpartum nursing unit and obstetrical facilities. The nurseries shall be located and arranged to preclude the need for nonrelated pedestrian traffic. No nursery shall open directly into another nursery. See Section 49.D, Physical Facilities, Critical Care Unit, for critical care units for neonatal infants.

A. General. Each nursery shall contain:

1. At least one (1) lavatory, equipped with handwashing controls that can be operated without use of hands, for each eight (8) infant stations;

2. Glazed observation windows to permit the viewing of infants from public areas, workrooms, and adjacent nurseries;

3. Convenient, accessible storage for linens and infant supplies at each nursery room;

4. A consultation/demonstration/breast feeding or pump room shall be provided convenient to the nursery. Provision shall be made, either within the room or conveniently located nearby, for sink, counter, refrigeration and freezing, storage for pump and attachments, and educational materials. The area provided for the unit for these purposes, when conveniently located, may be shared by the newborn nursery;

5. Enough space shall be provided for parents to stay twenty-four (24) hours;

6. An airborne infection isolation room is required in or near at least one (1) level of nursery care. The room shall be enclosed and separated from the nursery unit with provisions for observation of the infant from adjacent nurseries or control area(s). All airborne infection isolation rooms shall comply with the requirements of Section 48.C, Patient Accommodations (Adult Medical, Surgical, Communicable or Pulmonary Disease), except for separate toilet, bathtub, or shower;

B. Full-Term Nursery. Each full-term nursery room shall contain no more than sixteen (16) stations. The minimum floor areas shall be twenty-four (24) square feet for each infant station, exclusive of auxiliary work areas. When a rooming-in program is used, the total number of bassinets provided in these units may be appropriately reduced, but the full-term nursery may not be omitted in its entirety from any facility that includes delivery services. (When facilities use a rooming-in program in which all infants are returned to the nursery at night, a reduction in nursery size may not be practical.)

1. Baby Holding Nurseries. Hospitals may replace traditional nurseries with baby holding nurseries in postpartum and labor-delivery- recovery-postpartum (LDRP) units. The minimum floor area per bassinet, ventilation, electrical, and medical vacuum and gases shall be the same as that required for a full-term nursery. These holding nurseries should be next to the nurse station on these units. The holding nursery shall be sized to accommodate the percentage of newborns who do not remain with their mothers during the postpartum stay.

C. Charting Facilities. Provision shall be made for physician and nurse charting and dictation. This may be in a separate room or part of the workroom.

D. Workroom(s). Each nursery shall be served by a connecting workroom. The workroom shall contain scrubbing and gowning facilities at the entrance for staff and housekeeping personnel, work counter, refrigerator, storage for supplies, and handwashing fixture. One (1) workroom may serve more than one (1) nursery room provided that required services are convenient to each.

The workroom serving the full-term and continuing care nurseries may be omitted, if equivalent work and storage areas and facilities, including those for scrubbing and gowning, are provided within the nursery. Space required for work areas located within the nursery is in addition to the area required for infant care.Adequate provision shall be made for storage of emergency cart(s) and equipment out of traffic and for the sanitary storage and disposal of soiled waste.

E. Infant Examination and Treatment Areas. Such areas, when required by the narrative program, shall contain a work counter, storage facilities, and a handwashing fixture.

F. Infant Formula Facilities.

1. When infant formula is prepared onsite, direct access from the formula preparation room to any nursery room is prohibited. The room may be located near the nursery or at other appropriate locations in the hospital, but must include:

a. Cleanup facilities for washing and sterilizing supplies. This area shall include a handwashing fixture, facilities for bottle washing, a work counter, and sterilization equipment.

b. Separate room for preparing infant formula. This room shall contain warming facilities, refrigerator, work counter, formula sterilizer, storage facilities, and a handwashing fixture.

c. Refrigerated storage and warming facilities for infant formula accessible for use by nursery personnel at all times.

2. If a commercial infant formula is used, the separate clean-up and preparation rooms may be omitted. The storage and handling may be done in the nursery workroom or in another appropriate room in the hospital that is conveniently accessible at all hours. The preparation area shall have a work counter, a sink equipped for handwashing, and storage facilities.

G. Housekeeping/Environmental Services Room. A housekeeping/environmental services room shall be provided for the exclusive use of the nursery unit. It shall be directly accessible from the unit and shall contain a service sink or floor receptor and provide for storage of supplies and housekeeping equipment.

SECTION 51: PHYSICAL FACILITIES, PEDIATRIC AND ADOLESCENT UNIT. The unit shall meet the following standards:

A. Patient Rooms. Each patient room shall meet the following standards:

1. Maximum room capacity shall be four (4) patients.

2. The space requirements for pediatric patient beds shall be the same as for adult beds due to the size variation and the need to change from cribs to beds, and vice-versa. See Section 48, Patient Accommodations (Adult Medical, Surgical, Communicable or Pulmonary Disease), for requirements. Additional provisions for hygiene, toilets, sleeping, and personal belongings shall be included where the program indicates that parents will be allowed to remain with young children. See Sections 49, Physical Facilities, Critical Care Unit and 50, Physical Facilities, Newborn Nursery Units for pediatric critical care units and for newborn nurseries.)

3. Each patient room shall have a window in accordance with Section 48, Physical Facilities, Patient Accommodations (Adult Medical, Surgical, Communicable or Pulmonary Disease).

B. Nursery. To minimize the possibility of cross infection, each nursery room serving pediatric patients shall contain no more than eight (8) bassinets; each bassinet shall have a minimum clear floor area of forty (40) square feet. Each room shall contain a lavatory equipped for handwashing operable without hands, a nurses emergency calling system, and a glazed viewing window for observing infants from public areas and workrooms. (Limitation on number of patients in a nursery room does not apply to the pediatric critical care unit.)

C. Nursery Workrooms. Each nursery shall be served by a connecting workroom. It shall contain gowning facilities at the entrance for staff and housekeeping personnel: Work space with a work counter; storage facilities; and a handwashing fixture. One (1) workroom may serve more than one (1) nursery.

D. Nursery Visiting and Feeding. Each pediatric nursery shall have an area for instruction and parent contact with the infant including breast and/or bottle feeding. This may be a section of the workroom with provisions for privacy and quiet.

E. Examination/Treatment Rooms. This room shall be provided for pediatric and adolescent patients. A separate area for infant examination and treatment may be provided within the pediatric nursery workroom. Examination/treatment rooms shall have a minimum floor area of one-hundred-twenty (120) square feet. The room shall contain a handwashing fixture; storage facilities; and a desk, counter, or shelf space for writing. This room is not required if all rooms are private.

1. Multipurpose or individual room(s) shall be provided within or adjacent to areas serving pediatric and adolescent patients for dining, education, and developmentally appropriate play and recreation, with access and equipment for patients with physical restrictions. If the narrative program requires, an individual room shall be provided to allow for confidential parent/family comfort, consultation, and teaching. Insulation, isolation, and structural provisions shall minimize the transmission of impact noise through the floor, walls, or ceiling of these multipurpose room(s).

2. Space for preparation and storage of infant formula shall be provided within the unit or other convenient location. Provisions shall be made for continuation of special formula that may have been prescribed for the infant prior to admission or readmission.

3. Patient toilet room(s) with handwashing facility(ies) in each room, in addition to those serving bed areas, shall be conveniently located to multipurpose room(s) and to each central bathing facility.

4. Storage closets or cabinets for toys and educational and recreational equipment shall be provided.

5. Storage space shall be provided to permit exchange of cribs and adult beds. Provisions shall also be made for storage of equipment and supplies (including cots or recliners, extra linen, etc.) for parents who stay with the patient overnight.

6. A least one (1) airborne infection isolation room shall be provided in each pediatric unit. The total number of infection isolation rooms shall be determined by an infection control risk assessment. Airborne infection isolation room(s) shall comply with the requirements of item C. of Section 48, Physical Accommodations (Adult Medical, Surgical, Communicable or Pulmonary Disease).

7. Separate clean and soiled workrooms or holding rooms shall be provided as described in Section 48 B.8 and B.9, Physical Accommodations (Adult Medical, Surgical, Communicable or Pulmonary Disease).

SECTION 52: PHYSICAL FACILITIES, PSYCHIATRIC NURSING UNIT. Units intended for psychiatric nursing care shall provide a safe and secure facility for patients needing close supervision. The unit shall be designed to facilitate care of ambulatory inpatients, to permit flexibility in arranging various types of psychiatric therapy, and to present as noninstitutional an atmosphere as possible. Security and safety devices shall not be presented in a manner to attract or challenge tampering by patients.

A. Patient Rooms. The patient room requirements noted in Section 48, Physical Accommodations (Adult Medical, Surgical, Communicable or Pulmonary Disease), shall be applied to patient rooms in psychiatric nursing units except as follows:

1. A nurses' call system is not required;

2. Rods and supports in closets and curtains for tub/showers or windows, if provided, shall be of a material that shall break away. Visual privacy in multiple bed rooms (e.g., cubicle curtains) is not required;

3. Mirrors in patient rooms and in bathrooms shall be of a material with high impact resistance properties;

4. Small soap dispenser may be installed in patient rooms/toilets upon approval of the Division;

5. Bedpan-flushing devices shall be omitted from patient room toilets;

6. The operation of windows shall be restricted to inhibit possible escape or suicide. Where windows or vents require the use of tools or keys for operation, the tools or keys shall be located on the same floor in a prominent location accessible to staff. Safety glazing and/or other appropriate security features shall be used. Detention screens are permissible;

7. Suitable hardware (key or tool by staff) shall be provided on doors to patient toilet rooms so access to these rooms can be controlled by staff. The toilet door shall permit access from the outside;

8. Ceilings in patient rooms shall be of monolithic or bonded construction of not less than five-eighths (5/8) inch thickness. Lockable access panels, a minimum of two (2) feet square, shall be provided where mechanical or electrical maintenance, repair, or service above the ceiling is needed. Locations include, but are not limited to, cut-off valves, air filters, clean outs, etc. All plaster surfaces shall have a smooth finish;

9. Institutional type shower heads and bathroom hardware shall be provided;

10. Vacuum and medical gas outlets shall be covered or rendered inoperable, or equipped with special connection devices;

11. Wall hung fixtures shall be avoided (e.g., television, lights, cords, coat hooks and etc.);

12. No electric power cords shall be used in patient rooms for beds, lamps, IV poles, etc.;

13. Door locks to patient rooms, if provided, shall not be lockable from inside the room;

14. "Hospital" type patient beds (i.e., electric or manual) shall not be allowed in patient rooms unless rendered inoperative and made stationary by securing to the floor or wall. Operational beds may be used provided the method of control (e.g., electrical cord, crank) is restricted to staff use only. Weighted beds may be considered; however, all other types shall be stationary;

15. Electrical receptacles located in patient care areas shall be tamper resistant and/or ground-fault circuit interrupter protection.

16. Light fixtures shall be recessed into the ceiling.

17. Storage for patients' clothing.

B. Seclusion Treatment Room. A minimum of one (1) seclusion room for up to thirty-six (36) beds or a major fraction thereof. The seclusion room is intended for short-term occupancy by a violent or suicidal patient requiring security and protection. The room(s) shall be located for direct nursing staff supervision. Each room shall be for only one (1) patient. It shall have an area of at least sixty (60) square feet and shall be constructed to prevent patient hiding, escape, injury, or suicide. Where restraint beds are required by the narrative program, eighty (80) square feet shall be required. Seclusion rooms may be grouped together. Special fixtures and hardware for electrical circuits shall be used. Minimum ceiling height shall be nine (9) feet. Doors shall be three (3) feet eight (8) inches wide and shall permit staff observation of the patient while also maintaining provisions for patient privacy. Seclusion rooms shall be accessed by an anteroom or vestibule which also provides direct access to a toilet room. The toilet room and anteroom shall provide for safe management of the patient. Where the interior of the seclusion room is padded with combustible materials, these materials shall be of a type acceptable to NFPA standards. The room area, including floor, walls, ceilings, and all openings shall be protected with not less than one (1) hour fire rated construction;

C. Service Areas. The service areas noted in the Section 48, Physical Accommodations (Adult Medical, Surgical, Communicable or Pulmonary Disease), shall be provided or made available to each psychiatric nursing unit except that the following elements shall be provided within and for the exclusive use of the unit:

1. Dedicated facility for charting, clinical records, work counters, communication system, space for supplies and convenient access to handwashing;

2. At least two (2) separate social spaces, one (1) appropriate for noisy activities and one (1) for quiet activities. The combined area shall be a minimum of forty (40) square feet per patient with a minimum of one-hundred-twenty (120) square feet for each of the two (2) spaces. This may be shared by dining activities;

3. Examination and Treatment Room(s). The room(s) shall have a minimum floor area of one-hundred-twenty (120) square feet excluding space for vestibule, toilets, and closets. The room shall contain a lavatory or sink equipped for handwashing, storage facilities and a desk, counter or shelf space for writing. This room is not required if all rooms are private;

4. Space for Group Therapy. Two-hundred-twenty-five (225) square feet of enclosed private space is available for group therapy activities. This may be combined with the quiet space noted above in item 2 when the unit accommodates not more than twelve (12) patients;

5. Charting facilities for physicians;

6. Space for consultation room(s). One-hundred (100) square feet each consultation room. A room to bed ratio of one (1) consultation room for each twelve (12) psychiatric beds. The room(s) shall be designed for acoustical and visual privacy and constructed to achieve a noise reduction of at least forty-five (45) decibels. This room is not required if all rooms are private;

7. Medication distribution areas located for security against unauthorized access;

8. In psychiatric nursing units, a bathtub or shower for each six (6) beds not otherwise served by bathing facilities within the patient rooms. Bathing facilities shall be designed and located for patient convenience and privacy;

9. A secured storage area provided for patients' belongings that are determined to be potentially harmful (e.g., razors, nail files, cigarette lighters); this area shall be controlled by staff.

D. Safety measures shall include:

1. Doors for entrance and exit of the unit shall be equipped with an electric strike locking system or magnetic locks. Characteristics shall include:

a. A view panel, video monitor, or intercom arrangement at the main entry for the identification of persons wanting to enter the unit;

b. A separate system for each door;

c. A key for each employee to allow a manual override of the locking arrangement and permit exit and entry;

d. Electrical interconnection to the emergency power supply;

e. Deactivating switches for the main entry shall be located at the nurses station;

f. Exterior doors do not require the manual arrangement on the outside;

2. Fire alarm pull stations shall be key activated or tamper-resistant with audible alarms.

NOTE: Storage space for stretchers and wheelchairs may be outside the psychiatric unit,

provided provisions are made for convenient access as needed for patients. See also Section 11, Patient Care Service, for the consideration of bed count exclusion within a general hospital.

SECTION 53: PHYSICAL FACILITIES, SURGICAL FACILITIES. The Surgical Suite shall be located and arranged to preclude unrelated traffic through the Suite. The Surgical Suite shall be designed in accordance with NFPA 99 except that, within suites, mixed facilities as defined in NFPA 99 shall not be allowed. The Suite(s) shall provide the following elements.

A. General Operating Room(s). At least one (1) general operating room shall be provided for each fifty (50) beds or major fraction thereof up to two hundred (200) beds. Over two hundred (200) beds, additional operating room needs shall be based on the projected surgical workload. In new construction, each room shall have a minimum clear area of four-hundred (400) square feet exclusive of fixed or wall-mounted cabinets and built-in shelves, with a minimum of twenty (20) feet clear dimension between fixed cabinets and built-in shelves, and a system for emergency communication with the surgical suite control station. X-ray film illuminators for handling at least four (4) films simultaneously shall also be provided. In renovation projects, every effort shall be made to meet the floor space requirements indicated above. In no event shall the clear floor area be less than three-hundred-sixty (360) square feet with a minimum dimension of eighteen (18) feet.

B. Specialty Operating Rooms for cardiovascular, orthopedic, neurological, and other procedures that require additional personnel and/or large equipment. When included, this room shall have, in addition to the above requirements for general operating rooms, a minimum clear area of six-hundred (600) square feet, with a minimum of twenty (20) feet clear dimension exclusive of fixed or wall-mounted cabinets and built-in shelves. When open-heart surgery is performed, an additional room in the restricted area of the surgical suite shall be designated as a pump room where extra corporeal pump(s), supplies and accessories are stored and serviced. When complex orthopedic and neurosurgical surgery is performed, additional rooms shall be in the restricted area of the surgical suite which shall be designated as equipment storage rooms for the large equipment used to support these procedures. Appropriate plumbing, medical gases, and electrical connections shall be provided in the pump storage room. When included, a room for orthopedic surgery shall, in addition to the above, have enclosed storage space for splints and traction equipment. Storage outside the operating room shall be conveniently located. If a sink is used for the disposal of casting material, an appropriate trap shall be provided. In renovation projects, every effort shall be made to meet the floor space requirements indicated above. In no event shall the clear floor area be less than four-hundred (400) square feet (except for Orthopedic procedures shall be three-hundred-sixty (360) square feet) with a minimum dimension of eighteen (18) feet.

C. Room(s) for Surgical Cystoscopic and Endo-Urologic Procedures. When provided and/or required by the written narrative program, the cystoscopic and endo-urologic procedures room(s) shall follow these requirements. A scrub sink or large lavatory shall be provided within or adjoining the cystoscopy room. In new construction, these rooms shall have a minimum clear area of three-hundred-fifty (350) square feet, exclusive of fixed or wall-mounted cabinets and built-in shelves with a minimum of fifteen (15) feet clear dimension between fixed cabinets and built-in shelves. Additional clear space may be required by the narrative program to accommodate special functions in one (1) or more of these rooms. An emergency communications system shall connect with the Surgical Suite control station. Facilities for the disposal of liquid wastes shall be provided. If a floor drain is installed to provide for disposal of liquid wastes, it shall be completely insulated from ground by means of an insulating type floor drain and nonconductive waste connections. The drain shall also be provided with a flushing device. X-ray viewing capability to accommodate at least four (4) films simultaneously shall be provided. In renovation projects, every effort shall be made to meet the clear floor space requirements indicted above for construction. In no event shall the clear floor space be less than two-hundred-fifty (250) square feet.

D. Service Areas. Individual rooms shall be provided when so noted; otherwise alcoves or other open spaces which shall not interfere with traffic may be used. Services, except the soiled workroom and the janitor's closet, may be shared with and organized as part of the obstetrical facilities if the approved narrative program reflects this sharing concept. Service areas shall be arranged to avoid direct traffic between the Operating and Delivery Suites. The following areas shall be provided.

1. Control station located to permit visual surveillance of all traffic which enters the Operating Suite.

2. Sterilizing facilities conveniently located to serve all operating rooms. The sterilizing facility shall have work counter space and a handwashing sink. When the narrative program indicates that adequate provisions have been made for replacement of sterile instruments during surgery, sterilization facilities in the Surgical Suite shall not be required.

3. Medication Distribution. Provisions shall be made for storage and distribution of medications. This may be done from a medication preparation room or unit, from a self-contained medication dispensing unit, or by another system approved by the Department. If used, a medication preparation room or unit shall be under visual control of nursing staff. It shall contain a work counter, sink, refrigerator, and double-locked storage for controlled substances and shall have a minimum area of fifty (50) square feet with convenient access to handwashing facilities provided. Each blood bank refrigerator shallbe on an emergency power circuit.

4. Scrub Facilities. Two (2) scrub stations shall be provided near the entrance to each operating room; however two (2) scrub stations may serve two (2) operating rooms if the scrub stations are located adjacent to the entrance of each operating room. Scrub facilities shall be arranged to minimize any incidental splatter on nearby personnel or supply carts. In new construction, view windows at scrub stations permitting observation of room interiors shall be provided. The scrub sinks shall be recessed into an alcove out of the main traffic areas. Equipment and supplies for timed scrub technique shall be available at each scrub sink with manual and/or automatic two (2) way controls.

5. Soiled Workroom. An enclosed soiled workroom (or soiled-holding room that is part of a system for the collection and disposal of soiled material) for the exclusive use of the surgical suite shall be provided. It shall be located in the restricted area. The soiled workroom shall contain a flushing-rim clinical sink or equivalent flushing-rim fixture, a work counter, a handwashing fixture, and space for waste receptacles, and soiled linen receptacles. Rooms used only for temporary holding of soiled material may omit the flushing-rim clinical sink and work counters. However, if the flushing-rim clinical sink is omitted, other provisions for disposal of liquid waste shall be provided. This room shall not have direct connection with operating rooms or other sterile activity rooms. Soiled and clean work or holding rooms shall be separated.

6. Clean Workroom or a Clean Supply Room. A clean workroom is required when clean materials are assembled within the surgical suite prior to use, or following the decontamination cycle. It shall contain a work counter, a handwashing fixture, storage for clean supplies, and space to package reusable items. The storage for sterile supplies shall be separated from this space. If the room is used only for storage and holding as part of a system for distribution of clean and sterile supply materials, the work counter and handwashing fixture may be omitted. Storage space for sterile and clean supplies shall be adequate for the narrative plan. The space shall be moisture and temperature controlled and free from cross traffic.

7. The location of sterilization for surgical instruments and the direction of flow from the decontamination location to the sterile location shall be addressed by the written narrative program.

a. An operating room suite design with a sterile core shall provide for no cross traffic of staff and supplies from the decontaminated/soiled areas to the sterile/clean areas.

b. The use of facilities outside the operating room for soiled/decontaminated processing and clean assembly and sterile processing shall be designed to move the flow of goods and personnel from dirty to clean/sterile without compromising standard precautions or aseptic techniques in both departments. This room shall have no direct opening into an operating room.

8. Anesthesia storage shall be provided in accordance with NFPA 99.

9. An anesthesia workroom for testing and storing anesthesia equipment shall contain a work counter, sink and racks for cylinders.

10. Equipment storage room(s) for equipment and supplies used in the Surgical Suite shall be provided.

11. Staff Dressing Room. Appropriate room(s) shall be provided for males and females working within the Surgical Suite. The room(s) shall contain lockers, showers, toilets, lavatories equipped for handwashing, and space for donning scrub suits and boots. These room(s) shall be arranged to provide a one-way traffic pattern so personnel entering from outside the Surgical Suite can change, shower, gown, and move directly into the Surgical Suite.

12. Stretcher storage area out of direct line of traffic.

13. Staff lounge and toilet facilities. Separate or combined lounges for males and females shall be provided. Lounge(s) shall be located to permit use without leaving the Surgical Suite and to provide convenient access to the Recovery Room.

14. Emergency equipment storage under direct control of the nursing staff and not obstructing the corridor.

15. Environmental Services closet. See Section 69, Physical Facilities, Cleaning and Sanitizing Carts and Environmental Services, for detailed requirements.

16. A waiting room, with toilets, telephones, and drinking fountains conveniently located. The toilet room shall contain handwashing facilities. If outpatients, as defined by the written narrative program, are required to wait in this area, then a separate area shall be provided. Provisions shall be made for examinations, interviews, testing, and obtaining vital signs.

NOTE: A separate area shall be provided where outpatients may change from street clothing into hospital gowns.

17. Ethylene Oxide Sterilization Facilities. Where ethylene oxide is used for sterilization, provisions shall be made for complete exhaust of gases to the exterior. When the door is opened, arrangement shall ensure that gases are pulled away from the operator. Provisions shall be made for appropriate aeration of supplies. Aeration cabinets shall be vented to the outside. Where aeration cabinets are not used in ethylene oxide processing, provision for isolated area mechanically vented to the outside for aeration, OSHA standards shall be met.

