JOFOC (Signed).pdf

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TMPLT 2016.06-011

Justification for Other than Full and Open Competition

1. Identification of the agency and contracting activity:

a. Federal agency and contracting activity.

FDA/OAGS

b. Sponsoring organization.

HFP/OLOAS/ORTS/ARHAFL

c. Contracting Officer’s Representative (COR)/Requiring Activity Point of Contact (POC) information.

i. Name: Rachel Rochelle

ii. Mailing address: 3900 NCTR Road, Bldg. 26, Jefferson, AR 72079

iii. E-mail address: rachel.rochelle@fda.hhs.gov

iv. Telephone number: 870-543-4649

2. Nature and/or description of the action being approved.

Preventative Maintenance (PM) and Repair Servive for 6 ABI 7500 Fast Real-time PCR systems (S/N:275013447, 275013452, 275012572, 2750107889, 2750109522, 2750108420).

a. Acquisition purpose and objectives.

Arkansas Human and Animal Food Laboratory (ARHAFL) operates six ABI 7500 Fast Real Time PCR Systems (S/N: 275013447, 275013452, 275012572, 2750107889, 2750109522, 2750108420). These instruments are required for the development and execution of efficient, cost-saving and rapid molecular screening methods in a high through-put format (96 well plates). To ensure these instrument working properly and generate accurate and reliable data and, an annual PM and repair serive contract is needed.

b. Project background.

The FDA Human Food Program (HFP), Office of Regulatory Testing and Surveillance, Arkansas Human and Animal Food Laboratory (ARHAFL) operates six ABI 7500 Fast Real Time PCR Systems (S/N: 275013447, 275013452, 275012572, 2750107889, 2750109522, 2750108420). These instruments are required for the development and execution of rapid molecular screening methods in a high through-put format (96 well plates). In Microbiological Branch, ABI 7500 Fast have been validated and intensively utilized for the high throughput screening of high-risk pathogens, such as Hepatitis A, Norovirus, Cyclospora,E. coli O157:H7 and Salmonella, life

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A service contract including annual instrument preventative maintenance (PM) and calibration, and timely remedial repair by OEM-certified engineer with OEM parts are indispensable for generation of precise and reliable scientific data. It is also a requirement of all ISO/IEC 17025 for Accredited laboratories. This new initiated contract will cover these 6 ABI 7500 Fast systems from 9/1/2025 to 8/31/2030.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

1. The offeror must provide certified Original Equipment Manufacturer (OEM) parts for all repairs and maintenance.

2. Service must be provided by engineers who are trained and certified by the original manufacturer.

If not directly from OEM (Thermo Fisher Scientific and Life Technologies), an OEM training certificate of engineer must be provided before dispatch of the engineer. Arkansas Laboratory has the right to reject the service if engineer does not meet the training requirement.Engineers shall have access to the manufacturer’s latest technical developments, repair procedures, application updates, diagnostic software, and planned maintenance procedures.

3. The contract shall enable the instrument operators to have access to the manufacturer’s call center for technical assistance, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument. All recommendations for follow-up on-site service shall be provided by the offeror.

4. The offeror shall also include coverage for software and firmware updates.

5. The offeror’s service contract shall include an annual preventative maintenance visit, unlimited phone support, and onsite technical assistance. All parts, labor, and travel expenses shall be included with the contract at no additional charges.

6. All consumables shall be provided as required to complete preventive maintenance and repairs of equipment. All consumables shall be replaced during an annual PM of ABI 7500 Real-time PCR system.

7. The government agency deals with time sensitive analyses that are critical to public health. The repair and maintenance of these instruments can be critical to public health. Therefore, the offeror shall guarantee onsite service for parts, repairs and maintenance within 3 business days from original notification.

8. The offeror’s service contract will guarantee that the instrument will be brought back to full working performance. If a component cannot be brought back to full working performance by a qualified service engineer, the offeror will replace the component free of charge.

9. Computers purchased from Thermo-Fisher Scientific for the purpose of instrument operation that are not functioning shall be replaced at no cost to the government.

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10. This is a 5-year contract including one base year and 4 option years starting from 9/1/2025 to 8/31/2030, and the estimated value of the contract is $232,357.32

a. Project title.

ABI 7500 Fast Real-time PCR System Service Contract (6EA)

b. Project Description.

The Arkansas laboratory require a vendor to service six (6) ABI 7500 Fast Real-time PCR systems on an annual basis and provide documentation of such service to meet ARHAFL’s ISO/IEC 17025 requirement. Please prefer to SOW for detail description.

