6_JA_PCR.pdf

Control No.:

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JUSTIFICATION AND APPROVAL FOR OTHER THAN FULL AND OPEN

COMPETITION FOR ACQUISITIONS NOT EXCEEDING $700,000

1. Agency/Contracting Activity: Mission & Installation Contracting Command – Dugway

Proving Ground

2. Description of Action:

Nature: New Requirement Follow-on Requirement

Mod to Purchase Order/Contract Number:

Pricing: Firm-Fixed Price Time & Materials Cost Type

Funds: Operation & Maintenance RDT&E Other Funds:

Name of Contractor / Vendor: Life Technologies (a brand of Thermo Fisher, Inc.)

Street Address: 5781 Van Allen Way City, State, Zip Code: Carlsbad, CA 92008 Phone: (203) 589-0833 (Patrick Bremer)

3. Description of Services or Supplies:

Estimated Total Value for Section 3.0: $699,500.00

3.1 Contractor shall provide technical expertise to perform routine annual preventative maintenance (PM) and emergency repairs for the 11 thermal cyclers and 1 flow cytometer laboratory equipment, which includes:

Qty per yr per unit Name of equipment

3 1 Viia7 4 1 QuantStudio12K Flex 2 1 QuantStudio12K Flex OA 2 1 Accufil 1 1 Attune Flow Cytometer

The services described above should be provided for the duration of one base year and three option years. Please note that three (3) QuantStudio12K Flex instruments are to be procured during the base year of this contract and will initially be covered by a 1-year manufacturer's warranty, each. Thereafter, these units are to be added to the equipment list for annual

-2-preventative maintenance servicing on this contract for Option Years 1, 2 and 3. For simplicity, these units are inlcuded in the above table.

The requiring activity is the West Desert Test Center Life Sciences Division.

3.2 QuantStudio 12K Flex, Fast 96-Well PCR System to include Flex OA calibration kits, shipping, and installation. Contractor shall provide Three (3) QuantStudio 12K Flex polymerase chain reaction (PCR System) with Fast 96-well Block to include: Fast interchangeable block format that can accommodate QuantStudio or Viia7 thermal blocks and TaqMan Array card blocks, has a sensitivity 1 to 10 copies, dynamic range of 9 logs, can detect TaqMan MGB primers/probe, accommodates reaction volumes from 10 to 30 microliters, has a footprint no greater than 54cm x 76cm x 70cm, has a high throughput and multiplexing capability, weighs no greater than 155 lbs, has 4 or more emission filters in the 520 to 700nm range, and has a input voltage of 110V.

3.3 Trade in of two (2) Viia7 model thermal cyclers on the contingency of purchasing the items in 3.2. and Credit - $20,000 each.

3.4 The estimated value breakout of the proposed actions in paragraphs 3.1, 3.2, and

3.3 is shown in the following table:

Item Qty Unit Price Total

3.1 – Annual Preventative Maintenance and Emergency Repairs, Base plus Option Years

4 years x 365 days

$452,000.00

3.2 – Procurement of QuantStudio 12K Flex PCR Systems with Fast 96 Well Block

$90600

$271,800.00

3.3.2 – QuantStudio 12K Flex OA Calibration Kit 3 $0.00 $0.00

3.3.3 – Trade-in Credit for Viia7 Thermal Cyclers 2 ($13,000) ($26,000)

3.3.4 – Shipping and Handling 1 $1,160.64 $1,700.00

3.3.5 – No Cost Installation 1 $0.00 $0.00

Total Estimated Cost $699,500.00

4. Authority:

Actions other than simplified acquisition procedures (select one):

FAR 6.302-1: Only one responsible source and no other supplies or services will satisfy agency requirements, 10 USC 2304(c)(1).

5. Reasons for Authority Cited:

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5.1 Only one contractor, Life Technologies, can meet the specifications of this requirement and deliver the brand name QuantStudio 12K Flex Real-Time PCR System and give trade-in value for the Viia7 thermal cyclers. The QuantStudio 12K Flex Real-Time is the only instrument that can meet all of the specifications. Specifically, this instrument is the only PCR system on the market that can be operated interchangeably with Life Technologies’ proprietary equipment: 96-well Fast, 384-well, OpenArray, and Array Card thermal blocks as well as the Accufill Sytem and Twister II robots.

The U.S. Army Dugway Proving Ground has invested hundreds-of-thousands of dollars in the aforementioned blocks and automated plate systems and is sole-sourcing this contract to avoid duplicating those costs. Additional cost to support multiple systems if other manufacturers’ systems were introduced would be incurred, as a separate maintenance contract would be required. This additional equipment would lead to duplicative contractor overhead cost and additional labor and cost to government personnel to issue and administer two contracts versus one.

