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US · guidance

CMS SOM App. C, Tag D2082

§493.837 Standard: General immunology

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

(e)(1) For any unsatisfactory analyte or test performance or testing event for

reasons other than a failure to participate, the laboratory must undertake

appropriate training and employ the technical assistance necessary to correct

problems associated with a proficiency testing failure.

(2) For any unacceptable analyte or testing event score, remedial action must be

taken and documented, and the documentation must be maintained by the

laboratory for two years from the date of participation in the proficiency testing

event.

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
2c75d6446dc1dfc18119b74457d5b2d749cb16ff060075ca9e18b84d330146ed
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