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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
  1. Silvia Deandrea1,2,
  2. Enrica Tidone2,
  3. Aldo Bellini2,
  4. Luigi Bisanti2,
  5. Nico Gerardo Leonardo2,
  6. Anna Rita Silvestri2,
  7. Dario Consonni3
  1. 1European Commission, Directorate-General Joint Research Centre (JRC), Ispra VA, Italy
  2. 2Agenzia di Tutela della Salute della Citta Metropolitana di Milano, Milano, Italy
  3. 3Epidemiology Unit, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milano, Italy
  1. Correspondence to Dr Silvia Deandrea; sdeandrea{at}


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.

  • failure modes and effects analysis (fmea)
  • healthcare quality improvement
  • quality improvement

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  • Contributors SD designed and conducted the project analysis. ARS and LB were involved in supervising the project. ET was the project lead. AB, DC and NGL collected data and performed analyses. All the authors assisted in drafting and editing of the manuscript. All the authors have had the opportunity to draft and revise this manuscript and have approved it in this final form.

  • Funding SD working time on this project (from March 2012 to January 2018) and the open access fee were funded under Administrative Arrangements 17.030600/12//SI2.635313 and 17.030100/16//SI2.746515 between the European Commission Directorate-General Health and Food Safety and the Directorate-General Joint Research Centre.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; internally peer reviewed.

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