36C10B19Q0057-003.pdf

National Teleradiology Program PACS Control Number: TAC-19-52327 Service/Support

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMEPTION

1. Contracting Activity: Department of Veterans Affairs (VA) Office of Procurement, Acquisition and Logistics

Technology Acquisition Center 23 Christopher Way Eatontown, New Jersey 07724

2. Description of Action: The proposed action is for a sole source, firm-fixed-price (FFP) contract with Intelerad for maintenance, software support, partial hardware support, and ongoing system/application sustainment for the existing VA National Teleradiology Program (NTP) Picture Archive and Communication System (PACS).

3. Description of the Supplies or Services: VA requires ongoing software updates, upgrades, system enhancements, and 24x7x365 support for the existing NTP’s PACS and integrated Powerscribe 360 system. The support will include furnishing all necessary replacement hardware or hardware components, software, software updates, upgrades, ongoing software development for the PACS system and assignment engine optimization and technical support services required to maintain the NTP PACS and all associated components at a minimum 99.9% uptime. The Contractor is required to have Federal Drug Administration (FDA) 510K certification to provide ongoing software updates and upgrades for the NTP PACS application (IntelePACS). In order to use a medical device for diagnosis, treatment or therapy of a patient, the device must be certified by the FDA. Any changes and/or updates must undergo a review to ensure that the device remains safe and effective and the changes did not modify the device in a way that alters its intended use. Failure to conduct such a review would result in loss of the FDA 510K certification. The period of performance is 12 months from date of contract award with four 12-month option periods. VA requires this length of PoP as it anticipates utilizing this system for a minimum of five years. No new software is being procured or renewed under this proposed action and only hardware replacement parts will be procured when required. The total estimated price of the proposed action inclusive of the option periods 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 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. Since Intelerad does not sell the required support through resellers, Intelerad is the only source that is able to provide the updates and upgrades to the IntelePACS software. In addition, only Intelerad brand name hardware replacement parts can meet all of VA’s form, fit and function requirements.

Specifically, use of other brand name hardware components would not function in the existing Intelerad items. In addition, only the existing brand name hardware used on the IntelePACS can be used for replacement parts since no other brand name items can meet all of VA’s form, fit and function requirements. Specifically, use of other brand name hardware components would not function in the existing Intelerad system. In addition the hardware maintenance required must be configured to work with the Intelerad brand name software and thus cannot be separated.

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’s PACS from Intelerad, IntelePACS, falls under this requirement. 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 (K150707) for the IntelePACS and InteleViewer products.

Accordingly, Intelerad is the singular entity that can legally provide software updates and upgrades to the system and possesses the proprietary knowledge of the system and associated coding components required for ongoing system sustainment and expansion. Only Intelerad has the detailed understanding and access to the proprietary code of the software capabilities and function to immediately address any software functionality issues.

As NTP is a mission critical medical system delivering care for up to 2500 critical patients per day, it is imperative that maintenance, support and sustainment of the system be provided by a contractor with expert level knowledge of the application/system and access to the proprietary code which is only available through the OEM who developed the application and provides ongoing support as a key component of their core business. Utilization of another vendor’s PACS support team would require replacement of the IntelePACS software and associated hardware as they would have no capability to support the system in place.

Replacement of the PACS would require 18-24 months for deployment, which would result in extensive delivery delays and duplication of costs that would not be recovered through competition and would also be clinically unacceptable, particularly given the strict system uptime requirements.

Continuity of service/support coverage is essential to maintain continuous operation of the NTP PACS. Due to the scale and complexity of the NTP PACS, there are multiple work orders or support tickets submitted every day that require action by the PACS vendor to resolve a technical issue to allow one or more exams to be successfully received and dictated. While issues may be as limited as impacting a single STAT case, they can also be significant in scope such that it will impact an entire VISN or the NTP PACS as a whole. For larger scale issues such as those on a VISN level, they can impact hundreds of critical patients, delaying their care and treatment. Significant harm can come to critical patients when their STAT interpretations and subsequent treatments are delayed, which is why it is imperative that there is no break in support coverage for the NTP PACS.

6. Efforts to Obtain Competition: Market research was conducted, details of which are in the market research section of this document. No competition is anticipated. In accordance with FAR 5.201, the proposed action will be synopsized on the Federal Business Opportunities Page (FBO) and this justification will also be made publicly available within 14 days after contract award in accordance with FAR 6.302-1(c). Any responses received from the synopsis posting will be evaluated.

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 May of 2018 by reviewing similar clinical products and services such as Philips Intellispace, Agfa Impax and McKesson PACS to ascertain if these vendors could meet VA’s requirements for the service and support of the NTP's IntelePACS.

Specifically, the Government’s technical experts conducted research on web sites and utilized first-hand knowledge of commercial PACS that are deployed within VA. 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.

Further Market Research was conducted in October 2018 through a Request for Information was released on the Federal Business Opportunities (FBO) webpage to gauge industry to determine if there were other sources capable of providing the required maintenance support for the NTP PACS and Powerscribe 360 system. Two responses were received from Intelerad and VetMed Group. Intelerad is the sole provider of the required services. The Government’s experts reviewed the response from VetMed Group and determined they were unable to meet VA’s requirements.

VetMed did not address or provide evidence that demonstrated it could provide ongoing software updates and upgrades to the existing NTP PACS infrastructure, and VetMed Group does not have access to the proprietary source code for IntelePACS software which is required to service, support, update and upgrade the components of the PACS.

Further, VetMed is not licensed to provide upgrades to the IntelePACS and InteleViewer products as is required. VetMed was contacted on October 25, 2018 and advised of the VA’s assessment that it could not meet VA’s needs. No objections were received.

Based on the above, only Intelerad has the capability to provide the required support services which meet all of the Government’s requirements.

VA contacted Intelerad in October of 2018 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.

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.

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.

Procuring Contracting Officer Signature: ______________________

Approval

In my role as procuring activity Advocate for Competition, based on the foregoing justification, I hereby approve the acquisition of brand name Intelerad maintenance support on an other than fair opportunity basis pursuant to the authority cited in paragraph 4 above, subject to availability of funds, and provided that the property and services herein described have otherwise been authorized for acquisition.

Date: ______________ Signature: _______________________________

JUSTIFICATION FOR AN EXCEPTION TO FAIR OPPORTUNITY

COORDINATION MATRIX

Date Concur/Non-Concur