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 »
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 »
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