E. Pre and Postanesthesia Care Units.

1. Preoperative Preparation Holding Area. If preparation is not performed in the patients' room, then a holding area is required near the surgical suite. The size of the holding area shall be based upon the relative use of the surgical suite by inpatients and outpatients as defined in the written narrative program or a minimum of one (1) preoperative station for every two (2) operating rooms. The area shall accommodate stretcher patients waiting for surgery and shall be under the visual control of the nursing staff.

2. The Postanesthesia Care Unit (PACU) shall provide:

a. Adequate lighting;

b. A duplex electrical receptacle for each bed;

c. An emergency call and telephone system;

d. A clock;

e. One (1) electrical supply for the use of portable X-ray equipment;

f. Medical gases, oxygen and emergency equipment;

g. Wall mounted sphygmomanometers for each bed space or every two (2) bed spaces;

h. Suction equipment. A central piped vacuum system is required with connections for every two (2) beds as a minimum;

i. A clean work room. See Section 48.B, Patient Accommodations (Adult Medical, Surgical, Communicable or Pulmonary Disease);

j. An administrative center with charting facilities and medication storage;

k. A soiled work room with clinical sink. See Section 48.B, Patient Accommodations (Adult Medical, Surgical, Communicable or Pulmonary Disease);

l. At least one (1) door from the postanesthesia care unit shall connect directly to the surgical suite and it shall not cross or open onto public corridor(s);

m. A staff toilet located within the working area to maintain staff;

n. A patient toilet room.

3. The size of the PACU area shall provide a minimum of eighty (80) square feet for each patient with a space for additional equipment described in the narrative program or a minimum of two (2) PACU stations for each (1) operating room. As a minimum, a clearance of four (4) feet shall be between patient and between patient bedsides and adjacent walls. Provisions for patient privacy shall be made (at a minimum cubicle curtains shall be provided);

SECTION 54: PHYSICAL FACILITIES, OBSTETRICAL FACILITIES. The obstetrical suite shall be located and designated to prohibit non-related traffic through the unit. Except as permitted otherwise herein, existing facilities being renovated shall, as far as practicable, provide all the required support services.

A. Delivery Suite.

1. Caesarean room(s) shall meet operating room requirements and shall be used exclusively for Caesarean births. There shall be a minimum of one (1) such room in every delivery suite.

2. If the written narrative program requires a delivery room, it shall have minimum clear area of three-hundred (300) square feet exclusive of fixed cabinets and built-in shelves. An emergency communication system shall be connected with the obstetrical suite control station.

3. Space shall be provided for infant resuscitation within the delivery and/or Caesarean room(s).

4. Labor room(s) (LDR or LDRP rooms may be substituted).

Where LDRs or LDRPs are not provided, a minimum of two (2) labor beds shall be provided for each Caesarean room and/or delivery room. In facilities that have only one (1) Caesarean delivery room, two (2) labor rooms shall be provided. Each room shall be designed for either one (1) or two (2) beds with a minimum clear area of one-hundred-twenty (120) square feet per bed. Each labor room shall contain a handwashing fixture and have access to a private toilet room. Labor rooms shall have controlled access with doors that are arranged for observation from a nurses' station. Windows in labor rooms, if provided, shall be located, draped, or otherwise arranged to preserve patient privacy from causal observation from outside the labor room.

5. Recovery room(s). Each recovery room shall contain at least two (2) beds and have a nurses' station with charting facilities located to permit visual control of all beds. The number of recovery room(s) shall be based upon the relative use of the caesarean room(s) and delivery room(s) by inpatients as defined in the written narrative program or a minimum of one (1) recovery room for every caesarean room and/or delivery room. Each room shall include facilities for handwashing and dispensing medicine. A clinical sink with bedpan flushing device shall be available, as shall storage for supplies and equipment. There shall be enough space for baby and crib and a chair for the support person. There shall be the ability to maintain visual privacy of the new family.

6. Service Areas. The following areas shall be provided:

a. An administrative center located to restrict unauthorized traffic into the suite.

b. Soiled workroom or soiled holding room. This room shall be separate from the clean workroom. The soiled workroom shall contain a clinical sink (or equivalent flushing-rim fixture). The room shall contain a handwashing fixture. The above fixtures shall have a hot and cold mixing faucet. The room shall have a work counter and space for separate covered containers for soiled linen and waste. Rooms used only for temporary holding of soiled material may omit the clinical sink and work counter. If the flushing-rim clinical sink is eliminated, facilities for cleaning bedpans shall be provided elsewhere.

c. Fluid waste disposal.

d. A waiting room, with toilets, telephones, and drinking fountains conveniently located. The toilet room shall contain handwashing facilities.

e. Sterilizing facilities with high-speed sterilizers convenient to all Caesarean and delivery rooms. Sterilization facilities shall be separate from the delivery area and adjacent to clean assembly. High-speed autoclaves shall only be used in an emergency situation (i.e., a dropped instrument and no sterile replacement readily available). Sterilization facilities would not be necessary if the flow of materials were handled from a central service department based on the usage of the delivery room.

f. A drug distribution station with handwashing facilities and provisions for controlled storage, preparation, and distribution of medication.

g. Scrub facilities for Caesarean and delivery rooms. Two (2) scrub stations shall be provided adjacent to entrance to each Caesarean and delivery room. In new construction, view windows shall be provided at scrub stations to permit the observation of room interiors.

h. Clean workroom or clean supply room. A clean workroom shall be provided if clean materials are assembled within the obstetrical suite prior to use. If a clean workroom is provided it shall contain a work counter, sink equipped for handwashing and space for storage of supplies. A clean supply room may be provided when the narrative program defines a system for the storage and distribution of clean and sterile supplies.

i. Medical gas storage facilities.

j. A clean sterile storage area.

k. An anesthesia workroom for cleaning, testing, and storing anesthesia equipment. It shall contain a work counter, sink, and provisions for separation of clean and soiled items.

l. Equipment storage room(s) for equipment and supplies used in the obstetrical suite.

m. Male and female staff clothing change areas. The clothing change area shall be designed to minimize physical contact between clean and contaminated personnel. The area shall contain lockers, showers, toilets, handwashing facilities, and space for donning and disposing scrub suits and booties.

n. Male and female support persons change area (designed as described above).

o. Toilet facilities for obstetrical staff convenient to delivery, labor, and recovery areas.

The toilet room shall contain handwashing facilities.

p. An on-call room(s) for physician and/or staff may be located elsewhere in the facility.

q. Environmental Services Closet. See Section 69, Physical Facilities, Cleaning and Sanitizing Carts and Environmental Services, for detailed requirements.

r. An area for storing stretchers out of the path of normal traffic.

B. LDR and LDRP Facilities. When provided by the narrative program, delivery procedures in accordance with birthing concepts may be performed in the LDR or LDRP rooms. LDR room(s) may be located in a separate LDR suite or as part of the Caesarean/Delivery suite. The postpartum unit may contain LDRP rooms. These rooms shall have a minimum of two-hundred-fifty (250) square feet of clear floor area with a minimum dimension of thirteen(13) feet, exclusive of toilet room, closet, alcove, or vestibules. There should be enough space for crib and reclining chair for support person.

An area within the room but distinct from the mothers area shall be provided for infant stabilization and resuscitation. See Table 4 of the Appendix for medical gas outlets. These outlets shall be located in the room so that they are accessible to the mother's delivery area and infant resuscitation area.

Each LDR or LDRP room shall be for single occupancy and have direct access to a private toilet with shower or tub. Each room shall be equipped with handwashing facilities (handwashing facilities with hands-free operation area acceptable for scrubbing). Examination lights may be portable, but shall be immediately accessible.

Finishes shall be selected to facilitate cleaning and with resistance to strong detergents. Window(s) shall be provided for LDRP room(s). Windows or doors within a normal sightline that would permit observation into the room shall be arranged or draped as necessary for patient privacy. Additional requirements for windows are provided below in C.1.c.

C. Postpartum Unit.

1. Postpartum Room.

a. A postpartum room shall have a minimum of one-hundred (100) square feet of clear floor area per bed in semi-private rooms and one-hundred-twenty (120) square feet of clear floor area in single-bed rooms. These areas shall be exclusive of toilet rooms, closets, alcoves, or vestibules.

b. In semi-private rooms there shall be a minimum clear distance of four (4) feet between the foot of the bed and the opposite wall, three (3) feet between the side of the bed and nearest wall, and four (4) feet between beds.

c. The maximum number of beds per room shall be two (2).

d. Each patient room shall have a window with outside exposure and where the operation of windows or vents require the use of tools or keys, those items shall be on the same floor and easily accessible to staff. The windowsills shall not be higher than three (3) feet above the floor and shall be above the grade. Patient rooms in new construction intended for twenty-four (24) hour occupancy shall have windows. If operable windows are installed, such devices shall be restricted to inhibit possible escape or suicide.

e. Handwashing facilities shall be provided in each patient room. In semi-private rooms the handwashing sink shall be located outside the patients' cubical curtains so it is accessible to staff.

f. Each patient shall have access to a toilet room with handwashing facilities without entering a general corridor. One (1) such room shall serve no more than two (2) beds and no more than two (2) patient rooms.

2. The following support services for this unit shall be provided.

a. Nurses' station.

b. Charting facilities.

c. Toilet room for staff.

d. Staff lounge.

e. Closets or cabinets for staff.

f. Consultation/conference room(s).

g. Clean workroom or clean supply room. A clean workroom is required if clean materials are assembled within the obstetrical suite prior to use. It shall contain a work counter, a handwashing fixture, and storage facilities for clean and sterile supplies. If the room is used only for storage and holding as part of a system for distribution of clean and sterile supply materials, the work counter and handwashing fixtures may be omitted. Soiled and clean workrooms or holding rooms shall be separated and have no direct connection.

h. Soiled workroom or soiled holding room for the exclusive use of the obstetrical suite. This room shall be separate from the clean workroom. The soiled workroom shall contain a clinical sink (or equivalent flushing-rim fixture) and a handwashing fixture. The above fixtures shall have a hot and cold mixing faucet. The room shall have work counter and space for separate covered containers for soiled linen and waste. Rooms used only for temporary holding of soiled material may omit the clinical sink and work counter. If the flushing-rim clinical sink is omitted, facilities for cleaning bedpans shall be provided elsewhere.

i. Medication station. Provision shall be made for storage and distribution of drugs and routine medications. This may be done from a medicine preparation room or unit, from a self-contained medicine dispensing unit, or by another approved system. If used, a medicine preparation room or unit shall be under visual control of nursing staff. It shall contain a work counter, sink, refrigerator, and double-locked storage for controlled substances. Convenient access to handwashing facilities shall be provided. (Standard cup-sinks provided in many self-contained units are not adequate for handwashing.)

j. Clean linen storage may be part of a clean workroom or a separate closet. When a closed cart system is used, the cart shall be stored out of the path of normal traffic.

k. Nourishment station shall contain sink, work counter, ice dispenser, refrigerator, cabinets, and equipment for serving hot or cold food. Space shall be included for temporary holding of unused or soiled dietary trays.

l. Equipment storage room.

m. Storage space for stretchers and wheelchairs shall be provided in a strategic location, out of corridors and away from normal traffic.

n. A housekeeping room shall be provided for the exclusive use of the obstetrical suite.

It shall be directly accessible from the suite and shall contain a service sink or floor receptor and provisions for storage of supplies and housekeeping equipment.

o. Examination/treatment room and/or multipurpose diagnostic testing room shall have a minimum clear floor area of one-hundred-twenty (120) square feet. When utilized as a multipatient diagnostic testing room, a minimum clear floor area of eighty (80) square feet per patient shall be provided. An adjoining toilet room shall be provided for patient use.

p. Emergency equipment storage shall be located in close proximity to the nurses' station.

SECTION 55: PHYSICAL FACILITIES, EMERGENCY SUITE.

A. General. The following shall be provided:

1. Grade-level well-marked, illuminated, and covered entrance with direct access from public roads for ambulance and vehicle traffic. Entrance and driveway shall be clearly marked. If a raised platform is used for ambulance discharge, a ramp shall be provided for pedestrian and wheelchair access.

2. Paved emergency access to permit discharge of patients from automobiles and ambulances, and temporary parking convenient to the entrance.

3. Reception, triage, and nurses' station shall be located to permit staff observation and control of access to treatment area, pedestrian and ambulance entrances, and public waiting area. The triage area requires special consideration. As the point of entry and assessment for patients with undiagnosed and untreated airborne infections, the triage area shall be designed and ventilated to reduce exposure of staff, patients and families to airborne infectious diseases. If determined by the infection control risk assessment, one (1) or more separate, enclosed spaces designed and ventilated as airborne infection isolation rooms shall be required.

4. Wheelchair and stretcher storage shall be provided for arriving patients. This shall be out of traffic with convenient access from emergency entrances.

5. Public waiting area with toilet facilities, drinking fountains, and telephones shall be provided. The hospital shall conduct infection control risk assessment to determine if the emergency department waiting area shall require special measures to reduce the risk of airborne infection transmission. These measures may include enhanced general ventilation and air disinfection similar to inpatient requirements for airborne infection isolation rooms.

6. Communication center shall be convenient to nurses' station and have radio, telephone, and intercommunication systems.

7. Examination and Treatment Room(s). Examination and treatment room(s) shall have minimum floor area of one-hundred-twenty (120) square feet. The room shall contain work counter(s); cabinets; handwashing facilities; supply storage facilities; examination lights; a desk, counter, or shelf space for writing; and a vision panel adjacent to and/or in the door. When treatment cubicles are in open multiple-bed areas, each cubicle shall have a minimum of eighty (80) square feet of clear floor space and shall be separated from adjoining cubicles by curtains. Handwashing facilities shall be provided for each four treatment cubicles or major fraction thereof in multiple-bed areas. For oxygen and vacuum requirements, see Table 4 of the Appendix. Treatment/exam rooms used for pelvic exams should allow for the foot of the examination table to face away from the door.

8. Trauma/cardiac rooms for emergency procedures, including emergency surgery, shall have at least 250 square feet of clear floor space. Each room shall have cabinets and emergency supply shelves, X-ray film illuminators, examination lights, and counter space for writing. Additional space with cubicle curtains for privacy may be provided to accommodate more than one patient at a time in the trauma room. Provisions shall be made for monitoring the patient. There shall be storage provided for immediate access to attire used for universal precautions. Doorways leading from the ambulance entrance to the cardiac trauma room shall be a minimum of six (6) feet wide to simultaneously accommodate stretchers, equipment, and personnel. In renovation projects, every effort shall be made to have existing cardiac/trauma rooms meet the above minimum standards.

9. Orthopedic and cast work. These may be in separate room(s) or in the trauma room. They shall include storage for splints and other orthopedic supplies, traction hooks, X-ray film illuminators, and examination lights. If a sink is used for the disposal of plaster of paris, a plaster trap shall be provided. The clear floor space for this area shall depend on the functions program and the procedures and equipment accommodated here.

10. Scrub stations located in or adjacent and convenient to each trauma and/or orthopedic room.

11. Convenient access to radiology and laboratory services.

12. Poison Control Center and EMS Communications Center may be part of the work and charting area.

13. Storage area out of line of traffic for stretchers, wheelchairs and emergency equipment;

14. A toilet room for patients;

15. Soiled workroom for the exclusive use of the emergency suite. This room shall be separate from the clean workroom. The soiled workroom shall contain a clinical sink or equivalent flushing type fixture, work counter, sink equipped for handwashing, waste receptacle and linen receptacle. This room shall be separate from the clean workroom and shall have separate access doors.

16. Clean workroom or clean supply room. A clean work room is required if clean materials are assembled within the emergency suite prior to use. It shall contain a work counter, a handwashing fixture, and storage facilities for clean and sterile supplies. If the room is used only for storage and holding as part of a system for distribution of clean and sterile supply materials, the work counter and handwashing fixtures may be omitted. Soiled and clean workrooms or holding rooms shall be separated and have no direct connection.

17. Nurses' Station(s). Facilities for charting, clinical records, work counter, communication system, space for supplies and convenient access to handwashing facilities shall be provided. Visual observation of all traffic into the suite, where feasible.

18. Securable closets or cabinet compartments for personnel.

19. Staff lounge. Convenient and private access to staff toilets, lounge, and lockers.

20. Housekeeping room.

21. Bereavement Room shall be located within or adjacent to the emergency suite. A telephone shall be provided.

SECTION 56: PHYSICAL FACILITIES, IMAGING SUITE.

A. General.

1. Equipment and space shall be as required by the narrative program.

2. A certified physicist or other qualified expert shall specify the type, location, and amount of radiation protection to be installed in accordance with the final approved department layout and equipment selections. Where protected alcoves with view windows are required, a minimum of one (1) foot six (6) inches between the view window and the outside partition edge shall be provided. Radiation protection requirements shall be incorporated into the specifications and the building plans.

3. The Division of Radiation Control and Emergency Management shall be notified when any existing and/or new equipment has been relocated or introduced into the facility. Radiation Control approval for the equipment(s) and space(s) shall be obtained prior to use.

B. Angiography.

1. Space shall be provided as required by the narrative program. The procedure room shall be a minimum of four-hundred (400) square feet.

2. A control room shall be provided as necessary to meet the needs ofthe narrative program. A view window in the control room shall be provided to permit full view of the patient.

3. A viewing area shall be provided and be a minimum of ten (10) feet in length.

4. A scrub sink located outside the staff entry to the procedure room shall be provided for use by staff.

5. A patient holding area shall be provided to accommodate two (2) stretchers per procedure room.

6. Storage for portable equipment and supplies shall be provided. Closed cabinets shall be provided for patient care equipment and supplies.

7. Provision shall be made within the facility for extended post-procedure observation of outpatients.

C. Computerized Tomography (CT) Scanning.

1. A control room shall be provided which is designed to accommodate the computer and other controls for the equipment. A view window shall be provided to permit full view of the patient. The angle between the control and equipment centroid shall permit the control operator to see the patient's head.

2. The control room shall be located to allow convenient film processing.

3. A patient toilet room shall be convenient to the procedure room, and if directly accessible to the scan room, arranged so that a patient may leave the toilet without having to reenter the scan room.

D. Diagnostic X-ray (e.g., Tomography, Radiography/Fluoroscopy Rooms, Mammography). Radiology rooms shall be of a size to accommodate the narrative program. Each X-ray room shall include a shielded control alcove. This area shall be provided with a view window designed to provide full view of the examination table and the patient at all times, including full view of the patient when the table is in the tilt position or the chest X-ray is being utilized. For mammography machines with built-in shielding for the operator, the alcove may be omitted when approved by the certified physicist or state radiation protection agency.

E. Magnetic Resonance Imaging (MRI).

1. Space shall be provided as required by the narrative program.

2. A control room shall be provided with full view of the MRI.

3. A patient holding area should be located near the MRI unit.

4. Cryogen venting shall comply with manufacturer's recommendations.

F. Ultrasound.

1. Space shall be provided as required by the narrative program.

2. A patient toilet room, accessible from the procedure room and from the corridor, shall be provided.

G. Support Spaces. The following spaces are common to the imaging department and are minimum requirements unless stated otherwise.

1. Patient Waiting Area. The area shall have a seating capacity in accordance with the narrative program. If the suite is used for outpatients and inpatients at the same time, separate waiting areas shall be provided with screening for visual privacy between the waiting areas.

2. Control Desk and Reception Area.

3. Holding Area. A convenient holding area under staff control shall be provided to accommodate patients on stretchers or beds.

4. Patient Toilet Rooms. Toilet rooms shall be provided convenient to the waiting rooms and shall be equipped with an emergency call system. Separate toilets with handwashing facilities shall be provided with direct access from each radiography/fluoroscopy room so that a patient may leave the toilet without having to reenter the radiography/fluoroscopy room. Rooms used only occasionally for fluoroscopy procedures may utilize nearby patient toilets if they are located for immediate access.

5. Patient Dressing Rooms. Dressing rooms shall be provided convenient to the waiting areas and X-ray rooms. Each room shall include a seat or bench, mirror, and provisions for hanging patients' clothing.

6. Staff Facilities. Toilets may be outside the suite but shall be convenient for staff use. In larger suites of three (3) or more procedure rooms, toilets internal to the suite shall be provided.

7. Image Storage. Provisions shall be provided by the facility for the active and inactive image storage. A room with cabinet or shelves for filing patient image for immediate retrieval shall be provided. A room or area for inactive image storage shall be provided. It may be outside the imaging suite, but must be under imaging's administrative control and properly secured to protect films against loss or damage.

8. Storage for Unexposed Image. Storage facilities for unexposed images shall include protection of film against exposure or damage and shall not be warmer than the air of adjacent occupied spaces.

9. Provisions for image viewing, individual consultation, clerical spaces and charting shall be provided.

10. Contrast Media Preparation. This area shall be provided with sink, counter, and storage to allow for mixing of contrast media. One (1) preparation area, if conveniently located, may serve any number of rooms. When prepared media is used, this area may be omitted, but storage shall be provided for the media.

11. Image Processing Room. A darkroom shall be provided for processing image unless the processing equipment normally used does not require a darkroom for loading and transfer. When daylight processing is used, the darkroom may be minimal for emergency and special uses. Image processing shall be located convenient to the procedure rooms and to the quality control area.

12. Quality Control Area. An area shall be provided near the processor for viewing film immediately after it is processed. All view boxes shall be illuminated to provide light of the same color value and intensity for appropriate comparison of several adjacent images.

13. Cleanup Facilities. Provisions for cleanup shall be located within the suite for convenient access and use and shall include service sink or floor receptacle as well as storage space for equipment and supplies. If automatic film processors are used, a receptacle of adequate size with hot and cold water for cleaning the processor racks shall be provided.

14. Handwashing Facilities. Handwashing facilities shall be provided within each procedure room unless the room is used only for routine screening such as chest X-rays where the patient is not physically handled by the staff. Handwashing facilities shall be provided convenient to the MRI room, but need not be within the room.

15. Clean Storage. Provisions shall be made for the storage of clean supplies and linens. If conveniently located, storage may be shared with another department.

16. Soiled Holding. Provisions shall be made for soiled holding. Separate provisions for contaminated handling and holding shall be made. Handwashing facilities shall be provided.

17. Provision shall be made for locked storage of medications and drugs.

H. Cardiac Catheterization Lab. Note: The number of procedure rooms and the size of the prep, holding, and recovery areas shall be based on expected utilization.

1. The cardiac catheterization lab is normally a separate suite, but may be within the imaging suite when the appropriate sterile environment is provided. It may be combined with angiography in low usage situations.

2. The procedure room shall be a minimum of four-hundred (400) square feet exclusive of fixed and movable cabinets and shelves.

3. A control room or area for the efficient functioning of the X-ray and image recording equipment. A view window permitting full view of the patient from the control console shall be provided.

4. Scrub facilities shall be provided adjacent to the entrance of procedure rooms, and shall be arranged to minimize incidental splatter on nearby personnel, medical equipment, or supplies.

5. The following shall be available for use by the cardiac catheterization suite:

a. A viewing room;

b. A film file room.

6. Staff change area(s) shall be provided and arranged to ensure a traffic pattern so that personnel entering from outside the suite can enter, change their clothing, and move directly into the cardiac catheterization suite.

7. A patient preparation, holding, and recovery area or room shall be provided and arranged to provide visual observation before and after the procedure.

8. A clean workroom or clean supply room shall be provided. If the room is used for preparing patient care items, it shall contain a work counter and handwashing sink. If the room is used only for storage and holding of clean and sterile supply materials, the work counter and handwashing facilities may be omitted.

