Analysis and evaluation of the external quality assessment results of quality indicators in laboratory medicine all over China from 2015 to 2018
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Min Duan
Abstract
Background
This study aimed to comprehensively evaluate laboratory quality in China and explore factors affecting laboratory errors through analyzing the external quality assessment (EQA) results of quality indicators (QIs).
Methods
According to model 3 (interpretive) of the proficiency testing scheme, the National Center for Clinical Laboratories of China (CNCCL) developed a questionnaire for 15 QIs. Clinical laboratories from different provinces of China participated in the EQA program of QIs annually and submitted data via an online reporting system named Clinet-EQA. The results of QIs were expressed in percentage and sigma value or minute. Three levels of quality specifications (QSs) were defined based on percentile values. Furthermore, the QIs were analyzed by disciplines, hospital scales and information construction levels of participant laboratories.
Results
A total of 3450 laboratories nationwide continuously attended the EQA program and submitted complete data from 2015 to 2018. The performance of most QIs has improved year by year. QIs in post-analytical gained the best performance with sigma values that varied from 5.3σ to 6.0σ. The comparison of results among different disciplines showed significant differences for five QIs. More than half of QIs had statistical differences among different hospital scales measured by hospital grades and number of hospital beds. The performance of nine QIs were influenced by information construction levels of participant laboratories.
Conclusions
The overall laboratory quality in China has improved since the initiation of EQA program for QIs, but the performance of some QIs was still unsatisfactory. Therefore, laboratories should make efforts for continuous quality improvement based on information provided by QSs.
Acknowledgments
We are thankful to the laboratories that participated in the EQA program of QIs. We appreciate the contribution of Weixing Li (Zhejiang Center for Clinical Laboratory), Zhiming Lu (Shandong Center for Clinical Laboratory), Bin Xu (Jiangsu Center for Clinical Laboratory), Falin Chen (Fujian Center for Clinical Laboratory), Yuqi Jin (Henan Center for Clinical Laboratory), Weiping Zhu (Hubei Center for Clinical Laboratory), Liqiang Wei (Shanxi Center for Clinical Laboratory), Wenfang Huang (Sichuan Center for Clinical Laboratory), Lin Zhang (Liaoning Center for Clinical Laboratory), Hua Niu (Yunnan Center for Clinical Laboratory), Guobing Ma (Shan Xi Center for Clinical Laboratory Quality Control), Qingtao Wang (Beijing Center for Clinical Laboratory), Xiaomei Gui (Jiangxi Center for Clinical Laboratory), Xiangyang Zhou (Guangxi Autonomous Region Center for Clinical Laboratory), Yuefeng Lu (Hunan Center for Clinical Laboratory), Lijun Zhang (Inner Mongolia Center for Clinical Laboratory), Weiming Zou (Guangdong Center for Clinical Laboratory), Pu Liao (Chongqing Center for Clinical Laboratory), Jian Xu (Guizhou Center for Clinical Laboratory), Shengmiao Fu (Hainan Center for Clinical Laboratory), Zhaoxia Zhang (Xinjiang Autonomous Region Center for Clinical Laboratory), Hualiang (Shanghai Center for Clinical Laboratory), Lin Peng (Tianjin Center for Clinical Laboratory), Jianhong Zhao (Hebei Provincial Center for Clinical Laboratory), Zuojun Shen (Anhui Provincial Center for Clinical Laboratory), Lianhua Wei (Gansu Center for Clinical Laboratory), Xiangren A (Qinghai Center for Clinical Laboratory), Liangjun Liu (Jilin Center for Clinical Laboratory), Haoyu Wu (Heilongjiang Medical Service Management Evaluation Center), Wenhua Pu (Ningxia Hui Autonomous Region Center for Clinical Laboratory) and Zhijuan Liu (Tibet Autonomous Region Center for Clinical Laboratory) made in data collection.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: National Natural Science Foundation of China in 2018 (81871737).
Employment or leadership: None declared.
Honorarium: None declared.
Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
References
1. Miligy DA. Laboratory errors and patient safety. Int J Health Care Qual Assur 2015;28:2–10.10.1108/IJHCQA-10-2008-0098Suche in Google Scholar PubMed
2. Beastall GH. Adding value to laboratory medicine: a professional responsibility. Clin Chem Lab Med 2013;51:221–7.10.1515/cclm-2012-0630Suche in Google Scholar PubMed
3. Ambachew S, Adane K, Worede A, Melak T, Asmelash D, Damtie S, et al. Errors in the total testing process in the clinical chemistry laboratory at the University of Gondar Hospital, Northwest Ethiopia. Ethiop J Health Sci 2018;28:235–44.10.4314/ejhs.v28i2.15Suche in Google Scholar PubMed PubMed Central
4. ISO 15189:2012. Medical laboratories-requirements for quality and competence. Geneva, Switzerland: International Organization for Standardization, 2012.Suche in Google Scholar
5. Migliarino GA. External quality assessment schemes in Latin America. eJIFCC 2015;26:226–37.Suche in Google Scholar
6. Plebani M, Sciacovelli L, Marinova M, Marcuccitti J, Chiozza ML. Quality indicaors in laboratory medicine: a fundamental tool for quality and patient safety. Clin Biochem 2013;46:1170–4.10.1016/j.clinbiochem.2012.11.028Suche in Google Scholar PubMed
7. Plebani M. The journey toward quality and patient safety in laboratory medicine continues. N Am J Med Sci 2014;6:229–30.10.4103/1947-2714.132942Suche in Google Scholar PubMed PubMed Central
8. Sciacovelli L, Plebani M. The IFCC Working Group on laboratory errors and patient safety. Clin Chim Acta 2009;404:79–85.10.1016/j.cca.2009.03.025Suche in Google Scholar PubMed
9. Shahangian S, Snyder SR. Laboratory medicine quality indicators: a review of the literature. Am J Clin Pathol 2009;131:418–31.10.1309/AJCPJF8JI4ZLDQUESuche in Google Scholar PubMed
10. Tosuner Z, Gücin Z, Kiran T, Büyükpinarbaşili N, Turna S, Taşkiran O, et al. A Six Sigma trial for reduction of error rates in pathology laboratory. Turk Patoloji Derg 2016;32:171–7.10.5146/tjpath.2015.01356Suche in Google Scholar PubMed
11. Westgard JO, Westgard SA. Assessing quality on the Sigma scale from proficiency testing and external quality assessment surveys. Clin Chem Lab Med 2015;53:1531–5.10.1515/cclm-2014-1241Suche in Google Scholar PubMed
12. Sciacovelli L, Lippi G, Sumarac Z, West J, Garcia Del Pino Castro I, Furtado Vieira K, et al. Quality indicators in laboratory medicine: the status of the progress of IFCC Working Group “Laboratory Errors and Patient Safety” project. Clin Chem Lab Med 2017;55:348–57.10.1515/cclm-2016-0929Suche in Google Scholar PubMed
13. Zeng R, Wang W, Wang Z. National survey on critical values notification of 599 institutions in China. Clin Chem Lab Med 2013;51:2099–107.10.1515/cclm-2013-0183Suche in Google Scholar PubMed
14. Cohen-Bacrie S, Ninove L, Nougairède A, Charrel R, Richet H, Minodier P, et al. Revolutionizing clinical microbiology laboratory organization in hospitals with in situ point-of-care. PLoS One 2011;6:e22403.10.1371/journal.pone.0022403Suche in Google Scholar PubMed PubMed Central
15. Zhang X, Fei Y, Wang W, Zhao H, Wang M, Chen B, et al. National survey on turnaround time of clinical biochemistry tests in 738 laboratories in China. J Clin Lab Anal 2018;32.10.1002/jcla.22251Suche in Google Scholar PubMed PubMed Central
16. Al-Ali R, Reti S, Feldman H, Safran C, Niaz R, Erskine A, et al. Hospital information system survey in Qatar. Stud Health Technol Inform 2013;192:959.Suche in Google Scholar
17. Henricks WH. Laboratory information systems. Surg Pathol Clin 2015;8:101–8.10.1016/j.path.2015.02.016Suche in Google Scholar PubMed
Supplementary Material
The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2018-0983).
©2019 Walter de Gruyter GmbH, Berlin/Boston
Artikel in diesem Heft
- Frontmatter
- Obituary
- Professor Howard A. Morris
- Editorial
- The silk road to total quality in Laboratory Medicine
- Reviews
- Moving average quality control: principles, practical application and future perspectives
- Serum α-fetoprotein in pediatric oncology: not a children’s tale
- Mini Review
- Value-based healthcare: the role of laboratory medicine
- Opinion Paper
- Advantages and limitations of total laboratory automation: a personal overview
- General Clinical Chemistry and Laboratory Medicine
- Analysis and evaluation of the external quality assessment results of quality indicators in laboratory medicine all over China from 2015 to 2018
- A pilot study for establishing quality indicators in molecular diagnostics according to the IFCC WG-LEPS initiative: preliminary findings in China
- Quality assessment of interpretative commenting and competency comparison of comment providers in China
- Lower creatinine concentration values and lower inter-laboratory variation among Swedish hospital laboratories in 2014 compared to 1996: results from the Equalis external quality assessment program
- Development of the Point-of-Care Key Evidence Tool (POCKET): a checklist for multi-dimensional evidence generation in point-of-care tests
- Analytical and clinical performance evaluation of two POC tests for therapeutic drug monitoring of infliximab
- Hematology and Coagulation
- Provisional standardization of hepcidin assays: creating a traceability chain with a primary reference material, candidate reference method and a commutable secondary reference material
- Danger of false negative (exclusion) or false positive (diagnosis) for ‘congenital thrombophilia’ in the age of anticoagulants
- Point-of-care haemostasis monitoring during liver transplantation is cost effective
- Reference Values and Biological Variations
- Evaluation of reference intervals of haematological and biochemical markers in an Austrian adolescent study cohort
- Cancer Diagnostics
- A novel machine learning-derived decision tree including uPA/PAI-1 for breast cancer care
- Cardiovascular Diseases
- Evaluation of analytical performances using standardized analytical protocols and comparison of clinical results of the new ADVIA BNP and NT-proBNP immunoassays for the Centaur XPT platform
- Infectious Diseases
- Improvement in detecting sepsis using leukocyte cell population data (CPD)
- Letters to the Editor
- The biological variation of plasma proenkephalin: data from a stable heart failure cohort
- Hemoglobin variants found in relation to HbA1c testing: high occurrence of Hb Athens-Georgia in the Northern Jutland, Denmark
- Eltrombopag interferes with the measurement of plasma total bilirubin in pediatric patients in an automated colorimetric method
- A challenging case: highly variable TSH in a mother and her two children
- Suppressing all test results in grossly hemolyzed samples: is this approach appropriate in every case?
