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Subject:
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Non-Financial End-Use Certificate for Updated MALDI Biotyper Reference Library
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REPORT/RECOMMENDATION TO THE BOARD OF SUPERVISORS
OF SAN BERNARDINO COUNTY
AND RECORD OF ACTION
September 9, 2025
FROM
JOSHUA DUGAS, Director, Department of Public Health
SUBJECT
Title
Non-Financial End-Use Certificate for Updated MALDI Biotyper Reference Library
End
RECOMMENDATION(S)
Recommendation
1. Approve and authorize the submission of a non-financial end-use certificate to the Federal Republic of Germany as required to receive an updated reference library for the MALDI Biotyper Sirius CA System used to test for infectious agents.
2. Authorize the Director of the Public Health Laboratory to execute and submit the end-use certificate, as well as any subsequent non-substantive amendments, to the Federal Republic of Germany, as necessary to receive an updated reference library for the MALDI Biotyper Sirius CA System, on behalf of the County, subject to review by County Counsel.
3. Direct the Director of the Public Health Laboratory to transmit the executed end-use certificate, and any subsequent non-substantive amendments, as required to receive an updated reference library for the MALDI Biotyper Sirius CA System, to the Clerk of the Board of Supervisors within 30 days of execution.
(Presenter: Joshua Dugas, Director, 387-9146)
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COUNTY AND CHIEF EXECUTIVE OFFICER GOALS & OBJECTIVES
Provide for the Safety, Health and Social Service Needs of County Residents.
FINANCIAL IMPACT
This item will not result in the use of Discretionary General Funding (Net County Cost) as it is non-financial in nature. Submission of an end-use certificate to the Federal Republic of Germany (Germany), and subsequent delivery of an updated reference library for the MALDI Biotyper sirius CA System (MALDI) does not involve a cost.
BACKGROUND INFORMATION
On March 1, 2022 (Item No. 29), the Board of Supervisors ratified the purchase of a MALDI from Bruker Scientific, LLC (Bruker), for identification of bacteria, mycobacteria, fungi, and yeasts, to increase COVID-19 testing capabilities, in the amount of $267,984.
The MALDI continues to be a crucial asset for the Department of Public Health (DPH) to quickly, accurately, and safely test for infectious agents. The MALDI has replaced outdated, labor-intensive technologies and has become the industry standard over the last decade. The Bruker MALDI is used by other local health departments including Orange and Sonoma Counties.
Testing with the MALDI is performed by analyzing a sample and comparing it against a library of identified specimens. Periodically, Bruker releases free updates to their reference library to improve accuracy. Due to the sensitive nature of the information, installation of reference library updates requires an export license from Germany. The end-use certificate is used to ensure the recipient is permitted to receive the information and that it will only be used for authorized purposes and that it will not be re-exported absent authorization from German authorities. Germany requires that the certificate be signed by someone qualified to access and use the information. Recommendation No. 3 would allow the Director of the Public Health Laboratory, a High-complexity Clinical Laboratory Director (HCLD), to execute the end-use certificate. DPH recommends approval of this item to further improve the testing capabilities of the Public Health Laboratory.
PROCUREMENT
Not applicable.
REVIEW BY OTHERS
This item has been reviewed by County Counsel (Daniel Pasek, Deputy County Counsel, 387-9000) on August 12, 2025; and County Finance and Administration (Iliana Rodriguez, Administrative Analyst, 387-4205) on August 21, 2025.