The federal government instituted the Clinical Laboratory Improvement Amendments in 1988 as a way to ensure accurate and reliable medical test results. These CLIA rules require any organization that runs clinical tests on human specimens to register with the Centers for Medicare & Medicaid Services and become CLIA-certified. The rules make an exception for certain tests (including many HIV tests) that are simple and have a low chance of error. To administer these tests legally, you must apply for a CLIA waiver. The form is available on the Centers for Medicare & Medicaid Services website.
Items you will need
Clinic or community organization
Approved Quality Assurance plan for testing procedures
CLIA waiver application (see Resources section)
Fill in the "General Information" section with the address of your clinic or community organization. Leave the "CLIA Identification Number" box blank if this is an initial application.
Check the "Certificate of Waiver" box in the "Type of Certificate Requested" section. Continue to the "Type of Laboratory" section. Select the description closest to the type of facility you operate. If none of the choices fits, select "Other" and write in your own description.
Fill out the hours you'll be testing (Section IV), then note whether you plan to test at multiple sites. If you are applying for only one site, continue to Section VI, "Waived Testing."
Indicate approximately how many waived tests you expect to administer each year. Unless your facility also administers non-waived tests, continue to Section VIII, "Type of Control." Select the best description of your organization. If nothing fits, select "Other" and write in a brief description.
If this is the only facility your director is affiliated with, continue to Section X, "Individuals Involved in Laboratory Testing." Indicate how many people in your organization will be carrying out tests. Sign and date the application.
On cdc.gov, find the office in your state that handles CLIA waivers and follow its instructions for application submission.
Every state has different rules about waived testing, so become familiar with local regulations to ensure you're compliant. Once approved, Certificates of Waiver are good for two years.
Nine months before your certificate expires, you must re-submit your application for a Certificate of Waiver if you wish to renew it.
Organizations in Washington State and New York (except for doctors' office labs in New York) do not need to apply for a CLIA waiver because both states' own regulations meet or exceed CLIA's. Apply directly to state health agencies if located in these states.
Even when you are outside a traditional clinic setting, comply at all times with CDC guidelines for working with blood and bodily fluids. The most important thing is for your employees and coworkers to stay safe.
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