P03 - HCA Executed - Medicom Technologies Sole Source.pdf

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 5: Request for Sole Source Justification Format >SAT

OFOC SOP Revision 11 Original Date: 03/22/11 Revision 11 Date: 02/11/2021

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C242-21-AP-0888

1. Contracting Activity: Department of Veterans Affairs, VISN 02 VA Network New York/New Jersey.

2237: 528-21-2-3760-0027.

2. Nature and/or Description of the Action Being Processed: This requirement is for a VISN-wide system that enables the electronic, bi-directional exchange of radiology imaging exams and reports with commercial healthcare facilities providing services to VA patients.

The Mission Act has made it possible for Veterans to seek diagnostic imaging services outside of the VA. As a result, diagnostic results in the form of DICOM images and textual reports need to be couriered back to the VA for further patient care. As it exists currently, CD-ROMs and DVD- ROMs are hand-carried or mailed to and from the VA at the completion of a diagnostic test; this causes bottlenecks and delays in the continuity of Veteran care. There have also been delays in archiving the images delivered to the ordering provider by the patient. The VA relies on CDs to share imaging examinations with community care providers, but examinations are often repeated when CDs are not requested, get misplaced, or are not “readable” due to software incompatibility.

Misplaced CDs and repeat imaging add unnecessary cost to the process and increase the risk to Veterans due to delayed diagnoses, additional workups, and increased radiation exposure.

A peer-to-peer network that would give VA Hospitals the ability to electronically exchange data with the community is required. Medicom’s Imagex system minimizes delays in the delivery of care and reduces the operational costs associated with seeing a Veteran imaged outside of VA under the Mission Act.

The estimated annual cost for this system is $278,587.50 or $1,392,938 for five years. A base year plus four option years contract is anticipated.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The Medicom Imagex system will integrate with VistA Imaging Importer, Vista Imaging, Computerized Patient Record System (“CPRS”), Philips IntelliSpace, Agfa Impax PACS (which may be implemented in the future), Laurel Bridges’ Compass DICOM router or any other DICOM router provisioned by the VA, and Cerner which will be implemented in the future.

Acquisition Plan Action ID: 36C242-21-AP-0888

OFOC SOP Revision 11 Original Date: 03/22/11 Revision 11 Date: 02/11/2021

Imagex will ensure the VA can continue to save diagnostic images to the aforementioned systems and pathways and will authenticate and validate bi-directional, electronic exchange of DICOM images, Radiology reports, and Radiology orders using a FIPS 140-2 validated cryptographic methodology.

Imagex allows the Radiology department to search the commercial imaging providers located within VISN 2, locate prior medical images and reports, and retrieve them to the VA where they can be inducted to VA systems using a quality assurance step.

In addition, Imagex automatically matches patient IDs to update the patient’s Medical Record Number (MRN) with the VA’s MRN, when possible. The system will generate a non-VA order through VistA Imaging in CPRS and update the inbound studies with the VA accession number for reconciliation in Philips IntelliSpace or Agfa Impax PACS. In some cases, these studies may be stored through Compass DICOM Router.

4. Statutory Authority Permitting Other than Full and Open Competition:

( X ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Medicom is the only fully-federated health information exchange provider that connects disparate silos of health information so that they can be easily and securely searched and shared. The VA intends to purchase the Imagex product from Medicom. Imagex facilitates the exchange of radiology information such as reports and images through encrypted conduits between providers on the fully federated health information network. Medicom is the only vendor to provide this fully federated image sharing architecture. Unique system features include:

OFOC SOP Revision 11 Original Date: 03/22/11 Revision 11 Date: 02/11/2021

Allows system queries to the healthcare community to locate VA patients’ prior images in the private sector. Without a fully integrated approach, VA providers have to coordinate via phone and fax to locate prior images.

The Imagex model allows data sent from community care providers to the VA via a secure conduit by through a FIPS 140-2 validated connection with the VA Trusted Internet Connection (TIC). Medicom is currently the only provider to offer this architecture and is the only vendor to exceed VA requirements for handling sensitive information. Other methods utilize cloud environments to store and process VA Sensitive Data which are not authorized to operate under the Federal Risk and Authorization Management Program (FEDRAMP ATO).

