Six comments about risk management for labs


Inspired by a post by Sten Westgard, here is my list on risk management for labs.

  1. One can apply simple risk management to before and after EQC. Before, many patient results were protected from many process faults because twice daily QC would pick up the fault in time for the results to be repeated. After EQC, the risk of reported wrong patient results was higher because there could be a month before a fault was detected. Thus, EQC never made sense.
  2. The comments in Sten’s posting that “it’s up to the lab director” are similar to CLSI statements about requirements in many of their evaluation protocol documents.
  3. The CLSI EP23 document about risk management for the lab was written by a group that was largely untrained in risk management. (This group had high expertise in other areas). Hence, the document is non-standard with respect FMEA and fault trees. Moreover, it focuses on analytical faults that have been largely validated by the manufacturer but the document neglects lab user error.
  4. Hospitals are required (at least they used to be) to perform at least one FMEA per year. In my experience in trying to provide software for this, the hospitals had little interest in actually performing a FMEA. Without guidance, training, and some prescriptive methods, risk management in labs is suspect.
  5. The situation wasn’t much different for in vitro diagnostic manufacturers. I’ve never met an engineer who willingly participated in risk management activities.
  6. The IHI (Institute for Healthcare Improvement) has a method for implementing FMEAs that is almost guaranteed to cause problems since it looks for a numerical reduction in “risk”. Take surgery as an example and I simplify things for illustration. You score severity and probability of occurrence of each event, multiply the severity x probability and add up for all events. For example, wrong site surgery would get severity=5 (the highest), probability=1 (the lowest) for a 5. Waiting more than an hour for an appointment would get severity=1 (the lowest), probability=5 (the highest) for a 5. BUT, in general you can’t change severity, only probability so in this case, you would try to change the appointment process and ignore the wrong site surgery. (The wrong site surgery probability is already at the lowest value of 1.) Your overall number would improve (in this case the initial 10 would be reduced) and you would declare victory. But in spite of the universal protocol (to prevent wrong site surgery), there is still room for improvement, so this IHI program focuses on less severe items and ignores the important ones.

What’s needed is training on standard methods in risk management for labs.


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