P03 JA - ATTACH1 - KYOCERA PRINTERS - 766_mm_bs - Redacted.pdf

Page 1 of Acquisition ID#:

DEPARTMENT OF VETERANS AFFAIRS

Acquisition Plan Action ID:_ __

Contracting Activity: Department of Veterans Affairs, NCO15, Charleston VA CMOP, 4136 Carolina Commerce Parkway, North Charleston, SC 29 ature and/or Description of the Action Being Processed: The Charleston CMOP requires an upgrade to the BPM that directly support the Automated Pharmacy Fulfillment System (APFS). The Kyocera printers that print the associated prescription (Rx) information for the patient order have reached the end of useful life. To continue using this critical and complex automation to support service to Veterans, CMOP needs to purchase 30 new printer engines and accessories. The current Kyocera model is no longer in production, so the manufacturer has recommended an alternate model Kyocera print engine. For the alternate print engine to function properly, the vendor needs to modify the software, hardware, and interface between the BPM and associated printers. This upgrade will require hardware and programming changes at the manufacturer’s site for initial modification, configuration, and testing. Additional modification and testing will be completed on-site at the Charleston CMOP. This final phase will need to be coordinated with Production to ensure that there is not interruption of service to the Veteran patients.

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

Thirty (30) Kyocera P4060dn printer engines and accessories to support the Tension BPM subsystem. The printers and accessories are estimated at each for a total of .

The vendor will need to provide delivery to their site for initial hardware modifications, controls systems logic configuration, software programming and testing. The estimate for the software and controls logic is 60 hrs each for a total of . The factory portion of the hardware modification is estimated to be , not including labor. The on-site portion of the configuration and testing, including travel and shipping is in excess of . The extensive hardware modifications on-site is estimated at another The delivery period for this acquisition will be dependent upon multiple factors, some of which are outside the control of the vendor. The anticipated time of this install is October 2024 with full factory modification, delivery and testing on-site at CMOP by the end of November 2024. Some of these factors are the Kyocera distributor’s ability to provide the large number of printers for delivery to the vendor, availability of shipping from the vendor to CMOP, and the time required on-site to finish fabrication, modification and testing. The expected on-site time is two weeks from the initial install of the first BPM until all testing is completed and work accepted. The premise for the schedule is that the first BPM must be

Page 2 of fully functional and tested/accepted by the CMOP using mutually approved acceptance criteria prior to proceeding with any other upgrades to BPMs.

Statutory Authority Permitting Other than Full and Open Competition:

Unusual and Compelling Urgency ( ) 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):

and their subcontractor Tension Corporation are solely suited to perform this modification with the selected Kyocera printers. Due to the proprietary nature of the software, logic controls and the overall complexity of this advanced system, it would not be feasible nor cost effective to allow another vendor to evaluate, reverse engineer, and design a modification for the BPM to work with a replacement printer. Since Tension is the manufacturer of the BPM and the machine was designed to work with a specific printer model that has been discontinued, they are the best equipped to recommend the replacement model based on the intricate hardware interface between the printer and the automated packaging system. They have specified a newer model Kyocera print engine (P4060DN) as the design replacement. This is why this request is not only vendor specific, but brand specific as well.

It is important to understand that these are not your typical office printers that you simply plug in and turn on. These are printers that need to be custom integrated into a highly sophisticated and technically complex Automated Pharmacy Fulfillment System (APFS). The modification to the equipment for a different print engine requires a retrofit kit which includes new hardware to provide proper safety interlocks and machine guards, new scanners to allow copy on the bottom, new print decks for the transfer from the printer to the bagging system, and other modifications as necessary to accept the differences in form factor for these new print engines. This unique retrofit kit has been vetted and tested by the sole manufacturer of this equipment to ensure proper operation. The height, speed and orientation of the Kyocera P4060DN makes it the most compatible to this application. There may be other printers that could work in this application, but in order to develop additional retrofit kits, manufacture and test them would be a significant cost that would override any savings generated by finding another alternate print engine that the Government could procure at a lowewr price point.

Additionally, the timeline to undertake the development, prototype and testing, once a more cost effective printer is identified (if there is one that would meet the requirements of this highly complex system), could be excessive and result in loss of productivity as the aging print engines reach end of life. Finally, there is an existing extended

Attachment 1: Request for Sole Source Justification Format >SAT

Page 3 of warranty for the entire APFS with iA. Purchasing a print engine that is not recommended by the BPM manufacturer, Tension Corporation, could potentially void that warranty for the BPM subsystem.

