US · guidance
CMS SOM App. C, Tag D5737
§493.1278 Standard: Histocompatibility
(a)(4) Participate in at least one national or regional cell exchange program, if
available, or develop an exchange system with another laboratory in order to
validate interlaboratory reproducibility.
Interpretive Guidelines §493.1278(a)(4)
Programs that meet the requirement for validating interlaboratory variability must assess
the primary areas of testing in histocompatibility laboratories by test techniques. For
example, antibody screening and identification, HLA typing for Class I (HLA-A, B, C)
and Class II (HLA-DR, DQ), and lymphocyte crossmatching. If a national or regional
program is not available, laboratories participating in a local exchange system should
document information concerning the frequency of exchange and the grading system. A
laboratory’s performance in a regional or national exchange program should be evaluated
against a peer group performing the same technique. Cite the deficiency D2000 if the
laboratory is not enrolled in a program or has not developed an exchange program or is
enrolled in a program/has developed an exchange program but fails to participate.
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
f1753bb316f264af66677755ced9c5a4418ce35d5bdd84eff343449aeee82132
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