A facility must be administered in a manner that enables it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident.
(a)Licensure. A facility must be licensed under applicable State and local law.
(b)Compliance with Federal, State, and local laws and professional standards. The facility must operate and provide services in compliance with all applicable Federal, State, and local laws, regulations, and codes, and with accepted professional standards and principles that apply to professionals providing services in such a facility.
(c)Relationship to other HHS regulations. In addition to compliance with the regulations set forth in this subpart, facilities are obliged to meet the applicable provisions of other HHS regulations, including but not limited to those pertaining to nondiscrimination on the basis of race, color, or national origin (45 CFR part 80); nondiscrimination on the basis of handicap (45 CFR part 84); nondiscrimination on the basis of age (45 CFR part 91); protection of human subjects of research (45 CFR part 46); and fraud and abuse (42 CFR part 455). Although these regulations are not in themselves considered requirements under this part, their violation may result in the termination or suspension of, or the refusal to grant or continue payment with Federal funds.
(1) The facility must have a governing body, or designated persons functioning as a governing body, that is legally responsible for establishing and implementing policies regarding the management and operation of the facility; and
(2) The governing body appoints the administrator who is—
(i) Licensed by the State where licensing is required; and
(ii) Responsible for management of the facility.
(e)Required training of nursing aides—
Licensed health professional means a physician; physician assistant; nurse practitioner; physical, speech, or occupational therapist; physical or occupational therapy assistant; registered professional nurse; licensed practical nurse; or licensed or certified social worker.
Nurse aide means any individual providing nursing or nursing-related services to residents in a facility who is not a licensed health professional, a registered dietitian, or someone who volunteers to provide such services without pay. Nurse aides do not include those individuals who furnish services to residents only as paid feeding assistants as defined in § 488.301 of this chapter.
(2)General rule. A facility must not use any individual working in the facility as a nurse aide for more than 4 months, on a full-time basis, unless:
(i) That individual is competent to provide nursing and nursing related services; and
(A) That individual has completed a training and competency evaluation program, or a competency evaluation program approved by the State as meeting the requirements of §§ 483.151-483.154 of this part; or
(B) That individual has been deemed or determined competent as provided in § 483.150 (a) and (b).
(3)Non-permanent employees. A facility must not use on a temporary, per diem, leased, or any basis other than a permanent employee any individual who does not meet the requirements in paragraphs (e)(2) (i) and (ii) of this section.
(4)Competency. A facility must not use any individual who has worked less than 4 months as a nurse aide in that facility unless the individual—
(i) Is a full-time employee in a State-approved training and competency evaluation program;
(ii) Has demonstrated competence through satisfactory participation in a State-approved nurse aide training and competency evaluation program or competency evaluation program; or
(5)Registry verification. Before allowing an individual to serve as a nurse aide, a facility must receive registry verification that the individual has met competency evaluation requirements unless—
(i) The individual is a full-time employee in a training and competency evaluation program approved by the State; or
(ii) The individual can prove that he or she has recently successfully completed a training and competency evaluation program or competency evaluation program approved by the State and has not yet been included in the registry. Facilities must follow up to ensure that such an individual actually becomes registered.
(6)Multi-State registry verification. Before allowing an individual to serve as a nurse aide, a facility must seek information from every State registry established under sections 1819(e)(2)(A) or 1919(e)(2)(A) of the Act the facility believes will include information on the individual.
(7)Required retraining. If, since an individual's most recent completion of a training and competency evaluation program, there has been a continuous period of 24 consecutive months during none of which the individual provided nursing or nursing-related services for monetary compensation, the individual must complete a new training and competency evaluation program or a new competency evaluation program.
(8)Regular in-service education. The facility must complete a performance review of every nurse aide at least once every 12 months, and must provide regular in-service education based on the outcome of these reviews. The in-service training must—
(i) Be sufficient to ensure the continuing competence of nurse aides, but must be no less than 12 hours per year;
(ii) Address areas of weakness as determined in nurse aides' performance reviews and may address the special needs of residents as determined by the facility staff; and
(iii) For nurse aides providing services to individuals with cognitive impairments, also address the care of the cognitively impaired.
