Topic
External quality assessment
About: External quality assessment is a research topic. Over the lifetime, 1293 publications have been published within this topic receiving 14966 citations. The topic is also known as: EQA & Laboratory Proficiency Testing.
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Dissertation•
01 Jan 2011
TL;DR: The accreditation of DIPPS will provide the participants of the AEQ Program in Serology evidence that it is planned and conducted according to procedures established in legal standards and meets quality patterns set by regulations for carrying out tests with human biological material.
Abstract: The accreditation of proficiency testing (PT) providers is a legal instrument for the recognition by
an entity's compliance with requirements previously defined, and the demonstration of
competence in conducting the performance evaluation of participating institutions, by means of
interlaboratory comparisons. For this purpose it was published in 2010 the ISO / IEC 17043 -
Conformity Assessment - General Requirements for Proficiency Testing. Aiming to build a
model of Quality Management at the Production Division of Serological Panels (DIPPS), Bio-
Manguinhos/FIOCRUZ and its accreditation in the future it was performed the interpretation of
ISO / IEC 17043 and a qualitative and quantitative analysis of the adhesion of the External
Quality Assessment (AEQ) Program in Serology with its requirements. These were characterized
as implemented, partially implemented or not implemented according to the evidence of
compliance observed. It was then proposed an Action Plan aimed to implement all the
requirements and the steps for the establishment of accreditation of the DIPPS by Inmetro.
Although ISO / IEC 17043 is recent and not yet implemented by Inmetro in Brazil, the AEQ
Program in Serology, coordinated by DIPPS showed a good adherence rate for most of the
requirements of this standard, considering the total items implemented and partially implemented
ones. The accreditation of DIPPS will provide the participants of the AEQ Program in Serology
evidence that it is planned and conducted according to procedures established in legal standards
and meets quality patterns set by regulations for carrying out tests with human biological
material. Furthermore, the integration of the ISO / IEC 17043 will enable the continuous
improvement of the Quality System of Bio-Manguinhos by expanding its scope of standards,
helping to build a reference model in the field of quality management and for increasing its selfsustainability.
After completion of the Action Plan the next step will be a pre-audit aimed at
detecting and correcting potential non-conformities, before to request the final audit of Inmetro.
345 citations
TL;DR: PT/EQA provides substantial value to the practice of laboratory medicine by assessing the performance of individual laboratories and, when commutable samples are used, the status of standardization or harmonization among different measurement procedures.
Abstract: BACKGROUND: Proficiency testing (PT), or external quality assessment (EQA), is intended to verify on a recurring basis that laboratory results conform to expectations for the quality required for patient care.
CONTENT: Key factors for interpreting PT/EQA results are knowledge of the commutability of the samples used and the process used for target value assignment. A commutable PT/EQA sample demonstrates the same numeric relationship between different measurement procedures as that expected for patients' samples. Noncommutable PT/EQA samples frequently have a matrix-related bias of unknown magnitude that limits interpretation of results. PT/EQA results for commutable samples can be used to assess accuracy against a reference measurement procedure or a designated comparison method. In addition, the agreement of the results between different measurement procedures for commutable samples reflects that which would be seen for patients' samples. PT/EQA results for noncommutable samples must be compared to a peer group mean/median of results from participants who use measurement procedures that are expected to have the same or very similar matrix-related bias. Peer group evaluation is used to asses whether a laboratory is using a measurement procedure in conformance to the manufacturer's specifications and/or in conformance to other laboratories using the same technology. A noncommutable PT/EQA sample does not give meaningful information about the relationship of results for patients' samples between different measurement procedures.
SUMMARY: PT/EQA provides substantial value to the practice of laboratory medicine by assessing the performance of individual laboratories and, when commutable samples are used, the status of standardization or harmonization among different measurement procedures.
253 citations
TL;DR: The present status of analytical and clinical aspects of determining the HbA1c concentration is described and the challenges involved are highlighted.
Abstract: After the relationship between glycemic control and the HbA1c concentration was demonstrated, many tests have been developed to determine the HbA1c concentration. The test results are standardized to the International Federation of Clinical Chemistry (IFCC) Reference Measurement Procedure (RMP) in harmony with the efforts of the National Glycohemoglobin Standardization Program (NGSP). The longitudinal use of the test requires strict quality management including accreditation of the laboratory, a dedicated internal control design, participation in an external quality assessment (EQA) program (proficiency test), and careful consideration of pre- and post-analytical aspects of the test. Performance goals for optimizing determination of the HbA1c concentration have been described. As an index of long-term glycemic control and a risk predictor, the HbA1c concentration is an indispensable part of routine management of diabetes. Because of the improving quality of the test, the HbA1c concentration is being increasingly applied in the diagnosis of diabetes. There are, however, concerns of this application in point-of-care settings. The HbA1c concentration is also used to achieve stringent control in pregnant diabetic patients. Strict standardization enables the definition of universal reference values and clinical decision limits. This review describes the present status of analytical and clinical aspects of determining the HbA1c concentration and highlights the challenges involved.
223 citations
Book•
01 Jan 1995
TL;DR: Some interest regarding quality assessment a blueprint for external quality assessment guidelines for self-assessment the review committee at work the European dimension in EQA as mentioned in this paper, which is a review committee for quality assessment.
Abstract: Some interest regarding quality assessment a blueprint for external quality assessment guidelines for self-assessment the review committee at work the European dimension in EQA.
206 citations
TL;DR: This paper provides an update of the guidelines for HER2 testing in the UK by providing guidelines of test performance parameters, and recommendations on the postanalytical interpretation of test results.
Abstract: Human epidermal growth factor receptor 2 (HER2) overexpression is present in approximately 15% of early invasive breast cancers, and is an important predictive and prognostic marker. The substantial benefits achieved with anti-HER2 targeted therapies in patients with HER2-positive breast cancer have emphasised the need for accurate assessment of HER2 status. Current data indicate that HER2 test accuracy improved following previous publication of guidelines and the implementation of an external quality assessment scheme with a decline in false-positive and false-negative rates. This paper provides an update of the guidelines for HER2 testing in the UK. The aim is to further improve the analytical validity and clinical utility of HER2 testing by providing guidelines of test performance parameters, and recommendations on the postanalytical interpretation of test results. HER2 status should be determined in all newly diagnosed and recurrent breast cancers. Testing involves immunohistochemistry with >10% complete strong membrane staining defining a positive status. In situ hybridisation, either fluorescent or bright field chromogenic, is used either upfront or in immunohistochemistry borderline cases to detect the presence of HER2 gene amplification. Situations where repeat HER2 testing is advised are outlined and the impact of genetic heterogeneity is discussed. Strict quality control and external quality assurance of validated assays are essential. Testing laboratories should perform ongoing competency assessment and proficiency tests and ensure the reliability and accuracy of the assay. Pathologists, oncologists and surgeons involved in test interpretation and clinical use should adhere to published guidelines and maintain accurate performance and consistent interpretation of test results.
198 citations