Final_Sole_Source_Justification_Zephyr-PathSensors_2016a.pdf

9/1/2016

USDA, APHIS, MARKETING AND REGULATORY SERVICES

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

(JOFOC)

POLICY:

In accordance with the authority granted under FAR Part 13.4, the contracting officer must promote competition to the maximum extent practicable to obtain supplies and services from the source whose offer is the most advantageous to the Government, considering the administrative cost of the purchase.

(a) The contracting officer must not—

Solicit quotations based on personal preference; or Restrict solicitation to suppliers of well-known and widely distributed makes or brands.

(b) If using simplified acquisition procedures and not using either FACNET or providing access to the notice of proposed contract action and solicitation information through the Government-wide point of entry (GPE), maximum practicable competition ordinarily can be obtained by soliciting quotations or offers from sources within the local trade area. Unless the contract action requires synopsis pursuant to FAR 5.101 and an exception under FAR 5.202 is not applicable, consider solicitation of at least three sources to promote competition to the maximum extent practicable. Whenever practicable, request quotations or offers from two sources not included in the previous solicitation.

Each justification shall contain sufficient facts and rationale to justify the use of the specific authority cited, and shall include evidence that any supporting data that is the responsibility of technical or requirements personnel (e.g., verifying the Government’s minimum needs or schedule requirements or other rationale for other than full and open competition) and which form a basis for the justification have been certified as complete and accurate by the technical or requirements personnel.

(TEMPLATE)

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

(SOLE OR SINGLE SOURCE – LESS THAN $100,000)

In accordance with the authority granted under FAR Part 13, this request for a noncompetitive acquisition is hereby submitted for consideration for acquisition approval.

1. IDENTIFICATION OF THE AGENCY AND THE CONTRACTING

ACTIVITY:

Requesting Agency:

USDA, APHIS, CPHST, S&T

1730 Varsity Dr., Suite 400, Raleigh, NC 27606-2194

Contracting Activity:

USDA, APHIS, MRPBS, ASD

Minneapolis Procurement Branch Butler Square, Fifth Floor 100 North 6th Street Minneapolis, MN 55403

2. NATURE AND/OR DESCRIPTION OF THE ACTION BEING

APPROVED:

The APHIS Scientific Technologies Program is requesting the purchase of the following equipment, the Zephyr CANARY Biosensor detection platform, acquired using noncompetitive procurement in support of the evaluation and implementation of molecular diagnostics in the AQI environment, one of three technology initiatives of the PPQ Deputy Administrator.

3. A DESCRIPTION OF THE SUPPLIES, EQUIPMENT, OR SERVICES

REQUIRED TO MEET AGENCY NEEDS (INCLUDING THE ESTIMATED

VALUE OF THE ACQUISITION INCLUSIVE OF OPTIONS):

The Zephyr Identifier being procured is a portable, modular system that provides rapid, sensitive and specific detection of the reaction of CANARY biosensors to their pathogen target. The rapid reaction of the biosensor produces light emission that requires specific equipment for its detection. Zephyr is a system that integrates a centrifuge and luminometer that is automated by an on-board computer that contains step-by-step user-friendly instructions for operation and automatic start/stop of the integrated equipment. The computer also contains the data collection system that transfers output from the luminometer to the algorithm that accurately identifies the target. The systems step-by-step user instruction, automated equipment functioning and results interpretation using the systems algorithm decreases user error.

Previous detection of the CANARY biosensors used individual pieces of equipment (luminometer, centrifuge, and computer) that were not portable or rugged. The footprint of the individual pieces take up more space and require more electrical capacity. Linking all equipment to “talk” to each other was often done incorrectly by users during our piloting of CANARY biosensor technology at two Plant Inspection Stations in 2014/15. The integrated Zephyr system avoids these mistakes as well as compromising the assay due to the users moving samples from one piece of equipment to the other too slowly in the non-integrated system.

The integrated system includes Zephyr, a system storage/shipping case and a validated companion liquid nitrogen (LN) dry shipper/storage to maintain frozen temperature of CANARY biosensor on the lab bench so labs do not have to purchase freezers to maintain cells at freezing temperatures and also allows for use of biosensors in field settings if needed during outbreaks or in-field detection.

The individual system is sold at approximately $23,500, system case at $1,250, training and support at $1,900 and the LN biosensor dry shipper/storage at $2,800. The total system cost is approximately $29,450. We are requesting the procurement of 5 systems.

4. IDENTIFICATION OF THE STATUATORY AUTHORITY PERMITTING

NONCOMPETITIVE ACQUISITIONS:

6.302-1 -- 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 CANARY® biosensors and the assays developed with the biosensors are a unique serological diagnostic system that was developed by Massachusetts Institute of Technology, Lincoln Laboratory (MIT-LL) for the rapid, inexpensive, and sensitive and specific detection of the targets for which the biosensors are developed. The CANARY® system, is able to provide fast and reliable detection of a host of human pathogens using either aerosol or liquid based samples.

Working with USDA APHIS and MIT-Lincoln Labs, the already proven technology is being adapting to detect plant pathogens and reduce their impact on our nation's economy and food supply through monitoring and early detection of plant disease pathogens at ports of entry.

