Notice of Intent to Award Sole Source to Bruker Scientific LLC.pdf

Notice of Intent to Sole Source No.: 75D30125Q78561

THIS IS A NOTICE OF INTENT TO AWARD A SOLE SOURCE CONTRACT TO BRUKER

SCIENTIFIC, LLC AND IS NOT A REQUEST FOR COMPETITIVE QUOTES. The Centers for Disease Control and Prevention (CDC), Office of Acquisition Services (OAS) intends to award a firm fixed-price (FFP) sole source contract to provide an annual maintenance agreement for complete service coverage for a Bruker MALDI Biotyper Sirius One Instrument in support of the Clinical and Environmental Microbiology Branch (CEMB) / Division of Healthcare Quality Promotion (DHQP), Royal Campus, Atlanta, Georgia UNDER THE AUTHORITY OF Federal Acquisition Regulation (FAR) 13.501(a), Sole Source acquisitions and FAR 13.106-1(b)(1)(i), only one source being available to meet the Government’s needs to:

Bruker Scientific, LLC 40 Manning Road Billerica, Massachusetts 01821-3915

The anticipated North American Industry Classification System (NAICS) code is 811210 – Other Electronic and Precision Equipment Repair and Maintenance with a business size standard of $34.0 million. The Product Service Class (PSC) code is J066 – Maintenance/Repair/Rebuild of Equipment – Instruments and Laboratory Equipment.

The objective of this sole source award is to procure a supply contract for a one-year base period, plus four (4) 12-month option periods. The anticipated period of performances is:

Performance Year Period of Performance Base Year 26 November 2024 – 25 November 2025 Option Period One 26 November 2025 – 25 November 2026 Option Period Two 26 November 2026 – 25 November 2027 Option Period Three 26 November 2027 – 25 November 2028 Option Period Four 26 November 2028 – 25 November 2029

SERVICE:

Bruker Scientific, LLC is the Original Equipment Manufacturer (OEM) of the Bruker MALDI Biotyper Sirius One Instrument and is required to be under a maintenance agreement by the agency’s Quality Management System (QMS) policy and Federal Clinical Laboratory Improvement Amendments (CLIA) regulations for the reference laboratory to maintain the integrity of the instrument and provide assurance results obtained from the samples analyzed are accurate. These results are used to perform essential analysis with the existing Bruker Instrument, which also may require emergency onsite visits within 3-5 days. Software and equipment upgrade to maintain the unit are performed with matrix assisted laser desorption ionization time-of-flight mass spectrometry (MALDITOF MS) and used in the confirmation and identification of bacteria from healthcare associated infections, including Gram-negative, Gram-positive, and Nontuberculous Mycobacteria received within the Clinical and Environmental Microbiology Branch.

MALDI-TOF MS is a rapid, reliable, and low-cost method of bacterial identification. The instrument is currently being used by nearly all lab activities, including outbreak, surveillance, and research testing. The system will also be validated for CLIA reference testing in the coming year to report diagnostic patient testing results. This maintenance agreement contract will provide complete service coverage of the MALDI Biotyper Sirius One from Bruker for one year. Due to this being a highly specialized instrument and the manufacturer’s warranty requirements, only a Bruker trained service technician can service and repair the instrument.

The required Bruker Instrument is subject to OEM annual maintenance instructions and restrictions. This contract will provide complete service coverage of the Bruker MALDI Biotyper Sirius One Instrument for five years, which will be less expensive than purchasing periodic maintenance (PM) annually over the same 5-year period. Due to this being a highly specialized instrument with manufacturer’s warranty requirements, only a trained service Bruker technician can service and repair the instrument. This vendor and their instrument were previously selected due to the Bruker’s Instrument mobility and modular design capabilities, which are ideal for the changing lab space and

Notice of Intent to Sole Source No.: 75D30125Q78561 needs of CEMB. Due to this being a specialized instrument, maintenance and repairs must be performed by a Bruker-trained technician to perform at original levels. The Contract level agreement is specifically designed to ensure that the Bruker Instrument receives the essential scheduled preventative maintenance necessary to maintain peak efficiency and reliable operation throughout the products service life.

The items shall integrate the utilization of the uniquely configured existing installed equipment. Only the OEM brand names (or equivalents/comparable substitute) products will be accepted due to the compatibility with OEM instrument to reduce risk. Bruker Scientific, LLC is the original vendor of this equipment; and as such is the only vendor capable of servicing the equipment. The program also conducted market research to determine if there were other qualified vendors who could provide an annual maintenance agreement for the Bruker MALDI Biotyper Sirius One Instrument, and no additional qualified vendors were found.

Based on market research and previous acquisition history, it has been determined that Bruker Scientific, LLC is the only OEM authorized dealer, authorized distributor, and authorized reseller for the required annual maintenance to maintain the Bruker Instrument. Bruker is the only proven contractor capable of providing the required annual maintenance used for manual bench testing for this equipment at the CDC laboratory. It is in the best interest of the Government for Bruker to provide the specific complete maintenance requirements under the equipment’s OEM warranty restrictions with one contract as required by government for a period of 5-years.

Bruker Scientific, LLC manufactures, sells, services, and supports the Bruker MALDI Biotyper Sirius One Instrument directly. No other company manufactures this equipment or is authorized to distribute, service or support

it. To the best of our knowledge, there is not another product on the market that performs automated semen analysis of the semen parameters. Bruker is the sole producer and maintenance source, and there are no similar systems offered for sale in the market, which are based on our technology at a price that is more cost-effective than procuring an annual maintenance agreement for the next 5-years.

This Notice of Intent is not a request for Expressions of Interest (EOIs) or competitive quotations. No solicitation document exists for this requirement. No contract award will be made based on EOIs, or quotations received in response to this notice.

Sources interested in responding to this notice are required to furnish detailed data concerning their capabilities to provide the services sought including pricing data and technical data sufficient to determine that a comparable source to the government is available. The Government will be the sole determiner regarding an offeror’s ability to meet all requirements. All capability statements received by the due date of this notice will be considered by the Government.

A request for documentation or additional information or submissions that only ask questions will not be considered as an affirmative response. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole source purchase order.

EOIs sent via Federal Express, or hand carried will not be accepted. EOIs may be submitted via email to xvw0@cdc.gov and icx2@cdc.gov. The email must clearly identify this notice and the name of the point of contact on the first page. Submitters bear the burden of ensuring that the EOI reaches the designated point of contact above on time and should allow a reasonable time for emails to be received. All information must be received before the deadline specified below and any information received after the deadline will not be considered. The submitter bears the risk of non-receipt of emails.

The anticipated award date is 26 November 2024. If a vendor challenges the basis of this requirement, please email product capability statements (formats for submission: PDF, MS Word, or MS Excel) to Ms. Kenyadah Gamble at xvw0@cdc.gov and Mr. Philip Denis at icx2@cdc.gov. Closing date for challenges is no later than 1400 Pacific Standard Time (PST) on 15 November 2024.

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