36C25226D0048_1.docx

SUBJECT*

V12 Hands Free Clinical Communication and Workflow System (Vocera) Brand Name Only

GENERAL INFORMATION

BASE NOTICE TYPE

SET-ASIDE

36C252 115 South 84th Street, Suite 101 Milwaukee WI 53214-1476

POINT OF CONTACT*

Contracting Officer Jim Hedman james.hedman2@va.gov

AWARD INFORMATION

LINE ITEM NUMBER

AWARDEE ADDRESS LINE 1*

AWARDEE ADDRESS LINE 2*

AWARDEE ADDRESS LINE 4*

DESCRIPTION

Award Notice Award Notice VISN 12 Hands Free Clinical Communication and Workflow System, Vocera Brand Name Only. Includes hardware, implementation, licenses, support, and warranties.

*= Required Field Award Notice Award Notice

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) for Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C252-26-AP-1553

1. Contracting Activity: Justification for Other Than Full and Open Competition, Department of Veterans Affairs, Veterans Integrated Service Network (VISN) 12 Medical Centers and Clinics. 2237s for first orders:

537-26-2-969-0110: Jesse Brown VA Medical Center (Chicago, IL) 556-26-2-2993-0060: Captain James Lovell Federal Health Care Center (North Chicago, IL) 585-26-2-063-0030: Oscar G. Johnson VA Medical Center (Iron Mountain, MI).

676-26-2-969-0032: Tomah VA Medical Center

1. Nature and/or description of the action being approved: The proposed action is to establish a new brand name only, firm fixed Indefinite-Delivery, Indefinite-Quantity (IDIQ)-type contract with five-year ordering period. VISN 12 intends to establish a contract for Stryker Sales, LLC/Vocera Communications, Inc. hands‑free clinical communication devices, accessories, and service.

2. Description of supplies/services required to meet the agency’s needs: VISN 12 facilities – including the VA Illiana Health Care system (Danville, IL), Captain James Lovell Federal Health Care Center (FHCC) (North Chicago, IL), Jesse Brown VA Medical Center (Chicago, IL), Edward Hines, Jr. VA Hospital (Hines, IL), William S. Middleton Memorial Veterans Hospital (Madison, WI), Clement J. Zablocki VA Medical Center (Milwaukee, WI)/Milo C. Huempfner Department of Veterans Affairs Outpatient Clinic (Green Bay, WI), Tomah VA Medical Center (Tomah, WI), and the Oscar G. Johnson VA Medical Center (Iron Mountain, MI) – intend to procure and implement a communication system that provides a secondary method for displaying patient information as well as supports extension-to-extension calling, voicemail, and connectivity to public telephone networks. This system will integrate mobile telecommunications devices with various medical systems to improve communication efficiency and effectiveness in patient care processes.

The total estimated amount of the proposed action is [REDACTED] over a five-year ordering period to begin on or around 9/1/2026.

3. 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 RFO 6.103-1;

(X) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by RFO 6.103-2;

(X) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by RFO 6.103-3;

(X) (4) International Agreement per 41 USC §3304(a)(4) as implemented by RFO 6.103-4

(X) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by RFO 6.103-5;

(X) (6) National Security per 41 USC §3304(a)(6) as implemented by RFO 6.103-6;

(X) (7) Public Interest per 41 USC §3304(a)(7) as implemented by RFO 6.103-7;

Demonstration that the contractor’s unique qualifications or nature of the acquisition requires the use of the authority cited above (applicability of authority): Vocera is the only communication system that meets VISN 12’s essential requirements for secure, hands-free clinical communication. VA policy requires that wireless devices transmitting sensitive information use Federal Information Processing Standard (FIPS) 140-2 validated encryption, as outlined in VA Directive 6512, which firms may apply for and obtain at any time. The National Institute of Standards and Technology’s (NIST’s) FIPS standards (FIPS 140-2/140-3) define the cryptographic module validation VA relies on, and CMVP certificates are the authoritative proof of validation. Vocera Smartbadge/V5000 holds NIST Cryptographic Module Validation Program (CMVP) Certificate #3865, which is evidence of FIPS 140-2 validation for the device’s firmware module used to secure clinical communications over wireless networks, meeting VA 6512 requirements. Note: FIPS 140-3 is the modernized successor to FIPS 140‑2, aligning with updated international standards (ISO/IEC 19790/24759) and adding stricter, clearer requirements for modern cryptographic modules. Enterprise hands‑free clinical communication endpoints with 140‑3‑validated embedded modules are not yet broadly found in market research. Vendors may still be relying on FIPS 140‑2 modules during the transition period.