APHIS has provided funding and in-kind contributions to MIT under cooperative agreements to develop and evaluate this technology for plant pathogens of interest to APHIS PPQ and found it to be a superior serological detection system with sensitivities reaching the level of polymerase chain reaction (PCR) technology, the gold standard for nucleic acid detection. There is no other serological detection assay that achieves this level of sensitivity-that of a nucleic acid detection system.

CANARY® biosensor technology is a superior serological technology when compared to existing serological diagnostic technologies such as ELISA and lateral flow devices such as Immunostrips® or Pocket Diagnostics® and the reason why APHIS PPQ has supported and evaluated it for use. No other company can provide this technology for commercial sale since it is licensed only to PathSensors. At this time, they are the sole source for CANARY® biosensor kits and the Zephyr Identifier System for detection which is being requested.

6. A DESCRIPTION OF EFFORTS MADE TO ENSURE THAT OFFERS ARE

SOLICITED FROM AS MANY POTENTIAL SOURCES AS IS

PRACTICABLE, INCLUDING WHETHER A NOTICE WAS, OR WILL BE,

PUBLICIZED AS REQUIRED BY FEDERAL ACQUISITION REGULATION

(FAR) SUBPART 5.2, AND IF NOT, WHICH EXCEPTION UNDER FAR 5.202

APPLIES:

Due to the technology being developed specifically with this use in mind and the proprietary MIT licensing granted exclusively to Path Sensors, there are no rerasonable expectations of competition in the near future. Should the technology ultimately be licensed to other manufacturers, future procurements will make reasonable efforts to obtain competition.

Per FAR Subpart 5.2, a notice of the proposed action has been publicized on FBO.gov for 14 days.

7. A DETERMINATION BY THE CONTRACTING OFFICER THAT THE

ANTICIPATED COST TO THE GOVERNMENT WILL BE FAIR AND

REASONABLE, AND THE BASIS FORTHAT DETERMINATION:

The cost of the equipment is deemed to be fair and reasonable based on the Contracting Officer’s market research of the cost of the equipment this will replace with a premium considered for the portability and proprietary features. Further, the prices paid are in-line with catalog prices offered to other commercial customers.

8. A DESCRIPTION OF THE MARKET RESEARCH CONDUCTED (FAR

PART 10) AND THE RESULTS, OR AN EXPLANATION OF THE REASON

MARKET RESEARCH WAS NOT PERFORMED:

Market research was conducted comparing the cost of similar equipment with the pricing offered for the subject acquisition. Further consideration was given to the proprietary nature of the new technology, the ruggedization and portability of the new equipment. The technical POC was relied on for their knowledge of the existing technologies in the commercial marketplace. The results of this market research revealed that there are no comparable technologies that can achieve the level of accuracy while providing the needed portability.

9. ANY OTHER FACTS SUPPORTING THE USE OF OTHER THAN FULL

AND OPEN COMPETITION - FAR 6.303-2(a)(9):

There is no other serological detection assay that achieves this level of sensitivity.

Patents for this biosensor technology were granted to MIT-LL and the CANARY biosensor technology has been exclusively licensed by MIT-LL to PathSensors Inc.in Baltimore, MD for commercialization.

Earlier licensing arrangements by MIT to PathSensors for biowarfare agents led to the CANARY® biosensor commercialization by PathSensors, Inc. that have provided CANARY® biosensor assays to the Department of Defense since 2007.

In 2014 PathSensors, Inc. received the exclusive license from MIT for commercialization of CANARY® biosensor for agricultural targets and has recently developed a commercial CANARY® biosensor kit for Ralstonia solanacearum, a USDA APHIS Select Agent plant pathogen. They are currently working with MIT, USDA APHIS and ARS to develop and evaluate additional CANARY® biosensor kits for agricultural targets to that USDA APHIS may procure in the future. The Zephyr Identifier system is used to complete the detection of pathogen targets using CANARY® biosensor kits.

10. A LISTING OF SOURCES, IF ANY, THAT EXPRESSED, IN WRITING, AN

INTEREST IN THE ACQUISITON:

Not Applicable

11. A STATEMENT OF THE ACTIONS, IF ANY. THE AGENCY MAY TAKE

TO REMOVE OR OVERCOME ANY BARRIERS TO COMPETITION

BEFORE ANY SUBSEQUENT ACQUISITION FOR THE SUPPLIES,

EQUIPMENT, OR SERVICES REQUIRED:

Surveys of the marketplace will be conducted periodically by the program to watch for any new entrants to market with comparable or superior technology.

Future acquisitions for the same or similar equipment will re-confirm the appropriateness of a sole source acquisition.

12. I HEREBY CERTIFY THAT THE INFORMATION PROVIDED IN THIS

JOFOC IS ACCURATE AND COMPLETE TO THE BEST OF MY

KNOWLEDGE AND BELIEF.

Robert Zeglin Date Laurene Levy Date Contracting Officer Program Manager/Coordinator

Minneapolis Procurement Branch PPQ S&T Scientific Technologies Program

6.302-1 -- Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.