D03-1 - JA-24-04-31023 SOLE SOURCE LIfe Technologies Rev for Competition Advocate_Redacted.pdf

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Control Number: JA-24-05-31023

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Sole Source Justification and Approval Under FAR 13.501

Contracting Activity: The Contracting Activity responsible for this action is the United States Army Medical Research Acquisition Activity (USAMRAA), FCMR-ACO-AC, Contracts Branch 3, 808 Schreider Street, Fort Detrick, MD 21702-5014. The requiring activity requesting this action is the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), Division of Pathology, Building 1425, Room 782, 1425 Porter Street, Fort Detrick, Maryland, 21702-5014.

Description of Action: USAMRIID requires a new one (1) 12-month base period plus four (4) 12-month option periods with one (1) 6-month extension Firm Fixed Price contract for timely equipment maintenance and certification to ensure normal and continual operation of Thermo Fisher Scientific instruments (7500FAST DX and Quantstudio DX) to meet Federal Drug Administration (FDA) and International Organization for Standardization (ISO) requirements.

Indirect funds for Research, Development, Test and Evaluation from the Joint Science and Technology Office, Center for Disease Control and Prevention, and other organizations requiring Good Laboratory Practices (GLP) will fund this requirement.

Description of Supplies/Services: This requirement is for severable, non-personal services to conduct all required preventative and unscheduled maintenance services and repair for Thermo Fisher Scientific instruments tied to GLP studies &/or clinical work. This requirement is not for the purchase or installation of new equipment.

The estimated value of this effort is , inclusive of all options and extensions in accordance with Federal Acquisition Regulation (FAR) 52.217-8.

SUMMARY:

BASE YEAR $

OPTION YEAR 1 $

OPTION YEAR 2 $

OPTION YEAR 3 $

OPTION YEAR 4 $

OPTION 6 month $

TOTAL $

Controlled by: Defense Health Agency (DHA) Controlled by: USAMRAA CUI Category: Source Selection Limited Dissemination Control: FEDCON POC: Emily O’Hara, 301-619-9599

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4. Authority Cited: 41 United States Code 1901 as implemented in FAR 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

5. Reason for Authority Cited: The proposed contractor for this action is Life Technologies, part of Thermo Fisher Scientific (the original equipment manufacturer (OEM) for the equipment to be maintained and serviced under this contract), is the only organization that provides services related for maintenance and repair of the 7500FAST DX and Quantstudio DX Service instruments that meets FDA and ISO requirements for use of these instruments in human research and clinical diagnostics. Only Life Technologies has technical service representatives who receive comprehensive and on-going factory training and regular technical updates, as well as having direct access to original manufacturer’s parts to help maintain Thermo Fisher Scientific 7500FAST DX and Quantstudio DX in the timeframe required to meet USAMRIID’s needs. USAMRIID may only be serviced by the OEM certified technicians, and Life Technologies is the only OEM authorized provider of services in the United States. Thermo Fisher Scientific is the sole manufacturer of the required instruments and has not issued a letter of assurance nor provided a manufacturer’s training certification to any third party (or its employees, subcontractors, or agents) for the servicing of its manufactured instruments. The instruments are used in the mission critical operational testing of clinical and environmental samples for high consequence pathogens and the generation of testing data to support countermeasure development and product submission to the FDA, which requires timely equipment maintenance and certification to ensure normal and continual operation of the equipment, as well as, to meet ISO requirements.

6. Efforts to Obtain Competition: This contract is for service, maintenance, and certification for proprietary Thermo Fisher Scientific instruments used in human research and clinical diagnostics.

There are no other vendors that can maintain and service these instruments with the timeframe required for USAMRIID to meet FDA and ISO requirements for human research and clinical diagnostics. However, A Notice of Intent (NOI) to Sole Source was posted to System for Award Management (SAM). No capability statements were received in response to the NOI to Sole Source by the due date of 15 August 2024.

7. Actions to Increase Competition: USAMRIID and USAMRAA will periodically conduct future market research and analysis to determine if other potential sources emerge that are capable of providing the required preventive and unscheduled maintenance and repair. Additionally, all future maintenance requirements will be synopsized in accordance with FAR 5.201 and if other potential sources do emerge, USAMRAA, in conjunction with USAMRIID, will assess whether competition for future requirements is feasible.

