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External Quality Assessment (EQA) is the verification, on a recurring basis, that laboratory results conform to expectations for the quality required for patient care. It is now widely recognised that both the pre- and post-laboratory phase of testing, termed the diagnostic phases, are a significant source of laboratory errors. These errors have a...
Context in source publication
Context 1
... it is rec- ognised that some countries have made steps in this direction, this is far from widespread, and cur- rently lacking in Australia. The pre-pre-analytical phase, which is primarily composed of test order- ing, and the post-post-analytical phase, which is primarily composed of test result interpretation, can be regarded as the diagnostic phases (as op- posed to the analytical phases) and sub-divide it into a pre-laboratory and post-laboratory phase (Figure 1). This terminology has been chosen to re- move the laboratory as the focus of the process and shift it back to the referring clinician. ...
Citations
... En efecto, existen programas de evaluación externa, validos en numerosos países, dirigidos a las fases extraanalíticas; dichos programas desarrollan varios esquemas de evaluación, entre ellos, el esquema que considera la aplicación de cuestionarios para identificar el cumplimiento de procedimientos de las fases pre y postanalítica del proceso de laboratorio clínico (8)(9)(10)(11)(12)(13). ...
... El manejo efectivo de las fases extra analíticas en el laboratorio clínico es solo posible a través de la aplicación continua del enfoque basado en la evidencia, que incluya dentro del control que: 1) los procesos de laboratorio sean monitoreados; 2) la existencia de un sistema operativo y funcional de detección de errores; y 3) el análisis de las causas de error, como parte de la continua mejora de la gestión de la calidad (15,(26)(27). ...
En la actualidad el laboratorio clínico evoluciona adaptándose a cambios científicos tecnológicos, organizativos y de gestión, inducidos por los avances en el campo de la medicina, nuevas pruebas y metodologías analíticas, así como la creciente sensibilización y expectativas de los usuarios por disponer de servicios y productos de mayor calidad; en toda esta perspectiva el éxito ante los nuevos desafíos para mejorar su eficacia, dependerá de su desempeño a la vanguardia de la gestión de la calidad, asegurando el logro de los mayores beneficios posibles para la salud del paciente y procurando el óptimo uso de los recursos disponibles en todo su proceso. Sobre esta base, resulta indispensable un sistema de gestión de calidad eficaz, que incluya evaluación interna y programas de evaluación externa de la calidad, lo que proporciona información sobre el nivel de rendimiento del laboratorio en comparación con otros, para promover la armonización de criterios, procedimientos, evaluación de intervenciones, además de ser una estrategia para proporcionar educación y capacitación del recurso humano. Dichos fines requieren que los programas de evaluación externa de la calidad incluyan el proceso total de análisis, no solo enfoque en la fase analítica, sino también la preanalítica y postanalítica, para la obtención de las mejores evidencias que llevan a identificar fuentes de variación, errores en el proceso y oportunidades de mejora de la gestión de la calidad de estos servicios de atención del sector salud en el contexto demandante de los tiempos de hoy. Palabras clave: aseguramiento de la calidad, fase preanalítica, indicadores, seguridad del paciente, laboratorios Abstract Currently, the clinical laboratory get moving adapting to technological, organizational and management changes, induced by advances in the field of medicine, new tests and analytical methodologies, technological innovation, as well as the growing sensitivity and expectations of users to have higher quality services and products; in all this perspective, success in the face of new challenges to improve its effectiveness resulted from its performance at the forefront of quality management, ensuring the achievement of the greatest possible benefits for the patient's health and seeking the optimal use of resources, available throughout your process. On this basis, an effective quality management system, including an internal assessment system and external quality assessment programs, providing information on the level of performance of the laboratory compared to others, is essential to promote harmonization criteria, procedures, exposure assessment, in addition to being a strategy to provide education and training of human resources. These purposes require that external quality assessment programs include the total analysis process, not only focusing on the analytical phase, but also the pre-analytical and post-analytical phases, in order to obtain the best evidence that leads to identifying sources of variation, errors in the process and opportunities to improve the quality management of these health care services in the demanding context of today's times. Key words: Clinical laboratory, quality assurance, extra-analytical phase, indicators, Patient Safety
... The performance of laboratories in PTP has become a crucial and objective indicator of the testing quality in the clinical setting. [6][7][8] At the beginning of the SARS-CoV-2 pandemic, little was known about the efficiency, accuracy and sensitivity of in-house developed NAT assays or published protocols in a variety of settings. 9 This required the rapid development of a SARS-CoV-2 PTP to assess these assays and the performance of individual laboratories. ...
