Dombrádi Viktor, Csenteri Orsolya Karola, Sándor János, Godény Sándor
Department of Preventive Medicine, Faculty of Public Health, University of Debrecen, Kassai Street 26, 4028 Debrecen, Hungary.
Division of Biostatistics and Epidemiology, Department of Preventive Medicine, Faculty of Public Health, University of Debrecen, Kassai Street 26, 4028 Debrecen, Hungary.
Int J Qual Health Care. 2017 Apr 1;29(2):283-289. doi: 10.1093/intqhc/mzx016.
To investigate how International Organization for Standardization (ISO) 9001 and the Hungarian Health Care Standards (HHCS) certifications are associated with quality management, patient safety, patient rights and human resource management activities.
A cross-sectional study was implemented using the 2009 Hungarian hospital survey's database.
Hungary.
Fifty-three general hospitals were included in the statistical analysis.
No intervention was carried out in the study.
The outcomes included the percentage of compliance in the dimensions of quality management, patient safety, patient rights, human resource management and the overall score for each hospital, and they were grouped according to the hospitals' certifications.
Sixteen hospitals did not have either ISO 9001 or HHCS certifications, 19 had ISO 9001 certification only and 18 had both. Hospitals with ISO 9001 alone or in combination with the HHCS significantly outperformed hospitals with no certifications in terms of quality management and human resource management activities but not in terms of patient safety or patient rights activities. Combined, the two models provided the highest median levels in all cases. Nevertheless, no significant differences were observed when the hospitals with both certifications were compared with hospitals with ISO 9001 only.
Although the combination of ISO 9001 and the HHCS showed the best results, the benefits were not decisive. Furthermore, although the HHCS include standards addressing patient safety, no direct association was found with regard to compliance. Thus, further investigation is required to understand this enigma.
探讨国际标准化组织（ISO）9001认证与匈牙利医疗保健标准（HHCS）认证如何与质量管理、患者安全、患者权利及人力资源管理活动相关联。
采用2009年匈牙利医院调查数据库进行横断面研究。
匈牙利。
53家综合医院纳入统计分析。
本研究未实施干预。
结果包括质量管理、患者安全、患者权利、人力资源管理各维度的合规百分比以及每家医院的总体得分，并根据医院的认证情况进行分组。
16家医院既无ISO 9001认证也无HHCS认证，19家仅有ISO 9001认证，18家同时拥有两者。仅获得ISO 9001认证或同时获得ISO 9001与HHCS认证的医院在质量管理和人力资源管理活动方面显著优于未获认证的医院，但在患者安全或患者权利活动方面并非如此。综合来看，两种模式在所有情况下均提供了最高的中位数水平。然而，将同时拥有两种认证的医院与仅拥有ISO 9001认证的医院进行比较时，未观察到显著差异。
尽管ISO 9001与HHCS的组合显示出最佳结果，但益处并不具有决定性。此外，尽管HHCS包含涉及患者安全的标准，但未发现与合规性有直接关联。因此，需要进一步调查以解开这个谜团。
