In healthcare, the only constant is change and compliance is no exception. From digital recordkeeping to data security to staff competency, the expectations placed on clinical and diagnostic laboratories continue to evolve. Regulatory bodies like CLIA, CAP, and The Joint Commission (TJC) are updating standards faster than ever, driven by technology advances and an increased […]
Futureproofing Labs for Inspection Read More »
When it comes to laboratory compliance, surprises are rarely good news. A missing signature, an outdated SOP, or an unrecorded competency can turn a routine inspection into a costly and stressful experience. Many laboratories manage these issues reactively, which is to say fixing problems only after they’re discovered. A proactive approach, however, is both possible
From Reactive to Proactive: How to Build a Risk Register for Laboratory Compliance Read More »
Training is unfortunately often thought of and labeled as a cost center in healthcare. When budgets tighten, training is often one of the first cuts. But cutting training ultimately doesn’t save money because it invites hidden costs. From overtime to citations, poor training costs far more than it saves. The reality is that effective training
Measuring ROI of Training Programs Read More »
Microlearning is increasingly a top choice for distributing training and instruction in the workplace. If you aren’t familiar with it, microlearning is an instructional approach that breaks content down into small, focused bursts of content, usually no more than 10 minutes in length. It’s a great solution for anyone whose often pressed for time and
The Benefits of Microlearning in Healthcare Read More »
When inspectors walk into a healthcare facility, they don’t just want to see policies, they want proof. Proof that training was completed, that procedures were followed, and that records haven’t been altered after the fact. For many organizations, that proof lies in the audit trail. Often overlooked, digital audit trails are quietly becoming one of
Digital Audit Trails: The Silent Hero of Inspections Read More »
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
Proficiency Testing Mistakes That Get Labs Cited Read More »
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
New Test? Don’t Skip Performance Specification Verification Read More »
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
Twice-Yearly Verification: Why Labs Miss It (and How to Get It Right) Read More »
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
How to Fix the #2 CLIA Deficiency: Personnel Competency Assessment Read More »
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
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