The selection of iA and their subcontractor Tension Corporation is based on multiple considerations, primarily that they are the equipment manufacturer and the primary source for the Charleston APFS. This extremely complex system of pharmacy dispensing equipment has complicated hardware, software, and control system interfaces. The company best suited to perform this upgrade is iA with the support of their manufacturing partners. Much of the software and logic controls are proprietary and would require significant reverse engineering to allow a third party vendor to perform this upgrade. Based on previous experience at the Charleston CMOP and at other CMOPs has proven this can be time consuming and extremely costly. The software interface between the Tension Packaging application and iA’s Nexia is critical to the proper processing of patient medication. The current interface is proven and has provided superb patient safety to the Veterans that CMOP serves. CMOP would need to conduct extensive testing and Healthcare Failure Modea and Effect Analysis (HFMEA). Since this has already been completed on the current BPM subsystem, working with iA and Tension will require minimal rework to this process. Involving other vendors unfamiliar with the process and a different set of software interfaces would require a significant investment of CMOP resources.

Simply put, iA and Tension have a proven, solid interface for the BPM system. They have selected an alternative commercial printer that will meet CMOP needs with minimal redesign and recoding at a reasonable cost point. The BPM has been used for over a year at Charleston CMOP with extensive testing and analysis. iA and Tension have proprietary software and logic code that would need to be reverse engineered and new code developed at a non-negligible cost and potentially a lengthy delay to implement. They are the best option for the Government to provide an upgrade to the existing BPM equipment.

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

National VA CMOP is working with an automation integrator to attempt to provide a better interface for all CMOPs that would allow more of a plug and play system. This project has encountered numerous obstacles due to the extremely competitive nature of pharmacy automation and the proprietary nature of the software and controls logic. Once this project is completed, it should provide the opportunity to allow more competition when purchasing and integrating new systems/subsystems. Upgrades to existing systems may still be more limited, but since there will be a better understanding of the interface, even this could be opened more.

If vendors are not willing to provide competitive prices for upgrades, then the entire subsystem might be replaced based on return on investment analysis.

Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

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

Extensive Market Research was conducted to determine whether the cost of the upgrade was fair and reasonable, and whether the print engine selected was comparable to other commercial options of equal or lesser price. The Kyocera print engine is a reliable piece of equipment based on the current experience of CMOP compared to like systems that used other makes/models of printer. The cost of the Kyocera print engine is well within commercial cost standards for the specifications needed by CMOP. Previous procurements for pharmacy automation print solutions resulted in much higher cost solutions.

The Kyocera print engine and needed accessories use consumables that have an established track record at CMOP for availability and pricing. The cost of supplies was evaluated during the initial procurement of the APFS, and the alternative Kyocera print engine will use similar materials, making that evaluation an appropriate benchmark for this acquisition.

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

The APFS was purchased in 2016 through a contract with Innovations Associates (now DBA iA) with a three (3) year, extended warranty. This contract was competed and awarded to iA, and as such, they have proprietary rights to the source code, controls logic, and interface constructs to the database and subsystem equipment. While the warranty is in place and iA has proprietary rights to software and system controls, they will stay the primary vendor for upgrades, expansion, and equipment replacement which will limit opportunities for full and open competition. As the designer, integrator, and installer of this major system which includes highly complex pharmacy automation, software, and interfaces, iA is in the best position to quickly and cost effectively provide the appropriate support. For a third party to reverse engineer a solution, design, test and install, the added costs would exceed a quote for just the work required by iA.

Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Innovation Associates

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: No actions have been taken to overcome barriers to competition. There are three main reasons for this.

VA CMOP has an extended warranty with iA for another two years. During this time, they will be to primary contract source to ensure that the extended warranty is not negatively impacted.

iA’s proprietary Nexia software controls the APFS and provides the interface with all subsystems manufactured by other vendors. This interface controls the major pharmacy fulfillment system and is extremely complex. Any changes to this software would require substantial investment and VA resources to test, evaluate, and validate patient safety.

The new print engines specified are not anticipated to be sunset prior to the end of lifecycle. Replacement of the printers involved in this upgrade should not require substantial upgrade other than the retrofit kit, which would be required to be installed and factory tested at Tension prior to delivery to the VA CMOP.

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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.

Lisa Harle Date Director VA CMOP Charleston

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.

Date

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.

Date

LISA HARLE Digitally signed by LISA HARLE Date: 2024.08.13 11:12:02 -04'00'

MICHAEL MCALHANEY Digitally signed by MICHAEL MCALHANEY Date: 2024.09.04 07:41:34 -05'00'

JUSTIN SMITH Digitally signed by JUSTIN SMITH Date: 2024.09.04 08:01:46 -05'00'