Genetic Testing: A Survey of Quality Assurance and Proficiency Standards [electronic resource] /
Organisation for Economic Co-operation and Development.
Organisation for Economic Co-operation and Development.
Paris : OECD Publishing,
2007.
This report presents the results of a survey of over 800 genetic testing laboratory directors in 18 OECD countries. It provides the first detailed overview of the availability and extent of molecular genetic testing across OECD member countries. The survey allowed the OECD to compare practices in individual countries in order to inform international action in setting standards and developing guidelines for practice. Based on the survey results, the report puts forward recommendations for action for better quality assurance and proficiency of molecular genetic testing. It shows, for example, that requirements for licensing and accreditation/certification of diagnostic molecular genetic testing laboratories have not penetrated OECD countries to a high degree or with any consistency. Considerable variations exist in mechanisms of licensing, certification and accreditation, including the standards by which tests are performed, results are reported, and the qualifications for laboratory personnel.
Description based upon print version of record.
Foreword; TABLE OF CONTENTS -; Summary; Introduction; Study population; Growth, configuration and organisation of genetic testing services; Close collaboration between clinical and laboratory services; Technology; Referral systems and gatekeeping arrangements; Funding and uptake of genetic tests; Geographical disparity in the range of genetic tests available; The growth of genetic testing networks; Handling of samples and data; Risk management; Determinants of laboratory personnel competence; References; Résumé; Introduction; Composition de l'échantillon
Essor, configuration et organisation des services de test génétiqueCollaboration étroite entre services cliniques et laboratoires; Technologie; Systèmes de référents et mécanismes d'aiguillage/filtrage; Financement et utilisation effective des tests génétiques; Disparités géographiques dans la gamme des tests disponibles; L'essor des réseaux sur les tests génétiques; Manipulation des échantillons et des données; Gestion des risques; Facteurs déterminant la compétence du personnel des laboratoires; Références
Chapter 1. Quality Assurance in Molecular Genetic Testing: Results of a Survey of 18 CountriesIntroduction; Methods; Steering committee; Study population; Survey development; Validation of the survey instrument; Contact of potential laboratory directors; Prevention of duplicate entries; Calculation of result reporting and QA best practice indices; Statistical analysis; Results; Study population; Laboratory setting; Personnel qualifications; Specimens; Types of testing being offered; Number of specimens accessioned; Methods used; Reporting practices; Informed consent and confidentiality
Licensing and proficiency testing participationPatented tests; Quality assurance practices of the laboratories; Chapter 2. Transborder Flow and Rare Diseases; Introduction; Background information; Summary of survey results; Dimension of transborder flow; Countries receiving samples; Current practice; Bivariate analysis of the transborder flow; Multivariate analysis of the transborder flow; Discussion; Dimension of transborder flow; Regulatory environment; Current practice; Conclusions; Improving availability of rare-disease testing; Promoting quality testing
Improving access to rare-disease testingChapter 3. Report Writing; Introduction; The reporting quality score; Survey results: analysis and discussion; Respondents not issuing reports; Range of scores; Factors influencing reporting quality score; Conclusions; References; Chapter 4. Consent, Storage and Confidentiality; Introduction: critical issues; Storage; Confidentiality; Informed consent; Survey results, analysis and discussion; Laboratory setting; Confidentiality; Conclusions; References
Chapter 5. Licensing, Accreditation, Certification and Proficiency Testing/External Quality Assessment
Includes bibliographical references.
This report presents the results of a survey of over 800 genetic testing laboratory directors in 18 OECD countries. It provides the first detailed overview of the availability and extent of molecular genetic testing across OECD member countries. The survey allowed the OECD to compare practices in individual countries in order to inform international action in setting standards and developing guidelines for practice. Based on the survey results, the report puts forward recommendations for action for better quality assurance and proficiency of molecular genetic testing. It shows, for example, that requirements for licensing and accreditation/certification of diagnostic molecular genetic testing laboratories have not penetrated OECD countries to a high degree or with any consistency. Considerable variations exist in mechanisms of licensing, certification and accreditation, including the standards by which tests are performed, results are reported, and the qualifications for laboratory personnel.
Human chromosome abnormalities
Laboratories
Scientific surveys
Human chromosome abnormalities