What do I really need to know about Risk Management and EP23-A? There was a lot of hubbub about it last year but it seems to have gone away.

Stay tuned! It’s coming.

In March 2012, CMS announced in a memo to its surveyors Individualized Quality Control Plans (IQCPs), based on the concepts presented in CLSI’s guidance document, EP23-A: Laboratory Quality Control Based on Risk Management. IQCPs will become a new CLIA QC policy and replace the current EQC policy once CMS releases its revised Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services and announces the implementation date for the new QC policy.

Typically, CMS allows for a 2-year education and phase-in period for new policies. If CMS releases these Guidelines in fall of 2013, the effective date will most likely be fall 2015. In the meantime, CLIA-inspected test sites performing nonwaived testing and using manufacturers’ built-in quality assessments to meet CLIA’s daily QC requirements should begin to learn about risk management and the many concepts to develop IQCPs covering the entire testing process – preanalytical, analytical, and post-analytical. Those test sites not choosing to develop IQCPs will need to run at least two levels of external QC per test per day a test is performed. CMS terms this “default” QC. At this time, it is not known whether or not CMS-approved accrediting bodies such as CAP, TJC, and COLA will follow CLIA’s lead.

[Reference: CMS]

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