A.02.04_J&A_Sole_Source.pdf

Control Number: 18-RHCO-C-176

Limited Sources Justification or Sole Source Determination for Actions under the Simplified Acquisition Threshold (Currently $150K)

1. Contracting Activity: Regional Health Contracting Office-Central, US Army Health Care Acquisition Activity, San Antonio Military Medical Center, Fort Sam Houston, Texas 78234

2. Description of Action: San Antonio Military Medical Center, Fort Sam Houston, TX is requesting a Sole source contract for patient specific spinal implants. This action will be accomplished through Firm Fixed Price.

Requirement: New Repeat Pricing: Firm-Fixed Price Time & Materials Cost Funds: OMA Other Funds: _________ Total Dollar Value: $ 149,650.00

Name of Intended Contractor: NEVRO CORP Street Address: 1800 BRIDGE PARKWAY City, State, Zip: REDWOOD CITY, PA 94065

Phone: 210-819-9825

3. Description of Supplies/Services: Provide Spinal Implant, which includes the following: Part# NIPG1500, Lead Anchor Kit (N300): Part# ACCK5300, Lead Kit 50cm: Part# LEAD1058, Charger Kit:

Part# CHGR1000, Patirnt Remote Kit: Part# PTRC1000

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: These implants are a physician prescribed surgically implanted medical device selected for specific patient’s case. The surgery is to treat chronic pain resulting from trauma related injuries. This is the only device that delivers high frequency electrical 10 kHz, Control Number: 18-RHCO-C-176 manufactured to be implanted in the lower spinal area for the treatment of back and leg pain.

Combining high frequency at 10 kHz with a unique waveform and a specific treatment algorithm results in HF10 therapy: A paresthesia free treatment proven to provide superior pain relief to more patients. Traditional spinal cord stimulation leaves patients with a burning or prickling sensation that is usually felt in the hands, arms, legs, or feet, a condition known as Paresthesia. The patient has received no relief from physical therapy or pharmaceutical interventions.

6. Actions to Increase Competition: The Government will continue to seek new resources that will satisfy these requirements thorough continued market research, requests for Statements of Capability and telephonic inquiries.

This will be posted on ASFI to increase competition.

7. Market Survey: Market research reveals there are other spinal implants in the marketplace, but due to the specific patient’s health, the physician has prescribed this particular implant device to the specific patient. Nevro Corp. is a Certified Small Disadvantaged Business and is the sole manufacturer of these implants.

8. Procurement History:

Previous Contract or Purchase Order Number: or W81K00-18-P-0641 Previously competed? N/A No Yes Previous authority for less than Full & Open Competition: FAR 13.106-1(b)(1)(i)

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.

Signature:

Submitted By: MAJ Gonzalez, Hiram Position Title : Surgical Floor Coordinator

Email address: Hiram.gonzalez1.mil@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: Emerita Torres Position Title: Contracting Officer

Email address: Emerita.torres.civ@mail.mil

(21 October 2016)

Date: 18 January 2018