Justification_Exception_to_Fair_Opportunity_Brand_Name_Exceeding_SAT _Redacted.pdf

JEFO No. 26-220

Justification for Brand Name Exception to Fair Opportunity Exceeding the SAT pursuant to RFO 16.507-7

JEFO No.: 26-220 Date: August 10, 2026, PR Number: WX03364Y2026T

Pursuant to the Federal Acquisition Regulations (FAR) 16.5, FAR Class Deviation 26-04, Revision 1 for FAR Part 16 and in accordance with the requirements of RFO 16.507-7, the justification for the use of a brand name description is supported by the following facts and rationale required under RFO 16.507-7.1

1. Identification of the agency and the contracting activity, and specific identification of the document as a “Justification for an Exception to Fair Opportunity.

The Department of Homeland Security (DHS), Federal Emergency Management Agency (FEMA) intends to issue a brand-name call under the DHS Strategic Sourcing Vehicle (SSV) Blanket Purchase Agreement (BPA) Medical Supplies II, referred to as MedS2, for Stryker LIFEPAK CR2 Automated External Defibrillators and associated operational accessories.

This justification is submitted pursuant to RFO 16.507-7. RFO 16.507-7 is cited as the applicable brand-name documentation requirement because FEMA’s minimum needs require supplies that are unique to the Stryker LIFEPAK CR2 AED and associated accessories. This justification does not authorize award to a single BPA holder without competition. The BPA Call will be competed among eligible MedS2 Category 2 Small Business (SB) BPA holders capable of providing the required brand-name supplies.

Contractor Business Size BPA Number

Atlantic Trading Small Business 70B03C23A00000021 AVMedical Small Business 70B03C23A00000027 The Janz Corporation Small Business 70B03C23A00000035

2. Nature and/or description of the action being approved.

The Department of Homeland Security, Federal Emergency Management Agency, Office of the Chief Administrative Officer, Medical Division, Emergency Medical Services Branch, prepared this justification for a brand-name exception to fair opportunity.

FEMA intends to issue a firm-fixed-price commercial BPA Call on a brand-name basis to procure Stryker LIFEPAK CR2 Automated External Defibrillators and associated operational accessories. Competition regarding this requirement will be conducted among the three SB eligible DHS MedS2 BPA holders capable of providing Stryker products.

1 In this document, citations to RFO Part 15 and RFO Part 16 are citations specifically to Federal Acquisition Regulation (FAR) Class Deviation 26-08, Revision 1 for FAR Part 15 and FAR Class Deviation 26-04, Revision 1 for FAR Part 16, which were issued as part of the Revolutionary FAR Overhaul (RFO), which was implemented in response to Executive Order 14275, Restoring Common Sense to Federal Procurement, signed April 15, 2025.

These commercial supplies provide continuous cardiac monitoring, 4G cellular data connectivity for remote readiness tracking, high-joule defibrillation capability, and CPR training tools required to maintain workforce safety across FEMA-managed facilities, Joint Field Offices, Long-Term Recovery Offices, regional locations, and disaster field operations.

4. Identify the exception to fair opportunity and supporting rationale.

The Government’s minimum needs require the Stryker LIFEPAK CR2 brand-name AED platform and associated accessories because the supplies are unique or highly specialized and are peculiar to one manufacturer. This justification supports limiting the requirement to the Stryker LIFEPAK CR2 brand-name product and associated accessories pursuant to RFO 16.507-7.

This justification does not authorize award to a single BPA holder without competition. The resulting RFQ/call will be competed among eligible DHS Strategic Source Vehicle Blanket Purchase Agreement Medical Supplies II (MedS2) BPA holders capable of providing the required Stryker brand-name supplies.

Only the Stryker LIFEPAK CR2 brand-name product can meet the Government’s minimum needs; however, multiple eligible BPA holders may be capable of providing that product.

