[Code of Federal Regulations]

[Title 42, Volume 4]

[Revised as of October 1, 2006]

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

[CITE: 42CFR486.342]



[Page 653]

 

                         TITLE 42--PUBLIC HEALTH

 

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

                  HEALTH AND HUMAN SERVICES (CONTINUED)

 

PART 486_CONDITIONS FOR COVERAGE OF SPECIALIZED SERVICES FURNISHED BY 

 

Subpart G_Requirements for Certification and Designation and Conditions 

              for Coverage: Organ Procurement Organizations

 

Sec.  486.342  Condition: Requesting consent.



    An OPO must encourage discretion and sensitivity with respect to the 

circumstances, views, and beliefs of potential donor families.

    (a) An OPO must have a written protocol to ensure that, in the 

absence of a donor document, the individual(s) responsible for making 

the donation decision are informed of their options to donate organs or 

tissues (when the OPO is making a request for tissues) or to decline to 

donate. The OPO must provide to the individual(s) responsible for making 

the donation decision, at a minimum, the following:

    (1) A list of the organs and/or tissues that may be recovered.

    (2) The most likely uses for the donated organs or tissues.

    (3) A description of the screening and recovery processes.

    (4) Information about the organizations that will recover, process, 

and distribute the tissue.

    (5) Information regarding access to and release of the donor's 

medical records.

    (6) An explanation of the impact the donation process will have on 

burial arrangements and the appearance of the donor's body.

    (7) Contact information for individual(s) with questions or 

concerns.

    (8) A copy of the signed consent form if a donation is made.

    (b) If an OPO does not request consent to donation because a 

potential donor consented to donation before his or her death in a 

manner that satisfied applicable State law requirements in the potential 

donor's State of residence, the OPO must provide information about the 

donation to the family of the potential donor, as requested.



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