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 and provider resources

Select a link to learn more.

Laboratory look-up

• CMS CLIA Laboratory Lookup - The CMS website allows you to search for CLIA-certified laboratories using CLIA numbers, facility names, addresses, geographic locations, or types of CLIA certificate.
• Wisconsin Provider Search - Use this tool to look up Wisconsin CLIA labs. This database includes Statement of Deficiencies and Plan of Corrections for Wisconsin Certificate of Compliance laboratories. For Provider/Facility Type, select Clinical Laboratory.
• Implied Consent Alcohol Testing Laboratories (PDF) - DQA issues permits for analysts in laboratories throughout Wisconsin to perform legal forensic testing under Wis. Stat. ch. 343. This directory lists the laboratories that can perform the required testing under this statute.

Regulatory Compliance

• Clinical Laboratory Improvement Amendments (CLIA) - Learn from CMS (Centers for Medicare & Medicaid Services) about CLIA laws and regulations with links to categorization/complexity of tests, CLIA brochures, proficiency testing information and more.
• CMS State Operations Manual (SOM) Chapter 6 - Special Procedures for Laboratories (PDF) - Learn about CMS's policy regarding survey and certification for clinical laboratories.
• CMS SOM App. C - Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services (PDF) - Learn about CMS's survey protocol and interpretive guidelines for CLIA regulations.
• Code of Federal Regulations 42 CFR Part 493 Laboratory Requirements - Learn more about the federal CLIA regulations.
• Food and Drug Administration (FDA) CLIA Database - Search for records of all commercially marketed laboratory tests approved by the FDA.
• 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.
• WI Department of Health Services (DHS) Survey Guide: Clinical Laboratories, P-01227 (PDF) - Learn about DHS's CLIA survey process and complaint investigations for Wisconsin CLIA laboratories.

Education and support

• CDC Division of Laboratory Systems (DLS) - Learn about CDC's resources to improve the quality and safety of clinical and public health testing and practice.
  • CDC's Next Generation Sequencing (NGS) Quality Initiative - NGS-focused quality management system (QMS) based on the Clinical & Laboratory Standards Institute (CLSI) framework of 12 Quality Systems Essentials (QSEs) that includes more than 100 ready-to-implement guidance documents, customizable standard operating procedures, and other tools to download and customize for your laboratory specific methods and needs.
  • CDC's Provider-Performed Microscopy (PPM) Webpage - Find links to educational and training resources to support CLIA PPM laboratories.
    • CDC's Basic Microscopy Online Course
  • CDC's Waived Testing Webpage - Find links to educational and training resources to support CLIA Certificate of Waiver laboratories.
• CDC About OneLab^TM - Learn about CDC's initiative that bridges, trains, and sustains a network of laboratory professionals and testers. It is a multi-faceted platform that includes: OneLab REACH^TM, OneLab Network, OneLab TEST, OneLab VR, OneLab Summit, OneLab Resources, and OneLab Assessments.
• CLIA Brochures - CMS developed brochures to help explain CLIA regulation requirements and more.
  • CLIA Brochure: Laboratory Director Responsibilities (PDF)
  • CLIA Brochure: Proficiency Testing and PT Referral (PDF)
  • CLIA Brochure: What Do I Need to Do to Assess Personnel Competency? (PDF)
  • CLIA Brochure: Verification of Performance Specifications (PDF)
  • CLIA Brochure: Calibration and Calibration Verification (PDF)
• CMS Individualized Quality Control Plan (IQCP) - CMS webpage with IQCP resources.
  • CLIA Brochure: CLIA Individualized Quality Control Plan Introduction (PDF)
  • CLIA Brochure: CLIA IQCP, What is an IQCP? (PDF)
  • CLIA Brochure: CLIA IQCP, Consideration When Deciding to Develop an IQCP (PDF)
  • IQCP Workbook: Developing an IQCP, A Step-by-Step Guide (PDF)
• Federal Resources - Find links to the CDC, CMS, Health Insurance Marketplace, the U.S. Department of Labor, and more.
• Non-federal resources – Note: CMS and/or the CDC cannot attest to the accuracy of non-federal websites and linking to a non-federal website does not constitute an endorsement by CMS or the CDC of any information or products presented on these websites.
  • Association of Public Health Laboratories (APHL) represents state and local governmental health laboratories in the United States.
    • APHL Learning Center – Register for access to free on-demand courses and webinars.
    • APHL Publications Library – Search “free” for published laboratory resources available to non-members.
      • APHL CLIA Internal Audit Checklist (PDF)
      • APHL Test Verification and Validation Toolkit
  • Clinical and Laboratory Standards Institute (CLSI) Free Resources - Micro Free (formerly M100 Free) includes read-only access to critical microbiology standards focused on Antimicrobial Susceptibility Testing (AST).

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