Triggered_CANARY_(TCAN)_B-Cells_Sole_Source_Justification_Final.pdf

DEPARTMENT OF DEFENSE

WASHINGTON HEADQUARTERS SERVICES

1155 DEFENSE PENTAGON

WASHINGTON, DC 20301-1155

ACQUISITION DIRECTORATE

SOLE SOURCE JUSTIFICATION FOR SIMPLIFIED PROCEDURES FOR CERTAIN

COMMERCIAL ITEMS

FAR 13.501(a)(1)(ii)

TRIGGERED CANARY B-CELLS

1. Contracting Organization: The Washington Headquarters Services, Acquisition Directorate, located in Arlington, Virginia, on behalf of the Pentagon Force Protection Agency (PFPA), Chemical, Biological, Radiological, Nuclear, and Explosives (CBRNE) Directorate, Pentagon Reservation, United States.

2. Description of Action: The purpose of this action is to award a sole source Firm-Fixed Price (FFP) contract to PathSensors Inc. for the continued production and delivery of B-cells for the Triggered CANARY (TCAN) biological detection system. CANARY B-cells are the reagents critical for the operation of the TCAN system. The previous contract for this requirement was awarded through competitive solicitation, HQ0034-10-R-0106; however only the incumbent, PathSensors, submitted a proposal for consideration. In an effort to upgrade the Pentagon’s Interior Biological Sensor Network, PFPA is evaluating new technologies to replace the TCAN. As such, this sole source contract will be for the minimum period of time required to research new biological detection technologies, conduct performance and suitability testing at the Pentagon, and procure a life cycle replacement for the TCAN.

The sole source contract shall be funded using FY15 Pentagon Reservation Maintenance Revolving Funds (PRMRF). This requirement is being procured under FAR 13.5, Simplified Procedures for Certain Commercial Items utilizing simplified acquisition procedures for sole source awards. This document is prepared in accordance with the requirements of FAR 13.501(a)(1)(ii) using the format at FAR 6.303-2 modified to reflect that the procedures in FAR subpart 13.5.

3. Description of Services: The TCAN is a custom biological detection system designed and built by Massachusetts Institute of Technology Lincoln Laboratories (MIT LL) to provide a detect-to-protect biological detection capability for the Pentagon. In October 2014, MIT LL granted PathSensors Inc.

exclusive patent rights to manufacture TCAN B-cells. This requirement is to supply PFPA with batches of CANARY B-cells to utilize with the TCAN system for bio threat agent detection and identification. In support of PFPA’s mission to protect and safeguard the occupants of the Pentagon and consequently, the production of the CANARY B-cells will continue as long as there is a biological threat against the United States of America (USA) or any DoD Activity and personnel in the National Capital Region (NCR).

Anticipated Period of Performance: One base year with two option years (Base Year: 30 September 2015 to 29 September 2016; Option Year 1: 30 September 2016 to 29 September 2017; Option Year 2: 30 September 2017 to 29 September 2018). During this period, PathSensors will continue to perform the main requirement, which is to supply CANARY B-cells for bio-threat detection and identification (see Section 11).

Triggered CANARY B-Cells Sole Source Justification for Simplified Procedures for Certain Commercial Items

Total Value of Contract: $1,169,283.02 (Base year); $1,203,192.23 (Option Year 1); $1,238,084.80 (Option Year 2) for a total of $3,610,560.05

4. Authority: This action is authorized under provisions of 10 USC 2304(c)(1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

5. A demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited: The Government intends to award this sole source follow-on contract to PathSensors because as the sole licensee, the contractor owns exclusive rights to produce the B-cells critical to operating the TCAN system. (See Attachment 4 – Massachusetts Institute of Technology (MIT) License). PFPA and WHS contacted MIT LL between March 31- April 17, 2015, about potentially granting other vendors rights to make CANARY B-cells, but MIT LL is not in a position to do so as long as the incumbent continues to perform the terms of the contract, or one of the criteria in the license agreement is met. Per the MIT Technology and Licensing Office (TLO), the Government may only demand that other contractors, besides PathSensors, obtain permission to produce the TCAN B-cells unless one of the following criteria is met:

I. Action is necessary because the contractor or assignee has not taken, or is not expected to take within a reasonable time, effective steps to achieve practical application of the subject invention in such field of use;

II. Action is necessary to alleviate health or safety needs which are not reasonably satisfied by the contractor, assignee, or their licensees;

III. Action is necessary to meet requirements for public use specified by Federal regulations and such requirements are not reasonably satisfied by the contractor, assignee, or licensees; or

IV. Action is necessary because the agreement required by section 204 has not been obtained or waived or because a licensee of the exclusive right to use or sell any subject invention in the United States is in breach of its agreement obtained pursuant to section 204.

None of the above conditions have been met and the criteria to allow other contractors to obtain permission to manufacture the B-cell reagents have not been satisfied. Failure to award a sole source contract to the incumbent would jeopardize the Pentagon’s defensive posture by removing the building’s only biological detection capability and leaving Pentagon occupants vulnerable to biological attacks.

Since the incumbent is performing satisfactorily in accordance with the terms of the contract, MIT LL will not license another vendor to make B-cells.