[REDACTED]. New endpoint devices must integrate seamlessly with existing Vocera servers, software, managed services, and clinical workflows to avoid costly downtime, retraining, and operational risk. The VA has previously expanded and integrated Vocera solutions into nurse call and VistA/CPRS, demonstrating enterprise compatibility and clinical workflow integration across VA healthcare. Vocera helps preserve operational continuity and is expected to minimize risk by avoiding the need for new platforms from other brands, retraining burdens, integration rework, or downtime that would disrupt clinical operations. Prior VA deployments emphasize two-way nurse call integration and urgent order or critical lab result notifications to endpoints, which VISN 12 seeks to standardize.

Devices must allow hands-free operation to reduce contamination risk and cognitive load during urgent workflows. Vocera’s hands-free, voice-activated wearables are designed for hospital workflows with features like a handset mode for privacy, prioritized clinical event notifications, and seamless integration with EHRs, nurse call, monitors, and scheduling systems via Vocera Engage middleware. The Vocera ecosystem supports role and group messaging, device fleet management, and web-based configuration and administration, enabling devices to be shared among users without compromising security. This is a hospital-specific requirement where shift-based assignments drive usage.

Based on available market research, brands such as Ascom, Spectralink, Zebra, Cisco, and Apple offer smartphones or handheld devices, some with FIPS-validated modules, but none provide a true hands-free wearable solution. These alternatives rely on touchscreens and app navigation, which are impractical in sterile environments and would require new platforms, workflow redesign, and retraining. The Vocera devices provide a lightweight, wearable form factor designed for hands-free operation, which is critical for caregivers working in sterile environments or under PPE. Some competitor FIPS modules are listed as historical, and others do not have publicly documented evidence of integration with VA systems, which raises uncertainty about their ability to meet VA-specific workflow and infrastructure requirements. Adopting these alternatives would compromise operational continuity and increase risk, making them unsuitable for VISN 12’s requirements.

Additional alternative solutions include TigerConnect, Spok, Voalte Messenger, OnPage, and PerfectServe. The platform distinguishes itself through intelligent message prioritization that reduces alarm fatigue by using real-time situational awareness to route actionable messages with clinical context to the appropriate care team member, interoperability with over 140 clinical and operational systems including electronic health records, and a unified solution that combines hands-free communication via the Vocera Badge, secure text messaging, and alert management in a single platform. Critically for federal users, Vocera has achieved FIPS 140-2 validation for both its Smartbadge Cryptographic Module (CVMP #3865) and Vocera Cryptographic Module (CVMP #4393), meeting the stringent cryptographic security requirements mandated for federal agencies protecting sensitive government data. The platform provides proven reliability (more than 1,700 facilities worldwide using Vocera solutions) alongside the necessary federal security certifications required for VA implementation. While competitors such as TigerConnect and Spok claim FIPS 140-2 compliance in their marketing materials, it is compliant through third parties and not validated through NIST. The distinction is critical for federal users: FIPS 140-2 compliance means a product uses cryptographic modules that claim to meet the standard, where FIPS 140-2 validation means the cryptographic module has undergone formal testing by an accredited laboratory and received a certificate number from NIST's CMVP.

The proposed procurement strategy supports OMB Memorandum M-25-31 issued on July 18, 2025, implementing Executive Order 14240, which requires agencies to consolidate and standardize contracts. For these reasons, Vocera is uniquely qualified to deliver the required level of quality and security. It is the only brand that combines hands-free, lightweight wearable endpoints with validated FIPS encryption and proven interoperability with existing VA infrastructure. This makes Vocera the only viable solution for VISN 12’s needs and justifies a brand name procurement under RFO 11.204, with limited competition among authorized resellers.

Accordingly, Vocera is the only manufacturer capable of providing the supplies and services described above without the Veteran’s Health Administration experiencing unacceptable delays in fulfilling its requirements.

4. Description of efforts made to ensure that offers are solicited from as many potential sources as possible (including whether a notice was or will be publicized as required by RFO Part 5 and, if not, which exception under RFO Part 5 applies): Market research was conducted, details of which are in the market research section of this document. This effort yielded two sources that can meet the Government’s requirements on a Brand Name Only basis. There is competition anticipated for this acquisition. In accordance with RFO 5.101(d)(2), a presolicitation notice will be posted with the solicitation.

