To: Board of Supervisors
From: DHHS: Public Health
Agenda Section: Consent
SUBJECT:
title
California Department of Public Health (CDPH) Abbott BinaxNOW Antigen Testing Supplies Acknowledgement and Acceptance of Responsibility State Standard Agreement
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RECOMMENDATION(S):
Recommendation
That the Board of Supervisors:
1. Approve the attached Acknowledgment and Acceptance of Responsibility state standard agreement with the CDPH to accept Abbott BinaxNOW COVID-19 antigen testing supplies and data use and disclosure regarding the Primary Diagnostics, Incorporated (Inc.) system;
2. Authorize the Director of Public Health, or a designee thereof, to sign the agreement; and
3. Authorize the Director of Public Health, or a designee thereof, to sign all future amendments and documents directly related to the agreement upon review and approval of County Counsel and Risk Management.
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SOURCE OF FUNDING:
Public Health Funds (1175).
DISCUSSION:
The United States Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) on August 26, 2020 for BinaxNOW antigen tests, the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in direct nasal swabs from individuals suspected of COVID-19 by their healthcare provider, pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. ?360bbb-3). Testing was limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, that meet the requirements to perform moderate, high, or waived complexity tests. This test was authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
On June 14, 2022, the ratification of a Memorandum of Understanding (MOU) and approval of amendment number 001 to the MOU with CDPH was approved by your Board (File #22-713). The amendment allowed Humb...
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