National surveys on 15 quality indicators for the total testing process in clinical laboratories of China from 2015 to 2017
-
Min Duan
and
Zongjiu Zhang
Abstract
Background
As effective quality management tools, quality indicators (QIs) are widely used in laboratory medicine. This study aimed to analyze the results of QIs, identify errors and provide quality specifications (QSs) based on the state-of-the-art.
Methods
Clinical laboratories all over China participated in the QIs survey organized by the National Health Commission of People’ Republic of China from 2015 to 2017. Most of these QIs were selected from a common model of QIs (MQI) established by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). All participants were asked to submit general information and original QIs data through a medical quality control data collection system. The results of QIs were reported in percentages and sigma, except turnaround time (TAT) which was measured in minutes. The 25th, 50th and 75th percentiles were, respectively, calculated as three levels of QSs, which were defined starting from the model proposed during the 1st Strategic Conference of the EFLM on “Defining analytical performance 15 years after the Stockholm Conference on Quality Specification in Laboratory Medicine”.
Results
A total of 76 clinical laboratories from 25 provinces in China continuously participated in this survey and submitted complete data for all QIs from 2015 to 2017. In general, the performance of all reported QIs have improved or at least kept stable over time. Defect percentages of blood culture contamination were the largest in the pre-analytical phase. Intra-laboratory TAT was always larger than pre-examination TAT. Percentage of tests covered by inter-laboratory comparison was relatively low than others in the intra-analytical phase. The performances of critical values notification and timely critical values notification were the best with 6.0σ. The median sigma level of incorrect laboratory reports varied from 5.5σ to 5.7σ.
Conclusions
QSs of QIs provide useful guidance for laboratories to improve testing quality. Laboratories should take continuous quality improvement measures in all phases of total testing process to ensure safe and effective tests.
Acknowledgments
We appreciate those participant laboratories and institutions that attended the national QIs survey. We also thank the contribution of Provincial Health Commissions 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: The organization of national survey on 15 QIs was supported by the National Health Commission of the People’s Republic of China, and the data management and statistics analysis was supported by the National Center for Clinical Laboratories. There was no funding source involved in this study.
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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©2019 Walter de Gruyter GmbH, Berlin/Boston
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Articles in the same Issue
- Frontmatter
- Obituary
- Jillian Russyll (AKA Jill) Tate
- Editorial
- The long way to standardization of practices: HbA1c as archetypal example
- Reviews
- Secretory tumors of the pituitary gland: a clinical biochemistry perspective
- Thalassemia in the laboratory: pearls, pitfalls, and promises
- Opinion Paper
- Diagnostic biomarkers of muscle injury and exertional rhabdomyolysis
- General Clinical Chemistry and Laboratory Medicine
- Patient’s knowledge and awareness about the effect of the over-the-counter (OTC) drugs and dietary supplements on laboratory test results: a survey in 18 European countries
- National surveys on 15 quality indicators for the total testing process in clinical laboratories of China from 2015 to 2017
- Urinary albumin strip assay as a screening test to replace quantitative technology in certain conditions
- Cerebrospinal fluid free kappa light chains and kappa index perform equal to oligoclonal bands in the diagnosis of multiple sclerosis
- Different immunoreactivity of monomers and dimers makes automated free light chains assays not equivalent
- The utility of saliva testing in the estimation of uremic toxin levels in serum
- Determination of cannabinoids in oral fluid and urine of “light cannabis” consumers: a pilot study
- Moving from the second to the third generation Roche PTH assays: what are the consequences for clinical practice?
- Baseline hepcidin measurement in the differential diagnosis of anaemia for elderly patients and its correlation with the increment of transferrin saturation following an oral iron absorption test
- Reference Values and Biological Variations
- A multicenter study for the evaluation of the reference interval for TSH in Italy (ELAS TSH Italian Study)
- Cancer Diagnostics
- Urinary measurement of circulating tumor DNA for treatment monitoring and prognosis of metastatic colorectal cancer patients
- BCL2L12: a multiply spliced gene with independent prognostic significance in breast cancer
- Diabetes
- The global impact of the International Federation of Clinical Chemistry and Laboratory Medicine, Education and Management Division: engaging stakeholders and assessing HbA1c quality in a multicentre study across China
- The frequency of testing for glycated haemoglobin, HbA1c, is linked to the probability of achieving target levels in patients with suboptimally controlled diabetes mellitus
- Letters to the Editor
- Response to article by Caponi et al. about serum free light chains
- Response to Letter to the Editor about immunochemical measurement of urine free light chains
- Estimated GFR-specific 99th percentiles for high-sensitive cardiac troponin T based on the adjusted analytical change limit (adjACL) in hospitalized patients
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- Genetic polymorphisms and variants in the LDL receptor associated with familial hypercholesterolemia: cascade screening and identification of the variants 666C>A, 862G>A, 901G>A, and 919G>A of a Brazilian family
- Undetected paraganglioma by functional imaging techniques: case report
- A particular case of AML patient with the polymorphism G105G (rs11554137) and the missense mutation R132C in IDH1 gene
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