J-and-A-Other-Than-Full-and-Open-v2 _SRSU Abbott i1000SR CO_PDF_Redacted.pdf

services to support its Abbott Architect i1000SR immunoanalyzer. A list of reagents and consumables is provided in a separate quote. The period of performance is from 1 January 2025 to 31 December 2025.

b. Project background. The Abbott Architect i1000SR immunoanalyzer was placed into service in 2022. Due to contracting issues, the GPA Biomed department could not exercise the Option Year. GPA IHS contracting approved a one-year bridge contract to carry over the service unit until another contract was awarded. Since the analyzer is relatively new, the service unit does not want to switch analyzers at this time. Due to its proprietary nature, Abbott technicians are the only authorized personnel allowed to work on the analyzer.

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

a. Project title. Firm Fixed-Price, Non-Personal Service Type, Commercial Item Delivery/Task Order to provide Immunoassay Reagents, Supplies, and Cost Per Reportable Result Analyzer Services (Architect i1000SR) for the Standing Rock Service Unit (SRSU), Fort Yates IHS Hospital, Fort Yates, North Dakota. Period of Performance: 01/01/2025 - 12/31/2025.

b. Project description. The Contractor shall provide reagents to the Standing Rock Service Unit laboratory which will be used on the Abbott Architect i1000SR Immunoassay Analyzer. For the determination of protein, bacterial, or viral toxins, drug concentration, infectious diseases, testing allergy and endocrine hormones, and cardiac markers.

Requirement type. Check the appropriate box:

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 (specify): ____________________

Type of action. Check the appropriate box:

New requirement Follow-on Other (specify): ______________________

Proposed contract/order type. Check all that apply:

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): ___________ Completion Form Term form

Acquisition identification number. IHS1507022, 36F79721D0233/75H70625F80003.

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

$21,921.00 (Total Award & IGCE).

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

This acquisition is conducted under FAR 13.106-1 (b)(1)(i)

(b) Soliciting from a single source.

(1) For purchases not exceeding the simplified acquisition threshold.

(i) Contracting officers may solicit from one source if the Contracting Officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name or industrial mobilization).

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited. Provide the following information, as applicable:

a. Name and address of the proposed contractor(s). Abbott Laboratories, Inc., 100 Abbott Park Road, Building AP6D; Department 32L, Abbott Park, IL 60064.

b. Nature of the acquisition and proposed unique qualifications of the contractor(s). Reagent for the Abbott Architect Immunoassay Analyzer.

The analyzer is in place in the laboratory and a reagent contract is needed.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies. The Standing Rock Service Unit (Ft. Yates Hospital) already has the Abbott Architect i1000SR immunoassay analyzer. The analyzer was placed into service in 2022. Due to contracting issues the Option year 1 was not exercised. GPA IHS contracting approved a one-year bridge contract to carry over the service unit until this contract is awarded. They do not wish to replace the analyzer at this time since it is relativity new. The current bridge contract expires 31 December 24. A sources sought for ISBEE was issued on 11/21/2024 with ISBEE vendors being able to provide due to the Service Unit renting the analyzer from the vendor.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable. Fair and reasonable pricing is based on comparison to the IGCE which is the same as the purchase price, and comparison to historical data.

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.

Sources sought was issued on 11/21/2024 with no available vendors that were able to provide the service associated with the Immunoassay supplies. See Market Research Report.

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

The Abbott Architect i1000SR immunoanalyzer was placed into service in 2022.

Due to contracting issues, the GPA Biomed department could not exercise the Option Year. GPA IHS contracting approved a one-year bridge contract to carry over the service unit until another contract was awarded. Since the analyzer is relatively new, the service unit does not want to switch analyzers at this time.

Due to its proprietary nature, Abbott technicians are the only authorized personnel allowed to work on the analyzer.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition. “No other sources have expressed an interest, in writing, in the proposed acquisition.”

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. When the analyzers reach the end of their life cycle, the service unit can submit an open competition, replacing the analyzer, reagents, and maintenance service.

12. Program office certification. The program officials cited shall complete the information required below and sign the certification in the blocks provided.

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.

10.Additional Information to support the justification:

If applicable, explain why technical packages or specifications to facilitate competition were not developed or available;

describe actions taken to remedy the situation.

11. Technical / Requirements Certification: By my signature below, I certify that the supporting data included in this J&A is accurate and complete.

Program Manager

Name:

Position Title:

Email address:

Phone:

Program Manager Supervisor (or one level above Program Manager)

Name:

Position Title:

Email address:

Signature:

Date:

12. Fair and Reasonable Price/Cost Determination: As Contracting Officer, by my signature below, I hereby determine that the anticipated price/cost to the Government for this contract action will be fair and reasonable.

Provide the basis for this determination, e.g., describe techniques to be used to determine fair and reasonable price (FAR Subpart 15.402), such as price analysis, cost analysis, cost realism. Per FAR Subpart 15.403-4(a)(1), the threshold for obtaining cost or pricing data is $750,000.

Name: Phone:

Signature: Date:

13. Contracting Officer's Approval (Required for proposed contract not to exceed $700,000 (value calculated including all options)): I hereby certify that this justification is accurate and complete to the best of my knowledge. I approve this justification subject to availability of funds, and provided that the services and supplies herein described have otherwise been authorized for acquisition.

Name: Phone:

Signature: Date:

Donald Johnston donald.johnston@ihs.gov

GPA IHS Deputy Laboratory Consultant

605-226-7772

Kelly Thomas kelly.thomas@ihs.gov

GPA IHS Laboratory Consultant

12-31-2024

Sole source due to the maintenance support provided by the vendor which is proprietary.

-S Digitally signed by -S Date: : : -

The price is fair and reasonable compared to the reasonable price list, the IGCE, the previous contract, and the price quote.