BNJ_NATUS_CCPCV2_Redacted.pdf

JUSTIFICATION AND APPROVAL

BRAND NAME

CONNECTED CARE PRODUCT CATALOG

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:

The purpose of this action is to justify VA’s need for Natus Medical brand name items for the Connected Care Product Catalog (CCPC) Blanket Purchase Agreement (BPA) Contracts, including Natus Medical TeleAudiology peripherals that are used to deliver VA health care services to Veterans. VA’s 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 and Telehealth services, including Clinical Video Telehealth (CVT) via the Clinical Enterprise Video Network (CEVN), Store and Forward Telehealth (SFT), and Home Telehealth (HT).

This Brand Name Justification (BNJ) for brand name products covers only a portion of the procurement (5 out of 266 contract line items) and the brand name, as detailed below, is required for seamless operation of the connected care technology network.

Aside from these 5 line items and separate BNJs, the procurement will be solicited as Full and Open Competition and conducted utilizing Federal Acquisition Regulation (FAR) Part 12 in conjunction with FAR Part 13.

3. Description of Supplies or Services:

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. These connected care technologies expand the operations of VA’s expansive health care network by remotely connecting Veterans with health care professionals who can best meet their needs. The scale of VA’s connected care 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.

Historically, all products and contractor support for VA’s connected care technology network have been delivered through the single-award Clinical Enterprise Video Network (CEVN) Blanket Purchase Agreement (BPA) (VA119-15A-0131), awarded in 2015, and the follow-on, single-award OCC Equipment and Services Transition Requirements Contract (36C10G21D0016), awarded in 2021. Acquisition planning for future connected care technology network support has resulted in the development of three distinct and separate contracts to leverage innovation and flexibility to meet mission needs by establishing:

a) Program Support Integration (PSI), planned as a single-award IDIQ responsible for all program and project management functions required by OCC, including program integration and program support; project, release, and implementation management; communications; and training.

b) Connected Care Integrated Network (CCIN), planned as a single-award IDIQ responsible for all technical support services required by OCC, including product ordering, inventory, and asset management; help desk support; connected care technology software and mobile medical application design, development, enhancement, and remediation; infrastructure and architecture support.

c) Connected Care Products Catalog (CCPC), planned as a catalog of multiple BPAs and outlined below.

VHA will utilize the CCIN contract for product ordering, distribution, and inventory and asset management services. The CCIN Contractor will place orders against the CCPC Product List, which will be formed by awarding Blanket Purchase Agreements (BPA) to Original Equipment Manufacturers (OEM), suppliers, and authorized resellers of connected care technologies (referred to as “BPA Holders”).

This procurement will establish multiple BPAs in direct support of VA’s Connected Care Program. This procurement is a key element in the success of the program as the BPAs will provide the mechanism that will supply connected care products for distribution to VHA facilities located in the United States (US) and US Territories. The CCPC Product List will include supplies awarded under BPAs.

The period of performance (PoP) is anticipated to be 60 months from the date of award.

This BNJ covers the Natus Medical brand name items throughout the PoP. The justification for these brand name items is included in the sections below:

Product Description: In combination with necessary hardware and software, GlobalMed telemedicine carts combine high-definition cameras, diagnostic medical device peripherals, and proprietary software on mobile carts to enable the delivery of video care to patients in locations at a distance from VA health care providers. Natus TeleAudiology diagnostic medical device peripherals are integrated by GlobalMed into the manufacturer’s telemedicine carts to deliver remote audiology services. GlobalMed does not currently enable the installation of any other audiology equipment on GlobalMed carts.

For both pediatric and adult clients, Includes, Coupler Based Fitting using RECD according to DSL v5.0b and NAL NL2, Directionality testing, Built-in induction loops, Autodetecting battery pills, Designed for wireless Hearing Instruments, Innovative design and small footprint, USB powered, HI testing according to IEC and ANSI standards, Snap-on couplers

Estimated dollar value: over the 60-month PoP.

Justification: Natus Medical TeleAudiology peripheral equipment, including associated software, are highly specialized, proprietary, FDA-certified medical devices. These devices and software are integrated with existing VA-owned GlobalMed equipment and systems. GlobalMed carts with Natus TeleAudiology peripherals enable video visits and diagnostic quality audiology examinations that are used to make medical determinations, which classifies the hardware and software as a medical device.

