US · guidance
CMS SOM App. C, Tag D5735
§493.1278 Standard: Histocompatibility
(a)(3) If the laboratory uses immunologic reagents to facilitate or enhance the
isolation or identification of lymphocytes or lymphocyte subsets, the efficacy of the
methods must be monitored with appropriate quality control procedures.
Interpretive Guidelines 493.1278(a)(3)
Lymphocytes can be isolated from peripheral blood, lymph nodes, and spleen. These
cells can be further separated into subsets, such as T cells and B cells. The laboratory
should have policies and/or procedures for assessment of these specimens to determine
their acceptability, and efficacy of the methods, to include criteria for acceptability.
Quality control procedures must be sufficient to determine the acceptability of specimens
that have been treated for the enhancement or isolation of cellular lines or subsets. For
deficiencies related to the procedure, to assess specimen acceptability use D5403 through
D5409, depending on the issue identified; for control material acceptability, use D5469.
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
f1a6c8caba3edf0eb9d4343f7b18bd1440710b291d4e1bb086bad626abbaa8a9
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