JOFOC - Brainlab -signed.pdf

Attachment 1: Request for Sole Source Justification Format >SAT

VHAPG Part 806.3 OFOC Page 1 of 5 Revision: 04 Effective Date: 12/15/25 Acquisition ID#: 36C242-27-AP-0251

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C242-27-AP-0251

1. Contracting Activity: Department of Veterans Affairs, VISN 02, James J. Peters VA Medical Center (Bronx VAMC) Brainlab Maintenance Contract, 2237#:

526-27-1-041-0014.

2. Nature and/or Description of the Action Being Approved: The requested action is the approval of a sole source contract award for a new Brainlab Maintenance and Support service contract for the James J. Peters VA Medical Center (Bronx VAMC).

The procurement will establish a Firm‑Fixed‑Price (FFP) service contract covering all required OEM maintenance, software support, corrective service, and system updates for the facility’s existing Brainlab surgical navigation equipment.

The contemplated period of performance for this requirement is October 1, 2026 through September 30, 2031 (one-year base period plus four option years). The estimated total contract value is $603,443.76.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

The James J. Peters VA Medical Center, Bronx, NY, requires continued Original Equipment Manufacturer (OEM) maintenance, service, and technical support for its installed Brainlab surgical navigation and radiotherapy-related systems. These systems are integral to the facility’s radiation therapy programs and are used in the diagnosis, treatment planning, and operative guidance for veteran patients with complex cranial, spinal, oncologic, and trauma-related conditions.

The required maintenance and support services include, but are not limited to:

• OEM-certified preventive maintenance at intervals established by Brainlab, ensuring equipment accuracy, calibration integrity, software stability, and compliance with OEM specifications.

• Unlimited OEM corrective maintenance, including parts, labor, repairs, and hardware component replacements as needed to restore equipment to full operational status with minimal downtime.

• Software support, including security patches, system updates, firmware upgrades, and access to proprietary Brainlab software platforms necessary for surgical navigation and treatment workflows.

• Remote technical support and troubleshooting, available 24/7 from OEM-authorized engineers familiar with proprietary interfaces, diagnostic tools, and clinical configurations specific to the Bronx VAMC environment.

VHABRXFernaL1 Sticky Note Accepted set by VHABRXFernaL1

VHAPG Part 806.3 OFOC Page 2 of 5 Revision: 04 Effective Date: 12/15/25 Acquisition ID#: 36C242-27-AP-0251

• On-site OEM technician response when remote remediation is insufficient, including expedited dispatch for critical system failures impacting patient care.

• Access to OEM documentation, proprietary tools, and protected system configurations, necessary to maintain the equipment safely, reliably, and in accordance with FDA regulations governing medical device servicing.

Brainlab equipment contains proprietary hardware, software, and firmware which may only be accessed, modified, or calibrated by Brainlab or Brainlab-authorized partners. Third-party vendors do not possess OEM authorization, required specialized diagnostic software, parts, or system passwords. Attempted third-party service would risk system failure, miscalibration, patient safety hazards, and regulatory non-compliance.

This maintenance and support contract is essential to guarantee functionality of the Brainlab navigation systems, avoid clinical downtime, and ensure continuation of critical surgical services for Bronx VAMC patients. Any lapse in coverage would result in unacceptable delays or cancellation of surgeries requiring image-guided precision.

4. Statutory Authority Permitting Other than Full and Open Competition:

( X ) (1) Only One Responsible Source and No Other Supplies or Services Will

Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by

RFO 6.103-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by RFO 6.103-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by RFO 6.103-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by RFO 6.103-4

( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by RFO 6.103-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by RFO 6.103-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by RFO 6.103-7;

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

The Department of Veterans Affairs, Bronx VA Medical Center, requires continued support, maintenance, and compatibility assurance for its existing Brainlab OEM neurosurgical and image-guided systems. In accordance with RFO 6.103-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements, contracting without providing for full and open competition is appropriate when the required supplies or services are available from only one

VHAPG Part 806.3 OFOC Page 3 of 5 Revision: 04 Effective Date: 12/15/25 Acquisition ID#: 36C242-27-AP-0251 responsible source and no other type of supplies or services will meet the agency’s needs.

