Synopsis: A copy of testimony our General Counsel provided at the November 2014 CLIAC meeting, highlighting the public health need for CLIA Waiver reform, both to improve access to point-of-care testing and laboratory quality.
Synopsis: In July 2014, AACC published an article, "Managing Risks at the Point of Care," that provided useful information about application of Individualized Quality Control Plans the point-of-care environment. Unfortunately, the article also perpetuated misinformation about quality issues in point-of-care testing, and failed to recognize the importance of regulatory reforms that would expand access to valuable point-of-care tests. This letter to the editor, submitted by our General Counsel, addresses these issues.
Guidance on Clinical Laboratory Improvement Amendments of 1988 (CLIA) Criteria for Waiver: Draft Guidance for Industry and FDA (Mar. 2001)
Synopsis: This first CLIA waiver guidance draft includes the correct interpretation of the CLIA waiver law. Returning to this interpretation is the first, and most important, step in developing new process for CLIA waivers.
Coalition for CLIA Waiver Reform
J Boiani and S Gerson, Missing The Point (Of Care): FDA's Misreading Of CLIA Waiver Law Undermines Cost-Effective Health Testing (Oct. 2013)
Synopsis: Written by our General Counsel (J Boiani) and former Acting Attorney General of the United States (S Gerson), this article takes a critical look at the CLIA Waiver Program, addresses the policy and legal concerns with FDA's current program, and gives a useful overview of CLIA waiver history.
Letter to 21st Century Cures Initiative (June 2014)
Synopsis: In May 2014 the House Energy and Commerce's 21st Century Cures Initiative requested information on important health regulatory issues. The Coalition letter to the initiative highlights the current concerns with the CLIA Waiver Process.
Improving Access to Point of Care Testing through Sound Science & Regulatory Reform
Synopsis: This document is a useful two-page summary of the CLIA Waiver Issue and the reforms that are needed to improve healthcare through better access to point-of-care testing.