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Applying international organization for standards 9001 to create an effective surgical quality committee
Authors:Douglas P. Slakey  James S. George  Edwin Anderson  Donna Willeumier  Kelly Guglielmi
Affiliation:1. USF Morsani College of Medicine, Dept of Surgery 2 Tampa General Circle, Rm 7015, Tampa, FL, 33606, United States;2. Loyola University Medical Center, Maywood, IL 60153, United states;1. Indiana University School of Medicine, Indianapolis, IN, USA;2. Department of Surgery, Indiana University School of Medicine, Indianapolis, IN, USA;1. Department of Surgery, University Hospitals Cleveland Medical Center, Cleveland, OH, USA;2. Neurology Department, University Hospitals Cleveland Medical Center, Cleveland, OH, USA
Abstract:BackgroundEfforts to improve surgical safety are limited by several factors and no consensus exists regarding the most effective way to improve surgical quality. The use of ISO 9001 quality standards within healthcare is recognized but has not been widely applied for improving surgical outcomes.MethodsA surgical quality committee was created using ISO 9001:2015 standards. Quality objectives were assessed to understand how any suggested changes will be impacted due to risks and opportunities inherent in the system.ResultsThe initial quality focus was on surgical site infections in 5 services. Change in surgical infection ratio from 2018 to 2019 showed significant improvement: coronary bypass 1.288 vs. 0.901; Colon 1.359 vs. 0.589; Hysterectomy 2.119 vs. 1.022; Knee 1.391 vs. 0.306; Hip 0 vs. 0.302.ConclusionsThis is one of the first studies using ISO 9001 to improve surgical quality. The results indicate both acceptance and success of applying continual improvement strategies.
Keywords:Patient safety  Surgical quality  ISO9001  Surgical site infection  Quality management system
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