Redacted HCA Signed NCO 6 RFO FSS Sole Source Justifcation GSAM.71043b over SAT 36C246-26-AP-2030.pdf

Request for Sole Source >SAT GSAM/R 538.7104-3(b) Sole Source Federal Supply Schedule Ordering Procedures

Acquisition ID#: 36C246-26-AP-2030

SOLE SOURCE JUSTIFICATION GSAM/R 538.7104-3(b)

This justification aligns with the deviation outlined in the Revolutionary FAR Overhaul (RFO) for FAR

8.4 - Ordering under the Federal Supply Schedule and GSAM/R 538.71, as required by Executive Order (E.O.) 14275, Restoring Common Sense to Federal Procurement, signed April 15, 2025.

Deviation effective date: November 3, 2025.

Acquisition Plan Action ID: 36C246-26-AP-2030

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 6, located at

100 Emancipation Drive, Hampton, VA, 23667, in support of VISN 6 VA Fayetteville Coastal Health Care System. Purchase request number 565-26-2-737-2546.

2. Description of Action: This acquisition is conducted under the authority of the Multiple-Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501). Network Contracting Office 6 intends to establish a new VA FSS Blanket Purchase Agreement (BPA), to issue firm-fixed-price delivery orders, with QB Medical Inc., a verified SDVOSB, for CEFALY Connected migraine devices. These devices will support the VA Fayetteville Coastal Health Care System providers in delivering effective migraine treatment and prevention for Veteran patients.

Order against: FSS Contract Number: 36F79718D0560

Name of Proposed Contractor: QB Medical Inc Street Address: 816 Starboard Street City, State, Zip: Chula Vista, CA 91914 Phone: 619-421-7993

3. Description of Supplies or Services: The VA Fayetteville Coastal Health Care System requires

CEFALY Connected Migraine devices to treat Veteran migraines. The CEFALY Connected devices are wearable devices that use external trigeminal nerve stimulation (e-TNS) to relieve migraine pain and reduce the frequency of migraine attacks without medication. The devices send micro-impulses through a forehead electrode to desensitize the trigeminal nerve reducing attack frequency and alleviating pain during a migraine episode. The requirement includes 2,500 CEFALY Connected Devices with electrodes. The estimated award date is May 15, 2026. The delivery period is for a 12-month base year and four (4) 12-month options from 05/18/2026 – 05/17/2031. The total estimated order value is $2,245,000.00, pricing per year is as follows:

Base Year: 05/25/2026 – 05/24/2027 $449,000.00—quantity 500 Option 1: 05/25/2027 – 05/24/2028 $449,000.00—quantity 500 Option 2: 05/25/2028 – 05/24/2029 $449,000.00—quantity 500 Option 3: 05/25/2029 – 05/24/2030 $449,000.00—quantity 500 Option 4: 05/25/2030 – 05/24/2031 $449,000.00—quantity 500

4. Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

GSAM/R 538.7104-3(b)(1)(i): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

GSAM/R 538.7104-3(b)(1)(ii): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized;

GSAM/R 538.7104-3(b)(1)(iii): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures.

GSAM/R 538.7104-3(b)(1)(iv): It is necessary to place the order with a particular FSS contractor to satisfy a minimum guarantee established in the FSS BPA; or

GSAM/R 538.7104-3(b)(1)(v): A law expressly authorizes or requires that the purchase be made from a specified source.

GSAM/R 538.7104-4: Items peculiar to one manufacturer: CEFALY Technology is the original equipment manufacturer and has authorized QB Medical Inc., a certified SDVOSB, as its authorized distributor under the VA FSS contract. Providers at the VA Fayetteville Coastal Health Care System determined that the facility requires a migraine-management device with a forehead-applied configuration that eliminates sizing constraints, avoids restrictive headgear, and allows patients to apply the device without lifting or positioning their arms. This configuration is clinically necessary for bariatric Veterans and individuals with limited mobility or reduced range of motion, ensuring safe and consistent application across all patient demographics. The CEFALY device is the only identified product that provides this configuration, and the required characteristics cannot be replicated or modified in other devices. For this reason, the requirement is considered peculiar to one manufacturer, supporting a sole-source award through the OEM’s authorized SDVOSB distributor.

5. Describe Why You Believe the Order Represents the Best Value consistent with GSAM/R 538.7102-2(4) to aid the contracting officer in making this best value determination: The award represents the best value to the Government because it secures the only commercially available device that meets the VA Fayetteville Coastal Health Care System’s requirements and ensures effective delivery of care to the intended Veteran population. The selected product aligns directly with the facility’s clinical objectives, supports safe and independent use by all eligible Veteran patients, and avoids expenditures on devices that would be unsuitable or unusable throughout the VA Fayetteville Coastal Health Care System’s treatment environment. Pricing on the VA FSS contract has been determined to be fair and reasonable. A separate determination of fair and reasonable pricing is not required, but prior to award the Contracting Officer will confirm offered prices against the contract prices and seek additional discount before establishing the blanket purchase agreement.

6. Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted. Market research was conducted across multiple sources, including the SBA Small Business Search (SBS) database, the VA Medical Supplies Program Office (MSPO) SharePoint, FPDS, and both VA and GSA Federal Supply Schedules, to identify non-invasive neuromodulation devices. Four alternative manufacturers were identified. A technical review of each product found that all alternatives utilized band-based, wrap-around, or sizing-dependent systems that could not meet VA Fayetteville Coastal Health Care System minimum clinical and accessibility requirements. These devices presented risks such as improper fit, skin irritation, or inability to apply independently for Veterans with mobility limitations. Because none of the identified devices met the minimum requirements, only the CEFALY device was determined capable of meeting the Government’s needs. QB Medical Inc., an SBA SBS verified SDVOSB, is as an authorized reseller of CEFALY devices under their VA FSS contract. No other sources were identified that can provide the CEFALY devices.

7. Any Other Facts Supporting the Justification: None.

8. A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made: The Government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future actions of this type to be competed.

9. 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. I understand that processing of this sole source justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by GSAM/R 538.71 as directed by FAR 8.4.

Shane Dupre Chief, Prosthetics Fayetteville VA Medical Center

DATE

5/5/2026

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

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

Cherisse Hall DATE Contracting Officer, NCO 6

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

Keeshia Newman DATE Division Chief I, NCO 6

c. NCO 6 Director of Contracting: I certify the justification meets requirements for other than full and open competition.

Irma Ferro DATE Director of Contacting, NCO 6

HIGHER LEVEL APPROVAL (Required for orders over $900,000)

d. VHA RPO HCA Review and Approval (over $900,000 to $90 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for restricting consideration of the Federal Supply Schedule contractors to fewer than the number required by GSAM/R 538.71 ordering procedures as directed by FAR 8.4.

Gerald F. Jacobs Date Executive Director Regional Procurement Office East