References

1. Medicare, Medicaid and CLIA Programs: Regulations Implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Final rule. Fed. Regi. 57:7002, 1992. Available at http://www.fda.gov/ cdrh/clia.

2. Medicare, Medicaid and CLIA Programs; Laboratory Requirements Relating to Quality Systems and Certain Personnel Qualifications; Final Rule (January 24, 2003) Fed. Regi. 68:3640, 2003.

3. American College of Medical Genetics (ACMG). Standards and Guidelines for Clinical Genetics Laboratories. 3rd ed. Avalable at http://www.acmg.net.

4. College of American Pathology. Molecular pathology checklist. Avalable at http://www.cap.org.

5. NCCLS. Molecular Diagnostic Methods for Genetic Diseases; Approved Guideline. NCCLS document MM1-A. NCCLS, Wayne, PA, 2000.

6. McGovern, M., Benach, M., Wallenstein, S., Desnick, R., and Keenlyside, R. Quality assurance in molecular genetic testing laboratories. JAMA 281:835-840, 1999.

7. Hofgartner, W. T. and Tait, J. F. Characteristics of clinical molecular-genetic testing laboratories in the United States. Clin. Chem. 45(8): 1288-1290, 1999.

8. Van Deerlin,V. Personal communication, 2003.

9. Beutler, E., Gelbart ,T., and Kuhl, W. Interference of heparin with the polymerase chain reaction. BioTechniques. 9:166, 1990.

10. Ginocchio, C. C., Wang, X. P., Kaplan, M. H., et al. Effects of specimen collection, processing and storage conditions on stability of human immunodeficiency virus type 1 RNA levels in plasma. J. Clin. Microbiol. 11:2886-2893, 1997.

11. Farkas, D. H., Drevon, A. M., Kiechle, F. L., DiCarlo, R. G., Heath, E. M., Crisan, D. Specimen stability for DNA-based diagnostic testing. Diagn. Mol. Pathol. 5(4): 227-235, 1996.

12. Dicover, R. E., Herman, S. A., Saddiqu, K., Wafer, D., Dillon, M., and Bryson, Y. J. Optimization of specimen-handling procedures for accurate quantitation of levels of human immunodeficiency virus RNA in plasma by reverse transcriptase PCR. J. Clin. Microbiol. 36: 1070-1073, 1998.

13. New York State Department of Health Laboratory, Wadsworth Center. Clinical Laboratory Evaluation Program, Laboratory Standards. Available at http://www.wadsworth.org/labcert/. (accessed February 2002).

14. NCCLS. Clinical Laboratory Technical Procedure Manuals, 4th ed. Approved Guideline GP2-A4.NCCLS Wayne, PA, 2002.

15. Gentra Systems. Purigene DNA Isolation Kit, Gentra Systems, Minneapolis, MN. Available at http://www.gentra.com.

16. Kwok, S. and Higuchi, R. Avoiding false positive with PCR. Nature 339:237-238, 1989.

17. Longo, M. C., Berninger, M. S., and Hurtley, J. L. Use of uracil DNA glycosylase to control carry-over contamination in poly-merase chain reactions. Gene 93:125-128, 1990.

18. Association for Molecular Pathology Statement. Recommendations for in-house development and operation of molecular diagnostic tests. Am. J. Clin. Pathol. 111:449-463, 1999.

19. Shahangian, S., Holmes, E. H., and Taylor, R. Toward optimal PT use. Med. Lab. Observ. 32(4):32-43, 2000.

20. Schwartz, M. K. Genetic testing and the Clinical Laboratory Improvement Amendment of 1988: present and future. Clin. Chem. 45(5):739-745, 1999.

21. The Health Insurance Portability and Accountability Act of 1996 (Public Law 104-191). Standards for Privacy of Individually Identifiable Health Information-45 CFR Parts 160 and 164.

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