P03 JA PHARMACY OPTIFILL REDACTED.pdf

Attachment 1: Request for Sole Source Justification Format >SAT

VHAPG Part 806.3 OFOC Page 1 of 3 Revision: 04 Effective Date: 12/15/25 Acquisition ID#: 36C257-26-AP-3012

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C257-26-AP-3012 JFOC: FY26-NCO-17-1085

1. Contracting Activity: Department of Veterans Affairs (VA), Veterans Integrated Service Network (VISN) 17, Network Contracting Office (NCO) 17. In support of El Paso VA Health Care System (ELPVAHCS) 5001 N. Piedras St. El Paso, Texas 79930.

2237: 756-26-4-045-0221

2. Nature and/or Description of the Action Being Approved: The proposed sole source action will continue the maintenance and service agreement for the OptiFill ARxIUM Automated Pharmaceutical Dispensing System. Because the OptiFill system’s software and hardware are proprietary, only certified OptiFill technicians can provide installation, maintenance, and repair services.

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

The Government needs contractor services to maintain and repair pharmacy fulfillment systems using proprietary software and hardware from ARxIUM, Inc. ARxIUM is the sole manufacturer and distributor of OptiFill Systems, including PPS Endicia Integration, specialized packing workstations, FastFill™ 54 vial filling devices, and PPS signature capture bases. ARxIUM does not allow third-party vendors to upgrade, install, support, or supply replacement parts for OptiFill Systems in the commercial market.

The estimated value of this contract, including the base year and four option years, is $693,234.80. The base period will begin on the award date and continue until the end of the fiscal year.

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;

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VHAPG Part 806.3 OFOC Page 2 of 3 Revision: 04 Effective Date: 12/15/25 Acquisition ID#: 36C257-26-AP-3012

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

ARxIUM is the only manufacturer, intellectual property holder, and authorized distributor of the OptiFill medication management and dispensing system used by the El Paso VA Health Care System. ARxIUM does not permit third-party vendors to sell, service, or supply components, software, or firmware for OptiFill Systems. Only ARxIUM-certified engineers, with proprietary tools and credentials, are qualified to maintain and repair the system.

Because of OptiFill’s specialized and proprietary design, only ARxIUM has the technical expertise and capacity to meet the VA’s requirements for medication management in a timely and reliable manner. Awarding a contract to another source would lead to excessive costs (such as reengineering, re-validation, testing, and re-certification) and delays that could negatively affect patient care and safety.

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): Market Research shows that ARxIUM is the original equipment manufacturer and the only provider of PPS licenses and firmware for OptiFill. This service is considered proprietary. ARxIUM operates exclusively and does not contract its products or services with third parties and it is recommended that this requirement be procured as a Sole Source to the MFR, ARxIUM. A Presolicitation notice will not be publicized in accordance with RFO 5.101(b)(2).

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

Reasonable: The Contracting Officer will assess whether the anticipated cost is fair and reasonable by comparing prices previously paid for similar ARxIUM OptiFill maintenance and license agreements at other VA facilities, adjusting for inflation, time period, and scope differences. An Independent Government Cost Estimate (IGCE) was also prepared using current OEM parts lists and software licensing requirements, and validated against VA’s historical spending on OptiFill maintenance. This combined method ensures the price aligns with market conditions and past government experience

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

Market research has determined that ARxIUM is the original equipment manufacturer and the sole provider of PPS licenses and firmware for OptiFill systems. This service is considered proprietary. ARxIUM operates exclusively and does not contract its products or services to third-party vendors. Previous VA procurements for OptiFill systems have also resulted in sole source awards to ARxIUM. Based on this information, ARxIUM is confirmed as the only vendor capable of meeting these requirements.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

There are no other factors supporting the use of other than full and open competition beyond the fact that ARxIUM is the sole manufacturer, sole holder of intellectual property, and the only authorized distributor of the OptiFill medication management and dispensing system currently utilized at the El Paso VA Health Care System. No other vendor is capable of providing services that are compliant, safe, or technically acceptable for this system.

VHAPG Part 806.3 OFOC Page 3 of 3 Revision: 04 Effective Date: 12/15/25 Acquisition ID#: 36C257-26-AP-3012

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

No other sources could express interest since ARxIUM is the sole manufacturer, sole intellectual-property holder, and sole authorized distributor of the OptiFill medication management and dispensing system used at the El Paso VA Health Care System. ARxIUM provided a sole source justification letter in compliance with RFO 6.103-1.

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: The Government will continue to monitor the market and conduct market research to identify potential sources for future similar requirements, including any new vendors or solutions that may become compatible with the current infrastructure.

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.

Enow Ayokosok Clinical Pharmacy Specialist

VHA

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

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

Donald D. Smith Contracting Officer

NCO 17

b. One Level Above the Contracting Officer (Required over SAT but not exceeding

$900K): I certify the justification meets requirements for other than full and open competition.

Latasha Messer Branch Chief

NCO 17

ENOW

AYOKOSOK

Digitally signed by ENOW

AYOKOSOK

Date: 2026.05.07 08:59:18 -06'00'

DONALD

SMITH

Digitally signed by

DONALD SMITH

Date: 2026.05.01 14:47:31 -05'00'

LATASHA

MESSER

Digitally signed by

LATASHA MESSER

Date: 2026.05.06 11:58:46 -05'00'

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