TY - JOUR T1 - 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 Milan colorectal cancer screening programme JF - BMJ Open Quality JO - BMJ Open Qual DO - 10.1136/bmjoq-2017-000299 VL - 7 IS - 1 SP - e000299 AU - Silvia Deandrea AU - Enrica Tidone AU - Aldo Bellini AU - Luigi Bisanti AU - Nico Gerardo Leonardo AU - Anna Rita Silvestri AU - Dario Consonni Y1 - 2018/03/01 UR - http://bmjopenquality.bmj.com/content/7/1/e000299.abstract N2 - 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 faecal occult blood tests.Methods HFMEA comprised four steps: (1) identification and mapping of the process steps (subprocesses); (2) analysis of failure modes and calculation of the risk priority numbers (RPNs); (3) identification of corrective actions; and (4) follow-up and evaluation of corrective actions.Results The team identified 9 main failure modes, 12 effects and 34 associated causes. RPN scores ranged from 2 to 96. Failure modes within the first five positions in the ranking list ordered by RPN concerned: ‘degraded haemoglobin in the specimen’, ‘mixed-up kits’ and ‘anonymous specimen’. All of these could lead to false-negative results and/or subjects with positive tests not being recalled for assessment. The team planned corrective actions for those failure modes. 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 (relative reduction of 59%). The HFMEA exercise led to a reduction in: missed positive tests; missed cancer and high-risk adenomas; complaints about the communication of test results to a person who never did the test; and false-negative results due either to haemoglobin degradation or an expired sampling tube.Conclusions HFMEA is a useful tool for reducing errors in colorectal cancer screening programmes using faecal occult blood tests and is characterised by a straightforward interpretation of results and ease of communication to healthcare managers and decision makers. ER -