OECD Guidelines for Quality Assurance in Molecular Genetic Testing

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General elementsReporting Quality Index% Total complying % US complyingBasic ElementsTwo unique identifiers 100100Result 95 92Added SpecificityDate of Birth 88 100Reason for testing 89 94Statement of limitations 78 79Director’s s signature 84 94Implications for other familymembersAlso Useful61 64Date of report 99 100Sample collection date 86 98Suggestion for further testing 82 79
Variables associated with higher quality indices• Standard Operating Procedures exist• Standard operating procedures are reviewed by director• Laboratory test result report is issued (written or electronic)• Laboratory test result report is reviewed by director• Offering of prenatal / pre-implantation testing• Affiliation with a genetics unit• Licensing and accreditation• Participation in proficiency testing• Not primarily in a research setting• Maintaining data on turnaround time• Lab director has an MD or PhD• Lab director is certified• Lab director has formal training• Lab technicians have a university degree• lab technicians have relevant training
Page 4: What is theOrganization for Economi
Page 7 and 8: Quality Assurance and Proficiency T
Page 9 and 10: SpecimensProcessedSpecimens Process
Page 11: Quality Assurance IndexInformation
Page 15 and 16: Guideline for Quality Assurancein M
Page 17 and 18: OECD Guidelines for Quality Assuran
Page 19 and 20: Quality Assurance Systemsin Molecul
Page 21 and 22: Quality of Result ReportingD.1 - Al
Page 23 and 24: Next Step: ImplementationOECD Persp
Page 25: Questions?Thank You

OECD Guidelines for Quality Assurance in Molecular Genetic Testing

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