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 »
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
Procedure Manual Problems: What Inspectors Flag First Read More »
If it’s not documented, it didn’t happen. That phrase is gospel during a CAP or CLIA inspection and it’s why incomplete or missing test records consistently ranks high in the list of deficiency citations. Inspectors want clear, retrievable, and complete documentation for every test your lab performs. This includes manual logs, instrument outputs, QC records,
Proficiency Testing (PT) is one of the most regulated elements of laboratory compliance, and for good reason: it directly assesses your lab’s ability to produce accurate, reliable results. Unfortunately, labs often file their PT scores and move on without review, reflection, or remediation. CLIA requires that PT results are formally reviewed by the Laboratory Director
Why Proficiency Testing (PT) Results Must Be Reviewed and Acted Upon Read More »
In the fast-paced world of healthcare and laboratory operations, the alignment of compliance and workforce scheduling is crucial to ensuring both regulatory adherence and uninterrupted patient care. Compliance demands—from CLIA, CAP, TJC, and other regulatory bodies—dictate competency requirements, staff-to-patient ratios, and licensure verifications, making it essential that scheduling is not just about shift coverage but
The Intersection of Compliance & Scheduling: How to Avoid Coverage Gaps Read More »
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