Providers may include
physicians, nurse practitioners,physicians’ assistants, or nurse midwives
. The following procedures are consisdered as Provider-Performed Microscopy Procedures (PPMP) and the performing laborotories should obtain a Certificate for Provider Performed Microscopy Procedures.
Who can perform moderately complex laboratory tests?
Moderate complexity classification has requirements for
the laboratory director, clinical consultant, technical consultant, and testing personnel
. High complexity classification has requirements for the laboratory director, clinical consultant, technical supervisor, general supervisor, and testing personnel.
What is CLIA Ppmp?
Certificate for Provider-Performed Microscopy Procedures
(PPMP) This certificate is issued to a laboratory in which a physician, midlevel practitioner or dentist performs no tests other than the microscopy procedures. This certificate permits the laboratory to also perform waived tests.
Who can perform waived testing?
The target audience includes individuals who perform testing in waived testing sites (
physician offices, nursing facilities, home health agencies, clinics, pharmacies and other non
-laboratory sites) throughout the United States.
What provider-performed microscopy procedures?
A CLIA Certificate for Provider-Performed Microscopy (PPM) procedures
permits physicians and midlevel practitioners to perform a limited list of moderate complexity microscopic tests
, as well as waived tests, as part of a patient’s visit.
Is blood bank considered high complexity testing?
The high complexity testing environments that include blood banking, microbiology identification procedures, microscopy, etc. require a
high level of independent judgment
and should only be performed by MTs.
What is considered a moderately complex test?
A test defined by the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as
one requiring basic lab knowledge and training for personnel performing the test
.
What is the purpose of CLIA?
The Clinical Laboratory Improvement Amendments (CLIA) program
regulates laboratories that test human specimens and ensures they give accurate, reliable, and timely patient test results
regardless of where the test is performed.
What are the 3 levels of CLIA testing?
Current Regulation: CLIA established three categories of tests:
waived tests, moderate complexity tests, and high complexity tests
.
What do you need to be CLIA certified?
CLIA generally requires
all facilities that perform even one applicable test
, including waived tests, on “materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings” to meet …
What are examples of waived tests?
These are simple tests with a low risk for erroneous results.
Drug test dip cards and drug test cups
are considered CLIA Waived tests. Sites that only perform waived testing require a CLIA certification.
What is waived test?
Waived Testing. As defined by CLIA, waived tests are
simple tests with a low risk for an incorrect result
. They include: Certain tests listed in the CLIA regulations. Tests cleared by the FDA for home use.
What tests are considered CLIA waived?
As defined by CLIA, waived tests are categorized as “
simple laboratory examinations and procedures that have an insignificant risk of an erroneous result
.” The Food and Drug Administration (FDA) determines which tests meet these criteria when it reviews manufacturer’s applications for test system waiver.
How is microscopy performed?
Optical or light microscopy involves
passing visible light transmitted through or reflected from the sample through a single lens or multiple lenses
to allow a magnified view of the sample. The resulting image can be detected directly by the eye, imaged on a photographic plate, or captured digitally.
What is a Ppmp?
A
Certificate of Provider-Performed Microscopy Procedures
(PPMP) permits a laboratory to perform a limited list of moderate complexity tests, as well as any waived tests. No survey is required but may be conducted and compliance with CLIA regulations is required.
What are microscopic tests?
Microscopic examination, which
identifies and counts the type of cells, casts, crystals, and other components
such as bacteria and mucus that can be present in urine.
