NOTE: Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 establishing authority to
promulgate standards for certain laboratory testing to ensure the accuracy, reliability and timeliness of test results regardless
of where or by whom the test was performed. The CLIA requirements are based on the complexity of the test and the type of
laboratory where the testing is performed. While every effort has been made to ensure the accuracy of this restatement, this
brochure is not a legal document. The official CLIA program requirements are contained in the relevant law, regulations and
rulings. Please note that state, local, and accreditation requirements may be more stringent.
Clinical Laboratory
Improvement Amendments (CLIA)
How to obtain a
CLIA Certificate
2
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.
3
As of the date of this publication’s release, there are seven CMS-approved accreditation
organizations:
•
AABB
•
American Association for Laboratory Accreditation (A2LA)
•
Accreditation Association for Hospitals and Health Systems/ Healthcare Facilities
Accreditation Program (AAHHS/HFAP)
•
American Society for Histocompatibility and Immunogenetics (ASHI)
•
COLA
•
College
of
American
Pathologists
(CAP)
•
The
Joint
Commission
Contact information for the above CMS-approved accreditation organizations is available
on the CMS CLIA website under Accreditation Organizations/Exempt States. If you
apply for accreditation by one of the CMS-approved accreditation organizations, you
must concurrently apply to CMS for a COA.
What is a waived test?
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 a
manufacturer’s application for test system waiver.
Where can
I
find a list of waived tests?
For a list of waived tests sorted by analyte name, visit the FDA website at:
CLIA – Currently Waived Analytes
Where can I find a list of Provider-performed Microscopy Procedures?
A list of provider-performed microscopy procedures is available on the
CMS CLIA website
.
Where can I find information about tests categorized as nonwaived (moderate
and/or high complexity)?
To determine which tests are categorized as waived or nonwaived (i.e., moderate or high
complexity), refer to the FDA CLIA Database.
4
How do I apply for a CLIA certificate?
The CLIA application (Form CMS-116) is available online. Send your completed
application to the address of the local State Agency for the State in which your
laboratory is located. Additionally, check with your
State
Agency
for any other state-
specific requirements. If you do not have online access and do not have information
about your
State
Agency
, you may contact the CLIA program at 410-786-3531 for the
address and phone number of your State Agency.
Is there any type of laboratory testing of human specimens that is not subject to
a CLIA certificate?
Yes, there are some testing exceptions that do not require CLIA certification.
The following exceptions to CLIA certification apply regardless of a laboratory’s
location:
•
Any laboratory that only performs testing for forensic purposes;
•
Research laboratories that test human specimens but do not report patient-specific
results for the diagnosis, prevention or treatment of any disease or impairment of, or
the assessment of the health of, individual patients; or
•
Laboratories certified by the Substance Abuse and Mental Health Services
Administration (SAMHSA), in which drug testing is performed that meets SAMHSA
guidelines and regulations. However, a CLIA certificate is needed for all other testing
conducted by a SAMHSA-certified laboratory.
NOTE:
The purpose for which the test is conducted, not the test itself, determines
whether a facility conducting testing is subject to the CLIA requirements. Testing that is
used to gather evidence for legal purposes, and is not performed for purposes of clinical
treatment, medical diagnosis, health assessment or disease prevention is not subject to
CLIA.
5
Are there any states in which
I do not have to apply for a
CLIA certificate?
Any laboratory located in a
state that has a CMS approved
laboratory program is exempt
from CLIA certification.
Currently, there are two states
with approved programs:
Washington and New York.
New York has a partial
exemption; therefore, if your
laboratory is located in that
state, contact the New York
State Agency
concerning yo
ur
need for a CLIA certificate.
If I have more than one laboratory location, do I need a CLIA certificate for each
location?
You will need a CLIA certificate for
each
location where you perform testing,
unless
you
qualify for one of the exceptions listed below:
•
Laboratories that are not at a fixed location; that is, laboratories that move from
testing site to testing site, such as mobile units providing laboratory testing, health
screening fairs, or other temporary testing locations may be covered under the
certificate of the designated primary site or home base, using its address.
•
Not-for-profit or Federal, State or local government laboratories that engage in limited
public health testing (not more than a combination of 15 moderately complex or
waived tests per certificate) may file a single application.
•
Laboratories within a hospital that are located at contiguous buildings on the same
campus and under common direction may file a single application for the laboratory
sites within the same physical location or street address.
Contact your
State
Agency
if you have questions or you are filing a single application for
more than one testing site.
6
What kind of fees do I have to pay for a CLIA certificate?
•
If you apply for a COW or a PPM certificate, you will pay
a waiver fee or PPM fee every two years. There are no
registration or compliance fees.
•
If you apply for a COC, you will pay a one-time registration
fee that covers the cost of the CLIA enrollment in addition
to a compliance survey fee that covers the cost of the initial
inspection by the State Agency. CMS will send you a Certificate
of Registration. Once compliance has been determined by your
inspection, you will pay a compliance certificate fee to CMS
and CMS will send you a COC. A two-year certificate cycle is
then established, and you will pay a compliance survey fee
and have a survey every two years. As long as the survey finds your laboratory to
be in compliance, you will pay a compliance certificate fee and CMS will send you a
renewed COC.
•
If you apply for a COA
, you will pay a registration fee that covers the cost of the CLIA
enrollment. Once CMS receives verification from the accreditation organization
that you have selected, you will pay an accreditation certificate fee and validation
survey fee to CMS and CMS will send you a COA.
A two-year certificate cycle is then
established and you will pay an accreditation certificate fee and a validation survey fee
every two years. CMS will send you a renewed COA every two years, as long as your
laboratory remains compliant. You will also pay fees to the accreditation organization.
