Experiences with External Quality Assessment (EQA) in Molecular Diagnostics in Clinical Laboratories in Germany

2000 ◽  
Vol 38 (2) ◽  
Author(s):  
Michael Neumaier ◽  
Andreas Braun ◽  
Reinhard Gessner ◽  
Harald Funke
Keyword(s):  
Quality Assessment ◽  
Molecular Diagnostics ◽  
External Quality Assessment ◽  
External Quality ◽  
Clinical Laboratories

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 External Quality Assessment of MERS-CoV Molecular Diagnostics During the 2015 Korean Outbreak

2016 ◽  
Vol 36 (3) ◽  
pp. 230-234 ◽  
Author(s):  
Moon-Woo Seong ◽  
Seung Jun Lee ◽  
Sung Im Cho ◽  
Kyungphil Ko ◽  
Mi-Na Kim ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Molecular Diagnostics ◽  
External Quality Assessment ◽  
External Quality

scholarly journals First international external quality assessment of molecular diagnostics for Mers-CoV

2015 ◽  
Vol 69 ◽  
pp. 81-85 ◽  
Author(s):  
Suzan D. Pas ◽  
Pranav Patel ◽  
Chantal Reusken ◽  
Cristina Domingo ◽  
Victor M. Corman ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Molecular Diagnostics ◽  
External Quality Assessment ◽  
External Quality

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.

scholarly journals External quality assessment programs in the context of ISO 15189 accreditation

2018 ◽  
Vol 56 (10) ◽  
pp. 1644-1654 ◽  
Author(s):  
Laura Sciacovelli ◽  
Sandra Secchiero ◽  
Andrea Padoan ◽  
Mario Plebani
Keyword(s):  
Quality Assessment ◽  
Specific Activity ◽  
External Quality Assessment ◽  
International Standards ◽  
Fundamental Importance ◽  
External Quality ◽  
Iso 15189 ◽  
Laboratory Staff ◽  
Clinical Laboratories ◽  
The Right

Abstract Effective management of clinical laboratories participating in external quality assessment schemes (EQAS) is of fundamental importance in ensuring reliable analytical results. The International Standard ISO 15189:2012 requires participation in interlaboratory comparison [e.g. external quality assessment (EQA)] for all tests provided by an individual laboratory. If EQAS is not commercially available, alternative approaches should be identified, although clinical laboratories may find it challenging to choose the EQAS that comply with the international standards and approved guidelines. Great competence is therefore required, as well as knowledge of the characteristics and key elements affecting the reliability of an EQAS, and the analytical quality specifications stated in approved documents. Another skill of fundamental importance is the ability to identify an alternative approach when the available EQAS are inadequate or missing. Yet the choice of the right EQA program alone does not guarantee its effectiveness. In fact, the fundamental steps of analysis of the information provided in EQA reports and the ability to identify improvement actions to be undertaken call for the involvement of all laboratory staff playing a role in the specific activity. The aim of this paper was to describe the critical aspects that EQA providers and laboratory professionals should control in order to guarantee effective EQAS management and compliance with ISO 15189 accreditation requirements.

Sign in / Sign up

Export Citation Format

Share Document