Objectives Describe the application of a risk assessment to identify failures in the hospital discharge process of a high-risk patient group, liver transplant (LT) recipients with diabetes mellitus (DM) and/or hyperglycaemia who require high-risk medications.
Design A Failure Modes, Effects and Criticality Analysis (FMECA) of the hospital discharge process of LT recipients with DM and/or hyperglycaemia who required DM education and training before discharge was conducted using information from clinicians, patients and data extraction from the electronic health records (EHR). Failures and their causes were identified and the frequency and characteristics (harm, detectability) of each failure were assigned using a score of low/best (1) to high/worst (10); a Criticality Index (CI=Harm×Frequency) and a Risk Priority Number (RPN=Harm×Frequency×Detection) were also calculated.
Setting An academic, tertiary care centre in Chicago, Illinois.
Participants Healthcare providers (N=31) including physicians (n= 6), advanced practice providers (n=12), nurses (n=6), pharmacists (n= 4), staff (n=3) and patients (n=6) and caregivers (n=3) participated in the FMECA; EHR data for LT recipients with DM or hyperglycaemia (N=100) were collected.
Results Of 78 identified failures, the most critical failures (n=15; RPNs=700, 630, 560; CI=70) were related to variability in delivery of diabetes education and training, care coordination and medication prescribing patterns of providers. Underlying causes included timing of patient education, lack of assessment of patients’ knowledge and industry-level design failures of healthcare products (eg, EHR, insulin pen).
Conclusion Most identified critical failures are preventable and suggest the need for the design of interventions, informed by the failures identified by this FMECA, to mitigate safety risks and improve outcomes of high-risk patient populations.
- diabetes mellitus
- quality improvement methodologies
- Failure Modes, Effects and CriticalityAnalysis (FMECA)
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TAP and VI contributed equally.
Contributors AW, TAP, RK, VI and JLH planned the study. AW, TAP, VI, GA and DJO helped recruit study participants (patients and clinicians). AW, TAP, RK, VI and JLH gathered and analysed the data. RK and JLH provided guidance as subject matter experts in the methodologies. AW, TAP, RK, VI, JLH, GA and DJO all participated in the interpretation of the study results and preparation of the manuscript.
Funding American Diabetes Association Junior Faculty Award (1-13-JF-54).
Competing interests AW currently receives research salary/grant support from Merck and El Lilly and is a consultant for Glytec and completes adjudication for Lexicon Pharmaceuticals. GA currently receives research salary/grant support from Bristol-Myers Squibb, AstraZeneca and Helmsley Charitable Trust and is a consultant for Novo Nordisk, Dexcom and Boehringer Ingelheim.
Ethics approval NU Institutional Review Board Office.
Provenance and peer review Not commissioned; externally peer reviewed.
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