Diagnostic testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has undergone significant changes over the duration of the pandemic. In early 2020, SARS-CoV-2 specific nucleic acid testing (NAT) protocols were predominantly in-house assays developed based on protocols published in peer reviewed journals. As the pandemic has progressed, there has been an increase in the choice of testing platforms. A proficiency testing program for the detection of SARS-CoV-2 by NAT was provided to assist laboratories in assessing and improving test capabilities in the early stages of the pandemic. This was vital in quality assuring initial in-house assays, later commercially produced assays, and informing the public health response. The Royal College of Pathologists of Australasia Quality Assurance Programs (RCPAQAP) offered three rounds of proficiency testing for SARS-CoV-2 to Australian and New Zealand public and private laboratories in March, May, and November 2020. Each round included a panel of five specimens, consisting of positive (low, medium or high viral loads), inconclusive (technical specimen of selected SARS-CoV-2 specific genes) and negative specimens. Results were received for round 1 from 16, round 2 from 97 and round 3 from 101 participating laboratories. Improvement in the accuracy over time was shown, with the concordance of results in round 1 being 75.0%, in round 2 above 95.0% for all samples except one, and for round 3 above 95.0%. Overall, participants demonstrated high capabilities in detecting SARS-CoV-2, even in samples of low viral load, indicating excellent testing accuracy and therefore providing confidence in Australian and New Zealand public and private laboratories test results.
... Laboratory mistakes have been reported all over the world and can sometimes cause permanent harm or even death of patients [2]. Molecular techniques are one of tests that help clinicians in making the final decision and hence require strict supervision on various aspects. ...
... No scientific report has been released on their success in reducing nonconformities within the laboratories yet. It seems the procedures selected by both organizations are not able to upgrade the laboratory performance and to reveal their weaknesses [2]. ...
... Therefore, identifying appropriate quality metrics is crucial in determining the quality of laboratory services [17]. According to the model of quality indicators developed by the Working Group of the International Fed-eration of Clinical Chemistry and Laboratory Medicine [17], proficiency testing and EQA schemes have allowed clinical laboratories to measure, monitor, and improve their analytical performance over time [18][19][20]. It may be helpful to introduce extraanalytical quality indicators in the KEQAS EQA scheme to monitor and improve the overall quality of more laboratories. ...
External quality assessment (EQA) is important for evaluating clinical laboratories and enhancing their testing quality. EQA schemes are variable; thus, it is crucial that the EQA organizers share their experiences to continuously improve the EQA scheme. The Korean Association of External Quality Assessment Service (KEQAS) has been the leading, authorized EQA institute for the standardization and quality management of laboratory testing in Korean medical institutions since 1976. The EQA scheme underwent a major change in 2016, and the number of EQA programs increased significantly since then. The key changes implemented in EQA scheme include a fully computerized assessment to accelerate feedback and unification of the testing and reporting methods. We provide an overview of the EQA schemes and performance evaluation criteria of the KEQAS and suggest directions for achieving the global harmonization of EQA.
... Today, PT schemes are an essential component of a laboratory's quality management system, and in many countries, PT is a component of laboratory accreditation requirements [2]. PT is the verification, on a recurring basis, that laboratory results conform to expectations for the quality required for adequate patient care [3]. PT allows a comparison of the own results with those of other laboratories (e.g., with a homogeneous comparison group or with a reference laboratory). ...
Background:
In medical laboratories, it is mandatory to ensure the analytical quality of the measurement procedures by proficiency testing (PT). The aim of this study was to evaluate whether the PT results of seven medical laboratories in South Tyrol - as a measure of the analytical performance - were different.
Methods:
As a measure for the analytical performance of the individual laboratories, we used the PT results (RIQAS, Randox international quality assessment scheme) of one year for 34 analytes. We calculated annual 'total scores' of each analyte for all participating laboratories and compared them statistically.
