StacksVerified U.S. regulatory reference

42 CFR §493.1365

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
The testing personnel are responsible for specimen processing, test performance, and for reporting test results. Any PPM procedure must be—
  1. (a)Personally performed by one of the following practitioners:
    1. (1)A physician during the patient's visit on a specimen obtained from his or her own patient or from a patient of a group medical practice of which the physician is a member or employee.
    2. (2)A midlevel practitioner, under the supervision of a physician or in independent practice if authorized by the State in which the laboratory is located, during the patient's visit on a specimen obtained from his or her own patient or from the patient of a clinic, group medical practice, or other health care provider, in which the midlevel practitioner is a member or an employee.
    3. (3)A dentist during the patient's visit on a specimen obtained from his or her own patient or from a patient of a group dental practice of which the dentist is a member or an employee; and
  2. (b)Performed using a microscope limited to a brightfield or a phase/contrast microscope.