EP18 is the CLSI document about risk management. As it is being released there have been some comments which merit a response.
A few comments object to devoting attention to failure modes – implying that failure modes are events that have occurred. The proposal is to restrict the document to managing risk of events that have not yet occurred. I suspect that these people are familiar with the ISO standard on risk management 14971, which ignores failures that have occurred.
ISO 14971 was written for manufacturers who wish to release medical devices. In that sense, risk of potential errors is important since the device has not yet been released. But in the clinical laboratory, the product, which is reporting results of diagnostic assays to physicians, has been released and errors are occurring which can harm patients.
Consider HAMA interference in laboratory ABC. HAMA interference is a failure mode that has occurred in some laboratories and has caused harm. It may have already occurred in laboratory ABC but whether it has or hasn’t, it is a known cause of patient harm. If it is occurring in laboratory ABC, then it has a rate and needs to be reduced. If it has never occurred then it is a risk and needs to be controlled. In either case, harm may still occur since the risk will never be zero and it is possible that the rate may not reach zero. Note that even if the rate reaches zero, then it becomes a risk which is never zero.
Whether harm from HAMA interference occurs in this laboratory depends on how much effort (cost) is applied to prevent harm. This is a decision made by society which is largely misrepresented in ISO 14971 as a risk benefit tradeoff made by the site. What really happens is that the laboratory works at preventing errors until the money allocated for that task is used up. The amount of money is often a function of satisfying regulations, which in turn are dictated by society.
Here’s a real medical example for putting in central lines. This is an example to reduce failures (FRACACS) – although the word FRACAS is never used. From the article:
“Still, Pronovost asked the nurses in his I.C.U. to observe the doctors for a month as they put lines into patients, and record how often they completed each step. In more than a third of patients, they skipped at least one.”
This is a key step in FRACAS – measuring a failure rate. The steps that were skipped had the potential to lead to harm to patients and when controls were put in place – a check list was used – the rate of harm to patients decreased dramatically.
So risk management and EP18 needs to talk about the rate of actual failures as well as the risk of potential failures.