NOI JOFOC-NHP Cage and Rack Washer.pdf

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health - Office of Research Services / Division of Veterinary Resources

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION (JOFOC)

Prepared in accordance with FAR 6.303 and FAR 6.302-1

Acquisition Title Large Capacity Nonhuman Primate Cage and Rack Washer

Requiring Activity NIH, Office of Research Services, Division of Veterinary Resources

(DVR)

Contracting Activity National Institutes of Health, Office of Acquisitions

Proposed Contractor Tecniplast USA, Inc.

Proposed Contract Type Firm Fixed Price

Estimated Value $400,000 (estimated value)

Statutory/Regulatory Authority

41 U.S.C. 3304(a)(1); FAR 6.302-1

NAICS Code / PSC 339999 / 6640

1. Background and Purpose

The National Institutes of Health (NIH), Office of Research Services (ORS), Division of Veterinary Resources (DVR), requires replacement of an end-of-life large-capacity, pass-through cage and rack washer supporting nonhuman primate (NHP) housing operations at the NIH main campus, Bethesda, Maryland. This JOFOC documents the basis for proceeding without full and open competition and supports award to Tecniplast USA, Inc. for the Atlantis EVO XL system.

The existing unit has been in continuous service for approximately twenty (20) years, has exceeded its expected service life, and is experiencing increasingly frequent mechanical failures. It is projected to remain operational for approximately six (6) months, after which failure would immediately impact cage wash throughput, animal housing sanitation, research continuity, and regulatory compliance under the Guide for the Care and Use of Laboratory Animals, the Animal Welfare Act (AWA), and AAALAC International accreditation standards. This acquisition has been designated mission-critical in accordance with HHSAR 304.7301.

2. Description of the Supplies/Services Required

DVR requires the procurement, delivery, installation, commissioning, validation, and operator training for a commercial-grade, pass-through cage and rack washer capable of processing NHP cages, transport equipment, racks, feeders, enrichment devices, and ancillary husbandry equipment on a daily basis. Full minimum technical requirements are set forth in the Statement of Work (SOW). Of these requirements, two are mission-essential and dispositive to this justification:

• HVAC-integrated exhaust: The DVR NHP cage wash room was designed and built to exhaust through the facility's existing HVAC system and has no dedicated roof exhaust penetration or independent exhaust duct pathway.

• Processing cycle time of approximately 20 minutes: Required to resolve the operational and scheduling inefficiencies caused by the existing unit's approximately 45-minute cycle time and to meet DVR's daily NHP husbandry throughput needs.

3. Statutory Authority

FAR 6.302-1 — Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements (41 U.S.C. 3304(a)(1)).

4. Rationale / Unique Source Qualifications

Market research (see Market Research Report identified five commercial manufacturers of large-capacity, pass-through cage and rack washers generally suited to laboratory animal facilities:

Tecniplast USA, Getinge USA, STERIS Corporation (Amsco), Allentown Inc., and Alternative Design Manufacturing and Supply. All five generally offer systems with baseline features common to the category (stainless steel construction, steam heating, dual wash tanks, touchscreen controls, remote diagnostics, 480V/3-phase compatibility).

Technical evaluation against DVR's two mission-essential requirements, however, identified only one responsive source:

• HVAC-integrated exhaust: Only the Atlantis EVO XL was confirmed, through published specifications and direct vendor confirmation, to be designed for integration into a building's existing HVAC system without an independent, dedicated exhaust duct or roof penetration. The other four manufacturers' systems all require an independent exhaust pathway terminating at the building exterior.

• Cycle time: Only the Atlantis EVO XL was confirmed to achieve a processing cycle time of approximately 20 minutes for large NHP rack loads. The comparable models offered by the other four manufacturers have materially longer published or vendor-confirmed cycle times.

