J and A_RFP SHOP-PR-24-002426_Redacted for RFP.pdf

FEDERAL BUREAU OF INVESTIGATION

FINANCE AND FACILITIES DIVISION | PROCUREMENT SECTION

JUSTIFICATION AND APPROVAL (J&A) FOR OTHER THAN FULL

AND OPEN COMPETITION

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION IN ACCORDANCE WITH 41 U.S.C. 3304 (A) (X)

Requisition Number: SHOP-PR-24-002726

Date: 05/13/2024

Estimated Contract Dollar Value: $500,000

1. Identification of the agency and contracting activity.

The U.S. Department of Justice, Federal Bureau of Investigation (FBI), National Acquisition Programs Unit (NAPU), has prepared this justification for other than full and open competition for Combat Application Tourniquets (CAT) on behalf of the Medical Operations Readiness Unit (MORU), the Human Resources Division (HRD).

2. The nature and/or description of the action being approved, i.e., sole source, limited competition, establishment of a new source, etc.

The proposed action is to acquire Combat Application Tourniquets (CAT). This procurement will be advertised on Sam.gov as a brand name only requirement. The resultant contract is intended to be awarded as a firm-fixed price (FFP), single award Indefinite Delivery Indefinite Quantity (IDIQ)contract to include one (1) year base, with four (4) twelve-month option periods. The FBI anticipates ordering at least 12,000 kits over the course of the contract, as well as replacement items for the kits as necessary.

3. A description of the supplies or services required to meet the agency’s needs.

This requirement is to provide Brand Name Only CAT Tourniquets with red tip technology at an estimated cost of $500,000 over the life of the contract. This will allow the Human Resources Division (HRD) to accomplish its mission of acquiring approximately 12,000 fully pre- assembled General Agent Population (GAP)Individual First Aid Kits (IFAK) in training and real-world versions. The CAT tourniquet is to be part of these pre- assembled kits.

The IFAK is an individual first aid kit. Its design intent is to be used by the wearer for self-aid in the event they receive an injury – or – it may be used by another responder to treat the wearer under buddy-aid. As our personnel most commonly operate with other FBI personnel, sustaining uniformity with the equipment contained in the kit allows for equipment familiarity to improve the response and care for the casualty.

4. The statutory authority permitting other than full and open competition.

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 6.302-1entitled, “Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.”

(c) Application for brand-name descriptions. (1) An acquisition or portion of an acquisition that uses a brand-name description or other purchase description to specify a particular brand-name, product, or feature of a product, peculiar to one manufacturer-

5. Demonstrate the unique qualifications of the proposed contractor or the nature of the action requiring the use of the authority.

The CAT, NSN: 6515-01-521-7976, is manufactured by CAT Resources and the sole US authorized distributor is North American Rescue (NAR). NAR has also patented the Red Tip Technology included on the CAT tourniquet. There are multiple authorized resellers available in the marketplace.

The CAT’s design implements a visual cue for its use through its employment of the Red Tip Technology (NAR has a patent on this Red Tip Technology). The designers of the CAT implemented a red tip at the distal end of the tourniquet where it must be slipped through the friction buckle to be secured to the hook and loop.

The Red Tip Technology employed by the CAT is a feature of the tourniquet which differentiates from other tourniquets and makes it the preferred tourniquet for FBI issuance. Not only for continuity in the agency but because it is a known visual cue. OSHA 1910.144(a)(1) identifies RED as the color of fire protection and safety equipment/markings in the industrial setting. Red is the color in the light spectrum with the longest wavelength at 700 nm λ (Visible Light - NASA Science). This reduces the potential for the color red to be scattered where the beam of light deviates from its straight path of travel as a result of dust, water vapor, etc. The minimized potential for red to be scattered is affirmed by Rayleigh’s law which says the scattering of light is inversely proportional to wavelength of light to the fourth power. Red’s existence at the extreme of the visible light spectrum (to humans) also makes it stand out against a backdrop of other colors. While green is the most perceived color by the human eye and is also a functional optic color for those that suffer astigmatism, it is infrequently used because it doesn’t stand out enough.

https://science.nasa.gov/ems/09_visiblelight https://science.nasa.gov/ems/09_visiblelight

During moments of acute stress, the radial muscles of the iris contract causing the pupils to open which allows more light to enter. The ciliary muscle within the eye also relaxes to adjust the focus of the eye to be on objects further away (Alshak et al., Neuroanatomy, Sympathetic Nervous System, 2023). This inhibits near focus; thus, the need to make access to body worn life-saving kit stand out visually. The use of NARs Red Tip Technology meets the FBIs needs to have the SLIM FAK stand out visually.

Color contrast is the emphasized theme in using colors for effect (designsystem.digital.gov/design-tokens/color/overview/). As green (the color of the kit) sits at the mid-point of the light spectrum, it is necessary to go to the left or right ends of the spectrum to ensure adequate contrast for visual observation. As referenced above, red is OSHA’s prescribed color for safety equipment.

In a 2015 study published in the Frontiers in Human Neuroscience by Kuniecki et al. titled The Color Red Attracts Attention in an Emotional Context, it was found that the color red captures attention and facilitates congruent motor response – as in, when the color red is the stimulus, the test subjects responded more quickly and strongly. Another study published in 2011 by Elliot and Aarts showed that when the color red is employed as the stimulus, as compared to blue and gray, motor processes were more rapid and precise. In the Kuniecki study’s discussion, they closed by stating that the presence of the color red speeds response in all conditions, and the process of red stimulus to response is bottom up and automatic. This means that we are not functioning at the pre-frontal cortex level – rather, we are operating at the basal level of automaticity. As the intended use of an IFAK is during periods of extreme sympathetic (fight or flight) activation, this relationship to the basal level of automaticity is critical. To maximize efficacy of the CAT, its manufacturer CAT Resources in collaboration with its US-based distributor North American Rescue employs a red tip on the working end of the Gen 7 CAT. This contrast is designed to aid the individual using it under stress to identify the tip which must be correctly placed in order for the tourniquet to function correctly.

