6.09a - Redacted ASSP GSA LSJ Above SAT - signed_Redacted.pdf

Source Selection Information – See FAR 2.101 and 3.104

LSJ# 25-096

LIMITED-SOURCES JUSTIFICATION (above SAT)

1. Identification of Requiring Activity and Contracting Activity.

This is a Limited Source Justification. The requiring activity is Naval Expeditionary Medicine Warfighter Development Center (NEMWDC), Camp Pendleton, CA, 92055; The contracting activity is NAVSUP Fleet Logistics Center (FLC) Norfolk, Contracting Dept., BUMED/FM&C Directorate, 700 Robbins Ave – Bldg. 2B, Philadelphia, PA 19111.

2. Nature and description of contract action. This acquisition is conducted under the authority of the Multiple Award Schedule Program (Title 41 U.S.C. 152 (3) and Title 40 U.S.C.

501, Services for Executive Agencies). This is a limited source action to be awarded as a new task order to the small business Strategic Operations identified in paragraph 3 below. The placement of a firm-fixed-price order is anticipated.

This is a sole source action for the provision of Abdominal and Chest Advanced Surgical Skills Package (ASSP) Simulator consumables, including Subject Matter Expert (SME) support for the required supplies. Strategic Operations, Inc. (Strategic Operations), a small business, previously supplied the required items/performed the required services under Contract N6264518D5071, Task Order N6264523F0009; Contract N6264518D5071, Task Order N0018924FZ188; and Contract N0018924CZ048. All previous contracts and task orders were awarded on a sole source basis as firm fixed-price contracts to Strategic Operations a small business; the existing contract, N0018924CZ048 expires on May 14, 2025.

3. Description of Required Supplies/Services. The proposed acquisition is to meet NEMWDC’s requirement for Abdominal and Chest ASSP Simulator consumables for abdominal trauma procedures and chest trauma procedures conducted during Expeditionary Resuscitative Surgical System (ERSS) training. ERSS training provides rapid surgical and resuscitative capability for forward deployed elements in the Navy. ERSS is one of the courses provided by NEMWDC as part of its mission to provide unit level training of medical personnel worldwide.

As part of the training simulation, Abdominal and Chest ASSP Simulator consumables must be capable of integrating with a human worn cut suit simulator to mimic Point of Injury (POI) emergency assessment and treatment processes with live human interaction. Abdominal and Chest ASSP Simulator consumables must be capable of simulating user customizable wounds and repair procedures including stenting/ligation of injuries of the aorta, common iliacs, external iliacs, internal iliacs, and the inferior vena cava. The ASSP Simulator consumables must be capable of mimicking the following abdominal and chest trauma procedures:

Abdominal:

- Hemorrhage control in all four quadrants by packing with laparotomy pads

- Bowel leakage control

- Suturing/stapling of the bowel

- Roux-en-Y gastric bypass

- Gastro-colonic anastomosis

- Intra-abdominal exploration

- Ostomy formation

Chest:

- Cross clamping of the aorta in an open chest procedure

- Partial pneumonectomy

- Stapling/removal of injuries of the lungs

- Hemorrhage control in chest

Specifically, NEMWDC has a need for five Abdominal ASSP simulator consumables and five Chest ASSP simulator consumables per training exercise. In addition, the Government requires licensing renewals, maintenance, software, and hardware upgrades for the Abdominal and Chest simulator consumables and suits. Additionally, NEMWDC has a requirement for SME Support during training exercises at the training facilities. Specifically, a need for one ASSP SME to provide services for 16 training sessions. The ASSP and SMEs are responsible for coordinating an ASSP delivery time prior to each training exercise. The ASSP and SMEs must provide a STOPS surgical cut suit for each day of support during the training exercises and will provide operation and guidance on the proper usage of the surgical cut suits during the training sessions.

The estimated total value of the 12-month base period of this action is the overall total estimated value this action if the 12-month base and all four 12-month options are exercised is . The 12-month base period of performance will start date on 15 May 2025 and end on 14 May 2026. The resultant contract will be funded with FY25 Navy Operations & Maintenance (O&MN) appropriations. These funds are currently available under Navy ERP Purchase Requisition# 1301231283. Options will be funded utilizing O&MN appropriations of the fiscal year in which the option year is exercised.

4. Identification of the Justification Rationale and/or Demonstration of Contractor’s Unique Qualifications to provide the required supply or service. The statutory authority which permits restricting consideration of schedule contractors to fewer than that required in FAR 8.405-1 (Ordering procedures for supplies and services not requiring a statement of work) or 8.405-2 (Ordering procedures for services requiring a statement of work) is 41 U.S.C. 251 et seq., as implemented by FAR 8.405-6.

The proposed requirement is to acquire Abdominal and Chest ASSP Simulator consumables and SME support for abdominal trauma procedures and chest trauma procedures conducted during Expeditionary Resuscitative Surgical System (ERSS) training.

The justification for limiting sources is (ii) FAR 8.405-6(a)(1)(i)(B) – Only one source is capable of responding due to the unique or specialized nature of the work.

NEMWDC currently utilizes STOPS human worn cut suits, which are manufactured by and proprietary to Strategic Operations. As detailed in Section 3 of this Justification, NEMWDC has a requirement for Abdominal and Chest ASSP Simulator consumables for abdominal trauma procedures and chest trauma procedures that must be compatible with the human worn cut suits currently utilized by NEMWDC. These Abdominal and Chest ASSP Simulator consumables are an expansion of human worn cut suits and are manufactured by Strategic Operations. They are the only products compatible with and capable of integrating with STOPS human worn cut suits.

