The following was excerpted from the Code of Federal
Regulations: Title 42, Volume 3, Parts 430 to END (Revised 10/1/97) and contains the current list of provider-performed microscopy (PPM) procedures.
Sec. 493.19 Provider-performed microscopy (PPM) procedures.
(a) Requirement:
To be categorized as a PPM procedure, the procedure must meet the criteria
specified in paragraph (b) of this section.
(b) Criteria:
Procedures must meet the following specifications:
(1) The examination must be personally performed by one of the following practitioners:
(i) 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 an employee.
(ii) A midlevel practitioner, under the supervision of a physician or in independent
practice only if authorized by the State, during the patient's visit on a specimen
obtained from his or her own patient or from a patient of a clinic, group medical
practice, or other health care provider of which the midlevel practitioner is a member or
an employee.
(iii) 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.
(2) The procedure must be categorized as moderately complex.
(3) The primary instrument for performing the test is the microscope, limited to
bright-field or phase-contrast microscopy.
(4) The specimen is labile or delay in performing the test could compromise the accuracy
of the test result.
(5) Control materials are not available to monitor the entire testing process.
(6) Limited specimen handling or processing is required.
(c) A laboratory may qualify to perform tests under this section:
if it restricts PPM examinations to one or more of the following procedures (or
additional procedures added to this list as provided under paragraph (d) of this section),
waived tests and no others:
(1) All direct wet mount preparations for the presence or absence of bacteria, fungi,
parasites, and human cellular elements.
(2) All potassium hydroxide (KOH) preparations.
(3) Pinworm examinations.
(4) Fern tests.
(5) Post-coital direct, qualitative examinations of vaginal or cervical mucous.
(6) Urine sediment examinations.
(7) Nasal smears for granulocytes.
(8) Fecal leukocyte examinations.
(9) Qualitative semen analysis (limited to the presence or absence of sperm and detection
of motility).
(d) Revisions to criteria and the list of PPM procedures:
(1) The CLIAC conducts reviews upon HHS' request and recommends to HHS revisions to the
criteria for categorization of procedures.
(2) HHS determines whether a laboratory procedure meets the criteria listed under
paragraph (b) of this section for a PPM procedure. Revisions to the list of PPM procedures
proposed by HHS are published in the Federal Register as a notice with an opportunity for
public comment.
(e) Laboratory requirements:
Laboratories eligible to perform PPM examinations must--
(1) Meet the applicable requirements in subpart C or subpart D, and subparts F, H, J,
K, M, and P of this part.
(2) Be subject to inspection as specified under subpart Q of this part.
[60 FR 20044, Apr. 24, 1995]
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