9. A soiled workroom shall be provided which shall contain a handwashing and a clinical sink (or equivalent flushing rim fixtures). When the room is used for temporary holding of soiled materials, the clinical sink may be omitted.

10. A housekeeping closet containing a floor receptor or service sink and provisions for storage of supplies and housekeeping equipment shall be provided.

SECTION 57: PHYSICAL FACILITIES, NUCLEAR MEDICINE.

A. Equipment and space shall be provided to accommodate the narrative program.

B. A certified physicist or other qualified expert representing the owner shall specify the type, location, and amount of radiation protection to be installed in accordance with final approved department layout and equipment selection. This information shall be indicated on the floor plan.

C. Floors and walls shall be constructed of materials that are easily decontaminated in case of radioactive spills.

D. If radiopharmaceutical preparation is performed onsite, an area adequate to house a radiopharmacy shall be provided with appropriate shielding.

E. Nuclear medicine area when operated separately from the imaging department shall include the following:

1. Space adequate to permit entry of stretchers, beds, and able to accommodate imaging equipment, electronic consoles, and if present, computer terminals;

2. A darkroom onsite available for film processing. The darkroom should contain protective storage facilities for unexposed film that guard the film against exposure or damage;

3. Provisions for cleanup located within the suite for convenient access and use. It shall include service sink or floor receptacle as well as storage space for equipment and supplies;

4. Film storage with cabinets or shelves for filing patient film for immediate retrieval;

5. Inactive film storage under the departmental administrative control and properly secured to protect film against loss or damage;

6. A consultation area with view boxes illuminated to provide light of the same color value and intensity for appropriate comparison of several adjacent films;

7. Provisions for physicians, assistants and clerical office space, individual consultation, viewing, and charting of film;

8. Waiting areas out of traffic, under staff control, with seating capacity in accordance with the narrative program. If the department is routinely used for outpatients and inpatients at the same time, separate waiting areas with screening or visual privacy between the waiting areas;

9. A private area for dose administration located near the preparation area;

10. A holding area for patients on stretchers or beds which may be provided and may be combined with the dose administration area with visual privacy between the areas;

11. Patient dressing rooms convenient to the waiting area and procedure rooms. Each dressing room shall include a seat or bench, a mirror, and provisions for hanging patient's clothing;

12. Toilet rooms convenient to waiting and procedure rooms;

13. Staff toilet(s) convenient to the nuclear medicine laboratory;

14. Handwashing facilities within each procedure room;

15. Control desk and reception area;

16. Storage area for clean linen with a handwashing facility;

17. Provisions for holding soiled material with separate provisions for holding contaminated material.

F. Positron Emission Tomography (PET).

1. Equipment and space shall be provided as required by the narrative program.

2. A certified physicist or other qualified expert representing the owner shall specify the type, location, and amount of radiation protection to be installed in accordance with final approved department layout and equipment selection. This information shall be indicated on the floor plan.

3. Floors and walls shall be constructed of materials that are easily decontaminated in case of radioactive spills.

G. Radiotherapy.

1. Rooms and spaces shall be provided as required by the narrative program.

2. Cobalt, linear accelerators, and simulation rooms require radiation protection. A certified physicist or other qualified expert representing the owner shall specify the type, location, and amount of radiation protection to be installed in accordance with final approved department layout and equipment selection. This information shall be indicated on the floor plan.

3. Cobalt rooms and linear accelerators shall provide for prevention of the escape of radioactive particles. Openings into the room, including doors, ductwork, vents, and electrical raceways and conduits, shall be baffled to prevent direct exposure to other areas of the facility.

4. Additional Support Areas for Linear Accelerator:

a. Mold room with exhaust hood and handwashing facility.

b. Block room with storage. The block room may be combined with the mold room.

5. Additional Support Areas for Cobalt Room:

a. Hot lab.

H. General Support Areas. The following areas shall be provided unless they are accessible from other areas such as imaging:

1. A stretcher holding area adjacent to the treatment rooms, screened for privacy which may be combined with a seating area for outpatients;

2. Exam rooms as specified by the narrative program. Each shall be a minimum of one-hundred-twenty (120) square feet and equipped with a handwashing facility;

3. Darkroom convenient to the treatment room(s) and the quality control area. Where daylight processing is used, the darkroom may be minimal for emergency use. If automatic film processors are used, a receptacle of adequate size with hot and cold water for cleaning the processor racks shall be provided either in the darkroom or nearby;

4. Patient gowning area with provision for safe storage of valuables and clothing. At least one (1) space should be large enough for staff-assisted dressing;

5. Business office and/or reception/control area;

6. Housekeeping room equipped with service sink or floor receptor and large enough for equipment or supplies storage;

7. Image file area; and

8. A storage area for unprocessed media.

I. Optional Support Area. The following areas may be required by the narrative program:

1. Quality control area with view boxes illuminated to provide light of the same color value and intensity;

2. Computer control area normally located just outside the entry to the treatment room(s);

3. Dosimetry equipment area;

4. Hypothermia room (may be combined with an exam room);

5. Consultation room;

6. Oncologist's office (may be combined with consultation room);

7. Physicist's office (may be combined with treatment planning);

8. Treatment planning and record room; and

9. Work station/nutrition station.

SECTION 58: PHYSICAL FACILITIES, MOBILE, TRANSPORTABLE, AND RELOCATABLE UNITS.

A. General. This section applies to mobile, transportable, and relocatable structures.

B. Definitions.

1. Mobile Unit - Any premanufactured structure, trailer, or self-propelled unit equipped with a chassis on wheels and intended to provide shared medical services to the community on a temporary basis.

2. Transportable Unit - Any premanufactured structure or trailer, equipped with a chassis on wheels, intended to provide shared medical services to the community on an extended basis.

3. Relocatable Unit - Any structure, not on wheels, built to be relocated at any time and provide medical services.

C. General Considerations.

1. Classifications. These facilities shall be classified as either a small outpatient facility, large outpatient facility, ambulatory surgery center, or a hospital based upon the definitions provided in the Rules and Regulations, the program narrative and construction type.

2. Applicable Requirements. Facilities classified as a small outpatient clinic shall be designed in accordance with the requirements stipulated in Section 79, Physical Facilities, Outpatient Care Facilities, classified as a large outpatient facility shall be designed in accordance with the requirements stipulated in item F. of Section 79, Physical Facilities, Outpatient Care Facilities, classified as an ambulatory surgery center shall be designed in accordance with the requirements stipulated in Section 78, Physical Facilities, Free-standing Ambulatory Surgery Centers, classified as a hospital shall be designed in accordance with the requirements stipulated in Section 47, Physical Facilities.

3. These requirements shall be applicable to mobile, transportable, and relocatable structures, when such structures are used to provide shared medical services on an extended or a temporary basis.

4. When any mobile unit, transportable and relocatable unit(s) are situated in a fixed location and rendered immobile they shall be classified and designed as a health care facility.

D. Common Elements for Mobile, Transportable, and Relocatable Units.

1. Site Conditions.

a. Access for the unit to arrive shall be taken into consideration for space planning. Turning radius of the vehicles, slopes of the approach (six (6) percent maximum), and existing conditions shall be addressed.

b. Gauss fields of various strengths of magnetic resonance imaging (MRI) units shall be considered for the environmental effect on the field homogeneity and vice versa. Radio frequency interference shall be considered when planning the site.

c. Sites shall be provided with properly sized power, including emergency power, water, waste, telephone, and fire alarm connections.

d. Site shall have level concrete pads or piers and be designed for the structural loads of the facility.

e. Site utilizing MRI systems shall consider providing adequate access for cryogen-servicing of the magnet. Storage of dewars also shall be included in space planning.

f. Each site shall provide a covered walkway or enclosure to ensure patient safety from the outside elements.

g. Diesel exhaust of the tractor and/or unit generator shall be twenty-five (25) feet away from the fresh air intake of the facility.

h. Sites shall provide hazard-free patient drop-off zones and adequate parking.

i. The facility shall provide waiting space for patient privacy and patient and staff toilets as close to the unit docking area as possible.

j. Each site shall provide access to the unit for wheelchair/stretcher patients.

k. Mobile units shall be provided with handwashing facilities unless each site can provide handwashing facilities within a twenty-five (25) foot proximity to the unit. Transportable and relocatable units shall be provided with handwashing facilities.

E. General Standards for Details and Finishes for Unit Construction.

1. Horizontal sliding doors and power-operated doors shall comply with NFPA 101.

2. Units shall be permitted a single means of egress as permitted by NFPA 101.

3. All glazing in doors shall be safety or wire glass.

4. Fire detection, alarm, and communications capabilities shall be installed and connected to the facility's central alarm system on all new units in accordance with NFPA 101. Where fire alarm compatibility problems arise with mobile units, a fire alarm pull station shall be located near the door of the primary exit discharge.

5. Radiation protection for X-ray and gamma ray installations shall be in accordance with State requirements.

6. Interior finish materials shall be class A as defined in NFPA 101.

7. Textile materials having a napped, tufted, looped, woven, nonwoven, or similar surface shall be permitted on walls and ceilings provided such materials have a class A rating and rooms or areas are protected by an automatic extinguishment or sprinkler system.

8. Curtains and draperies shall be noncombustible or flame retardant and shall pass both the large and small scale tests required by NFPA 101. Fire retardant coatings shall be permitted in accordance with NFPA 101.

F. Mechanical Standards.

1. Air conditioning, heating, ventilating, ductwork, and related equipment shall be installed in accordance with NFPA 90A, Standard for the Installation of Air Conditioning and Ventilation systems.

2. Plumbing Standards.

a. Plumbing and other piping systems shall be installed in accordance with the Arkansas State Plumbing Code.

b. Mobile units, requiring sinks, shall not be required to be vented through the roof. Ventilation of waste lines shall be permitted to be vented through the sidewalls or other acceptable locations. Transportable and relocatable units shall be vented through the roof per model plumbing codes.

c. Backflow prevention shall be installed at the point of water connection on the unit.

d. Medical gases and suction systems, if installed, shall be in accordance with NFPA 99.

SECTION 59: PHYSICAL FACILITIES, LABORATORY SERVICES.

A. Facilities necessary for providing laboratory services described in the narrative program shall be provided. The laboratory shall be constructed, arranged and maintained to ensure adequate space, ventilation and utilities necessary for conducting all phases required of testing.

1. Work areas shall be arranged to minimize problems in specimen handling, examination and testing of specimens and reporting of test results.

2. Laboratory work counters shall provide sufficient space for test performance, necessary instruments, equipment, computer systems, etc. Works areas shall be well lighted and shall include sinks (lavatories and counter sinks) with water and access to vacuum, gases, air and electrical outlets as needed.

3. Refrigerated facilities for the storage of donor blood shall be provided. The blood storage refrigerator shall be connected to an emergency power source and shall be equipped with temperature monitoring and an audible alarm system that shall sound in the laboratory and a twenty-four (24) hour manned station.

4. Appropriate storage facilities for reagents, supplies, specimen blocks, stained specimen microscopic slides, records, etc. shall be provided.

5. Specimen collection facilities shall be provided. These facilities may be located outside the laboratory suite. The blood collection area shall have a work counter, space for patient seating, and handwashing facilities. Urine and feces collection room(s) shall be equipped with a water closet and a lavatory.

6. Provisions shall be made for safety from physical, chemical and biological hazards. There shall be eye flushing devices, appropriate storage of flammable liquids, emergency spill kit(s) and fire extinguishers as required by NFPA 99. If mycobacteriology or mycology cultures are manipulated, a microbiological safety cabinet shall be provided.

7. Based on the narrative program, equipment for terminal sterilization of contaminated specimens (autoclave or microwave) shall be provided.

8. Locker and toilet facilities for both male and female staff shall be located convenient to the laboratory area.

9. Provisions shall be made for the following procedures to be performed on-site: blood counts, urinalysis, blood glucose, electrolytes, and nitrogen (BUN), coagulation, and transfusions (type and cross-match capability). Provisions shall also be included for specimen collection and processing.

SECTION 60: PHYSICAL FACILITIES, REHABILITATION THERAPY DEPARTMENT.

A. Common Elements. Each rehabilitative therapy department shall include the following, which may be shared or provided as separate units for each service:

1. Office and clerical space with provisions for filing and retrieval of patient records.

2. Reception and control station(s) with visual control of waiting and activities area. (This may be combined with office and clerical space.)

3. Patient waiting area(s) out of traffic with provision for wheelchair patients.

4. Patient toilets with handwashing facilities accessible to wheelchair patients.

5. Space(s) for storing wheelchairs and stretchers out of traffic while patients are using the services. These spaces may be separate from the service area but must be conveniently located.

6. A conveniently accessible housekeeping room and service sink for housekeeping use.

7. Locking closets or cabinets within the vicinity of each work area for securing staff personal effects.

8. Convenient access to toilets and lockers.

9. Access to a demonstration/conference room.

10. Lockable storage for medications.

B. Physical Therapy. If physical therapy is part of the service, the following at least, shall be included:

1. Individual treatment area(s) with privacy screens or curtains. Each such space shall have not less than seventy (70) square feet of clear floor area.

2. Handwashing facilities for staff either within or at each treatment space (one (1) handwashing facility may serve several stations).

3. Exercise area and facilities.

4. Clean linen and towel storage.

5. Storage for equipment and supplies.

6. Separate storage for soiled items.

7. Patient change area. (If required by the narrative program.)

C. Occupational Therapy. If this service is provided, at least the following shall be included:

1. Work areas and counters suitable for wheelchair access.

2. Handwashing facilities.

3. Storage for supplies and equipment.

4. An area for daily living activities shall be provided. It shall contain an area for a bed, kitchen counter with appliances and sink, bathroom, and a table/chair.

D. Prosthetics and Orthotics. If this service is provided, at least, the following shall be included:

1. Work space for technicians;

2. Space for evaluating and fitting, with provisions for privacy;

3. Space for equipment, supplies and storage.

E. Recreation Therapy. NOTE: Recreation therapy assists patients in the development and maintenance of community living skills through the use of leisure-time activity tasks. These activities may occur in a recreation therapy department, in specialized facilities (e.g., gymnasium), multipurpose space in other areas (e.g., the nursing unit), or outdoors. If this service is provided, at least, the following shall be included:

1. Activity areas suitable for wheelchair access;

2. Handwashing facilities if required by the program;

3. Storage for supplies and equipment;

4. Secured storage for supplies and equipment potentially harmful;

5. Remote electrical switching for equipment potentially harmful.

F. Speech, Hearing, and Audio Therapy. If this service is provided, at least, the following shall be included:

1. Space for evaluation and treatment of patients. The space shall be protected with acoustical treatment of walls and finishes.

2. Space for equipment storage and supplies.

G. Respiratory Care. If respiratory care is part of the service, the following, at least, shall be included as a minimum:

1. Storage of equipment and supplies.

2. Space and utilities for cleaning and sanitizing equipment. Provide physical separation of the space for receiving and cleaning soiled materials from the space for storage of clean equipment and supplies. Appropriate local exhaust ventilation shall be provided if glutaraldehyde or other noxious disinfectants are used in the cleaning.

3. If respiratory services, such as testing and demonstration for outpatients are part of the program, additional facilities and equipment shall be provided as necessary for the appropriate function of the service, including but not limited to:

a. Patient waiting area with provision for wheelchairs;

b. Reception and control station;

c. Patient toilets and handwashing facilities;

d. Room(s) for patient education and demonstration;

4. Cough-Inducing and Aerosol-Generating Procedures. All cough-inducing procedures performed on patients who may have suspected or active infectious Mycobacterium tuberculosis shall be performed in rooms that meets the requirements for airborne infection control.

SECTION 61: PHYSICAL FACILITIES, MORGUE AND NECROPSY. These facilities shall be directly accessible to an outside entrance and shall be located to avoid movement of bodies through public areas. The following elements shall be provided when autopsies are performed within the hospital:

A. Refrigerated facilities for body-holding;

B. Autopsy Room. This room shall contain:

1. Work counter with sink equipped for handwashing;

2. Storage space for supplies, equipment, and specimens;

3. Autopsy table;

4. Clothing change area;

5. A deep sink for washing of specimens;

6. A housekeeping service sink or receptor for cleanup and housekeeping.

NOTE: If autopsies are performed outside the facility, only a well ventilated, temperature-controlled, body-holding room need be provided.

SECTION 62: PHYSICAL FACILITIES, PHARMACY. The size and type of services to be provided in the pharmacy can largely depend upon the type of medication distribution system used, number of patients to be served, and extent of shared or purchased services. This shall be described in the narrative program. The pharmacy room or suite shall be located for convenient access, staff control, and security. Facilities and equipment shall be as necessary to accommodate the functions of the program. See Section 16, Pharmacy, for additional requirements. (Satellite facilities, if provided, shall include those items required by the program.) As a minimum, the following elements shall be included:

A. Dispensing.

1 A pickup and receiving area.

2. An area for reviewing and recording.

3. An extemporaneous compounding area that includes a sink and sufficient counter space for medication preparation.

4. Work counters and space for automated and manual dispensing activities.

5. An area for temporary storage, exchange, and restocking of carts.

6. Security provisions for medications and personnel in the dispensing counter area.

B. Manufacturing.

1. A bulk compounding area.

2. Provisions for packaging and labeling.

3. A quality control area.

C. Storage (may be cabinets, shelves, and/or separate rooms or closets).

1. Bulk storage.

2. Active storage.

3. Refrigerated storage.

4. Volatile fluids and alcohol storage constructed according to applicable fire safety codes for the substances involved.

5. Double-locked storage for controlled substances.

6. Storage for general supplies and equipment not in use.

D. Administration.

1. An area for education and training (may be in a multipurpose room shared with other departments).

2. An area for patient counseling and instruction (may be in a room separate from the pharmacy).

3. A separate area for office functions.

E. Other.

1. Handwashing facilities shall be provided within each separate room where open medication is handled and readily accessible.

2. Provide for convenient access to toilet and locker.

3. If unit dose procedure is used, provide additional space and equipment for supplies, packaging, labeling, and storage, as well as for the carts.

4. If IV solutions are prepared in the pharmacy, provide a sterile work area with a laminar-flow work station designed for product protection. The laminar-flow system shall include a nonhydroscopic filter (HEPA) rated at 99.97 percent, as tested by DOP tests and have a visible pressure gauge for detection of filter leaks or defects.

5. Hoods used for chemotherapy shall be one-hundred (100) percent exhausted to the exterior.

6. As a minimum the partitions enclosing the pharmacy shall extend from the floor to the deck above, with gypsum board on both sides of metal studs.

SECTION 63: PHYSICAL FACILITIES, DIETARY FACILITIES. Construction, equipment, and installation shall comply with the standards specified in FDA U.S. Public Health Service Food Code. Food service facilities shall be designed and equipped to meet the requirements of the narrative program. These may consist of an onsite conventional food preparing system, a convenience food service system, or an appropriate combination of the two. The following shall be provided:

A. Receiving/Control Stations. An area for the receiving and control of incoming dietary supplies shall contain a control station, and a breakout for loading, uncrating, and weighing supplies;

B. Storage Spaces. Space shall be convenient to the receiving area and shall be located so as to preclude entry through the food preparation areas. Storage spaces for bulk, refrigerated, and frozen foods shall accommodate a minimum of four (4) days' supplies. A minimum of six (6) inches shall be maintained between the finished floor and a bottom shelf;

C. Food Preparation Facilities. Conventional food preparation systems shall have adequate space and equipment for preparing, cooking, and baking. Convenience food preparation systems shall have adequate space for equipment for thawing, portioning, cooking, and/or baking. These areas shall be as close as possible to the user (i.e., tray assembly and dining);

D. Assembly and Distribution Areas. A patient tray assembly area shall be located within close proximity to the food preparation and distribution areas;

E. Food Service Carts. A cart distribution area shall provide space for storage, loading, distribution, receiving, and sanitizing of food service carts. The cart traffic shall be designed to eliminate any danger of cross circulation between outgoing food carts and incoming, soiled carts, and the cleaning and sanitizing process. Cart circulation shall not traffic through food processing areas;

F. Handwashing Fixtures. These shall be operable without the use of hands and be readily accessible at locations throughout the dietary department;

G. Dining Area. There shall be dining space for ambulatory patients, staff, and visitors which is separate from the food preparation and distribution areas;

H. Area for Receiving, Scraping, and Sorting Soiled Tableware. Area shall be adjacent to ware washing and separate from food preparation areas. A handwashing fixture shall be conveniently available;

I. Dishwashing Space. An area shall be located in a room separate from food preparation and serving areas. Commercial-type dishwashing equipment shall be provided. Clean and soiled dish areas shall be separated with an opening in the partition between the clean and soiled dish area large enough for the dishwasher and ventilation of the area. The clean dish area may be either a separate room or a portion of the kitchen. A lavatory shall be conveniently available. The soiled dish area shall be so located as to prevent soiled dishes from being carried through the food preparation area;

J. Ware Washing and Pot Washing Facilities. These shall be designed to prevent contamination of clean wares with soiled wares. The clean wares shall be transferred for storage or use in the dining area without having to pass through food preparation areas. The final rinse water shall be at least one-hundred-eighty degrees (180º) Fahrenheit. A commercial pot washer or three (3) compartment sink with drain board provided at each end for washing, rinsing, and sanitizing pots and pans is required. Supplemental heat for hot water to clean pots and pans may be by booster heater or by steam jet;

K. Waste Storage Facilities. Either an automatic waste disposal system or a separate room for waste disposal shall be provided which is easily accessible to the outside for direct pick-up or disposal. Can washing facilities (if cans are used) shall also be provided at this location (if located outside, the cans shall be screened);

L. Storage Rooms and Areas. A room for cans, carts, mobile tray conveyors, and cleaning and sanitizing carts shall be provided. There shall be a separate storage room for the storage of non-food items that might contaminate edibles (i.e., cleaning supplies). A separate space or room for the storage of cooking wares, extra trays, flatware, plastic and paper products, and portable equipment is required;

M. Toilets and Locker Spaces. Lockers, if provided in the dietary facility, shall be for the exclusive use of the dietary staff. Toilets and lockers shall not open directly into the food preparation areas, but shall be in close proximity to them;

N. Office(s). Dietary service manager/supervisor offices shall be conveniently located for visual control of receiving area and food preparation areas;

O. Janitor's Closet. A closet shall be provided for the exclusive use of the dietary department to contain a floor sink and space for mops, pails, and supplies. Where hot water or steam is used for general cleaning, additional space within the room shall be provided for the storage of hoses and nozzles;

P. Ice Making Equipment. Equipment shall be convenient for service and easily cleaned. It shall be provided for both drinks (self-dispensing equipment), and for general use (storage bin type equipment);

Q. Commissary or Contract Services from Other Areas. If a service is used, above items may be reduced as appropriate. The process of food delivery shall insure freshness, retention of hot and cold, and avoidance of contamination. If delivery is from outside sources, protection against weather shall be provided. Provisions shall be made for thorough cleaning and sanitizing of equipment to avoid mix of soiled and clean equipment;

R. Equipment. Mechanical devices shall be heavy duty, suitable for intended use and easily cleaned. Movable equipment shall have heavy duty locking casters. If equipment is to have fixed utility connections, it shall not be equipped with casters. Walk-in coolers, refrigerators, and freezers shall be insulated at floor, walls and top. Coolers and refrigerators shall be capable of maintaining a temperature down to freezing. Freezers shall be capable of maintaining a temperature of twenty degrees (20º) below zero (0º) Fahrenheit. Coolers, refrigerators, and freezers shall be thermostatically controlled to maintain desired temperature settings in increments of two degrees (2º) or less. Interior temperatures shall be visible from the exterior. Controls may include audible and visible high and low temperature alarm. Walk-in units may be lockable from outside but shall have release mechanism for exit from inside at all times. Interior shall be lighted. All shelving shall be corrosion resistant, easily cleaned, and constructed and anchored to support a loading of at least one-hundred (100) pounds per linear foot. All cooking equipment shall be equipped with automatic shut off devices to prevent excessive heat buildup. Under counter conduits, piping, and drains shall be arranged to not interfere with cleaning of floor below or of the equipment;

S. Plumbing. Refer to Section 75, Physical Facilities, Plumbing and Other Piping Systems, for plumbing requirements; and

T. Hoods and Venting Equipment. Hoods and venting equipment shall meet the requirements of NFPA 96.

SECTION 64: PHYSICAL FACILITIES, ADMINISTRATION AND PUBLIC AREAS. The following areas shall be provided:

A. Facility entrance, at grade level, sheltered from the weather, and able to accommodate wheelchairs;

B. Lobby, which shall include:

1. Reception and information counter or desk;

2. Waiting space(s);

3. Public toilet facilities (one (1) for each sex);

4. Public telephone(s); and

5. Drinking fountain(s).

C. Interview space(s) for private interviews relating to social service, credit, and admissions;

D. General or individual office(s) for business transactions, medical and financial records, and administrative and professional staffs;

E. Multipurpose room(s) with provisions for the use of visual aids for conferences, meetings, and health education. One (1) multipurpose room may be shared by several services;

F. Storage for office equipment and supplies; and

G. Staff toilet facilities.

SECTION 65: PHYSICAL FACILITIES, HEALTH INFORMATION UNIT. The following rooms and areas shall be provided:

A. Health Information Director's office or space;

B. Review and dictating room(s) or spaces;

C. Work area for sorting, recording, or microfilming records;

D. Medical record storage, (Refer to Section 72A.26); and

E. The security of the medical records shall be provided by the facility through a means of door hardware or an electronic alarm system.

