[Code of Federal Regulations]

[Title 42, Volume 3]

[Revised as of October 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR482.45]



[Page 498-499]

 

                         TITLE 42--PUBLIC HEALTH

 

  CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF 

                  HEALTH AND HUMAN SERVICES (CONTINUED)

 

PART 482_CONDITIONS OF PARTICIPATION FOR HOSPITALS--Table of Contents

 

                   Subpart C_Basic Hospital Functions

 

Sec. 482.45  Condition of participation: Organ, tissue, and eye 

procurement.



    (a) Standard: Organ procurement responsibilities. The hospital must 

have and implement written protocols that:

    (1) Incorporate an agreement with an OPO designated under part 486 

of this chapter, under which it must notify, in a timely manner, the OPO 

or a third party designated by the OPO of individuals whose death is 

imminent or who have died in the hospital. The OPO determines medical 

suitability for organ donation and, in the absence of alternative 

arrangements by the hospital, the OPO determines medical suitability for 

tissue and eye donation, using the definition of potential tissue and 

eye donor and the notification protocol developed in consultation with 

the tissue and eye banks identified by the hospital for this purpose;

    (2) Incorporate an agreement with at least one tissue bank and at 

least one eye bank to cooperate in the retrieval, processing, 

preservation, storage and distribution of tissues and eyes, as may be 

appropriate to assure that all usable tissues and eyes are obtained from 

potential donors, insofar as such an agreement does not interfere with 

organ procurement;

    (3) Ensure, in collaboration with the designated OPO, that the 

family of each potential donor is informed of its options to donate 

organs, tissues, or eyes or to decline to donate. The individual 

designated by the hospital to initiate the request to the family must be 

an organ procurement representative or a designated requestor. A 

designated requestor is an individual who has completed a course offered 

or approved by the OPO and designed in conjunction with the tissue and 

eye bank community in the methodology for approaching potential donor 

families and requesting organ or tissue donation;

    (4) Encourage discretion and sensitivity with respect to the 

circumstances, views, and beliefs of the families of potential donors;

    (5) Ensure that the hospital works cooperatively with the designated 

OPO, tissue bank and eye bank in educating staff on donation issues, 

reviewing death records to improve identification of potential donors, 

and maintaining potential donors while necessary testing and placement 

of potential donated organs, tissues, and eyes take place.

    (b) Standard: Organ transplantation responsibilities. (1) A hospital 

in which organ transplants are performed must be a member of the Organ 

Procurement and Transplantation Network (OPTN) established and operated 

in accordance with section 372 of the Public Health Service (PHS) Act 

(42 U.S.C. 274) and abide by its rules. The term ``rules of the OPTN'' 

means those rules provided for in regulations issued by the Secretary in 

accordance with section 372 of the PHS Act which are enforceable under 

42 CFR 121.10. No hospital is considered to be out of compliance with



[[Page 499]]



section 1138(a)(1)(B) of the Act, or with the requirements of this 

paragraph, unless the Secretary has given the OPTN formal notice that he 

or she approves the decision to exclude the hospital from the OPTN and 

has notified the hospital in writing.

    (2) For purposes of these standards, the term ``organ'' means a 

human kidney, liver, heart, lung, or pancreas.

    (3) If a hospital performs any type of transplants, it must provide 

organ-transplant-related data, as requested by the OPTN, the Scientific 

Registry, and the OPOs. The hospital must also provide such data 

directly to the Department when requested by the Secretary.



[63 FR 33875, June 22, 1998]