GlobalMed carts and GlobalMed WallDocs include a software package developed by GlobalMed that is implemented by VA’s Office of Information and Technology (OIT).

The software enables synchronous and asynchronous transmission of audio and visual images from the cart to the remote provider. The asynchronous images are transmitted to VA’s Veterans Health Information Systems and Technology Architecture (VistA). It also enables the connection of a camera and microphone from the provider side to a camera and microphone on the GlobalMed cart so the patient and their VA healthcare provider can see and speak to each other.

GlobalMed carts using Natus TeleAudiology medical peripherals are integrated into VA’s Telehealth Management Platform (TMP), the software that supports the scheduling of virtual care visits. TMP includes data on all assets necessary to schedule virtual care visits, including the location of wall-mounted GlobalMed WallDocs, Clincal Access Station (CAS), and TeleAudiology carts, and the location of compatible equipment on the provider side. This integration took over three years to accomplish and is necessary to enable the scheduling of any clinic-based telehealth appointment.

In an email sent on 4/14/2023, Samuel Price, Executive VP of Government Affairs at GlobalMed, confirmed that GlobalMed does “not install any other audiology equipment on our CAS Carts.” Further, market research indicated that “GlobalMed has designed and engineered its teleaudiology CAS solution around the Natus audiology products… Given the complexity of our teleaudiology CAS solution and the sensitivity and value of the integrated equipment, GlobalMed requires installation services to be completed by trained GlobalMed service technicians. This places the liability for any integration failures or equipment malfunctions squarely on the shoulders of GlobalMed and as such would be covered under the national GlobalMed maintenance contract.”

VA has invested over in the purchase of its more than 2300 GlobalMed carts and wall-mounted GlobalMed WallDoc units. While the WallDoc units are used only in support of primary care, the GlobalMed TeleAudiology carts with the integrated Natus medical peripherals support both primary care and TeleAudiology. VA requires that both system types must be capable of communicating with each other. A change in vendor for the teleaudiology carts would require the use of the same vendor to provide the CAS carts. In addition to the equipment and software purchases, VA has spent approximately in software development to integrate the carts with TMP, and approximately in the development and delivery of VA staff-facing training materials. Staff at the OCC Help Desk have also undergone specific training to enable them to support these FDA-certified systems.

The introduction of a new TeleAudiology vendor into this telehealth ecosystem would have significant impacts. VA would be required to replace the current peripherals, including more than 1,375 from Natus, and to integrate replacement carts with legacy ones as well as with VA Video Connect (VVC), VistA, and TMP. OCC would have to develop and deliver training on the new carts to VAMC and clinic staff. OCC Help Desk staff would have to get certified to support the new items. The risk of patient safety incidents would increase since staff would now have to operate two different platforms during the technology transition. Incorrect use of new equipment could result in an improper or missing diagnosis, delaying needed care, and have a negative impact on patient health.

Impact of the failure to obtain a brand-name product: Based on the facts above, no other brand-name product would work for VA. Natus diagnostic medical device peripherals are the only products that can be integrated with VA-owned GlobalMed TeleAudiology Carts. Award to any other source would require a replacement of the carts themselves. In this circumstance, VA would incur a substantial duplication of costs to the Government not expected to be recovered through competition. VA has purchased approximately 303 GlobalMed Carts with Natus Medical Audiology devices integrated at approximately per cart for a total replacement cost of . As explained above, however, the teleaudiology carts must integrate with the CAS carts, so, if interoperability cannot be established, a replacement of one system would dictate a replacement of all with a total estimated cost of around .

To replace the teleaudiology carts, OCC and OIT would be required to:

a) identify other FDA-certified options;

b) conduct extensive assessment and testing of each option to ensure they meet all

VA requirements, including patient safety requirements as well as security and privacy for devices that run on VA’s network;

c) develop the software to collect and transmit data from the peripherals through VistA to a device at the provider location; and,

d) develop and deliver new training materials for VA clinical and Help Desk staff.

This process would introduce unacceptable delays of at least three years in fulfilling VA’s requirements. The use of carts and peripherals from different manufacturers also increases the possibility of human error in using the equipment. These types of errors can have direct and deleterious effects on patient safety and health outcomes.

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) Subpart 6.302-1 entitled, “Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements, for brand name applications.”

