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Public Health at Risk: Failures in Oversight of Genetic Testing Laboratories

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Publication Date: September 2006

Publisher(s): Genetics and Public Policy Center

Author(s): Kathy Hudson; Gail H. Javitt

Funder(s): Pew Charitable Trusts

Funder(s): Pew Charitable Trusts

Topic: Health (Medical research and technology)

Keywords: Clinical Laboratories Improvement Amendments; Public health; Genetic testing; Oversight

Type: Report

Coverage: United States


This report describes the role of the Clinical Laboratories Improvement Amendments of 1988 (CLIA) in ensuring laboratory quality, and documents the repeated failure of the Centers for Medicare and Medicaid Services (CMS) to implement this law with respect to genetic testing laboratories. It identifies the lack of transparency regarding laboratory quality as a key impediment to sound healthcare decision making by healthcare providers and patients.

The report also summarizes data from the Genetics and Public Policy Center's recent survey of genetic testing laboratory directors. Survey findings indicate a clear correlation between participation in proficiency testing, which is not currently required under CLIA for genetic testing, and test quality. The findings also show that nearly three-quarters of laboratory directors surveyed support more oversight of genetic testing under CLIA, and more than 90 percent found proficiency testing to be useful in improving genetic testing quality.

The report concludes that implementation of CLIA with respect to genetic testing laboratories through the creation of a genetic testing specialty is necessary to ensure the quality of genetic testing, to fulfill the promise of genetic medicine, and to protect the public's health.