(f)Proficiency of Nurse aides. The facility must ensure that nurse aides are able to demonstrate competency in skills and techniques necessary to care for residents' needs, as identified through resident assessments, and described in the plan of care.
(1) The facility must employ on a full-time, part-time or consultant basis those professionals necessary to carry out the provisions of these requirements.
(2) Professional staff must be licensed, certified, or registered in accordance with applicable State laws.
(h)Use of outside resources.
(1) If the facility does not employ a qualified professional person to furnish a specific service to be provided by the facility, the facility must have that service furnished to residents by a person or agency outside the facility under an arrangement described in section 1861(w) of the Act or (with respect to services furnished to NF residents and dental services furnished to SNF residents) an agreement described in paragraph (h)(2) of this section.
(2) Arrangements as described in section 1861(w) of the Act or agreements pertaining to services furnished by outside resources must specify in writing that the facility assumes responsibility for—
(i) Obtaining services that meet professional standards and principles that apply to professionals providing services in such a facility; and
(ii) The timeliness of the services.
(1) The facility must designate a physician to serve as medical director.
(2) The medical director is responsible for—
(i) Implementation of resident care policies; and
(ii) The coordination of medical care in the facility.
(1) The facility must provide or obtain laboratory services to meet the needs of its residents. The facility is responsible for the quality and timeliness of the services.
(i) If the facility provides its own laboratory services, the services must meet the applicable requirements for laboratories specified in part 493 of this chapter.
(ii) If the facility provides blood bank and transfusion services, it must meet the applicable requirements for laboratories specified in part 493 of this chapter.
(iii) If the laboratory chooses to refer specimens for testing to another laboratory, the referral laboratory must be certified in the appropriate specialties and subspecialties of services in accordance with the requirements of part 493 of this chapter.
(iv) If the facility does not provide laboratory services on site, it must have an agreement to obtain these services from a laboratory that meets the applicable requirements of part 493 of this chapter.
(2) The facility must—
(i) Provide or obtain laboratory services only when ordered by the attending physician;
(ii) Promptly notify the attending physican of the findings;
(iii) Assist the resident in making transportation arrangements to and from the source of service, if the resident needs asistance; and
(iv) File in the resident's clinical record laboratory reports that are dated and contain the name and address of the testing laboratory.
(k)Radiology and other diagnostic services.
(1) The facility must provide or obtain radiology and other diagnostic services to meet the needs of its residents. The facility is responsible for the quality and timeliness of the services.
(i) If the facility provides its own diagnostic services, the services must meet the applicable conditions of participation for hospitals contained in § 482.26 of this subchapter.
(ii) If the facility does not provide its own diagnostic services, it must have an agreement to obtain these services from a provider or supplier that is approved to provide these services under Medicare.
(2) The facility must—
(i) Provide or obtain radiology and other diagnostic services only when ordered by the attending physician;
(ii) Promptly notify the attending physician of the findings;
(iii) Assist the resident in making transportation arrangements to and from the source of service, if the resident needs assistance; and
(iv) File in the resident's clinical record signed and dated reports of x-ray and other diagnostic services.
(1) The facility must maintain clinical records on each resident in accordance with accepted professional standards and practices that are—
(ii) Accurately documented;
(iii) Readily accessible; and
(iv) Systematically organized.
(2) Clinical records must be retained for—
(i) The period of time required by State law; or
(ii) Five years from the date of discharge when there is no requirement in State law; or
(iii) For a minor, three years after a resident reaches legal age under State law.
(3) The facility must safeguard clinical record information against loss, destruction, or unauthorized use;
(4) The facility must keep confidential all information contained in the resident's records, regardless of the form or storage method of the records, except when release is required by—
(i) Transfer to another health care institution;
(iii) Third party payment contract; or
(iv) The resident.
