US · guidance
CMS SOM App. C, Tag D5763
§493.1278 Standard: Histocompatibility
(d) Crossmatching. For each type of crossmatch that a laboratory performs, the
laboratory must do the following, as applicable:
Interpretive Guidelines §493.1278(d)
Crossmatch methods in histocompatibility may include, but are not limited to, serologic
and non-serologic methods, such as flow cytometry, molecular methods, and any other
activity used to assess immunologic compatibility, such as a virtual or computer-based
crossmatch.
(d)(1) Establish and follow written policies and procedures for performing a
crossmatch.
Interpretive Guidelines §493.1278(d)(1)
The laboratory must have written policies and procedures that outline the decision
criteria for performing a crossmatch and the method to be used.
Confirm that the laboratory has verified the reagents appropriate for the specific
crossmatch method(s) in use. For deficiencies related to the verification of crossmatch
methods, use D5421; for the establishment of crossmatch methods, use D5423.
Probe §493.1278(d)(1)
What crossmatch method does that laboratory utilize? Does the laboratory have a policy
and procedure in place to ensure the validity of results?
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
9527a35dae4e0fcf1a34629bf79a8d4c35eb9c061911c697807855be250c2b0a
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