Life Tech AB Assurance JA customer and KO Signed redacted_Redacted.pdf

Control No: Gordon-2021-5 Life Technologies, Inc.

Life Technologies AB Assurance annual maintenance and repair – USACIL/OQIT

Version – March 2017 FOR OFFICIAL USE ONLY

FAR Subpart 13.5 Simplified Procedures for Certain Commercial Items – Sole Source Justification and Approval

1. Contracting Activity: Mission and Installation Contracting Command (MICC) - Fort Gordon, GA, 271 Heritage Park Lane, Building 35200, Fort Gordon, GA 30905

2. Description of Action: The Defense Forensic Science Center requests a firm-fixed-price contract with Life Technologies Corporation, 5781 Van Allen Way, Carlsbad, CA 92008. The projected award is December 2020 and fiscal year 2021, funds type Operations and Maintenance, Army funds will be used.

An acquisition plan is not required because this procurement does not meet the threshold at Defense Federal Acquisition Regulation Supplement 207.103(d)(i)(B).

This action is a follow-on contract/order to W91249-20-P-0005. That contract/order was competed under authority 10 USC 2304, 41 U.S.C. 1901 [FAR 13.5(a)(2)] “Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

3. Description of Supplies/Services: The Defense Forensic Science Center (DFSC) has a mission essential requirement for Life Technologies AB Assurance to provide maintenance and repair services to perform annual preventative maintenance and service repair for Life Technologies 7500 Real-Time polymerase chain reaction (PCR) systems, 3500 XL Genetic Analyzers, BSD 600 Duet, 9700-96 Well Sample Modules, COPAN 200, Veriti thermal cycler instruments, ProFlex thermal cycler instruments.

Services include preventative maintenance service, repairs, costs for any replacement parts and supplies, quarterly temperature calibration/verification for the thermal cycler instruments, and technical support line.

4. Authority Cited: Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 (or 41 U.S.C. 1903 for Special Emergency Procurement) as implemented by FAR Subpart FAR 13.5(a)(2) :

Other: Sole Source

5. Reason for Authority Cited:

a. The Defense Forensic Science Center (DFSC) located at the Gillem Enclave in Georgia, provides forensic laboratory services to the Department of Defense investigative agencies and other Federal law enforcement agencies and overseas contingency operations support. The Life Technologies Corporation Maintenance Agreement is required to support forensic laboratory accreditation compliance of installed instruments and equipment. (ISO 17025 ANSI-ASQ National Accreditation Board) DFSC must also maintain compliance with the Federal Bureau of Investigation (FBI) Quality Assurance Standards. Standard 10 specifies equipment maintenance and calibration for critical instruments within the laboratory. The 7500 RT-PCR instruments and 3500 XL Genetic Analyzers are considered a critical instrument according to standard 10.2.1.4.

b. The 7500 RT-PCR instrument is used by USACIL DNA Branch to determine the quantity of human DNA in a sample. This information is then used to determine whether a sample is suitable for DNA typing or not and what amount should be placed into the amplification reaction to obtain the best result. The BSD Duet is a sample punch instrument used for automated sampling of dried biological specimens. The COPAN CPA200 instrument is a semi-automated puncher with imaging technology, software capable of integrating with the laboratory Sample Tracking and Control System (STaCS).

The 9700-96, Veriti, and ProFlex thermal cyclers amplify the DNA for the creation of DNA fragments that make up a DNA profile. The 3500 XL Genetic Analyzers are used to separate DNA fragments of varying lengths based on size. This information is used to develop the DNA profile of an individual, which is used in forensic DNA casework. The accurate performance of these instruments is critical to the mission of the USACIL DNA Branch. Failure to perform repairs to manufacturer’s specifications could result in sub-standard performance of the instrumentation resulting in inaccurate data. Inaccurate data could result in samples not being carried forward for further analysis which otherwise would have. This could then result in an individual on the evidence processed not being identified.

c. Life Technologies Corporation is the sole provider of factory-trained service engineers who have exclusive access to manufacturer’s proprietary technical manuals, repair and maintenance procedures, and software application updates for this equipment. Life Technologies Corporation maintains intellectual property rights to its software and service tools software. Third party resellers and service providers are strictly prohibited from accessing, using or selling this software. Life Technologies does not authorize any third-party service provider in North America to perform maintenance and repair on Applied Biosystems Instruments. Life Technologies is the only source of replacement parts and manufacturer authorized service provider for AB instruments. Life Technologies is the only vendor capable of providing the necessary service inspections to maintain calibration and qualification services required for laboratory ISO accreditation. Life Technologies only trains service engineers employed with Life technologies.

d. Impact.

1) Award of this contract to any third party vendor will result in repair technicians attempting services without accurate or complete technical manuals, maintenance procedures, and access to proprietary software application updates required for this maintaining and calibrating this equipment to manufacturer standards, as required by ISO standards.

2) Engineer services from third party vendors would require that should the instrument in question need to be serviced by a Life Technologies engineer or placed back under service contract with Life Technologies, the instrument would need to be inspected first by an authorized Life Tech field service engineer and preventative maintenance performed at the customers expense, prior to any new maintenance, service or repair.

3) Failure to award this contract will result in failure to meet the standard 10.2.1 of the FBI Quality Assurance Standards which require that critical instruments are performance checked at least annually. Failure to meet this standard will negatively impact the USACIL maintaining status as an accredited laboratory.

6. Actions to Increase Competition:

To increase competition the MICC-Fort Gordon will continue to synopsize and conduct market research to ensure there are no other vendors that can provide the requirement.

The Government will issue a sole source synopsis and address any responses accordingly.

7. Market Research: Extensive research was conducted (Internet searches, telephonic communications, forensic conference exhibits, electronic communications, and literature searches) to determine the availability of manufacturer authorized warranty maintenance and repair programs for these instruments. These services are not available under GSA Schedule. A Sources Sought Notice was posted to Beta.SAM.gov on 10/22/2020. The Sources Sought notice closed on 10/29/2020 without responses. No other company offers the sale of manufacturer certified warranty maintenance of the proprietary instruments produced by Life Technologies. Life Technologies corporation provided a sole source letter.

Salient Characteristics: This acquisition is for Forensic Laboratory instrument Life Technologies maintenance repair service:

Services include one annual preventative maintenance service, which covers all of the required maintenance outlined in the instrument handbook provided by the instrument manufacturer. Included are the costs for any parts, which need to be replaced, and the consumables needed to perform the maintenance. The service also covers any repairs that are needed on the instrument and software updates during the covered period.

Repairs include the cost of the parts and labor associated with the repair. The technical support line is also available for use by the customer in troubleshooting possible instrumentation problems. Service included quarterly temperature verification and calibration on thermal cycler instruments.

9. Interested Sources: To date, no other sources have written to express interest in the acquisition.

10. Other Facts: Procurement History

Contract:

Contractor: Life Technologies Corporation

Award Date: 11 December 2019 Competitive Status: Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

Authority: FAR 13.5(a)(2)

Contract:

Contractor: Life Technologies Corporation Award Date: 11 December 2018 Competitive Status: Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

Authority: FAR 13.5(a)(2)

Contract:

Contractor: Life Technologies Corporation Award Date: 30 November 2017 Competitive Status: Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

Authority: FAR 13.5(a)(2)

Contract:

Contractor: Life Technologies Corporation Award Date: 31 October 2014 Competitive Status: Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

Authority: FAR 6.302-1

Contract:

Contractor: Life Technologies Corporation Award Date: 04 June 2013 Competitive Status: Sole Source Authority: Unknown

11. Technical / Requirements Certification: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

12. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable.