P03 - SSJ - Belimed - Intent to Sole Source.docx

Attachment 1: Request for Sole Source Justification Format >SAT

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C262-26-AP-5128

1. Contracting Activity: Department of Veterans Affairs, VISN 22, VA Medical Center, Research Service, located at 3350 La Jolla Village Dr., San Diego, CA 92161.

The contracting agency and organizational activity responsible for the proposed contracting action is Department of Veterans Affairs, Network Contracting Office 22, 3601 S 6th Ave, Tucson, AZ 85723.

Purchase Request number:

2. Nature and/or Description of the Action Being Approved: The action being reviewed and approved is a sole source for an annual firm-fixed price preventive and corrective maintenance service contract for the various Belimed sterilizers and washers owned by VASDHS.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: A VIP search was conducted under NAICS CODE 811210 key word Belimed sterilizers, Inc preventive maintenance. No SDVSOB or VOSB vendors were found that can provide the service. A notice of intent to sole source is also being posted to rule out other potential vendors that can perform the service, this posting yielded not responses. The specific services being purchased are quarterly on-site preventive maintenance inspections per year, including all hardware parts, labor and intervening corrective maintenance service. Telephone support offered 24 hours a day, 7 days a week, excluding holidays. Unlimited on-site service calls with a service response time of 48 hours. On-site work is for normal working hours, M-F, 8AM – 5PM. The Belimed sterilizers and washers are used to clean and disinfect instruments used in medical procedures. These devices are used by Sterile Processing Services.

The period of performance will be 06/01/2026-03/31/2031.

The estimated cost is $877,751.33.

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): Belimed is the original manufacturer of the Belimed washers and sterilizers. Belimed owns all proprietary rights to software systems and parts used with the Belimed systems. These units need to be maintained by authorized, trained personnel with access to original equipment parts. The Belimed units form a core set of reprocessing devices used by Sterile Processing Services at VASDHS, and as such, can only have minimal downtime without severely affecting the output of SPS. Without these devices, various medical cases have the potential of being cancelled because sterile supplies would not be able to be delivered. They require quarterly preventive maintenance service and continual corrective maintenance that Biomedical Engineering is unable to provide.

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): An intent to sole source was issued on July 13, 2020, under 36C26220R0158. A check of the VIP search and intent to sole source was conducted to verify if any SDVOSB or VOSB can conduct the required work within the scope performance requested by the VA San Deigo Healthcare System. No responses were received.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated cost of this requirement is considered fair and reasonable. This is based on the IGCE received and the comparison to past contracts of similar nature and their prices.

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 prior to solicitation to determine the availability of the Belimed Sterilizers. The Contracting Officer performed a Vendor Information Pages (VIP) search under the NAICS Code: 811219 – Other Electronic and Precision Equipment Repair and Maintenance. PSC Code: J065 – Maintenance and Repair of Medical, Dental and Veterinary Equipment for possible SDVOSB/VOSB concerns who could meet the needs of this request. Market research conducted pursuant to FAR Part 10 resulted in finding only one source capable of providing the desired services. Advanced Sterilization Products Service, Inc.

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: Belimed, Inc.

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: Belimed, Inc, owns all proprietary rights to software systems and parts used with the Belimed sterilizers and washers.

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.

VHAPG Part 806.3 OFOC Page 1 of 4 Revision: 04 Effective Date: 12/15/25 Acquisition ID#: 36C262-26-AP-2337