- Detection of antinuclear antibodies: a survey done by the European Organsation for External Quality Assurance Providers in Laboratory Medicine
- Patel D, Albarède S, Klotz W, Lambeck AJA, Musset L, Vayanos Z, Herold M. Lab Med. 2025, Link
- A questionnaire was sent to immunology laboratories worldwide by the European Organisation for External Quality Assurance Providers in Laboratory Medicine to evaluate current practice with regard to how antinuclear antibodies (ANAs) are routinely tested in clinical laboratories.
- Are the benefits of EQA recognized beyond the echo chamber?
- MacKenzie F, CCLM 2025, Link
- Behind the scenes of EQA – characteristics, capabilities, benefits and assets of external quality assessment (EQA), Part I – EQA in general and EQA programs in particular
- Buchta C et al. CCLM 2025, Link
- 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 in-vitro 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), Part II – EQA cycles
- Buchta C et al. CCLM 2025, Link
- 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. This aims to ensure the most significant possible information gain in every cycle using the lowest possible number of EQA samples and thus, under economically optimal conditions. Participants examine samples and the results are reported to the EQA provider, who compares them with the target values for individual measurands in every sample. The EQA provider assesses the laboratory performance, and finally communicates the assessment results to the participant. The participants evaluate the outcomes of the assessment of their examination results and can draw conclusions in the case of both failing and passing and, if necessary, define improvement measures. After completion, each cycle is evaluated by the provider so that limitations and weaknesses of the EQA program can be identified and appropriate measures taken, or to confirm its continued suitability and appropriateness.
- Behind the scenes of EQA – characteristics, capabilities, benefits and assets of external quality assessment (EQA), Part III – EQA samples
- Buchta C et al. CCLM 2025, Link
- 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. Thus, the samples are at the heart and in the centre of EQA and its success depends on their quality. This manuscript describes the requirements for EQA samples and the activities of EQA providers to achieve them.
- Behind the scenes of EQA – characteristics, capabilities, benefits and assets of external quality assessment (EQA), Part IV – Benefits for participant laboratories
- Buchta C et al. CCLM 2025, Link
- 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 in vitro 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. Participation in an EQA scheme for beneficiaries like medical, microbiological and histo- and molecular pathology laboratories, users of POCT and self-testing systems as well as National Metrology Institutes, calibration laboratories and reference laboratories that are dedicated to specific tasks and have particular expectations of the EQA scheme are presented here.
- Behind the scenes of EQA – characteristics, capabilities, benefits and assets of external quality assessment (EQA), Part V – Benefits for stakeholders other than participants
- Buchta C et al. CCLM 2025, Link
- 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 in vitro 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.
- The EQALM checklist of items recommended to be addressed in publications of interlaboratory comparison activities (PubILC) (docx)
- Buchta C, Gidske G, Henriksen GM, Badrick T; European Organisation of External Quality Assurance Providers in Laboratory Medicine (EQALM). The European Organisation of External Quality Assurance Providers in Laboratory Medicine (EQALM) Statement: guidelines for publishing about interlaboratory comparison studies (PubILC). Crit Rev Clin Lab Sci. 2024, Link
- Digital Blood Smear Analysis EQA Scheme Guidelines (pdf)
- Albe X, Juhos I, Albarede S, De la Salle B, Geilenkeuser WJ, Menezes ME, Sárkány E, Vives-Corrons JL: Digital Blood Smear Analysis EQA Scheme Guidelines. Poster. EQALM Symposium. 2021. Link