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Proficiency Testing (PT) is one of the most visible, and misunderstood, aspects of CLIA compliance. While being correct is important, it’s equally about how you treat PT samples, how thoroughly you document the process, and how you handle failures when they occur. Labs are frequently cited for PT issues even when their results are technically

Before any new test is used to produce patient results, CLIA requires you to verify that it performs accurately, precisely, and consistently in your lab and under your own conditions. Verification of performance specifications is one of the most critical and commonly overlooked CLIA requirements. Failing to verify a new test before clinical use is

If your lab performs moderate-complexity testing, CLIA requires you to verify test performance at least twice per year. Unfortunately, this requirement consistently ranks among the Top 10 CLIA deficiencies. Why? Because it falls into a gray area: not quite PT, not daily QC, and not tied to new test validation. As a result, it often

In recent CMS reports, failure to assess personnel competency consistently ranks in the top 3 of frequently cited CLIA deficiencies. When lab professionals aren’t properly evaluated and trained, every result they produce may be compromised. This risks patient outcomes, your accreditation status, and your lab’s reputation. This guide breaks down what “competency assessment” means under

Reagent and material storage issues are the most-cited CLIA deficiency in and for good reason. In 2024 alone, 5% of citations stemmed from issues as simple as a missing temperature log. A single oversight can compromise test accuracy, delay patient care, and land you with an avoidable deficiency citation. In this post, we’ll explore why

Your lab’s procedure manuals are the operational blueprint for every test you perform. And they’re almost always among the first documents a CAP or CLIA inspector will request. Yet “Incomplete or inaccurate procedure manuals” remain a commonly cited deficiency year after year. This post unpacks what inspectors expect from your SOPs, why so many labs