[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: 42CFR486.322]



[Page 650]

 

                         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.  486.322  Condition: Relationships with hospitals, critical access 



hospitals, and tissue banks.



    (a) Standard: Hospital agreements. An OPO must have a written 

agreement with 95 percent of the Medicare and Medicaid participating 

hospitals and critical access hospitals in its service area that have 

both a ventilator and an operating room and have not been granted a 

waiver by CMS to work with another OPO. The agreement must describe the 

responsibilities of both the OPO and hospital or critical access 

hospital in regard to donation after cardiac death (if the OPO has a 

protocol for donation after cardiac death) and the requirements for 

hospitals at Sec.  482.45 or Sec.  485.643. The agreement must specify 

the meaning of the terms ``timely referral'' and ``imminent death.''

    (b) Standard: Designated requestor training for hospital staff. The 

OPO must offer to provide designated requestor training on at least an 

annual basis for hospital and critical access hospital staff.

    (c) Standard: Cooperation with tissue banks.

    (1) The OPO must have arrangements to cooperate with tissue banks 

that have agreements with hospitals and critical access hospitals with 

which the OPO has agreements. The OPO must cooperate in the following 

activities, as may be appropriate, to ensure that all usable tissues are 

obtained from potential donors:

    (i) Screening and referral of potential tissue donors.

    (ii) Obtaining informed consent from families of potential tissue 

donors.

    (iii) Retrieval, processing, preservation, storage, and distribution 

of tissues.

    (iv) Providing designated requestor training.

    (2) An OPO is not required to have an arrangement with a tissue bank 

that is unwilling to have an arrangement with the OPO.