Policies, requirements and surveys concerning frequency for participation in proficiency testing schemes

Örnemark, Ulf; Fostel, H.; Straub, Rolf; Kreeke, J. van de

doi:10.1007/s00769-004-0858-2

Cited by 10 publications

(7 citation statements)

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“…These guidelines present six main strengths. First, they are based on European recommendations [ 41 - 43 ] and on the clinical and laboratory practice to make them as broad and consistent as possible. Second, they have been developed by a working group composed of representatives of all BMCHG to ensure a harmonization at the national level.…”

Section: Discussionmentioning

confidence: 99%

Frequency of Participation in External Quality Assessment Programs Focused on Rare Diseases: Belgian Guidelines for Human Genetics Centers

et al. 2021

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Background Participation in quality controls, also called external quality assessment (EQA) schemes, is required for the ISO15189 accreditation of the Medical Centers of Human Genetics. However, directives on the minimal frequency of participation in genetic quality control schemes are lacking or too heterogeneous, with a possible impact on health care quality. Objective The aim of this project is to develop Belgian guidelines on the frequency of participation in quality controls for genetic testing in the context of rare diseases. Methods A group of experts analyzed 90 EQA schemes offered by accredited providers and focused on analyses used for the diagnosis of rare diseases. On that basis, the experts developed practical recommendations about the minimal frequencies of participation of the Medical Centers of Human Genetics in quality controls and how to deal with poor performances and change management. These guidelines were submitted to the Belgian Accreditation Body and then reviewed and approved by the Belgian College of Human Genetics and Rare Diseases and by the National Institute for Health and Disability Insurance. Results The guidelines offer a decisional algorithm for the minimal frequency of participation in human genetics EQA schemes. This algorithm has been developed taking into account the scopes of the EQA schemes, the levels of experience, and the annual volumes of the Centers of Human Genetics in the performance of the tests considered. They include three key principles: (1) the recommended annual assessment of all genetic techniques and technological platforms, if possible through EQAs covering the technique, genotyping, and clinical interpretation; (2) the triennial assessment of the genotyping and interpretation of specific germline mutations and pharmacogenomics analyses; and (3) the documentation of actions undertaken in the case of poor performances and the participation to quality control the following year. The use of a Bayesian statistical model has been proposed to help the Centers of Human Genetics to determine the theoretical number of tests that should be annually performed to achieve a certain threshold of performance (eg, a maximal error rate of 1%). Besides, the guidelines insist on the role and responsibility of the national public health authorities in the follow-up of the quality of analyses performed by the Medical Centers of Human Genetics and in demonstrating the cost-effectiveness and rationalization of participation frequency in these quality controls. Conclusions These guidelines have been developed based on the analysis of a large panel of EQA schemes and data collected from the Belgian Medical Centers of Human Genetics. They are applicable to other countries and will facilitate and improve the quality management and financing systems of the Medical Centers of Human Genetics.

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Section: Discussionmentioning

confidence: 99%

Frequency of Participation in External Quality Assessment Programs Focused on Rare Diseases: Belgian Guidelines for Human Genetics Centers

et al. 2021

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“…External Quality Assessment (EQA) is a continuous process for quality improvement in which the participating laboratory uses an outside unbiased source to verify the quality of patient's results. [13][14][15][16][17][18] Participating in an EQA program permits a laboratory to confirm that its results are consistent with those of other laboratories using the same or similar methods for an analyte and thus to confirm it is using a method correctly. 7-9 EQA is an imperative aspect for any laboratory operation to maintain the good quality laboratory practice and smooth operation.…”

Section: What Is External Quality Assessment: Current Practice ?mentioning

confidence: 99%

“…If not, there may be several issues with the linearity of the method. 16,49 Yundt chart has been described in fig. 3.…”

Section: Yundt Chartmentioning

confidence: 99%

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External Quality Assessment Practices in Clinical Biochemistry Laboratory: What is the need?

Niraula

Bataju

2020

Kathmandu Univ. Med. J.

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Health Care services is considered as an amalgamation between the doctor undergoing the examination and laboratory personnel behind the proper diagnosis of the patient. It has evolved to a large extent from a simple process of examination to handling the prescription to the patient. During this evolution, there has been a remarkable development in the field of laboratory diagnosis. A good laboratory is abided by the rule of quality services including quality control; both internal and external. External quality assessment program contributes to the long term accuracy of the analytical method used by the laboratory. It determines the number of quality element of the practicing laboratory and helps in the upliftment of the status of the laboratory to laboratory accreditation and certification. This review article is intended to review the importance of the external quality assessment program over internal quality control, its need in the laboratory and the current practices in external quality assessment. Medline search was done for the articles published in English language from 1945 to 2018. Keywords employed to search the articles were external quality assessment, EQA programs, quality assurance, and quality control in clinical biochemistry, respectively. We searched for any articles with the details of external quality assessment tools that were original articles, review, editorial and the official website of the EQAS program. The unavailable articles were searched through research gate and the authors were requested for full text. A total of 5 full text original research article were found and rest of the articles like review article, editorial, national policy were studied in detail. Standard textbooks for clinical chemistry and chapters for EQA under quality assurance was reread in detail. Studies and policy makers have depicted that External Quality Assessment scheme (EQAS) as an integral component for the efficient and high quality laboratory operation. The western countries haizve their own laboratory accreditation body which conducts the EQAS program and offers participation to other clinical laboratories. Countries in South East Asia have shown to be burgeoning in the field of EQA program with establishment of their own laboratory accreditation bodies and incorporating the non-accredited laboratories in EQA programs.

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“…Os ensaios de proficiência permitem esta avaliação, conduzindo os participantes à melhoria contínua. As participações em ensaios de proficiência e em avaliações externas da qualidade são atividades que fornecem aos laboratórios, seus clientes e organismos de acreditação e reguladores uma valiosa informação sobre a medição realizada pelo laboratório (ÖRNEMARK et al, 2004 …”

Section: Introductionunclassified

A influência do sistema de gestão de laboratórios nos resultados dos ensaios de proficiência da construção civil

2008

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Para Cortez et al. (2003), os laboratórios devem produzir resultados precisos e exatos o suficiente para serem usados por seus clientes para o propósito planejado. Porém, até mesmo laboratórios experientes podem produzir resultados ocasionalmente errados. Isso pode acontecer devido a vários fatores como, por exemplo: enganos humanos que causam erros aleatórios e sistemá-ticos. A utilização de um sistema de gestão formalmente avaliado como, por exemplo, acreditação ISO/IEC 17025 e certificação ISO 9001, pode auxiliar no controle dos fatores que geram erros na realização de calibrações e ensaios.Este artigo tem por objetivo verificar se o tipo de sistema de gestão dos laboratórios de ensaio da construção civil do Brasil influencia nos resultados dos ensaios de proficiência. Objetiva ainda discutir como contemplar o resultado dos ensaios de proficiência no cálculo da incerteza de medição dos ensaios.Na seção 2, este artigo aborda os sistemas de gestão de laboratórios; na seção 3, os ensaios de proficiência; na IntroduçãoMedidas erradas ou inexatas podem conduzir a decisões erradas que podem ter conseqüências sérias como desperdício de recursos materiais, financeiros e, até mesmo, de vidas. As conseqüências humanas e econô-micas de decisões erradas baseadas em medições inexatas podem ser incalculáveis. Então, é importante ter medidas seguras e exatas que sejam aceitas pelas autoridades nacionais e internacionais (BIPM, 2004).Os laboratórios que realizam medições são fator de suma importância no momento de fornecer dados confiáveis. Uma das formas de garantir a confiabilidade das medições realizadas por laboratórios é a avaliação freqüente de seu desempenho. Os ensaios de proficiência permitem esta avaliação, conduzindo os participantes à melhoria contínua. As participações em ensaios de proficiência e em avaliações externas da qualidade são atividades que fornecem aos laboratórios, seus clientes e organismos de acreditação e reguladores uma valiosa informação sobre a medição realizada pelo laboratório (ÖRNEMARK et al., 2004

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Policies, requirements and surveys concerning frequency for participation in proficiency testing schemes

Cited by 10 publications

References 1 publication

Frequency of Participation in External Quality Assessment Programs Focused on Rare Diseases: Belgian Guidelines for Human Genetics Centers

Frequency of Participation in External Quality Assessment Programs Focused on Rare Diseases: Belgian Guidelines for Human Genetics Centers

External Quality Assessment Practices in Clinical Biochemistry Laboratory: What is the need?

A influência do sistema de gestão de laboratórios nos resultados dos ensaios de proficiência da construção civil

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