5. Rationale Supporting Use of Authority Cited Above:

This is a brand name justification in accordance with FAR 11.105, Items Peculiar to One Manufacturer. The overall requirement consists primarily of critical connected care products needed to maintain VA’s connected care technology network, including web and mobile applications and Telehealth Services enterprise CEVN/CVT, SFT, and HT.

The brand name products identified in the CCPC solicitation are proprietary to the manufacturer listed above. As described and justified more fully in Section 3, the brand name products are major components of VA’s connected care technology network and are essential to the Government’s requirements. Based on the justification above, it was determined that only Natus Medical Inc. can meet the Government’s requirements. VA has made a significant investment in integrating the systems with VVC and TMP, developing training materials, and training staff in their use and support. The replacement would result in a duplication of costs as well as a significant effort to develop, test, and deploy new integration software. Additionally, VA would need to retrain thousands of staff through the 80-hour telemedicine cart training program while increasing the risk to patient safety and interfering with access to care.

GlobalMed Telemedicine Carts have a separate brand name justification. Natus is the only audiology equipment GlobalMed has integrated with its cart solution, and it enables video visits and diagnostic quality examinations used in making medical determinations.

Procuring equivalent teleaudiology equipment from another source would result in a duplication of costs which would not be recovered through competition.

Use of other than the identified brand products would cause a significant interruption to direct patient care, create unnecessary risks to patient safety, invalidate the FDA certification of the carts, and introduce potential security vulnerabilities, at a level unacceptable to VA’s mission and the connected care technology network. Additionally, the Government would experience a significant increase in costs associated with delays in the delivery of connected care technology products and services and a disruption of VA’s ability to deliver virtual patient care.

VA’s connected care capabilities have become a vital part of VA’s health care system.

The importance has never been more apparent than during the COVID-19 pandemic when record numbers of Veterans and VA health care professionals used virtual care for the first time to access VA care safely and virtually. Beginning in March of 2020 telehealth video appointments surged exponentially due to the COVID-19 pandemic.

This expansion of telehealth care was made possible by the reengineering of VA’s information technology infrastructure, rapid adoption by VA healthcare professionals, and an increase in VVC capacity to accommodate a greater number of concurrent users. As recently as FY22, VA provided over 9.2 million documented video encounters to the home, for an average of 185,703 per week.

During a time of year-over-year growth of connected care provided by VA, including the significant growth during the COVID-19 pandemic, any delays and/or disruptions to the connected care technology network would have an even more dramatic negative impact on Veterans’ access to health care. This impact is even greater in rural areas where VA health clinics are not easily available, requiring Veterans to physically travel long distances to VA locations or receive care in the community, resulting in increased costs to the Government for reimbursements both in Veterans’ travel fees and private care providers and their facilities.

Use of any other brand name would cripple the operation of the current connected care technology network. Integration of new technologies other than those required by this justification into a new connected care technology network would cause redevelopment of significant portions of VA’s connected care infrastructure, resulting in a monumental duplication of costs and a level of effort that would be almost impossible to recover 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. The Natus Medical Audiology brand name items are being acquired to support an FDA-certified medical device 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-certified, 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 (https://sam.gov/content/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 price for this 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 from July 2021 to February 2023. VA issued three Requests for Information (RFI) (July 2021, October 2021, and December 2021) utilizing the NAICS code 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 from Dec 2021 included responses from 4 companies. An analysis of the RFI revealed that 3 of the 4 respondents indicated they can provide 100% of the parts list, including 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.

On January 25, 2023, SAC posted a Special Notice to SAM.gov with the draft Statement of Work and the draft Product Catalog to receive additional feedback from industry. This notice generated a total of nineteen questions from one large, one small, and one SDVOSB business that informed the SOW and the product groupings within the catalog. Additionally, an internet search performed in February 2023 showed that there are multiple reseller sources capable of providing Natus Medical equipment.

Also as required as part of the market research process, the following databases were queried:

Services on the Procurement List maintained by the Committee for Purchase From People Who Are Blind or Severely Disabled, known as Ability One (FAR subpart 8.7) http://www.abilityone.gov/procurement_list/index.html;

VetBiz databases (IAW VAAR 810.001-70);

GSA eLibrary databases;

Dynamic Small Business Search.

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