US · guidance
CMS SOM App. C, Tag D5407
§493.1251 Standard: Procedure manual
(d) Procedures and changes in procedures must be approved, signed, and dated by
the current laboratory director before use.
Interpretive Guidelines §493.1251(d)
Verify that the methods in the procedure manual are current for tests offered by the
laboratory (e.g., reagent test kits and instruments used in the laboratory correlate with
methods in the procedure manual).
All laboratory procedures including CDC manuals, manufacturer’s operator manuals, and
package inserts must reflect the director’s review and approval including any
modifications in the procedure.
Approval of procedures and changes to procedures is the responsibility of the laboratory
director. This responsibility cannot be delegated. A coversheet may be used for the
director to approve the manual. Annual review of procedures is not required.
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
05791b8add113c159b9fc2ff9d92c8ced7717cda3643233d2503b4a1dead1fcd
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