- Prozone effect observed for heavy chain α in the serum immunofixation electrophoresis of a patient with monoclonal IgA-λ gammopathy
- Significant allelic dropout phenomenon of Oncomine BRCA Research Assay on Ion Torrent S5
- Evaluation of immature platelet fraction in patients with myelodysplastic syndromes. Association with poor prognosis factors
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Artikel in diesem Heft
- Frontmatter
- Obituary
- Professor Howard A. Morris
- Editorial
- The silk road to total quality in Laboratory Medicine
- Reviews
- Moving average quality control: principles, practical application and future perspectives
- Serum α-fetoprotein in pediatric oncology: not a children’s tale
- Mini Review
- Value-based healthcare: the role of laboratory medicine
- Opinion Paper
- Advantages and limitations of total laboratory automation: a personal overview
- General Clinical Chemistry and Laboratory Medicine
- Analysis and evaluation of the external quality assessment results of quality indicators in laboratory medicine all over China from 2015 to 2018
- A pilot study for establishing quality indicators in molecular diagnostics according to the IFCC WG-LEPS initiative: preliminary findings in China
- Quality assessment of interpretative commenting and competency comparison of comment providers in China
- Lower creatinine concentration values and lower inter-laboratory variation among Swedish hospital laboratories in 2014 compared to 1996: results from the Equalis external quality assessment program
- Development of the Point-of-Care Key Evidence Tool (POCKET): a checklist for multi-dimensional evidence generation in point-of-care tests
- Analytical and clinical performance evaluation of two POC tests for therapeutic drug monitoring of infliximab
- Hematology and Coagulation
- Provisional standardization of hepcidin assays: creating a traceability chain with a primary reference material, candidate reference method and a commutable secondary reference material
- Danger of false negative (exclusion) or false positive (diagnosis) for ‘congenital thrombophilia’ in the age of anticoagulants
- Point-of-care haemostasis monitoring during liver transplantation is cost effective
- Reference Values and Biological Variations
- Evaluation of reference intervals of haematological and biochemical markers in an Austrian adolescent study cohort
- Cancer Diagnostics
- A novel machine learning-derived decision tree including uPA/PAI-1 for breast cancer care
- Cardiovascular Diseases
- Evaluation of analytical performances using standardized analytical protocols and comparison of clinical results of the new ADVIA BNP and NT-proBNP immunoassays for the Centaur XPT platform
- Infectious Diseases
- Improvement in detecting sepsis using leukocyte cell population data (CPD)
- Letters to the Editor
- The biological variation of plasma proenkephalin: data from a stable heart failure cohort
- Hemoglobin variants found in relation to HbA1c testing: high occurrence of Hb Athens-Georgia in the Northern Jutland, Denmark
- Eltrombopag interferes with the measurement of plasma total bilirubin in pediatric patients in an automated colorimetric method
- A challenging case: highly variable TSH in a mother and her two children
- Suppressing all test results in grossly hemolyzed samples: is this approach appropriate in every case?
- Prozone effect observed for heavy chain α in the serum immunofixation electrophoresis of a patient with monoclonal IgA-λ gammopathy
- Significant allelic dropout phenomenon of Oncomine BRCA Research Assay on Ion Torrent S5
- Evaluation of immature platelet fraction in patients with myelodysplastic syndromes. Association with poor prognosis factors
- Influence of temperature of transport of whole blood on plasma Cu, I, Mn, Se and Zn and Mg concentrations in erythrocytes
- Absorbent materials to collect urine can affect proteomics and metabolomic biomarker concentrations
