19_RHCO_P_566_LSJ_COBAS_LIAT.pdf

Control Number: 19- RHCO-P 566

(30 November 2018) 1

Limited Sources Justification or

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

1. Contracting Activity: Regional Health Contracting Office-Pacific, Health Contracting Cell, Joint Base Lewis-McChord (JBLM), 673 Woodland Square Loop SE, Lacey, WA 98503.

2. Description of Action:

Requirement: New Repeat Pricing: Firm-Fixed Price Time & Materials Cost Funds: OMA Other Funds: _________ Total Dollar Value: $184,772.00

Required delivery date or period of performance: 1 Oct 2019 to 30 Sept 2020 plus one option year (24 Months)

Name of Intended Contractor: ROCHE Diagnostics Street Address: 9116 Hague Rd City, State, Zip: Indianapolis, IN 46256-1025

Phone: 503.288.1476

3. Description of Supplies/Services: The Department of Pathology at Madigan Army Medical Center (MAMC) requires a testing system that performs Point of Care testing for Flu, RSV and Strep A utilizing PCR technology within a small benchtop footprint. The platform must have an approved Authority to Operate (ATO) on the Defense Health Agency (DHA) network and be bi-directionally interfaced with the Laboratory Information System (LIS) Military Health System - Genesis.

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: Madigan Army Medical Center (MAMC) was the first Medical Treatment Facility to validate equipment on the Defense Health Agency (DHA) Cyber Logistics

Control Number: 19- RHCO-P 566

(30 November 2018) 2

Cybersecurity/Risk Management Framework(RMF) network so at this time no other Flu Analyzer testing system, other than Roche Cobas LIAT, has an authority to operate (ATO) on the DHA Network. The process to acquire ATO on the DHA network can take up to a year. Therefore, only the Cobas LIAT testing system can fulfill all the requirements.

6. Actions to Increase Competition: A general competitive effort is made throughout the requirement review process which considers the applicability of other products, if available from other sources to determine if compatibility in providing the same is available. Otherwise, at present the intended contractor is the only source capable of meeting this requirement in maintaining the best intent and interest of the Government.

This Limited Source Justification will be posted on FBO to increase competition.

7. Market Survey: Market Research was conducted and all mandatory sources were reviewed. No other Flu Analyzer system has the ATO on the DHA network.

8. Procurement History:

Previous Contract or Purchase Order Number: W81K02-17-P-0445 Previously competed? N/A No Yes Previous authority for less than Full & Open Competition: FAR 8.405-6(a)(1)(i)(B)

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 or delivery cannot be made by the required delivery date.

Signature:

Submitted By: DARIN HOUFEK Position Title : HEALTH SYS SPC

Email address: Darin.e.houfek.civ@mail.mil Date:

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:

Position Title: Contracting Officer

Email address:

Date: