36C24126Q0844_1.docx

SUBJECT*

523-26-4-1467-0076 Sun Nuclear QA 4 (VA-26-00078780) Intent to Sole Source

GENERAL INFORMATION

SET-ASIDE

150 SOUTH HUNTINGTON AVE

BOSTON MA

CONTACT INFORMATION

VAMC Manchester

718 Smyth Road Manchester NH 03104

POINT OF CONTACT*

Contract Specialist Kyle McCrory kyle.mccrory@va.gov 703-935-6380

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

DESCRIPTION

Presolicitation Notice Presolicitation Notice Daily QA 4 Pro Wireless System for Jamaica Plain VAMC

Presolicitation Notice

Brand Name Only FAR 11.105 / FAR 13.106-1(b)(1)(i) – Open Market

GENERAL INFORMATION

SET-ASIDE

VAMC Boston

150 SOUTH HUNTINGTON AVE

CONTACT INFORMATION

Network Contracting Office 1 (NCO 1) Contracting Officer (90C)

718 SMYTH ROAD

MANCHESTER, NH 03104-7007

POINT OF CONTACT*

Contract Specialist Kyle McCrory kyle.mccrory@va.gov

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

DESCRIPTION

[36C24126Qxxxx] INTENT TO SOLE SOURCE: BRAND NAME ONLY FAR 11.105 / FAR 13.106‑1(b)(1)(i): ONE‑TIME PROCUREMENT OF SUN NUCLEAR DAILY QA 4 PRO SYSTEM, PLUS ACCESSORIES & TRAINING.

INTENT TO SOLE SOURCE FOR PURCHASE REQUISITION: This is not a request for competitive proposals. This is not a solicitation or request for offers. No solicitation package is available, and telephone requests will not be honored.

The Department of Veterans Affairs VA Medical Center intends to award a one‑time, Firm Fixed Price, Sole‑Source contract for a SUN NUCLEAR DAILY QA 4 PRO SYSTEM, PLUS TRAINING for VAMC Boston. This requirement is for a Brand Name Only Sole Source procurement from the Original Equipment Manufacturer (OEM), Sun Nuclear Corporation (a Mirion Medical Company).

The Daily QA 4 Pro systems are the only brand/models that will meet the need at VAMC Boston. This requirement replaces an ageing QA3 system. The Daily QA 4 Pro direct replacement provides the government with the best value, ensuring full system integration, compatibility (fit, form, and function), and maintains uninterrupted clinical workflow and safety compliance.

Sun Nuclear has confirmed that the Sun Nuclear Daily QA 4 Pro System Plus Training platform is exclusive and proprietary to Sun Nuclear, the large business (LB) OEM. All repairs, software license renewals, phone and web‑based support, service loaners, and regular product updates are peculiar to the OEM who owns all patents, licenses, and software publishing rights. A Sole Source Letter has been provided by the OEM confirming that Sun Nuclear is the only authorized source capable of supplying the Daily QA 4 Pro, its required accessories, and related support services.

VAMC Boston is incorporating the Sun Nuclear Daily QA 4 Pro System into the Radiation Oncology quality assurance workflow, VHA Boston has standardized to the workflow platform. The Sun Nuclear Daily QA 4 fully integrates with and is fully compatible with the existing QA workflow platform. The Radiation Oncology Service relies on established daily beam‑quality analysis, independent verification, TG‑142 compliant QA processes, and integration with existing Sun Nuclear QA infrastructure. The Daily QA 4 Pro system is proprietary to Sun Nuclear Corporation, and no other linear‑accelerator QA system provides the same fit‑form‑function performance or supports the service’s standardized clinical procedures. The Daily QA 4 Pro is the only verification system that meets the facility’s technical, clinical, and documentation requirements and supports integration with existing workflow and equipment.

The authority for applying the Simplified Procedures for Commercial Items of FAR 12 is 41 U.S.C. 1901. The brand‑name statute is implemented by restricting competition on this procurement via FAR 11.105 and FAR 12.102-1(a). Consistent with FAR 11.105 (brand‑name) and RFO 12.102, this procurement will be restricted to the brand‑name Sun Nuclear Daily QA 4 Pro based on “one reasonably available source.” The Daily QA 4 Pro platform, including software licenses and data rights, is proprietary and exclusive to the OEM; all support, updates, and integration services are performed solely by Sun Nuclear.

The intent is to procure these supplies on a sole‑source basis. No solicitation will be posted to Contract Opportunities. The primary North American Industry Classification System (NAICS) code is 334517: Electromedical and Electrotherapeutic Apparatus Manufacturing. The most current Business Size Standard for this NAICS is 1,000 employees.

Capable parties may identify their interests and authorization to respond to this requirement by September 24th at 11:00 AM (EDT).

A determination by the Government not to compete for this proposed award upon response to this notice is solely within the discretion of the Contracting Officer.

