P03 Justification and Approval Pyxis AP1793__Redacted.pdf

Effective Date: 02/01/2022 Page 1 of 4

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C261-24-AP-1793 JOFOC Tracker: FY24 - NCO 21 - 1271

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO 21) on behalf of VISN (Veterans Integrated Service Network) 21, VA San Francisco Healthcare System (VASFHCS) at 4150 Clement Street, San Francisco, CA 94121.

2237: 662-24-2-067-0057

2. Nature and/or Description of the Action Being Processed: This procurement is for the sole source of Pyxis Pharmacy Medication Dispensing Cabinets, Anesthesia Medication Printing, and Pharmacy IV Preparation Automation (PYXIS ES) for VASFHCS in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2.

This contract will be at a firm fixed price, and will contain four annual option years.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The proposed action is to provide continued monthly rental and support services for currently installed Carefusion Solutions LLC Pyxis Automated Medication Dispensing Systems as well as Pyxis IV Prep (Cato) Subscription and Pyxis Codonics Subscription. The proposed awardee, Carefusion Solutions LLC, is the OEM (Original Equipment Manufacturer) and will provide monthly support for all installed stations and items. This includes the completion of any required updates, upgrades, or onsite support to ensure bug fixes, patching, error correction, virus updates, minor enhancements or modifications to existing features to maintain the security and overall operation of the integral software.

The total estimated value of this action is

The proposed Period of Performance (PoP) is:

Base Year: 06/01/2024- 05/31/2025 Option Year 1: 06/01/2025- 05/31/2026 Option Year 2: 06/01/2026- 05/31/2027 Option Year 3: 06/01/2027- 05/31/2028 Option Year 4: 06/01/2028- 05/31/2029

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) 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

( ) Unusual and Compelling Urgency

Effective Date: 02/01/2022 Page 2 of 4

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

( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Pyxis equipment is exclusively manufactured by Carefusion. The VASFHCS utilizes Brand Name Carefusion Solutions LLC Pyxis Medstations throughout the healthcare system. CareFusion Solutions LLC is the exclusive manufacturer of Pyxis products. Only CareFusion and their Field Service Technician Affiliates have the capabilities and authorization necessary to perform installation and maintenance services for Pyxis products. Performance of those services by any other party voids the Government’s warranty for the serviced products.

This work can only be accomplished with Pyxis equipment. Equipment is already on site and would be unduly burdensome on the Government to remove all the medication dispensers and peripheral equipment from VA San Francisco. Additionally, staff is already trained and accustomed to the Pyxis systems and would need to be retrained, which would impact the Government’s mission.

The Pyxis MedStation™ (MS) ES system offers enhanced medication safety, workflow, and real time inventory features (please see attached capabilities statement for more details). The Pyxis system has been found to be the only unit with a tracking method for controlled substances, reporting capabilities, and compatibility with current VASFHCS technology, as the med stations integrate with CPRS (Computerized Patient Record System) and VistA (Veterans Health Information Systems and Technology Architecture) systems. This is imperative, as the systems interface with one another in streamlining the medication distribution process.

The cost to procure a whole new system would depend on whether we purchased or leased the new system equivalent to updates to current system to date. The Cost would range between dollars to include all peripheral equipment and not to include a service agreement. Medication cabinets are an industry of ever-changing design and technical advancements which is the biggest advantage when leasing, as the hardware can easily be exchange with the newest generation. In the last 10 years Pyxis has had three generations of medication cabinets (3500, 4000, and ES). Each generation has included a design feature to improve patient safety and reduce diversion risk.

Purchasing equipment with a 10-year life-span would not allow the station to change out the medication cabinets with the newest generation and is not conducive for a field with ever changing software updates.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Market research was conducted, details of which are stated in section 8 of this document. No known competitor brand can meet the needs of VASFHCS, and the OEM was contacted directly. The OEM stated that no other firm is authorized to support their equipment.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Pricing will be compared to market research results, past procurement data, and the Independent Government Cost Estimate (IGCE).

Effective Date: 02/01/2022 Page 3 of 4

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from interested parties . GSA (General Services Administration) eLibrary, GSA Advantage, The National Acquisition Center (NAC), The Supply Chain Master Catalogue (SCMC), FPDS (Federal Procurement Data System), SAM, (System for Award Management), SEWP (Solutions for Enterprise-Wide Procurement) were all reviewed. Additionally, the OEM Carefusion Solutions LLC confirmed via email that all maintenance and rental agreements should be sole sourced to the OEM. VetCert was also reviewed.

GSA eLibrary and advantage were reviewed searching for the needed rental items and for any comparable competitors, no results were found. SEWP was reviewed, searching for distributors of the OEM, no firms could be found. The SCMC was reviewed, where Contract 36C25519D0032 was found that could have been a possible procurement vehicle. Upon further analysis, only VISN (Veterans Integrated Service Network) 15 may use it. The NAC was reviewed, with no significant results. It appears that at one time 36F79718D0454 was utilized for Pyxis rental equipment, but the contract could not be found on the NAC or GSA and is expired. VetCert was utilized, where NAICS 339112 was searched resulting in 667 possible SDVOSBs and VOSBs (Veteran Owned Small Business). SAM.Gov was utilized, where 36C25523Q0799 was found, an intent to sole source to Carefusion Solutions LLC for the rental and maintenance of the needed equipment.

FPDS was reviewed, Contract 36C26123P1122 was found, the station’s current contract. That action was awarded to Carefusion Solutions LLC on 05/30/2023 in the amount of , it was not competed and issued as a sole source. Additionally, a BPA had been found under ID 36C25019A0051, the last day to order off of that contract is 09/27/2024. That action however, appears to only be available to the Northern Indiana Healthcare System. That procurement was also sole sourced to Carefusion Solutions LLC for its rental and maintenance of automated dispensing pharmacy cabinets. Contract 36C24923P0170 was also found, for the rental and maintenance of Pyxis pharmacy cabinets awarded to Carefusion Solutions LLC on 01/01/2023 in the amount of

, it was not competed and issued as a sole source.

The Contract Specialist emailed the Government Contract Operations Manager of the OEM, on 02/09/2024 asking for a list of any authorized distributors for the needed requirement. replied on 02/12/2024 stating that though they have authorized distributors to resell their products (such as

, a SDVOSB (Service-Disabled Veteran owned Small Business)) all acquisitions that involve maintenance, subscriptions, and rent of their equipment should go direct to Carefusion.

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: Carefusion Solutions LLC; 3750 Torrey View CT, San Diego, CA 92130.

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

Effective Date: 02/01/2022 Page 4 of 4

Government will continue to conduct market research to ascertain if there are additional changes in the marketplace that would enable future actions to be competed.

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.

Gabriella Orteza Date Biomedical Engineer VA San Francisco Healthcare System

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

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

David J. Alvarez Date Contracting Officer Network Contracting Office (NCO 21)

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Maxwell W. Derck Date Branch Chief, Supply II Network Contracting Office (NCO 21)