A.02 J&A - Kahook - New_Redacted.pdf

Control Number: 20-RHCO-A-169

RFQ/RFP #: W91YTZ20Q0093

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 1469 Fort Belvoir, VA 22060-5505

2. Description of Action:

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

Name of Intended Contractor: New World Medical Street Address: 10763 Edison Court City, State, Zip: Rancho Cucamonga, CA 91730

Phone: POC: Jason Carroll – (615) 295-1326

Period of Performance: 1 April 2020 – 30 September 2020.

3. Description of Supplies/Services: Womack Army Medical Center (WAMC) has a requirement to purchase Kahook supplies for surgical procedures scheduled from 1 April 2020 through 30 September 2020 for ophthalmic procedures

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: This system is only available through this vendor which provides instrumentation for a non-invasive approach to treating open angle glaucoma and ocular hypertension. According to the proprietary letter, New Work Medical, Inc (NWM) is the sole source provider of the Kahook Dual Blade a disposable ophthalmic instrument designed to lift and excise trabecular meshwork under gonioscopic view. The Kahook Dual Blade must be purchased by institutions directly from NWM at the address listed above. There are no other agents or dealers authorized to represent these instruments. It is the only treatment performed by an Ophthalmologist that is capable of providing relief of symptoms. The procedure is typically performed using local anesthesia in a physician’s office or ambulatory surgery center. Patients typically return home the same day without a catheter. If these disposable instruments are not procured, Womack Army Medical Center’s mission will not meet the needs of their patients.

6. Actions to Increase Competition: the solicitation will be posted out on BETASAM for potential increased competition.

7. Market Survey: Market Research conducted in accordance with FAR Part 10. I researched by using the General NAICS code 339112 and found no small business contractors having the capability to provide the implants. On-line search was conducted on the Small Business Administration (SBA) Quick Market Research on 5 December 2019 and nothing was revealed using the words “Kahook.”

Economic Group Number of Firms Found Service-Disabled Veteran 564 Currently SDB Certified 12 Currently HUBZone Certified 98 Currently 8(a) Certified 65 Woman or Women Owned 566 Veteran 759

Key word Search “Kahook”

Economic Group Number of Firms Found Service-Disabled Veteran 0 Currently SDB Certified 0 Currently HUBZone Certified 0 Currently 8(a) Certified 0 Woman or Women Owned 0 Veteran 0

The medical supplies and services are not available on the General Schedule Administration (GSA) contract schedule.

8. Procurement History:

a. Previous Contract or Purchase Order Number: None

b. Previously competed? N/A No Yes

c. Previous authority for less than Full & Open Competition: FAR 13.106-1(b) (1) (i): Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization)

d. Subcontracting Plan is not required in accordance with 52.219-9.

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. I certify required services and supplies are not available using mandatory sources and delivery cannot be made by the required delivery date.

Submitted By: Christen M. Barnhill Position Title : SGG CPT, AN, Surgical Logistics

Email address: christen.m.barnhill.mil@mail.mil Date: 10 Oct 2018

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: DONNA L. BLOSSOM Position Title: Contracting Officer

Email address: Donna.l.blossom.civ@mail.mil Date: