US · guidance
CMS SOM App. C, Tag D6168
§493.1487 Condition: Laboratories performing high complexity testing;
testing personnel.
The laboratory has a sufficient number of individuals who meet the qualification
requirements of §493.1489 of this subpart to perform the functions specified in
§493.1495 of this subpart for the volume and complexity of testing performed.
Interpretive Guidelines §493.1487
The Condition of Testing Personnel is not met when the testing personnel:
• Are not qualified; or
• Do not fulfill the testing personnel responsibilities.
The criteria used to determine the adequacy of the testing personnel involves evaluating
testing personnel responsibilities, ensuring that these responsibilities are specified by the
director in writing and are appropriate to ensure compliance with the reporting and
recordkeeping requirements, quality control monitoring, quality assessment activities,
and proficiency testing participation. Cite this deficiency only when problems are found
in areas that can be directly related to insufficient numbers of testing personnel. (Use
D6101 to relate the finding regarding 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
c9086fe37c4cd12d96f615c6b487a3a256dc4b618f832a214dc7c1574a101026
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