6. Efforts to Obtain Competition: A Sources Sought Notice was issued on the Federal Business Opportunities (FBO) website on May 28, 2015, in an effort to identify current and emerging biological detection and identification systems. Prior to this, PFPA was researching biological detection technologies for potential life cycle replacement for the TCAN. To date, PFPA has reviewed several biological detection technologies and found no other technologies which meet PFPA’s minimum requirements. For example, most systems do not detect, identify and quantify biological threats (to include toxins) inside the Pentagon within five (5) minutes or fewer or at the level of accuracy required to meet PFPA’s detect-to-protect mission. Very few can effectively interface with the PFPA Command & Control System to communicate data and alarms in near real time. In addition, as immature technologies, Triggered CANARY B-Cells Sole Source Justification for Simplified Procedures for Certain Commercial Items most of these systems are currently in the testing and development phase and are not ready for integration in the Pentagon. The incumbent contractor will continue to supply CANARY B-cells in quantities requested by the Government under this contract while PFPA pursues lifecycle replacement efforts.

7. Fair and Reasonable Determination: The Contracting Officer will make a fair and reasonable price determination prior to awarding the follow-on contract based on a comparison of the proposed price with historical prices paid and the independent government cost estimate (IGCE). There are several years of historical data from the current contract, HQ0034-10-C-0069, that will be used to evaluate price reasonableness.

8. Market Survey:

A Sources Sought Notice was posted on the FBO website on May 28, 2015, to obtain information from industry on biological detection capabilities. PFPA reviewed the responses to the Sources Sought Notice.

Of the nine responses, only two met the three key requirements specified, one of which is an immature technology and therefore not ready for integration in the Pentagon. Over the next two years, PFPA plans to integrate up to three biological detection systems in the Pentagon’s Interior Biological Sensor Network (IBSN) and evaluate their performance in comparison to the TCAN. At the end of this period, the system which performs best and has reasonable sustainment costs will be recommended. This effort may modernize the IBSN to an open source model allowing for more competition for this requirement.

9. Other Facts: The Government has rights to make b-Cells as MIT LL (owner of TCAN patent) is a Federally Funded Research and Development Center (FFRDC) and the effort to design and build the TCAN was funded by the Government. However, as a law enforcement agency, PFPA does not have the capability or expertise to manufacture TCAN B-cells in house. It would cost PFPA at least $800K in startup costs, material costs and salaries to make the B-cells in-house. In addition, since PFPA plans to replace the TCAN in the next few years, it is not in its best interest to pursue manufacturing B-cells in-house.

10. Interested Sources: The PathSensors BioFlash Biological Identifier is the first system selected for evaluation at the Pentagon. PFPA has developed a BioFlash interface with SENTRY for testing in the September SENTRY deployment upgrade. PFPA is still in the process of selecting two additional technologies for evaluation.

11. Actions taken to remove or overcome barriers to competition: PFPA plans to improve the performance of the IBSN by replacing the TCAN with an updated biological detector system. PFPA requires sufficient time to select systems which meet established requirements for biological detection for evaluation at the Pentagon. The Government anticipates completing this evaluation, to include acquiring and installing a life cycle replacement in three years. The timeline described below is based on the time to select these systems, develop an interface with SENTRY, integrate in the IBSN, and evaluate the system’s performance in the Pentagon. The timeline is also based on the SENTRY upgrade bi-annual schedule during which a limited number of major changes and upgrades are prioritized and deployed. Per the current contract with the Chemical, Biological, and Radiological (CBR) system integrator, the Government may deploy up to four major changes/upgrades a year such as developing an interface for a new system. The Government plans to devote one major change to developing an interface for each technology which is selected for evaluation. Other than the BioFlash, only Hamilton Sundstrand’s

Triggered CANARY B-Cells Sole Source Justification for Simplified Procedures for Certain Commercial Items

CBMS-X Biological Detector preliminarily meets PFPA’s three requirements. However, CBMS-X is not fully integrated and therefore not ready for integration and evaluation at the Pentagon. As mentioned, the Government plans to evaluate the BioFlash. To date, the CBR systems integrator has developed an interface which allows the BioFlash to communicate with SENTRY which will be deployed in September 2015. The Government continues to research emerging biological detection systems for systems which meet its requirements and are fully tested and developed. Below are the milestones to complete the modernization of the system:

YEAR 1: Begins 30 SEP 2015 – 29 SEP 2016 Integrate system #1 (BioFlash) in IBSN and evaluate performance Identify system #2 and develop requirements for SENTRY interface Develop, test and deploy SENTRY interface Integrate system #2 in IBSN and evaluate performance

YEAR 2: 30 SEP 2016 – 29 SEP 2017

Identify system #3 and develop requirements for SENTRY interface Develop, test and deploy SENTRY interface Integrate system #3 in IBSN and evaluate performance Compare performance of three systems and select one as lifecycle replacement for TCAN

YEAR 3: 30 SEP 2017 – 29 SEP 2018

Acquisition of new system Install in Pentagon Conduct system validation

Triggered CANARY B-Cells Sole Source Justification for Simplified Procedures for Certain Commercial Items

12. TECHNICAL/REQUIREMENTS CERTIFICATION: I certify that the above assertions are accurate and complete to the best of my knowledge.

Signature: Date: 9/9/15

Print Name/Title:

Vicente R. Tur Rojas II, P.E.

Acting Director CBRNE Office:

PFPA-CBRNE

13. CONTRACTING OFFICER CERTIFICATION: I certify that this justification is accurate and complete to the best of my knowledge.

Signature: Date:

Name/Title:

Catherine L. Stevens Contracting Officer Office:

WHS/AD/ESTSD

14. COMPETITION ADVOCATE APPROVAL: Since this Justification exceeds $650,000, but does not exceed $12.5 million, this review serves as approval.

Signature: Date:

Name/Title:

Wendy Schermerhorn Procuring Activity Competition Advocate Office:

WHS/AD

Tur-RojasV Pencil

StevensC Typewritten Text

StevensC Typewritten Text 9/11/15 rizzows Typewritten Text 9/11/15