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e-CFR data is current as of January 14, 2021

Title 42Chapter IVSubchapter GPart 486Subpart G → §486.346

Title 42: Public Health
Subpart G—Requirements for Certification and Designation and Conditions for Coverage: Organ Procurement Organizations

§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)(1) 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. This information is available to the transplant center electronically.

(2) The OPO must physically send a paper copy of the following documentation with each organ:

(i) Blood type;

(ii) Blood subtype, if used for allocation; and

(iii) Infectious disease testing results available at the time of organ packaging.

(3) The source documentation must be placed in a watertight container in either of the following:

(i) A location specifically designed for documentation; or

(ii) Between the inner and external transport materials.

(4) 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.

[71 FR 31046, May 31, 2006, as amended at 81 FR 79881, Nov. 14, 2016]

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