The CMS-3355-F final rule, effective December 28, 2024, modernized CLIA personnel qualifications for the first time in decades. Then in June 2025, QSO-25-21-CLIA added enforcement discretion that softened some of the new requirements. If you haven't reviewed your personnel files since these changes took effect, you may have a compliance gap you don't know about. What Changed Under CMS-3355-F The final rule updated personnel qualification pathways for several key roles, includ

Approximately 29.4% of all CAP inspection citations fall under competency assessment. That makes it the single most common deficiency category — by a wide margin. Despite this, many laboratories still treat competency assessment as an annual paperwork exercise rather than a meaningful evaluation of staff capability. Here is what the regulations actually require, where most labs fall short, and how to build a program that satisfies surveyors and genuinely improves the quality

Every two years, your CAP inspection team walks through the door with a checklist that covers thousands of requirements. But some deficiencies show up far more often than others. If you know where labs typically fail, you can focus your preparation where it matters most. Here are the five deficiency categories that account for the majority of CAP inspection findings — and what you can do about each one before your next survey. 1. Competency Assessment Documentation (~29% of A

Effective March 1, 2026, Maryland updated COMAR 10.10.01 through 10.10.08 and 10.10.12 — the state regulations governing clinical laboratories. If your lab operates in Maryland, these changes affect how you handle waived testing, quality control, and state-level compliance documentation. The Biggest Change: CLIA-Waived Tests Are Now Automatically 'Excepted' Under the updated COMAR 10.10, tests that CMS classifies as CLIA-waived are now automatically categorized as 'excepted'

CMS ended paper CLIA certificates March 1, 2026. Here's your action checklist for the electronic transition — what changed, why it matters, and what to do now.