36A77620Q0261-015.pdf

VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

VHAPM Part 813.106 Page 1 of 4 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36E776-20-AP-0046

1. Contracting Activity: Department of Veterans Affairs, Program Contracting Activity Central (PCAC) in support of VA Nebraska-Western Iowa Health Care system (NWIHS) Ambulatory Care Center (ACC) located at 4101 Woolworth Avenue; Omaha, NE 68105. Purchase Request# 636-20-1-1337-

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

The VA Nebraska-Western Iowa Healthcare System (NWIHS) has a requirement for a partial brand name requirement for spinal instrument sets. Part of the order is brand name or equal and the other part of the order is brand name required for the Medtronic Stealth Spine Navigation Instruments in support of the new Omaha ACC. These instruments are used with the StealthStation surgical navigation system currently in use at the NWIHS. The Contractor shall deliver and provide user and service manuals for the Medtronic Stealth systems by the required need date of May 30, 2020 to support timely opening of the new clinic.

The Medtronic StealthStation surgical navigation system enables you to precisely track the location of surgical instruments throughout a procedure. The StealthStation system provides Stealth technology — a combination of hardware, software, tracking algorithms, image data merging, and specialized instruments to help guide you during surgical procedures

The Medtronic Stealth Spine Instruments are spinal surgical tools for use in the new Ambulatory Care Center’s Operating Rooms for spinal surgeries.

Spine Referencing and Navigation Sets (Brand Name Only)

ITEM #

JSN Item Description Part # Qty

U0086-A Basic Spine Referencing (includes the following) 9735500 2

U0086-A FRAME, SPINE AIR 2

U0086-A CLAMP, SINGLE STANDARD 2

U0086-A CLAMP, SINGLE SHORT 2

U0086-A REFERENCE ELBOW, TITANIUM 2

U0086-A INST 960-559 PLANAR PASSIVE BALL 1.5MM 2

U0086-A DILATOR 9733817 NAVIGATED 2

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VHAPM Part 813.106 Page 2 of 4 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020

U0086-A TRACKER 9733816 DILATOR 2

U0086-A DRIVER, T HANDLE 2

U0086-A SPINE REFERENCING TRAY 2

U0086-A TOOLS CD 2

U0086-A PERCUTANEOUS PIN UPGRADE 9734501 2

U0086-A DRIVER NAV2024 SOLERA 4.75 STANDARD MAS NAV2024K 2

U0086-A CD HORIZON SOLERA Awl-Tip Taps (includes the following) 9735465 2

U0086-A Awl-Tip Tap 4.5 mm 2

U0086-A Awl-Tip Tap 5.5 mm 2

U0086-A Awl-Tip Tap 6.5 mm 2

U0086-A Awl-Tip Tap 7.5 mm 2

U0086-A Small Tissue Protector 2

U0086-A Large Tissue Protector 2

U0086-A Percutaneous Tray 2

U0086-A Taps Module 2

136 U0086-A INSERTER, CAPSTONE and CLYDESDALE SET (includes the following)

9734836 2

U0086-A 1 Navigated Inserter for Capstone and Clydesdale Implants 2

U0086-A Rotating tracker on Inserter 2

U0086-A Slap Hammer compatible with navigated and non-navigated trials 2

U0086-A NAVLOCK NAVIGATION INSTRUMENT SET 9734833 2

U0086-A NavLock Gray Tracker 9734590 2

U0086-A NavLock Orange Tracker 9734683 2

U0086-A NavLock Violet Tracker 9734682 2

U0086-A NavLock Green Tracker 9734734 2

U0086-A NavLock Container 9734692 2

VHAPM Part 813.106 Page 3 of 4 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020

U0086-A Ratcheting Small Straight Handle (2 each) 9733734 2

U0086-A Awl Tip 9734678 2

U0086-A Lumbar Probe 9734679 2

U0086-A Thoracic Probe Tip 9734680 2

U0086-A CAPSTONE TRIALS SET (TLIF/PLIF) (includes the following) 9734834 2

U0086-A 4 Navigated Capstone Trails: 2

U0086-A 8x26mm 2

U0086-A 10x26mm 2

U0086-A 12.26mm 2

U0086-A 14.26mm 2

U0086-A Slap Hammer compatibility 2

U0086-A HANDLE 9734410 RATCHETING EGG 9734410 2

TOTAL $99,819.99

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

The stealth spine navigation instruments work in conjunction with the StealthStation S7 Surgical Navigation System already owned and in use by the NWIHCS.

