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在临床实验室实施自我维持的质量控制程序。

Implementing self sustained quality control procedures in a clinical laboratory.

作者信息

Khatri Roshan, K C Sanjay, Shrestha Prabodh, Sinha J N

机构信息

College of Medical Sciences Teaching Hospital, Bharatpur, Chitwan, Nepal.

出版信息

JNMA J Nepal Med Assoc. 2013 Jan-Mar;52(189):233-7.

PMID:23591302
Abstract

INTRODUCTION

Quality control is an essential component in every clinical laboratory which maintains the excellence of laboratory standards, supplementing to proper disease diagnosis, patient care and resulting in overall strengthening of health care system. Numerous quality control schemes are available, with combinations of procedures, most of which are tedious, time consuming and can be "too technical" whereas commercially available quality control materials can be expensive especially for laboratories in developing nations like Nepal. Here, we present a procedure performed at our centre with self prepared control serum and use of simple statistical tools for quality assurance.

METHODS

The pooled serum was prepared as per guidelines for preparation of stabilized liquid quality control serum from human sera. Internal Quality Assessment was performed on this sample, on a daily basis which included measurement of 12 routine biochemical parameters. The results were plotted on Levey-Jennings charts and analysed with quality control rules, for a period of one month.

RESULTS

The mean levels of biochemical analytes in self prepared control serum were within normal physiological range. This serum was evaluated every day along with patients' samples. The results obtained were plotted on control charts and analysed using common quality control rules to identify possible systematic and random errors. Immediate mitigation measures were taken and the dispatch of erroneous reports was avoided.

CONCLUSIONS

In this study we try to highlight on a simple internal quality control procedure which can be performed by laboratories, with minimum technology, expenditure, and expertise and improve reliability and validity of the test reports.

摘要

引言

质量控制是每个临床实验室的重要组成部分,它维持着实验室标准的卓越性,辅助正确的疾病诊断和患者护理,并全面加强医疗保健系统。有许多质量控制方案,其程序组合多样,其中大多数繁琐、耗时且可能“过于技术化”,而市售的质量控制材料可能很昂贵,尤其是对于像尼泊尔这样的发展中国家的实验室。在此,我们介绍我们中心采用自制对照血清并使用简单统计工具进行质量保证的程序。

方法

按照从人血清制备稳定液态质量控制血清的指南制备混合血清。每天对该样本进行内部质量评估,包括测量12项常规生化参数。结果绘制在Levey-Jennings图上,并根据质量控制规则进行分析,为期一个月。

结果

自制对照血清中生化分析物的平均水平在正常生理范围内。该血清每天与患者样本一起进行评估。将获得的结果绘制在控制图上,并使用常见的质量控制规则进行分析,以识别可能的系统误差和随机误差。立即采取缓解措施,避免错误报告的发送。

结论

在本研究中,我们试图强调一种简单的内部质量控制程序,实验室可以用最少的技术、费用和专业知识来执行该程序,并提高测试报告的可靠性和有效性。

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