Beware of quality indicators


There is a new standard that is coming out at CLSI: GP35 “Development and Use of Quality Indicators for Process Improvement and Monitoring of Laboratory Quality; Proposed Guideline

Unfortunately, I can’t recommend it – here’s why.

This standard recommends that various aspects of the clinical laboratory be monitored for quality with so called quality indicators, such that 20 or maybe 50 such indicators will be monitored. The first question is, how will goals be determined for each quality indicator. This is no small task. Previous attempts at CLSI to set goals for accuracy failed and the projects were cancelled. Here, there are multiple processes that require goals.

Another problem is that the logic to select items to monitor is not optimal. FMEA should be used but it is only mentioned in passing.

No mention of severity occurs in the document. One is supposed to track all of the indicators without any notion as to which are the most important. Pareto charts are mentioned but based on frequency alone and not severity.

There is a solution. Use FMEA or FRACAS and reduce the numerous indicators to one or perhaps a few – the error rate of the clinical laboratory. This would be a severity adjusted rate that could be followed using the principles of reliability growth management (1).


  1. Assay Development and Evaluation: A Manufacturer’s Perspective. Jan S. Krouwer, AACC Press, Washington DC, 2002

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