FEMA intends to procure a brand-name specification for Stryker LIFEPAK CR2 Automated External Defibrillators (AEDs) and associated accessories. The exception is based on RFO 16.507-7 because the Stryker LIFEPAK CR2 cellular AED platform provides the combination of clinical, operational, remote monitoring, and deployment features required to meet FEMA’s mission needs.

FEMA personnel and emergency response teams deploy across the United States to austere disaster environments, including Joint Field Offices, Long-Term Recovery Offices, regional locations, temporary duty locations, and disaster field operating locations. These environments may lack municipal power, reliable local Wi-Fi, or immediate local emergency medical support.

Contracted medical support can take approximately 7 to 14 days to mobilize during initial disaster response phases. FEMA therefore requires an integrated AED fleet that can support immediate lifesaving cardiac response capability, remote automated readiness tracking, and effective CPR support for deployed personnel.

The Stryker LIFEPAK CR2 AED must be used because it provides the following essential capabilities:

a) Integrated 4G/LTE cellular connectivity.

The Stryker LIFEPAK CR2 cellular model provides automated daily status monitoring through LIFELINKcentral without reliance on local Wi-Fi or external agency IT infrastructure. This capability is essential because FEMA deploys to disaster environments where local network availability may be unavailable, unreliable, or restricted. AEDs relying on local Wi-Fi or manual data transfer would require physical inspections and would create readiness gaps across geographically dispersed field locations.

b) Continuous CPR rhythm analysis.

The Stryker LIFEPAK CR2 provides CPR INSIGHT technology, which enables continuous ECG rhythm evaluation during active chest compressions. This minimizes or eliminates pre-shock pauses and increases compression time during cardiac emergencies.

This capability is essential to support effective emergency cardiac response for deployed FEMA personnel.

c) High-energy biphasic shock output.

The Stryker LIFEPAK CR2 provides escalating shock delivery up to 360 joules for hard-to-defibrillate patients. This capability is required to meet FEMA’s clinical and operational standards for emergency responder support.

d) Immediate power activation.

The Stryker LIFEPAK CR2 powers on automatically when the lid is opened, without requiring secondary buttons. This supports rapid emergency use by deployed personnel during time-sensitive cardiac events.

e) Compatibility with FEMA’s current Stryker AED ecosystem.

FEMA currently maintains legacy Stryker HeartSine Samaritan 450P AEDs and requires lifecycle replacement with Stryker LIFEPAK CR2 units. The Stryker platform supports standardization, operator familiarity, accessory compatibility planning, software continuity, and fleet monitoring through the LIFELINK CENTRAL Campus Solution.

f) Integrated fleet readiness management.

The Stryker LIFEPAK CR2 platform, together with associated 4G data plans and LIFELINK CENTRAL software subscriptions, enables FEMA to conduct remote fleet monitoring and readiness tracking for AEDs located across FEMA facilities, Joint Field Offices, Long-Term Recovery Offices, regional locations, and temporary disaster response sites. This capability is necessary because the fleet will be geographically dispersed and may be deployed in locations where manual inspection is impracticable.

No portion of this medical supply package can be segregated for brand-neutral competition without compromising FEMA’s minimum requirements. The required cellular telemetry, software ecosystem, electrodes, batteries, data plans, training units, and trade-in program are tied to the Stryker LIFEPAK CR2 platform. Procuring an alternate AED platform would require separate accessories, separate readiness monitoring systems, additional training, and potentially manual inspection processes that would not meet FEMA’s operational requirements.

Market research evaluated major commercial AED lines, including Zoll Medical AED 3 Series and Defibtech Lifeline Series. FEMA determined that these alternatives do not meet the Government’s minimum requirements.

Zoll Medical AED 3 Series: Relies natively on local Wi-Fi networks for device readiness tracking, which may be unavailable or restricted at FEMA field locations; has a maximum 200-joule shock energy output; and requires CPR chest compressions to pause during heart rhythm analysis.

Defibtech Lifeline Series: Requires manual SD cards for data transfer; has a maximum 150-joule shock energy output; and requires chest compressions to stop during rhythm evaluation.

and escalating shock output up to 360 joules without reliance on local Wi-Fi or agency IT networks.

