GlobalMed BNJ Final_redact_Redacted.pdf

JUSTIFICATION AND APPROVAL

BRAND NAME

CONNECTED CARE INTEGRATED NETWORK

1. Contracting Activity: Department of Veterans Affairs (VA)

Office of Acquisition Operations Strategic Acquisition Center (SAC) 10300 Spotsylvania Ave, Suite 400 Fredericksburg, VA 22408

2. Description of Action:

for the Connected Care Integrated Network (CCIN) Indefinite-Delivery, Indefinite-Quantity (IDIQ) Contract. The required items are hardware maintenance and commercial-off-the-shelf (COTS) software licenses and subscriptions used to deliver VA health care services to Veterans. The V connected care technology network includes the combined VA ecosystem of clinical video equipment and software; store and forward technologies; web and mobile health applications; software-as-a-service (SaaS) technologies; commercial-off-the-shelf (COTS) software products; mobile medical devices, peripherals, and wearables; remote patient monitoring technologies; online health portals; future connected care technologies; and ancillary items. The network supports the delivery of Mobile Applications, Telehealth services, including Clinical Video Telehealth (CVT) via the Clinical Enterprise Video Network (CEVN), Store and Forward Telehealth (SFT), Home Telehealth (HT), and the My HealtheVet online patient platform.

This Brand Name Justification (BNJ) for GlobalMed brand name products only covers a portion of the CCIN procurement, currently identified as two (2) out of 126 contract line items in accordance with (IAW) Attachment 3 to the PWS titled CCIN Product List, which is primarily comprised of services. As described more fully below, the brand name products are required for seamless operation of the connected care technology network.

Aside from these 2-line items and separate BNJs, this procurement will be solicited as Full and Open Competition and is being conducted utilizing FAR part 12 in conjunction with FAR part 15 and ordering will be in accordance with FAR 16.504.

3. Description of Supplies or Services:

The Office of Connected Care (OCC) established a connected care technology network for the distribution of health care, self-care, and related services that consists of telehealth devices, web and mobile medical applications, and online health platforms.

care network by remotely connecting Veterans with health care professionals who can best meet their needs.

The scale of program and its basis is unique. The products and services provided by OCC comprise the largest, most innovative virtual care program in the US, used throughout all 50 states and US territories.

VA-developed products require highly specialized industry support to successfully perform at the scope and complexity required by all connected care integrated network functions. These efforts must be delivered at a national level and the processes must be orchestrated from product inception through to enhancement and operational maintenance with products and services delivered by highly specialized staff.

CCIN Requirements e accessibility, capacity, quality, and satisfaction, OCC requirements are to provide connected care integrated network services, including the following linked functional areas (FAs):

FA 1: Product Ordering, Inventory, and Asset Management Covers the ordering and distribution of connected care products from CCIN and the Connected Care Product Catalog (CCPC) as well as the inventory and asset management for connected care equipment and software licenses that support health care in all forms delivered from a distance (i.e., synchronous, asynchronous, and remote patient monitoring), including primary care, mental health, and specialty care such as dermatology, vision/eye, radiology, urgent care, intensive care, and many others.

FA 2: Help Desk Support Provides 24x7x365 help desk support for all currently fielded and future connected care technologies.

FA 3: Connected Care Technology Software and Mobile Medical Application Design, Development, Enhancement, and Remediation Includes all services required to design, develop, enhance, and remediate web and mobile medical applications, online platforms, and telehealth software. This development includes a mix of custom-developed code and modified commercial-off-the-shelf (COTS) products.

FA 4: Infrastructure and Architecture Support Ensures support for the backend unified infrastructure and architecture for mobile applications and other connected care technologies, including the policies, shared services, and development and testing pipeline for app production release functions as necessary for the ongoing operation, maintenance, and release of new and existing web and mobile medical applications. (Note: Shared services refer to software code that is written for common functions and is reused across multiple applications and functions, i.e., patient lookup service.)

The four (4) FAs are performed cohesively to ensure minimum downtime for Veteran access to virtual care and requires a single contractor to lessen the risk of overlap, duplication, and delayed responses to operations.

Additionally, the Contractor shall be required to purchase certain products (i.e., mobile device data plans and maintenance, COTS software product licenses) that are necessary to provide support services in the functional areas listed above. These products are detailed in Attachment 3 to the PWS, CCIN Products List.

The period of performance is anticipated to be five-years from the date of award, with two, one-year performance-based optional ordering periods. This BNJ covers the GlobalMed brand name items detailed below throughout the period of performance. The estimated value of this BNJ is

The following summary includes the GlobalMed brand name items necessary for this requirement, the product description, the requirement, estimated value, a brief justification, and impact to the program.

Product Description: VA owns approximately 2,075 GlobalMed Primary Care and 275 Audiology Carts that have operated across VA since FY17. Every VA Medical Center and Clinic has at least one GlobalMed Cart. VA conducted 603,788 video visits in FY20, over 400K fewer than FY19 due to COVID 19, using these fielded GlobalMed Carts.

GlobalMed Telemedicine carts bundle hardware and software together to integrate high-definition cameras and diagnostic medical devices. These carts enable the delivery of video care to remote GlobalMed Telemedicine peripherals attached to the telemedicine carts are certified as Food and Drug Administration (FDA) medical devices. The Primary Care GlobalMed Cart has 3 peripherals, and the Audiology GlobalMed Cart has between 5 and 6 peripherals attached. Primary Care peripherals include a stethoscope, TotalExam and otoscope cameras for visual examinations. The Audiology Cart includes the same peripherals as the Primary Care Cart plus some combination of Zodiac2, Astera, Noahlink, Aurical PMM, Aurical hit box, and specialized headsets.

