There have been several objections to measuring errors that are not as easy as calculating a standard deviation.
One comment was – pre-analytical error is important but can’t be measured in a method comparison protocol. It needs to be handled by risk management.
Similar arguments were made during a meeting for measurement uncertainty, where it was suggested that large but rare analytical errors be handled by risk management.
I favor limited guidelines, but not measurement. Measurement has too many unintended consequences.
ISO 15197, a standard for home glucose meters has a specification for total analytical error which does not include errors due to pre-analytical error. User errors are to be evaluated separately and without stating any analysis procedure:
Results shall be documented in a report
Unfortunately, risk management as used by these people means sweeping these problems under the rug and is the same as DB’s advice about not measuring things or the ISO guidance.
It’s time to start measuring errors from all sources – it’s possible and necessary.