Clinical Laboratory Improvement Amendments (CLIA): Memos, Publications, and Resources

This page includes helpful resources related to clinical laboratories. Publications are files or websites with additional information. Division of Quality Assurance (DQA) numbered memos are documents that deal with:

• Policies for clinical laboratories.
• Guidelines for clinical laboratories managed by DQA.
• Information and interpretation of federal and state regulations.

Questions? Email dhsdqaclia@dhs.wisconsin.gov.

Publications

Select a link to learn more:

• Survey Guide: Clinical Laboratories, P-01227 (PDF) - Learn about Wisconsin Department of Health Services (DHS) CLIA surveys of clinical laboratories.

Provider resources

Wisconsin resources

• Provider Search - Use this tool to look up a clinical laboratory’s certificate of compliance. For Provider/Facility Type, select Clinical Laboratory.
• COVID-19: Requirements for Testing Providers - Important steps that need to be taken when planning to provide COVID-19 testing services in Wisconsin.
• Implied Consent Alcohol Testing Laboratories (PDF) - Find a list of implied consent approved labs for alcohol, controlled substances, and controlled substance analogs.

Federal resources

• Clinical Laboratory Improvement Amendments (CLIA) - Learn more from CMS (Centers for Medicare & Medicaid Services) about laws and regulations, documents, test complexities, and more.
• CLIA Information - Pay CLIA fees, get started on CLIA certification, and get more information from CMS.
• CMS CLIA Interpretive Guidelines (Appendix C) (PDF) - Learn about interpretive guidelines for CLIA regulations.
• CMS State Operations Manual - Learn more about regulations and guidance for clinical laboratories.
• eCFR :: 42 CFR Part 493 – Laboratory Requirements - Learn more about the federal CLIA regulations.
• Federal Resources - Find information about CMS, civil rights, the U.S. Department of Labor, and more.
• Laboratory Demographics Lookup - The CMS website allows you to search for CLIA-certified laboratories using CLIA numbers, facility names, addresses, geographic locations, or types of CLIA certificates.
• U.S. Food and Drug Administration (FDA) CLIA Database - Search for records of all commercially marketed laboratory tests approved by the FDA.
• U.S. Food and Drug Administration (FDA) COVID-19/SARS-CoV-2 EAU Database - Search for records of commercially marketed COVID-19 laboratory tests with Emergency Use Authorizations.

Memos

Memos from the Wisconsin Department of Health Services (DHS)

View our Memos Library to access a wealth of communications issued by DHS regarding policies and procedures and how they should be put into action.

DQA numbered memos

Select a link to view the memo. You can also view the list of all DQA Memos.

For an official paper copy of any numbered memo, email or write:

• Email dhswebmaildqa@dhs.wisconsin.gov.
• Mailing address:
  Administrator’s Office
  Division of Quality Assurance
  PO Box 2969
  Madison, WI 53701