The Need for Accuracy in Hemoglobin A1c Proficiency Testing: Why the Proposed CLIA Rule of 2019 Is a Step Backward

摘要

On February 4, 2019, the Centers for Medicare & Medicaid Services (CMS) and Centers for Disease Control and Prevention (CDC) proposed a rule change to update proficiency testing regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to address current analytes and newer technologies. One of the analytes specified was hemoglobin A1c (HbA1c). The criterion for acceptable performance of a laboratory measuring this analyte was specified to be ±10%.