FAR 12 Sole Source Justification SAT-SAP - Surfacide Helios Plus UVC Disinfection Systems_Redacted.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Request for Sole Source Justification Template >SAT-SAP under FAR 12

Effective Date: 12/30/2025 Page 1 of 5 Revision: 02 Acquisition ID#: 36C242-26-AP-2952

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR THE ACQUISITION OF

COMMERCIAL PRODUCTS AND COMMERICAL SERVICES IN ACCORDANCE WITH FAR 12

Acquisition Plan Action ID: 36C242-26-AP-2952

1. Contracting Activity: Department of Veterans Affairs, VISN 02, New Jersey VA Health Care System.

Purchase request # 561-26-3-3087-0017.

2. Nature and/or Description of the Action Being Processed: This procurement is for a new firm-fixed-price contract for the purchase of five (5) Surfacide Helios+ UV-C Disinfection Systems for the New Jersey VA Health Care System (NJ VAHCS), in accordance with FAR 12 Acquisition of Commercial Products and Commercial Services and specifically FAR 12.102 Restricting competition.

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

The NJ VAHCS has a brand name requirement for five (5) Helios+ UV-C Disinfection Systems manufactured by Surfacide, LLC. These systems are FDA-cleared Class II electromedical devices that use ultraviolet-c light to eliminate harmful bacteria, viruses, and pathogens from environments like operating rooms, patient rooms, and clinics. The Surfacide Helios+ uses continuous 254 nm UV-C light and features three simultaneously operating emitters. The system includes the following parts:

Automated Triple Emitter Whole Room Microbial Reduction UV-CSystem. Includes 3 emitters, 1 control tablet, 1 joiner with tablet holder, 1 joiner with motion sensor, 1 Joby tripod with motion sensor (Manufacturer Part Number: 1271000).

Equipment shall be delivered within ninety (90) days after contract award.

The estimated value of the proposed action is .

4. Statutory Authority Permitting Restricted Competition:

FAR 12 Acquisition of Commercial Products and Commercial Services. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 12 is 41 U.S.C. § 1901 and is implemented by FAR 12.201-1 for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

(X) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 U.S.C. § 1901 as implemented by FAR 12.201-1;

( ) Unusual and Compelling Urgency per 41 U.S.C. § 1901 as implemented by FAR 12.201-1;

( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services per 41 U.S.C. § 1901 as implemented by FAR 12.201-1;

( ) International Agreement per 41 U.S.C. § 1901 as implemented by FAR 12.201-1;

( ) Authorized or Required by Statute per 41 U.S.C. § 1901 as implemented by FAR 12.201-

1;

( ) National Security per 41 U.S.C. § 1901 as implemented by FAR 12.201-1;

Effective Date: 12/30/2025 Page 2 of 5

Acquisition ID#: 36C242-26-AP-2952

( ) Public Interest per 41 U.S.C. § 1901 as implemented by FAR 12.201-1

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 Surfacide Helios+ is one of only two systems that have received full FDA clearance for whole room microbial reduction in clinical environments.

The Surfacide Helios+ UV-C Disinfection System is the only triple-emitter technology cleared by the FDA for whole-room microbial reduction that completes a cycle without requiring repositioning under 21 CFR 880.6510 (Product Code QXJ) that satisfies all the performance, safety, and workflow criteria required by the NJ VAHCS.

Although there are competing UV-C devices that hold FDA clearance as medical devices, they are not FDA cleared for whole room microbial reduction using synchronized multi emitter continuous UV-C systems under 21 CFR 880.6510 (Class II, QXJ), with the ability to operate in a single cycle when being operated in a hospital inpatient room. Competing devices do not meet NJ VAHCS’ requirements, including:

The ability to operate coordinated multi-emitter UV-C units as one unified system The ability to achieve whole room microbial reduction in a single uninterrupted cycle

(doesn’t require repositioning during a cycle) The ability to automate device repositioning between cycles instead of relying on manual intervention A UV-C concentrator to overcome shadowing and increase delivered doses Third party safety certification such as UL or ETL

The Xenex LightStrike+ - which is the other system cleared by the FDA for whole room microbial reduction - uses a single tower and needs to be placed (repositioned) in different locations within the room to make sure all surfaces receive enough UV saturation. One cycle is positioned on the left side of the patient bed, one cycle is positioned on the right side of the bed, and one cycle is positioned inside the bathroom. Each cycle takes about 10 minutes to complete, for a total of 30 minutes per room, not including setup time for each cycle by hospital staff. Whereas the Helios+ runs three linked towers simultaneously, allowing for the entire room to be completed in a single cycle of about 10 minutes without staff having to setup/reposition multiple devices.

These limitations create operational, workflow, and safety challenges that prevent these systems from meeting NJ VAHCS requirements.

