Tenn. Comp. R. & Regs. 1200-08-35-.06 - BASIC SERVICES

(1) Radiological services. If laboratory tests are performed in the nuclear medicine services, they shall meet applicable requirements for laboratory services as specified in T.C.A. § 68-29-101 et seq.
(a) Radiological services provided shall be maintained free of hazards for patients and personnel.
(b) Personnel monitoring shall be maintained for each individual working in the area of radiation. Readings shall be on at least a monthly basis and reports kept on file and available for review.
(c) Patients, employees and the general public shall be provided protection from radiation in accordance with "State Regulations for Protection Against Radiation". All radiation producing equipment shall be registered and all radioactive material shall be licensed by the Division of Radiological Health of the Tennessee Department of Environment and Conservation.
(d) Periodic inspections of equipment must be made and hazards identified must be promptly corrected.
(e) Radiology personnel shall be qualified by education, training and experience for the type of service rendered.
(f) X-rays shall be retained for four (4) years and may be retired thereafter provided that a signed interpretation by a radiologist is maintained in the patient's record under T.C.A. § 68-11-305.
(g) Patient safety shall be ensured in all areas of the facility.
(h) Radioactive materials must be prepared, labeled, used, transported, stored, and disposed of in accordance with acceptable standards of practice.
(i) In-house preparation of radiopharmaceuticals shall be accomplished by, or under the direct supervision of, an appropriately trained registered pharmacist or a doctor of medicine or osteopathy.
(j) The Outpatient Diagnostic Center shall maintain records of the receipt and disposition of radiopharmaceuticals.
(2) Invasive Procedures.
(a) If the facility provides invasive diagnostic procedures eg. cardiac catheterization, percutaneous transluminal coronary angioplasty, vascular embolization or stereotactic procedures using anesthesia, the services must be well organized and provided in accordance with acceptable standards of practice.
(b) A qualified registered nurse shall be present during invasive diagnostic procedures, as listed in subparagraph (2)(a), where anything greater than local anesthesia is used during a procedure.
(c) Properly executed informed consent forms shall be in the patient's chart before procedure is performed, except in emergencies.
(d) Adequate equipment and supplies shall be available to the invasive diagnostic room and to the post procedure care area. The following equipment and supplies shall be provided for cardiac catheterization or angioplasty:
1. Call-in system
2. Cardiac monitor
3. Pulse Oximeter
4. Resuscitator
5. Defibrillator
6. Aspirator
7. Tracheotomy set
(e) A crash cart must be available with appropriate medications.
(f) A qualified registered nurse shall be in the post procedure area during the patient's recovery period during invasive diagnostic procedures, as listed in subparagraph (2)(a), where anything greater than local anesthesia is used during a procedure.
(g) A report describing techniques, findings, and tissues removed or altered must be written or dictated immediately following the procedure and signed by the physician.
(h) The Outpatient Diagnostic Center shall provide one or more procedure rooms which shall be constructed, equipped, and maintained to assure the safety of patients and personnel.
(3) Anesthesia. General anesthesia shall not be administered in Outpatient Diagnostic Centers.
(a) Written policies and procedures relative to the administration of anesthesia shall be developed and approved by the governing body, or responsible individual.
(b) After the completion of anesthesia, patients shall be constantly attended by competent personnel until responsive and able to summon aid. Each center shall maintain a log of the inspections made prior to each day's use of the anesthesia equipment. A record of all service and maintenance performed on all anesthesia machines shall also be on file.
(c) Any patient receiving conscious sedation shall receive:
1. continuous EKG monitoring;
2. continuous oxygen saturations;
3. serial BP monitoring at intervals no less than every 5 minutes; and
4. supplemental oxygen therapy and immediately available:
(i) ambubag;
(ii) suction;
(iii) endotracheal tube; and
(iv) crash cart.
(4) Pharmaceutical Services. The Outpatient Diagnostic Center must provide drugs and biologicals in a safe and effective manner in accordance with accepted federal and state standards of practice. Such drugs and biologicals must be stored in a separate room or cabinet which shall be kept locked at all times.
(5) Environmental Services.
(a) The facility shall provide a safe, accessible, effective and efficient environment of care consistent with its mission, service, law and regulation.
(b) The facility shall develop policies and procedures that address:
1. Safety;
2. Security;
3. Control of hazardous materials and waste;
4. Emergency preparedness;
5. Life safety;
6. Medical equipment; and,
7. Utility systems.
(c) Staff shall have been oriented to and educated about the environment of care and possess knowledge and skills to perform responsibilities under the environment of care policies and procedures.
(d) Utility systems, medical equipment, life safety elements, and safety elements of the environment of care shall be maintained, tested and inspected.
(e) Safety issues shall be addressed and resolved.
(f) Appropriate staff shall participate in implementing safety recommendations and monitoring their effectiveness.
(g) The building and grounds shall be suitable to services provided and patients served.
