Men'shikov V V
Klin Lab Diagn. 2013 Aug(8):59-63.
The external evaluation of quality of clinical laboratory examinations was gradually introduced in USSR medical laboratories since 1970s. In Russia, in the middle of 1990 a unified all-national system of external evaluation quality was organized known as the Federal center of external evaluation of quality at the basis of laboratory of the state research center of preventive medicine. The main positions of policy in this area were neatly formulated in the guidance documents of ministry of Health. Nowadays, the center of external evaluation of quality proposes 100 and more types of control studies and permanently extends their specter starting from interests of different disciplines of clinical medicine. The consistent participation of laboratories in the cycles of external evaluation of quality intrinsically promotes improvement of indicators of properness and precision of analysis results and increases reliability of laboratory information. However, a significant percentage of laboratories does not participate at all in external evaluation of quality or takes part in control process irregularly and in limited number of tests. The managers of a number of medical organizations disregard the application of the proposed possibilities to increase reliability of laboratory information and limit financing of studies in the field of quality control. The article proposes to adopt the national standard on the basis of ISO 17043 "Evaluation of compliance. The common requirements of professional competence testing".
自20世纪70年代起，苏联的医学实验室逐渐引入临床实验室检查质量的外部评估。在俄罗斯，20世纪90年代中期，在国家预防医学研究中心实验室的基础上，组织了一个统一的全国性外部评估质量体系，即联邦质量外部评估中心。卫生部的指导文件对该领域的主要政策立场进行了明确阐述。如今，质量外部评估中心提供100多种类型的对照研究，并从临床医学不同学科的利益出发，不断扩大其范围。实验室持续参与质量外部评估周期，本质上促进了分析结果准确性和精密度指标的提高，并增加了实验室信息的可靠性。然而，相当大比例的实验室根本不参与质量外部评估，或不定期且仅参与有限数量检测的控制过程。一些医疗组织的管理人员忽视应用所提议的可能性来提高实验室信息的可靠性，并限制质量控制领域研究的资金投入。本文提议在ISO 17043《合格评定 专业能力验证的通用要求》的基础上采用国家标准。
