[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: 42CFR486.346]



[Page 655]

 

                         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.  486.346  Condition: Organ preparation and transport.



    (a) The OPO must arrange for testing of organs for infectious 

disease and tissue typing of organs according to current standards of 

practice. The OPO must ensure that testing and tissue typing of organs 

are conducted by a laboratory that is certified in the appropriate 

specialty or subspecialty of service in accordance with part 493 of this 

chapter.

    (b) The OPO must send complete documentation of donor information to 

the transplant center with the organ, including donor evaluation, the 

complete record of the donor's management, documentation of consent, 

documentation of the pronouncement of death, and documentation for 

determining organ quality. Two individuals, one of whom must be an OPO 

employee, must verify that the documentation that accompanies an organ 

to a transplant center is correct.

    (c) The OPO must develop and follow a written protocol for 

packaging, labeling, handling, and shipping organs in a manner that 

ensures their arrival without compromise to the quality of the organ. 

The protocol must include procedures to check the accuracy and integrity 

of labels, packaging, and contents prior to transport, including 

verification by two individuals, one of whom must be an OPO employee, 

that information listed on the labels is correct.

    (d) All packaging in which an organ is transported must be marked 

with the identification number, specific contents, and donor's blood 

type.