US · guidance
CMS SOM App. Y, Tag Z177
(Standard) §486.344(c)(2) Ensure that screening and testing of the potential donor
(including point-of-care testing and blood typing) are conducted by a laboratory
that is certified in the appropriate specialty or subspecialty of service in accordance
with part 493 of this chapter.
Interpretive Guidelines §486.344(c)(2)
The OPO may accomplish laboratory testing in one of three ways.
a) The hospital laboratory of the donor hospital;
b) An agreement with an off-site laboratory;
c) Point of Care Testing (POCT); and/or
Verify through the Regional CLIA staff that all laboratories performing tests for the OPO
are appropriately CLIA certified. Ensure that if the OPO uses POCT (as identified in
donor records) the testing is performed by an OPO staff member who has received
training from laboratory personnel.
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
b13fd302e4da01898ee8a24f43f9a8afa5142b19d1bdca4ee1efce4e72deb933
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