Risk management within financial constraints – a mini course

Actually a femto course would be more accurate. My last post was a critique. This post outlines what I would do for risk management for a clinical laboratory to protect against patient harm.

  1. Excluding phlebotomy, there are only two top level errors a laboratory can make that cause patient harm: provide an incorrect result to a clinician, or no result. (Thanks to Don Powers, where I first saw this).
  2. For incorrect results, although the severity of harm depends on several factors, the most severe harm should be used in classification.
  3. There are two types of errors and risk management tools:
    1. (potential )errors that have never occurred  – metric; probability of occurrence; risk management tool: FMEA
    2. errors that have occurred – metric; rate of occurrence; risk management tool: FRACAS

  4. Risk management attempts to answer 4 questions:
    1. what can go wrong (FMEA) or what did go wrong (FRACAS)
    2. how serious
    3. how likely
    4. what to do about it.

  5. To answer 4.1, what can go wrong requires a process map, not just of the assay but all sub processes. For example hiring and training policies could be potential causes of laboratory error.
  6. The potential failures of each process step are enumerated. These process steps may be:
    1. Basic process steps (centrifuge a sample)
    2. Detection steps (examine a sample for hemolysis)
    3. Recovery steps (prevent a hemolyzed sample from being analyzed)

  7. Numbers #1 and #2 are used to classify the severity of the effect of an error (4.2).
  8. To answer 4.3:
    1. The probability of occurrence is estimated for errors that have never occurred. This is done using judgment on a qualitative scale (e.g., 1-5)
    2. The frequency of occurrence is used for errors that have occurred.
    3. The two scales must be related (e.g., an actual error rate must be higher than the probability of an error that has never occurred).

  9. To answer 4.4, one prepares a Pareto by multiplying occurrence times severity and implements mitigations for the top items until:
    1. Rates for errors which cause serious harm are zero (FRACAS)
    2. Probability of occurrence for errors which cause serious harm is lower than some designated amount (FMEA)
    3. One runs out of funds allotted for this purpose.

The risk management described above is a combination of FMEA and FRACAS.


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