From a mailing list that I get, I became aware of patient safety events in Minnesota. In particular there were 44 wrong site surgery events in 2008 out of 2.6 million surgeries or 1 out of every 60,000 surgeries or a rate of 0.0016923%. Wrong site surgery is the plane crash of hospital errors although as pointed out in this report and elsewhere, wrong site surgery often causes less patient harm than thought. During the same reporting period there were 38 cases of retained foreign objects, which is usually more harmful than wrong site surgery.
If the wrong site surgery sounds like a low rate, it also translates to about 17 events per million and many clinical laboratories report a million results per year. The plane crash of errors in clinical laboratories is probably a patient sample mix-up (or perhaps a severe interference). One reported patient sample mix-up rate was 0.0038928% which is twice the wrong site surgery rate. And a patient sample mix-up is something that can’t be controlled by analyzing an assay for precision and bias. Nor does it have anything to do with the inner workings of an analyzer instrument. Mitigation of patient sample mix-ups requires risk management methods.
The consequence of a patient sample mix-up can of course be no harm, if say a negative new born screening patient is mixed-up with a different negative new born screening patient. But the potential for a serious consequence is still present and the event can be prevented.
Wrong site surgery was addressed by the universal protocol but this is clearly not effective in preventing all wrong site surgeries. Thus, a one size fits all FMEA doesn’t necessarily work. Strictly speaking one should use the term FRACAS, because one is trying to reduce rates, not prevent something that has never happened. So we need to pay more attention to risk management.