| 摘要: |
| 在检验医学领域中，有很多研究已描述检验全过程不同阶段出现的最频繁的差错，且这些差错的很大部分都出现在检验前阶段。检验中阶段的误差登记然后反馈给参加者的方案已经由室间质评（External Quality Assessment，EQA）组织在大多数国家进行了数十年。但是迄今为止，只有很少的组织专注于检验前阶段，而且大多数的EQA组织并不提供检验前EQA方案（External Quality Assessment Schemes，EQAS）。执行和标准化检验前EQAS是比较困难的，认可机构也并没有对实验室参加这类方案提出要求。然而，一些正在进行的检验前阶段EQA计划是存在的，使用的方法可以分为三种类型：收集实验室检验前程序的信息、发放真实样品来收集可能影响测量程序的干扰因素、或者登记真实的实验室差错并将这些内容关联到质量指标。这三个类型有不同的侧重点和不同的实施挑战，这三者的结合可能是检出和监视出现在检验前阶段的广泛差错所必须的。 |
| 关键词: 质量保证 检验前 质量指标 室间质量评价 |
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| Design of External Quality Assessment Schemes for the Pre-examination Phase in Clinical Laboratory |
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| Abstract: |
| In laboratory medicine, several studies have described the most frequent errors in different phases of the total testing process, and a large proportion of these errors occur in the pre-examination phase. Schemes for registration of errors and subsequent feedback to the participants have been conducted for decades concerning the examination phase by External Quality Assessment (EQA) organizations operating in most countries. However so far, very few EQA organizations have focused on the pre-examination phase, and most EQA organizations do not offer pre-examination EQA schemes(EQAS). It is more difficult to perform and standardize pre-examination EQAS and also, accreditation institutions do not ask the laboratories for results from such schemes. However, some ongoing EQA programs for the pre-examination phase do exist, and the methods used can be divided into three different types: collecting information about pre-examination laboratory procedures, circulating real samples to collect information about interferences that might affect the measurement procedure, or register actual laboratory errors and relate these to quality indicators. These three types have different focuses and different challenges regarding implementation, and a combination of the three is probably necessary to be able to detect and monitor the wide range of errors occurring in the pre-examination phase. |
| Key words: quality assurance,pre-examination,quality indicator,external quality assessment |
