Prospective risk analysis for clinical laboratories

doi:10.3969/j.issn.1673-8640.2017.010.019

Abstract

Abstract:

Prospective risk analysis（PRA） is an element in quality assurance for clinical laboratories.However,practical approaches to conducting PRA are scarce. On the basis of classical failure mode and effect analysis（FMEA） method,an approach to PRA is developed for key laboratory processes. Firstly,major steps of the process under investigation are identified. Scores are then given for the probability（P） and consequence（C） of predefined types of failures and the chances of detecting（D） these failures. Based on the P and C scores,an overall risk score（R） is calculated. Based on predetermined criteria for R and D,it is determined whether a more detailed analysis is required for potential failures and where risk-reducing measures are necessary. As an illustration,this review presents the results of the application of PRA to pre-analytical and analytical activities.

Key words: Prospective risk analysis, Risk management, Failure mode and effect analysis, Clinical laboratory

CLC Number:

R446.1

ZHANG Xiaoyan, WANG Wei, WANG Zhiguo. Prospective risk analysis for clinical laboratories[J]. Laboratory Medicine, 2017, 32(10): 917-921.

Figures/Tables 3

References 15

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项目	急诊检验前	急诊检验中	常规检验前	常规检验中	合计	风险分数（R）	检测度（D）	不理想潜在差错数
识别错误	8	9	8	9	34	10.0±7.3	2.2±0.7	12
标本丢失或采集错误	11	6	11	6	34	8.2±5.3	2.9±0.2	0
不适当标本处理	2	5	2	5	14	13.0±5.6	1.9±0.6	3
不正确分析	0	3	0	3	6	15.0±1.1	1.7±0.5	3
延迟处理或分析	15	18	15	18	66	9.2±7.3	2.6±0.5	6
不适当报告	1	12	1	12	26	10.2±6.5	1.9±0.7	9
合计	37	53	37	53	180	9.6±6.7	2.4±0.7	33
风险分数(R)	7.8±4.9	14.2±7.1	5.3±3.2	9.9±6.5	9.6±6.7
检测度（D）	2.9±0.4	2.1±0.6	2.8±0.5	2.1±0.6	2.4±0.7
不理想潜在差错数	1	23	0	9	33

项目	急诊检验前	急诊检验中	常规检验前	常规检验中	合计	风险分数（R）	检测度（D）	不理想潜在差错数
识别错误	8	9	8	9	34	10.0±7.3	2.2±0.7	12
标本丢失或采集错误	11	6	11	6	34	8.2±5.3	2.9±0.2	0
不适当标本处理	2	5	2	5	14	13.0±5.6	1.9±0.6	3
不正确分析	0	3	0	3	6	15.0±1.1	1.7±0.5	3
延迟处理或分析	15	18	15	18	66	9.2±7.3	2.6±0.5	6
不适当报告	1	12	1	12	26	10.2±6.5	1.9±0.7	9
合计	37	53	37	53	180	9.6±6.7	2.4±0.7	33
风险分数(R)	7.8±4.9	14.2±7.1	5.3±3.2	9.9±6.5	9.6±6.7
检测度（D）	2.9±0.4	2.1±0.6	2.8±0.5	2.1±0.6	2.4±0.7
不理想潜在差错数	1	23	0	9	33