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检验医学中的能力验证:用途与局限性

Proficiency testing in laboratory medicine: uses and limitations.

作者信息

Shahangian S

机构信息

Division of Laboratory Systems, Public Health Practice Program Office, Centers for Disease Control and Prevention, Atlanta, GA 30341-3724, USA.

出版信息

Arch Pathol Lab Med. 1998 Jan;122(1):15-30.

PMID:9448012
Abstract

OBJECTIVE

To provide a critical review of recently published literature on the effectiveness, uses, and limitations of proficiency testing (PT) as a mechanism for laboratory improvement, and to explore ways to improve the PT process.

DATA SOURCE

All publications identified by a MEDLINE search of the literature dating back to 1987 on the subject of "proficiency testing" in laboratory medicine, as well as selected references cited in recent review articles.

STUDY SELECTION

No specific selection criteria were used for inclusion of publications identified by the MEDLINE database as long as they dealt with PT as a mechanism of medical laboratory improvement or a measure of laboratory performance.

DATA EXTRACTION

Abstractions of data were made depending on relevance of the data.

DATA SYNTHESIS

Proficiency testing data are an indicator, but not a measure, of laboratory performance. Limitations of current PT practices are incomplete assessment of the total testing process, PT materials being treated differently than those from patients, PT performance criteria, and "matrix effect." Proficiency testing performance has been related to length of PT experience, test environment and volume, institutional size, laboratory and analyst workload, difficulty of PT materials, performing quality control, testing methodology, and degree of automation.

CONCLUSIONS

Proficiency testing has a well-established role as both a laboratory improvement and an educational tool. There are, however, several practical and design limitations even for the best-administered PT programs. Suggestions to improve the PT process include increased reliance on PT results in combination with other quality indicators (such as performance in regional surveys), occasional use of "blind" PT, introduction of biological materials to PT participants, electronic grading and reporting of PT results, and introduction of challenging PT materials to fulfill the educational role of PT.

摘要

目的

对近期发表的有关能力验证(PT)作为实验室改进机制的有效性、用途和局限性的文献进行批判性综述,并探索改进PT流程的方法。

数据来源

通过对MEDLINE数据库中可追溯至1987年的有关医学实验室“能力验证”主题的文献进行检索所确定的所有出版物,以及近期综述文章中引用的选定参考文献。

研究选择

只要涉及将PT作为医学实验室改进机制或实验室性能衡量标准的出版物,均未采用特定的选择标准来纳入MEDLINE数据库所确定的出版物。

数据提取

根据数据的相关性进行数据摘要。

数据综合

能力验证数据是实验室性能的一个指标,但不是衡量标准。当前PT实践的局限性包括对整个检测过程的评估不完整、PT材料与患者样本的处理方式不同、PT性能标准以及“基质效应”。能力验证性能与PT经验时长、检测环境和检测量、机构规模、实验室及分析人员工作量、PT材料的难度、实施质量控制、检测方法以及自动化程度有关。

结论

能力验证作为实验室改进和教育工具具有既定的作用。然而,即使对于管理最佳的PT计划,也存在一些实际和设计上的局限性。改进PT流程的建议包括更多地依赖PT结果并结合其他质量指标(如区域调查中的表现)、偶尔使用“盲法”PT、向PT参与者引入生物材料、电子评分和报告PT结果,以及引入具有挑战性的PT材料以实现PT的教育作用。

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