You can obtain more information concerning the amount of certificate fees from the
CMS
CLIA website under “CLIA Certificate Fee Schedule” or from your State Agency. For
information concerning compliance (survey) fees, you may contact your
State
Agency
or
accreditation organization. These fees are based on the number and types of testing you
perform and must cover the cost of the CLIA program because CLIA is entirely user fee
funded.
Will I receive an identifying CLIA number?
You will receive a ten-character alpha-numeric code on the CLIA certificate. This number
will be utilized to identify and track your laboratory throughout its entire history. You
should use this number when making inquiries to the State Agency and CMS about your
laboratory.
7
When can I begin testing?
After you apply for your certificate, you will receive a coupon notifying you of the
corresponding fee. Follow the instructions on the fee coupon for payment. After your
payment is received, your certificate will be mailed to you. You generally may begin
testing once you have received your CLIA certificate, but you need to check with your
State
Agency
since some states have additional state-based requirements.
Will my laboratory receive a CMS survey?
Laboratories that have a COW or PPM certificate are not subject to routine surveys.
If your laboratory performs any nonwaived testing, the laboratory may have either a COC
or COA. All laboratories with either of these certificate types must meet all nonwaived
testing requirements and are subject to biennial surveys,
by
CMS or a CMS agent (such
as a surveyor from the State Agency) or by a CMS-approved accreditation organization, if
the laboratory elects to be accredited. COA laboratories must also meet the requirements
of their accreditation organization which may exceed or be more stringent than the CLIA
requirements.
Additionally, a limited percentage of laboratories with a COA will receive a validation
survey by CMS or a CMS agent. This is a survey performed by CMS or a CMS agent
to evaluate the results of the most recent survey performed by an accreditation
organization.
NOTE:
If CMS or the State Agency receives a complaint against your laboratory, you may
receive an unannounced on-site survey, even though you only perform waived tests or
PPM procedures.
If I have a certificate for PPM procedures, a certificate of registration, a COA or a
COC, can I also perform waived tests?
Yes,
these
certificates
permit
laboratories
to
also
perform
waived
tests.
If I have a COA or a COC, can I also perform PPM procedures?
Yes, these certificates permit laboratories to perform PPM procedures as well as waived
tests. The certificate you obtain should be for the highest (most complex) category of
testing you perform.
8
Do I need to notify anyone if I make any changes in my laboratory?
For
all
types of CLIA certification, you must notify the
State
Agency
within 30 days of
any changes in:
•
Ownership
•
Name
•
Location
•
Laboratory
Director
For laboratories with a Certificate of Accreditation (COA), you must also notify your
accreditation organization, in addition to the State Agency, within 30 days of any
changes mentioned above.
For Certificate of Compliance (COC) laboratories performing high complexity testing, you
must also notify the State Agency within 30 days of any changes in Technical supervisor.
If you perform only waived tests and wish to add PPM procedures or other nonwaived
(moderate or high complexity) testing to your menu, you must reapply for the
appropriate certificate using the same CLIA application (
Form
CMS-116
) you used for
your initial CLIA certification.
However, you cannot begin nonwaived testing until you have paid the appropriate fee,
and have received the appropriate certificate.
If you perform PPM procedures and wish to add other nonwaived (moderate or high
complexity) testing, you must first apply for the appropriate certificate.
If you have a COC or COA and wish to add tests categorized under a different laboratory
specialty or subspecialty than those on your current certificate or that employ a different
test method from those you are already performing, you must notify the
State
Agency
or
the accreditation organization of the new testing.
If I have any questions about my certificate or changes in my test menu, whom
should I contact?
You
should
contact
the
State
Agency
where
your
laboratory
is
located.
9
Where can I find additional information and guidance?
Refer to the “State Operations Manual,” Appendix C – Interpretive Guidelines (CMS
Publication 7) available on the CMS website. Links to other laboratory-related resources
can be found at these websites:
CLIA Law & Regulations
CDC CLIA website
FDA CLIA website
You can also email questions to the CMS Lab Excellence mailbox at:
LabExcellence@cms.hhs.gov
10
Hyperlink Table
Embedded Hyperlink
Complete URL
State Agency
https://www.cms.gov/Regulations-and-G
uidance/Legislation/CLIA/
Downloads/CLIASA.pdf
List of Provider-performed
Microscopy Procedures
https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/
Downloads/ppmplist.pdf
Accreditation Organizations
Exempt States
https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/
Accreditation_Organizations_and_Exempt_States.html
CLIA – Currently Waived Analytes
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/
analyteswaived.cfm
CMS PPMP List website
https://www.cms.gov/Regulations-and-G
uidance/Legislation/CLIA/
Downloads/ppmplist.pdf
FDA CLIA Database
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.
cfm
Form
CMS-116
https://www.cms.gov/Medicare/CMS-Fo
rms/CMS-Forms/
Downloads/CMS116.pdf
CMS CLIA website
https://www.cms.gov/Regulations-and-G
uidance/Legislation/CLIA/
index.html?redirect=/CLIA/
CLIA Certificate Fee Schedule
https://www.cms.gov/files/document/clia-ce
rtificate-fee-schedule-
updated-06/7/2024.pdf
Accreditation Organization
https://www.cms.gov/Regulations-and-G
uidance/Legislation/CLIA/
Downloads/AOList.pdf
State Operations Manual
https://www.cms.gov/Regulations-and-G
uidance/Guidance/
Manuals/Downloads/som107ap_c_lab.pdf
CLIA Law & Regulations
https://wwwn.cdc.gov/clia/Regulatory/default.aspx
CDC CLIA website
https://wwwn.cdc.gov/clia/default.aspx
FDA CLIA website
https://www.fda.gov/MedicalDevices/DeviceRegulationand
Guidance/IVDRegulatoryAssistance/ucm124105.htm
Marc h
2019
