UPDATED: Expired CLIA memos

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-15-08-CLIA: Information for Clinical Laboratories Concerning Possible Ebola Virus Disease expired on November 4, 2025.
• Memo # S&C-16-16-CLIA: Guidance for the Deployment of the Emergency Use Approval (EUA) Zika Virus Tests expired on November 4, 2025.
• Memo # S&C 13-54-CLIA: Individualized Quality Control Plan (IQCP): A New Quality Control (QC) Option expired on December 4, 2025.
• Memo # S&C-13-59-CLIA: Release of Clinical Laboratory Improvement Amendment’s (CLIA) Brochure #11, CLIA Individualized Quality Control Plan Introduction expired on December 4, 2025.
• Memo # S&C-15-07-CLIA: Effect on Microbiology Laboratories Due to the Removal of References to the Clinical Laboratory Standards Institute (CLSI) and to CLSI Documents expired on December 4, 2025.
• Memo # S&C-14-05-CLIA: Use of Direct for the Secure Transmission of Laboratory Test Results expired on December 4, 2025.
• Memo # 20-06-CLIA: CMS SARS-CoV-2 Laboratory Testing Comparison expired on December 4, 2025.
• 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.

This page is current as of 1/6/2026.