US · guidance
CMS SOM App. C, Tag D5981
§493.1357 Standard: laboratory director qualifications
The laboratory director must be qualified to manage and direct the laboratory
personnel and the performance of PPM procedures as specified in §493.19(c) and
must be eligible to be an operator of a laboratory within the requirements of
subpart R of this part.
(a) The laboratory director must possess a current license as a laboratory director
issued by the State in which the laboratory is located, if the licensing is required.
(b) The laboratory director must meet one of the following requirements:
(b)(1) Be a physician, as defined in §493.2.
(b)(2) Be a midlevel practitioner, as defined in §493.2, authorized by a State to
practice independently in the State in which the laboratory is located.
Interpretive Guidelines §493.1357(b)(2)
Midlevel practitioner means a nurse midwife, nurse practitioner, nurse anesthetist,
clinical nurse specialist, or physician’s assistant licensed by the State within which the
individual practices, if such licensing is required in the State in which the laboratory is
located.
(b)(3) Be a dentist, as defined in §493.2.
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
8f0c97e7ea1b75be5e96a21b44bcb713bd50eaa98515cbee19a605e0095469dc
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