Category Ranking

98%

Total Visits

921

Avg Visit Duration

2 minutes

Citations

20

Article Abstract

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). More broadly, the scientific and medical communities use EQA data to demonstrate that medical laboratory examination procedures are fit for clinical purposes, to evaluate common reference intervals, and inclusion of data in clinical databases. Scientific groups, the IVD industry, reference laboratories and National Metrology Institutes can work with EQA providers to identify measurands, which should urgently be supported by the development of reference materials or methods. The ability of health systems to respond effectively to fast-evolving medical challenges, such as the Coronavirus Disease-19 (COVID-19) pandemic, is reliant on EQA to demonstrate confidence in the performance of new laboratory methods and testing services. EQA providers are uniquely positioned to assess the performance of IVD-MDs in addition to individual laboratories and testing sites. Although the primary focus of EQA providers remains the improvement of the performance of individual laboratories, there are many stakeholders who benefit from EQA performance data.

Download full-text PDF

Source
http://dx.doi.org/10.1515/cclm-2024-1293DOI Listing

Publication Analysis

Top Keywords

eqa providers
12
eqa
10
eqa –
8
external quality
8
quality assessment
8
assessment eqa
8
eqa data
8
individual laboratories
8
scenes eqa
4
– characteristics
4

Similar Publications

Aims: Pharmacogenetic implementation requires awareness of the state-of-the-art practice of laboratories providing pharmacogenetic testing. This study investigated how pharmacogenetic guidelines and recommendations have been implemented over time by Italian laboratories participating in the external quality assessment (EQA) Pharmaco-scheme established since 2019 by the European Molecular genetics Quality Network (EMQN).

Methods: Anonymized clinical pharmacogenetic reports submitted by Italian laboratories participating in the EMQN Pharmaco-scheme between 2019 and 2023 were analysed.

View Article and Find Full Text PDF

Objectives: The intent of this study was to evaluate and improve microbiology laboratory diagnostic capacity in selected National AMR Reference laboratories from South and Southeast Asia for AMR testing utilizing EQA and targeted follow-up support.

Methods: A baseline assessment was conducted to evaluate quality management system (QMS) practices for laboratories participating in the Strengthening External Quality Assessment in Asia (EQASIA-EQA) programme for the first time. Following each EQA iteration, laboratory assessments were conducted, and underperforming laboratories received online consultations to identify root causes of deviations and implement corrective and preventive actions (CAPA).

View Article and Find Full Text PDF

Objective: To evaluate thyroid hormone test harmonization using external quality assessment (EQA) data, guiding laboratory quality enhancement and big data interoperability.

Methods: EQA data for T3, T4, FT3, FT4, and TSH from January 2022 to December 2024 were collected. We calculated the total allowable error for both our laboratory (TEa-Lab) and peer groups (TEa-peer) using bias and coefficient of variation data.

View Article and Find Full Text PDF

Objectives: Hereditary hearing loss is one of the most common birth defects in humans. Genetic screen in pregnant women and newborns could provide prenatal intervention or guidance on the early diagnosis and treatment. Currently, this screen has been widely applied; however, its accuracy and reliability have not been determined.

View Article and Find Full Text PDF

Background: This study applied the six sigma model to evaluate plasma protein testing performance in six laboratories, with customized quality control programs and targeted improvements introduced where necessary.

Methods: Internal quality control (IQC) and external quality assessment (EQA) data for plasma proteins were gathered from six laboratories. Sigma values for each analyte were determined based on the coefficient of variation (CV), bias, and total allowable error (TEa).

View Article and Find Full Text PDF