SECTION 66: PHYSICAL FACILITIES, CENTRAL MEDICAL AND SURGICAL SUPPLY DEPARTMENT. The following areas shall be provided:

A. Separate Soiled and Clean Work Areas

1. Soiled Workroom. This room shall be physically separated from all other areas of the department. Work space shall be provided to handle the cleaning and initial sterilization/disinfection of all medical/surgical instruments and equipment, work tables, sinks, flush-type devices, and washer/sterilizer decontaminators. Pass-through doors and washer/sterilizer decontaminators shall deliver into clean processing area/workrooms.

2. Clean Assembly/Workroom. This workroom shall contain handwashing facilities, workspace, and equipment for terminal sterilizing of medical and surgical equipment and supplies. Clean and soiled work areas shall be physically separated.

B. Storage Areas

Clean/Sterile Medical/Surgical Supplies. A room shall be provided for the breakdown of clean/sterile bulk supplies. Storage for packs etc., shall include provisions for ventilation, humidity, and temperature contraol.

C. Administrative/Changing Room

If required by the functional program, this room shall be separate from all other areas and provide for staff to change from street clothes into work attire. Lockers, sink, and showers shall be made available within the immediate vicinity of the department.

D. Storage Room for Patient Care and Distribution Carts

This area shall be adjacent, easily available to clean and sterile storage, and close to main distribution point to keep traffic to a minimum and to ease work flow.

SECTION 67: PHYSICAL FACILITIES, CENTRAL SUPPLY AND RECEIVING. In addition to supply facilities in individual departments, a central storage area shall also be provided. General stores may be located in a separate building onsite with provisions for protection against inclement weather during transfer of supplies. The following shall be provided:

A. Off-street unloading facilities;

B. Receiving area;

C. General Storage Room(s). General storage rooms(s) with a total area of not less than twenty (20) feet per inpatient bed shall be provided. Storage may be in separate, concentrated areas within the institution or in one (1) or more individual buildings onsite. A portion of this storage may be provided offsite; and

D. Additional Storage Room(s). Additional storage areas for outpatient facilities shall be provided in an amount not less than five (5) percent of the total area of the outpatient facilities. This may be combined with and in addition to the general stores or be located in a central area within the outpatient department. A portion of this storage may be provided offsite.

SECTION 68: PHYSICAL FACILITIES, LAUNDRY SERVICES. Each facility shall have provisions for storing and processing of clean and soiled linen for appropriate patient care.

A. Facility Processing. If linen is to be processed by the hospital (on or off site), the following shall be provided:

1. Laundry processing room with commercial type equipment which can process seven (7) days' needs within a regularly scheduled work week;

2. Soiled linen receiving, holding, and sorting room;

3. Storage for laundry supplies;

4 Clean linen inspection and mending room or area;

5. Clean linen storage, issuing, and holding room or area;

6. Cart storage area(s) for separate parking of clean and soiled linen carts out of traffic;

7. Employee handwashing facilities in each room where clean or soiled linen is processed and handled;

8. Arrangement of equipment that shall permit an orderly work flow and minimize cross traffic that might mix clean and soiled operations; and

9. Conveniently accessible staff lockers and toilets.

B. Commercial Processing. The hospital shall provide the following requirements in the facility:

1. Soiled linen holding room;

2. Clean linen receiving, holding, inspection, and storage room(s);

3. Cart storage area(s) for separate parking of clean and soiled linen carts out of traffic;

4. Employee handwashing facilities in each room where clean or soiled linen is processed and handled;

5. Arrangement of equipment that shall permit an orderly work flow and minimize cross traffic that might mix clean and soiled operations;

6. The hospital is responsible to insure the commercial laundry does comply with Section 46, Physical Environment.

SECTION 69: PHYSICAL FACILITIES, CLEANING AND SANITIZING CARTS, AND ENVIRONMENTAL CLOSETS. Facilities shall be provided to clean and sanitize carts serving the central medical and surgical supply department, dietary facilities, and linen services. These may be centralized or departmentalized or offsite as required by the written narrative. Each environmental services closet shall contain a floor receptor and/or services sink and storage space for environmental services equipment (cart, bucket, etc.) and supplies. There shall be at least one (1) environmental services closet for each floor.

SECTION 70: PHYSICAL FACILITIES, ENGINEERING SERVICE AND EQUIPMENT AREAS. Sufficient space shall be included in all mechanical and electrical equipment rooms for proper maintenance of equipment. Provisions shall also be made to provide for equipment removal and replacement. The following shall be provided:

A. Room(s) or separate building(s) for boilers, mechanical equipment, and electrical equipment, except:

1. Rooftop air conditioning and ventilation equipment installed in weatherproof housings;

2. Standby generators where the engine and appropriate accessories (i.e., batteries) are properly heated and enclosed in a weatherproof housing as recommended by the manufacturer;

3. Cooling towers and heat rejection equipment;

4. Electrical transformers and switchgear where required to serve the facility and where installed in a weatherproof housing;

5. Medical gas parks and equipment;

6. Air cooled chillers where installed in a weatherproof housing;

7. Trash compactors and incinerators. Site lighting, post indicator valves, and other equipment normally installed on the exterior of the building;

8. When elevated equipment rooms and mechanical penthouses are provided in the facility, the floor shall be sealed at penetrations and floor curbs around equipment to prevent damage to floors below.

B. Engineer's Office. Engineer's office with file space and provisions for protected storage of facility drawings, records, manuals, etc.;

C. General maintenance shop(s) for repair and maintenance as required by the program narrative;

D. Storage Room for Building Maintenance Supplies. Storage for solvents and flammable liquids shall comply with applicable NFPA codes;

E. Yard equipment and supply storage shall be located so equipment may be moved directly to exterior without interference with other work;

F. Separate area or room specifically for storage, repair, and testing of electronic and other medical equipment. The amount of space and type of utilities will vary with the type of equipment involved and types of outside contracts used.

SECTION 71: PHYSICAL FACILITIES, WASTE PROCESSING SERVICES.

A. Hazardous Waste and Antineoplastic Agent Disposal. The facility shall have policies and procedures for the identification, segregation, labeling, storage, transport and disposal of hazardous waste. The procedures shall conform with the latest edition of Hazardous Waste Management Regulation Twenty-Three (23), Arkansas Department of Environmental Quality , Little Rock, Arkansas. Within the facility, hazardous waste, especially antineoplastic agents, shall be labeled in a manner that it shall be easily recognized from all other waste. The facility shall compile a list of all antineoplastic agents used in the facility. There shall be policies and procedures for the clean up of spills, decontamination and treatment of personnel exposed to the waste.

B. Radioactive Waste Disposal. The facility shall have policies and procedures for the identification, segregation, labeling, storage, transport and disposal of radioactive waste and materials. All policies and procedures shall conform to the most current Rules and Regulations for Control of Sources of Ionizing Radiation, Arkansas Department of Health, Little Rock, Arkansas. The facility shall maintain records of all waste and materials which have been disposed.

C. Regulated Medical Waste (Infectious Waste) Disposal. The facility shall have policies and procedures for the identification, segregation, labeling, storage, transport and disposal of Regulated Medical Waste. All policies and procedures shall conform to the latest edition of the Rules and Regulations Pertaining to the Management of Medical Waste from Generators and Health Care Related Facilities, Arkansas Department of Health, Little Rock, Arkansas. The facility shall have procedures for the clean up of spills and for remedial actions to take when personnel are exposed to Regulated Medical Waste.

NOTE: Containers of medical waste shall be closed except when receiving waste.

Containers having swinging lids or lids that are easily contaminated are prohibited. Open containers, such as kick buckets lined with red bags, shall be emptied between patients and the container disinfected. Containers, such as plastic lined boxes that are used to collect plastic bags of medical waste, shall be kept closed except when receiving waste.

D. Solid Waste Disposal (Non-Infectious Waste). The facility shall have policies and procedures for the identification, segregation, labeling, storage, transport and disposal of solid waste. Policies and procedures shall conform with the latest edition of the Solid Waste Management Regulation Twenty-Two (22), Arkansas Department of Environmental Quality, Little Rock, Arkansas.

E. Other Waste. The facility shall have policies and procedures for the identification, segregation, labeling, storage, transport, and disposal of any waste not specifically mentioned in this section.

SECTION 72: PHYSICAL FACILITIES, DETAILS AND FINISHES. All details for alteration or expansion projects as well as for new construction shall comply with the following.

A. Details.

1. Compartmentation, exits, automatic extinguishing systems, and other details relating to fire prevention and fire protection shall comply with requirements listed in the NFPA referenced codes and be shown on the Fire Protection Plan. The Fire Safety Evaluation System (FSES) shall not be used as a substitute for the basic NFPA 101 design criteria for new construction or major renovation to existing facilities. (The FSES is intended as an evaluation tool for fire safety only.)

2. Minimum corridor width shall be eight (8) feet clear without projections. Increased width shall be provided at elevator lobbies and other places where conditions may demand more clearance. All service or administrative corridors shall not be less than forty-four (44) inches in width. Doors to patient rooms shall be a minimum door size of three (3) feet eight (8) inches wide and seven (7) feet high to provide clearance for movement of beds and other equipment.

3. Items such as drinking fountains, fold-down writing surfaces, telephone booths, vending machines, and portable equipment shall be located so as not to project into exit corridors in new construction. Incidental items shall be determined by the licensing agency.

4. Rooms containing bathtubs, sitz baths, showers, and water closets, subject to occupancy by patients, shall be equipped with doors and hardware which shall permit access from the outside in any emergency.

5. All doors between corridors, rooms, or spaces subject to occupancy, except elevator doors, shall be of the swing type. Openings to showers, baths, patient toilets, ICU patient compartments with the break away feature, and other such areas not leading to fire exits shall be exempt from this standard.

6. Roller latches for patient room door hardware shall not be permitted. All patient room door hardware shall be a positive latching device.

7. Doors to patients' toilet rooms and other rooms needing access for wheelchairs shall have a minimum width of thirty-six (36) inches for new facilities. Alcoves and similar spaces which generally do not require doors are excluded from this requirement.

8. Doors to occupiable spaces shall not swing into exit access corridors. Common non-occupiable spaces are mechanical equipment rooms, electrical vaults or panel equipment rooms, storage rooms, janitor's closets, tub rooms, shower rooms, or toilet rooms of less than fifty (50) gross square feet in size, elevator penthouse and equipment rooms, chases, boiler rooms, or similar spaces normally deemed non-occupiable by the licensing agency.

9. Windows shall be designed so that persons cannot accidentally fall out of them when they are open or shall be provided with security screens. Operation of windows shall be restricted to inhibit possible escape or suicide. Where the operation of windows or vents require the use of tools or keys, tools or keys shall be on the same floor and easily accessible to staff.

10. Glass doors, lights, sidelights, borrowed lights, and windows located within twelve (12) inches of a door jamb (with a bottom frame height of less than sixty (60) inches above the finished floor) shall be constructed of safety glass, wired glass, or plastic, break resistant material that creates no dangerous cutting edges when broken. Similar materials shall be used for wall openings in active areas such as recreation rooms and exercise rooms, unless otherwise equired for fire safety. Safety glass-tempered or plastic glazing materials shall be used for shower doors and bath enclosures. Plastic and similar materials used for glazing shall comply with the flame-spread ratings of NFPA 101. Safety glass or plastic glazing materials, as noted above, shall also be used for interior windows and doors, including those in pediatric and psychiatric unit corridors. In renovation projects, only glazing within eighteen (18) inches of the floor must be changed to safety glass, wire glass, or plastic, break-resistant material. NFPA 101 contains additional requirements for glazing in exit corridors, etc., especially in buildings without sprinkler systems.

11. Where labeled fire doors are required, these shall be certified by an independent test laboratory as meeting the construction requirements equal to those for fire in NFPA Standard 80. Reference to a labeled door shall be construed to include labeled frame and hardware.

12. Trash chutes shall be in accordance with NFPA standard 82. In addition, linen and refuse chutes shall meet or exceed the following requirements:

a. Service openings to chutes shall not be located in corridors or passageways but shall be located in a room which complies with NFPA 101;

b. Service openings to chutes shall have approved self-closing Class B one and one-half (1-1/2) hour labeled fire doors;

c. Minimum cross-sectional dimensions of gravity chutes shall not be less than two (2) feet;

d. Chutes shall discharge directly into collection rooms separate from incinerator, laundry, or other services. Separate collection rooms shall be provided for trash and for linen. Chute discharge into collection rooms shall comply with NFPA 101;

e. Gravity chutes shall extend through the roof with provisions for continuous ventilation as well as for fire and smoke ventilation. Openings for fire and smoke ventilation shall have an effective area of not less than that of the chute cross-section and shall be not less than four (4) feet above the roof and not less than six (6) feet clear of other vertical surfaces. Fire and smoke ventilating openings may be covered with single strength sheet glass.

13. Dumbwaiters, conveyors, and material handling systems shall comply with NFPA 101.

14. Thresholds and expansion joint covers shall be installed flush with the floor surface to facilitate use of wheelchairs and carts. Expansion and seismic joints shall be constructed to restrict the passage of smoke.

15. Grab bars shall be provided in all patients' toilets, showers, tubs, and sitz baths. The bars shall have one and one-half (1-1/2) inch clearance to walls and shall have sufficient strength and anchorage to sustain a concentrated load of two hundred fifty (250) pounds.

16. Soap dishes, soap dispensers and/or other devices shall be provided at showers, bath tubs, and all handwashing facilities except scrub sinks.

17. Location and arrangement of handwashing facilities shall permit proper use and operation. All sinks, except public toilets, janitor closets, and sinks used by patients only, shall have foot, knee, or wrist blade faucets. Particular care shall be given to the clearances required for blade-type operating handles. Installation of single-handle operators shall have prior approval by the licensing agency.

18. Mirrors shall not be installed at handwashing fixtures in food preparation areas, nurseries, clean and sterile supply areas, scrub sinks, or other areas where asepsis is essential. Provisions for hand drying shall be included at all handwashing facilities except scrub sinks. Paper units shall be enclosed to protect against dust or soil and to insure single unit dispensing.

19. Lavatories and handwashing facilities shall be securely anchored to withstand an applied downward vertical load of not less than two hundred fifty (250) pounds on the front of the fixture.

20. Radiation protection requirements of X-ray and gamma ray installations shall conform with Rules and Regulations for Control of Sources of Ionizing Radiation, Arkansas Department of Health.

21. The minimum ceiling height shall be seven (7) feet ten (10) inches with the following exceptions:

a. Boiler rooms shall have ceiling clearances not less than two (2) feet six (6) inches above the main boiler header and connecting piping.

b. Ceilings in radiographic, operating and delivery rooms, and other rooms containing ceiling-mounted equipment or ceiling-mounted surgical light fixtures shall be of sufficient height to accommodate the equipment or fixtures and their normal movement.

c. Ceilings in corridors, storage rooms, and toilet rooms shall be not less then seven (7) feet eight (8) inches in height. Ceiling heights in small, normally unoccupied spaces may be reduced.

d. Suspended tracks, rails, and pipes located in the traffic path for patients in beds and/or on stretchers, including those in inpatient service areas, shall be not less than seven (7) feet above the floor. Clearances in other areas may be six (6) feet eight (8) inches.

e. Where existing structures make the above ceiling clearance impractical, clearances shall be as required to avoid injury to individuals up to six (6) feet four (4) inches tall.

f. Seclusion treatment rooms shall have a minimum ceiling height of nine (9) feet.

22. Recreation rooms, exercise rooms, and similar spaces where impact noises may be generated shall not be located directly over patient bed area, delivery or operating suites, unless special provisions are made to minimize such noise.

23. Rooms containing heat-producing equipment (such as boiler or heater rooms and laundries) shall be insulated and ventilated to prevent any floor or partition surface from exceeding a temperature of ten degrees (10º) Fahrenheit above ambient room temperature.

24. Noise reduction criteria shown in Table 2 of the Appendix shall apply to partition, floor, and ceiling construction in patient areas. (Careful attention shall be given to penetrations.)

25. Approved fire extinguishers shall be provided in locations throughout the building in accordance with NFPA Standard No. 10. Extinguishers located in exit corridors shall be recessed.

26. Rooms for patient medical records and archived patient medical records that remain onsite shall be kept in an one (1) hour fire rated enclosure and protected by a sprinkler system, security system and a smoke detection system. Circulating records at nurses station or in active working areas are excluded from this requirement. The records shall be protected against undue destruction from dust, vermin, water, etc. Offsite buildings or freestanding buildings used for storage of archived patient medical records shall be built of noncombustible materials and provide security and smoke detection systems for the records. Records shall be arranged in an accessible manner and stored at least six (6) inches above the floor. Records shall be protected against undue destruction from dust, vermin, water, etc. X-ray film storage are not required to meet the above requirements.

27. Light fixtures shall be provided with protective covers in food reparation, serving areas, and patient care and treatment spaces. Protective light fixture covers are not required in corridors.

28. Minimum distance between patient room windows and adjacent structures shall be thirty (30) feet (new construction only).

29. A panic bar releasing device shall be provided for all required exit doors subject to patient traffic (new construction only).

30. Doors in smoke barrier partitions shall comply with NFPA 101.

31. Poly-styrofoam, styrene, urethane foam, or similar plastic insulation materials shall not be used except for exterior foundation installations which have at least a six (6) inch earth covering, for exterior laminated panels and for fire rated roof, roof/ceiling assemblies.

32. No fireplace shall be permitted.

33. Fire rated roof-ceiling assemblies shall be listed with a nationally recognized laboratory.

34. Mechanical smoke door coordinators shall not be used. Adjustable hydraulic closures or the full length header type shall be used.

35. Corridor partitions, smokestop partitions, horizontal exit partitions, exit enclosures, and fire rated walls required to have protected openings shall be effectively and permanently identified with signs or stenciling in a manner acceptable to the Division. Such identification shall be above any decorative ceiling and in concealed spaces.

B. Finishes.

1. Cubicle curtains and draperies shall be noncombustible or rendered flame retardant and shall pass both the large and small scale tests of NFPA Standard 701 and NFPA 13 when applicable.

2. Flame spread, fuel contributed, smoke density, and critical radiant flux of finishes shall comply with NFPA 101.

3. Floors in areas and rooms in which anesthetic agents are stored or dministered to patients shall comply with NFPA Standard 99. Conductive flooring may be omitted in anesthetizing areas where a written resolution is signed by the hospital board stating that no flammable anesthetic agents shall be used and appropriate notices are permanently and conspicuously affixed to the wall in each such area and room.

4. Floor materials shall be easily cleanable and have wear resistance appropriate for the location involved. Floors in areas used for food preparation or food assembly shall be water resistant and grease-proof. Joints in tile and similar material in such areas shall be resistant to food acids. In all areas frequently subject to wet cleaning methods, floor-materials shall not be physically affected by germicidal and cleaning solutions. Floors that are subject to traffic while wet (such as shower and bath areas, kitchens, and similar work areas) shall have a non-slip surface. Any facility designed to install carpet shall have prior approval from the Arkansas Department of Health. The prior approval in part shall be contingent upon submission of a laboratory test report from an approved independent laboratory indicating that the proposed carpet meets or exceeds the requirements listed in NFPA 101 and agreement by the Department as to the specific areas in which carpet is to be used. In all carpet installations no rubber backings or rubber padding shall be permitted except in cases where the carpet and backing are tested as an integral component and the integral component meets the requirements listed in NFPA 101. Carpet shall not be allowed in the following areas or rooms: operating rooms, delivery rooms, emergency rooms, intensive care units, nursery, recovery, kitchens, laboratories, LDR and LDRP rooms, clean and soiled holding/workrooms, and isolation rooms. Operating rooms shall have a seamless floor.

5. Wall bases in kitchens, operating rooms, soiled workrooms, and other areas which are frequently subject to wet cleaning methods shall be made integral and coved with the floor, tightly sealed within the wall, and constructed without voids that can harbor insects.

6. Wall finishes shall be washable. In the vicinity of plumbing fixtures, shall be smooth and water resistant.

7. Floors and walls penetrated by pipes, ducts, and conduits shall be tightly sealed to minimize entry of rodents and insects.

8. Ceilings in food-preparation and storage areas, shall be cleanable with routine housekeeping equipment.

9. Operating rooms, trauma rooms, delivery rooms for Caesarean sections, and protective isolation rooms shall have ceilings with a smooth finish plaster or gypsum board surface with a minimum of fissures equipped with access panels where needed.

10. In psychiatric patient rooms, toilets, and seclusion rooms, ceiling construction shall be smooth finish plaster or gypsum board surface with a minimum of fissures. Ceiling-mounted air and lighting devices shall be security type. Ceiling-mounted sprinkler heads shall be of the concealed type.

11. Ceilings shall be cleanable and in the following areas shall be washable, waterproof, smooth finish plaster or gypsum board or vinyl faced acoustic panels: cardiac cath labs, surgical suite corridors, delivery suite corridors, central sterilization suite, autopsy rooms, bacteriology, mycology, media preparation rooms, glass washing rooms located in the labs, soiled holding rooms, soiled and clean utility rooms, emergency suite-treatment rooms and trauma rooms.

12. Finished ceilings may be omitted in mechanical, electrical, equipment spaces and shops.

13. Finished ceilings shall be provided for corridors in patient areas.

14. Sound sensitive areas such as neonatal intensive care may have special floor and ceiling treatments.

SECTION 73: PHYSICAL FACILITIES, CONSTRUCTION, INCLUDING FIRE RESISTIVE REQUIREMENTS.

A. Design. Every building and every portion thereof shall be designed and constructed to sustain all dead and live loads in accordance with American Society of Civil Engineers, (ASCE), "Minimum Design Loads for Buildings and Other Structures."

