New and revised laboratory requirements maintain CMS alignment for proficiency testing analytes

New and revised requirements are effective Jan. 1, 2025, for Joint Commission accredited laboratories. The changes were made in response to revisions to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations for proficiency testing (PT) analytes and acceptable performance requirements. The updates reflect current practice and address the more accurate and precise technology that is being used.

The Joint Commission revised Quality System Assessment for Nonwaived Testing (QSA) Standards QSA.01.01.01, Element of Performance (EP) 5, and QSA.01.04.01, EP 1, and developed new Standard QSA.01.01.01, EP 9, to address the updated regulations. The revisions include the following:

• Requiring laboratories to report PT results for microbiology organism identification to the highest level that they report results on patient specimens
• Increasing satisfactory performance for unexpected antibody detection from 80% to 100%
• Clarifying which tests are included in the ban on improper PT referral

In addition to the updated requirements, a new Appendix E will be added to the Comprehensive Accreditation Manual for Laboratories (CAMLAB) to capture additional information related to the regulations. The new appendix will include the following regulatory information:

• Comprehensive analytes list as referenced in subpart I, including the 29 new analytes added with this final rule
• Criteria for acceptable performance limits for PT

The new and revised requirements are posted on the Prepublication Standards page of The Joint Commission’s website, will publish online in the fall 2024 E-dition^® update to the CAMLAB, and will be included in the hard-copy and PDF versions of the 2025 CAMLAB.

For more information about the revisions to the regulations, see the U.S. Centers for Medicare & Medicaid Services (CMS) final rule that was issued on July 11, 2022. Amendments to 42 CFR 493.20 and 42 CFR 493.25 were effective Aug. 10, 2022. These new and revised requirements address amendments to 42 CFR 493.2 and 42 CFR 493.801 through 493.959 that were effective July 11, 2024.

For more information about The Joint Commission’s requirements, please contact The Joint Commission’s Standards and Survey Methods.