42 CFR 403.738 - Condition of participation: Administration.
An RNHCI must have written policies regarding its organization, services, and administration.
(a)Standard: Compliance with Federal, State, and local laws. The RNHCI must operate in compliance with all applicable Federal, State, and local laws, regulations, and codes including, but not limited to, those pertaining to the following:
(2) Protection of human research subjects ( 45 CFR part 46).
(3) Application of all safeguards to protect against the possibility of fraud and abuse ( 42 CFR part 455).
(4) Privacy of individually identifiable health information ( 45 CFR part 164).
(b)Standard: Governing body.
(1) The RNHCI must have a governing body, or a person designated to function as a governing body, that is legally responsible for establishing and implementing all policies regarding the RNHCI's management and operation.
(c)Standard: Affiliations and disclosure.
(1) An affiliation is permissible if it is between one of the following:
(i) An individual serving as an uncompensated director, trustee, officer, or other member of the governing body of an RNHCI and a provider of medical treatment or services.
(ii) An individual who is a director, trustee, officer, employee, or staff member of an RNHCI and another individual, with whom he or she has a family relationship, who is affiliated with (or has an ownership interest in) a provider of medical treatment or services.
(iii) The RNHCI and an individual or entity furnishing goods or services as a vendor to both providers of medical treatment or services and RNHCIs.
(ii) The officers, directors, agents, or managing employees.