B. Foundations. Foundations shall rest on natural solid bearing if a satisfactory bearing is available at reasonable depths. Proper soil-bearing values shall be established in accordance with recognized standards. If solid bearing is not encountered at practical depths, the structure shall be supported on drive piles or drilled piers designed to support the intended load without detrimental settlement, except that one (1) story buildings may rest on a fill designed by a soils engineer. When engineered fill is used, site preparation and placement of fill shall be performed under the direct full-time supervision of the soils engineer. The soils engineer shall issue a final report on the compacted fill operation and certification of compliance with the job specifications. All footings shall extend to a depth not less than one (1) foot below the estimated maximum frost line.

C. Construction.

1. Construction shall comply with the applicable requirements of NFPA 101, and the Arkansas Fire Protection Code Volumes I and II and Arkansas State Building Services, Minimum Standards and Criteria - Accessibility for the Physically Disabled Standards.

NOTE: NFPA 101 generally covers fire/safety requirements only, whereas most model codes also apply to structural elements. The fire/safety items of NFPA 101 would take precedence over other codes in case of conflict. Appropriate application of each would minimize problems. For example, some model codes require closers on all patient doors. NFPA 101 recognizes the potential fire/safety problems of this requirement and stipulates that if closers are used for patient room doors, smoke detectors shall also be provided within each affected patient room.

2. For renovation projects, the extent of new construction shall be determined by the licensing agency. Construction shall comply with applicable requirements of NFPA 101.

D. Free-standing Buildings (For Patient Use). Buildings of this element category are considered to be greater than thirty (30) feet from the hospital or separated from the hospital by two (2) hour fire resistance rated construction. Buildings housing non-sleeping patient areas shall comply with NFPA 101.

E. Free-standing Buildings. Separate free-standing buildings over thirty (30) feet from an inpatient facility housing the boiler plant, laundry, shops, or general storage shall be built in accordance with applicable building codes for such occupancy.

F. Interior Finishes. Interior finish materials shall comply with the limitations as indicated in NFPA 101. If a separate underlayment is used with any floor finish materials, the underlayment and the finish material shall be tested as a unit. Tests shall be performed by an approved independent testing laboratory.

G. Insulation Materials. Building insulation materials, unless sealed on all sides and edges, shall have a flame spread rating of twenty-five (25) or less and a smoke developed rating of one hundred fifty (150) or less when tested in accordance with NFPA 255.

H. Flood Protection. Executive Order No 11296 was issued to minimize financial loss from flood damage to facilities constructed with federal assistance. In accordance with that order, possible flood effects shall be considered when selecting and developing the site. Insofar as possible, new facilities shall not be located on designated flood plains. Where this is unavoidable, consult with the Corps of Engineers regional office for the latest applicable regulations pertaining to flood insurance and protection measures that may be required.

I. Elevators. All hospitals having patient facilities (such as bedrooms, dining rooms, or recreation areas) or critical services (such as operating, delivery, diagnostic, or therapeutic) located on other than the grade-level entrance floor shall have electric or hydraulic elevators. Installation and testing of elevators shall comply with ANSI/ASME A17.1 for new construction and ANSI/ASME A17.3 for existing facilities. (See ASCE 7-93 for seismic design and control systems requirements for elevators.)

1. In the absence of an engineered traffic study the following guidelines for number of elevators shall apply:

a. At least one (1) hospital-type elevator shall be installed when one (1) to fifty-nine (59) patient beds are located on any floor other than the main entrance floor.

b. At least two (2) hospital-type elevators shall be installed when sixty (60) to two-hundred (200) patient beds are located on floors other than the main entrance floor, or where the major inpatient serves are located on a floor other than those containing patient beds. (Elevator service may be reduced for those floors providing only partial inpatient services.)

c. At least three (3) hospital-type elevators shall be installed where two-hundred-one (201) to three-hundred-fifty (350) patent beds are located on floors other than the main entrance floor, or where the major inpatient services are located on a floor other than those containing patient beds. (Elevator service may be reduced for those floors which provide only partial inpatient services.)

d. For hospitals with more than three-hundred-fifty (350) beds, the number of elevators shall be determined from a study of the hospital plan and the expected vertical transportation requirements.

2. Hospital-type elevator cars shall have inside dimensions that accommodate a patient bed with attendants. Cars shall be at least five (5) feet eight (8) inches wide by nine (9) feet deep. Car doors shall have a clear opening of not less than four (4) feet wide and seven (7) feet high. In renovations, existing elevators that can accommodate patient beds used in the facility will not be required to be increased in size.

NOTE: Additional elevators installed for visitors and material handling may be smaller than noted above, within restrictions set by standards for disabled access.

3. Elevators shall be equipped with a two (2) way automatic level-maintaining device with an accuracy of ± one-fourth (1/4) inch.

4. Each elevator, except those for material handling, shall be equipped with an independent keyed switch for staff use for bypassing all landing button calls and responding to car button calls only.

5. Elevator call buttons and controls shall not be activated by heat or smoke. Light beams, if used for operating door reopening devices without touch, shall be used in combination with door-edge safety devices and shall be interconnected with a system of smoke detectors. This is so the light control feature will be overridden or disengaged should it encounter smoke at any landing.

6. Field inspections and tests shall be made and the owner shall be furnished with written certification stating the installation meets the requirements set forth in this section as well as all applicable safety regulations and codes.

SECTION 74: PHYSICAL FACILITIES, MECHANICAL REQUIREMENTS.

A. General.

1. All mechanical systems shall be designed and installed in accordance with the requirements of the latest edition of the Arkansas State Mechanical Code. Prior to completion and acceptance of the facility, all mechanical systems shall be tested, balanced, and operated to demonstrate to the owner or his representative the installation and performance of these systems conform to the requirements of the plans and specifications. A test and balance report, done by an independent contractor when required by the licensing agency, shall be submitted along with approval of the test and balance report by the engineer of record. The test and balance report shall be based on ASHRAE Systems Guide Standards, and a copy of the final report shall be on file at the facility.

2. Upon completion of the contract, the owner shall be furnished with a complete set of manufacturers' operating, maintenance instructions, and parts list with numbers and description of each piece of equipment. The owner shall also be provided with inservice instruction in the operational use of systems and equipment as required.

3. Mechanical equipment, ductwork, and piping shall be mounted on vibration isolators as required to prevent unacceptable structure-borne vibration.

4. Supply and return mains and risers for cooling, heating, and steam systems shall be equipped with valves to isolate the various sections of each system. Each piece of equipment shall have valves at the supply and return ends.

B. Thermal and Acoustical Insulation.

1. Insulation within the building shall be provided to conserve energy, protect personnel, prevent vapor condensation, and reduce noise.

2. Insulation on cold surfaces shall include an exterior vapor barrier. (Material that will not absorb or transmit moisture will not require a separate vapor barrier.)

3. Insulation, including finishes and adhesives on the exterior surfaces of ducts, piping, and equipment, shall have a flame-spread rating of twenty-five (25) or less and a smoke-developed rating of fifty (50) or less as determined by an independent testing laboratory in accordance with NFPA 255.

4. Interior duct linings shall not be used. This requirement shall not apply to mixing boxes and acoustical traps that have special coverings over such linings.

5. Existing accessible insulation within areas of facilities to be modernized shall be inspected, repaired, and/or replaced, as appropriate.

C. Steam and Hot Water Systems and Pressure Vessels.

1. All pressure vessels shall have the ASME seal and shall meet the requirements of the Arkansas Boiler Inspector, Arkansas Department of Labor.

2. Boilers. Boilers shall have the capacity, based upon the net ratings published by the Hydronics Institute or another acceptable national standard, to supply the normal requirements of all systems and equipment. The number and arrangement of boilers shall be such that, when one (1) boiler breaks down or routine maintenance requires that one (1) boiler be temporarily taken out of service, the capacity of the remaining boiler(s) shall be sufficient to provide hot water service for clinical, dietary, and patient use; steam for sterilization and dietary purposes; and heating for operating, delivery, birthing (including LDR/LDRP), labor, recovery, intensive care, nursery, and general patient rooms. However, reserve capacity for facility space heating is not required in geographic areas where a design dry-bulb temperature of twenty-five (25) degrees Fahrenheit or more represents not less than ninety-nine (99) percent of the total hours in any one (1) heating month as noted in ASHRAE's Handbook of Fundamentals, under the "Table for Climatic Conditions for the United States." Boilers shall be designed for a standby fuel and onsite standby fuel shall be provided with a minimum two (2) day capacity.

3. Boiler Accessories. Boiler feed pumps, heating circulating pumps, condensate return pumps, and fuel oil pumps shall be connected and installed to provide normal and standby service.

4. Valves. Supply and return mains and risers of cooling, heating, and process steam systems shall be valved to isolate the various sections of each system. Each piece of equipment shall be valved at the supply and return ends.

D. Air Conditioning, Heating and Ventilating Systems.

1. All rooms and areas in the facility used for patient care shall have provisions for ventilation. The ventilation rates shown in Table 4 shall be used only as minimum standards; they do not preclude the use of higher, more appropriate rates. Though natural window ventilation for nonsensitive areas and patient rooms may be employed, weather permitting, availability of mechanical ventilation should be considered for use in interior areas and during periods of temperature extremes.

2. Fans serving exhaust systems shall be located at the discharge end and shall be readily serviceable. Air supply and exhaust in rooms for which no minimum total air change rate is noted may vary down to zero in response to room load. For rooms listed in Table 4 of the Appendix where VAV systems are used, minimum total air change shall be within limits noted. Temperature control shall also comply with these standards. To maintain asepsis control, airflow supply and exhaust should generally be controlled to ensure movement of air from "clean" to "less clean" areas, especially in critical areas. The ventilation systems shall be designed and balanced according to the requirements shown in Table 5 of the Appendix and in the applicable notes.

3. Exhaust systems may be combined to enhance the efficiency of recovery devices required for energy conservation. Local exhaust systems shall be used whenever possible in place of dilution ventilation to reduce exposure to hazardous gases, vapors, fumes, or mists.

4. Fresh air intakes shall be located at least twenty-five (25) feet from exhaust outlets of ventilating systems, combustion equipment stacks, medical-surgical vacuum systems, plumbing vents, or areas that may collect vehicular exhaust or other noxious fumes. Plumbing and vacuum vents that terminate at a level above the top of the air intake may be located as close as ten (10) feet. The bottom of outdoor air intakes serving central systems shall be as high as practical, but at least six (6) feet above ground level, or, if installed above the roof, three (3) feet above roof level. Exhaust outlets from areas that may be contaminated shall be above roof level and arranged to minimize recirculation of exhaust air into the building.

5. In new construction and major renovation work, air supply for operating and delivery rooms shall be from ceiling outlets near the center of the work area. Return air shall be near the floor level. Each operating and delivery room shall have at least two (2) return-air inlets located as remotely from each other as practical. Where extraordinary procedures, such as organ transplants, justify special designs, installation shall properly meet performance needs as determined by applicable standards. These special designs should be reviewed on a case-by-case basis.

6. In new construction and major renovation work, air supply for autopsy rooms, cardiac cath labs, cystoscopic rooms, trauma rooms, endoscopy rooms, bronchoscopy rooms, and/or rooms where anesthesia gases are used shall be from ceiling outlets near the center of the room and/or work area. Return or exhaust air inlets shall be near the floor level. Exhaust grills for anesthesia evacuation and other special applications shall be permitted to be installed in the ceiling.

7. Each space routinely used for administering inhalation anesthesia and inhalation analgesia shall be served by a scavenging system to vent waste gases. If a vacuum system is used, the gas-collecting system shall be arranged so that it does not disturb patients' respiratory systems. Gases from the scavenging system shall be exhausted directly to the outside. The anesthesia evacuation system may be combined with the room exhaust system, provided the part used for anesthesia gas scavenging exhausts directly to the outside and is not part of the recirculation system. Scavenging systems are not equired for areas where gases are used only occasionally, such as the emergency room, offices for routine dental work, etc.

8. The bottoms of ventilation openings shall be at least three (3) inches above the floor.

9. The space above ceilings in new construction shall not be used as plenum space to supply to, return air from, or to exhaust air from any patient room, operating room, trauma room, critical care room, delivery room, endoscopy room, cardiac cath lab, bronchoscopy room, autopsy room, exam room, treatment room, airborne infection isolation room, protective environment room, radiology suite, laboratory suite, soiled workroom, soiled holding, physical therapy and hydrotherapy, ETO-sterilizer room, sterilizer equipment room, and central medical and surgical supply areas or rooms. Plenum return air space conforming to NFPA 90A requirements shall be acceptable in areas where it is not listed above.

10. Direct gas-fired space heating equipment shall not be used in new construction. (Products of combustion exposed to air stream.)

11. All central ventilation or air conditioning systems shall be equipped with filters with efficiencies equal to, or greater than, those specified in Table 1 of the Appendix. Where two (2) filter beds are required, filter bed number one (1) shall be located upstream of the air conditioning equipment and filter bed number two (2) shall be downstream of any fan or blowers. Filter efficiencies, tested in accordance with ASHRAE 52-92, shall be average. Filter frames shall be durable and proportioned to provide an airtight fit with the enclosing ductwork. All joints between filter segments and enclosing ductwork shall have gaskets or seals to provide a positive seal against air leakage. A manometer or equal equivalent method of monitoring high and low pressure drop shall be installed across each flter bed having a required efficiency of ninety (90) percent or more including hoods requiring HEPA filters.

12. If duct humidifiers are located upstream of the final filters, they shall be located at least fifteen (15) feet upstream of the final filters. Ductwork with duct-mounted humidifiers shall have a means of water removal. An adjustable high-limit humidistat shall be located downstream of the humidifier to reduce the potential of condensation inside the duct. All duct take-offs should be sufficiently downstream of the humidifier to ensure complete moisture absorption. Steam humidifiers shall be used. Reservoir-type water spray or evaporative pan humidifiers shall not be used.

13. Air-handling duct systems shall be designed with accessibility for duct cleaning, and shall meet the requirements of NFPA 90A.

14. Ducts that penetrate construction intended to protect against X-ray, MRI, or other radiation shall not impair the effectiveness of the protection.

15. Fire and smoke dampers shall be constructed, located, and installed in accordance with the requirements of NFPA 101, 90A, and the specific damper's listing requirements. Fans, dampers, and detectors shall be interconnected so that damper activation will not damaged ducts. Maintenance access shall be provided at all dampers. All damper locations should be shown on design drawings. Dampers should be activated by fire or smoke sensors, not by fan cutoff alone. Switching systems for restarting fans may be installed for fire partment use in venting smoke after a fire has been controlled. However, provisions should be made to avoid possible damage to the system due to closed dampers. When smoke partitions are required, heating, ventilation, and air conditioning zones shall be coordinated with compartmentation insofar as practical to minimize need to penetrate fire and smoke partitions.

16. Hoods and safety cabinets may be used for normal exhaust of a space provided that minimum air change rates are maintained. If air change standards in Table 4 of the Appendix do not provide sufficient air for proper operation of exhaust hoods and safety cabinets (when in use), supplementary makeup air (filtered and preheated) shall be provided around these units to maintain the required airflow direction and exhaust velocity. Use of makeup air will avoid dependence upon infiltration from outdoor and/or from contaminated areas. Makeup systems for hoods shall be arranged to minimize "short circuiting" of air and to avoid reduction in air velocity at the point of contaminant capture.

17. Laboratory hoods shall meet the following general standards:

a. Have an average face velocity of at least seventy-five (75) feet per minute.

b. Be connected to an exhaust system to the outside which is separate from the building exhaust system.

c. Have an exhaust fan located at the discharge end of the system.

d. Have an exhaust duct system of noncombustible corrosion-resistant material as needed to meet the planned usage of the hood.

18. Laboratory hoods shall meet the following special standards:

a. Fume hoods, and their associated equipment in the air stream, intended for use with perchloric acid and other strong oxidants, shall be constructed of stainless steel or other material consistent with special exposures, and be provided with a water wash and drain system to permit periodic flushing of duct and hood. Electrical equipment intended for installation within such ducts shall be designed and constructed to resist penetration by water. Lubricants and seals shall not contain organic materials. When perchloric acid or other strong oxidants are only transferred from one (1) container to another, standard laboratory fume hoods and the associated equipment may be used in lieu of stainless steel construction.

b. In new construction and major renovation work, each hood used to process infectious or radioactive materials shall have a minimum face velocity of ninety (90) to one-hundred-ten (110) feet per minute with suitable pressure-independent air modulating devices and alarms to alert staff of fan shutdown or loss of airflow. Each shall also have filters with 99.97 percent efficiency (based on dioctyl-phthalate (DOP) test method) in the exhaust tream, and be designed and equipped to permit the safe removal, disposal, and replacement of contaminated filters. Filters shall be as close to the hood as practical to minimize duct contamination. Fume hoods intended for use with radioactive isotopes shall be constructed of stainless steel or other material suitable for the particular exposure and shall comply with NFPA 801, Facilities for Handling Radioactive Materials. Note: Radioactive isotopes used for injections, etc. without probability of airborne particulates or gases may be processed in a clean-workbench-type hood where acceptable to the Nuclear Regulatory Commission.

19. Exhaust hoods handling grease-laden vapors in food preparation enters shall comply with NFPA 96. All hoods over cooking ranges shall be equipped with grease filters, fire extinguishing systems, and heat-actuated fan controls. Cleanout openings shall be provided every twenty (20) feet and at changes in direction in the horizontal exhaust duct systems serving these hoods. (Horizontal runs of ducts serving range hoods should be kept to a minimum.

20. The ventilation system for anesthesia storage rooms shall conform to the requirements of NFPA 99, including the gravity option. Mechanically operated air systems are optional in this room.

21. The ventilation system for the space that houses ethylene oxide (ETO) sterilizers should be designed to:

a. Provide a dedicated (not connected to a return air or other exhaust system) exhaust system. Refer to 29 CFR Part 1910.1047.

b. All source areas shall be exhausted, including the sterilizer equipment room, service/aeration areas, over the sterilizer door, and the aerator. If the ETO cylinders are not located in a well-ventilated, unoccupied equipment space, an exhaust hood shall be provided over the cylinders. The relief valve shall be terminated in a well-ventilated, unoccupied equipment space, or outside the building. If the floor drain which the sterilizer(s) discharges to is not located in a well-ventilated, unoccupied equipment space, an exhaust drain cap shall be provided (coordinate with local codes).

c. Ensure that general airflow is away from sterilizer operator(s).

d. Provide a dedicated exhaust duct system for ETO. The exhaust outlet to the atmosphere should be at least twenty-five (25) feet away from any air intake.

22. An audible and visual alarm shall activate in the sterilizer work area, and a twenty-four (24) hour staffed location, upon loss of airflow in the exhaust system.

23. Rooms with fuel-fired equipment shall be provided with sufficient outdoor air to maintain equipment combustion rates and to limit workstation temperatures.

24. Gravity exhaust may be used, where conditions permit, for nonpatient areas such as boiler rooms, central storage, etc.

25. The energy-saving potential of variable air volume systems is recognized and these standard herein are intended to maximize appropriate use of that system. Any system utilized for occupied areas shall include provisions to avoid air stagnation in interior spaces where thermostat demands are met by temperatures of surrounding areas.

26. Special consideration shall be given to the type of heating and cooling units, ventilation outlets, and appurtenances installed in patient-occupied areas of psychiatric units. The following shall apply:

a. All air grilles and diffusers shall be of a type that prohibits the insertion of foreign objects. All exposed fasteners shall be tamper-resistant.

b. All convector or HVAC enclosures exposed in the room shall be constructed with round corners and shall have enclosures fastened with tamper-resistant screws.

c. HVAC equipment shall be of a type that minimizes the need for maintenance with the room.

27. Rooms or booths used for sputum induction, aerosolized pentamidine treatments, and other high-risk cough-inducing procedures shall be provided with local exhaust ventilation. See Table 4 of the Appendix for ventilation requirements.

28. Non-central air handling systems, i.e., individual room units that are used for heating and cooling purposes (fan-coil units, heat pump units, etc.) shall be equipped with permanent (cleanable) or replaceable filters. The filters shall have a minimum efficiency of sixty-eight (68) percent weight arrestance. These units may be used as recirculating units only. All outdoor air requirements shall be met by a separate central air handling system with the proper filtration, as noted in Table 4 of the Appendix.

SECTION 75: PHYSICAL FACILITIES, PLUMBING AND OTHER PIPING SYSTEMS. All plumbing systems shall be designed and installed in accordance with the requirements of the latest edition of the Arkansas State Plumbing Code and Laws, Rules, and Regulations Governing Boiler Inspection, Arkansas Department of Labor. Only metal piping or piping material of a type approved by the Arkansas Department of Health for corrosive wastes, etc., shall be permitted.

A. Plumbing Fixtures.

1. The material used for plumbing fixtures shall be nonabsorbent acid-resistant material.

2. The water supply spout for lavatories and sinks required in patient care areas (except patient rooms) shall be mounted so that the discharge point is a minimum distance of five (5) inches above the rim of the fixture.

3. All fixtures used by medical and nursing staff and all lavatories used by patients and food handlers shall be trimmed with valves which can be operated without the use of hands. Where blade handles are used for this purpose, they shall not exceed four and one-half (4 1/2) inches in length, except that handles on clinical sinks shall be not less than six (6) inches long. (Automatic controls are acceptable.) Scrub sinks shall be trimmed with foot, knee or ultrasonic controls.

4. Clinical sinks shall have an integral trap in which the upper portion of the water trap provides a visible seal.

5. Shower bases and tubs shall provide non-slip walking surfaces.

B. Water Supply Systems.

1. Systems shall be designed to supply water at sufficient pressure to operate all fixtures and equipment during maximum demand periods.

2. Each water service main, branch main, riser, and branch to a group of fixtures shall be valved. Stop valves shall be provided at each fixture. Appropriate panels for access shall be provided at all valves where required.

3. Backflow preventers (vacuum breakers) shall be installed on hose bibs, laboratory sinks, janitors' sinks, bedpan flushing attachments, autopsy tables, and on all other fixtures to which hoses or tubing can be attached.

4. Bedpan flushing devices shall be provided in each inpatient toilet room. Installation is optional in psychiatric and alcohol-abuse units where patients are ambulatory.

5. The following standards shall apply to hot water systems:

a. The water-heating system shall have sufficient supply capacity at the temperatures and amounts indicated in Table 9 of the Appendix. Water temperature is measured at the point of use or inlet to the equipment.

b. Hot-water distribution systems serving patient care areas shall be under constant recirculation to provide continuous hot water at each hot water outlet. The temperature of hot water for showers and bathing shall be appropriate for safe and comfortable use. (See table 9 of the Appendix)

6. Water distribution systems shall be arranged to provide hot water at each hot water outlet at all times. (See table 9 of the Appendix)

7. Water closets in patient spaces shall be quiet action type. Reservoir tank flushing devices shall be acceptable only if available water pressure is not sufficient to operate flush valves as mentioned above.

C. Drainage Systems. The following standards shall apply to drainage systems:

1. Drain lines used for acid waste disposal shall be made of acid-resistant material.

2. Drain lines serving some types of automatic blood-cell counters must be of carefully selected material that will eliminate potential for undesirable chemical reactions (and/or explosions) between sodium oxide wastes and copper, lead, brass, and solder, etc.

3. Insofar as possible, drainage piping shall not be installed within the ceiling or exposed in operating and delivery rooms, nurseries, food preparation centers, food serving facilities, food storage areas, central services, electronic data processing areas, electric closets, and other sensitive areas. Where exposed overhead drain piping in these areas is unavoidable, special provisions shall be made to protect the space below from leakage, condensation, or dust particles.

