Do you need help implementing a new test? Are you struggling to determine best practices for use and implementation of quality controls? Do you want to know what professional organizations are recommending or where to find a lab performing your new test? Are you looking for colleagues who may be struggling with similar issues? We hope the information and links below will be helpful to your work in molecular diagnostics, please don’t hesitate to contact us at MMQCI for further assistance.

  • The Clinical and Laboratory Standards Institute (CLSI), previously NCCLS, publishes guidelines which describe best laboratory practices. These guidelines are used by laboratories to implement all aspects of a quality assurance program, by laboratory inspectors, manufacturers and FDA. Click here to see a listing of CLSI guidelines for molecular diagnostic laboratories.
  • Dr. James Westgard has been the international QC guru of clinical laboratory medicine since the 1970s. His approach to use QC rigorously and apply statistical analyses to identify shifts and trends in test systems, known as Westgard Rules, has become adopted in established laboratory disciplines. The Westgard website is an excellent source of information about QC best practices that can be applied in molecular testing laboratories.
  • Accurate pipetting is key to achieving accurate results in molecular diagnostic testing. Click here for 10 tips on accurate pipetting from Artel USA.

Below are links to select professional organizations and resources that provide the latest news and information across the molecular testing community.

  • AMP - Association for Molecular Pathology
  • JMD - The Journal of Molecular Diagnostics
  • FDA - US Food & Drug Administration (includes lists of cleared or approved molecular tests)
  • AACC - American Association for Clinical Chemistry
  • ASHG - American Society of Human Genetics
  • ACMG - American College of Medical Genetics