8. Market Research: Market Research conducted in accordance with FAR Part 10 was multifaceted and was undertaken to ascertain 1) if the requirement meets the FAR definition of a Commercial Service and 2) if two or more small businesses exist that can meet the Government’s requirement.

The Market Research, which was performed in January and February of 2024, examined if the required services met the FAR definition of a commercial service, which is services of a type offered competitively in the commercial marketplace. Market Research found that the proprietary materials and skills of the original equipment manufacturer, Thermo Fisher Scientific, are required for service and maintenance that meet FDA and ISO requirements for human research and clinical diagnostics. There were no other vendors found offering the required services that could meet the necessary timeframe needed for USAMRIID’s mission.

9. Interested Sources: The synopsis required by FAR 5.201 was posted on SAM on 31 July 2024 with responses due on 15 August 2024, as this requirement meets the threshold stipulated in FAR

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5.101(a)(1). To date, no other sources have written to express an interest.

10. Other Facts:

a. Procurement History:

(1) Contract numbers and dates of all awarded contracts for these same requirements: W81XWH-21-F-0183, effective 5 May 2021, for one (1) 12-month base period plus four (4) 12-month option periods.

(2) The competitive status of these actions: W81XWH-21-F-0183 is a non-personal Indefinite Delivery Indefinite Quantity (IDIQ) Task Order awarded against Base IDIQ contract W81XWH-20- D-0062. Single Award IDIQ contract W81XWH-20-D-0062 was awarded to Goldbelt Frontier, LLC (Goldbelt), on 27 May 2020 under full and open competition.

(3) Authority previously cited if less than full and open competition was used: Base W81XWH- 20-D-0062 was awarded under full and open competition.

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results. N/A

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources: Current task order is a pass through for required service. Goldbelt is not an authorized service provider and Thermo Fisher was not contractually obligated to service the equipment as required.

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys. N/A

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes. N/A

b. Other facts:

Service requests have previously been fulfilled on a Task Order awarded against Base IDIQ contract W81XWH-20-D-0062, W81XWH-21-F-0183 to Goldbelt, by requesting at will, one-time service requests. However, USAMRIID has experienced challenges with this contract’s performance. The individual vendors response to one-time service requests appears to have no pathway for enforcement (i.e. purchase order is created by contract vehicle and provided to equipment manufacturer but they are under no contractual obligation to conduct the service in a timely manner). Thermo Fisher was not contractually obligated to service the equipment as required and Goldbelt is not an authorized service provider. USAMRIID’s FDA and ISO certifications are at risk of non-compliance by not having a service contract in place that provides scheduled preventative maintenance and unscheduled repair requirements to be performed in a timely manner.

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11. Technical 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.

Signatur

Date: See Electronic Signature

Typed Name:

Title:

12. 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.

Signature:

Date: See Electronic Signature

Typed Name: Enerida M. Rivera

Title: COR, USAMRIID AMLO

13. Fair and Reasonable Cost Determination:

Signature:

Date: See Electronic Signature

Typed Name: Emily K. O’Hara

Title: Contracting Officer

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14. Contracting Officer Certification:

I certify that this justification is accurate and complete to the best of my knowledge and belief.

Signature:

Date: See Electronic Signature

Typed Name: Emily K. O’Hara

Title: Contracting Officer

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Reviews

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

Concurrence

Emily K. O’Hara Contracting Officer

USMARAA

Tonya R. Kreps Branch Chief (One Level Above KO)

USAMRAA

John M. Niziolek Contracts Group Chief

USAMRAA

Jeffery S. Croley Chief of Contracting Office

USAMRAA

Approval

Based on the foregoing justification, I hereby approve the procurement of the required preventative and unscheduled maintenance services and repair for Thermo Fisher Scientific instruments tied to GLP studies &/or clinical work with an estimated value of $2,631,718.57 on an other than full and open competition basis pursuant to the authority of 41 U.S.C. 1901 as implemented by FAR 13.501(a)(1)(ii), subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Signatur Date: See Digital Signature Typed Name: CHRISTOPHER E. SHERMAN Command Advocate for Competition

USAMRAA