JA Sole Source Infectious Disease Testing Reagents Hologic Panther.pdf

Control Number: 20-RHCO-A-478 Solicitation: W91YTZ20Q0242

Sole Source Justification Acquisitions under the Simplified Acquisition Threshold

(Simplified Acquisition Threshold is $250K)

Regional Health Contracting Activity – Atlantic (RHCO-A) Contracting Cell 6021 5th Street, Building 1469 Fort Belvoir, VA 22060-5505

1. Description of Action:

Requirement: New Repeat Pricing: Firm-Fixed Price Time & Materials Cost Funds: OMA Other Funds: N/A Total Dollar Value: $ 249,000.00

Name of Intended Contractor: Hologic Inc.

Street Address: 10210 Genetic Center Drive City, State, Zip: San Diego, California 92020

Phone: (925) 799-9499

Period of Performance: 1 August 2020 – 31 December

2. Description of Supplies/Services: Panther/Fusion Assay Supplies. Hologic Inc. This is an FDA approved analyzer and supplies for performing in vitro diagnostic molecular testing assays for Chlamydia trachomatis and Neisseria gonorrhoeae, and has an Emergency Use Authorization from the FDA for COVID-19 testing.

3. 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.

4. Reason for Authority Cited: Womack Army Medical Center Department of Pathology possess a Hologic Panther/Fusion within their workspace. Competing this requirement would cause a break in service that would greatly affect current patient care and would drastically delay the implementation of high-throughput COVID-19 testing capabilities required to meet the current demand. Additionally, Womack Army Medical Center Department of Pathology already possesses a Hologic Tigris within their workspace with existing equipment. Competing this requirement would cause a break in service that would greatly affect current patient care and would add additional expenses to the Hospital. Services shall include the following but not limited to: The contractor shall Chlamydia trachomatis/Neisseria gonorrhoeae using Nucleic Acid Amplification technology (NAAT) that is a fully automated walk-a-way enclosed system.

Workload numbers for test performed are estimated. Payment will be made for actual items received.

Estimated annual workload for Chlamydia trachomatis/Neisseria gonorrhoeae testing is 30,000 samples annually. If action is not made; Womack Army Soldiers and their families mission will fail and patient care will suffer.

5. Actions to Increase Competition: Action was posted on BETA SAM for competition; however, to-date no response has been received. Hologic Inc, is the only supplier known to test above mentioned medical issues.

6. Market Survey: Sole Source purchase. Hologic is the only supplier of supplies required to run the

Hologic Panther/Fusion platform.

7. Procurement History:

Previous Contract or Purchase Order Number: W91YTZ20P0116; W91YTZ15A0011-

W91YTZ20F0036 or N/A Previously competed? N/A No Yes Previous authority for less than Full & Open Competition: N/A

8. 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: Angela Noles Position Title : Supervisor, Microbiology

Email address: angela.n.noles.civ@mail.mil Date: 20 July 2020

9. Contracting Officer Certification and Approval: I certify that this justification is accurate and complete to the best of my knowledge and belief. 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:

Typed Name: CHERYL A. RICKER .

Position Title: Contracting Officer

Email address:

Date:

mailto:angela.n.noles.civ@mail.mil