These spine navigation instruments are proprietary to Medtronic. Medtronic is the only company that makes the stealth instruments compatible with the Medtronic StealthStation Surgical Navigation system. Using other brand tools on a highly specialized proprietary system poses a significant risk to patient safety. These tools are specialized tools for spinal surgery. To eliminate the risk of serious spinal cord injury or death to our veteran patients by using incompatible tools, the Medtronic tools must be used with StealthStation S7 Surgical Navigation System. Medtronic is the only brand capable of providing these highly specialized supplies required by the Government at the level of quality required. No other brand on the market can provide tools that can be used in conjunction with this highly specialized surgical navigation system.

4. Description of market research conducted and results or statement why it was not conducted:

The Contract Specialist (CS) contacted a Ms. Kathy Munio, Principal Contract Analyst-Capital with Medtronic’s Restorative Therapies Group, via email. Ms. Munio had provided a quote to the program office for this system, which was included in the acquisition request package. The CS inquired if this system was proprietary to Medtronic, and if Medtronic had an Authorized Distributors List. Ms. Munio stated “we have several SDVO (Service Disabled Veteran Owned)

VHAPM Part 813.106 Page 4 of 4 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020 distribution partners located across the country who can transact this for you…they are: Marathon Medical (Denver, CO), Academy Medical (Miami, FL), Affirmative Solutions (Jacksonville, FL), Veterans Healthcare Supply Solutions/VHSS (Miami FL)”. The CS verified that these four (4) vendors are certified SDVOSB entities in VetBiz.

The CS posted a Sources Sought notice on beta.sam.gov (January 6, 2020) asking any vendor that believes they are capable to submit a response. Additionally, a search in VetBiz of NAICS 339113 and PSC code 6515 yielded 416 results. An email was sent to all 416 vendors asking for a response if they believe they are willing and capable of providing the items detailed in the Performance Work Statement (PWS) and are an authorized dealer/distributor of the Original Equipment Manufacturer (OEM) for all items.

We received (4) responses total; three (3) from SDVOSB vendors and one (1) from a Small vendor.

One (1) vendor, Academy Medical, provided an authorized dealer letter from Medtronic, the OEM.

VENDOR DUNS Authorized Distributor for Medtronic

Academy Medical 190309067 Yes New Market Veterans, LLC 796574825 Unknown NOVO surgical 033029433 No TrillaMed, LLC 828126321 Unknown

The Contract Specialist conducted additional market research that is documented in the contract file and determined there are multiple Service-Disabled Veteran-Owed Small Business (SDVOSB) concerns authorized and capable of providing the Medtronic Stealth Instrument System as required.

Further, the CS contacted the manufacturer to determine if Medtronic is the only supplier of these instrument and was informed that, “These sets can only be purchased directly from Medtronic or by using one of the authorized distributors previously provided. They are not available for purchase from any other company.”

The only system capable of meeting the VA’s needs is the Medtronic Stealth Instrument System.

Medtronic is an Other than Small Business. To obtain the most competition, the solicitation will be competed, unrestricted on the open market with partial quotes accepted due to the brand name or equal part of the requirement. Quotes received for the brand name part of the requirement will be evaluated to ensure they are authorized dealers of Medtronic and offering the Medtronic brand only.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Michelle Rhodes Date Contracting Officer

4/23/2020 https://acquisition.gov/far/current/html/Subpart%2013_1.html#wp1125466