S03 36C24126Q0813 Intent o Sole Source Heidelberg HEYEX2 Exp 09-23-26.docx

Presolicitation Notice Presolicitation Notice

GENERAL INFORMATION

SET-ASIDE

VAMC Providence

830 Chalkstone Avenue

CONTACT INFORMATION

Network Contracting Office 1 (NCO 1) Contracting Officer (90C) 1 VA Center Augusta ME 04330

POINT OF CONTACT*

Carlos Ortiz carlos.ortiz3@va.gov

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

DESCRIPTION

36C24126Q0813 INTENT TO SOLE SOURCE: 819.7008 SDVOSB/BRAND ONLY FAR 12.102-1(a): ONE-TIME PROCUREMENT OF HEIDELBERG HEYEX2 IMAGE MANAGEMENT PLATFORM SYSTEM

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 Providence intends to award a one-time, Firm Fixed Price Sole-Source contract for a HEIDELBERG HEYEX2 IMAGE MANAGEMENT PLATFORM SYSTEM for VAMC Providence.

This is to be a Name Brand Only Sole Source procurement from the sole OEM (Original Equipment Manufacturer)-authorized, SDVOSB distributor L1 Enterprises LLC. The Heidelberg Imaging Management Platform is the only brand of Image Management Platform that will meet the need at VAMC Providence.

VAMC Providence requires procurement and installation of the Heidelberg HEYEX 2 Image Management Platform to operate and integrate the VA-owned Heidelberg Spectralis® ophthalmic imaging system. The action includes server move, extended cache backend, software protector (USB), HP Z2 G9 workstation, TB3 conversion kit, OEM-trained installation, onsite training, and warranty support.

The Heidelberg HEYEX 2 Image Management Platform is proprietary and exclusive to the small business (SB) OEM Heidelberg Engineering, Inc. A Letter of Authorization has been provided by the large business OEM designating L1 Enterprises LLC as the sole authorized SDVOSB distributor to the Government for the Heidelberg HEYEX2 Image Management Platform System.

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 12.102-2(a): One reasonably available source. The SDVOSB Sole Source is authorized by VAAR 819.7003(d) and VAAR 819.7008. There is an NMR Waiver for this diagnostic and imaging device (85 Federal Register 13692).

The intent is to procure these services on a sole-source basis. No solicitation will be posted to Contract Opportunities. The primary North American Classification System Code (NAICS) is 334111: Electromedical and Electrotherapeutic Apparatus Manufacturing. The most current Business Size Rating for this NAICS is 1250 employees.

Capable parties may identify their interests and authorization to respond to this requirement by September 23rd 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: Carlos Ortiz: carlos.ortiz3@va.gov Please copy Contracting Officer: Deidra Thomas: deidra.thomas@va.gov on any email communications at:

STATEMENT OF WORK

VAMC PROVIDENCE

HEIDELBERG HEYEX2 IMAGE MANAGEMENT PLATFORM: COMPUTER/SERVER/SOFTWARE PLATFORM & PERIPHERALS

1.0 INTRODUCTION: The Department of Veterans Affairs (VA) Providence Health Care Center requires the procurement, delivery, installation, training, and warranty support for one (1) Heidelberg Engineering HEYEX 2 image management platform and associated components. The contractor shall furnish all labor, materials, equipment, tools, transportation, and supervision necessary to complete installation and integration of the HEYEX 2 system in compliance with VA technical, security, and infection control standards.

2.0 SCOPE: The contractor shall provide, deliver, install, configure, and test the Heidelberg Engineering HEYEX 2 system and all associated hardware, software, accessories, and integration components. Work includes turnkey installation, system commissioning, clinician training, Clinical Engineering familiarization, warranty coverage, records management compliance, and removal of waste and trade‑in equipment as applicable.

