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US · guidance

CMS SOM App. C, Tag D6106

§493.1445 Standard: Laboratory director responsibilities

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

(e)(14) Ensure that an approved procedure manual is available to all personnel

responsible for any aspect of the testing process; and

Interpretive Guideline §493.1445(e)(14)

The laboratory director can delegate to the technical supervisor the responsibility of

making the procedure manual available, but cannot delegate the responsibility for

signing, dating, and approving new and revised procedures.

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
f78f7d4e7b3473048d5890b553d07181dca20876d700a40fa9e329057ef119e8
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