US · guidance

CMS SOM App. C, Tag D6063

§493.1421 Condition: Laboratories performing moderate complexity

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

testing; testing personnel.

The laboratory must have a sufficient number of individuals who meet the

qualification requirements of §493.1423, to perform the functions specified in

§493.1425 for the volume and complexity of tests performed.

Interpretive Guidelines §493.1421

The Condition of testing personnel is not met when the testing personnel:

• Is not qualified; or

• Does not fulfill the testing personnel responsibilities.

The criteria used to determine the adequacy of the testing personnel involves evaluating

testing personnel responsibilities, and ensuring that these responsibilities are specified in

writing by the director, and that the responsibilities are appropriate to ensure compliance

with the requirements concerning reporting and recordkeeping, quality control

monitoring, quality assurance activities and proficiency testing participation. Cite this

deficiency only when compliance problems are found in these areas that can be directly

related to insufficient numbers of testing personnel. (Use D6028, which relates the

finding of insufficient personnel to director responsibilities.)

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: 995d04400456a41f925efc7638f241d610cf3c517a36ecca20b84fc3ff17a544

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