Please submit any follow-ups or questions to:

Contracting Specialist: Kyle McCrory: kyle.mccrory@va.gov Please copy Contracting Officer: Deidra Thomas: deidra.thomas@va.gov on any email communications at:

DEPARTMENT OF VETERANS AFFAIRS

Justification for Sole Source Awards IAW FAR 12.102(a) For Over Micro-Purchase Threshold but Not Exceeding the Simplified Acquisition Threshold

Acquisition Plan Action ID: 36C241-26-AP-3966

1. Contracting Activity: Department of Veterans Affairs, VISN 01, VISN1 VAMC Boston Medical Center.

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The equipment procurement includes Sun Nuclear Daily QA 4 Pro - Wireless, DQA4 adapter plate for 6DOF couches, and Customer Web-Based Training for use by qualified and trained Radiation Oncology professionals at the Boston VA Medical Center. These systems will enable daily beam quality analysis, independent verification of linear accelerator beam delivery errors, and compliance with TG 142 safety standards for patient treatment. The wireless option eliminates cable connections for ease of use, and the adapter plate ensures proper device positioning for advanced couch capabilities. The web-based training provides up to 4 hours of in-depth product instruction by a qualified Sun Nuclear representative.

Equipment Information:

· Qty 1 — Daily QA 4 Pro - Wireless system, including:

Ion chamber and diode array for completing daily beam quality analysis in one measurement Independent verification to efficiently detect linac beam delivery errors as the final safety check before daily patient treatments Compliant with TG 142 Wireless option eliminates cable connections for ease of use

· Qty 1 — DQA4 adapter plate for 6DOF couches, including:

Adapter plate introduces known deviations in device positioning for 6DOF capable couches

· Qty 1 — Customer Web-Based Training, including:

Training voucher for remote web-based product training Includes up to 4 hours of in-depth product training by a qualified Sun Nuclear representative for one Sun Nuclear product Additional web-based training can be purchased for additional Sun Nuclear products Allow 4 weeks minimum for scheduling

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The Radiation Oncology Service at VA Medical Center Boston requires a Sun Nuclear Daily QA 4 Pro system, DQA4 adapter plate for 6DOF couches, and web-based training. The service has standardized to Sun Nuclear QA platforms for daily linear accelerator quality assurance. This requirement replaces an ageing QA3 system. The Daily QA 4 Pro direct replacement provides the government with the best value, ensuring full system integration, compatibility (fit, form, and function), and maintains uninterrupted clinical workflow and safety compliance. The Daily QA 4 Pro system is peculiar in its capability to provide daily beam quality analysis in a single measurement, independent verification of linac beam delivery errors, and compliance with TG 142 standards for patient treatment. The DQA4 adapter plate enables proper device positioning for advanced couch capabilities. These features are essential for the Radiation Oncology Service to validate beam safety and performance for Veterans.

Unique Characteristics Peculiar to Sun Nuclear (FAR 11.105 / FAR 13.106‑1(b)(1)(i)):

The Daily QA 4 Pro system is a specialized QA instrument that provides:

· Ion chamber and diode array for daily beam quality analysis in one measurement

· Independent verification to efficiently detect linac beam delivery errors as the final safety check before daily patient treatments

· Compliance with TG 142

· DQA4 adapter plate introduces known deviations in device positioning for 6DOF capable couches

· Automated reporting and integration with Sun Nuclear QA infrastructure None other than the QA 4 provide QA accuracy, proprietary adapter plate architecture, wireless operation, and the full-suite feature testing required by the service.

Required Integration with Existing QA Systems: The Boston Medical Center has standardized to Sun Nuclear QA workflows, including daily TG 142 procedures, automated reporting, and documentation formats compatible with clinical integration. Daily QA 4 Pro systems are peculiar in compatibility, fit, form, and function with these existing processes. The QA 4 devices are a direct replacement for the QA 3 devices that are being retired. The QA 4 directly integrates with the Sun Nuclear QA software, supporting automated test-result exports in place at VHA Boston. Alternatives cannot be considered due to the need for uninterrupted diagnostic consistency.

Sun Nuclear confirms that the Daily QA 4 Pro product line supports the full suite of radiation oncology QA used at Boston, enabling unified workflows, measurement repeatability, and correct clinical documentation. No other manufacturer offers equivalent compatibility with the standardized QA and safety systems deployed at the facility.

FAR 12.102‑1(a) Determination: Only One Reasonably Capable Source: A Sole Source Letter from the OEM, Sun Nuclear Corporation, establishes that the OEM is the only source capable of supplying the Daily QA 4 Pro system to the Government. The Sun Nuclear QA 4 is the only reasonably capable source who can meet the VA’s minimum requirements due to direct system integration, reliable performance, safety, workflow efficiency, and full clinical functionality (FAR 11.105). The Daily QA 4 Pro fulfills these requirements as the only device providing the full suite of daily linear‑accelerator quality assurance functions required by the Radiation Oncology Service. No reseller, distributor, or third‑party vendor is authorized to provide this equipment to the Federal Government. Per the OEM’s Sole Source Letter, Sun Nuclear is the only capable and eligible source for this requirement.

