National External Quality Assessment follow-up: 2010–2017 Turkish experience

2019 ◽  
Vol 44 (1) ◽  
pp. 1-8 ◽  
Author(s):  
Ferzane Mercan ◽  
Muhittin A. Serdar ◽  
Mehmet Senes ◽  
Dildar Konukoglu ◽  
Tamer Cevat İnal ◽  
...  
Keyword(s):  
Quality Assessment ◽  
External Quality Assessment ◽  
Total Error ◽  
Data Entry ◽  
Error Rates ◽  
Performance Ratio ◽  
External Quality ◽  
Significant Discrepancy ◽  
Technical Problems

Abstract Objective Medical laboratories encounter critical obstacles in External Quality Assessment (EQA) practices that are key to assessment of the analytical period. Present study aims to unveil the challenges in nationwide inter-laboratory harmonization and suggest practical solutions. Materials and methods EQA results of 1941 laboratories participating in 18 different EQA-programs between 2010 and 2017 were examined. Standard Deviation Index (SDI) of each program calculated using 801,028 sample data from 24 different clinical chemical tests were used to conduct a process assessment. Results There is a significant discrepancy in unsatisfactory performance ratio among different EAQ-programs with an average of 3.4% (27,074 cases) between 2010 and 2017 and a decreasing trend (~40–50%) in 7-years. Programs with higher SDI display lower discrepancy rates. Reasons for unaccepted results appear to be data entry errors (8.27–22.2%), material dilution errors (5–11.4%), technical problems (3.76–7.9%); while random or unidentified causes account for a major of 44.9–59.5%. In 7-years, 15.7% reduction was observed in average SDI of all tests. Conclusion With the launch of national EQA follow-up program, increased awareness of the analytical processes led to a decrease in unaccepted results and variances in the analytical period. Staff training is suggested as a significant measure. In addition, simultaneous assessment of SDI and allowable total error rates would reduce the variation between programs.

scholarly journals To Win the Battle, First Know Your Enemy: Error Rates in Immunohematology External Quality Assessment Results

2019 ◽  
Vol 47 (1) ◽  
pp. 80-87 ◽  
Author(s):  
Christoph Buchta ◽  
Wim Coucke ◽  
Wolfgang R. Mayr ◽  
Mathias M. Müller ◽  
Günther F. Körmöczi
Keyword(s):  
Quality Assessment ◽  
External Quality Assessment ◽  
Error Rates ◽  
External Quality ◽  
Assessment Results

Candidate reference methods for determining target values for cholesterol, creatinine, uric acid, and glucose in external quality assessment and internal accuracy control. I. Method setup

1993 ◽  
Vol 39 (6) ◽  
pp. 993-1000 ◽  
Author(s):  
D Stöckl ◽  
H Reinauer
Keyword(s):  
Uric Acid ◽  
Quality Assessment ◽  
External Quality Assessment ◽  
Total Error ◽  
Reference Method ◽  
Gas Chromatography Mass Spectrometry ◽  
Accuracy Control ◽  
External Quality ◽  
Reference Methods ◽  
Target Values

Abstract In Germany, the target values for External Quality Assessment (EQA) and internal accuracy control are determined by Reference Methods for several analytes, including cholesterol, creatinine, uric acid, and glucose. We present candidate Reference Methods for these compounds, based on isotope dilution-gas chromatography--mass spectrometry methods that have been developed at INSTAND, one of the two official Germany EQA reference institutions. Each Reference Method target value is calculated from six independent measurements performed on three different days. The mean method CVs ranged from 0.66% for glucose to 0.96% for creatinine. The inaccuracy (bias) of the methods is < 0.7%, as compared with the Standard Reference Material 909 of the National Institute of Standards and Technology. The maximum total error of a Reference Method value, including the 95% confidence interval and systematic errors, is < 2.3%. The presented candidate Reference Methods have been successfully used to set target values in the German EQA scheme and the internal accuracy control of routine laboratories.

Quality Assessment of Tumor Marker Determinations: A Proposal for a Supraregional Scheme

1994 ◽  
Vol 9 (1) ◽  
pp. 48-52
Author(s):  
A. Piffanelli ◽  
M. Giganti ◽  
P. Colamussi ◽  
C. Cittanti ◽  
D. Pelizzola ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Tumor Marker ◽  
Tumor Markers ◽  
External Quality Assessment ◽  
Clinical Chemistry ◽  
External Quality ◽  
Realistic Information ◽  
Eqa Schemes

The use of tumor marker tests has increased progressively in the last decade concomitant with the advent of new monoclonal antibodies and their growing use in clinical oncology for various follow-up programs. External quality assessment (EQA) schemes widely adopted in clinical chemistry, have been extended in the last decade to immunoassays of hormones and tumor markers. EQA results can provide realistic information on the quality of the assays, performed under routine conditions. The goal of this article is to report the main results and discrepancies encountered so far in External Quality Assessment programs on tumor markers.

