US · guidance
CMS SOM App. C, Tag D5989
§493.1359 Standard: PPM laboratory director responsibilities
(d) Evaluate and document the performance of individuals responsible for PPM
testing at least semiannually during the first year the individual tests patient
specimens. Thereafter, evaluations and documentation must be performed at least
annually.
Interpretive Guidelines §493.1359(d)
Provider-performed microscopy (PPM) procedure is a non-waived moderate complexity
test per §493.19(b)(2). The competency assessment intervals are the same as those for
moderate and high complexity.
If a CLIA Certificate of Compliance (CoC) or Certificate of Accreditation (CoA)
laboratory performs PPM procedures, then that laboratory is subject to all CLIA
regulations related to moderate complexity testing. In those laboratories with a CoC or
CoA, a technical consultant can perform competency assessment for moderate
complexity testing, including PPM procedures under §493.1413(b)(8). However, in a
CLIA certificate for PPM, the laboratory director is responsible for performing the
competency assessment.
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
3e09921cb8688f18f5b5411741937fa03a02489cf5cb94d743e9bdee89cae3f9
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