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AMP releases statement on oversight of laboratory tests
Date:1/28/2010

proposals that would hinder innovation in diagnostics, slow the rapid development and modification of necessary tests and impede the practice of medicine as all specialties rely on diagnostic tests.

AMP's specific recommendations include:

  • Laboratory directors or medical directors should review and reaffirm their policies and procedures for reviewing and documenting that appropriate validation studies have been performed for all tests developed in their laboratories with due consideration of clinical utility and clinical utilization.
  • CLIA should reassess utilization of resources and enforcement capabilities in order to meet its current mandate. CLIA should strengthen its enforcement capabilities by hiring more inspectors and improve the training of its inspectors.
  • To increase transparency, CMS should make information collected from laboratories in the CLIA program available and easily accessible to the public and other regulators.
  • Proficiency testing is a requirement of certification. When a formal proficiency testing program is not available, laboratories must perform and document alternative assessments as directed by CLIA.
  • Some tests may require greater scrutiny, such as those with hidden or nontransparent algorithms, and should be subject to additional review by regulators.
  • All LDTs should be subject to the same oversight mechanisms, and molecular tests should not be unduly scrutinized.
  • Any changes to the current oversight system should occur after a formal rule making process or statutory change.


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Contact: Mary Steele Williams
mwilliams@amp.org
301-634-7921
Association for Molecular Pathology
Source:Eurekalert

Page: 1 2

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