Shaw Charles D, Groene Oliver, Botje Daan, Sunol Rosa, Kutryba Basia, Klazinga Niek, Bruneau Charles, Hammer Antje, Wang Aolin, Arah Onyebuchi A, Wagner Cordula
* Centre for Clinical Governance Research, University of New South Wales, Sydney, Australia.
Int J Qual Health Care. 2014 Apr;26 Suppl 1(Suppl 1):100-7. doi: 10.1093/intqhc/mzu023. Epub 2014 Mar 9.
To investigate the relationship between ISO 9001 certification, healthcare accreditation and quality management in European hospitals.
A mixed method multi-level cross-sectional design in seven countries. External teams assessed clinical services on the use of quality management systems, illustrated by four clinical pathways.
Seventy-three acute care hospitals with a total of 291 services managing acute myocardial infarction (AMI), hip fracture, stroke and obstetric deliveries, in Czech Republic, France, Germany, Poland, Portugal, Spain and Turkey.
Four composite measures of quality and safety [specialized expertise and responsibility (SER), evidence-based organization of pathways (EBOP), patient safety strategies (PSS) and clinical review (CR)] applied to four pathways.
Accreditation in isolation showed benefits in AMI and stroke more than in deliveries and hip fracture; the greatest significant association was with CR in stroke. Certification in isolation showed little benefit in AMI but had more positive association with the other conditions; greatest significant association was in PSS with stroke. The combination of accreditation and certification showed least benefit in EBOP, but significant benefits in SER (AMI), in PSS (AMI, hip fracture and stroke) and in CR (AMI and stroke).
Accreditation and certification are positively associated with clinical leadership, systems for patient safety and clinical review, but not with clinical practice. Both systems promote structures and processes, which support patient safety and clinical organization but have limited effect on the delivery of evidence-based patient care. Further analysis of DUQuE data will explore the association of certification and accreditation with clinical outcomes.
探讨欧洲医院的ISO 9001认证、医疗保健评审与质量管理之间的关系。
在七个国家采用混合方法多层次横断面设计。外部团队依据四个临床路径对质量管理体系的使用情况评估临床服务。
捷克共和国、法国、德国、波兰、葡萄牙、西班牙和土耳其的73家急症医院，共291项服务，涉及急性心肌梗死（AMI）、髋部骨折、中风和产科分娩的管理。
应用于四个路径的四个质量与安全综合指标[专业知识与责任（SER）、基于证据的路径组织（EBOP）、患者安全策略（PSS）和临床审查（CR）]。
单独的评审在AMI和中风方面显示出的益处多于分娩和髋部骨折；最大的显著关联是在中风的CR方面。单独的认证在AMI方面显示出的益处很少，但与其他病症有更积极的关联；最大的显著关联是在中风的PSS方面。评审和认证相结合在EBOP方面显示出的益处最少，但在SER（AMI）、PSS（AMI、髋部骨折和中风）和CR（AMI和中风）方面有显著益处。
评审和认证与临床领导力、患者安全系统和临床审查呈正相关，但与临床实践无关。这两种体系都促进了支持患者安全和临床组织的结构与流程，但对基于证据的患者护理的提供影响有限。对DUQuE数据的进一步分析将探讨认证和评审与临床结果之间的关联。
