Essential aspects of external quality assurance for point-of-care testing

Stavelin, Anne; Sandberg, Sverre

doi:10.11613/bm.2017.010

Cited by 12 publications

(5 citation statements)

References 15 publications

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“…Other issues have been discussed elsewhere (18). Consequently, there are few PT programmes and, in their absence, POCT results are generally assessed by comparing the results from a patient sample analysed using a POCT device and by a conventional laboratory method.…”

Section: Future Directions For Proficiency Testingmentioning

confidence: 99%

Proficiency testing and ring trials

Johnson¹,

Cabuang²

2021

Rev. Sci. Tech. OIE

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The validation of diagnostic methods (and the subsequent results generated by a laboratory) are improved through participation in inter-laboratory comparisons (IC), such as proficiency-testing (PT) programmes and other exercises referred to as 'ring tests' or 'ring trials' (RTs). This is a requirement to comply with international quality standards. Validating a method is a continuous process and taking part in ongoing PT programmes supports the management of a method's life cycle, providing continuing assessment of fitness (sometimes referred to as the 'validation retention status'). Proficiency-testing panel designs ensure that the methods used, particularly diagnostic specificity and sensitivity, are suitably challenged. Appraising PT results over time can illustrate whether the laboratory's performance is stable, improving or worsening, and proficiency tests also highlight variations in the performance of assays. The development of new proficiency tests can support the implementation of novel diagnostics technologies, such as whole genome sequencing and pointof-care testing, and assist in cross-sectoral partnerships focusing on One Health approaches, which are high on the agenda for infectious disease control. For example, the rapid design and distribution of emergency exempted assays for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) means that these assays were not as rigorously evaluated as assays for established infectious diseases. Therefore, participation in PT programmes for SARS-CoV-2 is essential to understand the performance of these assays. While other mechanisms help to underpin laboratory activities, PT has been, and should remain, an integral part of laboratory quality assurance. Resources must be directed towards increasing and improving the quality of PT (for example, availability and accessibility of suitable biological and reference materials are essential for a PT provider to execute its duties), to support established and novel methods such as genomic and point-of-care tests.

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Section: Future Directions For Proficiency Testingmentioning

confidence: 99%

Proficiency testing and ring trials

Johnson¹,

Cabuang²

2021

Rev. Sci. Tech. OIE

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“…A particular case of testing is the point-of-care (POC) technologies, which has the very prominent advantage of increasing the populations' access to diagnoses through introduction of a decentralized model. However, from the EQA program's point of view, POC analytical performance increases in the same manner the design difficulty: many EQA samples are necessary for multiple testing points, where nonspecialized staff is available with a poor and delayed participation [12]. To deal with this situation, connected devices to a central database for POC technologies have been developed to establish an efficient and on time EQA workflow.…”

Section: Quality Control In Laboratorymentioning

confidence: 99%

Quality Management Systems for Laboratories and External Quality Assurance Programs

Valdivieso-Gómez¹,

Aguilar‐Quesada²

2018

Quality Control in Laboratory

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A quality management system (QMS) plans, controls, and improves the elements that impact on the achievement of the desired results by the laboratory and on the satisfaction of the users. There are different standards that establish requirements for the implementation of a quality management system for laboratories, and a cross comparison between them is shown. Additionally, external quality assurance or assessment (EQA) programs offer multiple benefits to laboratories: method validation, comparing of results with other laboratories, testing problem identification, accreditation requirement compliance, and credibility. In order to control the quality of the procedures, these programs are a tool to keep the laboratory procedures and every variable involved in (staff, equipment, and method) well controlled. In the frame of a quality management system, benefits from external quality assurance programs are discussed, and different available designs are reviewed. On the other hand, previous benefits will be real only if reported results for each program are analyzed in detail. Because additional advantages are achieved when the EQA results are integrated in the quality management system of the laboratory, a procedure is proposed. In addition, results from external quality assurance programs corroborate the usefulness of internal controls implemented by the laboratory as part of its quality management system.

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“…Concerning POCT users, the EQA organizers are communicating directly with the users of tests and their co-workers. It is therefore important that this category of health personal find the EQA program useful and to the benefit of their patients [52]. The Norwegian Quality Improvement of Laboratory Examinations (Noklus), for example, offers different kinds of pre-analytical programs for POCT users: …”

Section: Pre-analytical Eqas Program For Poct Usersmentioning

confidence: 99%

Improving quality in the preanalytical phase through innovation, on behalf of the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Preanalytical Phase (WG-PRE)

Lippi

Baird

Banfi

et al. 2017

Clinical Chemistry and Laboratory Medicine (CCLM)

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Abstract:It is now undeniable that laboratory testing is vital for the diagnosis, prognostication and therapeutic monitoring of human disease. Despite the many advances made for achieving a high degree of quality and safety in the analytical part of diagnostic testing, many hurdles in the total testing process remain, especially in the preanalytical phase ranging from test ordering to obtaining and managing the biological specimens. The Working Group for the Preanalytical Phase (WG-PRE) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) has planned many activities aimed at mitigating the vulnerability of the preanalytical phase, including the organization of three European meetings in the past 7 years. Hence, this collective article follows the previous three opinion papers that were published by the EFLM WG-PRE on the same topic, and brings together the summaries of the presentations that will be given at the 4th EFLM-BD meeting "Improving quality in the preanalytical phase through innovation" in Amsterdam, 24-25 March, 2017.

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Essential aspects of external quality assurance for point-of-care testing

Cited by 12 publications

References 15 publications

Proficiency testing and ring trials

Proficiency testing and ring trials

Quality Management Systems for Laboratories and External Quality Assurance Programs

Improving quality in the preanalytical phase through innovation, on behalf of the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Preanalytical Phase (WG-PRE)

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