EP23 – Quality control based on risk management – misses the mark

CLSI EP23 looks like it is about to be published. To recall, EP23 was going to be how a laboratory would use EP22. But EP22 has been canceled so EP23 must stand on its own.

The way I review these standards is to go right to the example, which is about a hypothetical automated glucose assay. It seems as if there were a bunch of people sitting around a table asking what can go wrong with a glucose assay, what the manufacturer has done or recommends, and what things the laboratory can do. The list that was prepared sounds reasonable, but it’s not. Here’s why.

Most of the actions recommended for the laboratory would be done anyway such as: not to use expired reagents; or to send out samples to a proficiency program. Because of this, the result is that the list of actions merely documents what a laboratory already does. To stop there and call that risk management is a mistake. Documentation of existing procedures is a step in FMEA, but the more important part of FMEA asks what (if anything) the laboratory needs to do additionally. Of course, another way of looking at what the committee has done is to comment that has little to do with the real world – laboratories don’t start from scratch, they have existing procedures.

There are other problems such as:

  1. Deviating from a standard FMEA (for example there is no Pareto)
  2. By focusing on an assay, EP23 ignores the generic pre- and post-analytical errors that occur across assays.
  3. Ignoring FRACAS, which is a tool to reduce the rate of observed errors.

I made a proposal to the EP23 team last November to scrap most of EP23 and merge what is good into EP18. What would remain would be a series of real examples of FMEA (hard to find real examples) and FRACAS (easier to find real examples). These examples would need to be mapped into the language of FMEA and FRACAS. A non laboratory FRACAS example is the Pronovost work to reduce the rate of infections when placing central lines.


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