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Current issues of personnel and laboratory practices in genetic testing
  1. Hon Fong Louie Mark1,
  2. Thaddeus Kelly2,
  3. Michael S Watson3,
  4. Gerald Hoeltge4,
  5. Wayne A Miller5,
  6. Laurent Beauregard6
  1. Laboratory of Cytogenetics, FISH and Genotoxicology, Rhode Island Hospital, 593 Eddy Street, Providence, RI 02903, USA
  2. 2Division of Medical Genetics, University of Virginia Hospital, Box 386, Charlottesville, VA 22908-0001, USA
  3. 3Department of Pediatrics, Washington University School of Medicine, One Children's Place, St Louis, MO 63110-1014, USA
  4. 4Department of Blood Banking, Desk L-20, Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195, USA
  5. Prenatal Diagnostic Center, 80 Hayden Avenue, Lexington, MA 02173-7962, USA
  6. Eastern Maine Medical Center, 489 State Street, Bangor, ME 04401, USA

    Abstract

    As genetic testing is an area with implications extending far beyond that of the primary patient, it is appropriately an area that is under increased scrutiny. To ensure that high quality is maintained in the delivery of genetic services, several agencies have developed standards and guidelines. The present article summarises important recommendations made by the American College of Medical Genetics (ACMG), the College of American Pathologists (CAP), the US Health Care Financing Administration (HCFA), and the US Food and Drug Administration (FDA) as they relate to genetic testing. Some of the standards are based on voluntary compliance, whereas others have the force of regulation. They all address issues of personnel credentials, laboratory operations, and the most critical quality assurance and control measures for diagnostic laboratories from the perspective of various agencies. In most instances, the standards promulgated by these agencies are offered as minimum criteria. The exact impact of these regulations on the practice of medical genetics has yet to be established.

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