Prospective risk analysis adjusted to the reality of clinical and fertility laboratory processes.

Background: Prospective risk analysis (PRA) is a valuable instrument in quality assurance. The practical application of PRA in clinical laboratories according to the method we have described elsewhere leaves room for a number of adaptations to make it more applicable to and consistent with actual laboratory processes.

Methods: We distinguished between more and less critical tests and products in the laboratory processes and scored the consequences of failures at different steps in line with the previously described failure type and effect analysis (FMEA) method. PRA was carried out for two typical laboratory processes: standard clinical laboratory testing and the cryopreservation of semen.

Results: Tests in standard clinical laboratory in processes were labeled critical, semi-critical or non-critical. Consequence scoring (C) and assessed risk (R) were significantly higher for processes containing tests considered to be critical (C=6.6±1.5, R=19.3±13.5) as compared to processes containing tests considered semi- or non-critical (C=3.0±1.4, R=8.2±5.3 and C=3.2±1.8, R=8.6±5.9, respectively). There were no differences in the C and R scores for processes with tests considered semi- or non-critical. In the semen cryopreservation process, a distinction between the processes involving private semen and generally accessible semen was made. The C scores for these were significantly different (C=5.9±2.2 and 5.0±2.0, respectively), the R scores did not differ.

Conclusions: Introduction of a test criticality classification for the purpose of consequence scoring led to an improved PRA methodology, better reflecting the reality of clinical laboratory practice. We found that two levels of criticality, critical and less critical, were sufficient to achieve this improvement.