Certificate of Waiver Medical Test Site 2026

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  1. Click ‘Get Form’ to open the Certificate of Waiver Medical Test Site application in the editor.
  2. Begin with Section 1: Demographic Information. Fill in your Uniform Business Identifier (UBI) number and Federal ID number if applicable. Ensure that all entries are clear and accurate.
  3. Continue to provide the Legal Owner/Operator Entity Name, complete mailing address, and contact details including phone, fax, email, and web address.
  4. In Section 2: Facility Specific Information, select the appropriate site type from the provided options. If you have additional locations under this license, attach a list as instructed.
  5. For Section 3: Key Individuals, enter the names and professional license numbers of both the Lab Director and Lab Contact Person along with their email addresses.
  6. In Section 4: Additional Information—Waived Tests, check all applicable tests performed at your facility. Verify their waived status on the FDA website as needed.
  7. Complete Section 5 by listing any other licensure or certification information required. Ensure to sign and date at the end of the form before submission.

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By the CLIA law, waived tests are those tests that are determined by CDC or FDA to be so simple that there is little risk of error. Some testing methods for glucose and cholesterol are waived along with pregnancy tests, fecal occult blood tests, some tests, etc.
Examples include physician offices, nursing facilities, home health agencies, clinics, pharmacies and other non-laboratory sites. They include a variety of individuals, primarily those who do not have formal laboratory training.
Common CLIA-Waived Test Examples: Urinalysis (dipstick) Rapid strep and flu tests. Pregnancy tests ()
Key Updates to CLIA Personell Rules for Laboratories Performing Nonwaived Tests A doctoral degree in chemical, biological, clinical, or medical laboratory science or medical technology. At least two years of laboratory training or experience.
A site that holds a Certificate of Waiver under CLIA (Clinical Laboratory Improvement Amendments) is required to comply with specific regulations and guidelines related to personnel qualifications, quality control, proficiency testing, and recordkeeping.

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The Centers for Medicare Medicaid Services (CMS), in collaboration with the Centers for Disease Control (CDC) and the Food Drug Administration (FDA), support the CLIA program to ensure quality laboratory testing. Why is CLIA important?

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