Table 1.
Useful Resources for Laboratory Standards and Quality Control
Standards | References |
---|---|
National Committee for Clinical Laboratory Standards: Molecular diagnostic methods for genetic diseases. Approved guidelines. | 1 |
New York State Department of Health Laboratory Standards | http://www.wadsworth.org/labcert/clep/Survey/files/standardseffective12106.pdf (accessed 12/07/06) |
The American College of Obstetricians and Gynecologists and American College of Medical Genetics: Preconception and prenatal carrier screening for cystic fibrosis, clinical and laboratory guidelines. | 2 |
Department of Health and Human Services, Centers for Medicare and Medicaid Services: Clinical laboratory improvement amendments of 1988; Final rule. | 3 |
Department of Health and Human Services, Centers for Medicare and Medicaid Services: Genetic Testing under CLIA | 4 |
College of American Pathologists Checklist | http://www.cap.org/apps/docs/laboratory_accreditation/ checklists/molecular_pathology_october2005.pdf (accessed 12/07/06) |
American College of Medical Genetics Standards and Guidelines for Clinical Genetics Laboratories 2006 Edition | http://www.acmg.net/Pages/ACMG_Activities/stds-2002/stdsmenu-n.htm (accessed 12/07/06) |
U.S. Department of Health and Human Services, Food and Drug Administration: Center for Devices and Radiological Health, Center for Biologic Evaluation and Research: Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable: April 25, 2006. | http://www.fda.gov/cdrh/oivd/guidance/1588.html (accessed 12/07/06) |