4. Floor drains shall not be installed in operating and delivery rooms.

5. If a floor drain is installed in cystoscopy, it shall contain a nonsplash, horizontal-flow flushing bowl beneath the drain plate.

6. Drain systems for autopsy tables shall be designed to positively avoid splatter or overflow onto floors or back siphonage and for easy cleaning and trap flushing.

7. Building sewers shall discharge into community sewage. Where such a system is not available, the facility shall treat sewage in accordance with local and state regulations.

8. Kitchen grease traps shall be located and arranged to permit easy access without the need to enter food preparation or storage areas. Grease traps shall be of capacity required and shall be accessible from outside of the building without need to interrupt any services.

9. Where plaster traps are used, provisions shall be made for appropriate access and cleaning.

10. In dietary areas, floor drains and/or floor sinks shall be of a type that can be easily cleaned by removal of cover. Provide floor drains or floor sinks at all "wet equipment" (i.e., ice machines) and as required for wet cleaning of floors. Provide removable stainless steel mesh in addition to grilled drain cover to prevent entry of large particles of waste which might cause stoppages. Location of floor drains and floor sinks shall be coordinated to avoid conditions where locations of equipment make removal of covers for cleaning difficult.

D. The installation, testing, and certification of nonflammable medical gas and air systems shall comply with the requirements of NFPA 99. A level one (1) piped medical gas and air system is required. (See Table 4 of the Appendix for rooms that require station outlets.)

E. A complete level one (1) piped clinical vacuum system is required. (See Table 4 of the Appendix for rooms that require station outlets.)

F. All piping, except control-line tubing, shall be identified. All valves shall be tagged, and a valve schedule shall be provided to the facility owner for permanent record and reference.

G. When the narrative program includes hemodialysis, continuously circulated filtered cold water shall be provided.

H. Provide condensate drains for cooling coils of a type that may be cleaned as needed without disassembly. (Unless specifically required by local authorities, traps are not required for condensate drains.) Provide air gap where condensate drains empty into floor drains. Provide heater elements for condensate lines in freezer or other areas where freezing may be a problem.

I. No plumbing lines may be exposed overhead or on walls where possible accumulation of dust or soil may create a cleaning problem or where leaks would create a potential for food contamination.

SECTION 76: PHYSICAL ENVIRONMENT, ELECTRICAL STANDARDS.

A. General.

1. All electrical material and equipment, including conductors, controls, and signaling devices, shall be installed in compliance with and maintained per applicable sections of NFPA 70 and NFPA 99 and shall be listed as complying with available standards of listing agencies, or other similar established standards where such standards are required.

2. The electrical installations, including alarm, nurse call, and communication systems, shall be tested to demonstrate that equipment installation and operation is appropriate and functional. A written record of performance tests on special electrical systems and equipment shall show compliance with applicable codes and standards.

3. Shielded isolation transformers, voltage regulators, filters, surge suppressors, and other safeguards shall be provided as required where power line disturbances are likely to affect data processing and/or automated laboratory or diagnostic equipment.

B. Services and Switchboards. Main switchboards shall be located in an area separate from plumbing and mechanical equipment and shall be accessible to authorized persons only. Switchboards shall be convenient for use, readily accessible for maintenance, away from traffic lanes, and located in dry, ventilated spaces free of corrosive or explosive fumes, gases, or any flammable material. Overload protective devices shall operate properly in ambient room temperatures.

C. Panelboards. Panelboards serving normal lighting and appliance circuits shall be located on the same floor as the circuits they serve. Panelboards serving critical branch emergency circuits shall be located on each floor that has major users (operating rooms, delivery suites, intensive care, etc.). Panelboards serving Life Safety emergency circuits may also serve floors above and/or below.

D. Lighting.

1. The Illuminating Engineering Society of North America (IES) has developed recommended lighting levels for health care facilities. The reader should refer to the IES Handbook.

2. Approaches to buildings and parking lots, and all occupied spaces within buildings shall have fixtures that can be illuminated as necessary.

3. Patient rooms shall have general lighting and night lighting. A reading light shall be provided for each patient. Reading light controls shall be readily accessible to the patient(s). Incandescent and halogen light sources which produce heat shall be avoided to prevent burns to the patient and/or bed linen. The light source should be covered by a diffuser or lens. Flexible light arms, if used, shall be mechanically controlled to prevent the lamp from contacting the bed linen. At least one (1) night light fixture in each patient room shall be controlled at the room entrance. Lighting for coronary and intensive care bed areas shall permit staff observation of the patient while minimizing glare.

4. Operating and delivery rooms shall have general lighting in addition to special lighting units provided at surgical and obstetrical tables. General lighting and special lighting shall be on separate circuits.

5. Nursing unit corridors shall have general illumination with provisions for reducing light levels at night.

6. Light intensity for staff and patient needs should generally comply with health care guidelines set forth in the IES publication. Excessive contrast in lighting levels that make effective sight adaption difficult shall be minimized.

Many procedures are available to satisfy lighting requirements, but the design should consider light quality as well as quantity for effectiveness and efficiency.

7. An examination light shall be provided for examination, treatment, and trauma rooms.

8. Light intensity of required emergency lighting shall follow IES guidelines. Egress and exit lighting shall comply with NFPA 101.

9. All down directed incandescent light fixtures shall have lens covers.

E. Receptacles.

1. Each operating and delivery room shall have at least six (6) receptacles convenient to the head of the procedure table. Each operating room shall have at least sixteen (16) simplex or eight duplex receptacles. Where mobile X-ray, laser, or other equipment requiring special electrical configurations is used, additional receptacles distinctively marked for X-ray or laser use shall be provided.

2. Each patient room shall have duplex-grounded receptacles. There shall be one (1) at each side of the head of each bed; one (1) for television, if used; and one (1) on every other wall. Receptacles may be omitted from exterior walls where construction or room configuration makes installation impractical. Nurseries shall have at least two (2) duplex-grounded receptacles for each bassinet. Critical care areas as defined by NFPA 99 and NFPA 70, including pediatric and newborn intensive care units, shall have at least seven (7) duplex outlets at the head of each bed, crib, or bassinet. Trauma and resuscitation rooms shall have eight (8) duplex outlets located convenient to the head of each bed. Emergency department examination and treatment rooms shall have a minimum of six (6) duplex outlets located convenient to the head of each bed. Approximately fifty (50) percent of critical and emergency care outlets shall be connected to emergency system power and be so labelled. Each general care examination and treatment table and each work table shall have access to two (2) duplex receptacles.

3. Duplex-grounded receptacles (on emergency power) for general use shall be installed approximately fifty (50) feet apart in all corridors and within twenty-five (25) feet of corridor ends. Receptacles in pediatric and psychiatric unit corridors shall be of the tamper resistant type. Special receptacles marked for X-ray use shall be installed in corridors of patient areas so that mobile equipment may be used anywhere within a patient room using a cord length of fifty (50) feet or less. If the same mobile X-ray unit is used in operating rooms and in nursing areas, receptacles for X-ray use shall permit the use of one (1) plug in all locations. Where capacitive discharge or battery-powered X-ray units are used, special X-ray receptacles are not required.

4. Electrical receptacle cover plates or electrical receptacles supplied from the emergency systems shall be distinctively colored or marked for identification. If color is used for identification purposes, the same color shall be used throughout the facility.

5. For renal dialysis units, two (2) duplex receptacles shall be on each side of a patient bed or lounge chair. One (1) duplex receptacle on each side of the bed shall be connected to emergency power.

6. Receptacles located in patient care areas shall be hospital grade.

F. Equipment.

1. At inhalation anesthetizing locations, all electrical equipment and devices, receptacles, and wiring shall comply with applicable sections of NFPA 99 and NFPA 70.

2. Fixed and mobile X-ray equipment installations shall conform to articles 517 and 660 of NFPA 70.

3. The X-ray film illuminator unit or units for displaying at least tw(2) films simultaneously shall be installed in each operating room, specified emergency treatment rooms, and X-ray viewing room of the radiology department. All illuminator units within one (1) space or room shall have lighting of uniform intensity and color value.

4. Ground-fault circuit interrupters (GFCI) shall comply with NFPA 70. When ground-fault circuit interrupters are used in critical areas, provisions shall be made to ensure the other essential equipment is not affected by activation of one (1) interrupter.

5. In areas such as critical care units and special nurseries where a patient may be treated with an internal probe or catheter connected to the heart, the ground system shall comply with applicable sections of NFPA 99 and NFPA 70.

G. Nurse/Patient Communication Station.

1. In patient areas, each patient room shall be served by at least one (1) nurse/patient communication station for two (2) way voice communication. The signal shall activate an annunciator panel at the nurse station, a visible signal in the corridor at the patient's door, and at other areas defined by the narrative program. Each bed shall be provided with a call device. Two (2) call devices serving adjacent beds may be served on one (1) calling station. Calls shall activate a visible signal in the corridor at the patient's door, in the clean workroom, in the soiled workroom, medication, charting, nourishment, and examination/treatment room(s) and at the nurses' station. In multi-corridor nursing units, additional visible signals shall be installed at corridor intersections. In rooms containing two (2) or more nurse/patient communication stations, indicating lights shall be provided at each station. Nurse/patient communication stations at each calling station shall be equipped with an indicating light which remains lighted as long as the voice circuit is operating.

2. An emergency call system shall be provided at each inpatient/outpatient toilet, bath and shower room. An emergency call shall be accessible to a collapsed patient on the floor. Inclusion of a pull cord will satisfy this standard.

The emergency call shall be designed so that a signal activated at a patient's calling station will initiate a visible and audible signal distinct from the regular nurse/patient communication station that can be turned off only at the patient calling station. The signal shall activate an annunciator panel at the nurse station, a visible signal in the corridor at the patient's door, and at other areas defined by the narrative program. Provisions for emergency calls will also be provided in outpatient and treatment areas where patients are subject to incapacitation.

3. In areas such as critical care, recovery and pre-op, where patients are under constant visual surveillance, the nurse/patient communication call may be limited to a bedside button or station that activates a signal readily seen at the control station.

4. An emergency notification system (code blue) for staff to summon additional assistance shall be provided in each operating, delivery, recovery, emergency examination and/or treatment area, and in critical care units, nurseries, special procedure rooms, cardiac catheterization rooms, stress-test areas, triage, outpatient surgery admission and discharge areas, and areas for psychiatric patients including seclusion and security rooms, anterooms and toilet rooms serving them, communal toilet and bathing facility rooms, and dining, activity, therapy, exam and treatment rooms. This system shall annunciate audibly or visually in the clean work room, in the soiled work room, medication, charting, nourishment, and examination/treatment room(s) if provided and at the administrative center of the nursing unit with back up to another staffed area from which assistance can be summoned.

5. A nurse/patient communication station is not required in psychiatric nursing units, but if it is included, provisions shall be made for easy removal, or for covering call button outlets. In psychiatric nursing units all hardware shall have tamper-resistant fasteners.

H. Emergency power shall be provided in accordance with NFPA 99, NFPA 101, and NFPA 110.

I. Emergency electrical generators shall have a minimum forty-eight (48) hours of on-site fuel.

J. All health care occupancies shall be provided with a fire alarm system in accordance with NFPA 101 and NFPA 72.

K. Telecommunications and Information Systems.

1. Locations for terminating telecommunications and information system devices shall be provided.

2. A room shall be provided for telecommunications and information systems. Special air conditioning and voltage regulations shall be provided when recommended by the manufacturer.

SECTION 77: PHYSICAL FACILITIES, HELICOPTER LANDING AREA. Helicopter landing area (if provided) shall be documented.

A. Safe planning for the helicopter service shall include the following:

1. Plot plan showing the heliport for Department of Health files and inspection; and

2. More than one (1) approach/departure route.

B. Service shall be as close to the emergency service at the hospital as can be accomplished safely. The Department of Health will consider that a helicopter landing area does exist upon repeated or regular use of a location.

C. See NFPA 418 for roof top heliports.

NOTE: If there are wire obstacles, wire markers are available at no charge. They shall be picked up at the Arkansas Department of Aeronautics.

SECTION 78: PHYSICAL FACILITIES, FREESTANDING AMBULATORY SURGERY CENTERS.

A. General Construction Considerations. See Section 47.B, Physical Facilities.

B. Site Location, Inspection, Approval, and Subsoil Investigation. See Section 47. C-G, I, and J, Physical Facilities.

C. Construction Documents. See Section 47.H, Physical Facilities.

D. Codes and Standards. See Section 47.B and K, Physical Facilities.

E. General. Outpatient surgery is performed without anticipation of overnight patient stay. The narrative program shall describe in detail staffing, patient types, hours of operation, function and space relationships, transfer provisions, and availability of offsite services.

Visual and audible privacy shall be provided by design and include the registration, preparation, examination, treatment, and recovery areas.

F. Size. The extent (number and types) of the diagnostic, clinical, and administrative facilities to be provided will be determined by the services contemplated and the estimated patient load as described in the narrative program. Provisions shall be made for patient examination, interview, preparation testing, and obtaining vital signs of patient.

G. Parking. Four (4) spaces for each room routinely used for surgical procedures plus one (1) space for each staff member shall be provided. Additional parking spaces convenient to the entrance for pickup of patients after recovery shall be provided.

H. Administration and Public Areas. The following shall be provided:

1. A covered entrance for pickup of patients after surgery.

2. A lobby area including a waiting area, conveniently accessible wheelchair storage, a reception/information desk, accessible public toilets, public telephone(s), drinking fountain(s).

3. Interview space(s) for private interviews relating to admission, credit, and demographic information gathering.

4. General and individual office(s) for business transactions, records, and administrative and professional staff. These shall be separate from public and patient areas with provisions for confidentiality of records. Enclosed office spaces for administration and consultation shall be provided.

5. Multipurpose or consultation room(s).

6. A medical records room equipped for dictating, recording and retrieval.

7. Special storage, including locking drawers and/or cabinets, for staff personnel effects.

8. General storage facilities (fifty (50) square feet per operating room).

I. Sterilizing Facilities. A system for sterilizing equipment and supplies shall be provided. When sterilization is provided off site, adequate sterile supplies must be provided. If onsite processing facilities are provided, they shall include the following:

1. Soiled Workroom. This room shall be physically separated from all other areas of the department. Work space shall be provided to handle the cleaning and terminal sterilization/disinfection of all medical/surgical instruments and equipment. The soiled workroom shall contain work tables, sinks, flush-type devices, and washer/sterilizer decontaminators or other decontamination equipment. Pass-through doors and washer/sterilizer decontaminators shall deliver into clean assembling areas/workrooms.

2. Clean Assembly/Workroom. This room shall contain sterilization equipment. This workroom shall contain handwashing facilities, work space, and equipment for terminal sterilizing of medical and surgical equipment and supplies. Access to sterilization room shall be restricted.

This room is exclusively for the inspection, assembly, and packaging of medical/surgical supplies and equipment for sterilization and shall contain work tables, counters, ultrasonic cleaning facilities for backup supplies and instrumentation or equipment. The room shall be designed to hold sterilizer carts for loading or prepared supplies for sterilization.

3. Clean/Sterile Storage. Storage for packs, etc., shall include provisions for ventilation, humidity, and temperature control.

J. Clinical Facilities. Provisions shall be made to separate pediatric from adult patients. This shall include pre- and post-operative care areas and shall allow for parental presence.

1. At least one (1) room shall be provided for examination and testing of patients prior to surgery, assuring both visual and audible privacy. This may be an examination room or treatment room, as required by the written narrative for the program..

Each room shall have a minimum floor area of eighty (80) square feet, excluding vestibules, toilets, and closets. Room arrangement shall permit at least two (2) feet eight (8) inches clearance at each side and at the foot of the examination table. A handwashing fixture and a counter or shelf space for writing shall be provided.

2. Treatment room(s) for minor surgical and cast procedures shall have a minimum floor area of one hundred twenty (120) square feet excluding vestibules, toilets, and closets. The minimum room dimension shall be ten (10) feet.

3. Each operating room shall have a minimum clear area of three-hundred-sixty (360) square feet, exclusive of cabinets and shelves, but may be larger to accommodate the narrative plan which requires additional staff and/or equipment. An emergency communication system connected with the surgical suite control station shall be provided. There shall be at least one (1) X-ray film illuminator in each room.

4. Room(s) for post-anesthesia recovery shall be provided as required by volume and procedure type (two (2) per operating room is the minimum). At least three (3) feet shall be provided at each side and at the foot of each bed as needed for work and/or circulation. If pediatric surgery is part of the program, separation from the adult section and space for parents shall be provided. Soundproofing of the area and the ability to view the patient from the nursing station shall be considered. Bedpans shall be supplied in this area.

5. A supervised post-recovery area shall be provided for patients who do not require post-anesthesia recovery but need recovery time prior to leaving the facility.

6. The following services shall be provided in surgical service areas:

a. A control station located to permit visual surveillance of all traffic entering the operating suite.

b. A drug distribution station for the storage and preparation of medications to be administered to patients. The station shall include refrigeration for medications, double-locked security for controlled substances and convenient access to handwashing facilities.

c. Scrub facilities shall be located near the entrance to each operating room. Stations may serve two (2) operating rooms if needed, but shall be arranged to minimize incidental splatter on nearby personnel or supply carts.

d. A soiled workroom which includes a clinical sink or equivalent flushing-type fixture, a work counter, a sink for handwashing, and waste receptacle(s).

e. Fluid waste disposal facilities convenient to the general operating rooms. Note: A clinical sink or equivalent equipment in a soiled workroom shall meet this requirement.

f. Anesthesia storage facilities in accordance with NFPA 99.

g. Medical gas supply and storage to include space for reserve nitrous oxide and oxygen cylinders.

h. Storage room(s) for equipment and supplies used in the surgical suite.

i. Appropriate change areas for staff working within the surgical suite. The areas shall include lockers, showers, toilets, lavatories for handwashing, and space for donning scrub attire.

j. A separate patient change area which includes waiting room(s), lockers, toilets, clothing change or gowning area(s), and space for medication administration. The narrative shall include provisions for securing patients' personal effects.

k. A convenient stretcher storage area out of the direct line of traffic.

l. A housekeeping room which includes a floor receptor or service sink and space for housekeeping supplies and equipment. This room shall be for the exclusive use of the surgical suite.

m. Space for temporary storage of wheelchairs.

n. Convenient access to and use of emergency crash carts for both the surgical and recovery areas.

o. An area for the storage and processing of clean and soiled linen. Laundry Services shall conform to Section 68, Physical Facilities, Laundry Service.

K. Diagnostic Facilities. Diagnostic services shall be provided on or offsite for preadmission tests as required by the narrative program.

L. Details and Finishes. All details and finishes shall meet the standards in Section 72, Physical Facilities, Details and Finishes, with the following exceptions:

1. Details shall conform to the following guidelines:

a. Minimum public corridor width shall be six (6) feet, except that corridors in the operating room section, where patients are transported on stretchers or beds, shall be eight (8) feet wide.

b. Patient toilet rooms shall be equipped with doors and hardware that permit access from the outside in emergencies.

c. Flammable anesthetics shall not be used.

M. Finishes. Finishes shall conform to Section 72, Physical Facilities, Details and Finishes.

N. Plumbing. Plumbing shall conform to Section 75, Physical Facilities, Plumbing and Other Piping Systems.

O. Electrical. Electrical installations shall conform to Section 76, Physical Environment, Electrical Standards, with the following exceptions:

1. Eight (8) hours of on-site fuel for the emergency generator.

2. Emergency call system is required in all patient toilet rooms.

P. Fire Alarm System. A manually operated, electrically supervised fire alarm system shall be installed in each facility as described in NFPA 101.

Q. Mechanical. Mechanical systems shall conform to Section 74, Physical Facilities, Mechanical Requirements, with the exception that stand-by operation requirements shall be eight (8) hours.

R. Extended Recovery Time. See Section 39.M.

SECTION 79: PHYSICAL FACILITIES, OUTPATIENT CARE FACILITIES.

A. General Considerations. See Section 47.B, Physical Facilities.

1. This section applies to the outpatient care unit licensed under the facility as a department and under the rule of the Governing Body. An outpatient care unit can be a part of the facility or a separate freestanding facility. An outpatient unit within the main facility building shall be located so outpatients do not traverse inpatient areas.

2. The general standards set forth in the following sections shall apply to each of the items below.

a. Outpatient psychiatric centers;

b. Primary care outpatient centers; and c. Diagnosis and/or treatment centers.

3. Each element provided in the outpatient care facility shall be expanded in the written narrative program and meet the requirements outlined herein as a minimum.

B. General Construction Considerations. See Section 47.B, Physical Facilities.

C. Site Location, Inspection, Approval and Subsoil Investigation. See Section 47.C-G, I and J, Physical Facilities.

D. Construction Documents. See Section 47.H, Physical Facilities.

E. Codes and Standards. New/existing Outpatient Facilities which do not meet the criteria of the NFPA, Life Safety Code Volume 101 Chapter 12 (new)/13 (existing), Section 12-1.3 (new hospitals and/or ambulatory surgery centers)/13-1.3 (existing hospitals and/or ambulatory surgery centers) will be allowed to be classified as a business occupancy as defined in LSC 101, Chapter 26 (new)/27 (existing) with exceptions noted within these regulations.

F. General Requirements for Outpatient Care Facilities.

1. Narrative Program. See Section 79, Physical Facilities, Outpatient Care Facilities.

2. Patient Privacy. Each facility design shall ensure patient audible and visual privacy during interview, examination, treatment and recovery.

3. Administration and Public Areas. The following shall apply to each outpatient care facility described herein with additions and/or modification as noted for each specific type.

a. Entrance. Located at grade level and able to accommodate wheelchairs.

b. Public services shall include:

1) Conveniently accessible wheelchair storage;

2) A reception and information counter or desk;

3) Waiting space(s). Where an organized pediatric service is part of the outpatient care facility, provisions shall be made for separating pediatric and adult patients;

4) Public toilets;

5) Drinking fountain; and

6) Public telephones.

c. Interview space(s). Private interviews related to social services, credit, etc. shall be provided.

d. General or individual offices for business transactions, records, administrative and professional staffs shall be provided.

e. Clerical space or rooms for typing, clerical work, and filing, separated from public areas for confidentiality, shall be provided.

f. Multipurpose room(s) equipped for visual aids shall be provided for conferences, meetings and health education purposes.

g. Special storage for staff personal effects with locking drawers or cabinets (may be individual desks or cabinets) shall be provided. Such storage shall be near individual work stations and staff controlled.

h. General storage facilities for supplies and equipment shall be provided as needed for continuing operation.

4. General purpose examination rooms. For medical, and similar examinations, rooms shall have a minimum floor area of eighty (80) square feet, excluding vestibules, toilets, and closets. Room arrangement shall permit at least two (2) feet eight (8) inches clearance at each side and at the foot of the examination table. A handwashing fixture and a counter or shelf space for writing shall be provided.

5. Treatment Room(s). Rooms for diagnosis and/or treatment if provided, shall have a minimum floor area of one-hundred-twenty (120) square feet, excluding vestibule, toilet, and closets. The minimum room dimension shall be ten (10) feet. A handwashing fixture and counter or shelf for writing shall be provided.

6. Control Station. A work counter, communication system, space for supplies, and provisions for charting shall be provided.

7. Medication Distribution Station. This may be a part of the control station and shall include a work counter, sink, refrigerator, and locked storage for biologicals and medications.

8. Clean Holding. A separate room or closet for storing clean and sterile supplies shall be provided. This storage shall be in addition to that of cabinets and shelves.

