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Thursday, November 7, 2024

E&C Republicans question CMS over national security safeguards in CLIA lab accreditation

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Cathy McMorris Rodgers - the Chair of the House Energy and Commerce Committee | Official U.S. House headshot

Cathy McMorris Rodgers - the Chair of the House Energy and Commerce Committee | Official U.S. House headshot

Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chair Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA) have addressed a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure. The letter seeks clarification on whether the agency is adequately safeguarding Clinical Laboratory Improvements Amendments (CLIA) lab accreditation from national security concerns.

The committee members expressed particular concern regarding potential national security threats associated with the Chinese military and the unethical use of human subjects in research studies by entities of concern in China.

Beijing Genomics Institute (BGI), based in Shenzhen, operates the China National GeneBank, which is described as “a vast and growing government-owned repository that includes genetic data drawn from millions of people around the world.” In 2022, the Department of Defense listed BGI among several “Chinese military companies” operating within the United States. A 2021 U.S. intelligence assessment also linked BGI to efforts directed by Beijing to obtain more human DNA globally, including from the United States.

On March 6, 2023, the Department of Commerce Bureau of Industry and Security added BGI Tech Solutions (Hongkong) Co. Ltd., to its “Entity List.” This list identifies entities believed to be involved or at significant risk of becoming involved in activities contrary to U.S. national security or foreign policy interests. According to the department, "their collection and analysis of genetic data poses a significant risk of contributing to monitoring and surveillance by the government of China," which has been used in the repression of ethnic minorities in China. The department further noted that these actions present a significant risk of diversion to China's military programs.

CMS had accredited a laboratory owned by BGI between 2017-2019. Subsequently, it provided CLIA accreditation to BGI Tech Solutions (Hongkong) Co. Ltd., effective September 8, 2023, through September 7, 2025. Notably, this entity shares the same address and point of contact as the previously accredited BGI CLIA lab.

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