Compliance Tool: Checklist for Avoiding 10 Top CLIA Deficiencies for Labs

Even experienced laboratories can find themselves on the receiving end of CLIA citations if they aren’t prepared for an inspection. Here are 10 of the most common CLIA deficiencies, based on recent Centers for Medicare & Medicaid Services (CMS) data, and steps to avoid these issues.

1. Personnel Competency Assessment (complete and document)

• [ ]  ACTION: Create competency assessment entries for all staff, including consultants fulfilling CLIA responsibilities, on your lab’s shared calendar and ensure these assessments are completed.

• [ ]  ACTION: Create an SOP on how each staff member’s role should be specifically assessed. Ensure this SOP is available in the lab.

2. Analytic Systems (define criteria for lab conditions; monitor and document conditions)

• [ ]  ACTION: Develop clear SOPs for conditions and make them available in the lab.

3. General Lab Systems (accuracy assessed twice per year)

• [  ] ACTION: Create two accuracy check entries on your shared calendar per year and ensure the checks are completed. Document the checks.

4. Verification of Performance Specifications (match manufacturer’s specifications)

• [ ]  ACTION: Create an SOP with each equipment manufacturer’s specifications.

• [ ]  ACTION: Create a calendar entry ahead of your next inspection window to test equipment performance to ensure it is within the appropriate range.

5. Analytic Systems (procedural manual)

• [ ]  ACTION: Create a procedure manual with SOPs detailing each and every test’s full process, start to finish.

6. Procedure Manual (available and followed)

• [ ]  ACTION: Ensure your procedure manual is in the lab and available as a reference to all staff members.

• [ ]  ACTION: Ensure your staff follows each procedure appropriately during their competency evaluations.

7. Analytic Systems (maintenance frequency)

• [ ]  ACTION: Create calendar entries to schedule maintenance at frequencies specified by the manufacturer and ensure said maintenance occurs. Document the maintenance.

8. Analytic Systems (not using expired, deteriorated, and/or substandard supplies)

• [ ]  ACTION: Check supplies regularly; log expiration dates and procedures to follow when using certain supplies in the appropriate SOPs.

9. Post Analytic Systems (test report inclusions)

• [ ]  ACTION: Ensure your test report has the required information mandated by CLIA standard 493.1291(c).

10. Lab Director’s Responsibility (proficiency testing enrollment)

• • [ ]  ACTION: Work with your lab director to ensure your lab is enrolled in one of the U.S. Department of Health and Human Services (HHS) approved proficiency testing programs listed by specialty here.