Introduction: The Royal College of Pathologists of Australasia Quality Assurance Programs (RCPAQAP) Key Incident Monitoring and Management Systems (KIMMS) program has found that some existing Quality Indicators are too broad or not well defined. The risk matrix in use does not allow changes in incident Detection or Probability. In 2020, a review was performed: what issues should KIMMS include as Key Incidents and how could risk measurement be improved?
Materials and methods: Twenty-seven networked and stand-alone laboratories enrolled in KIMMS during 2020 were surveyed on 45 current and new indicators of risk in the total testing process. They were asked which indicators they considered were significant in causing patient harm. Existing risk matrices in use by members of the KIMMS Advisory Committee laboratories were reviewed regarding their size or structure (3x3 or 5x5) and the descriptions of consequences and probability.
Results: Thirteen participants indicated 21 indicators should be monitored, and the KIMMS Advisory committee added a further 13 (11 from the remaining 24 and 2 new). Of the five risk matrices reviewed, all consistently used a 5x5 matrix to estimate Consequences vs Probability of harm. The KIMMS advisory committee added a third parameter to the calculation of Risk, Detectability.
Conclusion: All 34 pre- and post- indicators should be monitored, covering all aspects of the total testing cycle other than analytical. The risk measurement can be improved by introducing a 5x5 risk matrix to evaluate harm (consequences x probability) and then evaluating risk by adding detectability; risk equals harm x detectability.
Keywords: extra-analytical phase; laboratory organisation and management; pre- and post-analytical incidents; quality assurance; risk matrix.
Croatian Society of Medical Biochemistry and Laboratory Medicine.