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US · guidance

CMS SOM App. C, Tag D2165

§493.861 Standard: Unexpected antibody detection

activein force · 2026-07-22 – presentas-observed

(b) Failure to participate in a testing event is unsatisfactory performance and results

in a score of 0 for the testing event.

Consideration may be given to those laboratories failing to participate in a testing

event only if--

(1) Patient testing was suspended during the time frame allotted for testing and

reporting proficiency testing results;

(2) The laboratory notifies the inspecting agency and the proficiency testing

program within the time frame for submitting proficiency testing results of the

suspension of patient testing and the circumstances associated with failure to

perform tests on proficiency testing samples; and

(3) The laboratory participated in the previous two proficiency testing events.

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
bd435d61582d092e55f37a95cb49a5096caa1a1442f056ec61b4b02ebcc0d4ca
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CMS SOM App. C, Tag D2165 — §493.861 Standard: Unexpe… · binding.law