NAR CLS KIT LSJ (final)_Redacted.pdf

Limited-Sources Justification

1. Defense Logistics Agency (DLA) Troop Support, Medical Supplier Operations, Electronic Catalog (ECAT) Division is the contracting activity.

2. This justification is for the acquisition of a unique and highly specialized, products essential to the Government’s requirements under

3. 1st Marine Division (1st MARDIV) I Marine Expeditionary Force Camp Pendleton, California has the following requirement:

Item Description(s): North American Rescue USMC Combat LifeSaver Kit- Coyote

Manufacturer: North American Rescue (NAR)

Manufacturer Part Number(s): 80-0159

Total Quantity: 708

The North American Rescue (NAR) product, USMC Combat LifeSaver (CLS) Kit- Coyote is an integral component of Tactical Combat Casualty Care (TCCC)’s, standardized approach to pre-hospital trauma care, required for training and real-world operational environments to support the mission of I Marine Expeditionary Force (I MEF). This requirement is being purchased to support I MEF on behalf of 1st Marine Division, Camp Pendleton, California to ensure mission readiness and survival of Marines combat environments.

4. This action is being conducted under the authority of the ECAT Multiple Award Schedule Program. The circumstances justifying waiving the competition requirements is FAR 8.405- 6(a)(1)(i)(B) – Only one source is capable of providing the supplies required at the level of quality required because the supplies are unique or highly specialized. As explained below, this particular product is essential to the Government’s requirements, and market research has established that no other companies’ products cannot meet the Government’s requirements.

The CLS kit shall be compatible with existing Individual First Aid Kit (IFAK) equipment utilized by I Marine Expeditionary Force (I MEF) for treatment of hemorrhage, airway obstruction, sucking chest wounds, burns and other combat injuries. The CLS Kit must contain additional medical supplies beyond standard IFAKs which serves as a supplementary aid to the basic supplies of IFAKs currently in use by 1st Marine Division. The access to a greater quantity and variety of items allows Marines to treat multiple victims and more severe injuries. The standardized rapid response to preventable deaths in combat situations requires seamless integration with existing IFAKs. These items will be used by Marines, the vast majority of whom do not have medical training, to provide first aid response in support of the mission. The CLS Kit shall be a portable, lightweight bag that can withstand combat load and contains approved medical devices with validated performance standards and FDA-cleared Class II medical device where applicable including the following-

• Tourniquet for rapid hemorrhage control capable of one-handed application

• Nasopharyngeal for airway management capable of maintaining shape regardless of storage conditions

• Dressing, Bandages, and Gauze of various sizing to treat abdominal wounds, arm sling and splint security, wound packing, severe bleeding,

• Non-adherent pain relief hydro-gel dressing to treat burn injuries capable of one-handed application

• Chest Seal for sucking chest wounds capable of adherence to adverse surfaces and temperatures

• Gloves for Body Substance Isolation (BSI) and infection control

• Decompression Needle for chest decompression

• Alcohol Pads for antiseptic cleaning of wound and injection sites

• Trauma Shears for clothing removal and injury access

• Splint to immobilize extremities and injuries capable of compact storage limitations

• Strap Cutter for boot removal and injury access

• Tape for securing items capable of compact storage limitations

• Casualty Card for pre-hospital casualty documentation capable of tear and water resistance

The CLS Kits must be designed and organized to meet TCCC standards and to supplement the basic supplies of IFAKs currently in use by 1st Marine Division. Every Marine must be equipped with CLS Kits and receive training on their use to provide first aid and trauma care to help stabilize casualties until evacuation for higher-level medical treatment. This training is intended to empower every Marine to immediately address life-threatening injuries in themselves or their teammates. The training increases the likelihood of effective intervention during real-world events.

As mentioned above, the standardization of the CLS Kit in conjunction with IFAKs already in use by 1st Marine Division is paramount and significantly reduces response time when applying first aid. The CLS Kit is a fully integrated life-saving component of the current USMC standardization. Their sizes, kit contents, packaging, and deployment methods have been standardized to ensure ease of access and proper supplementation to the IFAKs. This standardization allows Marines certified in Tactical Combat Casualty Care (TCCC-CLS) to use the specific tools in CLS Kits to treat life-threatening injuries like massive bleeding, airway issues, and tension pneumothorax. By standardizing the contents of the CLS kit, the Marine Corps ensure that every trained Marine is familiar with every piece of gear in the bag, regardless of who packed it. This uniformity facilitates consistent training, reduced response time, inventory management, and logistical support. Use of alternative components, or Standard Medical Trauma First Aid Kits available on the commercial market would cause disruption, potentially causing confusion or delay during emergency medical intervention. The CLS Kits allow for standardization in 1st Marine Corps training, streamlining protocols and logistics that are not achievable with other products. No other manufacturer has the capability of meeting the I MEF’s requirements listed above. Only the NAR CLS Kits are capable of satisfying the requirement.

5. DLA Troop Support has already determined the prices of the supplies under the ECAT Multiple Award Schedule Program fair and reasonable based on a favorable comparison to other than certified cost or pricing data.

his acquisition represents the best value to the Government consistent with FAR

8.404(d).

6. Market research was conducted by Assistant Supply Officer and

Material Readiness Officer of 1st Marine Division using the FDA website, Google, ECRI, and published literature. Within the product category of CLS Kits, there are no commercial items available on the market that can meet Marine Corps minimum requirements. Specifically, the inclusion of one-handed tourniquet and dressing applications, capability of maintaining splint shape regardless of storage conditions, ability to operate and withstand adverse conditions and environments, compatibility with existing IFAKs in use, combined with organization within CLS Kits that significantly reduce response time when applying first aid and trauma care in combat scenarios.

Standard Medical Trauma First Aid Kits available on the commercial market may contain medical supplies to handle real-life emergencies but they fail to meet the items and configurations codified in Stock List 3-11705A which cannot be substituted without deviation from Marine Corps standardization. This includes shelf-life controlled medical consumables (hemostatic dressings, burn dressings, decompression needles) and components (tourniquets, trauma dressings, splints) that match official NSNs. Additionally, commercial bags do not provide the gear, uniformity and organization used in standardized Marine training. Failure to meet these standards increases delays in treatment, inconsistency, further injury, and unreliability that threatens the overall survivability of injured Marines in combat environments.

Standard Medical Trauma First Aid Kits available on the commercial market such as Rescue Essentials Critical Event Individual Kit and Rescue Essentials Omnis Kit do not provide the light weight, durable, portable and mobile bag design comprised of 1000 denier fabric that can withstand extreme environments, and conditions. Standard Medical Trauma First Aid Kits are made of 500 denier fabric or nylon which has a lower resistance to abrasion and tears.

Additionally, Commercial market kits such as Rescue Essentials Omnis do not contain C-A-T tourniquets capable of one-handed application and do not offer splints and tapes capable of maintaining their integrity in compact storage limitations. Lastly, Rescue Essentials Omnis Kit lacks combat casualty response cards that are tear and water resistant and cover the 3 phases of TCCC. These cards are critical when documenting a casualty's injuries and the care provided pre-evacuation. This record is vital for medical personnel receiving the casualty and provide efficiency for emergency management in adverse environments.

The NAR CLS Kit is the only CLS Kit on the market that conforms to the Marine Corps-approved SL-3 configurations and currently in use by 1st Marine Division. Based on feedback