9. Soiled Holding. Provisions shall be made for separate collection, storage, and disposal of soiled materials.

10. Sterilizing Facilities. A system for sterilizing equipment and supplies shall be provided, if required by the narrative program.

11. Wheelchair Storage Space. Such storage shall be out of the direct line of traffic.

12. Imaging Suite. See Section 56, Physical Facilities, Imaging Suite.

13. Laboratory. See Section 59, Physical Facilities, Laboratory Services.

14. Rehabilitation Services. See Section 80, Physical Facilities, Rehabilitation Facilities.

15. Environmental Services, Safety Services, Physical Environment. See Sections 47, Physical Facilities.

16. Staff Facilities. See Section 70, Physical Facilities, Engineering Service and Equipment Areas.

17. Waste Processing Services. See Section 71, Physical Facilities, Waste Processing Services.

18. Social Spaces/Group Therapy. See Section 81, Physical Facilities for Psychiatric Hospitals - F.3 Service Areas

19. Details shall comply with the following standards:

a. Minimum public corridor width shall be five (5) feet. Work corridors less than six (6) feet long may be four (4) feet wide.

b. Each building shall have two (2) exits that are remote from each other. Other details relating to exits and fire safety shall comply with NFPA 101 and the standards outlined herein.

c. Items such as drinking fountains, telephone booths, vending machines, etc., shall not restrict corridor traffic or reduce corridor width below the minimum. Out of traffic storage space for portable equipment shall be provided.

d. The minimum door width for patient use shall be two (2) feet ten (10) inches. The minimum width of doors used by patients transported in beds shall be three (3) feet eight (8) inches.

e. Doors, sidelights, borrowed lights, and windows glazed to within eighteen (18) inches of the floor shall be constructed with safety glass, wired glass, or similar materials. Glazing materials used for shower doors and bath enclosures shall be safety glass or plastic.

f. Threshold and expansion joints covers shall be flush with thefloor surface.

g. Handwashing facilities shall be located and arranged to permit proper use and operation.

h. Provisions for hand drying shall be included at all handwashing facilities.

i. Radiation protection for X-ray and gamma ray installations shall be in accordance with the rules and regulations of the Arkansas Department of Health.

j. The minimum ceiling height shall be seven (7) feet eight (8) inches.

k. No fireplace shall be permitted in the facility.

l. Cabinets or casework shall be furred to the ceiling above or provided with sloping top to facilitate cleaning.

m. Onsite medical records shall be protected by a one (1) hour rated enclosure.

20. Finishes shall comply with the following:

a. Cubicle curtains and draperies shall be noncombustible or flame-retardant and shall pass both the large- and small-scale tests required by NFPA 701.

b. The flame spread and smoke development ratings of finishes shall comply with NFPA 101, Chapter 26.

c. Floor materials shall be readily cleanable and appropriately wear-resistant. In all areas subject to wet cleaning, floor materials shall not be physically affected by liquid germicidal and cleaning solutions. Floors subject to traffic while wet, including showers and bath areas, shall have a nonslip surface.

d. Wall finishes shall be washable, and in the proximity of plumbing fixtures, shall be smooth and water resistant.

e. Wall bases in areas frequently subject to wet cleaning methods shall be monolithic and coved with the floor, tightly sealed to the wall, and constructed without voids.

f. Floor and wall areas penetrated by pipes, ducts, and conduits shall be tightly sealed to minimize entry of rodents and insects. Joints of structural elements shall be similarly sealed.

21. Provision for Disasters. See Section 46, Physical Environment.

22. Mechanical, Plumbing and Electrical.

a. Small Outpatient Clinics that provide space and equipment serving four (4) or fewer direct patient care workers at one (1) time shall comply with the following minimum requirements:

1) Emergency lighting shall be connected to rechargeable back-up batteries as a means of emergency illumination.

2) A protected premises fire alarm system as defined in Chapter 3, NFPA 72 is required.

b. Large Outpatient Facilities that provide space and equipment for more than four (4) direct patient care workers at one (1) time shall comply with the following minimum requirements:

1) Emergency lighting and power shall be provided in accordance with NFPA 99, NFPA 101, and NFPA 110.

2) Any fire alarm system shall be as required by NFPA 101 and installed per NFPA 72.

3) The installation, testing, and certification of nonflammable medical gas and air systems shall comply with the requirements of NFPA 99.

4) Clinical vacuum system installed shall be in accordance with NFPA 99.

5) All electrical material and equipment shall be installed, tested and certificated in accordance with NFPA 70 and NFPA 99.

6) The mechanical system shall comply with Section 74, Physical Facilities, Mechanical Requirements, with the following exceptions:

a) Redundant space heating and water heating capability are not required, unless required by the written narrative; and

b) Ducted return air systems are not required, unless required by the written narrative.

c) Diagnosis and/or

7) A nurses emergency call system shall be provided for all patient use at each patient toilet, bath, sitz bath and shower room. This system shall be accessible to a patient lying on the floor. Inclusion of a pull cord shall satisfy this standard.

8) Fire extinguisher(s) shall be provided and be easily accessible per NFPA requirements.

G. Endoscopy

The endoscopy suite may be divided into three major functional areas: the procedure room(s), instrument processing room(s), and patient holding/preparation and recovery room or area.

NOTE: When invasive procedures are to be performed in this unit on persons who are known or suspected of having airborne infectious diseases, these procedures should not be performed in the operating suite. These procdures shall be performed in a room meeting airborne infections isolation ventilation requirements or in a space using local exhaust ventilation.

1. Procedures Room(s)

a. Each procedure room shall have a minimum clear area of 200 square feet (15.58 square meters) exclusive of fixed cabinets and built-in shelves.

b. A freestanding handwashing fixture with handsfree controls shall be available in the suite.

c. Station outlets for oxygen, vacuum (suction), and medical air.

d. Floor covering shall be monolithic and joint free.

e. A system for emergency communication shall be provided.

f. Procedure rooms shall be designed for visual and acoustical privacy for the patient.

2. Instrument Processing Room(s)

a. Dedicated processing room(s) for cleaning and disinfecting instrumentation must be provided. In an optimal situation, cleaning room(s) shall be located between two procedure rooms. However, one processing room may serve multiple procedure rooms. Size of the cleaning room(s) is dicated by the amount of equipment to be processed.

Cleaning rooms shall allow for flow of instrumentations from the contaminated area to the clean area, and finally to storage. The clean equipment rooms, including storage, should protect the equipment from contamination.

b. The decontamination room shall be equipped with the following:

1) Two utility sinks remote from each other.

2) One freestanding handwashing fixture.

3) Work counter space(s).

4) Space and plumbing fixtures for automatic endoscope cleaners, sonic processor, and flash sterilizers (where required).

5) Ventilation system. Negative pressure shall be maintained and minimum of 10 air changes per hour shall be maintained. A hood is recommended over the work counter. All air shall be exhausted to the outside to avoid recirculation within the facility.

6) Outlets for vacuum and compressed air.

7) Floor covering shall be monolithic and joint free.

3. Patient Holding/Prep/Recovery Area. The following elements shall be provided in this area:

a) Each patient cubicle shall be equipped with oxygen and suction outlets.

b) Cubicle curtains for patient privacy.

c) Medication preparation and storage with handwashing facilities.

d) Toilet facilities (may be accessible from patient holding or directly from procedure room(s) or both).

e) Change areas and storage for patients' personal effects.

f) Nurses reception and charting area with visualization of patients.

g) Clean utility room or area.

h) Environmental Services closet.

SECTION 80: PHYSICAL FACILITIES, REHABILITATION FACILITIES.

A. General Considerations. Rehabilitation facilities may be organized under hospitals(organized departments of rehabilitation), outpatient clinics, rehabilitation centers, and other facilities designed to serve either single- or multiple-disability categories including but not limited to: cerebrovascular, head trauma, spinal cord injury, amputees, complicated fractures, arthritis, neurological degeneration, genetic, and cardiac. In general, rehabilitation hospitals shall have larger space requirements than general hospitals, have longer lengths of stay and have less institutional and more residential environments.

B. General Construction Considerations. See Section 47.B, Physical Facilities.

C. Site Location, Inspection, Approval and Subsoil Investigation. See Section 47.C-G, I and J, Physical Facilities.

D. Construction Documents. See Section 47.H, Physical Facilities.

E. Codes and Standards. See Section 47.B and K, Physical Facilities.

F. Functional Units and Service Areas.

1. Required units. Each rehabilitation facility shall contain a medical evaluation unit and shall provide the following service areas, if the services are not otherwise conveniently accessible to the facility and appropriate to program functions:

a. Psychological services;

b. Social services;

c. Vocational services;

d. Patient dining, recreation and day spaces;

e. Dietary;

f. Personal care facilities;

g. Space for teaching activities of daily living;

h. Administration Department;

i. Medical Records;

j. Engineering service and equipment areas;

k. Laundry Services;

l. Housekeeping Rooms;

m. Employees' facilities;

n. Nursing unit;

o. Physical therapy;

p. Occupational therapy; and q. Speech and hearing.

2. Optional Units. The following special services areas, if required by the narrative program,

shall be provided as outlined in these sections. The sizes of the various departments will depend upon the services to be provided:

a. Sterilizing facilities;

b. Prosthetics and orthotics;

c. Dental;

d. Radiology;

e. Pharmacy;

f. Laboratory;

g. Home health;

h. Outpatient services; and

i. Therapeutic pool.

G. Evaluation Unit.

1. Office(s) for Personnel.

2. Examination Rooms. The rooms shall have a minimum floor area of one-hundred-forty (140) square feet excluding such spaces as the vestibule, toilet, closet, and work counter (whether fixed or movable). The minimum room dimension shall be ten (10) feet. The room shall contain a lavatory or sink equipped for handwashing, a work counter and storage facilities, and a desk, counter, or shelf space for writing.

3. Evaluation Rooms. The room areas shall be arranged to permit appropriate evaluation of patient needs and progress and to determine specific programs of rehabilitation. Rooms shall include a desk and work area for the evaluators, writing and work space for patients, and storage for supplies. Where the facility is small and workload light, evaluation may be done in the examination room.

4. Laboratory Facilities. Facilities shall be provided within the rehabilitation department or through contract arrangement with a nearby hospital or laboratory service for hematology, clinical chemistry, urinalysis, cytology, pathology, and bacteriology. If these facilities are provided through contract, the following minimum laboratory services shall be provided in the rehabilitation facility:

a. Laboratory work counter(s) with a sink, and gas and electric service;

b. Handwashing facilities;

c. Storage cabinet(s) or closet(s);

d. Specimen collection facilities. Urine collection rooms shall be equipped with a water closet and lavatory. Blood collection facilities shall have space for a chair and work counter.

5. Imaging Facilities. Imaging facilities, if required by the narrative program, shall be in accordance with Section 56, Physical Facilities, Imaging Suite.

H. Psychological Service. Office(s) and work space for testing, evaluation, and counseling shall be provided.

I. Social Service. Office space(s) for private interviewing and counseling shall be provided.

J. Vocational Services. Office(s) and work space for vocational training, counseling, and placement shall be provided.

K. Dining, Recreation, and Day Spaces.

1. The following standards shall be met for patient dining, recreation, and day spaces (areas may be in separate or adjoining spaces):

a. Inpatient and residents shall have a total of fifty-five (55) square feet per bed.

b. Outpatients, if dining is part of the day care program, a total of fifty-five (55) square feet per person shall be provided. If dining is not part of the program, at least thirty-five (35) square feet per person shall be provided for recreation and day spaces.

c. Storage spaces shall be provided for recreation equipment and supplies.

L. Dietary Department. See Section 63, Physical Facilities, Dietary Facilities.

M. Personal Care Unit for Inpatients. A separate room with appropriate fixtures and utilities shall be provided for patient grooming. The activities for daily living unit may serve this purpose.

N. Activities for Daily Living Unit. An area for teaching daily living activities shall be provided. It shall include a bedroom, bath, kitchen, and space for training stairs. Equipment shall be functional. The bathroom shall be in addition to other toilet and bathing requirements. The daily living area shall be similar to a residential environment for the purpose of facilitating the patient's skill for daily living.

O. Administration Department and Medical Records. See Sections 64, Physical Facilities, Administration and Public Areas.

P. Engineering Service and Equipment Areas. See Section 70, Physical Facilities, Engineering Service and Equipment Areas.

Q. Laundry Services. See Section 68, Physical Facilities, Laundry Service.

R. Housekeeping Rooms. See Section 69, Physical Facilities, Cleaning and Sanitizing Carts and Environmental Services.

S. Employee Facilities. See Section 70, Physical Facilities, Engineering Service and Equipment Areas.

T. Nursing.

1. The nursing units for rehabilitation facilities shall follow the standards as described in Section 48, Physical Facilities, Patient Accommodations (Adult Medical,Surgical,Communicable or Pulmonary Disease), with the following exceptions:

a. Patient Rooms. Minimum areas exclusive of toilet rooms, closets, lockers, wardrobes, alcoves, or vestibules shall be one-hundred-forty (140) square feet in single-bed rooms and one-hundred-twenty-five (125) square feet per bed in semi-private rooms.

b. Each patient shall have access to a toilet room without having to enter the general corridor area. One (1) toilet room shall serve no more than four (4) beds and no more than two (2) patient rooms. The toilet room shall contain a water closet, a handwashing fixture and a tub and/or shower. The handwashing fixture may be omitted from a toilet room that serves single-bed and two (2) bed rooms if each such patient's room contains a handwashing fixture. Each toilet room shall be of sufficient size to ensure that wheelchair users and staff shall have access.

c. Each patient shall have access to a wardrobe, closet, or locker with minimum clearance of one (1) foot ten (10) inches by one (1) foot eight (8) inches. A clothes rod and adjustable shelf shall be provided.

2. Nursing Unit Service Areas shall follow the standards described in Section 48, Physical Facilities, Patient Accommodations (Adult Medical, Surgical, Communicable or Pulmonary Disease), with the following exceptions:

a. Patient Bathing Facilities. At least one (1) island-type bathtub and/or gurney shower shall be provided in each nursing unit. Each tub and/or shower shall be in an individual room or privacy enclosure that provides space for the private use of bathing fixtures, for drying and dressing, and for a wheelchair and an assistant. Showers in central bathing facilities shall be at least four (4) feet square, curb-free and designed for use by a wheelchair patient;

b. At least one (1) room on each floor containing a nursing unit shall be provided for toilet training. It shall be accessible from the nursing corridor. A minimum clearance of three (3) feet shall be provided at the front and at each side of the water closet. The room shall also contain a lavatory; and c. Handrails shall be provided on both sides of corridors used by patients. A clear distance of one and one-half (1-1/2) inches shall be provided between the handrail and the wall, and the top of the rail shall be thirty-four (34) inches minimum and thirty-six (36) inches maximum above the floor. Exceptions for height shall be for special care areas such as those serving children.

U. Sterilizing Facilities. See Section 69, Physical Facilities, Cleaning and Sanitizing Carts and Environmental Services.

V. Rehabilitation Therapy. See Section 60, Physical Facilities, Rehabilitation Therapy Department.

W. Pharmacy Unit. See Section 62, Physical Facilities, Pharmacy.

X. Details and Finishes. See Section 72, Physical Facilities, Details and Finishes.

Y. Design and Construction, Including Fire-Resistant Standards. See Section 73, Physical Facilities, Construction, Including Fire Resistive Requirements.

Z. Waste Processing Services. See Section 71, Physical Facilities, Waste Processing Services.

AA. Elevators. See Section 76, Physical Facilities, Electrical Standards.

BB. Mechanical, Plumbing and Electrical Standards. See Sections 74, 75 and 76.

SECTION 81: PHYSICAL FACILITIES, PSYCHIATRIC HOSPITALS AND ALCOHOL/DRUG ABUSE INPATIENT TREATMENT CENTERS.

A. General Considerations. See Section 47.B, Physical Facilities.

B. General Construction Consideration. See Section 47.B, Physical Facilities.

1. The facility shall provide a therapeutic environment appropriate for the planned treatment programs. Security appropriate for the planned treatment programs shall be provided. The area shall be characterized by a feeling of openness, with emphasis on natural light and exterior view. Interior finishes, lighting, and furnishings shall suggest a residential rather than an institutional setting. These shall, however, conform with applicable fire safety codes. Security and safety devices shall not be presented in a manner to attract or challenge tampering by patients. Design, finishes, and furnishings shall be such as to minimize the opportunity for residents to cause injury to themselves or others. Special design considerations for injury and suicide prevention shall be given to the following elements:

a. Visual control of nursing units and passive activity areas such as day rooms and outdoor areas;

b. Hidden alcoves or enclosed spaces;

c. Areas secured from patients such as staff areas and mechanical space;

d. Door closers, latch handles and hinges;

e. Door swings to private patient bathrooms;

f. Shower, bath, toilet, and sink plumbing fixtures, hardware and accessories including grab bars and toilet paper holders;

g. Windows including interior and exterior glazing;

h. Light fixtures, electrical outlets, electrical appliances, nurse call systems, and staff emergency assistance systems;

i. Ceilings, ventilation grilles, and access panels in patient bedrooms and bathrooms;

j. Sprinkler heads and other protrusions; and

k. Fire extinguisher cabinets and fire alarm pull stations.

C. Site Location, Inspection, Approval and Subsoil Investigation. See Section 47.C-G, I and J, Physical Facilities.

D. Construction Documents. See Section 47.H, Physical Facilities.

E. Codes and Standards. See Section 47.B and K, Physical Facilities.

F. General Requirements for Psychiatric Hospitals and Alcohol/Drug Abuse Inpatient Treatment Centers.

1. Nursing Unit. See Section 52, Physical Facilities, Psychiatric Nursing Unit. (Seclusion Room is not required in the Alcohol/Drug Unit.)

2. Patient Rooms. See Section 52, Physical Facilities, Psychiatric Nursing Unit.

3. Service Areas. The service areas shall follow the standards described in Section 52, Physical Facilities, Psychiatric Nursing Unit, with the following exceptions:

a. At least two (2) separate social spaces, one (1) appropriate for noisy activities and one (1) for quiet activities, shall be provided. The combined area shall be a minimum of thirty (30) square feet per patient with a minimum of one-hundred-twenty (120) square feet for each of the two (2) spaces. This space may be shared by dining activities if an additional fifteen (15) square feet per patient is added; otherwise provide twenty (20) square feet per patient for dining. Dining facilities may be located off the nursing unit in a central area;

b. Space for group therapy shall be provided. This may be combined with the quiet space noted above when the unit accommodates not more than twelve (12) patients and when at least two-hundred-twenty-five (225) square feet of enclosed private space is available for group therapy activities;

c. Patient laundry facilities with an automatic washer and dryer shall be provided;

d. Examination and treatment room(s). The examination and treatment room(s) may serve several nursing units and shall be on the same floor and conveniently located for routine use. Examination rooms shall have a minimum floor area of one-hundred-twenty (120) square feet excluding space for vestibule, toilets, and closets. The room shall contain a lavatory or sink equipped for handwashing, storage facilities, and desk, counter, or shelf space for writing;

4. Outpatient Clinic Services. See Section 79, Physical Facilities, Outpatient Care Facilities.

5. Imaging Suite. See Section 56, Physical Facilities, Imaging Suite.

6. Laboratory Suite. See Section 59, Physical Facilities, Laboratory Services.

7. Physical Therapy Suite. See Section 60, Physical Facilities, Rehabilitation Therapy Department.

8. Occupational Therapy Suite. See Section 60, Physical Facilities, Rehabilitation Therapy Department.

9. Pharmacy Suite. See Section 62, Physical Facilities, Pharmacy.

10. Dietary Facilities. See Section 63, Physical Facilities, Dietary Facilities.

11. Administration and Public Areas. See Section 64, Physical Facilities, Administration and Public Areas.

12. Medical Record Unit. See Section 65, Physical Facilities, Health Information Unit.

13. Central Storage. See Section 67, Physical Facilities, Central Supply and Receiving.

14. Laundry Services. See Section 68, Physical Facilities, Laundry Service.

15. Facilities for Cleaning and Sanitizing Carts and Environmental Services. See Section 69, Physical Facilities, Cleaning and Sanitizing Carats and Environmental Services.

16. Employee Facilities. See Section 70, Physical Facilities, Engineering Service and Equipment.

17. Engineering Services and Equipment Areas. See Section 70, Physical Facilities, Engineering Service and Equipment.

18. Waste Processing Services. See Section 71, Physical Facilities, Waste Processing Services.

19. Details and Finishes. See Section 72, Physical Facilities, Details and Finishes.

20. Construction, Including Fire Requirements. See Section 73, Construction, Including Fire Resistive Requirements.

21. Elevator. See Section 76, Physical Facilities, Electrical Standards.

22. Mechanical, Plumbing and Electrical Requirements. See Sections 74, 75 and 76.

SECTION 82: PHYSICAL FACILITIES, INFIRMARIES.

A. General Considerations. See Section 47.B, Physical Facilities.

B. General Construction Considerations. See Section 47.B, Physical Facilities.

C. Site Location, Inspection, Approval and Subsoil Investigation. See Section 47.C-G, I and J, Physical Facilities.

D. Construction Documents. See Section 47.H, Physical Facilities.

E. Codes and Standards. See Section 47.B and K, Physical Facilities.

F. General Requirements for Infirmaries.

1. General Consideration (New Construction Only). See Section 47.B, Physical Facilities.

2. Nursing Unit (Medical). NOTE: The infirmaries shall only provide medical services as stated in Section 48, Patient Accommodations (Adult Medical, Surgical, Communicable or Pulmonary Disease).

a. Patient Rooms. See Section 48, Patient Accommodations (Adult Medical, Surgical, Communicable or Pulmonary Disease).

b. Service Areas. See Section 48, Patient Accommodations (Adult Medical, Surgical, Communicable or Pulmonary Disease).

c. Isolation Rooms. See Section 48, Patient Accommodations (Adult Medical, Surgical, Communicable or Pulmonary Disease).

G. Outpatient Clinic.

1. General. NOTE: The outpatient facilities, if provided shall be contained within the infirmary only. See Section 79, Physical Facilities, Outpatient Care Facilities.

2. Outpatient Clinical Services. See Section 79, Physical Facilities, Outpatient Care Facilities.

3. Administration and Public Areas. See Section 79, Physical Facilities, Outpatient Care Facilities.

4. Clinical Facilities. See Section 79, Physical Facilities, Outpatient Care Facilities.

H. Radiology Suite, if provided. See Section 56, Physical Facilities, Imaging Suite. NOTE: Mobile CT, MRI and Litho Units shall not be provided at infirmaries.

I. Laboratory Suite. See Section 59, Physical Facilities, Laboratory Services.

J. Physical Therapy and Respiratory Care Suite. See Section 60, Physical Facilities, Rehabilitation Therapy Department.

K. Occupational Therapy, Recreational Therapy, Speech/Hearing/Audio Unit Suite, if provided. See Section 60, Physical Facilities, Rehabilitation Therapy Department.

L. Pharmacy Suite. See Section 62, Physical Facilities, Pharmacy.

M. Dietary Facilities. See Section 63, Physical Facilities, Dietary Facilities.

N. Administration and Public Areas. See Section 64, Physical Facilities, Administration and Public Areas.

O. Medical Record Unit. See Section 65, Physical Facilities, Health Information Unit.

P. Central Medical Supply Department. See Section 67, Physical Facilities, Central Supply and Receiving.

Q. Central Supplies and Receiving. See Section 67, Physical Facilities, Central Supply and Receiving.

R. Laundry Services. See Section 68, Physical Facilities, Laundry Service.

S. Facilities for Cleaning and Sanitizing Carts and Environmental Services. See Section 69, Physical Facilities, Cleaning and Sanitizing Carts and Environmental Services.