6. A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by Subpart 5.2 and, if not, which exception under 5.202 applies.

A request for information was published by the FBI on Sam.gov in the first quarter of 2024 (calendar) to the industry detailing this requirement. This RFI led to vendor engagement over three days in April 2024 between the project team and industry vendors who included both manufacturers and distributors.

http://designsystem.digital.gov/design-tokens/color/overview/ https://www.acquisition.gov/far/html/Subpart%205_2.html#wp1107980 https://www.acquisition.gov/far/html/Subpart%205_2.html#wp1107990

This requirement will be publicized as a Request for Proposal on Sam.gov.

7. The anticipated dollar value of the proposed acquisition, including options if applicable, and a determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The anticipated dollar value of the portioned cost for this item in the proposed acquisition is $500,000.00. This is the estimated cost for one (1) base year and four (4) option years. The Contracting Officer will use price analysis to determine fair and reasonable price. Various price analysis techniques to include, but not limited to adequate price competition, comparison with historical pricing, and available commercial price list will be utilized.

8. A description of the market research conducted and the results.

Market research was conducted beginning in Fall 2023 to ascertain existing technologies available, identify trends since the time of the previous contract initiation, and determine sentiments around equipment issued under the current contract. Additionally, a team of medical subject matter experts who are also current FBI Special Agents was also assembled to serve as the project team where their years of experience as Special Agents and medical providers could be leveraged to design a requirement that addressed the operational concerns of a Special Agent or FBI Police Officer and the medical requirements set forth by the CoTCCC and EMSP. It is important to note that the members of the project team have decades of experience in working with a requirement such as the GAP IFAK. The team members have access to extensive amounts of equipment which they use and test in the course of their duties as law enforcement officers and medical providers.

The government and commercial database review was used to review current medical literature to determine whether the components carried in the IFAK met the assertions of current research into combat-related injuries. The components list was built around the findings of this research with modifications to the amount of equipment components carried based upon information provided by SMEs. These databases were found from the Defense Health Association, United States Army Institute for Surgical Research, Joint Theater Trauma System, and Committee for Tactical Combat Casualty Care.

Personnel from the Procurement Section attended the SHOT Show in January of 2024 to research availability and capabilities of these products in the marketplace.

Project team members reviewed white papers published by members of the combat medical community, reviewed peer reviewed contents from the Journal of Trauma, New England Journal of Medicine, The LANCET, and contents from the Society for Critical Care Medicine. Additionally, project team members reviewed relevant content from the Journal of Special Operations Medicine, podcast content from subject matter experts, and engaged with peers from other agencies and departments as part of the research phase of this requirement.

A request for information was published by the FBI on Sam.gov in the first quarter of 2024 (calendar) to the industry detailing this requirement. This RFI led to vendor engagement over three days in April 2024 between the project team and industry vendors who included both manufacturers and distributors.

9. Any other facts supporting the use of other than full and open competition.

The FBI Emergency Medical Support Program (EMSP) requires these devices to be in compliance with recommendations of the US Army Institute for Surgical Research (ISR) and the Committee for Tactical Combat Casualty Care (CoTCCC). Both ISR and CoTCCC conduct significant research to research the efficacy of recommended tourniquets; thus, the FBI EMSP follows these recommendations when selecting medical devices to be carried by the organization – both medical providers and non-medical personnel alike. FBI EMSP conducted subsequent evaluation of the under conditions simulating the tactical law enforcement environment in which they will be used. FBI EMSP found the Combat Applications Tourniquet to be the single recommended tourniquet to be acceptable for FBI use. Numerous alternative devices were tested by ISR and CoTCCC for their effectiveness in emergency bleeding control.

10. A listing of any sources that expressed a written interest in the acquisition.

A request for information was published on Sam.gov in the first quarter of 2024 (calendar) to the industry detailing this requirement. This RFI led to vendor engagement over three days in April 2024 between the project team and industry vendors who included both manufacturers and distributors. There was a total of 15 capability statements received for IFAK bag and contents.

11. A statement of any actions the agency may take to remove or overcome any barriers to competition, if subsequent acquisitions are anticipated.

Seven other mechanical tourniquets are currently on the aforementioned list of CoTCCC recommended devices. FBI EMSP personnel on this project team also evaluated the tourniquets on this list to identify the potential for replacement of the CAT in the FBI’s medical equipment carriage. Other devices use mechanical advantage systems, ratcheting systems, or lack the luminance contrast of the red tab Gen 7 CAT. While the thematic function of the devices is comparable, there are differences between them which are substantial to a degree that could present a danger to an individual who requires emergency application of such device. The danger is not presented by the device itself, rather, it is presented by the degree to which the other tourniquets listed on the differ. Given that the tourniquet – no matter the type – is carried for use during moments of extreme duress under imminent life threat, absent a robust and lengthy re-training program a deviation from reliance on the CAT poses a life-threat to FBI personnel, FBI collaborating agencies, and members of the public who may be treated by FBI personnel.

The previous statements, evidence, and examples support the ongoing procurement of the CAT from CAT Resources to ensure uniformity, consistency of training, and our ongoing ability to provide care to FBI personnel, FBI partners, and members of the public who are suffering from life-threatening extremity hemorrhage.

We will continually review developments and assess whether another device adequately meets our needs.