VA is Buying: VA requires continued hardware maintenance, warranties and software assurance, which includes phone/technical support, replacement of failed hardware, minor software updates and upgrades, for VA-owned GlobalMed telemedicine carts.

Estimated dollar value: over the life of the contract for hardware maintenance, warranty, and software assurance support.

Justification: Due to the proprietary nature of the GlobalMed carts, only GlobalMed and its authorized resellers are capable of providing hardware maintenance, warranties maintain the operational and functional integrity of VA-owned GlobalMed Telemedicine carts.

through price reductions achieved through competition. The aftermath of this would result in an unprecedented cessation of virtual care services as well as mandated requirements for OCC to provide telehealth services as a result of the CARES Act, MISSION Act, Hannon Act and others. Additionally, the GlobalMed brand name items are being acquired to support an FDA medical device data system. As part of the certification, FDA stipulates that only the vendor or one of its authorized resellers can provide maintenance and support.

6. Efforts to Obtain Competition:

Market research was conducted as set forth in paragraph eight of this document. Three separate Requests for Information (RFI) have been posted to the public, as well as extensive research of federally approved, FDA-approved and VA-approved equipment and associated services. As required by FAR 5.201, this action will be synopsized through SAM (http://sam.gov/). In addition, this justification will be published in accordance with FAR 6.305(c). The solicitation shall be provided to the public via Contract Opportunities to reasonably ensure proposals are received from vendors who can fulfill the requirement.

7. Determination of Fair and Reasonable Price:

The Government anticipates the cost for the requirement will be fair and reasonable.

The Government may utilize historical pricing, commercially available pricelists, and comparison of proposed pricing received in response to the solicitation. The Government, in accordance with FAR 15.404-1(b)(2), may also use various price analysis techniques and procedures and reserves the right to do so to ensure a fair and reasonable price is obtained.

8. Market Research:

Market research was conducted through three Requests for Information (RFI) (July 2021, October 2021 and December 2021) utilizing the NAICS code is 334111 Electronic Computer Manufacturing. These are commercial products. The most applicable Product Service Code (PSC) is 6515 Medical and Surgical Instruments, Equipment, and Supplies, specifically as it relates to products that support patient care. The RFI dataset included responses from 4 companies. All respondents indicated they can provide 100% of the parts list, to include all brand name equipment and services identified in this document, with existing distributor agreements or ones that can be obtained, indicating that the Government will get significant competition for items identified in this brand name justification.

Additionally, a special notice was issued in November 2022 under NAICS code 541512 Computer - Systems Design Services and applicable Product Service Code (PSC) DA01 IT and Telecom Business Application/Application Development Support Services. The special notice provided industry with the CCIN performance work statement (PWS) and Attachment 3, CCIN Product List. The product list is inclusive of all products which will be purchased under this requirement. No questions were received from industry regarding the GlobalMed brand name products.

Market research was completed on December 23, 2022 via an internet search which revealed that GlobalMed holds an International Organization for Standardization (ISO) 13485 Certificate of Registration with National Quality Assurance (NQA) which certifies the Quality Management System of GlobalMed. This certificate of registration is applicable to design, manufacturing, installation, and service of telemedicine stations, medical device cameras, and software for medical examination.

The manufacturer, GlobalMed, provided a memo to the Government on November 17, 2022 stating that both items covered under this brand name justification are proprietary to GlobalMed products and are not supported by any other company. As confirmed through market research, GlobalMed holds an ISO 13485 Certificate of Registration.

The memo provided to the Government further states that GlobalMed is the only

Medical Device Data Systems and associated peripheral products. This Warranty Service provides the VA a responsive support capability and access to replacement or repair parts to ensure GlobalMed end point stations and peripheral devices are operational.

9. Other Facts:

Not applicable.

10. Actions to Increase Competition:

The Government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable a deviation from the brand name requirement for future actions to be competed. Prior to exercising any option under this requirement, the VA will determine that exercise of options it the most advantageous

. VA will continue to monitor market trends, new/emerging products, looking for compatible and more advanced technologies to meet its needs.

Concurrence

Based on the foregoing justification, I concur with the acquisition of Connected Care Hardware Maintenance and Software Licenses and Subscriptions for the Connected Care Integrated Network in the estimated amount of on an other than full and open competition basis, pursuant to the authority cited in Section 38 U.S.C.

8153 and 41 U.S.C. 3304(a)(1) and implemented by the FAR 6.302-1(a)(2), subject to availability of funds, and provided that the services and commodities herein described have otherwise been authorized for this acquisition.

Christopher D.

Parker

Christopher D. Parker Associate Executive Director, Strategic Acquisition Center, and Acting Associate Executive Director, National Acquisition Center

Approval

Based on the foregoing justification, I concur with the acquisition of Connected Care Equipment Maintenance and Software Licenses and Subscriptions for the Connected Care Integrated Network in the estimated amount of on an other than full and open competition basis, pursuant to the authority cited in Section 38 U.S.C.

8153 and 41 U.S.C. 3304(a)(1) and implemented by the FAR 6.302-1(a)(2), subject to availability of funds, and provided that the services and commodities herein described have otherwise been authorized for this acquisition.

ANGELA

BILLUPS

Angela Billups, Ph.D.

Executive Director, Office of Acquisitions and Logistics, And Senior Procurement Executive