Justification_&_Approval.pdf

Control Number: 18-RHCO-C 821 Limited Sources Justification or Sole Source Justification for Acquisitions under the Simplified Acquisition Threshold (Simplified Acquisition Threshold is $150K)

1. Contracting Activity: Regional Health Contracting Office - Central, Ft Carson Health Contracting Cell, Ft Carson, Colorado.

2. Description of Action: Evans Army Community Hospital (EACH) requires the lease of the Hologic PANTHER which automates three (3) required tests onto one platform.

Requirement: New Repeat Pricing: Firm-Fixed Price Time & Materials Cost

Funds: OMA Other Funds: DHP Total Dollar Value: $ _244,020.00

Name of Intended Contractor: Hologic Inc.

Street Address: 250 Campus Drive City, State, Zip: Marlborough, MA 01752

Phone: 303-589-4218

3. Description of Supplies/Services: The Hologic Panther Molecular Analyzer with service, and consumables to provide testing capabilities for Chlamydia trachomatis, Neisseria gonorrhea, and Human Papillomavirus as a cost-per-reportable testing arrangement.

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.

(10 February 2016)

Signature: E.1368249609

Control Number: 18-RHCO-C 821

5. Reason for Authority Cited: EACH Department of Pathology and Laboratory Services (DPALS), requires a bridge contract to ensure no lapse of services or removal of leased equipment at the conclusion of the existing contract, which expires 30 September 2018. The Fort Carson Health Contracting Cell is working the re-procurement for the long term requirement and the follow-on will not be complete before 30 September 2018. The contracting officer has determined that a 12 month bridge contract is urgent for this situation and will ensure that EACH is able to keep the equipment currently in place and run the needed tests to identify relevant STDs for epidemiological reporting and compliance with Colorado Department of Health Regulations, US Army Public Health and MEDCOM guidelines. Given this time frame it is unrealistic to have a new contract in place on 01 October 2018.

Disruption of the labs ability to run these STD tests will negatively impact patient care.

6. Actions to Increase Competition: A sources sought notice for a cost-per-reportable test for STD testing was posted in August 2, 2018 and only one (1) source provided a response, BD (Becton, Dickinson and Company). This information was provided to the technical expert who indicated that the BD systems test for HPV was not FDA approved at this time.

7. Market Survey: Solicitation W81K00-15-T-0078 competed this exact requirement on 15 Aug 2015 that resulted in one offer, Hologic Inc. Since then there have been no changes in the market are known to exist that would indicate a change in prices from the original contract.

8. Procurement History:

Previous Contract or Purchase Order Number: or W91YU0-15-P-0650 Previously competed? N/A No Yes

Previous authority for less than Full & Open Competition: 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.

WEIDMAN.SHEA.NICOL Digitally signed by

WEIDMAN.SHEA.NICOLE.1368249609

Date: 2018.09.24 10:18:46 -06'00'

Typed Name: CPT Shea Weidman Position Title : Deputy Laboratory Manager

Email address: shea.n.weidman.mil@mail.mil

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

Digitally signed by

DAVIS.TROY.L.1031240189

(10 February 2016)

DAVIS.TROY.L.1

Signature: 031240189 Date: 2018.09.24 11:14:17

-06'00' Typed Name: Troy Davis Position Title: Contracting Officer

Email address: troy.L.davis1.civ@mail.mil