Home About us Contact
|
Home About us Contact | ||
|
|
||
EQA Scheme (eqa + scheme)
Selected AbstractsCPA assessment , the regional assessors' experienceCYTOPATHOLOGY, Issue 2007E. Welsh Many individuals within Laboratory Medicine will be unaware that CPA conducts assessments to two different sets of CPA Standards. There are the Standards for the Medical Laboratory and the Standards for EQA Schemes in Laboratory Medicine. The style and format of both sets of standards is very similar with each being presented in eight sections A , H. The EQA standards are almost identical to the laboratory standards with the exception of the E.F and G standards which are specific to EQA schemes. There are approximately 40 EQA Schemes registered with CPA compared with almost 2 500 laboratories. These EQA schemes vary from very large national/international schemes with numerous analytes to small interpretive schemes run by one individual with a personal interest in that specific subject. The large schemes usually come under the UKNEQAS consortia banner and due to their size and configuration do not present undue problems in the assessment process. Smaller interpretive EQA schemes present a challenge both for the scheme and CPA in gaining accreditation. These schemes are usually within the discipline of Histopathology and are regarded as educational rather than proficiency testing schemes. Very frequently, the scheme is organized by a single individual with a collection of microscope slides, storage facilities for the slides and a computer. This presents the Scheme Organizer with great difficulty in complying with the Quality Management System requirements of the CPA Standards. There are a number of models which can be applied in order to satisfy the requirement of the Quality Management System, but ultimately it must be recognized that in some circumstances it is not possible to accredit these small schemes. The NHSCSP Gynae Cytology EQA Scheme is probably the largest EQA scheme within the UK, in respect of the number of participants and the number of staff supporting the scheme. Scheme Management decided that all nine regions of England would apply for accreditation under one CPA Reference Number. This process meant that the scheme would be assessed as a Managed Pathology Network. This is unique in terms of EQA schemes and presented a number of problems not previously encountered in EQA scheme accreditation. This decision meant that all nine regions must comply with a single Quality Management System and other CPA standards whilst allowing flexibility within the system for each region to facilitate the assessment process specific to their user's requirements. The process worked in a satisfactory manner and the overall outcome was not dissimilar to that of other large EQA schemes. The assessment to the current EQA Standards only commenced in April 2006 whilst the Standards for Medical Laboratories commenced in 2003, and it is perhaps not surprising to find that the principal non-conformities are related to the Quality Management System. This parallels the findings encountered in laboratory accreditation. There is an ongoing educational process for Scheme Management and the Facilitators in each region in how to comply fully with the standards and a commitment to quality improvement which ultimately is beneficial to the participant's of the scheme and to patient safety. [source] Evaluation and use of a synthetic quality control material, included in the European external quality assessment scheme for cystic fibrosis,HUMAN MUTATION, Issue 8 2008Sarah Berwouts Abstract Assuring high quality within the field of genetic testing is fundamental, as the results can have considerable impact on the patient and his or her family. The use of appropriate quality control (QC) samples is therefore essential. Diagnostic laboratories mainly use patient samples as QC material, which of course include a maximum of two mutations per sample. Bearing in mind that some assays (such as for cystic fibrosis [CF] testing) can test for more than 100 mutations, multiplex QC materials including more than two mutations could save valuable time and reagents. Based on this need, synthetic multiplex controls have been developed by Maine Molecular Quality Controls, Inc. (MMQCI) for CF. A synthetic control, containing six homozygous mutations and one polymorphism for CF transmembrane conductance regulator (CFTR), was evaluated by distributing it through the CF external quality assessment (EQA) scheme, along with the EQA samples in 2005. A total of 197 participants returned results of the yearly EQA scheme and 133 laboratories participated in the evaluation of the synthetic sample. Respectively, 76% and 73% of the participants were assigned as successful. This evaluation study revealed that the multiplex QC material performed well in the majority of assays and could be useful in method validation, as a tool to challenge interpretation skills, and as potential proficiency testing (PT) material. Hum Mutat 0, 1,8, 2008. © 2008 Wiley-Liss, Inc. [source] Quality assurance for oral anticoagulation self management: a cluster randomized trialJOURNAL OF THROMBOSIS AND HAEMOSTASIS, Issue 3 2008E. T. MURRAY Summary.,Background and aims:,External quality assessment (EQA) should be an inherent component of patient self management (PSM) of oral anticoagulation. The aim of this study was to evaluate methods of EQA for patients within a cluster randomized trial. Method:,After development of methods, general practises were randomly allocated to a formal EQA scheme of patients performing the test independently at home or at their practise with supervision. The supervised group of practises was further sub divided to test two other EQA methods: (i) venous sample compared with patients' point of