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[医学诊断实验室的质量改进]

[Quality improvement of medical diagnostic laboratories].

作者信息

Horváth Andrea Rita, Endröczi Elemér, Mikó Tivadar

机构信息

Szegedi Tudományegyetem, Szent Györgyi Albert Orvos- és Gyógyszerésztudományi Centrum, Altalános Orvostudományi Kar, Klinikai Kémia Intézet, Szeged.

出版信息

Orv Hetil. 2003 Jul 13;144(28):1389-95.

PMID:12914124
Abstract

Service quality in medical laboratories is influenced by a number of variables. Medical laboratories have long recognized the need for total quality management that incorporates the continuous improvement of all stages, such as the pre-analytical, analytical and post-analytical phases, of the diagnostic process, in addition to the traditional internal and external quality control of analytical procedures. Based on national and international experience, continuous improvement of quality and its external assessment are of high priority in order to guarantee a reliable, effective and cost-effective diagnostic service. Certification of health care services, according to ISO 9001 standards in Hungarian hospitals, is not sufficient to prove professional competence of medical laboratories, which called for a system of laboratory accreditation. Accreditation is an external professional audit by which an independent accreditation body gives formal recognition that the medical laboratory is competent to provide high quality services that are compliant with rigorous professional standards of best practice. The primary aim of accreditation is the improvement of the quality of diagnostic services by voluntary participation, professional peer review, continuous training and education and compliance with professional standards. In vitro medical laboratories have pioneered quality control and quality assurance in health care. Based on these strengths and traditions, the introduction of the accreditation program of medical laboratories in Hungary is one of the key professional and ethical responsibilities of diagnostic professions, in order to improve the quality, efficiency and effectiveness of laboratory services during the course of Hungary's accession to the European Union.

摘要

医学实验室的服务质量受多种变量影响。长期以来,医学实验室已认识到全面质量管理的必要性,这种管理不仅包括分析程序的传统内部和外部质量控制,还涵盖诊断过程中所有阶段(如分析前、分析中和分析后阶段)的持续改进。基于国内和国际经验,为确保提供可靠、有效且具有成本效益的诊断服务,质量的持续改进及其外部评估至关重要。在匈牙利医院,依据ISO 9001标准对医疗服务进行认证,并不足以证明医学实验室的专业能力,因此需要一套实验室认可体系。认可是一种外部专业审核,由独立的认可机构正式确认医学实验室有能力提供符合严格最佳实践专业标准的高质量服务。认可的主要目的是通过自愿参与、同行专业评审、持续培训与教育以及遵守专业标准来提高诊断服务质量。体外医学实验室在医疗保健领域率先开展了质量控制和质量保证工作。基于这些优势和传统,在匈牙利加入欧盟的过程中,引入医学实验室认可计划是诊断行业关键的专业和道德责任之一,目的是提高实验室服务的质量、效率和效能。

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