A Sources Sought notice (36C25226Q0254) along with the Statement of Work was posted to NASA SEWP V contract holders on 2/6/2026, closing on 2/13/2026. One response was received, from [REDACTED].

5. Determination by the CO that the anticipated cost to the government will be fair and reasonable: The anticipated cost will be considered fair and reasonable based on price analysis in accordance with RFO 15.404-1(b)(1), (2), and (4). Certified cost or pricing data will not be required.

(1) Comparison of proposed prices received in response to the RFP. It is anticipated that at least two responses will be received.

(2) Comparison of the proposed prices to historical prices paid, whether by the Government or other than the Government, for the same or similar items. Vocera products have been provided by both vendors the Government expects proposals from. It has historical data to analyze price.

(4) Comparison with competitive published price lists, published market prices of commodities, similar indexes, and discount or rebate arrangements. Items/services are available [REDACTED]. Proposed prices will be compared with contract prices.

6. Description of the market research conducted and the results, or a statement of the reasons market research was not conducted: The CO conducted an SBA Small Business Search for NAICS 541519; 41,500 small business results were returned. Another search was done for the same NAICS and filtered for VOSBs or SDVOSBs; 11,205 results were returned. A final search was done for NAICS 541519 and keyword, “Vocera”; zero results were returned.

The CO has familiarity with the procurement of the Vocera system and administers one Vocera contract (36C25221P1364) and one Agency Catalog (an Agency Catalog is a now-outdated version of NASA SEWP V’s Strategic Marketplace or Storefront) (36C25221A0026). It is known that items and services are available [REDACTED]. Items and services are also available [REDACTED].

The CO attempted to generate additional competition on NASA SEWP V by posting a Sources Sought notification (36C25226Q0254) along with the Statement of Work. [REDACTED].

Finally, the CO contacted Vocera to determine availability of authorized distributors. It confirmed [REDACTED].

This is a Brand Name Only acquisition for Vocera products. An unrestricted Request for Proposal (RFP) for a firm fixed price IDIQ-type contract will be issued on the open market.

Note: RFO 8.104 mandates the use of “required use” contracts such as GSA FSS or NASA SEWP contracts unless excepted by the head of contracting activity; however, to date, the Office of Federal Procurement Policy has not designated any contract as “required use.”

Buy American Statute/Trade Agreements Act: The system’s main supply components (V5000 Smartbadge, adaptor, training kit), software, and licenses are all manufactured in the USA. However, this acquisition is considered information technology supplies and services. Per section 535(a) of Division F, Title V, Consolidated Appropriations Act (2004), the restriction on purchasing foreign end products does not apply to the acquisition of information technology that is a commercial product, when using Fiscal Year 2004 or subsequent Fiscal Year funds.

Nonmanufacturer Rule: This requirement is manufactured by a large business and there is no SBA Class Waiver for NAICS 541519. There are small businesses that distribute or sell the items, but the procurement strategy will not involve simplified acquisitions as it is estimated to be [REDACTED]. Therefore, this procurement can only be issued as an unrestricted solicitation or contract/order against existing Indefinite Delivery Vehicles (IDVs).

FITARA: The PSC assigned to this acquisition is 7A21 IT and Telecom - Business Application Software (Perpetual License Software). The Deputy Assistant Secretary (DAS), Deputy Chief Information Officer (DCIO) or equivalent of the requiring activity review and approval are required. Subsequent orders will require FITARA review and approval for compliance.

7. Any other facts supporting the use of other than full and open competition: None.

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

[REDACTED]

9. 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 clinical communication technology sector continues to evolve, with emerging solutions and new market entrants developing innovative approaches to real-time healthcare communication systems. To reduce barriers to competition in future acquisitions, the VA will actively monitor technological advancements in enterprise clinical communication platforms and engage in ongoing market research as needs mature and throughout contract lifecycle. Current market conditions present significant barriers to entry, as Vocera maintains substantial advantages through its acquisition by Stryker, providing expanded market reach and resources, established presence in existing VA medical centers with deeply integrated systems, proven hands-free communication capabilities critical to infection control and clinical efficiency, and validated FIPS 140-2 cryptographic compliance (not merely third-party certification) required for protecting sensitive patient health information. Until comparable solutions achieve equivalent security validation, operational maturity, and demonstrated compatibility with VA's complex healthcare IT environment, the agency anticipates limited competition for enterprise-wide clinical communication requirements.

10. 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.

[REDACTED]

11. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Jim R. Hedman Date Contracting Officer Network Contracting Office 12

b. [REDACTED]