Notice of Intent to Award Sole Source to Ecolab Inc-Final.pdf

Notice of Intent to Sole Source No.: 75D30125Q78560

THIS IS A NOTICE OF INTENT TO AWARD A SOLE SOURCE CONTRACT TO ECOLAB, INC 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 preventative maintenance service coverage for a Bioquell QUBE Mark IV Aseptic Processing Workstation(s) 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:

Ecolab, Inc.

702 Electric Drive, Suite 200 Horsham, Pennsylvania 19044

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 three (3) 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

SERVICE:

The Original Equipment Manufacturer (OEM) Bioquell QUBE is a subsidiary of Ecolab, Inc which is the vendor that will be providing the annual preventative maintenance coverage (or equivalents/comparable substitute) required to ensure the Bioquell QUBE equipment is operational to conduct critical clinical sterility testing. The Bioquell QUBE is a configurative isolator with a unique chamber design to optimize cycle times integrated with Bioquell’s Hydrogen Peroxide Vapor technology. These tests are used to perform essential analysis for the purpose of sterile testing, gene and cell therapy, small batch production, compounding, and cytotoxic preparation to test biopharmaceutical, laboratory research, and biotechnology. The Bioquell QUBE delivers unparalleled efficiency, reliability, and each of implementation to your aseptic environment. The Bioquell QUBE offers a rapid and reliable aseptic environment that can be used in various states of cell and gene therapy manipulation. The Bioquell QUBE Mark IV Aseptic Processing Workstation is required to be under a maintenance agreement by the agency’s Quality Management System (QMS) policy to maintain the integrity of the instrument and provide assurance that the results obtained from the samples analyzed are accurate. The contractor shall provide responsive preventative maintenance coverage to maintain laboratory operations with minimal downtime. These tests are temperature sensitive and have wide variations of shelf-life stability. Software upgrades to maintain the unit will be performed during the contract term. Essential re-calibration and recommended part replacements to ensure the Ecolab Bioquell machine is correct and functional to the original design specification. All re-calibrations are performed using multiple point methods to ensure linearity of operation.

The required Bioquell QUBE sterility testing is subject to OEM annual maintenance instructions and restrictions. This contract will provide complete service coverage of the Bioquell QUBE Mark IV Aseptic Processing Workstation for four years, which will be less expensive than purchasing periodic maintenance (PM) annually over the same 4-year period. Due to this being a highly specialized instrument and the manufacturer’s warranty requirements, only a trained service technician, such as provided by the workstation’s parent company (Ecolab) can service and repair the instrument. This vendor and their instrument were previously selected due to the QUBE’s mobility and modular design capabilities, which are ideal for the changing lab space needs of CEMB. Due to this being a specialized instrument, maintenance and repairs must be performed by an Ecolab-trained technician to perform at original levels.

Notice of Intent to Sole Source No.: 75D30125Q78560

The Contract level agreement is specifically designed to ensure that your Ecolab Bioquell equipment receives the essential scheduled preventative maintenance necessary to maintain peak efficiency and reliable operation throughout the products service life.

Only the OEM brand names (or equivalents/comparable substitute) preventative maintenance coverage and Bioquell authorized technicians and engineers will be accepted due to the compatibility with OEM testing platforms to reduce inaccurate maintenance procedures and protocols. Ecolab is the original vendor of this equipment; and as such are 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 Bioquell QUBE Mark IV Aseptic Workstation, and no additional qualified vendors were found.

Based on market research and previous acquisition history, it has been determined that Ecolab, Inc is the only OEM authorized dealer, authorized distributor, and authorized reseller for the required annual maintenance to maintain the Ecolab Bioquell Equipment (QUBE M-2 (Mk4) Serial Number 202210Q41651). Ecolab, Inc 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 Ecolab, Inc 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 4-years.

Ecolab, Inc. manufactures, sells, services, and supports the Bioquell QUBE Mark IV Aseptic Workstation 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. Ecolab, Inc 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 4-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.

mailto:xvw0@cdc.gov mailto:icx2@cdc.gov mailto:xvw0@cdc.govl mailto:icx2@cdc.gov