(6) Medical Records.
(a) The Outpatient Diagnostic Center shall comply with the Medical Records Act of 1974, T.C.A. § 68-11-301, et seq.
(b) A medical record shall be maintained for each person receiving services provided by the Outpatient Diagnostic Center and shall include:
1. Patient identification;
2. Name of nearest relative or other responsible agent;
3. Identification of primary source of medical care;
4. Dates and times of visits;
5. Signed informed consent;
6. Operative report;
7. Reports of all laboratory and diagnostic procedures along with tests performed and the results authenticated by the appropriate personnel; and,
8. Radiology reports.
(c) Medical records shall be current and confidential. Medical records and copies thereof shall be made available when requested by an authorized representative of the board or the department.
(7) Infection Control.
(a) The Outpatient Diagnostic Center must provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. There must be an active performance improvement program for the prevention, control, and investigation of infections and communicable diseases.
(b) The facility shall develop policies and procedures for testing a patient's blood for the presence of the hepatitis B virus and the HIV (AIDS) virus in the event that an employee of the facility, a student studying at the facility, or other health care provider rendering services at the facility is exposed to a patient's blood or other body fluid. The testing shall be performed at no charge to the patient, and the test results shall be confidential.
(c) The facility and its employees shall adopt and utilize standard precautions (per CDC) for preventing transmission of infections, HIV, and communicable diseases.
(d) All Outpatient Diagnostic Center's shall adopt appropriate policies regarding the testing of patients and staff for human immunodeficiency virus (HIV) and any other identified causative agent of acquired immune deficiency syndrome.
(e) An Outpatient Diagnostic Center shall have an annual influenza vaccination program which shall include at least:
1. The offer of influenza vaccination to all staff and independent practitioners at no cost to the person or acceptance of documented evidence of vaccination from another vaccine source or facility. The Outpatient Diagnostic Center will encourage all staff and independent practitioners to obtain an influenza vaccination;
2. A signed declination statement on record from all who refuse the influenza vaccination for reasons other than medical contraindications (a sample form is available at http://tennessee.gov/health/topic/hcf-provider);
3. Education of all employees about the following:
(i) Flu vaccination,
(ii) Non-vaccine control measures, and
(iii) The diagnosis, transmission, and potential impact of influenza;
4. An annual evaluation of the influenza vaccination program and reasons for non-participation; and
5. A statement that the requirements to complete vaccinations or declination statements shall be suspended by the administrator in the event of a vaccine shortage as declared by the Commissioner or the Commissioner's designee.
(f) The physical environment of the facility shall be maintained in a safe, clean and sanitary manner.
(g) Any condition on the facility site conducive to the harboring or breeding of insects, rodents or other vermin shall be prohibited. Chemical substances of a poisonous nature used to control or eliminate vermin shall be properly identified. Such substances shall not be stored with or near food or medications.
(8) Performance Improvement. The Outpatient Diagnostic Center shall have a planned, systematic, organization-wide approach to process design and redesign, performance measurement, assessment and improvement which is approved by the designated governing body or responsible individual. This plan shall address and/or include, but is not limited to:
(a) Infection control, including post-operative surveillance;
(b) Complications of procedures;
(c) Documentation of periodic review of the data collected and follow-up actions;
(d) A system which identifies appropriate plans of action to correct identified quality deficiencies;
(e) Documentation that the above policies are being followed and that appropriate action is taken whenever indicated.
(9) Ancillary Services. All ancillary or supportive health or medical services, including but not limited to, dietary, environmental, nursing, or medical laboratory services shall be provided in accordance with all applicable state and federal laws and regulations.
(10) Laboratory Services.
(a) The Outpatient Diagnostic Center shall provide on the premises or by written agreement with a laboratory licensed under T.C.A. § 68-29-105, a clinical laboratory to provide those services commensurate with the needs and services of the Outpatient Diagnostic Center.
(b) Any patient terminating pregnancy in an Outpatient Diagnostic Center shall have an Rh type, documented prior to the procedure, performed on her blood. In addition, she shall be given the opportunity to receive Rh immune globulin after an appropriate crossmatch procedure is performed within a licensed laboratory.
(11) Food and Dietetic Services. If a patient will be in the facility for more than four (4) hours post-op, an appropriate diet shall be provided.


Tenn. Comp. R. & Regs. 1200-08-35-.06
Original rule filed October 26, 2005; effective January 9, 2006. Amendment filed October 20, 2015; effective January 18, 2016. Amendments filed July 18, 2016; effective 10/16/2016.

Authority: T.C.A. §§ 4-5-202, 4-5-204, 68-11-202, 68-11-204, 68-11-206, 68-11-209, and 68-11-216.

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