3.0 REQUIREMENTS

3.1 Equipment

The contractor shall provide one (1) complete Heidelberg Engineering HEYEX 2 system, including the following components:

· HEYEX 2 Server Move

· HEYEX 2 Extended Cache Management Backend

· Software Protector USB (Duplicate Dongle H2E‑28079)

· HP Z2 G9 Workstation (specifications: i7‑14700 20‑core 2.1/5.4 GHz, 64GB RAM, 1TB SSD, Windows 11 Pro, RTX A2000 12GB, Serial ATA/600, NVMe Controller, vPro, DisplayPort, Gigabit Ethernet, USB ports, MK650 Keyboard/Mouse, Quiet Touch, 24 Shortcut Keys, Multi‑Device Connectivity, Dual‑Band Wi-Fi T2U Plus with 5dBi antenna)

· TB3 Conversion Kit

· All labor required for installation, configuration, and testing

4.0 SALIENT CHARACTERISTICS

4.1 HEYEX 2 Server Move

The system shall:

· Support secure, scalable PACS operations and EMR/HIS integration

· Operate on Windows Server environment with SQL Server/SAP‑based DBMS

· Support required CPU, RAM, storage, and virtualization for PACS workloads

· Utilize low‑latency, secure network architecture supporting HL7 and DICOM

4.2 Extended Cache Management Backend

The backend system shall:

· Provide optimized caching for rapid record/image retrieval

· Support background image processing

· Allow synchronized multisite data exchange

· Automate backups, version control, and software distribution

4.3 Software Protector USB

A hardware security dongle shall:

· Provide physical authentication required for Heidelberg software operation

· Enable secure, authorized system execution

4.4 HP Z2 G9 Tower Workstation

The workstation shall:

· Support AI‑augmented applications, rendering, real‑time ray tracing

· Operate without thermal throttling during high computation workloads

· Include advanced peripherals and dual‑band high‑gain Wi-Fi capability

4.5 TB3 Conversion Kit

The kit shall:

· Support Heidelberg multimodal imaging platform interoperability

· Be installed only by manufacturer‑trained personnel

5.0 PLACE OF PERFORMANCE

Department of Veterans Affairs VA Providence Health Care Center 830 Chalkstone Avenue Providence, RI 02908

6.0 INSTALLATION REQUIREMENTS

The contractor shall:

a. Provide all labor, materials, tools, and equipment for installation.

b. Coordinate implementation meetings with the COR as needed.

c. Coordinate installation dates in advance with the COR.

d. Ensure all personnel comply with VA Security and Police requirements.

e. Provide manufacturer‑trained personnel; submit resumes/certifications upon request.

f. Ensure personnel comply with PPE and infection control requirements.

g. Provide estimated downtime; if installation exceeds 24 hours, extend warranty equal to downtime.

h. Safely remove and dispose of trade‑in equipment, if applicable.

i. Remove all packing material and installation waste.

7.0 TRAINING

7.1 Clinical User Training

Contractor shall provide onsite training including:

· Technical training

· Operational training

· Administrative training

· Hardware/software troubleshooting

· Competency assessments Training must occur Monday–Friday, 7:00 AM–3:30 PM.

7.2 Clinical Engineering Training

Training shall include:

· Technical overview of system components

· Preventative maintenance procedures

· Troubleshooting and general maintenance instruction

8.0 INSPECTION AND ACCEPTANCE

a. Contractor shall conduct joint inspection with the COR upon delivery.

b. Contractor shall provide completion dates for punch list items and replacement components.

c. COR shall verify all work is satisfactorily completed. Disputes are resolved by the Contracting Officer.

9.0 WARRANTY

a. Contractor shall provide a one‑year manufacturer’s warranty on all parts and labor.

b. Warranty must include all travel and shipping for warranty repairs.

10.0 WORK SCHEDULE & TIMELINES

· Work shall be completed in a single visit (single or multiple days).

· Delivery shall not exceed installation by more than 20 days.

· Installation must be immediately followed by clinical user training and go‑live support.

· VistA CPRS integration must be completed within 90 days of award.