Market research also confirmed that multiple authorized distributors exist under the DHS Strategic Sourcing vehicle that can compete for this BPA call and provide Stryker products while honoring the per-unit trade-in credit for FEMA’s legacy HeartSine 450P fleet.

b) Delivery lead time and supply chain capability Market research evaluated vendor delivery capabilities and manufacturing supply chain lead times. Due to nationwide commercial demand and current lack of immediate off-the-shelf inventory or bulk manufacturer stock for 700 units, a phased delivery approach is required.

The Contracting Officer has established a phased fulfillment schedule to support production and distribution. Delivery and trade-in of the 700 Stryker LIFEPAK CR2 AEDs, associated electrodes and lithium batteries, 4G cellular subscriptions, and training units will occur in planned increments over four phases. This phased delivery approach mitigates supply chain constraints while ensuring continuous replacement of FEMA’s legacy fleet without disrupting emergency operational readiness.

c) Suitability of technical specifications A generic performance specification or open purchase description is not suitable for this requirement because the required clinical telemetry, automated status reporting, and software monitoring systems are proprietary to Stryker’s hardware ecosystem. A brand-neutral specification would not adequately capture the proprietary protocols required for seamless integration with FEMA’s current LIFELINK CENTRAL Campus Solution software infrastructure.

d) Inability to modify the requirement to enhance competition The requirement cannot be modified to permit generic commercial AED alternatives without compromising essential operational and clinical standards. Relaxing technical criteria, such as allowing Wi-Fi-only connectivity in place of direct cellular connectivity or accepting a lower maximum shock energy output, would introduce operational failure risks in disaster zones lacking network infrastructure and could compromise cardiac response capabilities during emergency deployments.

e) Duplication of cost and fleet standardization

Transitioning to an alternative non-Stryker AED fleet across 700 units would require replacement of accessory inventories, additional training for field responders across multiple FEMA regions, and potentially parallel software monitoring systems.

Standardizing on the Stryker LIFEPAK CR2 platform leverages existing operator familiarity, reduces redundant training burdens, supports lifecycle management, and optimizes the lifecycle value of the estimated $ trade-in allowance.

f) Public notice A separate public synopsis on SAM.gov is not anticipated for this BPA call. In accordance with FAR 5.202(a)(11), synopsis is not required when the proposed contract action is an order placed under an indefinite-delivery contract or similar ordering vehicle that was previously synopsized in sufficient detail. The requirement will be competed among the applicable DHS MedS2 BPA holders capable of fulfilling the Stryker brand-name requirement. This Brand Name Justification will be posted for 30 days at

SAM.GOV.

7. A statement of the actions, if any, the agency may take to remove or overcome any barriers that led to the exception to fair opportunity before any subsequent acquisition for the supplies or services is made.

FEMA will continue to conduct market research and monitor the commercial medical device industry for technological advancements in AED hardware, cellular telemetry, and remote fleet management platforms.

Before any future replacement or replenishment cycle, FEMA will evaluate whether other commercial AED manufacturers can meet the following minimum requirements:

a) Integrated 4G or 5G cellular tracking capabilities independent of local Wi-Fi networks;

b) Universal or interoperable remote monitoring software capabilities;

c) High-joule shock output up to 360 joules;

d) Continuous CPR rhythm analysis during active chest compressions;

e) Compatibility with FEMA’s deployed emergency medical operating environment; and

f) Ability to support fleet-wide readiness monitoring across geographically dispersed disaster response environments.

If future market research demonstrates that other commercial manufacturers can satisfy these mandatory operational, clinical, and remote fleet tracking requirements, FEMA will structure future acquisitions to allow broader competition.

For this current requirement, barriers to competition have been mitigated to the maximum extent practicable by avoiding a sole-source award directly to the original equipment manufacturer.

Instead, FEMA will compete the requirement among the eligible DHS MedS2 BPA holders capable of providing the required Stryker brand-name products, thereby preserving price competition among authorized distributors.