A.02 Sole Source JnA Staar Surgical-revised 7-12-21.pdfredacted.pdf

Control Number: 21-RHCO-A-554

RFQ#: W91YTZ21Q0190

Sole Source Justification For Acquisitions under the Simplified Acquisition Threshold

($250K and below)

1. Contracting Activity:

Regional Health Contracting Activity-Atlantic (RHCO-A) 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: _________ Total Dollar Value: xxxxxx

Name of Intended Contractor: STAAR Surgical Company Street Address: 1911 Walker Ave City, State, Zip: Monrovia, CA 91016

Phone: Jeff Johnson (904) 466-4463

POP 01 OCT 2021 through 30 SEP 2023

3. Description of Supplies/Services: Womack Army Medical Center (WAMC) has a requirement to purchase Visian Implantable Collamer Lenses (ICL) and Injectors for surgical 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 lens is being used for the deploying warfighter because of the minimal surgical cut to the eye allowing quicker healing time than other types of lenses which is critical for a deploying warfighter. The 100 percent pure collagen copolymer lens material is not viewed by the body as a foreign object by the body’s immune system which makes it biocompatible.

Unlike traditional contact lens, once the Visian Implantable Collamer Lens is implanted in the eye, there is no additional maintenance needed. The Visian ICL is designed to be permanently placed in the eye; however, the lens can be removed if the patient’s vision changes or if it otherwise needs to be removed or replaced. Failure to provide the needed supplies for these surgeries will result in diminished healthcare for the patients. A sole source justification memo from Visian states that the Myopia Implantable Collamer Lenses (MICL) this letter confirms that STAAR Surgical Company is the sole manufacturer and distributor of the Torie MICL and Visian MICL lens in the United Sates.

6. Actions to Increase Competition: Sources sought will be posted on the SAM.gov website for increased competition.

7. Market Survey: Market Research conducted in accordance with FAR Part 10. I researched by using the General NAICS code 339115 and found no small business contractors having the capability to provide the parts. On 22 June 2021 an on-line search was conducted on the Small Business Administration (SBA) Quick Market Research on and nothing was revealed using the words “Visian

ICL.”

Results of the search using the key words “Visian ICL”:

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

Results of the search using the NAICS code 339115:

Economic Group Number of Firms Found Service-Disabled Veteran 158 Currently SDB Certified 1 Currently HUBZone Certified 24 Currently 8(a) Certified 15 Woman or Women Owned 182 Veteran 201

The items are not available on the General Schedule Administration (GSA) contract schedule.

8. Procurement History:

a. Previous Contract or Purchase Order Number:

W91YTZ20P0039 from 1 Jun 2019 thru 30 Nov 2019 in the amount of $149K W91YTZ21P0026 from 1 Jun 2020 thru 30 Nov 2020 in the amount of $100K W91YTZ21P0106 from 1 Dec 2020 thru 31 May 2021 in the amount of $50K

b. Previously competed? N/A No Yes

c. Previous authority for less than Full & Open Competition: FAR 13.106-1(b)(1)(i)

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.

Submitted By: Stefan Lin Position Title : SGT, Surgical Logistics

Email address: Stefan.lin.mil@mail.mil Date: 22 June 2021

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 Blossom Position Title: Contracting Officer

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