No source other than Tecniplast USA, Inc. was identified that satisfies both requirements. Because these requirements arise from (a) fixed, non-relocatable facility infrastructure, and (b) the operational needs of daily animal care for an active NHP colony, they cannot be waived, relaxed, or met through a functionally different system design without imposing substantial additional cost, schedule delay, and risk of disruption to animal welfare, sanitation compliance, and research continuity. Selecting an alternative manufacturer would require the Government to separately design, fund, and construct significant structural modifications — roof penetration, new exhaust ductwork through occupied building space, and associated mechanical/structural engineering — before installation could occur, a timeline incompatible with the existing unit's approximately six-month remaining operational life.

5. Efforts to Obtain Competition / Actions Taken to Solicit Offers from as Many Sources as Practicable

Market research under FAR Part 10 included review of published manufacturer specifications, vendor websites, direct vendor/manufacturer technical inquiries, SAM.gov registration data, GSA Federal Supply Schedule listings, and prior comparable Government acquisitions. Five manufacturers were identified and technically evaluated, as described in Section 4.

Prior to award, NIH will post a notice of intent to sole source on SAM.gov in accordance with FAR

5.201 and 6.302-1 for the regulatory posting period, inviting any other potential source to submit, in writing, a demonstration of its capability to meet the stated requirements — including HVAC-integrated exhaust compatibility and the required processing cycle time. Any timely, credible response received will be evaluated, and the sole-source determination will be reassessed accordingly before proceeding to award.

6. Determination of Fair and Reasonable Cost

In the absence of price competition, the Contracting Officer will determine that the negotiated price is fair and reasonable through cost or price analysis under FAR 15.404-1, including comparison to the Independent Government Cost Estimate (IGCE) developed from market research and vendor quote data, any available historical/published pricing for comparable Tecniplast systems, and, if warranted, a request for cost or pricing data (certified or otherwise) under FAR 15.403. This determination and its supporting analysis will be documented in the contract file prior to award.

7. Market Research Summary

Market research is documented in full in the Market Research Report, NHP Rack Washer incorporated by reference. That report concludes that this requirement is not appropriate for full and open competition and recommends sole-source award to Tecniplast USA, Inc. under FAR 6.302-1, consistent with the findings summarized above. Market research also confirmed that none of the identified manufacturers qualifies as a small business under NAICS 339999; accordingly, a small business set-aside is not recommended.

8. Other Facts Supporting the Justification

• Continuing to operate or repeatedly repair the existing 20-year-old unit is not a viable alternative given its escalating failure rate and imminent (approximately six-month) end of operational life.

• DVR has limited redundant cage wash capacity, so any gap between failure of the existing unit and installation of a replacement would directly and immediately affect animal welfare, sanitation, and research continuity.

• The Atlantis EVO XL simultaneously resolves both the facility exhaust-compatibility constraint and DVR's throughput/cycle-time deficiency, an outcome not achievable with any other identified system without incurring the cost and schedule impact of major facility construction.

9. Listing of Sources Expressing Written Interest

None to date. Any written expressions of interest received in response to the FAR 5.201 synopsis will be logged in the contract file and addressed per Section 5.

10. Actions to Remove Barriers to Competition for Future Acquisitions

The barrier to competition is a fixed physical characteristic of the facility (absence of an independent exhaust pathway), not a specification drafted to favor a particular source. DVR will consider, as part of separate long-term facility planning independent of this acquisition, the feasibility and cost of constructing a dedicated, independent exhaust pathway for the NHP cage wash room. If completed prior to the next replacement cycle for this equipment, such a modification would remove the HVAC-integration constraint and allow a broader range of commercial systems to compete for any future replacement. For any future acquisition, the agency will continue to draft requirements in performance-based, non-proprietary terms to the maximum extent consistent with its actual minimum needs.

11. Technical/Requirements Certification

I certify that this justification is accurate and complete to the best of my knowledge and belief, and that the technical requirements stated herein reflect DVR's actual minimum needs.

12. Contracting Officer's Certification

I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

13. Legal Sufficiency Review

14. Approval