Behind the scenes of EQA-characteristics, capabilities, benefits and assets of external quality assessment (EQA).

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.

Behind the scenes of EQA - characteristics, capabilities, benefits and assets of external quality assessment (EQA).

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.

Behind the scenes of EQA - characteristics, capabilities, benefits and assets of external quality assessment (EQA).

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.

Behind the scenes of EQA - characteristics, capabilities, benefits and assets of external quality assessment (EQA).

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).

Behind the scenes of EQA - characteristics, capabilities, benefits and assets of external quality assessment (EQA).

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.

Sigma Metrics misconceptions and limitations.

Objectives: This paper further explores the Sigma Metric (SM) and its application in clinical chemistry. It discusses the SM, assay stability, and control failure relationship.

Content: : SM is not a valid measure of assay stability or the likelihood of failure.

Update on methods used for mycological testing: wide diversity and opportunities for improvement persist.

Past analysis of laboratory methods used for mycology specimens revealed significant variation in practices, many of which fell short of recommended procedures. In 2016 these findings led to a set of recommendations for laboratories to consider modification of their methods where appropriate, to analyse current laboratory methods used by participants in the Royal College of Pathologists of Australasia Quality Assurance Programs (RCPAQAP) Mycology module, and to compare these to the 2016 recommendations. Seven test items, with 105-107 participants each, were analysed.

Quality control for serological testing.

Objectives: The quality control of serological assays remains controversial. The aim of this project was to describe the problems associated with a working model for controlling these assays and solutions, including using a source of well-defined targets and acceptable limits, a process to identify lot-to-lot reagent variation and an interpretation of the result that accounted for the clinical situation. False-negative results are problematic but can be reduced by identifying and comparing reagent lot variation with previous results.

External Quality Assessment (EQA) for SARS-CoV-2 RNA Point-of-Care Testing in Primary Healthcare Services: Analytical Performance over Seven EQA Cycles.

In April 2020, the Aboriginal and Torres Strait Islander COVID-19 Point-of-Care (POC) Testing Program was initiated to improve access to rapid molecular-based SARS-CoV-2 detection in First Nations communities. At capacity, the program reached 105 health services across Australia. An external review estimated the program contributed to averting between 23,000 and 122,000 COVID-19 infections within 40 days of the first infection in a remote community, equating to cost savings of between AU$337 million and AU$1.

Six Sigma - is it time to re-evaluate its value in laboratory medicine?

The Sigma metric is widely used in laboratory medicine.

Next-Generation Patient-Based Real-Time Quality Control Models.

Patient-based real-time QC (PBRTQC) uses patient-derived data to assess assay performance. PBRTQC algorithms have advanced in parallel with developments in computer science and the increased availability of more powerful computers. The uptake of Artificial Intelligence in PBRTQC has been rapid, with many stated advantages over conventional approaches.

Enhanced patient-based real-time quality control using the graph-based anomaly detection.

Objectives: Patient-based real-time quality control (PBRTQC) is an alternative tool for laboratories that has gained increasing attention. Despite the progress made by using various algorithms, the problems of data volume imbalance between in-control and out-of-control results, as well as the issue of variation remain challenges. We propose a novel integrated framework using anomaly detection and graph neural network, combining clinical variables and statistical algorithms, to improve the error detection performance of patient-based quality control.

The European Organisation of External Quality Assurance Providers in Laboratory Medicine (EQALM) Statement: guidelines for publishing about interlaboratory comparison studies (PubILC).

Data and results from interlaboratory comparison (ILC) studies, external quality assessment (EQA) and proficiency testing (PT) activities are important and valuable contributions both to the further development of all disciplines of medical laboratory diagnostics, and to the evaluation and comparison of diagnostic assays. So far, however, there are no recommendations as to which essential items should be addressed in publications on interlaboratory comparisons. The European Organization of External Quality Assurance Providers in Laboratory Medicine (EQALM) recognized the need for such recommendations, and these were developed by a group of experts.

Sharing reference intervals and monitoring patients across laboratories - findings from a likely commutable external quality assurance program.

Objectives: Laboratory results are increasingly interpreted against common reference intervals (CRIs), published clinical decision limits, or previous results for the same patient performed at different laboratories. However, there are no established systems to determine whether current analytical performance justifies these interpretations. We analysed data from a likely commutable external quality assurance program (EQA) to assess these interpretations.

Ensuring quality in 17OHP mass spectrometry measurement: an international study assessing isomeric steroid interference.

Objectives: Interference from isomeric steroids is a potential cause of disparity between mass spectrometry-based 17-hydroxyprogesterone (17OHP) results. We aimed to assess the proficiency of mass spectrometry laboratories to report 17OHP in the presence of known isomeric steroids.

Methods: A series of five samples were prepared using a previously demonstrated commutable approach.

A model for managing quality control for a network of clinical chemistry instruments measuring the same analyte.

Objectives: Monitoring quality control for a laboratory or network with multiple instruments measuring the same analyte is challenging. We present a retrospective assessment of a method to detect medically significant out-of-control error conditions across a group of instruments measuring the same analyte. The purpose of the model was to ensure that results from any of several instruments measuring the same analytes in a laboratory or a network of laboratories provide comparable results and reduce patient risk.

Methods for determining clinical utility.

Measuring the clinical utility of a diagnostic test involves evaluating its impact on patient outcomes, clinical decision-making, and healthcare resource utilization. Determining clinical utility requires accessing patient medical history and outcomes data. These studies involve enrolling patients undergoing diagnostic tests and tracking their clinical outcomes.

Clinical utility - Information about the usefulness of tests.

The clinical utility of a diagnostic test refers to its usefulness in improving patient outcomes, informing clinical decision-making, and optimizing healthcare resources. A diagnostic test with high clinical utility provides accurate, reliable, and actionable information that can guide appropriate treatment decisions, monitor treatment response, and identify potential adverse events or complications. Ultimately, the clinical utility of a diagnostic test depends on how well it can improve patient outcomes by guiding appropriate treatment decisions, improving clinical outcomes, and optimizing healthcare resource utilization.