Programmatic evaluation of measurement uncertainty using IQC and PT data in medical laboratory

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Author: Hai-Feng DING ^1, ² Qi ZHANG ¹ Peng-Fei WEI ³  Jian-Tao ZHOU ^1, ²

Affiliation: 1. Wuhan Chain Medical Laboratories, Wuhan 430010, China, 2. Department of Medical Laboratory, School of Medicine, Huanggang Polytechnic College, Huanggang 438021, Hubei Province, China, 3. Zhengzhou Qianmai Beikang Medical Laboratory, Zhengzhou 450066, China

Keywords: Measurement uncertainty Medical laboratories Excel software Internal quality control Proficiency testing

DOI: 10.12173/j.issn.1004-4337.202303086

Reference: Ding HF, Zhang Q, We PF, Zhou JT. Programmatic evaluation of measurement uncertainty using IQC and PT data in medical laboratory[J]. Journal of Mathematical Medicine, 2023, 36(5): 346-351. DOI:10.12173/j.issn.1004-4337.202303086[Article in Chinese]  Copied

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Abstract

Objective To establish a procedural evaluation method of measurement uncertainty on Excel software, and to promote the popularization and application of measurement uncertainty in medical la-boratories.

Methods According to the “top-down” approach, using internal quality control (IQC) data and pro-ficiency testing (PT) evaluation data, the measurement uncertainty introduced by the basis of the with-in-laboratory reproducibility and the uncertainty of laboratory bias was calculated respectively on the Excel software, then synthesized into the standard measurement uncertainty to evaluate whether the laboratory measurement values meet the application requirements.

Results Using IQC and PT data, the laboratory quick-ly assessed the measurement uncertainty of quantitative test items, which met the requirements of ISO15189 accreditation standards.

Conclusion It is feasible to select the “top-down” approach to evaluate and analyze the measurement uncertainty in the measurement stage using laboratory IQC and PT data, and the results can be calculated conveniently on Excel software, which is suitable for the universal application of measurement un-certainty in medical laboratory.

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References

1.中华人民共和国国家质量监督检验检疫总局, 中国国家标准化管理委员会. GB/T27418-201, 测量不确定度评定和表示[S]. (2017-12-29) [2022-09-16]. [General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of China. GB/T27418-2017, Guide to the evaluation and expression of uncertainty in measurement[S]. (2017-12-29) [2022-09-16].] https://openstd.samr.gov.cn/bzgk/gb/newGbInfo?hcno=4BAEA7D58DD78FD31710D69E0F9CDCF7.

2.中国合格评定国家认可委员会. CNAS-CL01-G003,测量不确定度的要求[S]. (2021-01-09) [2022-09-16]. [China National Accreditation Service for Conformity Assessment. CNAS-CL01-G003, Requirements for measurement uncertainty[S]. (2021-01-09) [2022-09-16].] https://www.cnas.org.cn/zxtz/910514.shtml.

3.ISO. ISO/IEC 17025. Testing and calibration laboratories[S]. (2017) [2022-09-16]. https://www.iso.org/ISO-IEC-17025-testing-and-calibration-laboratories.html.

4.ISO. ISO 15189: 2012. Medical laboratories—requirements for quality and competence[S]. (2012-11) [2022-09-16]. https://www.iso.org/standard/56115.html.

5.CLSI. EP29. Expression of measurement uncertainty in laboratory medicine, 1st edition[S]. (2012) [2022-09-16]. https://www.clsi.org/standards/products/method-evaluation/documents/ep29/.

6.Magnusson B, Näykki T, Hovind H. et al. Handbook for calculation of measurement uncertainty in envi-ronmental laboratories (NT TR 537–Edition 4)[M]. Denmark: Nordtest. 2017. https://xueshu.baidu.com/usercenter/paper/show?paperid=1c160ec0jr5g0p70gj0h02a09v781973&site=xueshu_se.

7.ISO. ISO/TS 20914:2019. Medical laboratories—practical guidance for the estimation ofmeasurement uncertainty[S].(2019) [2022-09-22]. https://www.iso.org/standard/69445.html.

8.中国合格评定国家认可委员会. CNAS-CL02, 医学实验室质量和能力认可准则[S]. (2013-11-22) [2022-09-22]. [China National Accreditation Service for Conformity Assessment. CNAS-CL02, Accreditation criteria for the quality and competence of medical laboratories[S]. (2013-11-22) [2022-09-22].] https://www.cnas.org.cn/rkgf/sysrk/jbzz/2019/02/895562.shtml.

