How to Obtain a Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver
The Clinical Laboratory Improvement Amendments of
1988 (CLIA) establish quality standards for laboratory testing to ensure the
accuracy, reliability, and timeliness of patient test results. CLIA requires
that any facility examining human specimens for diagnosis, prevention, treatment
of a disease or for assessment of health must register with the federal Centers
for Medicare & Medicaid Services (CMS) and obtain CLIA certification.
The Food and Drug
Administration (FDA) has approved several rapid HIV tests as waived tests
under CLIA. Waived tests must use unprocessed specimens (whole blood or oral
fluid), be easy to use, and have little risk of an incorrect result. So far,
more than 1,400 test systems have been waived. A Certificate of Waiver is
one of four types of certificates issued under CLIA, and is the type to
request if you plan to conduct only waived rapid HIV tests.
Waived rapid HIV tests can be used at many
clinical and non-clinical testing sites, including community and outreach
settings. Any agency that is performing waived rapid HIV tests is considered
a clinical laboratory. Non-clinical testing sites that plan to offer waived
rapid HIV tests must either apply for their own CLIA Certificate of
Waiver or establish an agreement to work under the CLIA Certificate of an
restrictions also require that any facility planning to perform waived rapid
HIV tests must have a quality assurance plan – step-by-step
activities that ensure testing is carried out correctly, results are
accurate, and mistakes are found and corrected.
View the quality assurance guidelines
for rapid HIV testing.
that order rapid HIV tests must certify to the manufacturer that they agree to
comply with specific requirements and restrictions that the FDA has established
for rapid HIV tests:
- Sale is restricted to
clinical laboratories (Any agency that performs rapid HIV tests is
considered a clinical laboratory, and must have a CLIA certificate.)
- A quality assurance plan for rapid HIV testing
must be in place
- Staff have been trained to perform the test using
will receive a “Subject Information” pamphlet before the test is given and
receive appropriate information* when results are provided
more about counseling with rapid HIV testing.
states have additional regulations that apply to laboratory testing, and
some require separate applications to the state agency. Some regulations
also apply specifically to HIV testing. These regulations may require
training to provide counseling, testing, and referral services, draw blood,
or perform the test. Some states regulate who may provide HIV testing,
perform the test, or give test results. For example, some states require a
written HIV test order from a licensed medical professional.
applying, you should consider these applicable requirements and the best method
for receiving the authority for testing, including contacting your state health
department and your local CMS inspector for guidance.
View CLIA contacts for all
State is exempt from CLIA regulations. New York is also exempt from CLIA, except
for physicians' office labs, which are required to have a CLIA certificate. Both
states have their own requirements that meet or exceed CLIA requirements.
How to Apply for a CLIA Certificate of Waiver
Obtaining a Certificate of Waiver is generally a straightforward process. An
application (form CMS-116) can be obtained at the
CMS Web site or from
your state health department. The application is four pages and requests the
– provide information about your organization, including street address,
name of director, and federal tax identification number. Don't fill out
the CLIA identification number if this is an initial application.
Type of Certificate
request a Certificate of Waiver.
Type of Laboratory
– indicate the facility or setting in which you will perform the rapid
test, e.g., community clinic, health fair, mobile laboratory (van). If
none of the categories apply to your setting, check “other.”
Hours of Laboratory
indicate the times you plan to do testing.
– indicate if you will be doing testing at more than one site. If you
will have multiple sites, provide the number of sites and complete the
remainder of this section. In general, a mobile van is considered a
multiple site if it is not in a fixed location and moves from site to
site for testing. If that is the case, the name and address of the
testing site for that van would be the same as the organization it
operates under or the physical location where the van is housed.
– estimate the number of tests you will be performing annually.
– skip this section if you are performing a waived test only.
Type of Control
– check the type of organization for which you are making this
application (private non-profit, for-profit, government).
With Other Laboratories
– provide the name and address of other laboratories (facilities) that
your director also directs. (CLIA regulations allow a director to direct
a maximum of five laboratories.)
Individuals Involved in
Laboratory Testing – indicate the total number of individuals involved in testing
(those who are directing, supervising, consulting, or testing). Include
counselors only if they will perform or supervise testing.
- Consent and Signature – carefully read the consent information at the bottom of p. 4 before
signing and dating.
a sample completed form.
The Certificate of Waiver application should be
forwarded to the address of the local state agency of the state in which the
testing will be performed.
View CLIA contacts for all
You can also contact your local state agency for
assistance in filling out the application.
The Certificate of Waiver is
valid for two years. A renewal application will need to be completed and
sent to the state agency not less than 9 months before the certificate's
The fee for a Certificate of waiver is $150.
For additional information or assistance in
filling out the CLIA waiver application, please call CMS Toll-Free:
877-267-2323; Local: 410-786-3000; TTY Toll-Free: 866-226-1819; TTY Local:
410-786-0727. Or visit the CLIA Web site.