Department of pathology and laboratory medicine at Jigme Dorji Wangchuck National Referral Hospital striving for quality: external quality assessment scheme in hematology

2016 ◽  
Vol 2 (1) ◽  
pp. 5-10
Author(s):  
Kuenzang Dorji ◽  
Rixin Jamtsho ◽  
Puja D. Samal ◽  
Partab Rai ◽  
Dorji Wangchuk
Keyword(s):  
Quality Assessment ◽  
External Quality Assessment ◽  
Internal Quality ◽  
External Quality ◽  
External Quality Assessment Scheme ◽  
Gradual Improvement ◽  
Laboratory Services ◽  
Effective System ◽  
Corrective Actions

Introduction: Quality Assurance comprising External Quality Assessment Scheme (EQAS) and Internal Quality Control (IQC) is an indispensible part of the laboratory analytical process to ensure reliable results from the laboratories. However, due to various challenges in many developing countries such as limitations in resources and manpower, EQAS samples are often given less importance at laboratories. The objective of this study is to assess performance on hematology EQAS samples received from Pacific Paramedical Training Center- External Quality Assesment Scheme (PPTC-EQAS) and International External Quality Assesment Scheme-United Kingdom (IEQAS-UK)since 2007 and 2008 respectively. The findings from this study will be helpful to establish an effective system to ensure timely follow up and corrective actions to improve the quality of laboratory services. Methods:The feedback of the EQAS results submitted thrice a year to the PPTC-EQAS and six times a year to the IEQAS-UK since 2007 and 2008 respectively were reviewed to assess the laboratory’s performance and to determine the effectiveness of EQAS participation for improving the performance of laboratory hematology in Bhutan. Results:For PPTC-EQAS, the average yearly scores were 69.00%, 75.00%, 87.66%, 87.50%, 70.00%, 80.33%, 80.50%, 85.00% for the years 2007-2014. For IEQAS-UK, the average yearly scores were 76.66%, 75.95%, 77.91%, 85.83%, 92.50%, 63.88% and 98.14% for the years 2008-2014. Our results show inconsistent performances on both EQAS samples despite gradual improvement over the last seven years. Conclusions:We conclude that, strengthening the system for regular follow up and implementing corrective actions for the outlying results in addition to replacement of the equipment could improve the trend and ensure consistency of the performance.

External Quality Assessment in the Examination of Blood Films for Malarial Parasites Within Ontario, Canada

2000 ◽  
Vol 124 (1) ◽  
pp. 57-60 ◽  
Author(s):  
Sam Thomson ◽  
Reinhard C. Lohmann ◽  
Linda Crawford ◽  
Ruby Dubash ◽  
Harold Richardson
Keyword(s):  
Quality Assessment ◽  
External Quality Assessment ◽  
Good Practice ◽  
Further Education ◽  
Educational Strategies ◽  
External Quality ◽  
Medical Laboratories ◽  
Detection And Identification ◽  
Total Testing Process

Abstract Objective.—To assess laboratory practice in the examination of blood films for malarial parasites. Method.—Ontario medical laboratories, licensed by the Ministry of Health, are required to participate in external quality assessment by the Laboratory Proficiency Testing Program, which assesses performance of laboratory assays and also examines the total testing process. Educational strategies are used to improve performance. Results.—A 1995 survey indicated shortcomings in detection and identification of malarial parasites in blood films. Consequently, recommendations for the investigation of malarial parasites in blood were issued. In 1996 and 1997, 16 workshops were conducted. A 1997 follow-up external quality assessment survey indicated that problems persist as 27% of laboratories failed to correctly speciate Plasmodium falciparum. Good Practice Guidelines were issued in 1998. Conclusion.—Further education and assessment are required. Laboratories lacking expertise must establish referral arrangements with more proficient laboratories.

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.

scholarly journals Mapping the coverage, availability and uptake of External Quality Assessment programmes across One Health sectors in Asia

2021 ◽  
Author(s):  
Ondari D Mogeni ◽  
Freshwork Ayalew Abegaz ◽  
Jong-Hoon Kim ◽  
Hea Sun Joh ◽  
Vicky Gaedt Kastbjerg ◽  
...  
Keyword(s):  
Quality Assessment ◽  
One Health ◽  
External Quality Assessment ◽  
External Quality ◽  
Laboratory Surveillance ◽  
Readiness Level ◽  
Support Mechanisms ◽  
Eqa Schemes