9.中国合格评定国家认可委员会. CNAS-CL02-A001,医学实验室质量和能力认可准则的应用要求[S]. (2021-06-11) [2022-09-25]. [China National Accreditation Service for Conformity Assessment. CNAS-CL02-A001, Ap-plication requirements of accreditation criteria for the quality and competence of medical laboratories[S]. (2021-06-11) [2022-09-25].] https://www.cnas.org.cn/rkgf/sysrk/rkyyzz/2021/06/905785.shtml.

10.Westgard SA. Rhetoric versus reality? Laboratory surveys show actual practice differs considerably from proposed models and mandated calculations[J]. Clin Lab Med, 2017, 37(1): 35-45. DOI: 10.1016/j.cll.2016.09.004.

11.Coskun A, Theodorsson E, Oosterhuis WP, et al. Measurement uncertainty for practical use[J]. Clin Chim Acta, 2022, 531(1): 352-360. DOI: 10.1016/j.cca.2022.04.1003.

12.Joint Committee for Guides in Metrology. JCGM100:2008. Evaluation of measurement data — guide to the expression of uncertainty in measurement[S]. (2008) [2022-09-25]. https://www.iso.org/sites/JCGM/GUM/JCGM100/C045315e-html/C045315e.html?csnumber=50461.

13.Panteghini M. Application of traceability concepts to analytical quality control may reconcile total error with uncertainty of measurement[J]. Clin Chem Lab Med, 2010, 48(1): 7-10. DOI: 10.1515/CCLM.2010.020.

14.Rigo-Bonnin R, Blanco-Font A, Canalias F. Different top-down approaches to estimatemeasurement uncertainty of whole blood tacrolimus mass concentration values[J]. Clin Biochem, 2018, 57: 56-61. DOI: 10.1016/j.clinbiochem.2018.05.005.

15.中国合格评定国家认可委员会. CNAS-TRL-001:2012,医学实验室-测量不确定度的评定与表达[S]. (2012-11-08) [2022-09-25]. [China National Accreditation Service for Conformity Assessment. CNAS-TRL-001: 2012, Medical Laboratory–Evaluation and expression of measurement uncertainty[S]. (2012-11-08) [2022-09-25].] https://www.cnas.org.cn/zxtz/703169.shtml.

16.Martinello F, Snoj N, Skitek M, et al. The top-down approach to measurement uncertainty: which formula should we use in laboratory medicine?[J]. Biochem Med (Zagreb), 2020, 30(2): 020101. DOI: 10.11613/BM.2020.020101.

17.国家卫生健康委临床检验中心. 室间质量评价标准2022[S]. [National Center for Clinical Laboratories. Evaluation criteria of ex-ternal quality assessment(EQA)2022[S]. https://www.nccl.org.cn/showEqaPlanProDetail?id=363.

18.Braga F, Infusino I, Panteghini M. Performance criteria for combined uncertainty budget in the imple-mentation of metrological traceability[J]. Clin Chem Lab Med, 2015, 53(6): 905-912. DOI: 10.1515/cclm-2014-1240.

19.Panteghini M. The simple reproducibility of a measurement result does not equal its overall measurement uncertainty[J]. Clin Chem Lab Med, 2022, 60(10): e221-e222. DOI: 10.1515/cclm-2022-0618.

20.中国合格评定国家认可委员会. CNAS-RL02:2018《能力验证规则》[S]. (2018-03-01) [2022-09-25]. [China National Accreditation Service for Conformity Assessment. CNAS-RL02:2018, Rules for Proficiency Testing[S]. (2018-03-01) [2022-09-25].] https://www.cnas.org.cn/rkgf/sysrk/rkgz/2018/03/889058.shtml.

21.中华人民共和国卫生部. WS/T403-2012, 临床生物化学检验常规项目分析质量指标[S]. (2012-12-25) [2022-09-25]. [Ministry of Health of the People's Republic of China. WS/T403-2012, Analytical quality specifications for routine analytes in clinical biochemistry[S]. (2012-12-25) [2022-09-25].] http://www.nhc.gov.cn/wjw/s9492/201301/c8dd48222ab14387a6503667be78bec3.shtml.