[Code of Federal Regulations]

[Title 42, Volume 4]

[Revised as of October 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR493.19]



[Page 987-988]

 

                         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



[[Page 988]]



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]