Expired CLIA memos

CMS has officially expired multiple CLIA memos and guidance documents, including those related to quality control, personnel competency, and emergency testing procedures, impacting laboratory operations.
Dec. 12, 2025
2 min read

The Centers for Medicare & Medicaid Services (CMS) has expired several Clinical Laboratory Improvement Amendments of 1988 (CLIA) memos and guidance recently. The following memos are no longer in practice:

  • Memo # S&C-12-20-CLIA: Implementing the Individualized Quality Control Plan (IQCP) for Clinical Laboratory Improvement Amendments (CLIA) expired on December 4, 2025.
  • Memo # S&C-13-07-CLIA: Release of CLIA Brochure #10, What Do I Need to Do to Assess Personnel Competency expired on November 4, 2025.
  • Memo # S&C-13-39-CLIA: Guidance Regarding the Deployment of the Emergency Use Approval (EUA) Bird Flu Test (H7N9) to State Public Health Laboratories (PHLs) by the Centers for Disease Control and Prevention (CDC) expired on November 4, 2025.
  • Memo # S&C-09-06-CLIA: Revised CLIA Policy on Quality Control for Commercially Available Microbial Identification Systems expired on December 4, 2025.
  • Memo # 12-28-CLIA: Process Change for Histocompatibility Laboratories expired on December 4, 2025.
  • Memo # QSO-20-10-CLIA: Notification to Surveyors of the Authorization for Emergency Use of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel Assay and Guidance for use in CDC Qualified Laboratories expired on December 4, 2025.
  • Memo # QSO-20-21-CLIA: Clinical Laboratory Improvement Amendments (CLIA) Laboratory Guidance During COVID-19 Public Health Emergency expired on May 23, 2023, but CMS posted the updated memo on December 4, 2025.
  • Memo # QSO-21-04-CLIA: Clinical Laboratory Improvement Amendments of 1988 (CLIA) CMS Locations and State Agency Remote Survey Guidance - Optional Process expired on December 4, 2025.
  • Memo # QSO-22-13-CLIA: Clinical Laboratory Improvement Amendments (CLIA) Guidance for Temporary Testing Sites under the Multiple Site Exception expired on December 4, 2025.

About the Author

Erin Brady

Managing Editor

Erin Brady is Managing Editor of Medical Laboratory Observer.

Sign up for our eNewsletters
Get the latest news and updates