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[样本运输至临床实验室过程中错误检测的模态失效分析及其影响]

[Modal failure analysis and effects in the detection of errors in the transport of samples to the clinical laboratory].

作者信息

Parés-Pollán L, Gonzalez-Quintana A, Docampo-Cordeiro J, Vargas-Gallego C, García-Álvarez G, Ramos-Rodríguez V, Diaz Rubio-García M P

机构信息

Servicio de Análisis Clínicos/Bioquímica, Hospital universitario 12 de Octubre, Madrid, España.

Servicio de Análisis Clínicos/Bioquímica, Hospital universitario 12 de Octubre, Madrid, España.

出版信息

Rev Calid Asist. 2014 Jul-Aug;29(4):197-203. doi: 10.1016/j.cali.2014.03.001. Epub 2014 Apr 13.

DOI:10.1016/j.cali.2014.03.001
PMID:24725518
Abstract

OBJECTIVE

Owing to the decrease in values of biochemical glucose parameter in some samples from external extraction centres, and the risk this implies to patient safety; it was decided to apply an adaptation of the «Health Services Failure Mode and Effects Analysis» (HFMEA) to manage risk during the pre-analytical phase of sample transportation from external centres to clinical laboratories.

MATERIALS AND METHODS

A retrospective study of glucose parameter was conducted during two consecutive months. The analysis was performed in its different phases: to define the HFMEA topic, assemble the team, graphically describe the process, conduct a hazard analysis, design the intervention and indicators, and identify a person to be responsible for ensuring completion of each action.

RESULTS

The results of glucose parameter in one of the transport routes, were significantly lower (P=.006). The errors and potential causes of this problem were analysed, and criteria of criticality and detectability were applied (score≥8) in the decision tree. It was decided to: develop a document management system; reorganise extractions and transport routes in some centres; quality control of the sample container ice-packs, and the time and temperature during transportation.

CONCLUSIONS

This work proposes quality indicators for controlling time and temperature of transported samples in the pre-analytical phase. Periodic review of certain laboratory parameters can help to detect problems in transporting samples. The HFMEA technique is useful for the clinical laboratory.

摘要

目的

由于来自外部采血中心的一些样本中生化葡萄糖参数值降低,且这对患者安全构成风险;因此决定采用“卫生服务失效模式与效应分析”(HFMEA)的一种改编方法,以管理样本从外部中心运输至临床实验室的分析前阶段的风险。

材料与方法

连续两个月对葡萄糖参数进行回顾性研究。分析在其不同阶段进行:确定HFMEA主题、组建团队、以图形方式描述流程、进行危害分析、设计干预措施和指标,并确定负责确保每项行动完成的人员。

结果

其中一条运输路线上的葡萄糖参数结果显著较低(P = 0.006)。分析了该问题的误差和潜在原因,并在决策树中应用了临界性和可检测性标准(分数≥8)。决定:开发文件管理系统;在一些中心重新组织采血和运输路线;对样本容器冰袋以及运输过程中的时间和温度进行质量控制。

结论

本研究提出了用于控制分析前阶段运输样本的时间和温度的质量指标。定期审查某些实验室参数有助于检测样本运输中的问题。HFMEA技术对临床实验室有用。

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