A02. Redacted Justification and Approval (JA) for Other Than Full and Open Competi~2nd relook 8.7.2024_CC.pdfKO.pdf

CUI/SP-PROCURE

Source Selection Information- See FAR 2.101 and 3.104-4

Control Number: 24-RHCO-A-286 Solicitation Number: W91YTZ24Q0097

Sole Source Determination for Actions under the Simplified Acquisition Threshold (Currently $250K)

1. Contracting Activity:

Medical Readiness Contracting Office-East (MRCO-E) Fort Liberty Health Contracting Branch 2817 Rock Merritt Ave Fort Liberty NC 28310

2. Description of Action:

Requirement: New Repeat Pricing: Firm-Fixed Price Time & Materials Cost Funds: OMA Other Funds: Total Dollar Value: $200,000.00

Required delivery date: 01 Aug 2024 – 31 July 2026

Name of Intended Contractor:

Street Address:

City, State, Zip:

Phone:

Ordering Period: 01 August 2024 through 31 July 2026

3. Description of Supplies/Services: This requirement is for a Blanket Purchase Agreement (BPA) for the procurement of 24 each (12 patients X two implants) saline filled breast implants, silicone gel implants and breast tissue expander surgical supplies for patients in-waiting.

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

Controlled by: USAHCA CUI Category: SP-PROCURE Limited Dissemination Control: FEDCON POC: Megan Byrnes, megan.byrnes.civ@health.mil

Control Number: 24-RHCO-A-286 Solicitation Number: W91YTZ24Q0097

(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: Womack Army Medical Center has approximately 12 patients awaiting reconstructive breast surgery for cancer who have been pre-fitted Expanders.

From September 2019 to January 2020, the Government contracted directly with for these implants. From February 2020 until 2024 the Government procured implants via through DLA’s ECAT system. However, the relationship between and has been dissolved creating a barrier to obtaining implants from through

ECAT. We are requesting expedited procurement until a long-term solution is implemented.

Currently, there are only two vendors, offering the required breast expanders/implants. The patients awaiting the Implant Expanders require the secondary procedure using the Implant placement. implants are not acceptable because There are patients with expanders already in their bodies. is not compatible with these items.. In addition, conversion to would negatively impact patients by reinitiating a process to calculate the proper implant size and risk possible return procedures which would also negatively impact the standard of care. There are no other vendor(s) that can provide the extenders.

is the only company that can provide the extenders as they have no third- party distributors (see proprietary letter in PCF, folder A.03 dated 22 April 2024). Additionally the WAMC plastic surgeon only has expertise with products. His familiarity with sizing cuts down on waste by allowing the MTF to reliably order the correct implant size without needing to order/sterilize/utilize sizing devices. The medical considerations supporting use of implants also include a decrease in the need for sizers and reduced surgical anesthesia times. Lifetime Product Replacement Policy, Federal Drug Administration (FDA) approval, commitment to safety, and successful extensive clinical performance uniquely meet the health and satisfaction needs of patients who receive the brand. provides a wide range of implant options to accommodate diverse preferences and anatomy for our patient population. is the only company that can provide the extenders as they have no third- party distributors (see Market Research and proprietary letter in PCF, folder A.03 dated 22 April 2024).

Control Number: 24-RHCO-A-286 Solicitation Number: W91YTZ24Q0097

6. Actions to Increase Competition: A sources sought was posted 03 June 2024 with no responses. There is no effective competition expected for this requirement, the supplier is the only one that carries the product and has pre-fitted patients with expanders. The solicitation will be posted to www.SAM.gov. The Agency will conduct new market research for future similar supplies to determine whether other sources for these products exist at that time.

7. Market Survey: Market Research conducted in accordance with FAR Part 10. I researched by using the General NAICS code 339113 and found no small business contractors having the capability to provide the parts. On 9 April 2024, an on-line search was conducted on the Small Business Administration (SBA) Quick Market Research, and nothing was revealed using the words “Smooth Breast Implants,” and “Tissue Expanders.”

Results of the search using the key words “Smooth Breast Implants,” and “Tissue Expanders”:

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 339113:

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

8. Procurement History:

Control Number: 24-RHCO-A-286 Solicitation Number: W91YTZ24Q0097

Previous Contract or Purchase Order Number: W91YTZ-19-P-0399 and W91YTZ-19-P-0100 or N/A

Previously competed? N/A No Yes 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)

9. Technical / Requirements Certification: I certify that the support data under my cognizance which are included in this sole source determination are accurate and complete to the best of my knowledge and belief.

I certify this product/service is not available using mandatory sources.

Signature:

Submitted By:

Position Title :

Email address:

Date:

10. Contracting Officer Certification and Approval: I certify that this justification is accurate and complete to the best of my knowledge and belief. I have determined that the anticipated cost to the Government for this contract action will be fair and reasonable. Fair and Reasonable determination will be based on historical prices and the Independent Government Estimate. Certified cost or pricing data is not required per FAR 15.403-1(b) (3), because the items are commercial in nature.

Signature:

Typed Name: Donna L. Blossom Position Title: Contracting Officer

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