[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: 42CFR485.643]



[Page 612]

 

                         TITLE 42--PUBLIC HEALTH

 

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

                  HEALTH AND HUMAN SERVICES (CONTINUED)

 

PART 485_CONDITIONS OF PARTICIPATION: SPECIALIZED PROVIDERS--Table 

of Contents

 

 Subpart F_Conditions of Participation: Critical Access Hospitals (CAHs)

 

Sec. 485.643  Condition of participation: Organ, tissue, and eye 

procurement.



    The CAH must have and implement written protocols that:

    (a) 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 CAH. The OPO determines medical 

suitability for organ donation and, in the absence of alternative 

arrangements by the CAH, 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 CAH for this purpose;

    (b) 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;

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

family of each potential donor is informed of its option to either 

donate or not donate organs, tissues, or eyes. The individual designated 

by the CAH to initiate the request to the family must be 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;

    (d) Encourage discretion and sensitivity with respect to the 

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

    (e) Ensure that the CAH 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.

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

human kidney, liver, heart, lung, pancreas, or intestines (or 

multivisceral organs).



[65 FR 47110, Aug. 1, 2000, as amended at 66 FR 39938, Aug. 1, 2001]