Tools, Technologies and Training for Healthcare Laboratories

Essays

Essays on Risk, Risk Management, and related tools like FMEA, PRA, etc.

Risk-Based QC Plans: Clinical Chemistry Journal Club Comments

A recent discussion in Clinical Chemistry assessed the risk of HbA1c methods using Sigma-metrics. Dr. Westgard reviews the various approaches of assessing risk and Sigma-metrics. Do we need patient-weighted averages, regular averages, point estimates, or something more complex? Or perhaps, are there simple solutions?

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IQCP: Does the P stand for Placebo?

The momentum behind IQCP is accelerating. Companies are launching education initiatives, new software programs, and there are webinars, workshops, and online tutorials. But does anyone really understand what an IQCP is yet? Does anyone know what the P stands for? Problem? Plan? Placebo?

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Thinking Fast and Slow about Risk QC

As 2013 draws to a close (boy, it went fast!), we take some time to think about one of the biggest changes in laboratory quality control (at least for the US): Risk QC. Is Risk QC a quick and easy solution to all our problems? Not so fast... 

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Talking and tackling Risk-Based QC Plans

The clock is ticking down for EQC. CMS stated in an initial memo on EP23 that Risk-based QC would replace EQC protocols at the end of 2013, and that by 2014, EQC would no longer be an acceptable laboratory procedure. While the CLSI EP23 protocol has been out for more than a year, though, CMS has yet to issue any regulations or guidelines on how to implement, comply, or inspect Risk QC. What's going on?

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Will Bad Risk drive out Good QC?

With the expiration date on EQC drawing ever closer, US labs still await the details about its replacement. While CLSI EP23 has been public for more than a year, and CMS has made press releases about the new IQCP (Individualized Quality Control Plans) and has announced the benefits of this new forthcoming policy, the actual regulatory language has yet to be released or described.

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