Systems that require manual repositioning during disinfection introduce operational impacts. Each repositioning event forces disinfection cycles to pause and reset, severely extending downtime, increasing staff labor, and raises the risk of inconsistent UV-C dose delivery. This room downtime also negatively impacts the number of patients that can be seen and environmental services workflow, all of which make such systems unsuitable for the facility’s clinical environment.

The Surfacide Helios+ is the only device available that can meet all required technical, operational, and regulatory criteria. Accordingly, Surfacide, LLC is the only firm capable of providing the supplies described in Section III above without the Veteran’s Health Administration experiencing unacceptable delays in fulfilling its requirements.

Effective Date: 12/30/2025 Page 3 of 5

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

As stated in Section 8 below, market research confirmed that the Helios+ UV-C System is currently the only patented triple-emitter technology cleared by the FDA for whole-room microbial reduction that completes a cycle without requiring repositioning. An Intent to Sole Source notice was posted alerting Industry to the Government’s intent to pursue a sole source contract with JMC Solutions.

The only response received was from a vendor offering a UV-C Light Disinfection Robot that has been improperly promoted for use as a whole room microbial reduction device but has not been cleared by the FDA for use in a hospital.

Surfacide, LLC is the OEM and JMC Solutions is their authorized distributor of this equipment.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable:

A search of ADDS UP revealed prices for similar UV-C Disinfection Systems purchased by the VA typically range from $103,677.58 - $125,000.00 per device. During market research efforts the program office obtained an unofficial quote from JMC Solutions which quoted a price of per device for the exact Surfacide Helios+ UV-C Disinfection System model the Government is looking to purchase. Based on this, an official quote submitted by JMC Solutions in response to a request for quotes is anticipated to be similar to what they’ve already unofficially quoted and in line with what the VA has historically paid for such devices.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted:

Market research was conducted in May of 2026.

An internet search located a letter from the FDA to Surfacide, LLC confirming they have been granted FDA clearance to market the Helios+ UV-C System as a Class II medical device for Whole Room microbial Reduction. This is currently the only patented triple-emitter technology cleared by the FDA for whole-room microbial reduction that completes a cycle without requiring repositioning.

A search of GSA Advantage using keyword “surfacide” returned four products, one of which is the exact Surfacide Helios+ model required by NJ VAHCS, as confirmed by the using service. This item is being sold by the OEM Surfacide, LLC, a small business, via FSS contract 47QSWA23D002C. Note:

Breeworld LLC, a SDVOSB, is also shown to have a FSS contract that provides this item, however the OEM has confirmed Breeworld is not able to provide the item as they’re no longer a distributor for Surfacide.

A search of SBA’s Small Business Search using keywords “surfacide helios” returned one vendor – Surfacide, LLC.

A search of ADDS UP returned 15 contracts awarded by the VA, however most of these contracts were for maintenance and repair services and did not provide any equipment. The five contracts that were for equipment were for the Surfacide Helios (not Plus) model. The non-Plus model does not meet NJ VAHCS’ needs as it’s an older model and is not an FDA-cleared Class II medical device for whole room microbial reduction.

Effective Date: 12/30/2025 Page 4 of 5

A search of SAM using keywords “surfacide helios” returned four contracts however all four were previously identified through the above mentioned ADDS UP search and determined to be unsuitable as they provided an older Surfacide Helios (not Plus) model.

The requirements package included a quote from John Elzinga dba JMC Solutions, as SDVOSB.

Surfacide confirmed via email that JMC Solutions is their authorized distributor.

An Intent to Sole Source notice was posted to SAM alerting Industry to the Government’s intent to pursue a sole source contract with JMC Solutions for the Surfacide Helios+ UV-C system. One response was received from Lovell Government Services, who provided a capability statement, a quote offering an OhmniClean UV-C Light Disinfection Robot manufactured by OhmniLabs (a subsidiary of Symbotic LLC), as well as a letter from Symbotic LLC noting that Lovell is authorized to distribute this product. This information was forwarded to the customer who stated this product could not meet their needs as it’s not FDA-cleared for whole room microbial reduction in healthcare facilities. Contracting Officer reviewed the FDA website and discovered an incident report describing an incident where this robot caught fire at a medical center and caused significant smoke damage.

The report also noted that the device had been improperly promoted for use as a whole room microbial reduction device but has not been cleared by the FDA for use in a hospital.

The Surfacide Helios+ is manufactured in the United States.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: None.

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

John Elzinga dba JMC Solutions (SDVOSB) 5630 Heirloom DR Murfreesboro, TN 37129

UEI: CLSBVB6VU997

11. 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:

If subsequent acquisitions are contemplated, the Agency will conduct market research to determine if changes in the marketplace, if any, will allow for the acquisition to be conducted using competitive procedures. In particular, the Agency will look to see if any new UV-C Disinfection Systems have come to market that could meet the Agency’s needs.

12. 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.