External quality assessment (EQA) programs have been conducted by the Japanese Association of Medical Technologists (JAMT) since 1989. The nationwide EQA programs have provided feedback for improving clinical tests quality in individual laboratories. The participating laboratories have been expected to process the survey samples according to their usual practice for patient specimens. However, many problems relating to the EQA programs in clinical microbiology have been raised. Dishonesty in the responses, survey samples being handled in a manner that improves assessment results, surveys depending on volunteers because of time and cost limitations were some of the initial problems. In addition, the criteria used to evaluate the results were poorly understood, so that neither examiners not participants were clear as to how the evaluation worked. And finally, the nationwide EQA programs can detect only gross errors and use invalid methods for evaluating routine performances. They have been measuring only a few steps in specimens processing. To assess overall laboratory competence, other methods are needed. It is time to reform the JAMT nationwide EQA program to initiate real proficiency testing and to this end it is necessary to increase collaboration between JAMT and the regional associations of medical technologists, so that the improved testing program can be properly administered.
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Behind the scenes of EQA-characteristics, capabilities, benefits and assets of external quality assessment (EQA).
Clin Chem Lab Med
January 2025
Canadian Microbiology Proficiency Testing Program (CMPT), Department of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, Canada.
The main stakeholders in external quality assessment (EQA) programs are the participants, in whose interests these challenges are ultimately organised. EQA schemes in the medical field contribute to improving the quality of patient care by evaluating the analytical and diagnostic quality of laboratory and point-of-care tests (POCT) by independent third parties and, if necessary, pointing out erroneous measurement results and analytical or diagnostic improvement potential. Other benefits include the option of using EQA samples for other important laboratory procedures, such as the verification or validation of diagnostic medical devices (IVD-MDs), a contribution to the estimation of measurement uncertainty, a means of training and educating laboratory staff through educational EQA programmes or samples, or even for independent and documented monitoring of staff competence, such as on samples with unusual or even exceptional characteristics.
View Article and Find Full Text PDFBehind the scenes of EQA - characteristics, capabilities, benefits and assets of external quality assessment (EQA).
Clin Chem Lab Med
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Department of Pathology and Laboratory Medicine, Canadian Microbiology Proficiency Testing Program (CMPT), University of British Columbia, Vancouver, Canada.
This is the first in a series of five papers that detail the role and substantial impact that external quality assessment (EQA) and their providers' services play in ensuring diagnostic (IVD) performance quality. The aim is to give readers and users of EQA services an insight into the processes in EQA, explain to them what happens before EQA samples are delivered and after examination results are submitted to the provider, how they are assessed, what benefits participants can expect, but also who are stakeholders other than participants and what significance do EQA data and assessment results have for them. This first paper presents the history of EQA, insights into legal, financing and ethical matters, information technology used in EQA, structure and lifecycle of EQA programs, frequency and intensity of challenges, and unique requirements of extra-examination and educational EQA programs.
View Article and Find Full Text PDFBehind the scenes of EQA - characteristics, capabilities, benefits and assets of external quality assessment (EQA).
Clin Chem Lab Med
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Department of Pathology and Laboratory Medicine, Canadian Microbiology Proficiency Testing Program (CMPT), University of British Columbia, Vancouver, Canada.
External quality assessment (EQA) cycles are the smallest complete units within EQA programs that laboratories can use to obtain external assessments of their performance. In each cycle, several samples are distributed to the laboratories registered for participation, and ideally, EQA programs not only cover the examination procedures but also the pre- and post-examination procedures. The properties and concentration range of measurands in individual samples are selected with regard to the intended challenge for the participants so that each sample fulfils its purpose.
View Article and Find Full Text PDFBehind the scenes of EQA - characteristics, capabilities, benefits and assets of external quality assessment (EQA).
Clin Chem Lab Med
January 2025
Canadian Microbiology Proficiency Testing Program (CMPT), Department of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, Canada.
External quality assessment (EQA) enhances patient safety through the evaluation of the quality of laboratory-based and point of care testing. Regulatory agencies and accreditation organizations utilize the results and the laboratory's response to them as part of assessing the laboratory's fitness to practice. In addition, where EQA samples are commutable and the assigned value has been determined using reference measurement procedures (RMPs), EQA data contributes to the verification of metrological traceability of assays as part of the post-market surveillance of diagnostic (IVD) medical devices (IVD-MDs).
View Article and Find Full Text PDFBehind the scenes of EQA - characteristics, capabilities, benefits and assets of external quality assessment (EQA).
Clin Chem Lab Med
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Canadian Microbiology Proficiency Testing Program (CMPT), Department of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, Canada.
Providers of external quality assessment (EQA) programs evaluate data or information obtained and reported by participant laboratories using their routine procedures to examine properties or measurands in samples provided for this purpose. EQA samples must offer participants an equal chance to obtain accurate results, while being designed to provide results in clinically relevant ranges. It is the responsibility of the EQA provider to meet the necessary requirements for homogeneity, stability and some other properties of the EQA items in order to offer participants a fair, reliable and technically interesting EQA experience.
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