US · guidance
CMS SOM App. C, Tag D3019
§493.1103 Standard: Requirements for transfusion services
(b) Provision of testing. The facility must provide prompt ABO grouping, D (Rho)
typing, unexpected antibody detection, compatibility testing, and laboratory
investigation of transfusion reactions on a continuous basis through a CLIA-certified laboratory or a laboratory meeting equivalent requirements as determined
by CMS.
Interpretive Guidelines §493.1103(b)
Review the agreement and determine if the outside laboratory is CLIA-certified or
equivalent, as determined by CMS. An equivalent laboratory is a Veterans Health
Administration (VHA) laboratory, a CLIA-exempt laboratory or a laboratory under the
auspices of the Department of Defense (DoD).
Probes §493.1103
For laboratories performing ABO grouping, D typing, unexpected antibody detection or
compatibility testing using automated methods, is there a back-up system in place to
ensure availability of service on a continuous basis when the automated system is
malfunctioning?
Is staff trained and competent in the back-up system?
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
c96f0e7ae23672d1c23fc465bc53cb2e7aa16199ba3694ec780ffa4ff5c21634
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