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.

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

Combined international external quality assessment results of medical laboratory performance and reporting of samples with known antimicrobial resistance

Diagnosis ◽  
2018 ◽  
Vol 5 (3) ◽  
pp. 161-166
Author(s):  
Michael A. Noble ◽  
Robert Rennie
Keyword(s):  
Antimicrobial Resistance ◽  
Quality Assessment ◽  
Clinical Laboratory ◽  
External Quality Assessment ◽  
Medical Laboratory ◽  
External Quality ◽  
Laboratory Performance ◽  
Reporting Practices ◽  
Medical Laboratories ◽  
Poor Treatment

Abstract Background Reporting on the presence of antimicrobial resistance is of considerable concern both for individual patient care and for understanding the underlying health status within the community at large. Antimicrobial resistance is solely dependent upon clinical laboratory detection and thus can be impacted upon by the quality and competence of medical laboratories. Proficiency testing or external quality assessment (PT/EQA) is the international standard for the direct measurement of medical laboratory performance on critical testing. Methods An international, intercontinental collaborative retrospective study of medical laboratory performance in antibiotic resistance was performed by the Microbiology Working Group (MWG) of the European Organisation for External Quality Assurance for Laboratory Medicine (EQALM) with particular examination of laboratory performance on the testing and reporting of methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE) and carbapenem-resistant Enterobacteriaceae (CRE). Results The results of 1880 medical laboratories were compiled. Strictly accurate reporting of isolates as resistant occurred with MRSA 96.9%, with VRE 91.3% and with CRE 93.1% of the time. On the other hand, very major errors (reporting of false susceptibility) were observed with 2.2% of MRSA and 2.4% of VRE and 0.8% of CRE. Major errors (false resistance) were reported for vancomycin susceptibility testing for MRSA at a rate of 0.6%. Conclusions Depending on how clinical physicians read and understand microbiology susceptibility reports, proficient acceptable results were reported either between 91% and 94% of the time, or between 97% and 100%. While very major errors are infrequently reported, they were found in all regions and could potentially cause poor treatment decisions by clinicians. A collective analysis of multi-program PT/EQA information can provide valuable insights into the testing and reporting practices of medical laboratories.

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.

External quality assessment of laboratory performance in analysis of toxicological cases

2001 ◽  
Vol 121 (1-2) ◽  
pp. 27-32 ◽  
Author(s):  
J.F. Wilson ◽  
P.A. Toseland ◽  
N.E. Capps ◽  
L.N. Sandle ◽  
B.L. Smith ◽  
...  
Keyword(s):  
Quality Assessment ◽  
External Quality Assessment ◽  
External Quality ◽  
Laboratory Performance

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 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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