Imagex provides advanced automation features that improve patient safety through consistent access to information and reduces operational overhead for the VA with significant operational savings expected. Features include Automated Federated Search, Patient Matching, Automated Internal Pre-fetch, and Electronic Requests.

o Automated Federated Search utilizes an upcoming VA Care in the Community Appointment to automatically query the network of providers and retrieve health information relevant to an upcoming VA care event.

o Automated internal prefetch routes data internally using trigger events to ensure data is available where clinicians need it. Imagex procedure code mappings and advanced routing rules are not available from other solutions.

o Patient Matching allows Imagex to update DICOM images and reports as they arrive from the private sector so the system can automatically add the information to the patient’s chart in CPRS and jacket in Philips IntelliSpace or Agfa Impax. This workflow avoids manual intervention and increases process efficiency.

o Electronic Requests enables VA employees to request and search for patient information at facilities participating and not participating on the network.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Since the Mission Act of 2018 Medicom has worked in collaboration with the government and the Department of Veterans Affairs to create and deliver a federated health information network that provides accessibility to medical imaging and records data for Veterans in the VA healthcare system who may seek medical services outside of the VA.

Medicom's federated platform solves the interoperability challenges faced in health care with its proprietary peer-to-peer secure network technology that enables indexing, search, and retrieval of information in a decentralized manner. The Imagex system allows VA healthcare providers retrieve requested images and reports from community providers electronically through temporary encrypted conduits and seamlessly induct the data into their existing healthcare IT record systems.

Existing VA methods require system diagnostic results on CD-ROMs and DVD-ROMs be couriered back to the VA, resulting in considerable delays in diagnoses and continuity of care. To date the VA has executed fifteen contracts with Medicom for the Imagex system.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Medicom’s Facility-Based pricing for Imagex is discounted 50% for the VA from private sector rates:

OFOC SOP Revision 11 Original Date: 03/22/11 Revision 11 Date: 02/11/2021

Product Private Sector Rates Medical Center Rates with VA Discount

Imagex with Assistant Edition $60,000/year/hospital $30,000/year/VAMC and/or

HCS

Maintenance, and Training Agreement

20% of total contracted value = $12,000/year/hospital

15% of total contracted value = $4,500/year/VAMCs and/or

HCS

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research was conducted for competing brands of image sharing systems with the requisite features. The medical image and information sharing market is robust across a wide range of capabilities, but none were found with a mature federated approach capable of efficiently integrating with VA systems. Systems offered by Ambra and Nuance for example provide for some capability but utilize the cloud or are not sufficiently able to seamlessly connect to VA diagnostic and record keeping systems. Research was also conducted regarding the existing collaborative relationship between the Department of Veterans Affairs and Medicom Technologuies, Inc. In accordance with the information presented above and the fact that 15 Veterans Administration Health Care Systems and VA Medical Centers across 11 states have now contracted with Medicom Technologies Inc. to become members of the Medicom health information network, no further market research is required to be conducted at this time.

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

Medicom's current VA contracts include:

Southern Arizona VA Health Care System (AZ) Phoenix VA Health Care System (AZ) William S Middleton VA Medical Center (WI) Clement J Zablocki VA Medical Center (WI) Oscar G. Johnson VA Medical Center (MI) Asheville VA Medical Center (NC) VA Southern Nevada Health Care System (NV) Ft. Harrison VA Health Care System (MT) Cheyenne VA Health Care System (WY, CO) Eastern Colorado VA Health Care System (CO) Western Colorado VA Health Care System (CO, UT) Eastern Oklahoma VA Health Care System (OK) Oklahoma City VA Health Care System (OK) Salt Lake City VA Health Care System (UT, ID, NV) Sheridan VA Health Care System (WY)

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Medicom Technologies Inc.

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

OFOC SOP Revision 11 Original Date: 03/22/11 Revision 11 Date: 02/11/2021

Jeffrey D Digitally signed by Jeffrey D

Wilkinson 395614 Date: 2021.04.27 14:19:48 -04'00' Wilkinson 395614

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.

Jeffrey Wilkinson Date VISN2 Health Systems Specialist Albany VA/VISN2

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.

Sam A DeMuzio 375167

Digitally signed by Sam A DeMuzio 375167 Date: 2021.04.27 14:05:47 -04'00'

Sam DeMuzio Date Contracting Officer Canandaigua VA/NCO2

OFOC SOP Revision 11 Original Date: 03/22/11 Revision 11 Date: 02/11/2021

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.

David Warunek Date NCO2 Branch Chief – Supply Team Bath VA/NCO2

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and recommend approval (if over $75 million) or approve ($750K to $75 million) for other than full and open competition.

Joseph P. Maletta Date Executive Director, Regional Procurement Office – East (RPO-E) Head of Contracting Activity (HCA)

David C. Warunek 506536

Digitally signed by David C.

Warunek 506536 Date: 2021.05.20 10:36:15 -04'00'