Current issues of personnel and laboratory practices in genetic testing. Issue 10 (October 1995)

• Record Type: Journal Article
• Authors: Mark, Hon Fong Louie; Kelly, Thaddeus; Watson, Michael S; Hoeltge, Gerald; Miller, Wayne A; Beauregard, Laurent
• Is Part Of: Journal of medical genetics. Volume 32:Issue 10(1995)
• Page Start: 780
• Page End: 786
• Publication Date: 1995-10
• Subjects: Medical genetics -- Periodicals; 616.042
• DOI: 10.1136/jmg.32.10.780
• Languages: English
• ISSNs: 1468-6244

Abstract

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.