CLIA Certificate of Waiver

How to Obtain a Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver

hiv testing nonclinical 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 existing laboratory.

FDA 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 [PDF – 142 KB].

All sites 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 manufacturer’s instructions
  • Clients will receive a “Subject Information” pamphlet before the test is given and receive appropriate information* when results are provided

State Involvement

Many 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.

Before 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 states.

Exceptions: Washington 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 following information:

  1. General Information – 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.
  2. Type of Certificate Requested – request a Certificate of Waiver.
  3. 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.”
  4. Hours of Laboratory Testing – indicate the times you plan to do testing.
  5. Multiple Sites – 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.
  6. Waived Testing – estimate the number of tests you will be performing annually.
  7. Non-Waived Tests – skip this section if you are performing a waived test only.
  8. Type of Control – check the type of organization for which you are making this application (private non-profit, for-profit, government).
  9. Director Affiliation 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.)
  10. 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.
  11. Consent and Signature – carefully read the consent information at the bottom of p. 4 before signing and dating.

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 states. 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 expiration date.

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.

Regulatory Oversight of Laboratory Testing:

Clinical Laboratory Improvement Amendments (CLIA)