care (POC) device; and (ii) patients POC compared with reference POC. Primary trial outcome measure was reliability of results from the formal scheme taking into account adherence and test errors. Results:,Proportion of EQA scheme tests in range was 633/836 (75.7%). Proportion in range was significantly higher in group performing independently compared with supervised group, 80.1% vs. 71.5% respectively, P = 0.02. Sixty-six percent of tests were in range with venous compared with patients POC, and 88% in patients POC compared with reference POC. Conclusion:,Patients are able to undertake a formal EQA scheme and perform more reliably at home independently. There are satisfactory alternatives if a formal scheme is not acceptable. [source] External quality assessment of rapid prenatal detection of numerical chromosomal aberrations using molecular genetic techniques: 3 years experiencePRENATAL DIAGNOSIS, Issue 5 2007S. C. Ramsden Abstract Objectives Prenatal diagnosis using rapid molecular genetic techniques is now a widely used method for detecting the most prevalent chromosomal aneuploidies. The object of this work was to develop a methodology for delivering external quality assessment (EQA) appropriate to the needs of routine diagnostic testing laboratories. Methods We have provided three rounds of EQA using 15 different samples over 3 years. The scheme has developed to assess both the genotyping accuracy of the results and the appropriateness of the clinical reports issued to the referring clinician. Results Participation in the EQA scheme has increased from 9 to 27 laboratories from across Europe over the three sample distributions. All laboratories have used quantitative fluorescence-PCR (QF-PCR) to analyse these samples except for a sole participant in 2006 who used multiplex ligation-dependent probe amplification (MLPA). In total 265 samples have been distributed, of which four (1.5%) were not reported due to technical failures and one (0.4%) was reported incorrectly and must be regarded as a genotyping error. Conclusions We have demonstrated a significant and increasing demand for EQA in the rapid detection of aneuploidies in UK and other European laboratories. Using the methodologies described, we have had a very low rate of technical failures and demonstrated a high level of genotyping accuracy. However, the quality of the clinical reports was variable and suggestions are made for improvement. Copyright © 2007 John Wiley & Sons, Ltd. [source] CPA assessment , the regional assessors' experienceCYTOPATHOLOGY, Issue 2007E. Welsh Many individuals within Laboratory Medicine will be unaware that CPA conducts assessments to two different sets of CPA Standards. There are the Standards for the Medical Laboratory and the Standards for EQA Schemes in Laboratory Medicine. The style and format of both sets of standards is very similar with each being presented in eight sections A , H. The EQA standards are almost identical to the laboratory standards with the exception of the E.F and G standards which are specific to EQA schemes. There are approximately 40 EQA Schemes registered with CPA compared with almost 2 500 laboratories. These EQA schemes vary from very large national/international schemes with numerous analytes to small interpretive schemes run by one individual with a personal interest in that specific subject. The large schemes usually come under the UKNEQAS consortia banner and due to their size and configuration do not present undue problems in the assessment process. Smaller interpretive EQA schemes present a challenge both for the scheme and CPA in gaining accreditation. These schemes are usually within the discipline of Histopathology and are regarded as educational rather than proficiency testing schemes. Very frequently, the scheme is organized by a single individual with a collection of microscope slides, storage facilities for the slides and a computer. This presents the Scheme Organizer with great difficulty in complying with the Quality Management System requirements of the CPA Standards. There are a number of models which can be applied in order to satisfy the requirement of the Quality Management System, but ultimately it must be recognized that in some circumstances it is not possible to accredit these small schemes. The NHSCSP Gynae Cytology EQA Scheme is probably the largest EQA scheme within the UK, in respect of the number of participants and the number of staff supporting the scheme. Scheme Management decided that all nine regions of England would apply for accreditation under one CPA Reference Number. This process meant that the scheme would be assessed as a Managed Pathology Network. This is unique in terms of EQA schemes and presented a number of problems not previously encountered in EQA scheme accreditation. This decision meant that all nine regions must comply with a single Quality Management System and other CPA standards whilst allowing flexibility within the system for each region to facilitate the assessment process specific to their user's requirements. The process worked in a satisfactory manner and the overall outcome was not dissimilar to that of other large EQA schemes. The assessment to the current EQA Standards only commenced in April 2006 whilst the Standards for Medical Laboratories commenced in 2003, and it is perhaps not surprising to find that the principal non-conformities are related to the Quality Management System. This parallels the findings encountered in laboratory accreditation. There is an ongoing educational process for Scheme Management and the Facilitators in each region in how to comply fully with the standards and a commitment to quality improvement which ultimately is beneficial to the participant's of the scheme and to patient safety. [source] | |||||||||||||