Preliminary probe of quality indicators and quality specification in total testing process in 5753 laboratories in China
-
Yang Fei
und
Wenxiang Chen
Abstract
Background: The aim of the study was to promote the establishment and implementation of quality indicators (QIs) in clinical laboratories, catch up with the state of art, and provide preliminary quality specifications for established QIs.
Methods: Clinical laboratories from different provinces in China were included in this QIs survey in 2015. All participants were asked to collect data related to QIs and complete QIs questionnaires. Defect percentages and sigma values were calculated for each QI. The 25th percentile, median, and the 75th percentile of defect percentages and TATs were calculated as optimum, desirable and minimum quality specifications. While 25th, median, and 75th of sigma values were calculated as minimum, desirable and optimum quality specifications, respectively.
Results: Five thousand seven hundred and fifty-three clinical laboratories from 28 provinces in China participated in this survey. Median defect percentages of pre-examination QIs varied largely from 0.01% (incorrect sample container) to 0.57% (blood culture contamination) with sigma values varied from 4.0σ to 5.1σ. Median defect percentages of examination phase QIs were all really high. The most common problem in examination phase was test uncovered by inter-laboratory comparison (86.67%). Defect percentages of critical values notification and timely critical values notification were all 0.00% (6.0σ). While the median of defect percentages of incorrect laboratory reports was only 0.01% (5.4σ).
Conclusions: Improvements are needed in all phases of total testing process (TTP) in laboratories in China, especially in examination phase. More attention should be paid when microbiology specimens are collected and results are reported. Quality specifications can provide directions for laboratories to make effort for.
Acknowledgments
We appreciate those participant laboratories and institutions that attended the QIs investigation for this survey. We acknowledge the support of the Beijing Natural Science Foundation in 2014 and Beijing Hospital Foundation in 2015. We thank the contribution of Weiming Zou (Guangdong Center for Clinical Laboratory), Weixing Li (Zhejiang Center for Clinical Laboratory), Qingtao Wang (Beijing Center for Clinical Laboratory), Weiping Zhu (Hubei Center for Clinical Laboratory), Bin Xu (Jiangsu Center for Clinical Laboratory), Falin Chen (Fujian Center for Clinical Laboratory), Shengmiao Fu (Hainan Center for Clinical Laboratory), Wenfang Huang (Sichuan Center for Clinical Laboratory), Yuqi Jin (Henan Center for Clinical Laboratory), Guobing Ma (Shan Xi Center for Clinical Laboratory Quality Control), Pu Liao (Chongqing Center for Clinical Laboratory), Zhiming Lu (Shandong Center for Clinical Laboratory), Yuefeng Lu (Hunan Center for Clinical Laboratory), Hua Niu (Yunnan Center for Clinical Laboratory), Yuhai Tang (Liaoning Center for Clinical Laboratory), Xiaomei Gui (JiangXi Center for Clinical Laboratory), Liqiang Wei (Shanxi Center for Clinical Laboratory), Jian Xu (Guizhou Center for Clinical Laboratory), Zhaoxia Zhang (Xinjiang Autonomous Region Center for Clinical Laboratory), Lijun Zhang (Neimenggu Autonomous Region Center for Clinical Laboratory), and Xiangyang Zhou (Guangxi Autonomous Region Center for Clinical Laboratory) for their generous help with data collection. We also thank Clinet website (www.clinet.com.cn) (Minqi Wang, Bingquan Chen, and Jie Zhou) (Beijing Clinet Infor&Technology.Co.Ltd) who gave computer technology support to establish the network platform for survey and relevant services.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: Beijing Natural Science Foundation in 2014; No.7143182, Beijing Hospital Foundation in 2015 (BJ-2015-025).
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.
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©2016 by De Gruyter
Artikel in diesem Heft
- Frontmatter
- Editorials
- Laboratory analytical quality – the process continues
- Measurement uncertainty – a revised understanding of its calculation and use
- Review
- Substrate-zymography: a still worthwhile method for gelatinases analysis in biological samples
- Opinion Papers
- Is the combination of trueness and precision in one expression meaningful? On the use of total error and uncertainty in clinical chemistry
- The problem with total error models in establishing performance specifications and a simple remedy
- Measurement uncertainty for clinical laboratories – a revision of the concept
- Uncertainty in measurement and total error – are they so incompatible?
- General Clinical Chemistry and Laboratory Medicine
- Using the hazard ratio to evaluate allowable total error in predictive measurands
- Performance of electrolyte measurements assessed by a trueness verification program
- Analytical interference by monoclonal immunoglobulins on the direct bilirubin AU Beckman Coulter assay: the benefit of unsuspected diagnosis from spurious results
- Preliminary probe of quality indicators and quality specification in total testing process in 5753 laboratories in China
- Analytical and clinical evaluation of the new Fujirebio Lumipulse®G non-competitive assay for 25(OH)-vitamin D and three immunoassays for 25(OH)D in healthy subjects, osteoporotic patients, third trimester pregnant women, healthy African subjects, hemodialyzed and intensive care patients
- Patient-performed extraction of faecal calprotectin
- Comparison of the clinical utility of the Elia CTD Screen to indirect immunofluorescence on Hep-2 cells
- Reference Values and Biological Variations
- Sex-related differences in the association of ghrelin levels with obesity in adolescents
- Gestation specific reference intervals for thyroid function tests in pregnancy
- Cancer Diagnostics
- SOX17 promoter methylation in plasma circulating tumor DNA of patients with non-small cell lung cancer
- Dopamine concentration in blood platelets is elevated in patients with head and neck paragangliomas
- Letters to the Editor
- Cancer dynamics and the success of cancer screening programs
- Mother’s instinct – a rare case of multiple test interferences due to heterophile antibodies
- Sigma metric or defects per million opportunities (DPMO): the performance of clinical laboratories should be evaluated by the Sigma metrics at decimal level with DPMOs
- A national survey of preanalytical handling of oral glucose tolerance tests in pregnancy
- Updating pregnancy diabetes guidelines: is (y)our laboratory ready?
- Low serum bilirubin values are associated with pulmonary embolism in a case-control study
- Effect of Hb H on HbA1c measurements as measured by IFCC reference method and affinity HPLC
- Adipocytes in venipunctures cause falsely elevated S-100B serum values
- Earlier detection of sepsis by Candida parapsilosis using three-dimensional cytographic anomalies on the Mindray BC-6800 hematological analyzer
- Theranos phenomenon – part 4: Theranos at an International Conference
Artikel in diesem Heft
- Frontmatter
- Editorials
- Laboratory analytical quality – the process continues
- Measurement uncertainty – a revised understanding of its calculation and use
- Review
- Substrate-zymography: a still worthwhile method for gelatinases analysis in biological samples
- Opinion Papers
- Is the combination of trueness and precision in one expression meaningful? On the use of total error and uncertainty in clinical chemistry
- The problem with total error models in establishing performance specifications and a simple remedy
- Measurement uncertainty for clinical laboratories – a revision of the concept
- Uncertainty in measurement and total error – are they so incompatible?
- General Clinical Chemistry and Laboratory Medicine
- Using the hazard ratio to evaluate allowable total error in predictive measurands
- Performance of electrolyte measurements assessed by a trueness verification program
- Analytical interference by monoclonal immunoglobulins on the direct bilirubin AU Beckman Coulter assay: the benefit of unsuspected diagnosis from spurious results
- Preliminary probe of quality indicators and quality specification in total testing process in 5753 laboratories in China
- Analytical and clinical evaluation of the new Fujirebio Lumipulse®G non-competitive assay for 25(OH)-vitamin D and three immunoassays for 25(OH)D in healthy subjects, osteoporotic patients, third trimester pregnant women, healthy African subjects, hemodialyzed and intensive care patients
- Patient-performed extraction of faecal calprotectin
- Comparison of the clinical utility of the Elia CTD Screen to indirect immunofluorescence on Hep-2 cells
- Reference Values and Biological Variations
- Sex-related differences in the association of ghrelin levels with obesity in adolescents
- Gestation specific reference intervals for thyroid function tests in pregnancy
- Cancer Diagnostics
- SOX17 promoter methylation in plasma circulating tumor DNA of patients with non-small cell lung cancer
- Dopamine concentration in blood platelets is elevated in patients with head and neck paragangliomas
- Letters to the Editor
- Cancer dynamics and the success of cancer screening programs
- Mother’s instinct – a rare case of multiple test interferences due to heterophile antibodies
- Sigma metric or defects per million opportunities (DPMO): the performance of clinical laboratories should be evaluated by the Sigma metrics at decimal level with DPMOs
- A national survey of preanalytical handling of oral glucose tolerance tests in pregnancy
- Updating pregnancy diabetes guidelines: is (y)our laboratory ready?
- Low serum bilirubin values are associated with pulmonary embolism in a case-control study
- Effect of Hb H on HbA1c measurements as measured by IFCC reference method and affinity HPLC
- Adipocytes in venipunctures cause falsely elevated S-100B serum values
- Earlier detection of sepsis by Candida parapsilosis using three-dimensional cytographic anomalies on the Mindray BC-6800 hematological analyzer
- Theranos phenomenon – part 4: Theranos at an International Conference
