Implementation of failure mode and effects analysis to the specimens' flow in a population-based colorectal cancer screening programme using immunochemical faecal occult blood tests. A quality improvement project in the Milano colorectal cancer screening programme.

Background: A multidisciplinary working group applied the Healthcare Failure Mode and Effects Analysis (HFMEA) approach to the flow of kits and specimens for the first-level test of a colorectal cancer screening programme using immunochemical fecal occult blood tests. Methods: HFMEA comprised four steps: i) Identification and mapping of the process steps (sub-processes); ii) analysis of failure modes and calculation of the risk priority numbers (RPN); iii) identification of corrective actions; iv) follow-up and evaluation of corrective actions. Results: The team identified nine main failure modes, 12 effects and 34 associated causes. RPN scores ranged from 2 to 96. Failure modes within the first six positions in the ranking list ordered by RPN concerned: ‘degraded Hb in the specimen’, 'mixed-up kits', ‘anonymous specimen’, ‘expired sampling tube’ and ‘lost specimen’. All of these could lead to false negative results and/or subjects with positive tests not being recalled for second-level assessment. The team planned corrective actions for the first five ranks, which resulted in the RPN being reduced by 78.5 %, from a total of 681 before the actions to 147 after. As a result, the follow-up of corrective actions showed a significant decrease in the proportion of anonymous kits from 11.6 to 4.8 per 1000, leading to a reduction in the missed positive tests, complaints concerning the communication of test results to a person who never performed the test, false negative results due either to Hb degradation or an expired sampling tube, and finally to better information leaflets for users. Conclusions: HFMEA is a useful tool for reducing errors in the first level of colorectal cancer screening programmes, characterised by a straightforward interpretation of results and ease of communication to healthcare managers and decision-makers.JRC.F.1-Health in Societ