By Kristine Hansbery
Director of WSLH Proficiency Testing

I am perpetually surprised at how confusing the world of laboratory regulations can be; so, I decided to write a brief summary that gets down to the basics.

• Top agency is CMS Center for Medicare and Medicaid formally known as HCFA
• CMS enforces the rules
• The rules are CLIA 88
  https://www.cdc.gov/clia/law-regulations.html
• Inspecting agencies are listed below or can be found here
  https://www.cms.gov/Regulations-andGuidance/Legislation/CLIA/Downloads/AOList.pdf
• Joint Commission
  https://www.jointcommission.org/
• COLA http://www.cola.org/
• CAP https://www.cap.org/
• CLIA (state office)
• AABB (blood bank)
  http://www.aabb.org/Pages/default.aspx
• A2LA https://www.a2la.org/accreditation/clinical-testing
• HFAP https://www.hfap.org/
• ASHI https://www.ashi-hla.org/

All laboratories at minimum must meet CMS requirements as stated in CLIA 88 and can be inspected by their state agency.

If laboratory chooses to do more the agencies listed above are the most common alternates selected.

Proficiency testing is separate from the regulatory agencies. CLIA mandates which laboratory tests require proficiency testing; however, your regulatory agent may require more.

Proficiency testing providers provide unknown samples and score performance of laboratories testing those samples. The scores are reported to CMS and any other regulatory agent the laboratory is signed up with.

A list of proficiency testing providers can be found here.

In summary:

• Laboratories must comply with CLIA 88 regulations. Laboratories can be inspected by their state agency (CLIA office) or sign up with an alternate regulatory agent approved by CMS/CLIA
• Laboratories performing testing that is not waived must sign up for proficiency testing and there are several choices.

For further information, visit our Resource page.