20230822 PANHCA-23-P-0000 006566 LSJ_Redacted.pdf

Control No: 23-RHCO-C-433

Version February 2017

Memorandum for Record Limiting Competition at or below the Simplified Acquisition Threshold

1. Contracting Activity: Medical Readiness Contracting Office West, United States Army Health Contracting Activity.

2. Description of Action: Simbionix add-on modules for Simbionix Ultrasound Trainer.

Nature: X New Requirement Follow-on Requirement

Contract Vehicle: X Purchase Order Number _0011963692 (Requisition)__________ Blanket Purchase Agreement (BPA) Number _______________ Order/BPA# _______ against FSS Contract #_____ Order #___________ against Multiple Award IDIQ Contract Name or #______________ Order #_______ against a single award IDC Contract Modification # _______ to existing PO/TO/DO/Call Order

Pricing/Contract Type: X Fixed Price Time & Materials/Labor Hours Cost Reimbursable Hybrid

Funds: Operations & Maintenance, Army (OMA) x Other Funds: DHP (FY23)

Name of Proposed Contractor(s) and Address:

Simbionix USA Corporation 811 1st Ave Ste 408 Seattle, WA 98104-1418

Brand Name Buy: Yes X No

3. Description of Services or Supplies:

(a) This requirement is for add on training modules for an existing ultrasound simulation trainer that was purchased for William Beaumont Army Medical Center (WBAMC) in 2022. The modules include the echocardiography bedside module, advanced echocardiography bedside module, and the transesophageal echocardiogram package.

(b) In 2022 Simbionix ultrasound equipment was purchased for WBAMC under W81K00-22-F-0117 in the amount of . This equipment consists of training mannequins, software, and other necessary hardware for complete operation of the simulation training system. The ultrasound modules required under this purchase will integrate with existing equipment. The identifying information of this equipment is ECN:

/ SN:

(c) -alone training system that does not use an actual ultrasound device. It uses mock probes or endoscopes and

These modules allow clinical staff was WBAMC to develop and further refine sonography skills.

Specifically, clinical staff at WBAMC will use this software for Advanced Trauma Life Support training and certification, E-FAST skills certification, as well as other Individual Critical Task List (ICTL), Anesthesia and Cardiology medical simulation training.

(d) The anticipated cost for all three modules is $ .

4. Authority:

FAR 13.106-1(b)(1): For purchases not exceeding the simplified acquisition threshold (SAT), only one source reasonably available, urgency, exclusive licensing agreements, brand name, or industrial mobilization.

5. Reasons for Authority Cited:

(a) Simbionix USA Corporation is the only company that can provide both the required supplies and

(1) Simbionix equipment is only compatible with add-on software modules developed by Simbionix. This is due to the mannequin and its associated software and hardware being designed to accurately reflect the anatomical, physiological, and pathological conditions that are being simulated. Simbionix also holds patent number 11532244, This patent identifies the unique methods for developing simulation images, which are used for training and must be compatible with the Simbionix equipment.

(2) No other companies were located that have developed modules compatible with the existing Simbionix equipment owned by WBAMC. No other company can develop the ultrasound training modules utilizing the parameters that Simbionix requires for its equipment.

(3) No other companies are authorized by Simbionix to resell Simbionix equipment and its add-on modules; this is evidenced by market research performed by the Contract Specialist:

(i) Simbionix provided a letter indicating that it is the exclusive retailer of its own products. This was confirmed by a phone call on 5 July 2023 between Simbionix and the Contract Specialist.

(ii) A comprehensive web-based search confirmed that no other companies could be identified that resell these items. This was done so using Google, as well as by searching Government data- Dynamic Small Business Search (DSBS).

(c) Failure to purchase these supplies will prevent WBAMC from providing ongoing necessary training and development for clinical staff. Ultrasound simulation is necessary for training clinical staff in identifying anatomical, physiological, and pathological conditions. Failure to purchase these supplies will require alternative methods of training, such as utilizing real individuals. These methods will be less conducive to training staff, given that conditions may not be fully identified in advance and repeatability of training conditions will likely not be existent.

6. Publicizing Contract Actions: For FAR Part 13 actions, the public display and synopsis requirements of FAR 5.101 and FAR 5.203 do not apply due to the $ threshold, X apply and will be followed, or do not apply due to an exception at

5.202 ______________________.

Requirement to post justification in accordance with FAR 8.405-6(b)(3), FAR 13.105(c), or FAR 16.505(a)(4)(iii)(A)

X Action is NOT a brand name restriction and is under $250K, no posting required Action is a brand name restriction, under $25K, no posting required Action is a brand name restriction, over $25K. It will be redacted and posted with the solicitation.

Action is a brand name restriction over $25K but will not be posted due to exception:

FAR 6.305(f) FAR 8.405-6(b)(3)(iii)(A) FAR 8.405-6(b)(3)(iii)(B) FAR 8.405-6(b)(3)(iii)(C) FAR 16.505(a)(4)(iii(C)

7. Market Research:

(a) Market research for this requirement was performed from 14 June 2023 through 6 July 2023.

(b) Market research consisted of the following types of research:

(1) Online searches via search engines, (2)

(SBA) Dynamic Small Business Search (DSBS),

(3) Examination of literature pertaining to the product, and

(4) Validation of Patents through the USPTO.gov Public Patent Search tool.

(c) Market research revealed no other products capable of meeting this requirement due to intellectual property rights. No other companies manufacture Ultrasound trainer modules compatible with the Government-owned Simbionix Training Equipment. No other companies products can be modified to fit the Government-owned Simbionix training system.

8. Other Facts: No other facts are available.

9. Technical/Requirements Certification: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

Typed Name:

Date:

Title:

Signature:

10. Contracting Officer Certification/Approval:

I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable based upon pricing analysis.

I certify that this justification is accurate and complete to the best of my knowledge and belief, and that completing this purchase as a sole source is in the best interest of the Government. Additionally, I approve this justification to limit competition subject to the availability of funds and provided that the services or supplies herein described have otherwise been authorized for acquisition.

Typed Name:

Date:

Title:

Signature: