US · guidance
CMS SOM App. C, Tag D5731
§493.1278 Standard: Histocompatibility
(a)(2) Establish and follow written policies and procedures for the storage and
retention of specimens based on the specific type of specimen. All specimens must
be easily retrievable. The laboratory must have an emergency plan for alternate
storage.
Interpretive Guidelines §493.1278(a)(2)
In addition to current specimens, HLA laboratories may store historic specimens from
recipients necessary for pre-transplant crossmatching. These specimens may be used for
monitoring the recipient’s antibody status or for the investigation of organ rejection.
In addition to having a continuous monitoring system for specimens (and reagents), the
laboratory must have a plan in place to store all specimens in an alternate location when
storage temperatures are exceeded. An emergency plan for alternate storage of both
current and historic patient serum specimens for pre-transplant crossmatching and
investigation of organ rejection is critical.
Probe §493.1278(a)(2)
What is the laboratory’s plan for storage and retention that ensures easy retrieval of
specimen(s) for each specimen type
?
Does the laboratory have a policy for alternate storage of specimens?
Does the laboratory have an emergency plan to address widespread failures that may
affect specimen integrity, such as power outages, that may affect storage conditions and
continuous monitoring systems?
History
Rev. 233; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
a553fe4fd7b5af69c850a5e328a971ade76a4b894778e36f32786ad527ac5931
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