A one-year countdown is under way for July 11, 2024. That is the effective date for the proficiency testing (PT) requirement revisions that will affect some clinical laboratories.

The revisions include the additions of 29 new regulated analytes, the removal of five regulated analytes, and changes to grading and reporting. The changes cover Regulations §§ 493.2 and 493.801 through 493.959.

Other changes will take place in 2025, and some changes took effect August 10, 2022, as the Centers for Medicare & Medicaid Services (CMS) released a final rule to update Clinical Laboratory Improvement Amendments (CLIA) proficiency testing regulations. This is the first update to the CLIA 1988 PT regulations since its inception in 1992.

Key Dates for Some Laboratories

Based on the final CMS Proficiency Testing Final Rule (CMS-3355-F) released on July 11, 2022, three dates over the course of implementation may impact some laboratories:

• January 1, 2025: Implementation date for the PT requirements for both PT vendors and laboratories.
• July 11, 2024: Effective date for the PT requirement revisions that include the additions of 29 new regulated analytes, the removals of five regulated analytes, and changes to grading and reporting. (Regulations §§ 493.2 and 493.801 through 493.959.)
• August 10, 2022: CMS clarified that PT referral regulations apply to waived testing as well as non-waived testing when a moderate- and high-complexity laboratory chooses to perform PT for waived tests. (Regulations §§ 493.20 and 493.25.)

5 Analytes Removed from Subpart I

• LDH isoenzymes
• Ethosuximide
• Quinidine
• Primidone
• Procainamide (and its metabolite, N acetyl procainamide)

Criteria for Acceptable Performance

Clinical laboratories should be aware of changes in performance criteria:

• Most limits were changed from standard deviations to percentage-based limits.
• Fixed Concentration Units were added to Fixed Percentage Units to address lower concentrations. For example:
  • Bilirubin, total – ±20% or ±0.4 mg/dL.
  • Thyroid-stimulating hormone – ±20% or ±0.2 mIU/L.
  • Lithium – ±15% or ±0.3 mmol/L.

For complete acceptable performance criteria, the final rule may be viewed at

https://www.federalregister.gov/documents/2022/07/11/2022-14513/clinical-laboratory-improvement-amendments-of-1988-clia-proficiency-testing-regulations-related-to

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