NTP PACS Mammo License and AI J-A Final redacted.docx

National Teleradiology Program PACS Mammo License & AI Module

VA-22-00082609

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

2. Description of Action: The proposed action is for a sole source, firm-fixed-price contract with Les Systemes Medicaux Intelerad Incorporee Intelerad Medical Systems to provide a mammography Artificial Intelligence (AI) module for breast density image quality and risk assessment to be integrated into the existing Picture Archive and Communication System (PACS)/AI infrastructure as well as the PACS licenses to support 2D and 3D mammography interpretations.

3. Description of the Supplies or Services: The Department of Veterans Affairs (VA), Veterans Health Administration (VHA), National Teleradiology Program (NTP) has been designated as the responsible program for VHA compliance with H.R 4794 – Making Advances in Mammography and Medical Options for Veterans Act, and requires additional PACS capabilities to enable NTP Radiologists to perform screening mammography interpretations. NTP PACS licenses are required for 2D and 3D mammography ingestion and interpretation. In addition, NTP requires a mammography-specific AI module within the existing PACS for breast density, image quality and risk assessment. The AI module must be FDA510k approved and be integrated into the existing PACS/AI infrastructure.

The period of performance is 15 months from date of contract award. The total estimated price of the proposed action is $--

4. Statutory Authority: The statutory authority permitting other than full and open competition is Section 41 U.S.C. 3304(a)(1) as implemented by the Federal Acquisition Regulation (FAR) Subpart 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 action is Intelerad, 895 De La Gauchetiere Street West, Suite 400, Montreal, QC H3B4G1 Canada. Intelerad is the Original Equipment Manufacturer (OEM) of the NTP PACS brand name software (IntelePACS) and currently provides maintenance support for the existing PACS system. Intelerad is the only source capable of meeting VA’s requirements due to the proprietary nature of the current products. The NTP PACS is comprised of various interrelated components of hardware and IntelePACS brand name software and licenses. The IntelePACS software is proprietary in nature and is the intellectual property of Intelerad. Only Intelerad can access the proprietary source code for IntelePACS software which is needed to service, support, update and upgrade the components of the PACS. Access to this proprietary data is also required to ensure all the services provided are properly configured and the system remains in continuous operation. Since Intelerad does not sell the PACS software or support through resellers, Intelerad is the only source that is able to provide the updates and upgrades to the IntelePACS software.

The FDA requires medical device manufacturers to possess 510K certification to market medical devices and systems and ongoing software updates and upgrades must be similarly reviewed or go through the vendor’s internal quality certification process to ensure that they are safe and effective for their intended use. The NTP PACS from Intelerad, IntelePACS, currently has FDA 510K certification. In accordance with Section 510(k) of the Food, Drug and Cosmetic Act, medical devices used in patient care must be certified by the FDA and due to the proprietary nature of IntelePACS, only the OEM can update/upgrade the NTP PACS application. The 510K certification is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device. In this instance, the previously marketed devices are IntelePACS and InteleViewer. Intelerad is the only vendor possessing 510K certification (K192176) for the IntelePACS and InteleViewer products and therefore the only source that can provide software/license upgrades to the system.

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. In accordance with FAR 5.201, the proposed action will be synopsized on the System for Award Management Contracting Opportunities website and this justification will also be made publicly available within 14 days after contract award in accordance with FAR 6.302-1(c).

7. Actions to Increase Competition: In order to remove or overcome barriers to competition in future acquisitions for this requirement, the agency will work with the program office to perform additional market research so that other solutions can be considered.

8. Market Research: Market research was conducted by the Government’s technical experts in June 2022 by reviewing similar clinical products and services such as Philips Intellispace, Agfa Impax and McKesson/Change PACS to ascertain if these vendors could meet VA’s requirements for the service and support of the NTP's IntelePACS mammography requirements. Specifically, the Government’s technical experts conducted research on web sites and utilized first-hand knowledge of commercial PACS that are deployed within VA to determine if alternate vendors’ mammography modules could be incorporated into the NTP PACS. As a result, the technical experts confirmed that all of the vendors researched were unable to meet VA’s requirements as outlined in Section 5 of this justification and could not provide the approved functionality within the existing NTP PACS.

VA previously contacted Intelerad in September of 2022 in order to obtain information regarding the availability of the source code for purchase. Intelerad confirmed that their source code has never been sold nor was there a plan to sell their source code in the future. Therefore, no competition is anticipated for this effort.

9. Other Facts: None.

10. Technical and Requirements Certification: I certify that the supporting data under my cognizance, which are included in this justification, are accurate and complete to the best of my knowledge and belief.

Date: ______________________

Chief Healthcare Technology Manager NTP Signature: ______________________

11. Fair and Reasonable Cost Determination: I hereby determine that the anticipated price to the Government for this contract action will be fair and reasonable based on comparison of the proposed prices to historical prices paid, whether by the Government or other than the Government, for the same or similar items and comparison to the Independent Government Cost Estimate.

Date: ______________________

Procuring Contracting Officer Signature: ______________________

12. Procuring Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief. As this contract action does not exceed $750,000, the certification below required by FAR 6.304(a)(1) serves as approval.

Date: ______________________

Procuring Contracting Officer Signature: ______________________