11.0 SPECIAL WORK REQUIREMENTS

Contractor shall comply with:

· VA Infection Control Risk Assessment (ICRA) requirements

· VA security, privacy, and safety policies

12.0 PROPERTY DAMAGE

Contractor shall:

· Prevent damage to government property

· Report damage immediately

· Replace or repair damaged items at no cost to the Government

· Use like materials and obtain CO approval

13.0 SITE REGULATIONS

Contractor employees shall:

· Wear visible identification

· Park only in authorized areas

· Comply with smoking, radio, and cellular phone restrictions

· Comply with VA Police inspections of toolkits/containers

· Adhere to all federal facility rules

14.0 OSHA BLOODBORNE PATHOGENS STANDARD

Contractor shall maintain:

· Employee education on risks

· Policies/procedures reducing exposure risk

· Counseling/treatment mechanisms post‑exposure

· PPE including gloves, gowns, masks, protective eyewear, and mouthpieces

15.0 INFORMATION SECURITY REQUIREMENTS

Contractor shall comply with VA information security policies, privacy standards, and applicable federal regulations.

16.0 RECORDS MANAGEMENT

Contractor shall comply with 44 U.S.C. Chapters 21, 29, 31, 33; FOIA (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Parts 1222 & 1228. Key requirements include:

· Government retains full ownership of all records/data.

· Contractor may not create unauthorized records using Government equipment.

· No retention, reuse, sale, or dissemination of Privacy Act–protected data.

· No removal or destruction of records without CO approval.

· Protection of records against damage, alienation, or loss.

· Subcontractor arrangements require prior CO approval.

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 12.102-1(a) > Micro-Purchase Threshold - Not Exceeding the Simplified Acquisition Threshold

Acquisition Plan Action ID:36C241-26-AP-4032

1. Contracting Activity: Department of Veterans Affairs, NCO 01, in support of VAMC Providence RI 830 Chalkstone Avenue, Providence, RI 02908.

2. Brief Description of Supplies/Services & Intended Use / Estimated Amount: VAMC Providence requires procurement and installation of the Heidelberg HEYEX 2 Image Management Platform to operate and integrate the VA-owned Heidelberg Spectralis® ophthalmic imaging system. The action includes server move, extended cache backend, software protector (USB), HP Z2 G9 workstation, TB3 conversion kit, OEM-trained installation, onsite training, and warranty support. Estimated value: $27,000 (includes repair, travel, and installation).

Equipment Information (Summary):

· HEYEX 2 Server Mov

· HEYEX 2 Extended Cache Management Backend

· Software Protector – USB (duplicate dongle of H2E-28079)

· HP Z2 G9 Tower Workstation (Windows 11, 64GB RAM, 1TB SSD, RTX A2000)

· TB3 Conversion Kit

· OEM labor: installation, configuration, travel/repair

3. Unique characteristics that limit availability to only one source, and reason no other supplies or services can be used (FAR 12.102-1(a); Brand-name peculiar to one manufacturer):

· VAMC Providence has standardized the Heidelberg Spectralis® Ophthalmic Imaging System. HEYEX 2 is the proprietary Heidelberg image management platform that is the only validated software capable of acquiring, storing, and managing the SPECTRALIS full raw imaging data (including eye-tracking metadata) and providing pixel-level progression analysis. Third-party PACS cannot replicate these functions.

· The HEYEX2 Imaging Management Platform is peculiar to one manufacturer,” the SB OEM Heidelberg Engineering. Operation of the HEYEX2 Platform requires Heidelberg/OEM licensing via Software Protector USB, Extended Cache Management Backend, and theTB3 conversion kit**. Substitutions do not exist and would degrade clinical fidelity and continuity of care.

· Distribution of the HEYEX2 Imaging Management Platform to the Government is exclusive: there is one (1) OEM-authorized SDVOSB distributor, L1 Enterprises, Inc., that can supply, install, train, and support the HEYEX 2 upgrade for VA.

· The SOW mandates OEM-trained installers, onsite clinical and engineering training, and a one-year manufacturer’s warranty inclusive of travel/shipping; only Heidelberg and its authorized SDVOSB distributor meet these requirements.

