The Demise of EP22

EP22 – Presentation of Manufacturer’s Risk Mitigation Information for Users of In Vitro Diagnostic Devices – was started in 2004. My understanding is that at a recent CLSI meeting, the subcommittee voted to drop the document and disband. This is good news. I have critiqued this project before – here are more reasons why disbanding is the right choice.

EP22 has always been predicated on solving instrument problems for laboratories. But it has been shown (1) that most laboratory error is caused by user error (or as some like to say “use error”). So to focus on instrument errors doesn’t make sense.

Quality control (QC) works by detecting errors and allowing the laboratory to recover from them, meaning not to report suspect values to clinicians until the possible problems have been resolved. There is clearly a time limit at which the recovery phase becomes meaningless. Thus, if one runs QC monthly and finds a problem, it is too late to alert clinicians in a meaningful way. Hence there is a limit – defined by the recovery time – which limits how much one could reduce the frequency of QC.

  1. Bonini P, Plebani M, Ceriotti F and Rubboli F. Errors in Laboratory Medicine. Clin Chem 2002;48:691-98.

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