Results:
In 2018, there was a highly significant difference between the seven laboratories in the 'total scores' for the 34 analytes (p < 0.001). The laboratories had a 'cumulative, annual total score' of 75 - 91% of the maximum achievable values. Essentially, two groups could be distinguished. Laboratories 1 - 3 achieved better results (90 - 91%) than laboratories 4 - 7 (77 - 82%). In particular, the non-participation of the laboratories 4 - 7 in several PT cycles in 2018 and the registration in the wrong homogeneous group for some analytes in the laboratories 4 and 5 seem to be responsible for the worse results.
Conclusions:
The analytical performance as assessed by the PT results was different across the seven participating laboratories of the South Tyrolean Medical Service. Based on our study results, we defined a uniform key performance indicator for the seven laboratories with a limit value for the 'cumulative, annual total score' of > 80%.
... EQA is a very important tool for assessment of all phases of a laboratory test [9]. It is consistent with our approach to assess not only the analytical phase. ...
Objectives: Kidney Disease Improving Global Outcomes (KDIGO) guidelines recommend reporting the cystatin C concentration result together with estimated glomerular filtration rate (eGFRcys). The extent to which the recommendation is implemented to practice is not known. The aim of this study is to determine the implementation extent and to show how laboratories that have not yet implemented the measure can be guided to adopting it to their routines. Design: Cross-sectional study. Settings: SEKK, spol. s.r.o., Za Pasáží 1609, 530 02 Pardubice. Material and methods: Evaluation of cystatin C post-analytical phase was performed by an online electronic questionnaire which was added to routine cystatin C External Quality Assessment (EQA) scheme. A total of 70 participants (59 from the Czech Republic and 11 from Slovakia) were given the questionnaire. They reported traceability of their method calibration to international standard ERM DA471/IFCC, and equations for eGFRcys. Answers were analysed. Results: In the end, 63 participants responded to the questionnaire. Traceability of calibration to ERM DA471/IFCC was declared by 53 responders. A total of 53 laboratories stated reporting eGFR in all adult patients and 4 participants stated reporting eGFR only on direct request. Six laboratories did not report eGFR. The Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation was used by 57 laboratories. Of them, 22 laboratories also used combined equation with creatinine and three laboratories also calculated Caucasian, Asian, Pediatric and Adult (CAPA) equation. Conclusion: Majority of laboratories follow the KDIGO guidelines. Further education on calibration traceability and eGFR accompanying all cystatin C concentration results is still needed. SOUHRN Šálek T., Friedecký B., Budina M.: Cystatin C-Implementace do laboratorní a klinické praxe Cíl: Doporučení Kidney Disease Improving Global Outcomes (KDIGO) doporučuje vydávat výsledek koncentrace cystatinu C společně s odhadovanou glomerulární filtrací (eGFRcys). Míra implementace tohoto doporučení v praxi není známa. Cílem této studie je stanovit míru této implementace a laboratořím, které tak ještě neučinily, poskytnout návod k jejímu zavedení. Typ studie: průřezová. Název a sídlo pracoviště: SEKK, spol. s.r.o., Za Pasáží 1609, 530 02 Pardubice. Materiál a metody: Hodnocení implementace doporučení bylo provedeno pomocí internetového elektronického dotazníku, který byl přidán k cyklu externího hodnocení kvality (EQA). 70 účastníkům (59 z České republiky a 11 ze Slovenska). Účastníci odpovídali, jestli má jejich metoda návaznost kalibrace na mezinárodní referenční materiál ERM DA471/IFCC a jestli počítají eGFRcys. Odpovědi byly analyzovány. Výsledky: Na dotazník odpovědělo 63 účastníků. Návaznost kalibrace měření k mezinárodnímu referenčnímu materiálu ERM DA471/IFCC uvedlo 53 odpovědí. Celkem 53 laboratoří uvedlo vydávání eGFR u všech dospělých pacientů a čtyři vydávají eGFR jen na vyžádání. Šest laboratoří nepočítá eGFR. The Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) rovnice byla užívána 57 laboratořemi. Z nich 22 počítá také kombinovanou rovnici s kreatininem a tři laboratoře počítají také Caucasian, Asian, Pediatric and Adult (CAPA) rovnici. Závěr: Většina laboratoří dodržuje KDIGO doporučení. Nicméně další edukace ohledně návaznosti měření a výpočtu eGFR s každým výsledkem je stále potřebná.
