[Code of Federal Regulations]
[Title 42, Volume 3]
[Revised as of October 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR493.19]

[Page 979]
 
                         TITLE 42--PUBLIC HEALTH
 
  CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF 
                  HEALTH AND HUMAN SERVICES (CONTINUED)
 
PART 493_LABORATORY REQUIREMENTS--Table of Contents
 
                      Subpart A_General Provisions
 
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) Provider-performed microscopy (PPM) examinations. 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, and M of this part.
    (2) Be subject to inspection as specified under subpart Q of this 
part.

[60 FR 20044, Apr. 24, 1995; 68 FR 50723, Aug. 22, 2003]