Requirement type.

Research & Development (R&D)

R&D support services

Support services (non-R&D)

Supplies/equipment

Information Technology (IT)

Construction

Architect-Engineer (A&E) services

Design-build

Other: Service

Type of action.

New requirement

Follow-on

Other: [Specify]

Proposed contract/order type.

Firm-fixed-price

Other fixed-price: [Specify, e.g., fixed-price award-fee, fixed-price incentive-fee]

Cost-plus-fixed-fee

Other cost reimbursement: [Specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee]

Time and materials

Indefinite delivery: [Specify whether indefinite quantity, definite quantity, or requirements]

Other: [Specify]

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Completion Form

Term Form

Acquisition identification number.

TBD

c. Total estimated dollar value and performance/delivery period.

Total contract value for 1-base plus 4-option years is $232,357.32.

Base Period: 09/01/2025-08/31/2026 - $44,507.82 Option Year 1: 09/01/2026-08/31/2027 -$43,583.22 Option Year 2: 09/01/2027-08/31/2028 -$45,762.42 Option Year 3: 09/01/2028-08/31/2029 -$48,050.58 Option Year 4: 09/01/2029-08/31/2030 -$50,453.28

4. Identification of the statutory authority permitting other than full and open competition. Check the applicable block below based on the acquisition circumstance.

Federal Acquisition Regulation (FAR):

6.302-1 Only one responsible source and no other supplies or services will satisfy agency requirements. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(1) or 41 U.S.C. 3304(a)(1).

6.302-2 Unusual and compelling urgency. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(2) or 41 U.S.C. 3304(a)(2).

6.302-3 Industrial mobilization; engineering, developmental, or research capability; or expert services. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(3) or 41 U.S.C. 3304(a)(3).

6.302-4 International agreement. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(4) or 41 U.S.C. 3304(a)(4).

6.302-5 Authorized or required by statute. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(5) or 41 U.S.C. 3304(a)(5).

6.302-6 National security. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(6) or 41 U.S.C. 3304(a)(6).

6.302-7 Public interest. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(7) or 41 U.S.C. 3304(a)(7).

13.501(a)(1)(ii) Sole source, including brand name, under Simplified Procedures for Certain Commercial Items. This acquisition is using this justification format, modified to reflect that the procedures in FAR subpart 13.5 were used in accordance with 41 U.S.C. 1901 or the authority of 41 U.S.C. 1903.

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5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

Life Technologies Corp/Thermo Fisher Sceintific 5791 Van Allen Way Carlsbad, CA 92008

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

Thermo Fisher is the original manufacturer of ABI 7500 Fast PCR system and the only provider who can guarantee expedited and high quality service. Thermo Fisher never train engineers outside of the company, indicating service quality of engineer from third-party can not be guaranteed. Moreover, other providers do not have the same accessibility to parts, and Thermo is the sole supplier of these parts. Thermo Fisher Scientific service contract holders are provided the guaranteed 3-day on-site repair guarantee. Our past experiences with other providers have demonstrated issues with many taking weeks despite guarantees in their response of being onsite within 5 business days. Thermo prioritizes its service, and its contract holders are first priority with both parts, service, and labor.

6. 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 subpart 5.2 and, if not, which exception under 5.202 applies.

Market research found that only original manufacture of the ABI 7500 Fast Real-time PCR system can provide services needed.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

The quotation detailing cost pricing is attached and it is in range of fair market value.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted

Reviewed literature published by qualified organizations and have previous experience with multiple providers.

9. Any other facts supporting the use of other than full and open competition.

No additional information.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition

Thermo Fisher Scientific - No other sources have expressed an interest, in writing, in the proposed acquisition.

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11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

None. OEM is the only source that can provide highest quality and expedited service needed for this instrument.

12. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Signature:____________________________________

Huanli Liu COR/Requiring Activity POC

April 7, 2025

April 7, 2025 Signature:____________________________________

Sarah Phillips COR/POC Immediate Supervisor

Signature:___________________________________

Head of the Sponsoring Program Office

13. Contracting Officer Certification.

The CO shall complete the information required below and sign the certification in the block provided.

[NOTE: The CO’s signed certification may serve as approval of a J&A over $150,000 but not exceeding $700,000 (FAR 6.304(a)(1) and FAR 13.501(a)(2)(i)), depending on OPDIV procedures.]

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Signature:___________________________________

Sephora Calderon Contracting Officer

Michael D. Wichman

08/18/2025