At the recent AACC meeting, I went to a CLSI (Clinical And Laboratory Standards Institute) meeting about evaluation standards. I chair three such standards which were discussed at this meeting. This entry is about EP18, a standard about risk management.
A lab director commented that no clinical laboratory would ever use this document. He went on to say that medical technologists would not understand EP18 implying that perhaps some changed version (e.g. the magic bullet) of the document would help.
I got the impression that this lab director would never initiate a risk management program. EP18 is simply a standard. It is not a regulatory requirement and I suspect that without some incentive (regulatory or otherwise), not only this lab director but many clinical laboratories would not undertake a formal risk management program.
The need for risk management exists! After the meeting, another lab director told me about a death that was caused by pre-analytical error (patient sample mix up) in his laboratory.
What’s required for clinical laboratories to perform risk management? It’s true that medical technologists are not taught risk management and would benefit by training, hopefully by using EP18. Once people are trained, then the actual risk management must be carried out and while this is not a major project it won’t be completed in ten minutes either (no free lunches).
A general hospital example relates to this discussion (previously covered here). The infection rate for placing central lines was about 11 percent. This was a serious problem leading to patient harm and occurred in accredited hospitals. One clinician acted to do something on his own. He used one of the tools described in EP18 – he of course didn’t use EP18 – and reduced the infection rate to zero.
So CLSI has to decide. It can sit on the sidelines and let improvement in laboratory patient safety proceed without CLSI or it can try to promote the use of risk management. Once again, EP18 is only a standard. The writing can always be improved but there is a limit to how well one can explain an “OR gate”.