A.02.04_Brand_Name_Justification_W91YTZ18Q0163_-_Copy.pdf

Control Number: 18-RHCO-A-639

RFQ/RFP #: W91YTZ18Q0163

Brand Name Sole Source Justification for Acquisitions under the Simplified Acquisition Threshold (Simplified Acquisition Threshold is $250K)

1. Contracting Activity:

Regional Health Contracting Office – Atlantic (RHCO-A) Fort Bragg Health Contracting Cell 6021 5th Street, Building 1467 Fort Belvoir, VA 22060-5505

2. Description of Action:

Requirement: New Repeat Pricing: Firm-Fixed Price Time & Materials Cost Funds: OMA Other Funds: CEEP Total Dollar Value: $249,805.50

Name of Intended Contractor: CAE Healthcare Street Address: 6300 Edgelake Drive City, State, Zip: Sarasota, FL 34240

Phone: 941-377-5562

3. Description of Supplies/Services: “Brand Name” 1 Each: VirtaMed Gynecology Simulator Base Unit to include the following:

Simulation platform and anatomic Gynecology model with magnetic tracking, software framework,High-end PC with 23" multi touch screen, Movable VlrtaMed simulation caddy, 1 anteverted uterus Insert, 1 speculum, 1 tenaculum and First Year Full System Support and Maintenance. – VRM-200.

1 Each: VirtaMed HystSim Module Includes: 12 cases for diagnostic hysteroscopy, 8 cases for polyp removal, 8 cases for myoma removal (type 0), 4 cases for endometrium ablation with the rollerball and 1 resectoscope with passive working element. VRM-505.

1 Each: VirtaMed Advanced Resection Module Includes: 4 cases including multiple polyps, multiple intramural fibroids, synechiae and septum. VRM-506.

1 Each: VlrtaMed Essential Hysteroscopy Skills Module Includes: 8 cases for basic skills 1 training:

Access, distention, navigation, biopsy, polyp & adhesions removal with hysteroscoplc scissors, 1 hysleroscope with working channel and 1 hysteroscoplc grasper. VRM-507.

1 Each: VlrtaMed Essure Module Includes: 8 cases for training of the Essure procedure With increasing difficulty, 1 hysteroscope with working channel and 2 Essure handles. VRM-508.

1 Each: VirtaMed Gynecology IUD Placement Module Includes: 12 cases with anteverted and retroverted uterine cavities, as well as nulliparous and parous patient cases for both uterine sounding

Mary.A.Martin Highlight

Mary.A.Martin Sticky Note Completed set by Mary.A.Martin and IUD placement, 1 uterine sound, 1 relroverted uterus Insert (In addition to anteverted uterus Insert Included In platform), 1 nulliparous, uterus insert, 2 Mirena Evo devices, 2 Skyla devices and 2 Para Gard devices. VRM-509.

1 Each: VirtaMed Gynecology ASRM Embryo Transfer Module. VRM-515.

1 Each: Module VirtaMed ArlhroS Ankle Includes: 1 anatomic ankle model with magnetic tracking, 6 cases for basic skills training: guided diagnostic cases, trlangulation cases, 5 cases for diagnostic arthroscopy: healthy anatomy, cartilage defects, loose bodies and Impingement conditions, 2 cases for therapeutic arthroscopy: loose body removal, Impingement decompression.

1 Each: VirtaMed ArthroS FAST Module Includes: 6 cases for camera navigation (Image centering, horizon control & periscoping, following an object), 3 cases for basic triangulation, 1 ArthroS FAST stand with magnetic tracking and 1 Sawbones FAST work station containing 8 different non-virtual reality Inserts (to be used with your own standard arthroscopy Instruments). VRM-504.

1 Each: ACC-VRM01 VirtaMed Arthroscope, ACC-VRM02 VirtaMed Grasper/ Punch, ACC-VRM04 VirtaMed Hook, ACC-VRM03 VirtaMed Shaver and TRN-VRMG01 VirtaMed Gynecology On-Site Training-One Day.

Required delivery Date or Date of Surgery: 15 September 2018

4. Authority Cited:

(a) FAR 13.106-1(b)(1)(i): Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization); OR

(b) FAR 13.106-1(b)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item; OR

(c) FAR 8.405-6(a)(1)(i)(A): An urgent and compelling need exists, and following the procedures would result in unacceptable delays; OR

(d) FAR 8.405-6(a)(1)(i)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; OR

(e) FAR 8.405-6(a)(1)(i)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order not previously issued under sole-source or limited-sources procedures.

5. Reason for Authority Cited: CAE Healthcare is the sole North American Distributor for VertaMed Products, VertaMed AG is a manufacture located in Zurich Switzerland. There is only one manufacturer providing a single platform surgical simulator with the ability to use multiple modules for surgical simulation. This will eliminate the need to buy multiple simulators to train residents and student surgeons. Failure to procure this equipment from the sole vendor will lead to untrained professionals which could potentially cause harm to patients.

6. Actions to Increase Competition: No additional actions will be taken to increase competition for this requirement. CAE Healthcare is the sole North America Distributor for this equipment.

This action will be posted on FBO.gov to increase competition.

7. Market Survey: Internet search for a multi module surgical simulation platform was performed, there is only one manufacturer providing a single platform surgical simulator with the ability to use multiple modules for surgical simulation. This will eliminate the need to buy multiple simulators and save money while providing expansion capabilities as more Residency Programs are added. A review of all (Virtual Reality) VR Surgical Simulators demonstrated at the International Meeting for Simulation in Healthcare (JAN 2018), confirming the sole multi-platform system.

Internet search for vendors was performed, with the manufacturer and CAE Healthcare only showing as primary suppliers for the equipment. Purchasing direct from the manufacturer would be an international purchase.

8. Procurement History: No past contract for this type surgical stimulator found in PD2 or PCF.

Previous Contract or Purchase Order Number: or N/A Previously competed? N/A No Yes Previous authority for less than Full & Open Competition:

9. Technical / Requirements Certification: I certify that the support data under my cognizance which are included in this mini-J&A are accurate and complete to the best of my knowledge and belief.

Submitted By: Nancy A. Harnois Position Title : Medical Simulation Program Administrator

Email address: nancy.a.harnois.civ@mail.mil

10. Contracting Officer Certification and Approval: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Signature:

Typed Name:

Position Title: Contracting Officer

Email address:

Date: