CLIA – Clinical Laboratory
Improvement Amendments
What is CLIA?
CLIA
regulations include federal standards that are applicable to any US Facility
that performs laboratory testing on specimens derived from humans for the
purpose of providing information for:
<!--[if !supportLists]-->o
<!--[endif]-->Diagnosis
or treatment of disease or impairment
<!--[if !supportLists]-->o
<!--[endif]-->Health
assessments
The
objective of CLIA is to ensure the accuracy, reliability, and timeliness of
test results regardless of where the test is performed
Clinical laboratory
testing helps health care providers screen for or monitor specific diseases or
conditions. It also helps assess patient health to make clinical decisions for
patient care. The Clinical Laboratory Improvement Amendments (CLIA) of 1988 (42
USC 263a) and the associated regulations (42 CFR 493) provide the authority for
certification and oversight of clinical laboratories and laboratory testing.
Under the CLIA program, clinical laboratories are required to have the
appropriate certificate before they can accept human samples for testing. There
are different types of CLIA certificates, as well as different regulatory
requirements, based on the types and complexity of clinical laboratory tests a
laboratory conducts.
CLIA CERTIFICATIONS:
Certificate of Waiver This certificate is issued to a laboratory
to perform only waived tests.
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.
Certificate of
Registration This
certificate is issued to a laboratory that enables the entity to conduct
moderate or high complexity laboratory testing or both until the entity is determined
by survey to be in compliance with the CLIA regulations.
Certificate of
Compliance This
certificate is issued to a laboratory after an inspection that finds the
laboratory to be in compliance with all applicable CLIA requirements.
Certificate of
Accreditation This
is a certificate that is issued to a laboratory on the basis of the
laboratory's accreditation by an accreditation organization approved by CMS.
Three federal
agencies are responsible for administering the CLIA program: the Centers for
Medicare & Medicaid Services (CMS), the Food and Drug Administration (FDA),
and the Centers for Disease Control and Prevention (CDC). Each agency has a
unique role.
CMS
FDA
CDC
A surgical pathology, gross and microscopic examination was performed for a colorectal polyp by a CLIA waived lab. How is this coded?
<!--[if !supportLists]-->A. <!--[endif]-->88305
<!--[if !supportLists]-->B.
<!--[endif]-->88305QW
<!--[if !supportLists]-->C. <!--[endif]-->88307
<!--[if !supportLists]-->D. <!--[endif]-->88307QW
A surgical pathology,
gross and microscopic examination performed for a colorectal polyp will be
coded with 88305. Since the service was performed in a CLIA waived lab, and
88305 requires modifier QW to denote a waived test, 88305QW is the appropriate
CPT® code.
Which
CLIA certification allows labs to perform 12 microscopic procedures in addition
to waived tests?
<!--[if !supportLists]-->E. <!--[endif]-->Certificate
of Waiver
<!--[if !supportLists]-->F.
<!--[endif]-->Certificate of Provider Performed
Microscopy Procedures
<!--[if !supportLists]-->G. <!--[endif]-->Certificate
of Registration
<!--[if !supportLists]-->H. <!--[endif]-->Certificate
of Compliance
In addition to the CLIA waived tests, the
Certificate of Provider Performed Microscopy Procedures (PPMP) allows a lab to
perform an additional 12 microscopic tests
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