T. Employee Facilities. See Section 70, Engineering Service and Equipment Areas.

U. Engineering Services and Equipment Areas. See Section 70, Physical Facilities, Engineering Service and Equipment.

V. Waste Processing Services. See Section 71, Physical Facilities, Waste Processing Services.

W. Details and Finishes. See Section 72, Physical Facilities, Details and Finishes.

X. Construction. See Section 73, Physical Facilities, Construction, Including Fire Resistive Requirements.

Y. Elevators. See Section 76, Physical Facilities, Electrical Standards.

Z. Mechanical Requirements. See Section 74, Physical Facilities, Mechanical Requirements.

APPENDIX

TABLE 1

Filter Efficiencies for Central Ventilation and Air Conditioning Systems in Health Care Facilities
Area Designation	No. Filter Beds	Filter Bed No.1 (%)	Filter Bed No.2 (%)
All areas for patient care, treatment, and diagnosis, and those areas providing direct service or clean supplies such as sterile and clean processing.	3	30	90
Positive Protective Environment Room	2	30	99.97
Laboratories	1	80	-
Administrative, Bulk Storage, Soiled Holding Areas, Food Preparation Areas, and Laundries	1	30	-

Notes: The filtration efficiency ratings are based on dust spot efficiency per ASHRAE 52-76

TABLE 2

Sound Transmission Limitations in Health Care Facilities
	Airborne Sound Transmission Class (STC)1
	Partitions	Floors
Patients= Room to Patients= Room	35	40
Public Space to Patients= Room2	40	40
Service Areas to Patients= Room3	45	45

Notes:

1. Sound transmission class (STC) shall be determined per ASTM Standard E90 and E413.

2. Public space includes lobbies, dining rooms, recreation rooms, treatment rooms, and similar spaces.

3. Service areas include kitchens, elevators, elevator machine rooms, laundries, and similar spaces.

TABLE 3

Temperature and Relative Humidity Requirements
Area Designation	Design Temperatures oF	Relative Humidity (%) Minimum-Maximum
Operating Rooms, Delivery Rooms, Endoscopy, Bronchoscopy	68-73	30-60
Trauma Rooms	70-75	45-60
Recovery, Intensive Care, Radiological X-ray Surgical/Critical Care)	70-75	30-60
Nursery Units, Clean Work Room, ETO Sterilizer Room	75	30-60
Sterile Storage	68-73	70 (max)

Note: Where temperature ranges are indicated, the systems shall be capable of maintaining the rooms at any point within the range. A single figure indicates a heating or cooling capacity of at least the indicated temperature. This is usually applicable when patients may be undressed and require a warmer environment. Nothing in these guidelines shall be construed as precluding the use of temperatures lower than those noted when the patients= comfort and medical conditions make lower temperatures desirable. Unoccupied areas such as storage rooms shall have temperatures appropriate for the function intended.

RULES AND REGULATIONS FOR HOSPITALS AND RELATED INSTITUTIONS IN ARKANSAS

TABLE 4

Ventilation, Medical Gas, and Air Flow Requirements in Health Care Facilities¹

Area Designation	Air Movement Relationship To Adjacent Area2	Minimum Air Changes Outside Air Per Hour3	Minimum Total Air Changes Per Hour4	Air Recirculated By Means of Room Units6	All Air Exhausted Directly Outdoor5	Minimum Required Medical Gas Station Outlets oxygen/vacuum/air per patient
Operating room all outdoor air7	P	15	15	No	Yes	2/3/2
Operating room recirculating-air system7	P	3	15	No	Optional	2/3/2
Delivery room all outdoor air7	P	15	15	No	Yes	2/3/2
Delivery room recirculating-air system7	P	3	15	No	Optional	2/3/2
Recovery room7	P	2	6	No	Optional	1/3/1
Critical Care (General)	+/-	2	6	No	Optional	2/2/1
Nursery suite	P	2	6	No	Optional	1/1/1
Nursery ICU	P	2	6	No	Optional	3/3/3
Endoscopy	N	2	6	No	Optional	1/1/1
ER trauma room	P	3	15	No	Optional	2/3/1
Anesthesia storage/workroom	N	Optional	8	No	Yes	1/0/1
Patient room	+/-	2	2	Optional	Optional	1/1/014
Toilet room	N	Optional	10	No	Yes	NA
Intensive care	P	2	6	No	Optional	2/3/1
Airborne Infectious Isolation, Bronchoscopy Room10,13,15	N	2	12	No	Yes	1/1/0
Protective isolation9,16	P	2	12	Optional	Yes	1/1/0
Isolation anteroom	see note 13	2	10	No	Yes	NA
Labor room	+/-	2	6	Optional	Optional	1/1/0
Labor/delivery/ recovery/ post partum (LDRP)	+/-	2	6	Optional	Optional	1/1/0 1/1 (infant)
Activity - Dining Room (Except Psychiatric Units)	+/-	2	6	Optional (No Psych)	Optional	NA
Patient Corridor	+/-	2	2	Optional	Optional	NA

Area Designation	Air Movement Relationship To Adjacent Area2	Minimum Air Changes Outside Air Per Hour3	Minimum Total Air Changes Per Hour4	Air Recirculated By Means of Room Units6	All Air Exhausted Directly Outdoor5	Minimum Required Medical Gas Station Outlets oxygen/vacuum/air per patient
Radiology surgery and critical care	P	3	15	No	Optional	1/2/2
Radiology diagnostic and treatment	+/-	-	6	Optional	Optional	1/1/0
Radiology darkroom	N	-	10	No	Yes	NA
Lab general11	N	-	6	No	Yes	NA
Lab bacteriology	N	-	6	No	Yes	NA
Lab biochemistry	P	-	6	No	Yes	NA
Lab cytology	N	-	6	No	Yes	NA
Lab glass washing	N	-	10	Optional	Yes	NA
Lab histology	N	-	6	No	Yes	NA
Lab nuclear med	N	-	6	No	Yes	NA
Lab pathology	N	-	6	No	Yes	NA
Lab serology	P	-	6	No	Optional	NA
Lab sterilizing	N	-	10	No	Yes	NA
Lab media transfer	P	-	4	No	Optional	NA
Autopsy	N	-	12	No	Yes	NA
Nonrefrig. body holding room	N	-	10	No	Yes	NA
Pharmacy	P	-	4	Optional	Optional	NA
Examination room	+/-	-	6	Optional	Optional	1/1
Medication room	+/-	-	4	Optional	Optional	1/1
Treatment room	+/-	-	6	Optional	Optional	1/1
Physical therapy and hydrotherapy	N	-	6	No	Optional	1/1
Soiled workroom or soiled holding	N	-	10	No	Yes	NA
Clean workroom or clean holding	P	-	4	Optional	Optional	NA

Area Designation	Air Movement Relationship To Adjacent Area2	Minimum Air Changes Outside Air Per Hour3	Minimum Total Air Changes Per Hour4	Air Recirculated By Means of Room Units6	All Air Exhausted Directly Outdoor5	Minimum Required Medical Gas Station Outlets oxygen/vacuum/air per patient
Sterilizer equipment room	N	-	10	No	Yes	NA
Central medical and surgical supply	P	-	6	No	Yes	NA
Soiled or decontamination room	N	-	6	No	Yes	NA
Clean workroom17	+/-	-	4	Optional	Optional	NA
Sterile storage17
+/-	-	4	Optional	Optional	NA
Equipment storage	+/-	-	2	Optional	Optional	NA
Food preparation centers12	P	-	10	No	Yes	NA
Warewashing	N	-	10	No	Yes	NA
Dietary day storage	+/-	-	2	No	Optional	NA
Laundry, general	N	-	10	No	Yes	NA
Soiled linen sorting and storage	N	-	10	No	Yes	NA
Clean linen storage	+/-	-	2	Optional	Optional	NA
Soiled Linen and trash chute room	N	-	10	No	Yes	NA
Bedpan room	N	-	10	No	Yes	NA
Bathroom	N	-	10	No	Yes	NA
Janitor's closet	N	-	10	No	Yes	NA

TABLE 4 - NOTES

N = negative pressure, P = positive pressure, +/- = continuous directional control not required

1. Areas where specific ventilation rates are not given in the table shall be ventilated in accordance with ASHRAE Standard 62-1989, Ventilation for Acceptable Indoor Air Quality.

2. Design of the ventilation system shall provide air movement which is generally from clean to less clean areas. If any form of variable air volume or load shedding system is used for energy conservation, it must not compromise the corridor-to-room pressure balancing relationship or the minimum air changes required by the table. Except where specifically permitted by exit corridor plenum provisions of NFPA 90A, the volume of infiltration and exfiltration shall not exceed 15 percent of the minimum total air changes per hour, or 50 cfm, whichever is larger, as defined by the table.

3. To satisfy exhaust needs, replacement air from the outside is necessary. Table 4 does not attempt to describe specific amounts of outside air to be supplied to individual spaces except for certain areas such as those listed. Distribution of the outside air, added to the system of balance required exhaust, shall be as required by good engineering practice. Minimum outside air quantities shall remain constant while the system is in operation.

4. Number of air changes may be reduced to twenty-five (25) percent of minimum occupied requirement when the room is unoccupied if provisions are made to ensure that the number of air changes indicated is reestablished any time the space is being utilized. Adjustments shall include provisions so that the direction of air movement shall remain the same when the number of air changes is reduced. Areas not indicated as having continuous directional control may have ventilation systems shut down when space is unoccupied and ventilation is not otherwise needed, if the maximum infiltration of exfiltration permitted in Note 2 is not exceeded and if adjacent pressure balancing relationships are not compromised.

5 Air from areas with contamination and/or odor problems shall be exhausted to the outside and not recirculated to other areas. Not that individual circumstances may require special consideration for air exhaust to the outside, e.g., in intensive care units in which patients with pulmonary infection are treated, and rooms for burn patients.

6. Recirculating room HVAC units refers to those local units that are used primarily for heating and cooling of air, and not disinfection of air. Because of cleaning difficulty and potential for buildup of contamination, recirculating room units shall not be used in areas marked ANo.@ However, for airborne infection control, air may be recirculated within individual isolation rooms if HEPA filters are used. Isolation and intensive care unit rooms may be ventilated by reheat induction units in which only the primary air supplied from a central system passes through the reheat unit. Gravity-type heating or cooling units such as radiators or convectors shall not be used in operating rooms and other special care areas.

7. National Institute for Occupational Safety and Health (NIOSH) Criteria Documents regarding Occupational Exposure to Waste Anesthetic Gases and Vapors, and Control of Occupational Exposure to Nitrous Oxide indicate a need for both local exhaust (scavenging) systems and general ventilation of the areas in which the respective gases are utilized.

8. The term trauma room as used here is the operating room space in the emergency department or other trauma reception area that is used for emergency surgery. The first aid room and/or Aemergency room@ used for initial treatment of accident victims may be ventilated as noted for the Atreatment room.@ Treatment rooms used for bronchoscopy shall be treated as Bronchoscopy rooms. Treatment rooms used for cryosurgery procedures with nitrous oxide shall contain provisions for exhausting waste gases.

9. The positive protective environment room shall be solid organ transplant units, bone marrow units and other speciality units described in the written narrative program. The protective environment airflow design specifications protect the patient from common environmental airborne infectious microbes (i.e., Aspergillus spores). These special ventilation areas shall be designed to provide directed airflow from the cleanest patient care area to less clean areas. These rooms shall be protected with HEPA filters at 99.97 percent efficiency for a 0.3 um sized particle in the supply airstream. These interrupting filters protect patient rooms from maintenance-derived release of environmental microbes from the ventilation system components. Recirculations HEPA filters can be used to increase the equivalent room air exchanges. Constant volume airflow is required for consistent ventilation for the protected environment. Rooms with reversible airflow provisions for the purpose of switching between protective environment and airborne infection isolation functions are not acceptable.

10. The airborne infectious disease isolation room described in these guidelines is to be used for isolating the airborne spread of infectious diseases, such as measles, varicella, or tuberculosis. The design of airborne infection isolation (AII) rooms should include the provisions for normal patient care during periods not requiring isolation precautions. Supplemental recirculating devices may be used in the patient room, to increase the equivalent room air exchanges; however, such recirculating devices do not provide the outside air requirements. Air may be recirculated within individual isolation rooms if HEPA filters are used. Rooms with reversible airflow provisions for the purpose of switching between protective environment and AII functions are not acceptable.

11. When required, appropriate hoods and exhaust devices for the removal of noxious gases or chemical vapors shall be provided per NFPA 99.

12. Food preparation centers shall have ventilation systems whose air supply mechanisms are interfaced appropriately with exhaust hood controls or relief vents so that exfiltration or infiltration to or from exit corridor does not compromise the exit corridors does not compromise the exit corridors restrictions of NFPA 90A, the pressure requirements of NFPA 96, or the maximum defined in the table. The number of air changes may be reduced or varied to any extent required for odor control when the space is not in use.

13. Airborne infectious isolation room alcove or anteroom shall be negative to the corridor and positive to the patient room.

14. One (1) outlet accessible to each bed.

15. The design should prevent stagnation and short-circuiting of airflow. The supply and exhaust locations should direct clean air to areas where health care workers are likely to work, across the infectious source, and then to the exhaust, so that the health care worker is not in a position between the infectious source and the exhaust location. The design of the system should allow for easy access for scheduled preventive maintenance and cleaning.

16. Positive protective Isolation anteroom shall be negative to the corridor and negative to the patient room.

17. Maximum humidity 70%.

TABLE 5

Click here to view image

TABLE 6

Behavioral Screening Exam

Initial Observation: A room with minimal distraction is an appropriate test area. Allow the dog to investigate this area for several minutes without the tester present. The tester should enter the room, not speak, stand still at a discreet distance and observe the dog for about 15 seconds. Record the initial response.
Holds Ground 9	Crouches 9	No response 9
Approaches Tester 9	Hackles Up 9
Hackles Normal 9	Lips Puffed 9
Lips Normal 9	Moves Stiff-Legged 9
Sniffs Tester 9	Growls 9
Retreats 9
Barks 9
Avoids Eye Contact 9
Stares At You 9
Whines 9

Approaching the Dog: After initial brief observation, approach the dog with hand extended at the dog's nose level, palm and fingers pointed downward. Do not Arush@ in, but do not approach dog in a cautious or apprehensive manner. Walk up to the dog in a normal stride until your hand is within six to 12 inches of the dog's nose. Say nothing and wait for the dog to make the next move.
Extends Head or Steps Forward to Sniff Hand 9	Turns Head Away or Tries to Ignore Hand 9	Stares At You 9
Seeks Attention by Nudging or Leaning into Tester 9	Pulls Back or Retreats 9	No Response 9
Acts Playful by Barks or Actions 9	Raises Hackles 9
Licks Hand 9	Barks (Not to be Confused with Playful Barking 9
Lips Puffed 9
Overly Exuberant 9

Bares Teeth (Don=t Confuse with Grin) 9

Handling the Dog: If the dog has not been eliminated by Test 1 and 2, attempt to pet the dog starting with the top of the head. Pet the dog to determine its overall response on especially sensitive areas, such as ears and mouth.
Enjoys the Attention 9	Pulls Back or Retreats 9	Meets You, But With Head Lowered and Eyes Averted 9
Tries to Make Friends 9	Growls 9	Attempts to Lick Your Face 9
Becomes Playful 9	Lips Puffed 9
Enjoys Brushing 9	Raises Hackles 9
Quivers or Cowers 9
Barks 9
Rolls Over on Back 9
Submissively Urinates 9
Snaps, Bites 9
Shows Whites of Eyes 9
Overly Exuberant (Jumps Up) 9
Overly Sensitive to Grooming of Certain Areas 9
Aloof 9

Interacting with the Dog: See if he/she will retrieve a ball. Walk away briskly, sit on floor and call dog. Lay the dog down, then roll him/her over, rub his/her belly. Will he/she allow this subordination? Have a assistant place a novel stimulus such as a large stuffed animal or mirror close behind the dog when he/she is distracted. Does he/she have the self-confidence to investigate? How does the dog react to sudden arm movement?

Sound Sensitivity: While casually interacting with the dog, have an assistant make a loud noise without warning (e.g., hitting a metal pan with a spoon).
Notices, But Continues Previous Activity 9	Flees 9	9
Notices, Investigates 9	Cowers 9
Startles, But Recovers Quickly 9	Freezes 9

Trembles 9

Urinates 9

Moves As If To Attack 9

Pain Threshold: While playing with dog, briefly pinch the webbing between his/her toes or pull hair from his side to determine pain tolerance.
Tries to Pull Away, But Shows Forgiveness 9	Growls 9	9
Yelps, But is Not Aggressive 9	Snaps 9
Trusts You, Allows Further Petting 9	Acts Fearful 9
Acts Distrustful 9

Reacting to Unexpected Events (Choose One): Owner is to be present at all times. (Assess response using response categories from Test 5.)

A. Have your assistant hide around a corner, out of sight, with a noisy utility shopping cart. Walk with dog toward the intersection as the assistant rolls the cart in front of the dog as close as possible. Record the dog=s reaction.

B. While the dog is playing with you and is distracted, have the assistant hide in the closet and behind the door. Lead the dog to within six feet of the hiding place and have the assistant suddenly jump out at the dog and open an umbrella. Note reactions.

Manners: Test the dog for basic obedience commands such as heel and sit-stay.

TABLE 7

Click here to view image

TABLE 8

RECORD RETENTION TIME FRAMES

Administrative	Governing Body	Permanent
	Medical Staff	Permanent
	Executive Committee	Permanent
	Other Hospital Committees	2 years
Medical Records	Original/Microfilm Adult/Inpatient/Outpatient Electrocardiogram Strips/ Interpretations Electroencephalogram/ Interpretations	10 years after last discharge. Facility must maintain information in the master patient index.
	Original/Microfilm Minor/Inpatient/Outpatient Fetal Monitor Strips Electrocardiogram Strips/ Interpretations Electroencephalogram/ Interpretations	10 years after last discharge plus 2 years past majority. Facility must maintain information in the master patient index.
Radiology	Films	5 years
Nuclear Medicine	Films	5 years
Laboratory	Blood Gas Reports	2 years
	Patient Specimens	2 years
	Control Documentation	2 years
	Immunohematology	5 years
	Immunohematology Quality Control Records	5 years
	Cytology: Histopathology Quality Control Records	10 years
	Cytology: Slide Preparation	5 years
	Transfusions	5 years
	Blood Donor Samples	7 days post transfusion
	Quality Assurance	2 years
Pathology Lab	Pathology Reports	10 years
	Reference Pathology	2 years
	Preliminary/Corrected	Exact duplicate
Histopathology	Stained Slides	10 years
	Specimen Blocks	2 years
Pharmacy	All drug records to include: purchase invoices official records Prescription records	2 years

1

Inventory records, etc.

1

TABLE 9

MEDICATIONS	Refrigerators	36-46°F
	Medication Storage Room	59-86°F
DIETARY1	Temperature of Food at Bedside	Hot Foods = 140 °F
		Cold Foods = 40 °F
	Temperature of Heated Food Prior to Hot Holding	3160EF
	Temperature of Heated Leftovers Prior to Hot Holding	3165EF
	Temperature for Thawing Potentially Hazardous Food	Tempering Units = 45°F or less
		Refrigerator = 40°F or less
	Refrigerators	#40°F
	Freezers	#0°F
	Single Tank Stationary Rack Dual Temperature Machine	Wash Temperature = 150°F
		Final Rinse Temperature = 180°F
	Single Tank Conveyor Machine	Wash Temperature = 160°F
		Final Rinse Temperature = 180°F
	Multi-tank Conveyor Machine	Wash Temperature = 150°F
		Final Rinse Temperature = 180°F
		Pumped Rinse Temperature = 160°F
	Single Tank Pot, Pan & Utensil Washer	Wash Temperature = 140°F
		Final Rinse Temperature = 180°F
	Manual Warewashing	Wash Temperature = 110°F
		Rinse Temperature = 120°G - 140°F
		Chemical Sanitation (Manual or Mechanical)	Sanitation Temperature = > 171°F or Immersion in 75°F water and 50 ppm of hypochlorite for at least 1 minute or other method approved by Arkansas Department of Health.
	All Cutting Board Surfaces	Immersion in clean, hot water of > 180°F for at least 30 seconds or any other method approved.
LAUNDRY2	Water	Nothing under 120°F
	Water with Chlorine Bleach	150 parts per million ppm (parts per million)
CLINICAL	Gallons per hour per bed2	110°F - 120°F

9Notes:

1. Provisions shall be made to provide 180°F rinse water at warewasher. (may be by a separate booster.)

2. Provisions shall be made to provide 160°F hot water at the laundry equipment when needed. (This may be a steam jet or separate booster heater.) However, this does not imply that all water used would be at this temperature. Water temperatures required for acceptable laundry results will vary. Lower temperatures may be adequate for most procedures in many facilities but the higher 160°F should be available when needed for special conditions.

VERBAL ORDER

Basic Premise:	Verbal orders may be used when there is no reasonable alternative to obtaining a written order.
State Health Rules:	Permit licensed nurses and pharmacist (for drugs only) to take verbal orders and no one else. Section 12, Medications and Section 14, Health Information Services.
Practical Application:	Health professionals other than nurses may take verbal orders pertaining directly to their profession under specified circumstances.
Situation to Address:	1. Doctor in the department away from nurses station. 2. Doctor calls the department.
Policy Statement Parts:	1. Who are the authorized receivers? 2. Repeat order back for accuracy. 3. Identify ordering doctor. 4. Identify receiver by name and title. 5. The receiver of the order must enter the order on the medical record, and then sign first initial, last name and title.
Hospital Administration Responsibility:	1. Policy must be in writing, and approved by the Medical Staff and Governing Body (including identification of receivers). 2. Policy must be made a part of applicable department manuals. 3. Inservice training provided for all personnel involved. 4. Establish an effective monitoring system.
Outpatient Department (Emergency Services is not outpatient):	1. The therapist or other authorized receivers may take a verbal or telephone order from the doctor. 2. Must document on outpatient medical record. 3. Doctor must authenticate the order on his next visit.

RATIONALE

The Division of Health Facility Services has received numerous requests for a variance in the regulations relating to who may receive doctors orders for hospital inpatients and outpatients. This office realizes the communication problems involved between every expanding service departments of hospitals and the multiplicity of diagnostic treatment, therapy, and therapeutic duties necessary for coordinating of patient care. Other certification and accrediting organizations have also realized the communication difficulty.

The reason and intent of the regulation was, and still is, to coordinate all inpatient care through nursing service. The patient's medical record must be maintained at the nurses station to coordinate and implement physician orders for patient care and services.

It is the intent of this policy to have both communication between departments and also assure all physician orders and services rendered to patients are promptly documented on the patient's chart. In order to maintain continuity of care on an inpatient basis, it is necessary that all aspects of the patients= treatment be coordinated through the nursing service of the facility.

REUSE THIRD PARTY REPROCESSING OF SINGLE USE ITEMS

The Office of Compliance Center of Devices and Radiological Health of the Food and Drug Administration (FDA) provides guidelines for third party reprocessing of devices labeled for single use provided the reprocessing firm complies fully with all FDA regulatory requirements.

The Arkansas Department of Health will recognize FDA guidelines.

Notes

007.05.02 Ark. Code R. § 001

2/8/2002