Additionally, the simulated training covers treatment of specific injuries to the Abdomen and Chest as listed above. As detailed in Section 6, Strategic Operations is the only vendor capable of providing simulator consumables capable of replicating these injuries and the expertise required to treat them. No other company is capable of providing the required SMEs to work with the

STOPS cut suits due the proprietary nature of the suits. CAE Healthcare has been identified as an authorized distributor for Strategic Operations; however, Abdominal and Chest ASSP Simulator consumables are not included within the distributor agreement between CAE Healthcare and Strategic Operations. Thus, Strategic Operations is the only vendor capable of providing Abdominal and Chest ASSP Simulator consumables and the required SME support that meets the minimum requirements of the Government.

The previous contract’s period of performance will end on May 14, 2025. However, these consumables are required for every annual training, and therefore, a follow on contract is necessitated.

5. Determination of the Best Value. GSA has determined the prices of supplies and fixed-price services of the schedule contracts to be fair and reasonable for the purpose of establishing the schedule contract. Per FAR 8.404(d) DEVIATION, GSA’s determination does not relieve the ordering activity contracting officer from the responsibility of making a determination of fair and reasonable pricing for individual orders. Therefore, ordering activities are responsible to make a separate determination of fair and reasonable pricing for individual orders, BPAs, and orders under BPAs. The Contracting Officer will determine, using the procedures in FAR 15.404-1, that the prices are fair and reasonable and will document such determination with a level of detail commensurate with the complexity and circumstances of each order. By placing an order against a schedule contract, the ordering activity contracting officer concludes that the order represents the best value to the Government.

6. Description of market research among schedule holders and the results or a statement of the reason market research was not conducted. The requiring activity and contracting activity have conducted market research among schedule holders.

Market research was conducted by technical experts in December 2023, December 2024, and March 2025. This research consisted of reviews of similar previous procurements and a market survey through search engines of open market contractors and Federal Supply Schedule contractors. Search engines utilized include Federal Procurement Data System (FPDS-NG), FEDMALL, Google Internet, and GSA Advantage. Vendors that can provide simulator consumables include CAE Healthcare, Laerdal Medical, Simulab Corporation, Simulaid Inc., Gaumard Scientific, Beacon Point Associates, Marketing Assessment Inc. and Strategic Operations, Inc. A sources sought was posted on SAM.Gov for one week with a closing date of 21 March 2025, which resulted in no responses or capability statements submitted by interested sources.

CAE Healthcare, Laerdal Medical, Simulab Corporation, Simulaid Inc., Gaumard Scientific, Beacon Point Associates and Marketing Assessment Inc. can provide simulator consumables;

however, the simulator consumables offered by these vendors are not capable of mimicking the required procedures (detailed in section 3 of this Justification). The simulator consumables offered by these vendors include blood, skin replacements, and accessories for trauma scenarios;

the consumables are not "all-in-one" Abdominal and Chest packages capable of mimicking various abdominal and chest trauma procedures identified in the Government's minimum requirements. Additionally, due to Strategic Operations possessing proprietary rights to the human worn cut suits utilized by NEMWDC, simulator consumables manufactured by other vendors are not capable of integrating with a STOPS human worn cut suit, due to functionality and fit. As a result, the vendors listed above cannot meet the minimum requirements of the Government. Strategic Operations is also the only vendor capable of providing Abdominal and Chest simulators, licensing renewals, maintenance, and software and hardware upgrades that meet the minimum requirements of the Government. Additionally, Strategic Operations is the only vendor capable of providing Abdominal and Chest ASSP Simulator consumables capable of mimicking abdominal and chest trauma procedures and integrating with the STOPS human worn cut suits utilized by NEMWDC, and the associated required training and SMEs, due to the cut suit's proprietary nature.

7. Any other facts supporting the justification. This procurement uses a GSA Schedule and will be solicited and awarded in accordance with FAR Subpart 8.4.

8. Actions the Agency may take to remove or overcome barriers to competition.

For the reasons set forth in Section 4 of this Justification, NAVSUP Fleet Logistics Center Norfolk has no plans at this time to compete future contracts for the types of supplies/services covered by this document. If another potential source emerges, NAVSUP Fleet Logistics Center Norfolk will assess whether competition for future requirements is feasible. Market Research will be conducted for any future requirements to determine if there are any potential sources for competition.

9. Contracting Point of contact. The point of contact at NAVSUP Fleet Logistics Center Norfolk is Gerald Bowne, who may be contacted via e-mail at gerald.l.bowne.civ@us.navy.mil.

Justification Number: 25-096

CERTIFICATIONS AND APPROVAL

TECHNICAL/REQUIREMENTS CERTIFICATION

I certify that the facts and representations under my cognizance which are included in this Justification and its supporting acquisition planning documents, except as noted herein, are complete and accurate to the best of my knowledge and belief.

Technical Cognizance:

Signature Name (Printed) Phone No. Date

Requirements Cognizance:

LEGAL SUFFICIENCY REVIEW

I have determined this Justification is legally sufficient.

CONTRACTING OFFICER CERTIFICATION

I certify that this Justification is accurate and complete to the best of my knowledge and belief. To the extent that the Justification value is >$250K and <$750K, the Contracting Officer’s signature below also represents approval of the Justification.

CONTRACTING ACTIVITY COMPETITION ADVOCATE REVIEW

To the extent that the Justification value is >$750K and <$15M, the Competition Advocate’s signature below also represents approval of the Justification.