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.

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.

Traceable assigned values in external quality assessment schemes compared to those obtained by alternative procedure: a case study for Cu, Se and Zn in serum

2015 ◽  
Vol 30 (1) ◽  
pp. 148-153 ◽  
Author(s):  
Marina Patriarca ◽  
Cas Weykamp ◽  
Josiane Arnaud ◽  
Robert L. Jones ◽  
Patrick J. Parsons ◽  
...  
Keyword(s):  
Quality Assessment ◽  
External Quality Assessment ◽  
International Standards ◽  
Alternative Procedure ◽  
External Quality ◽  
Testing Laboratories ◽  
Measurement Results

International standards for the recognition of the competence of testing laboratories require that measurement results should be traceable to a conventionally agreed reference.

scholarly journals Serological diagnostic for SARS-CoV-2: an experimental External Quality Assessment Scheme

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Laura Sciacovelli ◽  
Andrea Padoan ◽  
Sandra Secchiero ◽  
Mario Plebani
Keyword(s):  
Quality Assessment ◽  
External Quality Assessment ◽  
High Standard ◽  
Medical Laboratory ◽  
Data Sets ◽  
External Quality ◽  
External Quality Assessment Scheme ◽  
Iso 15189 ◽  
Analytical Procedures ◽  
Medical Laboratory Professionals

Abstract Objectives Numerous analytical systems, rapidly made available on the market throughout the SARS-CoV-2 pandemic, aim to detect COVID-19, and to continuously update and improve the same systems. Medical laboratory professionals have also developed in-house analytical procedures in order to satisfy the enormous volume of requests for tests. These developments have highlighted the need control the analytical procedures used in order to guarantee patient safety. The External Quality Assessment (EQA) Scheme, an important quality assurance tool, aims to guarantee high standard performance for laboratory and analytical procedures. The aim of the present study was to report on the results collected in an experimental EQA scheme for the serological diagnosis of SARS-CoV-2. Methods All qualitative results collected in the different EQA surveys were summarized in order to identify the percentage of laboratory results in relation to typology of antibodies, results and samples. Results A total of 4,867 data sets were collected. The analysis of EQA data made, demonstrates a better agreement among laboratories results for total Ig than single immunoglobulins (IgG, IgM, IgA) in the case samples positive for SARS-CoV-2, and a wide divergence between IgM results for positive samples (only 34.9% were correct). Results for negative controls and specificity controls demonstrated a better overall agreement than results for positive samples. Conclusions Working in collaboration with the IVD manufacturers, laboratory professionals must strive to achieve harmonization of results, and to develop well-defined protocols complying with the ISO 15189 requirements.

scholarly journals External quality assessment program for biochemical assays of human seminal plasma: a French 6-years experience

2020 ◽  
Vol 30 (1) ◽  
Author(s):  
Safouane M. Hamdi ◽  
Erick Sanchez ◽  
Delphine Garimbay ◽  
Stéphanie Albarede
Keyword(s):  
Quality Assessment ◽  
Seminal Plasma ◽  
External Quality Assessment ◽  
Prostatic Acid Phosphatase ◽  
Seminal Vesicles ◽  
Human Seminal Plasma ◽  
External Quality ◽  
Iso 15189 ◽  
Accessory Glands ◽  
Health Authorities

Abstract Background In 1999, despite a longstanding use, the WHO manual for the examination of human semen finally proposed to assay several biochemical components of the seminal plasma for a functional exploration of the male accessory glands. At the same time, an international effort was made to standardize laboratory tests and to increase their performance through ISO 15189 accreditation. In this setting, participation to relevant external quality assessment (EQA) schemes is an essential requirement for laboratories. To fulfil this injunction, we have organized an EQA program for seminal biochemistry using presumed commutable samples. In this study, we aimed to report an overview of the French laboratory offer, the kinds of assays used, their performance as well as their likelihood of satisfying ISO15189 requirements for EQA. Results Between 2014 and 2019, we performed seven surveys. A median of six laboratories participated to each survey giving a ratio of one laboratory per 11.2 million inhabitants. Seven biomarkers are routinely assayed but the core set shared by all laboratories comprised citrate and zinc (prostate), fructose (seminal vesicles) and α-1, 4 glucosidase (epididymis). The use of CE-IVD marked methods concerned between 0 to 75% of overall assays. According to analytical specifications, 100% of laboratories results were compliant for zinc, 75% for citrate and α-1,4 glucosidase and 67% for fructose. By combining overall data in an empirical scoring system, we identified several types of seminal biomarkers: citrate, fructose and zinc appear as good candidates for a full accreditation, α-1,4 glucosidase still presents an analytical weakness, but prostatic acid phosphatase, free L-carnitine and glycerophosphocholine cannot be accredited in the current state. Conclusions We organized the first French EQA program for seminal biochemistry to help local laboratories to face their legal requirement to be fully accredited by 2020. It could be improved still further but it gave us an oversight on the analytic landscape. Effective methods are available for a confident biochemical exploration of prostate and seminal vesicles. However, that of epididymis appeared unexpectedly fragile. This andrological issue should be addressed by dedicated recommendations from health authorities and scientific societies.

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.

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