CDC and CLIA The
Centers for Disease Control and Prevention (CDC) currently
has the responsibility for test categorization under the
Clinical Laboratory Improvement Amendments (CLIA).
Provider
Performed Microscopy (PPM) Requirements
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]
PPM
CPT Codes
- Wet mounts, including preparations of vaginal, certical
or skin specimens
Q0112
- All potassium hydroxide (KOH) preparations
Q0113
- Pinworm examinations
Q0114
- Fern test
Q0115
- Post-coital direct, qualitative examinations of vaginal
or cervical mucous
81015
- Urinalysis; microscopic only
81000
- Urinalysis, by dipstick or tablet reagent for bilirubin,
glucose, hemoglobin, ketones, leukocytes, nitrite, pH,
protein, specific gravity, urobilinogen, any number of
these constituents; non-automated, with microscopy
81001
- Urinalysis, by dipstick or tablet reagent for bilirubin,
glucose, hemoglobin, ketones, leukocytes, nitrite, pH,
protein, specific gravity, urobilinogen, any number of
these constituents; automated, with microscopy (NOTE: May
only be used when the lab is using an automated dipstick
urinalysis instrument approved as waived.)
81020
- Urinalysis; two or three glass test (CWF effective date
7/14/97)
G0026
- Fecal leukocyte examination
G0027
- Semen analysis; presence and/or motility of sperm
excluding Huhner
89190
- Nasal smears for eosinophils
CPT Professional Code
Books
CPT
professional code books are available from the following
groups: