Chapter 12. Test Samples and Laboratory Protocols

  1. Neil F. Sharpe6,
  2. Prof. Dr. Ronald F. Carter PhD., FCCMG., FACMG Director7,8
  1. S. Annie Adams MS1,
  2. Daniel L. Van Dyke PhD1,
  3. Rhett P. Ketterling MD1,
  4. Erik C. Thorland PhD1,
  5. Timothy Caulfield LLB., LLM., Professor and Canada Research Chair in Health Law and Policy2,
  6. Lorraine Sheremeta Research Associate2,
  7. E. Richard Gold LLB, LLM, SJD Associate Professor and Director3,
  8. Jon F. Merz JD, PhD Associate Professor4,
  9. David Castle PhD Associate Professor5

Published Online: 4 JAN 2006

DOI: 10.1002/0471748897.ch12

Genetic Testing: Care, Consent, and Liability

Genetic Testing: Care, Consent, and Liability

How to Cite

Sharpe, N. F. and Carter, R. F. (2006) Test Samples and Laboratory Protocols, in Genetic Testing: Care, Consent, and Liability, John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/0471748897.ch12

Author Information

  1. 6

    Genetic Testing Research Group, 117 Inchbury Street, Hamilton, Ontario, Canada L8R 3B7; 1-905-529-2036; 1-905-577-6446 (fax)

  2. 7

    Department of Pathology and Molecular Medicine, McMaster University, HSC 3N15, 1200 Main Street West, Hamilton, Ontario, Canada; 1-905-521-5084; 1-905-521-2651 (fax)

  3. 8

    Genetic Services, Hamilton Health Sciences, Canada

Author Information

  1. 1

    Mayo Clinic Cytogenetics Laboratory, Department of Laboratory Medicine and Pathology, Rochester, New York, USA

  2. 2

    Health Law Institute, Faculty of Law, University of Alberta, Edmonton, Alberta, Canada

  3. 3

    Centre for Intellectual Property Policy, McGill University, Montreal, Quebec, Canada

  4. 4

    Department of Medical Ethics, University of Pennsylvania, Philadelphia, Pennsylvania, USA

  5. 5

    Department of Philosophy, University of Guelph, Ontario, Canada

Publication History

  1. Published Online: 4 JAN 2006
  2. Published Print: 11 NOV 2005

ISBN Information

Print ISBN: 9780471649878

Online ISBN: 9780471748892

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Keywords:

  • accreditation;
  • archiving;
  • biochemical genetics;
  • chromosomal abnormality;
  • cytogenetic;
  • diagnostic;
  • DNA chips;
  • duty of care;
  • duty to timely report;
  • fluorescence in situ hybridization technology (FISH);
  • gene patent;
  • health policy;
  • karyotype;
  • Klinefelter syndrome;
  • medical malpractice;
  • microarrays;
  • molecular diagnostics;
  • neonatal cytogenetics;
  • pediatric cytogenetics;
  • prenatal diagnosis;
  • quality assurance;
  • quality management

Summary

Clinicians need to be aware of the indications and arrangements necessary for appropriate specimen collection and submission to supporting laboratory services. General indications and testing considerations for cytogenetics, biochemical genetics, and molecular diagnostics are discussed including laboratory accreditation, the use of research laboratories in clinical care, the use of research specimens for clinical care, consent for specimen archiving, and the impact of human gene patents on clinical laboratory testing services. The importance of reviewing new test indications, repeat testing with updated and more accurate technologies, laboratory reporting standards, clinical implementation of test results, and medico-legal issues, are illustrated by case discussions.