(5) The clinical record must contain—
(i) Sufficient information to identify the resident;
(ii) A record of the resident's assessments;
(iii) The plan of care and services provided;
(iv) The results of any preadmission screening conducted by the State; and
(v) Progress notes.
(m)Disaster and emergency preparedness.
(1) The facility must have detailed written plans and procedures to meet all potential emergencies and disasters, such as fire, severe weather, and missing residents.
(2) The facility must train all employees in emergency procedures when they begin to work in the facility, periodically review the procedures with existing staff, and carry out unannounced staff drills using those procedures.
(1) In accordance with section 1861(l) of the Act, the facility (other than a nursing facility which is located in a State on an Indian reservation) must have in effect a written transfer agreement with one or more hospitals approved for participation under the Medicare and Medicaid programs that reasonably assures that—
(i) Residents will be transferred from the facility to the hospital, and ensured of timely admission to the hospital when transfer is medically appropriate as determined by the attending physician; and
(ii) Medical and other information needed for care and treatment of residents, and, when the transferring facility deems it appropriate, for determining whether such residents can be adequately cared for in a less expensive setting than either the facility or the hospital, will be exchanged between the institutions.
(2) The facility is considered to have a transfer agreement in effect if the facility has attempted in good faith to enter into an agreement with a hospital sufficiently close to the facility to make transfer feasible.
(o)Quality assessment and assurance.
(1) A facility must maintain a quality assessment and assurance committee consisting of—
(i) The director of nursing services;
(ii) A physician designated by the facility; and
(iii) At least 3 other members of the facility's staff.
(2) The quality assessment and assurance committee—
(i) Meets at least quarterly to identify issues with respect to which quality assessment and assurance activities are necessary; and
(ii) Develops and implements appropriate plans of action to correct identified quality deficiencies.
(3) A State or the Secretary may not require disclosure of the records of such committee except in so far as such disclosure is related to the compliance of such committee with the requirements of this section.
(4) Good faith attempts by the committee to identify and correct quality deficiencies will not be used as a basis for sanctions.
(p)Disclosure of ownership.
(1) The facility must comply with the disclosure requirements of §§ 420.206 and 455.104 of this chapter.
(2) The facility must provide written notice to the State agency responsible for licensing the facility at the time of change, if a change occurs in—
(i) Persons with an ownership or control interest, as defined in §§ 420.201 and 455.101 of this chapter;
(ii) The officers, directors, agents, or managing employees;
(iii) The corporation, association, or other company responsible for the management of the facility; or
(iv) The facility's administrator or director of nursing.
(3) The notice specified in paragraph (p)(2) of this section must include the identity of each new individual or company.
(q)Required training of feeding assistants. A facility must not use any individual working in the facility as a paid feeding assistant unless that individual has successfully completed a State-approved training program for feeding assistants, as specified in § 483.160 of this part.
(r)Facility closure-Administrator. Any individual who is the administrator of the facility must:
(1) Submit to the Secretary, the State LTC ombudsman, residents of the facility, and the legal representatives of such residents or other responsible parties, written notification of an impending closure:
(i) At least 60 days prior to the date of closure; or
(ii) In the case of a facility where the Secretary or a State terminates the facility's participation in the Medicare and/or Medicaid programs, not later than the date that the Secretary determines appropriate;
(2) Ensure that the facility does not admit any new residents on or after the date on which such written notification is submitted; and
(3) Include in the notice the plan for the transfer and adequate relocation of the residents of the facility by a date that would be specified by the State prior to closure, including assurances that the residents would be transferred to the most appropriate facility or other setting in terms of quality, services, and location, taking into consideration the needs, choice, and best interests of each resident.
(s)Facility closure. The facility must have in place policies and procedures to ensure that the administrator's duties and responsibilities involve providing the appropriate notices in the event of a facility closure, as required at paragraph (r) of this section.