1. Achieving quality reproducible results and maintaining compliance in molecular diagnostic testing of human papillomavirus
2. Visit Draft Genetic Test Review fromt the CDC.
3. Genomics and Health Weekly Update - Subscribe to their free email updates.
4. Case Study: United States of America
5. Visit the following websites for a review or more information about these organizations or topics:
   1. Center for Biologic Evaluation and Research (CBER) is a branch of the FDA -Premarket Approval Information - Devices and Approved Premarket Approval (PMA) Device Applications
   2. Current CLIA Regulations and CLIA Waived Tests
   3. Clinical and Laboratory Standards Institute (formerly NCCLS)
   4. College of American Pathologists (CAP) - this organization has a FREE publication which is EXCELLENT. I strongly encourage you to sign up for the free subscription. Go to the CAP Today website for more information.
   5. Visit "Standard Precautions" for the most CURRENT recommendations by the Center for Disease Control (CDC)
   6. DNA Advisory Board Quality Assurance Standards for Forensic DNA Testing Laboratories
   7. Scientific Working Group on DNA Analysis Methods - revised validation guidelines
   8. Nuclear Regulatory Commission
6. FOR ENRICHMENT ONLY:
   1. The Secretary's Advisory Committee on Genetic Testing has a draft report U.S. System of Oversight of Genetic Testing:
      A Response to the Charge of the Secretary of HHS , which is 192 pages long, addressing policy issues raised by the development
      and use of genetic technologies and their integration into clinical and public health practice. The home page has the bullets which the report addresses in detail. This report is open for comment until December 21, 2007. This demonstrates the steps being taken to address the moral and ethical issues of genetic testing.
   2. Quality Control For Molecular Diagnostics - I signed up for this and hope it will not be "junk" but useful information.

Last Update: February 12, 2012
Web Author: Terry Kotrla, MS, MT(ASCP)BB
Comments: kotrla@austincc.edu
Copyright ©2007 by Terry Kotrla - All Rights Reserved