4. Description of market research conducted and results or statement why it was not conducted: Market research conducted pursuant to FAR Part 10 and VAAR 810.001‑70 indicates that the Sun Nuclear Daily QA 4 Pro system is peculiar to one manufacturer, Sun Nuclear Corporation. This equipment fulfills the clinical and technical needs of the Boston VA Medical Center Radiation Oncology Service due to its specific daily beam‑quality verification capabilities (ion chamber and diode array measuring in one acquisition, independent linac delivery‑error detection, TG‑142 compliance) and integration into existing Sun Nuclear QA workflows.

Market research confirms that only Sun Nuclear’s Daily QA 4 Pro meets the specific clinical, technical, and workflow requirements of Boston. The Sun Nuclear platform is proprietary to Sun Nuclear Corporation, and no other manufacturer offers the same integration of daily QA, wireless operation, adapter plate compatibility, and automated reporting used by the service. These capabilities are unique and highly specialized, ensuring the level of diagnostic accuracy required by radiation oncology professionals.

Market Research Findings:

· VFCP (Veterans First Contracting Program): VetCert/SBA DSBS searches identified no SDVOSB or VOSB distributors authorized to sell or support the Daily QA 4 Pro system. Sun Nuclear is a Large Business, and no Veteran‑owned firms hold OEM authorization for this product.

· QA 4 Proprietary and Exclusive to the LB OM: Sun Nuclear, the OEM, is the sole source for the Daily QA 4 Pro and DQA4 adapter plate. No 3rd‑party distributor or reseller is authorized to sell or support these items. The Sole Source Letter verifies that the company exclusively manufactures, distributes, services, and updates the Daily QA 4 Pro product line. There are no authorized distributors other than the OEM.

· NAC (National Acquisition Center): The Sun Nuclear Daily QA 4 Pro is not available on the NAC.

· GSA Advantage: A GSA Advantage search returned zero results for the Daily QA 4 Pro, DQA4 adapter plate, or related training.

· GSA e‑Library: There are no FSS contracts carry the Daily QA 4 Pro system.

· DLA ECAT: The Daily QA 4 Pro system is not carried on ECAT.

· SCMC/ADDS Up: SCMC/ADDS Up review showed that the Daily QA 4 Pro has been historically offered open‑market.

· SAC Search: Search of the SAC Contract Catalog identified no SAC NX or EQ‑series contracts covering Sun Nuclear products.

· FPDS/SAM: FPDS/SAM searches confirmed that previous Government purchases of Sun Nuclear Daily QA equipment were open‑market transactions direct from the OEM.

· FAR 12.102-1(a): Market research and the Sole Source Letter support that there is only “one reasonably available source.”

· VAAR 819.7006/819.7008: Because the Rule of Two cannot be met and no OEM‑authorized SDVOSB/VOSB source exists, a set‑aside cannot be applied. An SDVOSB sole‑source path is not applicable because the OEM is a Large Business. The brand‑name requirement is justified via FAR 11.105 and FAR 12.102‑1(a): one reasonably available source.

NMR: Market research conducted IAW FAR Part 10 and VAAR 810.001‑70 confirms that only one OEM‑authorized source is reasonably available to supply the Sun Nuclear Daily QA 4 Pro system. Sun Nuclear Corporation, the OEM, is a Large Business. No SDVOSB or VOSB distributors are authorized, certified, or permitted to sell or support this brand‑name medical device. Because no SDVOSB/VOSB can meet OEM‑authorization requirements or the technical integration needs of the Boston VA Radiation Oncology Service, VAAR 819.7003(d) and VAAR 819.7008 do not apply, and the Rule of Two (38 U.S.C. 8127(d)) cannot be met.

The Nonmanufacturer Rule (13 CFR 121.406(b)) is satisfied: Sun Nuclear exclusively manufactures the Daily QA 4 Pro system and its required components. A Class NMR Waiver exists for NAICS 334517, which covers irradiation apparatus and linear‑accelerator quality‑assurance equipment, ensuring full compliance with NMR and subcontracting limitations.

Because no small‑business resellers or Veteran‑owned firms are OEM‑authorized, and the Daily QA 4 Pro is available from one sole responsible source, the requirement meets FAR 12.102‑1(a) and supports an open‑market, brand‑name sole‑source award to Sun Nuclear Corporation under FAR 11.105

Recommendation: The recommendation is for an Open Market Sole Source award to Sun Nuclear Corporation, the OEM and only authorized source for the Daily QA 4 Pro system, DQA4 adapter plate, and web‑based training. The Rule of Two cannot be met. Per the Class NMR Waiver for NAICS 334517 and based on OEM confirmation that Sun Nuclear is the sole authorized supplier, the Daily QA 4 Pro system is peculiar to one manufacturer—Sun Nuclear—and is available through only one reasonably capable source. The brand‑name sole‑source determination is authorized via RFO 12.102‑1(a): “one reasonably capable source.

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