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

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.

AbstractBlood smear analysis is a well-known technique in medical laboratories. The clinical relevance of this analysis and its interpretation are very important. Consequently, monitoring of laboratory performance by an external quality assessment scheme is strongly recommended. This article represents a very practical guidance document for External Quality Assessment Scheme (EQAS) organizers for setting up blood smear schemes. In the first part of the guidelines, the Hematology Working Group of the European External Committee for External Quality Assurance Programmes in Laboratory Medicine (EQALM) published practical information for the preparation of blood smears for use in an EQAS. Part II focuses on aspects such as survey preparation, statistical evaluation and reporting, and describes particular details for organizing blood morphology EQA surveys by means of virtual microscopy.Clin Chem Lab Med 2006;44:1039–43.


Author(s):  
Laura Sciacovelli ◽  
Andrea Padoan ◽  
Sandra Secchiero ◽  
Mario Plebani

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.


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 ◽  
...  

2012 ◽  
Vol 20 (12) ◽  
pp. 1209-1215 ◽  
Author(s):  
Sarah Berwouts ◽  
Emmanuelle Girodon ◽  
Martin Schwarz ◽  
Manfred Stuhrmann ◽  
Michael A Morris ◽  
...  

2016 ◽  
Vol 54 (12) ◽  
Author(s):  
Meredith L. Praamsma ◽  
Josiane Arnaud ◽  
David Bisson ◽  
Stuart Kerr ◽  
Chris F. Harrington ◽  
...  

AbstractBackground:Proficiency testing or external quality assessment schemes (PT/EQASs) are an important method of assessing laboratory performance. As each scheme establishes assigned values and acceptable ranges for the analyte according to its own criteria, monitoring of participant performance varies according to the scheme and can lead to conflicting conclusions.Methods:Standard deviations (SDs) for PT were derived from Thompson’s and biological variation models applied to blood and urine manganese (Mn) robust data from four EQASs from North America and Europe. The fitness for purpose was verified by applying these SDs to individual results.Results:Using Thompson characteristic function the relationship between SD and Mn concentration, expressed in nmol/L was the square root of [19.7Conclusions:The biological variation model can be used to propose quality specifications for blood, however it could not be applied to urine. The Thompson characteristic function model could be applied to derive quality specifications for Mn in urine and, to a lesser extent in blood. The more lenient quality specifications for blood highlight the difficulty of determining Mn in this matrix. Further work is needed to harmonize PT, such as using assigned ranges for the specimens.


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