Current issues of personnel and laboratory practices in genetic testing
| Autor: | Gerald Hoeltge, Thaddeus E. Kelly, Michael S Watson, L. J. Beauregard, Wayne A. Miller, Hon Fong L. Mark |
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| Rok vydání: | 1995 |
| Předmět: |
Quality Control
medicine.medical_specialty Scrutiny media_common.quotation_subject Control (management) Guidelines as Topic Genetics medicine Humans Quality (business) Genetic Testing Genetics (clinical) Genetic testing media_common Medical education medicine.diagnostic_test United States Food and Drug Administration business.industry Public health Original Articles United States Medical genetics Business Laboratories Quality assurance Administration (government) |
| Zdroj: | Journal of Medical Genetics. 32:780-786 |
| ISSN: | 1468-6244 |
| DOI: | 10.1136/jmg.32.10.780 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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