A3_EOTG JA Brand Name Justification_Redacted.pdf

J&A No. M67400-FY20-SSBN-15

V1.0, 13 June 2019

JUSTIFICATION AND APPROVAL (J&A)

FOR USE OF BRAND NAME OR EQUAL DESCRIPTIONS IN SOLICITATIONS

1. Contracting Activity.

Marine Corps Installations Pacific (MCIPAC) Regional Contracting Office (RCO), Okinawa, Japan

2. Description of the Action Being Approved.

Inclusion of a brand name or equal description in M67400-20-Q-0100 for TOMManikin Tactical/Medical Simulator Manikins.

3. Description of the Supplies/Services.

The proposed Tactical/Medical Simulator Manikin shall be a realistic replica of a human anatomy and when used as a system, comprises a tether-less, bleeding/breathing manikin.

The manikins will be used for realistic training scenarios for service members to practice field medical and First Responder techniques to improve survivability of members in a training or combat environment. In order to train and practice to the most realistic training scenarios, the manikin must be ruggedized and able to withstand up to 6000 lbs. of pressure in order to support vehicle roll-over and downed aircraft training scenarios. These manikins will support Marine and First Responder training with the most realistic capabilities available.

Manikins must meet or exceed below specifications:

• Powder-coated, welded steel frame and solid steel joints which allows for dragging by a single extremity.

• Quick replacement of extremities for flexibility with multiple wound configurations.

• No pinch points

• Weigh between 150-170 lbs.

• Interchangeable extremities between platforms.

• Extremities that are capable of being crushed, and or immobilized, with up to 6000 lbs.

(2720 kg) of pressure.

• Upper extremities able to be handcuffed behind their back with a single pair of handcuffs.

• Onboard compressor that enables realistic breathing with exhaled breaths.

• Realistic bilateral rise and fall of chest (with independent control of each lung).

• Remote controlled breathing rates: Slow, Normal, and Fast.

• Tether-less (non–cable) communication controller that can control as many as ten devices. WiFi, Bluetooth, VHF, etc., the method is not important, but it must be capable of “wireless” communications.

• Radial pulses in uninjured upper extremities and bilateral carotid pulses.

• Variable pulse rate & pressure (normal, bounding, thready).

• Capability to simulate bleeding from multiple locations on the manikin, the rate and location of which can be remotely controlled by wireless tablet.

• 1.2-gallon onboard blood reservoir

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• Ability to simulate a realistic sucking chest wound, with mid-axillary exit wound.

• Support advanced lifesaving airway techniques through the use of nasopharyngeal airways, oropharyngeal airways, supraglottic airway devices, endotracheal intubation and surgical airway techniques, i.e. cricothyroid intubation.

• Manikin must have human voice features that can be customized and able to transition from a talking “conscious patient” to an “unconscious” patient. Features must allow the upload of various pre-recorded or customized voice tracks.

• Have interchangeable eyes to reflect changing pupil conditions.

• Have non illuminating eyes.

• Arms, legs and waist that must bend and rotate for realistic patient movement.

• Provide onboard power via rechargeable batteries with charger voltage and frequency of 100-240VAC 2.0A 50-60Hz for US and International plugs.

4. Statutory Authority Permitting Other Than Full and Open Competition.

N/A. Full and Open Competition will be utilized. This document meets the regulatory requirement at DFARS 213.501(a)(ii) to execute the justification and approval addressed at FAR 13.501(a) in order to use brand name or equal descriptions. FAR Subpart 13.5 procedures are being utilized for this acquisition in accordance with 41 U.S.C. 1901 or the authority of 41 U.S.C. 1903.

5. Rationale Justifying Use of Cited Statutory Authority.

EOTG’s Medical Training Branch (MTB) has nine years extended experience and practical expertise using TOMManikins. The TOMManikin has proven to be the most rugged, realistic and reliable manikin available to train Marines, Corpsmen and First Responders.

The majority (~70%) of MTB medical training will occur in field conditions. The TOMManikin is able to withstand up 6,000 lbs. of pressure which supports realistic training scenarios e.g. rolled vehicle and downed-aircraft. A ruggedized manikin is absolutely essential to training. The TOMManikin is a proven effective in field conditions and will provide the capability required to conduct medical training for Marines, Corpsmen and First Responders.

Due to their quality and proprietary features, TOMManikins are the premier training aid currently used by several units and services across Okinawa. MTB EOTG has preexisting relationships with TOMM field representatives who are stationed on the island, which will facilitate warranty and maintenance repair. The following features of the TOMManikin make it the only manikin on the market that can meet the needs of III MEF EOTG MTB:

• TOMManikins have interchangeable parts that are quick and easy to change, maximizing training time.

• TOMManikins allows for multiple interventions, to include airway interventions, chest decompressions, surgical airways and chest tubes, effectively reducing the need for additional manikins and additional upgrades for specific procedures.

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• TOMManikins provide a prolonged battery life, allowing for continuous training without the need for battery changes or having the manikin plugged into a power source.

• Since the TOMManikin has rechargeable and removable batteries, they can easily be taken to ranges for complimentary training, without needing an electric source to plug into for re-charging.

• TOMManikins design aids in avoiding unnecessary break downs of other like capability elaborate systems.

• TOMManikins have wireless capabilities, allowing transition between on-scene care, extraction, vehicle loading and Emergency Aid Station care without need for administrative ‘stops’ for setting up/breaking down equipment. This also allows them to be taken outside of standard Wi-Fi stations, to further facilitate Range Training.

• One (1) controller can control up to ten (10) separate manikins, or other pieces of associated equipment (Blast or Ballistic simulators), minimizing equipment and personnel for operations.

• TOMManikin’s have proprietary silicone Skin (Rugged Softech®), non-environmentally reactive/non-leaching which has extreme temperature tolerance. This is critical in Okinawa heat and training environment, other brand names will not withstand the environmental abuses.

Market research, previous field testing and the use of other manikins on the market has determined that there are no other commercially available products that can provide the quality and durability to last the rigorous field training, nor the complex medical training attributes described in this document. Currently, there are limited commercial companies who make medical training mannequins specifically designed for rigorous military applications. EOTG MTB has “hands on” experience with the industries top three brands:

Laerdal SimMan, 3B Scientific Manikin and TOMManikin. Below explanation helps to outline why the Laerdal SimMan, and 3B Scientific do not meet the requirements.

In a previous purchase, the RCO procured a quantity of three Laerdal SimMan manikins for the Medical Simulation Training Center (MSTC) on Camp Foster. The Laerdal SimMan did not meet the needs of the training syllabus, which was a direct cause to sub-standard training. The Laerdal SimMan durability is quite questionable; our previous Laerdal Manikins were in constant need of maintenance and repair. The EOTG MTB manikins are used 3 or 4 days a week on a weekly basis. On average, 12-25 students engage each manikin during a standard training day. This training is conducted based in a field/tactical care environment, not a clinic hospital setting. The Laerdal mannequins are designed as a ‘clinical’ manikins and have not been able to withstand MTBs previous demands which are designed for continuous, on the ground manipulation by large volumes of students. The TOMMs are ‘ruggedized,’ to withstand the throughput and tactical needs that MTB requires for its POI training standards. Past Laerdal’s broke down quickly; arms, legs and compressors failed. They will not suffice.

Similarly, the Laerdal air compressor, which is housed in the right leg, has a history of breaking down regularly. When MTB used the Laerdal manikins from 2009 to 2012, the MTB was required to maintain 10 right legs for 3 manikins, in order to have enough “back-

V1.0, 13 June 2019 up” compressors on hand to support training. Valuable training time was lost each time a compressor required swapping out.

The Laerdal “Directions for Use” state that the Laerdal manikin should be used, “on clean surface only.” That negates applicability in our training environment: dirt, dust, mud, sweat, and other field-environment elements quickly degrade the Laerdal and result in failure.

Another major disqualifier for the Laerdal is the need for a laptop to be used to control it.

This is neither convenient nor efficient when testing-out students in a field environment. A computer does not survive in the heat and other elements (mud, rain, dust, sweat, heat, etc.). In addition, an instructor holding a computer and tethered next to a mannequin “patient” does not mimic a realistic wartime and field training scenario.

The 3B Scientific Manikin the other notable mannequin on the market. Per the 3B Scientific Manikin manual, it is designed for “Nurse Training.” Its primary function is to train nurses in patient care and advanced nursing skills in a hospital setting. The MTB training is for combat (at the site of injury) training. More specifically, the 3B manikin does not provide the following, which is necessary to our training:

• Bleeding (there is no blood reservoir or injuries for bleeding)

• Rise and fall of chest (breathing)

• One- or two-sided rise & fall of chest (Pneumothorax)

• A permeable skin, to allow for Chest Decompression (needle thoracentesis) [the 3B is a “resistant plastic” manikin]

• Have any ‘speech’ capability

• Pulses (at neck and wrist)

• Provide ‘combat-type’ injuries, such as traumatic amputations, gunshot wounds or blast/burn injuries

• Is an inert doll and therefore has no controlling device, as it does not bleed, breath or talk (as mentioned above)

• As it does not have the combat injuries we train and teach on, all ‘combat injuries’ would have to be presented verbally from the instructor. During our FINEX rotation, that would prove near impossible over the battle sounds being played

The first four items in the above list are the primary injuries that EOTG trains personnel to respond to in the Tactical Combat Casualty Care (TCCC) taught at the MTB. The injuries that are displayed on the manikin are mainly hospital specific: surgical staples, decubitus ulcer, diabetic foot syndrome; nothing dealing with combat injuries. Further, the manikin weighs only 31 lbs., making it completely unrealistic for patient movement training.

Finally, the 3B Manual states that manikins should be cleaned after every use, but must be “taken apart completely to assure that all parts are dry.” That would increase EOTG field maintenance time while decreasing capability to train Marines, Corpsmen and First Responders.

6. Description of Efforts Made to Solicit Offers from as Many Offerors as Practicable.

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A pre-solicitation notice was posted on beta.SAM on July 23, 2020 publicizing the Government’s intent to pursue a brand name source for this requirement. The pre-solicitation notice also requested interested vendors to provide capabilities of comparable products and to provide comments in response to the Name Brand or equal specifications listed within the notice for the TOMManikin trauma mannequin simulators. One vendor expressed interest and requested additional detail on the injury configuration. A response was provided to the vendor on July 27, 2020 with the injury configuration for the mannequins. No vendors expressed any concern with the use of Brand Name or equal descriptions.

Internet Market Research was conducted, there are various vendors who can provide TOMManikins at similar market pricing. See Market Research Attachment.

7. Determination of Fair and Reasonable Cost. The Contracting Officer has determined that the anticipated cost to the Government of the supplies/services covered by this J&A will be fair and reasonable.

The Contracting Officer will determine any resultant contract to be reasonable price based on the price analysis techniques of FAR 15.404-1(b).

8. Actions to Remove Barriers to Future Competition.

Because of the specific need for manikins designed for use in a military field training environment, the needs of the EOTG MTB to provide students with realistic field trauma training on manikins built to sustain the severe conditions of a realistic combat environment, competition for commercial products will be inadequate until other companies provide like products.