Formal and informal risk management

Our paper on error grids has been published online. As is often the case, there is another opinion paper that comments on our paper. One of the comments suggests we talk about “difficulties by clinical laboratories in adopting risk management techniques.” Actually, what we said is that “the risk management techniques including FMEA (Failure Mode Effects Analysis), fault trees, and FRACAS (Failure Reporting And Corrective Action System) are not well understood by clinical laboratories.”

To expand on things – and I’m sure previous blog entries cover this – the commentator cites ISO 15189 as a valuable tool to implement risk management. ISO 15189 is like ISO 9001 and I have commented on problems with ISO 9001 (1) and also with Six Sigma (2).

On another level, working on CLSI evaluation protocols which are mainly statistical, I notice that 1 or perhaps 2 people on a subcommittee know the statistics. The other people on the subcommittee make valuable contributions but steer clear of the statistics because they don’t know the statistics. But risk management is different. Everybody knows something about risk management – such as when driving, can I safely change lanes? But few people are knowledgeable about formal risk management as practiced by aerospace or automotive engineers and it is these techniques that have been adapted to healthcare. The problem is that standards are written by groups where all participants have an equal say on the topic due to their informal knowledge but they lack the formal knowledge. So what gets transferred to everyone misses the mark.

The commentator pleas for a systematic approach that “encompasses an infrastructure able to capture and – particularly – learn from adverse patient outcomes.”  But this is exactly what FRACAS does – which the commentator lists in his opening.

So I stand by our original statement: “the risk management techniques including FMEA (Failure Mode Effects Analysis), fault trees, and FRACAS (Failure Reporting And Corrective Action System) are not well understood by clinical laboratories.”

References

  1. Krouwer JS. ISO 9001 has had no effect on quality in the in-vitro medical diagnostics industry. Accred. Qual. Assur. 2004;9:39-43.
  2. Krouwer JS. Six Sigma can be dangerous to your health. Accred Qual Assur 2009;14:49-52.
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