Code of Federal Regulations]
[Title 42, Volume 3, Parts 430 to End]
[Revised as of October 1, 1999]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR482.45]
[Page 366-367]
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 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]
Texas has also adopted the Uniform Anatomical Gift Act. More
information about this act can be found at www.anantomicalgiftact.org.
