EP23 was the clinical laboratory follow on document to EP22.
Here’s my take on these two documents.
1. Manufacturers won’t provide the information as suggested by EP22. (This information consists of experiments to demonstrate the efficacy of internal control measures). It would be a lot of work (e.g., cost) and there’s no regulatory requirement to do so. Moreover, if this information were provided, then it is labeling which would require FDA to review it. It is not clear that FDA has accepted this review task.
Update on 8/4/08 – During a CLSI presentation at the AACC meeting in Washington, Alberto Gutierrez from the FDA gave a presentation. Afterwards, I asked him if FDA would review the material about internal control experiments that manufacturers might present as part of the package insert. He said that FDA would review this material – but from what was said it seemed that the review would be superficial and that only egregious problems would be flagged by the FDA.
2. Clinical laboratory staff does not have the expertise to review this information, were it provided. This does not mean that clinical laboratory staff is incapable of reviewing it – they could acquire the expertise – it just seems unlikely.
3. Should manufacturers provide this information and clinical laboratory staff review it, there would be no benefit with respect to improving QC. This is illustrated by an example in EP22 where the failure mode of “incorrect results due to low volume sample” is examined. After presenting the results of an experiment to show how an internal system control works, the user control measure is to “ensure that adequate volume of sample is presented to instrument.” But clinical laboratory staff would (or should) do this anyway. They don’t need EP22 and EP23 to know that one should follow the manufacturer’s instructions and to refrain from doing something stupid.
In clinical chemistry, risk management is “in.” But there are signs that its popularity is already starting to wane. This is unfortunate, as there is a great opportunity to use risk management tools to reduce both the risk and occurrence of laboratory errors. But one must focus not just on potential system errors, as EP22 and EP23 do, but on human errors as well.