· Market research confirms no other sources can provide a technically acceptable, compatible solution. Substituting a non-OEM platform would degrade clinical fidelity, eliminate pixel-level alignment, and jeopardize continuity of care, security, and workflow integration.

4. Description of market research conducted and results (FAR Part 10; VAAR 810.001-70):

· Market research included vendor verification responses confirming:

(a) The Heidelberg HEYEX 2 is proprietary and unique to Heidelberg devices;

(b) L1 Enterprises, Inc. a SDVOSB, is the sole OEM-authorized Government distributor;

(d) The HEYEX2 is not available from mandatory sources:

· VA Inventories

· Other Government agencies

· AbilityOne

· SAC NX contracts

e) The HEYEX2 Platform is not available via:

· NAC (National Acquisition Center) contracts

· GSA FSS contracts

· GWACs (Government-wide Contracts) such as SEWP and NIH

(f) The Dod (Department of Defense) ECAT is not usable for the complete configuration due to labor/repair line items;

(f) lead time is approximately 2–3 weeks after PO.

(g) The HP Z2 G9 workstation with Windows 11 is compatible;

These findings support that only one reasonably available source exists for the Government.

Vendor responses confirm HEYEX 2 is proprietary and unique to Heidelberg devices. The requirement qualifies for VFCP (Veterans First Contracting Program) IAW VAAR 819.7003(d)/819.7006. The NMR and the LOS are satisfied. Because L1 is the sole OEM-authorized distributor to the Government, the Rule of Two (2) cannot be met. However, as the sole brand name distributor, “one reasonably available distributor,” because the NMR and the LOS are satisfied, and because we cannot apply VFCP for one sole SDVOSB distributor, we can apply a SDVOSB Sole Source per VAAR 819.7008.

NMR (Nonmanufacturing Rule) An SBA Nonmanufacturer Rule (NMR) Class Waiver applies to NAICS 334111; per VAAR 819.7003(d), the NMR and the LOS are satisfied. Therefore, VAAR 819.7008 may be leveraged for a SDVOSB sole source.

FAR 12.102-1(a) Determination: Only one reasonably available source can meet the Government’s minimum needs: Heidelberg Engineering, through its **OEM-authorized SDVOSB distributor L1 Enterprises, Inc. The brand name peculiar requirements and exclusive distribution support a single-source award. Use of **VAAR 819.7008** is appropriate because the Rule of Two is not met and NMR/LOS are satisfied.

Recommendation: The recommendation is for a VAAR 819.7008 sole source award to L1 Enterprises LLC, the sole, OEM-authorized SDVOSB distributor for the Heidelberg HEYEX2 Engineering Imaging System. The HEYEX2 Platform is proprietary to one manufacturer, Heidelberg Engineering and SB. The HEYEX2 Platform can only be distributed to the Government via “one reasonably available source,” L1 Enterprises LLC.

Per 86 FR 13692, an SBA Nonmanufacturer Rule (NMR) Waiver applies to NAICS 334111. The NMR and the LOS are satisfied: 1) L1 has below 500 employees. 2) L1 distributes HEYEX2 in the normal course of business. 3) L1 takes possession of all hardware as soon as it ships all software as soon as it is released to the customer.

Per an LOA from the OEM Heidelberg, L1 is the sole OEM-authorized Government distributor; the Rule of Two cannot be met, and an SDVOSB Set-Aside is not applicable. A brand name sole source is authorized under FAR 12.102-1(a) (“one reasonably available source”). VAAR 819.7003(d) confirms that the NMR and Limitation on Subcontracting (LOS) requirements are satisfied, allowing application of VAAR 819.7008 for an SDVOSB sole source award.

5. Contracting Officer’s Certification: Purchase is approved in accordance with **FAR 12.102-1(a)**. I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Single Source Justification for MPT up to SAT Revision: 02 Effective Date: 12/30/2025 Page 1 of 1

Presolicitation Notice