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

The Clinical Laboratory Improvement Amendments of 1998 (CLIA) establishes 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.

Because the OraQuick® Rapid HIV-1 Antibody Test is simple and accurate, the Food and Drug Administration (FDA) approved it as a waived test. Waived tests are determined to 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 required certificates and is the type to request if you plan to conduct only waived tests, such as the OraQuick test.

As a waived test, the OraQuick test can be used at many clinical and non-clinical testing sites, including community and outreach settings. Non-clinical testing sites that plan to provide the OraQuick test must either apply for their own CLIA Certificate of Waiver or establish an agreement to work under the CLIA Certificate of an existing laboratory. Any agency that has a CLIA Certificate of Waiver and is performing the OraQuick test is considered a clinical laboratory.

FDA restrictions also require that any facility planning to perform the OraQuick test 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. Quality assurance guidelines for OraQuick testing can be found at: http://www.phppo.cdc.gov/DLS/default.asp.

All sites ordering the OraQuick test will receive a letter from its manufacturer, OraSure Technologies, indicating that they agree to various requirements and restrictions, including:

• Sale is restricted to clinical laboratories (Any agency that has a CLIA Certificate of Waiver and performs the OraQuick test is considered a clinical laboratory.)
  
  
• A quality assurance plan is in place
  
  
• Staff have been trained to perform the test using manufacturer's instructions
  
  
• Clients 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, even for the OraQuick test, 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. CLIA contacts for all states can be found at the following Web site: http://cms.hhs.gov/clia/ssa-map.asp.

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. Traditional and non-traditional sites that want to perform OraQuick testing should contact their CLIA representative, listed at: http://cms.hhs.gov/clia/ssa-map.asp.

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 at http://www.cms.hhs.gov/clia 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.

• Sample completed form (PDF 82.2 KB, 4 Pages)

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. CMS has a list of these agencies by state at http://cms.hhs.gov/clia/ssa-map.asp. You can also contact your local state agency for assistance in filling out the application. You will need to submit the $150 fee with 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 following Web site: http:///www.cms.hhs.gov/clia

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