PM_Part806.3_Atch5_FAR6_JA_OVER_SAT JA JOIMAX ENDOSCOPIC SPINE EQUIPMENT.pdf

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 5: Request for Sole Source Justification Format >SAT

OFOC SOP Revision 11 Page 1 of 7 Original Date: 03/22/11 Revision 11 Date: 02/11/2021

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A)

For Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C242-21-AP-1336

1. Contracting Activity: Department of Veterans Affairs, VISN 2

Manhattan Campus VA New York Harbor Healthcare System Neurosurgery 423 East 23rd Street New York, NY 10010

Network Contracting Office 2 (NCO2)

Purchase request (i.e. 2237) number: 630-21-3-3086-0124

2. Nature and/or Description of the Action Being Processed:

The NY Harbor Healthcare System, Manhattan campus, is the VISN 2 referral center for Neurosurgery providing comprehensive neurosurgical cranial and spine surgery service for veterans.

This is a request to purchase JOIMAX ENDOSCOPIC SPINE EQUIPMENT which is a complete system for minimally invasive endoscopic procedures on the spinal column.

This is an SDVOSB sole source to “Red One Medical Devices, LLC (DUNS 079250760), who is the only Authorized Service-Disabled Veteran-Owned Small Business (SDVOSB) Distributor for all joimax®, Inc. products including any corresponding applicable accessories.”

This action will be awarded as a new firm-fixed-price contract.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

Joimax® offers the latest digital technologies for endoscopic surgery, in particular for “joined minimal access” treatment. The system consists of Endoscopes for transforaminal, interlaminar;

cervical and intradiscal procedures. Endoscopic Joimax procedures to include minimal damage to soft tissue and muscle sparing; lower complication rates; shorter hospital stays; and less post-operative pain resulting in minimal Opioid need. Joimax is the only FDA approved pump based system for minimally invasive endoscopic spinal surgery. It provides trans-foraminal, interlaminar, and spinal stenosis solutions. In comparison to currently available minimally invasive options this product will allow treatment of most degenerative pathologies with less than 8mm incisions. All of the minimally invasive procedures are performed by using HD-endoscopes: the surgeon inserts the endoscope through a small incision which allows access to the surgical field and direct visualization of the nerve roots. As the surgeon progressively dilates the access through the soft tissue and muscles the problem area can be treated very gently, using instruments with ramping up diameters, and with minimal adverse effect on the surrounding structures. These procedures can be done

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Revision 11 Date: 02/11/2021 while patient is awake and have been shown to decrease pain, reduce hospital stays and is emerging technology that is expected to rapidly become standard of care for minimally invasive treatment.

There is no other company who makes this equipment with the salient features listed below.

Description/Part Number*

Qty

Total Estimated Item Value JEST1290US Joimax® Endoscopic Trolley with isolating transformer 1200 VA, complete pre-wiring, with sub-assembly system, infusion rod

FSMA3220 Adapter Plate for mounting joimax® Flatscreen Monitor on joimax® Endoscopic Trolley 1

JFMS3220 joimax Flatscreen Monitor 32'' Full HD TFT Monitor, LED Backlight, Picture in Picture function,... 1

ICS0401S joimax® Vitegra® Visual Integration System, Fully integrated Full HD documentation system w/ tablet control &multiple video inputs

CSCHD8000P* C- Camsource® HD Twister..storage capability and Text Generator, 5-in-1-System: HD-Camera, 100W Xenon Light Source, Video Twister with virtual Diaphragm, storage capability and Text Generatorstorage capability and Text Generator

CSCHDC80P* Combo Camera Head C-Camsource HD Twister (PAL), single cable technology with integrated focus, w/function buttons, L 3.0 m..

JSDC25012* joimax® Shrill® System PLUS, Multifunctional Drill and Resection system, includes Shaver Handpiece and Sterilization Tray

JEVS0202 joimax® Endovapor®2 System, Multi Radio Frequency System + Footswitch + Neutral Electrode Connecting Cable for mains voltage 100 – 127 V

JVK2-280 Vaporflex® KIT2 short for joimax® Endovapor® 2, includes Handle, Shaft L 280, Cable, Spare Sealing Rings and Sterilization Tray

JVK2-320 Vaporflex® KIT2 short for joimax® Endovapor® 2, includes Handle, Shaft L 320, Cable, Spare Sealing Rings and Sterilization Tray

JISP3000 joimax® Versicon® Spine Pump, 2 medical applications: Arthroscopy (10 - 200 mm Hg; 0 - 2500 ml/min.), Spine (0 - 100 mm Hg; 0 – 750 ml/min.)

TESBASIC TESSYS® Transforaminal Endoscopic Surgical System, Instrument Set, Basic 2

FS6342181C TESSYS® FHD Foraminoscope (3.7 WCh), combo WL 171 mm / OD 6.3 mm / 30° / WChD 3.7 mm / 2 x IC 1.5 mm

ILESSYSPRO iLESSYS® Pro Interlaminar Endoscopic Surgical System, Instrument Set, Pro 2

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Revision 11 Date: 02/11/2021

LS7347150C iLESSYS® Pro FHD Laminoscope (4.7 WCh), Combo WL 150 mm / OD 7.3 mm / 15° / WChD 4.7 mm / 2 x IC 1.5 mm

SST381666 Endoscope Sterilization and Transport Tray L 380 mm / W 162 mm / H 66 mm 1

UNI3816C Universal Lid for Sterilization Tray L 380 mm / W 162 mm 1

JMHID3224 joimax® Horizontal Isolation Drape prone position 320 cm x 245 cm (126" x 96") 5