... Researchers from the Royal College of Pathologists of Australasia Quality Assurance Programs (RCPAQAP) and Macquarie University recently published a paper describing the importance of pre-and post-laboratory phases which form the diagnostic phases of laboratory medicine testing [1]. The issues, however, have been known of in Australia since at least 1996 [2]. ...
... The issues, however, have been known of in Australia since at least 1996 [2]. These phases "beyond the lab" constitute a major source of errors that reduce laboratory effectiveness and threaten patient safety [1,3]. External quality assurance (EQA) ensures that verification is performed on a recurring basis, and that laboratory results conform to expectations for quality required for patient care [4]; however, most Australian laboratories have previously focused narrowly on laboratory processes such as test accuracy and precision [1]. ...
... These phases "beyond the lab" constitute a major source of errors that reduce laboratory effectiveness and threaten patient safety [1,3]. External quality assurance (EQA) ensures that verification is performed on a recurring basis, and that laboratory results conform to expectations for quality required for patient care [4]; however, most Australian laboratories have previously focused narrowly on laboratory processes such as test accuracy and precision [1]. Until recently, it was very difficult to quantify the number and magnitude of errors in the extra-analytical phases due to a lack of formal EQA measures in these areas. ...
External quality assurance (EQA) provides ongoing evaluation to verify that laboratory medicine results conform to quality standards expected for patient care. While attention has focused predominantly on test accuracy, the diagnostic phases, consisting of pre- and post-laboratory phases of testing, have thus far lagged in the development of an appropriate diagnostic-phase EQA program. One of the challenges faced by Australian EQA has been a lack of standardisation or “harmonisation” resulting from variations in reporting between different laboratory medicine providers. This may introduce interpretation errors and misunderstanding of results by clinicians, resulting in a threat to patient safety. While initiatives such as the Australian Pathology Information, Terminology and Units Standardisation (PITUS) program have produced Standards for Pathology Informatics in Australia (SPIA), conformity to these requires regular monitoring to maintain integrity of data between sending (laboratory medicine providers) and receiving (physicians, MyHealth Record, registries) organisations’ systems. The PITUS 16 Informatics EQA (IEQA) Project together with the Royal College of Pathologists of Australasia Quality Assurance Programs (RCPAQAP) has created a system to perform quality assurance on the electronic laboratory message when the laboratory sends a result back to the EQA provider. The purpose of this study was to perform a small scale pilot implementation of an IEQA protocol, which was performed to test the suitability of the system to check compliance of existing Health Level-7 (HL7 v2.4) reporting standards localised and constrained by the RCPA SPIA. Here, we present key milestones from the implementation, including: (1) software development, (2) installation, and verification of the system and communication services, (3) implementation of the IEQA program and compliance testing of the received HL7 v2.4 report messages, (4) compilation of a draft Informatics Program Survey Report for each laboratory and (5) review consisting of presentation of a report showing the compliance checking tool to each participating laboratory.
... Furthermore, the requesting and reporting diagnostic phases should also be covered by EQA programs due to two main reasons: high rate of errors associated and the deinition of quality Quality Control in Laboratory management system (QMS) mentioned at the beginning of this chapter of fulillment user requirements and satisfaction [24]. The design of such programs should be developed carefully to obtain useful information. ...
... The concept of EQAs might be extended to other adjacent areas. Accordingly, an EQA introduced a scheme to examine electronic laboratory reports [17]. ...
Health systems worldwide struggle to provide the optimal treatment amid the rapid pace of scientific progress and frequent structural changes. Learning health systems (LHS) that continuously analyze their data to generate evidence and to enable informed decisions have been proposed as a possible solution. This paper investigates the involvement of laboratory medicine in LHS and evaluates relevant systems according to their scope, enabling technologies, architecture for evidence generation, data-action latency, and social aspects. While laboratory medicine provides a central source of information in many large-scale LHS, there are also systems with a particular focus on laboratories. For example, external quality assessments are performed by sending samples with known quantities to laboratories worldwide to verify their analytical methods. This data are also analyzed for other purposes, such as post-market surveillance of devices. These schemes have operated successfully over several decades. Newer, innovative tools harvest the possibilities of wearable devices and increased connectivity. LHS in laboratory medicine need to be recognized and incorporated into systems of systems to generate better evidence. Further research on the roles of other stakeholders will identify opportunities and obstacles for building and maintaining successful LHS.
