US · guidance
CMS SOM App. Y, Tag Z197
(Standard) §486.346(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.
Interpretive Guidelines §486.346(c)
The OPO should develop its written protocols for packaging, labeling, handling and
shipping organs and the protocols should be consistent with OPTN rule 5.0 Standardized
Packaging and Transporting of Organ and Tissue Typing Materials.
The protocols must also require that an OPO staff member verify in writing that the ABO
indicated on the container label and the donor information documents being sent with the
organ are accurate. A second person, other than the person originally performing
verification of the labeling and documentation requirements, must also verify their
accuracy in writing. Review the sample of donor records to verify that the OPO has
documentation to confirm that this double confirmation occurred and was documented.
History
Rev. 115, Issued: 05-23-14, Effective: 05-23-14, Implementation: 05-23-14
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
504b5622da358ed03166f724e80bfdffe7005eb70eeeb75aeae348a4b3efd57a
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