分析影响不合格临床标本产生的因素及预防措施。

Analysis of factors influencing the generation of unqualified clinical samples and measures to prevent this generation.

机构信息

Department of Laboratory Medicine, First Affiliated Hospital of Chongqing Medical University, Chongqing, P.R. China.

出版信息

Ann Lab Med. 2012 May;32(3):216-9. doi: 10.3343/alm.2012.32.3.216. Epub 2012 Apr 18.

DOI:10.3343/alm.2012.32.3.216

PMID:22563558

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3339303/

Abstract

BACKGROUND

We investigated the influence of pre-analytical factors on the results of clinical tests and thereby analyzed approaches to improve quality management in clinical laboratories.

METHODS

Unqualified clinical samples were selected from all the samples received at our clinical laboratory. The data were collected for 2009 and 2010, i.e., the years before and after the establishment of the laboratory quality management system. The rate and causes of generation of unqualified samples were analyzed, and measures to improve the laboratory practices were studied and implemented.

RESULTS

A total of 1,051 unqualified samples were identified from among the 553,158 samples (the overall incidence rate of unqualified samples was 0.19%). The number of unqualified samples substantially varied according to the nature of the sample, and clinical samples collected for routine blood tests or coagulation tests were the predominant unqualified samples. The main causes of generation of unqualified samples were insufficient sample volumes and improper methods of mixing the samples. The rate of generation of unqualified samples decreased significantly after the implementation of improvement measures (0.26% in 2009 vs. 0.13% in 2010, P<0.001).

CONCLUSIONS

The number of unqualified samples decreased significantly after the establishment of the laboratory quality management system, which promoted active communication among and training of the clinical staff to reduce the occurrence of pre-analytical errors. Comprehensive control of pre-analytical factors is an important approach in improving the clinical laboratory practices.

摘要

背景

本研究旨在探讨分析前因素对临床检验结果的影响，从而分析改进临床实验室质量管理的方法。

方法

从我院检验科接收的所有标本中筛选出不合格标本。收集 2009 年和 2010 年（即实验室质量管理体系建立前后）的资料，分析不合格标本的产生率和原因，并研究和实施改进实验室操作的措施。

结果

共从 553158 份标本中检出 1051 份不合格标本（不合格标本的总发生率为 0.19%）。不合格标本的数量随标本性质的不同而有较大差异，常规血液或凝血试验采集的临床标本是主要的不合格标本。不合格标本产生的主要原因为标本量不足和标本混合方法不当。实施改进措施后，不合格标本的产生率显著降低（2009 年为 0.26%，2010 年为 0.13%，P<0.001）。