Abstract Introduction Establishing effective external quality assessment (EQA) programmes is an important element in ensuring the quality of, and building capacity for, antimicrobial resistance (AMR) laboratory surveillance. Objectives To understand the current coverage of, and challenges to participation in, EQAs in National Reference Laboratories (NRLs) across One Health (OH) sectors in Asia. Methods Current EQA coverage was evaluated through desktop review, online surveys and interviews of both EQA participants and providers. EQA coverage was mapped and summarized by laboratory type and ‘readiness’ level and identified challenges evaluated qualitatively. Results Of the 31 identified NRLs [16 Human Health (HH) and 15 Animal/Food Safety laboratories (A/FS)], 14 HH and 7 A/FS laboratories currently participated in international EQA schemes and several participated in two or more different schemes. Seven laboratories were currently not participating in any EQA scheme and two of these (one HH and one A/FS) do not currently perform microbiology; six HH NRLs provided national EQAs. Of the eight surveyed international EQA providers, three were based in Asia and all offered varying programmes in terms of pathogens, frequency and support mechanisms for reporting and follow-up. Only one provider currently served laboratories across all OH sectors. Conclusions The current coverage of EQA programmes for AMR in Asia was heterogeneous across countries but especially across OH sectors. This updated overview of the coverage and challenges associated with participation in, and provision of, EQAs for AMR suggest the benefit and relevance of introducing one comprehensive and high-quality EQA programme across OH sectors in Asia.

scholarly journals EurA1c: The European HbA1c Trial to Investigate the Performance of HbA1c Assays in 2166 Laboratories across 17 Countries and 24 Manufacturers by Use of the IFCC Model for Quality Targets

2018 ◽  
Vol 64 (8) ◽  
pp. 1183-1192 ◽  
Author(s):  
◽  
Cas Weykamp ◽  
W Garry John ◽  
Emma English ◽  
Rajiv T Erasmus ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Whole Blood ◽  
External Quality Assessment ◽  
State Of The Art ◽  
Total Error ◽  
Improve Quality ◽  
External Quality ◽  
Major Objective ◽  
Country Level ◽  
Blood Specimens

Abstract BACKGROUND A major objective of the IFCC Committee on Education and Use of Biomarkers in Diabetes is to generate awareness and improvement of HbA1c assays through evaluation of the performance by countries and manufacturers. METHODS Fresh whole blood and lyophilized hemolysate specimens manufactured from the same pool were used by 17 external quality assessment organizers to evaluate analytical performance of 2166 laboratories. Results were evaluated per country, per manufacturer, and per manufacturer and country combined according to criteria of the IFCC model for quality targets. RESULTS At the country level with fresh whole blood specimens, 6 countries met the IFCC criterion, 2 did not, and 2 were borderline. With lyophilized hemolysates, 5 countries met the criterion, 2 did not, and 3 were borderline. At the manufacturer level using fresh whole blood specimens, 13 manufacturers met the criterion, 8 did not, and 3 were borderline. Using lyophilized hemolysates, 7 manufacturers met the criterion, 6 did not, and 3 were borderline. In both country and manufacturer groups, the major contribution to total error derived from between-laboratory variation. There were no substantial differences in performance between groups using fresh whole blood or lyophilized hemolysate samples. CONCLUSIONS The state of the art is that 1 of 20 laboratories does not meet the IFCC criterion, but there are substantial differences between country and between manufacturer groups. Efforts to further improve quality should focus on reducing between-laboratory variation. With some limitations, fresh whole blood and well-defined lyophilized specimens are suitable for purpose.

Evidence for the positive impact of ISO 9001 and ISO 15189 quality systems on laboratory performance – evaluation of immunohaematology external quality assessment results during 19 years in Austria

2018 ◽  
Vol 56 (12) ◽  
pp. 2039-2046 ◽  
Author(s):  
Christoph Buchta ◽  
Wim Coucke ◽  
Wolfgang R. Mayr ◽  
Mathias M. Müller ◽  
Reinhard Oeser ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Quality Management System ◽  
External Quality Assessment ◽  
Positive Impact ◽  
Error Rates ◽  
Iso 9001 ◽  
Quality Systems ◽  
External Quality ◽  
Laboratory Performance ◽  
Iso 15189

Abstract Background ISO 9001 and ISO 15189 have been established as continuative models for quality systems beyond national laws, mandatory standards and guidelines of expert associations regarding analytical and organisational performance of medical laboratories and transfusion services. Although widely used, their impact on laboratory performance has not been investigated. Methods We retrospectively analysed the results of 167 laboratories in 59 distributions of the Austrian red cell immunohaematology external quality assessment (EQA) scheme in the years 1999–2017. The performance for each parameter and trends of individual participants were compared with respect to certification or accreditation status of participants’ quality systems and to laboratory type. Results Considering more than 52,000 EQA results, the absence or presence of a laboratory quality management system showed different error rates. Laboratories with ISO 9001 or ISO 15189 certification/accreditation had 0.7% incorrect results, while this rate was doubled without such quality systems (1.4%, p=0.0002). Statistically significant error reductions were seen upon ISO 9001/ISO 15189 implementation (1.3% before vs. 0.7% after; p=0.0468). Transfusion services had fewer errors (0.9%) compared to hospital and independent laboratories (both 1.2%). Conclusions Implementation and maintenance of quality systems according to ISO 9001 or ISO 15189 as well as laboratory specialisation result in better analytical performance as can be seen in immunohaematology EQA results. The conclusion is that these results apply to other laboratory tests and perhaps to other areas of health care.

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