The Bronx VA relies on Brainlab’s proprietary technology for neurosurgical navigation, software integrations, clinical workflows, and hardware components that are uniquely configured and serialized to Brainlab’s OEM specifications. Brainlab retains exclusive rights to its system architecture, software code, diagnostic tools, proprietary updates, security patches, and system-level integrations necessary to keep clinical equipment functioning safely and effectively. As a result, maintenance, software updates, and technical support for Brainlab Elements/ODM products cannot be performed, replicated, or replaced by any other vendor without violating OEM intellectual property protections or compromising patient safety.

Market research confirms that Brainlab is the sole entity capable of providing authorized OEM maintenance, updates, and support for its integrated neurosurgical platforms. Other vendors do not possess OEM authorization, proprietary software access, or certified technical capability to perform required services. Attempting to obtain these services from an unauthorized source would risk system degradation, void warranties, jeopardize accreditation compliance, and compromise continuity of patient care within critical surgical operations.

This justification is based on the unique nature of the OEM equipment already in place at the Bronx VA Medical Center and not on lack of advance planning or concerns related to fund availability, consistent with RFO 6.103(b). Brainlab’s exclusive ownership of technical data, software rights, and maintenance protocols unequivocally demonstrates that no other responsible source can meet the Government’s need for safe, effective, and compliant system operation. Therefore, use of the statutory authority under RFO 6.103-1 is fully justified to ensure uninterrupted support for Brainlab systems critical to patient care.

6.Description of Efforts Made to ensure that offers are solicited from as many potential sources as possible (including whether a notice was or will be publicized as required by RFO Part 5 and, if not, which exception under RFO Part 5 applies): Consistent with the requirements of RFO Part 5 and RFO 6.104-1(a)(6), the Government issued a public Intent to Sole Source notice on SAM.gov from June 30, 2026 through July 6, 2026, inviting all interested vendors to identify their capability to meet the requirement. The SAM synopsis clearly stated that the Bronx VA Medical Center sought support and maintenance for existing Brainlab OEM equipment and requested any responsible source to provide documentation—including OEM authorization—that would demonstrate the capability to fulfill this requirement.

During the solicitation period, no responses were received from any vendors. This absence of capability statements or expressions of interest was reviewed and validated https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-5 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-5 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-5

VHAPG Part 806.3 OFOC Page 4 of 5 Revision: 04 Effective Date: 12/15/25 Acquisition ID#: 36C242-27-AP-0251 through the formal market-research documentation contained in the Market Research which confirms that the SAM.gov notice generated zero respondents, and therefore did not identify any alternative manufacturers, service providers, or OEM-authorized entities beyond Brainlab and its exclusive federal distributor.

6. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: SAM.gov notices for similar Brainlab maintenance and software‑support procurements at other VA medical centers demonstrate comparable price ranges and multi‑year service structures for OEM‑authorized support. These procurement records confirm that Brainlab system support is consistently priced within predictable federal ranges for proprietary medical‑technology maintenance contracts. Published contract postings note estimated budgets ranging from $500,000 to $2,500,000 for five‑year Brainlab support contracts, depending on configuration and service level. These independent estimates provide a benchmark confirming that the anticipated Bronx VA pricing is within the standard federal pricing profile for Brainlab systems.

7. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

• No capable SDVOSBs or VOSBs exist under NAICS 811210 (VetCert/SBS) for this sole source requirement.

• No responses were received to the SAM.gov Intent to Sole Source notice.

• OEM exclusivity limits competition: Brainlab and its authorized federal distributor are the only parties able to provide compliant maintenance/service.

• No federal supply schedules or contract vehicles offer Brainlab OEM maintenance.

• Prior VA awards substantiate sole-source procurement for Brainlab systems.

8. Any Other Facts Supporting the Use of Other than Full and Open Competition:

Not Applicable

9. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Lovell Government Services 223 West Gregory St Pensacola FL 32502 United States Phone 850.684.1867 Fax 850.254.9853

10. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: Not applicable

VHAPG Part 806.3 OFOC Page 5 of 5 Revision: 04 Effective Date: 12/15/25 Acquisition ID#: 36C242-27-AP-0251

11. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Laura Fernandez Date Biomedical Engineer Bronx VA Facility

12. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Tevia Mastykarz Date

Contracting Officer

NCO 2

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $900K): I certify the justification meets requirements for other than full and open competition.

Joseph Cellino Date Contracting Officer/ Branch Chief

NCO 2

https://dvagov.sharepoint.com/sites/vhapromanual/SitePages/VHAPM-Part-806.3.aspx