Do I need to have a CLIA certificate?
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 certain Federal requirements. If a facility performs tests
for these purposes, it is considered a laboratory under CLIA
and generally must apply and obtain a certificate from the CLIA
program that corresponds to the complexity of tests performed.
However, you may not need a CLIA certificate if your laboratory
is located in the states of New York or Washington, as those
States
operate
their
own
laboratory
regulatory
programs.
Contact
the
appropriate
State Agency
to determine if you need a CLIA certificate.
What are the different types of CLIA certificates and how long are they effective?
All types of certificates are generally effective for two years, and the different types of
certificates are:
•
Certificate
of
Waiver
(COW):
Issued
to
a
laboratory
that
performs
only
waived
tests.
•
Certificate for Provider-performed Microscopy (PPM) procedures: Issued to a laboratory
in which a physician, midlevel practitioner or dentist performs specific microscopy
procedures during the course of a patient’s visit. A limited list of provider-performed
microscopy procedures is included under this certificate type, which are categorized
as moderate complexity testing.
•
Certificate of Registration
*
: Issued to a laboratory to allow the laboratory to conduct
nonwaived (moderate and/or high complexity) testing until the laboratory is surveyed
(inspected) to determine its compliance with the CLIA regulations. Only laboratories
applying for a certificate of compliance or a certificate of accreditation will receive a
certificate of registration.
•
Certificate of Compliance (COC): Issued to a laboratory once the State Agency or
CMS surveyors conduct a survey (inspection) and determine that the laboratory is
compliant with the applicable CLIA requirements. This type of certificate is issued to a
laboratory that performs nonwaived (moderate and/or high complexity) testing.
•
Certificate of Accreditation (COA): Issued to a laboratory on the basis of the
laboratory’s accreditation by an accreditation organization approved by CMS. This
type of certificate is issued to a laboratory that performs nonwaived (moderate and/or
high complexity) testing.
*
A registration certificate is valid until an inspection is conducted and compliance is determined.