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
The ability to collaborate, communicate, think critically, manage your calendar, and manage interpersonal relationships is crucial for the ongoing operation of your organization. Unfortunately, these soft skills are not always easy to teach, and it can sometimes be difficult to justify using limited time and resources to focus on improving them when faced with an
The Importance of Soft Skill Competency in Labs Read More »
Laboratory audits are stressful, even with the most strenuous preparation. For many people, the worst part of the inspection isn’t the actual inspection. It’s the preparation. Administrators can spend weeks and months working to get themselves ready and even then, still feel a sense of apprehension. Inspections and audits are often viewed as a single
At StaffReady, we often write about strategies for addressing coverage with a diminished workforce, and usually the problem is framed as a low pool of staff to schedule from. However, it isn’t always a scarcity of staff, but a scarcity of skills (or skill gaps) that makes constructing schedules and rotations challenging. In today’s piece,
Addressing Skill Gaps in Your Organization Read More »
It is no exaggeration to say that clinical laboratories live under constant pressure. Whether it’s the pressure of maintaining compliance, meeting deadlines, or managing staff, there is always a race to meet turnaround times and keep operations moving. Compliance can sometimes feel like a checkbox, or worse, a burden. Regulatory compliance isn’t an annual activity.
Building a Compliance-First Mindset in High-Pressure Lab Environments Read More »
Most labs are vigilant about running daily quality control. But what about the big picture? CLIA requires labs performing non-waived testing to conduct a formal, documented review of QC records at least twice a year. This is not optional and failing to do it is one of the most frequently cited deficiencies during inspections. The
The Twice-Yearly QC Review: The Most Forgotten CLIA Requirement Read More »
Test system failures happen. It’s how your lab responds to them that determines whether you stay compliant or end up with a citation. According to CLIA and CAP, labs must document every test system failure, investigate the root cause, and implement corrective and preventive actions (CAPA). But some labs either fail to document these incidents
The Hidden Deficiency: Undocumented Test System Failures Read More »
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