JVP32024 Vaporflex® Probe 320, Ball Tip, bipolar Disposable, WL=320 OD 2.5mm 5

JVP28024 Vaporflex Probe, Bipolar, Ball Tip, WL 275 mm, OD 2.5 mm 5

CSCC1324US REF 9900 joimax® Camsource® Camera Cable Cover, telescopic folded, with perforation and adhesive tape L 230 cm / W 12.5 cm

JTSB350D Single-use tubing set for joimax® Versicon® spine pump JISP3000 5

JSBDA323534C Diamond Abrasor, Coarse Ball Tip, L 320 mm / OD 3.5 mm / Ball OD 3.4 mm 5

JSBDA274544C Diamond Abrasor, Coarse Ball Tip, L 265 mm / OD 4.5 mm / Ball OD 4.4 mm 5

JSBOC274536 Olive Cutter, Olive Tip with side protection, L 265 mm / OD 4.5 mm / Olive OD 3.6 mm 5

JSBDD3613 Deflector Diamond Abrasor, L 360 mm / Ball Ø 3.5 mm / steerable - To be used with JSBDS3522 Deflector Shaft

TDAK0020 TESSYS® Disposable Access KIT2,with 3 Reamers,fine. Content: 2x Needles (20G / 21G), 1x 2ml / 1x 5ml / 2x 10ml Syringe, Scalpel, Skin Marker, 3x Dishes, 2x Guide Wires, 1x Sealing Cap, 2x Discography-/Chromography Needles (18G / 21G), 3x Reamers fine OD 5

Total estimated value of this acquisition:

Estimated delivery: 30 Days ARO

4. Statutory Authority Permitting Other than Full and Open Competition:

(X ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

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Revision 11 Date: 02/11/2021

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

FAR 6.302-1 Only one responsible source and no other supplies or services will satisfy agency requirements.

Red One Medical Devices, LLC is the only Authorized Service-Disabled Veteran-Owned Small Business (SDVOSB) Distributor for all joimax®, Inc. products including any corresponding applicable accessories.

This award will be made to Red One Medical Devices, LLC, via the authority provided by 819.7007 Sole source awards to service-disabled Veteran-owned small business concerns.

819.7007 Sole source awards to service-disabled Veteran-owned small business concerns.

(a) A contracting officer may award contracts to SDVOSB concerns on a sole source basis provided:

(1) The anticipated award price of the contract (including options) will not exceed $5 million;

(2) The requirement is synopsized in accordance with FAR part 5;

(3) The SDVOSB concern has been determined to be a responsible contractor with respect to performance; and

(4) Award can be made at a fair and reasonable price.

(b) The contracting officer’s determination whether to make a sole source award is a business decision wholly within the discretion of the contracting officer. A determination that only one SDVOSB concern is available to meet the requirement is not required.

(c) When conducting a SDVOSB sole source acquisition, the contracting officer shall ensure businesses are registered and verified as eligible in the VIP database prior to making an award.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

Published Special Notice – Notice of Intent to Sole Source Joimax Endoscopic Spine Equipment on beta.SAM.gov from April 7, 2021 through April 14, 2021. No responses were received.

See Section 8 for market research.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

THIS IS a SOLE SOURCE REQUEST. The Government will use various analyses and conduct price comparison based on historical data in accordance with FAR 15, 404-1 to ensure market fairness;

and acquisition at reasonable, cost-effective value.

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Revision 11 Date: 02/11/2021

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

Conducted a search on the VIP database using NAICS Code 339113 (Surgical Appliances and Supplies Manufacturing), and Keywords Joimax, Vaporflex, and Endovapor. No vendors were identified.

Conducted a search on the SBA DSBS using NAICS Code 339113 (Surgical Appliances and Supplies Manufacturing), and Keywords Joimax, Vaporflex, and Endovapor. No vendors were identified.

Conducted a search on GSA Advantage using Keywords Joimax, Vaporflex, and Endovapor. No products were found.

Received a letter from Maximilian Ries, General Manager, Joimax, Inc. verifying that Red One Medical Devices, LLC is an Authorized Distributor for all joimax products including any corresponding accessories where applicable.

Published Special Notice – Notice of Intent to Sole Source Joimax Endoscopic Spine Equipment on beta.SAM.gov from April 7, 2021 through April 14, 2021. No responses were received.

Verified via the VIP database that Red One Medical Devices, LLC is a SDVOSB.

Verified via the SBA DSBS that Red One Medical Devices, LLC is a registered small business.

Verified via SAM that Red One Medical Devices, LLC, DUNS 079250760 is registered with an expiration date of 12/9/2021.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

The Joimax Endoscopic system is used by our Neurosurgery affiliate Hospitals and is considered "state of the art." They attest that the requested system is superior and they are very satisfied with its performance. Our neurosurgery residents have been trained using this equipment therefore their familiarity with the equipment will enable them to provide the necessary patient care without a gap in training., thus new instrument purchase must be consistent for staff familiarity, ease of use, and patient safety. It is imperative that the equipment should be standardized when possible to ensure that set up, use, and reprocessing are conducted properly. This equipment is needed for immediate patient care. Due to high volume of neurosurgical procedures at the Manhattan VA Medical Center the need for this product is high. Availability of reliable Service to the Hospital Based on Experience with the Company: The system at our affiliate hospitals (NYU) has been outstanding. The ability of the contractor to meet the delivery time and the system past