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J Nephrol. 2010 Jan-Feb;23(1):111-8.

Clinical risk analysis with failure mode and effect analysis (FMEA) model in a dialysis unit.

Author information

1
U. Parini Regional Hospital, Aosta Valley Healthcare Organisation, Aosta, Italy. gbonfant@ausl.vda.it

Abstract

BACKGROUND:

The aim of clinical risk management is to improve the quality of care provided by health care organizations and to assure patients' safety. Failure mode and effect analysis (FMEA) is a tool employed for clinical risk reduction. We applied FMEA to chronic hemodialysis outpatients.

METHODS:

FMEA steps: (i) process study: we recorded phases and activities. (ii) Hazard analysis: we listed activity-related failure modes and their effects; described control measures; assigned severity, occurrence and detection scores for each failure mode and calculated the risk priority numbers (RPNs) by multiplying the 3 scores. Total RPN is calculated by adding single failure mode RPN. (iii) Planning: we performed a RPNs prioritization on a priority matrix taking into account the 3 scores, and we analyzed failure modes causes, made recommendations and planned new control measures. (iv) Monitoring: after failure mode elimination or reduction, we compared the resulting RPN with the previous one.

RESULTS:

Our failure modes with the highest RPN came from communication and organization problems. Two tools have been created to ameliorate information flow: "dialysis agenda" software and nursing datasheets. We scheduled nephrological examinations, and we changed both medical and nursing organization. Total RPN value decreased from 892 to 815 (8.6%) after reorganization.

CONCLUSIONS:

Employing FMEA, we worked on a few critical activities, and we reduced patients' clinical risk. A priority matrix also takes into account the weight of the control measures: we believe this evaluation is quick, because of simple priority selection, and that it decreases action times.

PMID:
20091494
[Indexed for MEDLINE]

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