A.02 JA Sole Source for FFN testing 19 Jan 2021_Redacted.pdf

Control Number: 21-RHCO-A-296

RFQ #: W91YTZ21Q0081

Sole Source Justification

1. Contracting Activity:

Regional Health Contracting Activity – Atlantic (RHCO-A) 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: N/A Total Dollar Value:

Name of Intended Contractor: Hologic Inc.

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

Phone: (925) 799-9499

3. Description of Supplies/Services: Fetal Fibronectin testing supplies by Hologic Inc. This testing is used to assess the risk of preterm delivery among pregnant women. This requirement will support the Pathology Department and Womack Army Medical Center (WAMC). FFN testing by Hologic is FDA approved. The contract has a Base Year (1 Oct 21 – 30 Sep 22) and four 12 month option periods.

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.

Control Number: 21-RHCO-A-296

RFQ #: W91YTZ21Q0081

5. Reason for Authority Cited: This requirement is for Hologic products to be used with Hologic testing equipment located in the Department of Pathology, Womack Army Medical Center (WAMC), Fort Bragg, NC. Hologic products are the only products that are compatible with the required Hologic equipment. Any other product can damage the current testing analyzers and force the Government to compensate Hologic for the damage to or replacement of their equipment. Hologic has confirmed that it is the sole proprietor and manufacturer of the Rapid fFN test for the system. Hologic has also confirmed that Hologic is the sole domestic distributor of the requested test and system.

The products are used as a predictor of preterm births of women with high risk factors. Failure to procure the products can be detrimental to patient health and well-being.

6. Actions to Increase Competition: A Sole source is necessary to ensure that there is no break in service for the patients seen at facilities supported by the WAMC laboratory. There are no practical alternatives available to increase competition for this requirement. Hologic is the only company that provides the products and testing equipment. The solicitation will be posted to beta.SAM.gov.

7. Market Survey: Sole Source Justification from Hologic received. Hologic is the only supplier of supplies required to perform FFN testing. Small Business Dynamic search conducted, no vendors were found that can provide these supplies as Hologic does not authorize third party distribution.

8. Procurement History:

Previous Contract or Purchase Order Number: W91YTZ16P0629 or N/A 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.

Submitted By: Bhavini Patel Position Title : Supervisor, Chemistry

Email address: .bhavini.n.patel.civ@mail.mil Date: 31 January 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: Lonnie Robinson Position Title: Contracting Officer

Email address: lonnie.k.robinson.civ@mail.mil Date: Click here to enter a date.