Analysis and evaluation of the external quality assessment results of quality indicators in laboratory medicine all over China from 2015 to 2018

2019 ◽  
Vol 57 (6) ◽  
pp. 812-821 ◽  
Author(s):  
Min Duan ◽  
Fengfeng Kang ◽  
Haijian Zhao ◽  
Wei Wang ◽  
Yuxuan Du ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Quality Indicators ◽  
External Quality Assessment ◽  
External Quality ◽  
Factors Affecting ◽  
Laboratory Errors ◽  
Continuous Quality ◽  
Clinical Laboratories ◽  
Information Construction ◽  
Quality Specifications

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.

Improvement in the performance of external quality assessment in Korean HIV clinical laboratories using unrecalcified human plasma

2012 ◽  
Vol 50 (9) ◽  
Author(s):  
Jin-Sook Wang ◽  
Mee-Kyung Kee ◽  
Byeong-Sun Choi ◽  
Chan-Wha Kim ◽  
Hyon-Suk Kim ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Hiv Testing ◽  
Human Plasma ◽  
External Quality Assessment ◽  
External Quality ◽  
Testing Laboratories ◽  
Clinical Laboratories ◽  
Immunodeficiency Virus ◽  
Acid Citrate Dextrose ◽  
Citrate Dextrose

AbstractThe external quality assessment schemes (EQAS) organizer provides a suitable program to monitor and improve the quality of human immunodeficiency virus (HIV) testing laboratories with EQAS panels prepared under various conditions. The aim of the current study was to investigate the effects of human plasma samples on the EQAS results of HIV obtained from hospital-based clinical laboratories.From 2007 to 2009, HIV EQAS panels consisted of four to six samples that consisted of undiluted positive and negative samples and were provided to laboratories twice per year. Up until the first half EQAS in 2008, EQAS panel materials were obtained by converting acid citrate dextrose treated plasma to serum via chemical treatment with CaClApproximately 300 HIV clinical laboratories participated in this program. The overall performance of clinical laboratories was shown to be improved when using unrecalcified plasma panels compared with recalcified panels. Significant differences were observed in EIA analyses of plasma for both positive (p<0.001) and negative (p<0.001) samples between the recalcified and unrecalcified groups.Our finding suggested that defibrination status of EQAS panels might affect the results of anti-HIV EQAS of Korean HIV testing laboratories.

scholarly journals Quality Specifications for the Determination of Copper, Zinc, and Selenium in Human Serum or Plasma: Evaluation of an Approach Based on Biological and Analytical Variation

2008 ◽  
Vol 54 (11) ◽  
pp. 1892-1899 ◽  
Author(s):  
Josiane Arnaud ◽  
Jean-Philippe Weber ◽  
Cas W Weykamp ◽  
Patrick J Parsons ◽  
Jurgen Angerer ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Trace Element ◽  
Interindividual Variability ◽  
External Quality Assessment ◽  
Serum Copper ◽  
External Quality ◽  
Target Concentration ◽  
Quality Specifications ◽  
Copper Zinc

Abstract Background: Trace element external quality assessment schemes monitor laboratory performance and provide a stimulus for improvement in accuracy. However, monitoring of participant performance varies according to the scheme and can lead to conflicting conclusions. Methods: Quality specifications based on biological intra- and interindividual variability were calculated and compared to those currently used by various trace element external quality assessment schemes for plasma or serum copper, zinc, and selenium concentrations. For this purpose, we evaluated results reported by participating laboratories in different schemes, at key concentrations, using z scores. Results: Minimal quality specifications developed from the biological intra- and interindividual variability were, for Cu, ±0.84 μmol/L or 12% of the assigned target concentration, whichever is greater; for Zn, ±1.20 μmol/L or 15% of the assigned target concentration, whichever is greater; and for Se, ±0.072 μmol/L or 12% of the assigned target concentration, whichever is greater. Reported performance of the participating laboratories depended on analyte, concentration, and the selected quality specification. In addition, the most commonly used methods for the determination of Cu, Zn, and Se may give different results. Conclusions: The proposed minimal quality specifications based on biological variation are generally slightly less stringent than those currently in use, although they do not drastically change the performance evaluation in the different schemes. These specifications are a first step in the harmonization of practices among the schemes and remain to be evaluated.

scholarly journals Comparison of Procedures for Evaluating Laboratory Performance in External Quality Assessment Schemes for Lead in Blood and Aluminum in Serum Demonstrates the Need for Common Quality Specifications

2002 ◽  
Vol 48 (11) ◽  
pp. 2000-2007 ◽  
Author(s):  
Andrew Taylor ◽  
Jurgen Angerer ◽  
Francoise Claeys ◽  
Jesper Kristiansen ◽  
Olav Mazarrasa ◽  
...  
Keyword(s):  
Quality Assessment ◽  
External Quality Assessment ◽  
Total Error ◽  
Blood Lead ◽  
External Quality ◽  
Target Concentration ◽  
Laboratory Performance ◽  
Environmental Laboratory ◽  
Z Scores ◽  
Quality Specifications

Abstract Background: The different scoring methods used by eight European External Quality Assessment Schemes (EQASs) for occupational and environmental laboratory medicine were compared to develop suitable quality specifications as a step toward harmonization. Methods: Real results for blood lead and serum aluminum assays, reported by participants in Italian and United Kingdom EQASs, were evaluated according to individual scheme scoring criteria. The same results were then used to produce z scores using scheme-based between-laboratory SDs as the estimate of variability to determine whether simple performance-derived quality specifications produced better agreement among schemes. Results: The schemes gave conflicting assessments of participants’ performance, and participants judged to be successful by one scheme could be defined as performing inadequately by another. An approach proposed by Kenny et al. (Scand J Clin Lab Invest 1999;59:585), which uses clinical inputs to set targets for analytical imprecision, bias, and total error allowable, was then used to elaborate quality specifications. Conclusions: We suggest that the CLIA ′88 recommendations for blood lead (± 40 μg/L or ± 10% of the target concentration, whichever is the greater) could be used as a quality specification, although a revision to ± 30 μg/L or ± 10% is recommended. For serum aluminum, a suitable quality specification of ± 5 μg/L or ± 20% of the target concentration, whichever is the greater, is suggested. These specifications may be used to compare laboratory performance across schemes.

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