A15_BN_Final_Redacted.pdf

United States Department of the Interior

INTERIOR BUSINESS CENTER

Washington, DC 20240

SINGLE SOURCE DETERMINATION

UNDER THE SIMPLIFIED ACQUISITION THRESHOLD (SAT)

FOR COMMERCIAL PRODUCT OR SERVICE

AUTHORITY: RFO 12.102(a)

Solicitation No.: 140D0426Q0772

1. Contracting activity/agency.

Department of the Interior (DOI), Interior Business Center (IBC), Acquisition Services Directorate (AQD), U.S. Department of Health and Human Services, National Institutes of Health (NIH), Center for Cancer Research.

2. Description of supplies or services required to meet agency needs.

CCR requires one Miltenyi Biotec (Miltenyi) automatic magnetic cell sorting systems (autoMACS) NEO Separator and attached MACS MiniSampler. This will replace the existing Miltenyi autoMACS Pro magnetic cell separator that was purchased in 2013 and has reached its end-of-life status. Installation and training will be included in the scope of work.

Estimated value with delivery 30 days after award. Installation will occur within 30 days of delivery. The total period of performance is 60 days.

3. Identification of the single source to be solicited.

The Miltenyi autoMACS NEO Separator and attached MACS MiniSampler has an identified authorized reseller (Government Scientific Source); therefore, this acquisition will be solicited on a brand name basis utilizing the procedures in Revolutionary Federal Acquisition Regulation (FAR) Overhaul (RFO) 12.102(a). Both Miltenyi and any reseller will be able to submit a quote.

4. Basis for Single Source Determination.

The Contracting Officer has determined that only the Miltenyi autoMACS NEO Separator and attached MACS MiniSampler will meet the Government’s needs.

Brand-name requirement – The particular brand name is essential to the requirement and market research indicates similar products do not meet or cannot be modified to meet agency needs.

5. Detailed Rationale.

Replacement of the Miltenyi autoMACS Pro magnetic cell separator is essential to maintain uninterrupted cell separation capabilities and ensure continued support for Office of Science and Technology Resources (OSTR) Building 41 Flow Cytometry Core users.

The autoMACS NEO provides direct continuity with existing Miltenyi-based workflows that are widely used throughout the Core. Numerous established protocols and applications have been optimized and validated on the autoMACS platform. Transitioning to an alternative manufacturer's system would require extensive method revalidation, staff retraining, protocol redevelopment, and potential modification of ongoing research studies, resulting in increased delays, and operational disruption. Acquisition of the autoMACS Neo will ensure compatibility with existing workflows, minimize downtime, and maintain the quality, reproducibility, and efficiency of cell separation services provided by the Core.

Additionally, no other instrument platform meets all the following requirements:

1. Provide fully automated immunomagnetic cell separation for research applications with minimal user intervention and hands-free operation.

2. Support automated cell labeling and magnetic separation workflows within a single integrated platform.

3. Be capable of processing multiple samples in an automated manner to improve throughput, efficiency, and reproducibility.

4. Accommodate a variety of starting sample materials, including peripheral blood mononuclear cells (PBMCs), dissociated tissue samples, whole blood, buffy coat preparations, and bone marrow specimens.

5. Provide high-performance magnetic cell separation with reproducible recovery, purity, and viability suitable for flow cytometry and downstream cellular analyses.

6. Include integrated temperature-control capabilities for reagents and samples during automated processing to maintain sample integrity and viability.

7. Include all required reagent racks, sample holders, cooling accessories, separation columns, column substitutes, fluidics components, and consumable interfaces necessary for full instrument operation upon installation.

8. Utilize automated magnetic separation technology with disposable or replaceable column-based separation capability to support a broad range of cell isolation applications.

9. Include an integrated, manufacturer-supported automated sample handling accessory that is fully compatible with the magnetic cell separation platform and enables automated sample loading, transfer, and processing as part of established workflows.

10. Support hands-free automated sample handling and processing to increase throughput, reduce manual labor, and minimize operator-to-operator variability.

11. Maintain compatibility with existing validated immunomagnetic cell separation workflows and protocols currently used within the Core Facility, minimizing the need for method redevelopment, retraining, or revalidation.

12. Be supplied with all components, covers, hardware, and accessories required for complete installation and operation of both the separation instrument and automated sample handling system.

13. Have a compact footprint suitable for installation and operation within the existing OSTR Building 41 Flow Cytometry Core laboratory environment.

14. Be supported by the manufacturer for installation, operation, maintenance, and service to ensure long-term reliability and continuity of Core Facility operations.

15. Maintain the quality, reproducibility, and efficiency of cell separation services while minimizing operational disruption to ongoing research programs.

6. Market Research.

The Internal National Institutes of Health (NIH) sources were reviewed to determine whether this requirement could be fulfilled through existing NIH resources. No capable internal sources were identified. The review included the NIH Supply Center, an internal, not-for-profit organization that provides commonly used supplies through its warehouse and on-campus retail store, and NIH IntraMall, the NIH's internal online procurement system used by staff to acquire laboratory supplies and equipment. Neither source was able to satisfy the requirements of this acquisition. The Contracting Officer also evaluated on-line wholesale resellers for availability of the “NEO.” Only one source reviewed had an option for obtaining a quote for the autoMACS NEO, but that source was not found in the System for Award Management (SAM), so a business size was not available.

Originally anticipating this acquisition would be sole source, the Contracting Officer posted a pre-solicitation notice/notice of intent to sole source on SAM.gov on 07/09/26 with a closing date and time of 07/23/26, 2 PM Eastern Daylight Time.

submitted a quote directly to the Contracting Officer, who subsequently confirmed that Government Scientific Source was a reseller. Therefore, this acquisition will be competed as a brand name acquisition. No additional responses with different suggested equipment were received in response to the pre-solicitation notice/notice of intent to sole source.

7. Certifications.

Under the authority of RFO 12.102(a), the undersigned hereby determines the circumstances of this contract action deem only one source is reasonably available as supported herein.

Concur