Laboratory Quality Control Based on Risk Management
Posted by James O. Westgard, Sten A. Westgard
As of October 25, 2010, CLSI EP23A is now available.
This is the long-awaited document on the application of Risk Analysis for developing laboratory QC Plans.
The cost of the document is $85 for CLSI members and $200 for non-members. A package that includes a workbook to guide applications is available for $135 for members and $300 for non-members. Other educational and supporting materials are expected. The first webinar was October 25 and two others are scheduled for November 8 and November 30 at a cost of $179. See www.clsi.org for the details.
So, it this all we need? Have we solved our quality problems in the laboratory?
Not quite. There's still another shoe to drop. We have to wait to see what CMS will do. Will CMS continue with the current EQC procedures, in spite of the problems with the validation protocols? Or, will CMS replace the EQC options with alternative QC Plans based on Risk Analysis? If the latter occurs, that's still not the end of the story. If CMS realigns its regulations with Risk Analysis, will manufacturers support the applications and make their Risk Analysis studies public? This was supposed to happen with EP22, but didn't. If manufacturers won't support EP23 and CMS by publishing Risk Analysis studies of their devices, that's still not the end of the story. Then the focus shifts to the laboratory. Will laboratories have the skills to perform Risk Analysis on their own? In addition, what support and guidance will be provided by the inspection and accreditation organizations (like CAP, JC, etc.) to systematize the review and approval of laboratory QC Plans?
EP23 is the answer to one question, but obviously, there are many more questions that remain. We will continue to follow this story and keep you informed on the developments.
While we favor getting rid of the current "EQC" because the validation protocols are not scientifically sound, substituting Risk Analysis for EQC isn't a magic bullet. Risk Analysis can be a more complex and expensive undertaking than EQC validation. Risk Analylsis can also be done poorly, particularly when a qualitative scale is used to assess risk and/or when detectability is not considered in the risk model. The danger is that Risk Analysis, for all the sophistication it implies, can mask little more than a subjective judgment on the acceptability of residual risks.
We have discussed these and other issues on this website in anticipation of the arrival of EP23A. We hope the final approved document and the additional educational materials will deal with these limitations and provide the guidance needed to apply risk analysis in a scientifically objective and quantitative way.
Our own studies and recommendations on the use of risk analysis are available in the book Six Sigma Risk Analysis: Designing analytic QC Plans for the medical Laboratory that was published in June, 2011.