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认可和 ISO 认证:它们能否解释欧洲医院质量管理的差异?

Accreditation and ISO certification: do they explain differences in quality management in European hospitals?

机构信息

European Society for Quality in Healthcare, Limerick, Ireland.

出版信息

Int J Qual Health Care. 2010 Dec;22(6):445-51. doi: 10.1093/intqhc/mzq054. Epub 2010 Oct 8.

DOI:10.1093/intqhc/mzq054
PMID:20935006
Abstract

BACKGROUND

Hospital accreditation and International Standardisation Organisation (ISO) certification offer alternative mechanisms for improving safety and quality, or as a mark of achievement. There is little published evidence on their relative merits.

OBJECTIVE

To identify systematic differences in quality management between hospitals that were accredited, or certificated, or neither. Research design

ANALYSIS

of compliance with measures of quality in 89 hospitals in six countries, as assessed by external auditors using a standardized tool, as part of the EC-funded

METHODS

of Assessing Response to Quality Improvement Strategies project.

MAIN OUTCOME MEASURES

Compliance scores in six dimensions of each hospital-grouped according to the achievement of accreditation, certification or neither.

RESULTS

Of the 89 hospitals selected for external audit, 34 were accredited (without ISO certification), 10 were certificated under ISO 9001 (without accreditation) and 27 had neither accreditation nor certification. Overall percentage scores for 229 criteria of quality and safety were 66.9, 60.0 and 51.2, respectively. Analysis confirmed statistically significant differences comparing mean scores by the type of external assessment (accreditation, certification or neither); however, it did not substantially differentiate between accreditation and certification only. Some of these associations with external assessments were confounded by the country in which the sample hospitals were located.

CONCLUSIONS

It appears that quality and safety structures and procedures are more evident in hospitals with either the type of external assessment and suggest that some differences exist between accredited versus certified hospitals. Interpretation of these results, however, is limited by the sample size and confounded by variations in the application of accreditation and certification within and between countries.

摘要

背景

医院认证和国际标准化组织 (ISO) 认证提供了改进安全性和质量的替代机制,或者作为成就的标志。关于它们的相对优点,发表的证据很少。

目的

确定在通过外部审计员使用标准化工具评估的六个国家的 89 家医院中,在质量管理方面的系统差异,这些医院分为已认证、已认证或未认证的组别。

研究设计

分析 89 家医院在六个方面的合规性得分,这些医院根据外部审计员的评估,根据认证、认证或两者都没有的情况进行分组。

方法

作为欧盟资助的评估质量改进策略项目的一部分。

主要观察指标

根据认证、认证或两者都没有的情况对每个医院组进行分组,以合规性得分来衡量。

结果

在选择进行外部审计的 89 家医院中,34 家获得了认证(没有 ISO 认证),10 家通过了 ISO 9001 认证(没有认证),27 家既没有认证也没有认证。质量和安全的 229 项标准的总体百分比得分分别为 66.9、60.0 和 51.2。分析证实,通过外部评估的类型(认证、认证或两者都没有)比较平均得分存在统计学显著差异;然而,仅在认证和认证之间并没有实质性的差异。这些与外部评估的关联中的一些与样本医院所在的国家有关。

结论

似乎在有外部评估类型的医院中,质量和安全结构和程序更为明显,并表明在认证医院和认证医院之间存在一些差异。然而,这些结果的解释受到样本量的限制,并受到认证和认证在国家内部和国家之间的应用差异的影响。

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