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. 2018 Mar 22;7(1):e000299.
doi: 10.1136/bmjoq-2017-000299. eCollection 2018.

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

Silvia Deandrea  1   2 , Enrica Tidone  2 , Aldo Bellini  2 , Luigi Bisanti  2 , Nico Gerardo Leonardo  2 , Anna Rita Silvestri  2 , Dario Consonni  3
Affiliations

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

Silvia Deandrea et al. BMJ Open Qual. .

Abstract

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.

Keywords: failure modes and effects analysis (fmea); healthcare quality improvement; quality improvement.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Flow chart of the selected processes and failure modes identified.
Figure 2
Figure 2
Trend in the proportions of anonymous specimens (per 1000) before and after intervention.
Figure 3
Figure 3
Run chart of the lost specimens process.
See this image and copyright information in PMC

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