Clinical risk analysis with failure mode and effect analysis (FMEA) model in a dialysis unit.
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.
Bonfant
Giovanna
G
U. Parini Regional Hospital, Aosta Valley Healthcare Organisation, Aosta, Italy. gbonfant@ausl.vda.it
Belfanti
Pietro
P
Paternoster
Giuseppe
G
Gabrielli
Danila
D
Gaiter
Alberto M
AM
Manes
Massimo
M
Molino
Andrea
A
Pellu
Valentina
V
Ponzetti
Clemente
C
Farina
Massimo
M
Nebiolo
Pier E
PE
D004868:Equipment Failure; D019544:Equipment Failure Analysis / Q000379:methods*; D006801:Humans; D007558:Italy; D010045:Outpatients; D006435:Renal Dialysis / Q000295:instrumentation*; D012308:Risk Management / Q000379:methods*