Paceart Database Conversion JA_Redacted.pdf

Medtronic Paceart License and Database Conversion Control Number VA-22-00081623

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

1. Contracting Activity: Department of Veterans Affairs

Office of Procurement, Acquisition, and Logistics Technology Acquisition Center 23 Christopher Way Eatontown, New Jersey 07724

2. Description of Action: The proposed action is a sole-source, firm-fixed-price contract to with Medtronic, located at 710 Metronic Pkwy Minneapolis, MN 55432 for Medtronic Paceart Optima perpetual software licenses, Medtronic Paceart Project Management and Application Specialist support, Medtronic Paceart Remote and On-site Training, and Medtronic Paceart Database Conversion and Merging.

3. Description of Supplies or Services: The Department of Veterans Affairs (VA) Office of Information and Technology (OIT) and the Electronic Health Record Modernization Integration Office (EHRM IO) requires 219 additional Medtronic Paceart Optima perpetual software licenses, Medtronic Paceart Project Management and Application Specialist Support, Medtronic Paceart Remote and On-site Training, and Medtronic Paceart Database Conversion and Merging. Medtronic Paceart Optima is the only product used within the VA that specifically monitors and stores cardiac implanted defibrillator and pacemaker data. It can collect, store, and retrieve data from programmers and remote monitoring systems from all major cardiac device manufacturers. A national instance of Medtronic Paceart Optima was stood up in VA Enterprise Cloud to support the National Cardiac Device Surveillance Program (NCDSP). Regardless of whether the data was generated in the hospital, the clinic, or by the patient’s monitor, the data is consumed and stored in the Paceart database and sent to the electronic health record (EHR), Veteran Health Information System and Technology Architecture (VistA) Computerized Patient Record System (CPRS). As the VA modernizes its EHR from VistA to Cerner Millennium, an interface was approved to allow Paceart to integrate with Cerner Millennium. In order to make the product functional at a national level, additional concurrent user licenses and training of the enterprise instance is required for clinical users. Additionally, all local instances of Paceart Optima will need professional services to convert and merge the local data to the enterprise database. The period of performance for this proposed action is 36 months from date of award. The total estimated value of the proposed action is

4. Statutory Authority: The statutory authority permitting other than full and open competition is 41 U.S.C. 3304(a)(1) as implemented by the Federal Acquisition Regulation (FAR) 6.302-1 entitled, “Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.”

5. Rationale Supporting Use of Authority Cited Above: The proposed source for this proposed action is Medtronic 710 Medtronic Parkway NE Fridley, MN 55432. Based on market research, as described in Section 8 of this document, the Government has determined that Medtronic is the only source capable of providing the required redacted

Medtronic Paceart Database Conversion Control Number VA-22-00081623 software licenses, Medtronic Paceart Project Management and Application Specialist support, Medtronic Paceart Remote and On-site Training, and Medtronic Paceart Database Conversion and Merging of local instances of Paceart Optima to the NCDSP’s Paceart database. Only Medtronic can provide software which is interoperable with existing Medtronic Paceart Optima software licenses deployed in VA. Additionally, no alternative vendor has access to the proprietary source code which is required for the conversion and merging of local instances of Paceart Optima to the NCDSP’s Paceart database; therefore, there is no competition for this acquisition.

Medtronic is the only authorized provider of licenses and technical support for Paceart, an integral part of VA’s National Cardiac Device Surveillance Program (NCDSP). The majority of standard operating procedures for the NCDSP have also been based on workflows unique to Medtronic Paceart Optima. Additionally, Medtronic Paceart Optima is the only clinical software for compiling and managing patients’ cardiac device data with an approved interface for Cerner Millennium in the VA. The use of any alternative software would require the redevelopment of the interface with Cerner Millenium. Based on previous acquisition history, VA technical experts estimate that the recreation of this interface would cost a minimum of

This duplicative cost would not be recovered through competition.

Additionally, VA would need to re-procure alternative software for the sites that have already procured and utilize the Medtronic Paceart Optima perpetual software licenses. Based on previous acquisition history, this would result in a further duplication of The combined estimated duplicative total of would not be recovered through competition. Additionally, the existing software is proprietary to Medtronic. If the contract was awarded to a new source, clinicians would no longer have access to 10 years’ worth of historical patient data that is critical to making patient care decisions because the data can only be migrated by Medtronic. Furthermore, over the past 10 years, ancillary applications have been developed by third parties and VA specifically for Medtronic Paceart Optima. If an alternative solution was chosen, these ancillary applications would need to be replaced. Failure to procure additional concurrent licenses and merging of the existing local databases to the national instance from Medtronic would leave VA without a centralized repository to compile and manage patients’ cardiac device data. This would lead to gaps and discrepancies in patient care throughout the healthcare system. Awarding to a source other than Medtronic for an alternative solution would negatively impact patient care and result in duplication of over Million and 10 years of effort.

6. Efforts to Obtain Competition: Market research was conducted, details of which are in the market research section of this document. This effort did not yield any additional sources that can meet the Government’s requirements. There is no competition anticipated for this acquisition. Additionally, the proposed action will be synopsized on the Federal Business Opportunities Page in accordance with FAR

5.201. Any proposals that are received shall be evaluated.

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Medtronic Paceart Database Conversion Control Number VA-22-00081623

7. Actions to Increase Competition: The Government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future actions to be competed. Specifically, the Government will continue to monitor the marketplace trends, new/emerging products, and determine whether other manufacturers are authorized to provide licenses and make the changes to allow the existing local databases to merge with the national instance.

8. Market Research: Market Research was conducted in February 2022 by VA’s technical subject matter experts to determine if another source was capable of providing additional Paceart Optima user licenses and merging the existing databases with the national instance. While there are other workflow solutions to enable management of patients’ cardiac device data, such as PaceMate Cardiac Remote Monitoring Platform and Boston Scientific LATITUDE NXT, neither solution is capable of meeting the government’s requirements to provide the additional user licenses for Paceart or to merge local Paceart databases to the NCDSP’s Paceart database.

The proposed action is a modification to the existing system, the existing system has proprietary software, and the manufacturer, Medtronic, is the only authorized vendor who can sell licenses and perform the required services. No other vendor can provide the customer support, or training of Medtronic’s software. Medtronic, the manufacturer of Paceart licenses provided a letter on March 24, 2022, indicating that they are the exclusive supplier of the Paceart software. Based on the market research efforts, the Government’s technical experts have determined that only a sole source award to Medtronic can meet all the VA’s requirements. There is no anticipation for competition, limited or otherwise, for this effort.

9. Other Facts: None