The QuantStudio 12K Flex PCR System is a system used by the West Desert Test Center Life Sciences Division to establish a Quality Analysis Program (ISO 17025). The Quality Analysis Program is for biological test materials and is predicated on the QuantStudio system. Any deviation to another system would negate the credibility of this program and cost the government an estimated one million eight hundred sixty one thousand and four hundred dollars ($1,861,400.00) to verify and validate a different PCR system and rewrite/staff standard operating procedures. This estimate includes the cost of procuring a new system from an alternative manufacturer, the government labor cost to develop all new molecular assays on that system, and the government labor cost to implement the new system into the test center ISO 17025 compliance program. The lapse in repair time would compromise on-going testing efforts and, therefore, procurement of the sited PCR system is in the best interest of the government to avoid costly delays that could result from having to duplicate verification and validation of standard operating procedures. In addition, LSD has already invested an estimated 1.5 million dollars in thermal blocks, reagents, and supplies specific to the QuantStudio that would be made obsolete and have to be replaced at an added cost to the government if any other PCR system were procured.

5.2 The data generated by Life Sciences Division (LSD) thermal cyclers has to be extremely precise and accurate. To ensure the reliability of the data being collected and used in evaluating system performance, it is critical that the instruments be systematically maintained by manufacturer qualified engineers. Life Technologies is the original manufacturer of the thermal cyclers employed by LSD and is the only firm that has the diagnostic equipment, OEM parts, and trained engineers to maintain and repair these sensitive instruments. The instrumentation also includes proprietary software which requires Life Technologies’ engineers to install, maintain, upgrade, and trouble-shoot. The instruments incorporate several proprietary technologies and use patented parts not available from other manufactures.

A statement about Life Technologies proprietary technology brochure: “Life Technologies has designed, built and serviced its instruments, we have created service documentation (e.g., service manuals, installation and operation protocol (IQ/OQ), planned maintenance checklist) and service tools (e.g., calibration software, temperature verification device) that

-4-we use in performing services. The service documentation and service tools are copyrighted and/or proprietary to Life Technologies. Life Technologies has not authorized any third party service providers to copy or make derivatives of or use any of the service documentation and/or service tools for any purposes including, but not limited, to the use of, or copying of, Life Technologies’ IQ/OQ protocol or portions of that protocol in performing its qualification services. The unauthorized use, copying, or making derivatives of the service documentation and service tools is a violation of Life Technologies intellectual property rights.”

6. Actions to Increase Competition: Pursuant to FAR 5.202(a) (1), Contracting activity will continue to advocate brand name or equivalent specification for equipment purchased by LSD and personnel will continue to monitor and seek to identify other vendors that may meet LSD’s specialized needs.

7. Market Research: Market research has revealed in writing that Life Technologies does not allow any known dealer/authorized repair firms to work on its equipment. Life Technologies, the original equipment manufacturer (OEM), is the only servicer of its thermal cyclers and sample robots. The system is built into the LSD Quality Analysis Program. Furthermore, Life Technologies does not subcontract work to other companies.

Life Technologies’ engineers are factory trained and ISO-certified and its replacement parts are factory authorized. Operating system software and data analysis software for Life Technologies thermal cyclers are written by Life Technologies, may only be sold by Life Technologies, and are only supported by Life Technologies. The instruments incorporate several proprietary technologies and patented parts which may not be manufactured by other companies.

8. Procurement History:

Previous Purchase Order or Contract: Yes

Contract number: W911S6-14-P-0069 Sole Source

9. Additional Information to support the justification. Life Technologies manufacturer’s parts and diagnostic equipment necessary to restore equipment to 100% functionality and to ensure adherence to manufacturer’s specifications. In addition, Life Technologies parts and repair service are proprietary and not releasable to the general public for equipment repairs.

After speaking to Government Scientific, a distributor of Life Technologies, the company does not do the trade-in being requested with this Justification and Approval.

After thorough review of contract’s directory online for other contracts under Life Technology, there are similar contracts with the same equipment. The similar PCR’s were procured as sole source. All services contracts for Life Technology equipment were procured directly through the OEM. The GSA identifies distributors for the Quant Studio PCR’s, and one company that offers maintenance services but no trade-in. The one company, Government Scientific, was contacted referred to OEM for services, and the trade

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in. The distributors do not support the equipment and refer the customer directly to Life Technologies for any support.

10. Technical / Requirements Certification: I certify that the supporting data under my cognizance which is included in this abbreviated J&A is accurate and complete to the best of my knowledge and belief.

11. Fair and Reasonable Price Determination: As contracting officer, I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable, based on contract history, published pricing and price analysis of labor rates. In accordance with FAR 15.403-4, certified cost and pricing data is not required for this requirement since the estimated monetary value is below the $700,000 regulatory threshold.

12. Reviews: I have reviewed this justification and find it adequate to support other than full and open competition.

Local Small Business Specialist:

Legal Counsel:

Name: Kateni T. Leakehe, Signature: Kateni T. Leakehe

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Date: 06/30/16

13. Contracting Officer’s Approval: I hereby certify that this justification is accurate and complete to the best of my knowledge and belief. Based on the foregoing, I approve this sole source justification subject to availability of funds, and provided that the services and supplies herein described have otherwise been authorized for acquisition.

Signature:

Name: Paul E. Frailey Title: Contracting Officer

Date: