REDACTED JA.pdf

b. Project background.

The FCS, RTB provides flow cytometric analytical and cell sorting technologies to the DIR, NIAID, NIH. The facility is equipped with specialized instrumentation dedicated to the science of the flow cytometry, which entails answering biological questions by analysis of multiparameters at the individual cell level. The acquisition of this service agreement will guarantee the optimal function and, therefore, reliable data for our customers’ flow cytometry analysis and sorting. Acquisition of state-of-the-art technologies promotes the overall mission of the DIR, NIAID by providing tools to advance projects in basic and clinical research. Modern Immunology research has seen an ever- increasing demand for identifying cellular subsets important in normal and disease states; this, in turn, has demanded the identification of an ever-increasing number of cell surface and intracellular markers. This acquisition addresses this mission by providing flow cytometers operating at peak performance.

This is a follow-on requirement to ensure maintenance and availability of this crucial equipment to research efforts. Previous purchases for similar requirements were FAR Part 13 sole source acquisitions made to Becton, Dickinson, and Company:

Contract/Order: 75N93023P00633 Vendor: Becton, Dickinson, and Co.

Award Date: May 18, 2023 Period of Performance: 5/22/2023 – 4/21/2024 Amount: $381,208.19

Contract/Order: 75N93022P00645, Modification P00001

Award Date: April 20, 2023 Period of Performance: 4/22/2023 – 5/21/2023 Amount: $34,655.29

Contract/Order: 75N93022P00645

Award Date: May 4, 2022 Period of Performance: 5/18/2022 – 4/21/2023 Amount: $320,949.41

Contract/Order: 75N93022P00645

Award Date: May 4, 2022 Period of Performance: 5/18/2022 – 5/21/2023 Amount: $355,604.70

Contract/Order: 75N93022P00585 Contractor: Becton, Dickinson, and Company Period of Performance: 4/22/2022 – 5/17/2023 Amount: $24,984.07

Contract/Order: 75N93021P00572

Award Date: 04/21/2021 Period of Performance: 4/22/2021 – 4/21/2022 Amount: $368,327.04

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

a. Project Title. Renewal Service Agreement for Various BD Flow Cytometers and Lasers

b. Project description

BD cytometers and lasers equipment is listed below in Appendix A- Bill of Materials.

The FCS/RTB requires a service agreement plan for various BD cytometers and lasers.

The cytometers and lasers are used daily and must be repaired and/or upgraded immediately to prevent the loss of research and maintain the continuity of experiments.

All services, including PMs, will be provided by BD trained and qualified field service engineer(s). The contractor will perform the following service and maintenance:

unlimited service visits by BD trained and qualified field service engineer(s) Monday - Friday, original equipment manufacturer (OEM) services parts, two (2) preventive maintenance inspections, two PM kits will be provided during the twelve-month (12) coverage agreement, software revisions released and immediately available during the agreement term, and unlimited telephone support by BD trained and qualified field service engineer(s) for instruments, reagents and applications.

Requirement type.

Research and 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.

New requirement Follow-on to 75N93023P00633

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):

Completion Form Term form

Acquisition identification number.

Other acquisition identification number: NOI-NIAID-24-2208669

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

The total estimated dollar value: $395,174.52

There are two periods of performance for this requirement. Period of Performance (POP):

Quotation 440076025, 04/22/2024 to 12/31/2024 and Quotation 440075954, 04/22/2024 to 04/21/2025. Quotation 440075954, the period of performance shall be twelve (12) months from the date of award. The anticipated period of performance is April 22, 2024 – April 21, 2024. The instrument listed in Quotation 440076025 with POP ending 12/31/2024 will no longer be used once the coverage expires.

The current period of performance for these services expires April 21, 2024. To avoid a lapse in these critical, mission-related services, the follow-on contract must be in place prior to expiration of the current contract.

4. Identification of the statutory authority permitting other than full and open competition.

This acquisition is conducted under the authority of 41 United States

Code (U.S.C) 253 (C) (_1_) as set forth in Federal Acquisition Regulation

(FAR) 6.302- _1_.

This acquisition is conducted under the authority of 41 United States Code (U.S.C. 1901(e) as set forth in Federal Acquisition Regulation (FAR) 13.106-1(b)(2) and 13.501(a).

This acquisition is conducted under the authority of the Services

Acquisition Reform Act of 2003 (41 U.S.C. 428a)

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).

Becton, Dickinson & Company USBDB Service Contract Admin 2350 Qume Drive San Jose, CA 95131 Tel:

877-232-2995

b. Nature of the Acquisition and proposed unique qualifications of the company.

NIAID requires a service plan for the cytometers and lasers manufactured by Becton, Dickinson and Company that are currently in in the FCS/RTB lab. To ensure their optimal performance and reliability, they require maintenance by specially trained, experienced, and certified service engineers. BD is the original manufacturer of the cytometers and lasers and the direct provider of service agreements specific to their instruments. There are no BD authorized third-party service providers who perform service on their instruments. Only BD’s authorized technicians and engineers have the most up-to-date knowledge and have access to the required OEM parts to provide the services needed to upgrade, repair, and maintain these instruments. Only BD has the capability to provide immediate access to software updates for these instruments. Non-authorized technicians do not have access to all of the required parts to maintain BD’s machinery. Using non-OEM services and parts may result in the use of non-standard calibrations and replacement parts, which may introduce variables that may jeopardize current research and invalidate the ability to compare data from previous research.

Furthermore, according to BD, failure to utilize BD and BD Authorized Partners for service may result in the voiding of the BD’s equipment warranty, if applicable, or the exclusion from any post-warranty service coverage of the parts, costs, repairs, or adjustments necessary for the equipment. Thus, only Becton, Dickinson, and Company have the engineers and technicians who have the skills, expertise, and authorization to work on BD manufactured equipment, and only BD has OEM parts.

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.

As required by FAR Subpart 5.2, a Pre-Solicitation (Notice of Intent to Sole Source) was publicized via SAM.gov (formerly FedBizOpps) under the following Record ID: NOI-NIAID-24- 2208669 on March 13, 2024, for a period of 15 days. The notice announced the Government’s intent to obtain maintenance services for Becton, Dickinson, and Company instruments on a non-competitive basis. Responsible sources who could provide comparable services were provided an opportunity to respond with a capability statement. If a reasonable capability statement from another source was provided, the intent was then to post a Request for Quotations on a full and open competition basis. NIAID received no response from the NOI which closed on April 3, 2024.

7. Determination by the Contracting Officer that the anticipated cost/price to the

Government will be fair and reasonable.

The techniques identified at FAR 13.106-3(a)(2) will be used to ensure award will be at a fair and reasonable price. NIAID will consider the Independent Government Estimate, market research, comparison with similar items in the marketplace, and quoted prices found reasonable on previous purchase as determining factors for price reasonableness. A final determination by the Contracting Officer will be conducted prior to award of a purchase order.

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.

The Program Office conducted the initial market research by reviewing FCS/RTB existing BD instruments and their maintenance agreements. After scanning the market for alternatives, their research concluded that BD is the only source that can meet FCS, RTB’s requirements. The Contract Specialist viewed the required sources, Federal Supply Schedules, NIH strategic sources, and commercial websites and found that BD is the only known source for these maintenance services. Additional market research by the Contract Specialist included reviewing previous purchases for similar requirements, contacting knowledgeable Government and Industry professionals. BD confirmed that they do not authorize third-party vendors to service their instruments. The Contract Specialist (CS) verified with BD that the required products/services are only available from them directly through the open market. BD products/services are not available through existing government-wide contract vehicles such as GSA Federal Supply Schedules. BD confirmed they would be the sole provider of NIAID’s renewal and verified they do not offer these services through an existing government-wide contract such as NITAAC, GSA, or NASA SEWP. Additionally, the NOI did not reveal alternative sources that could meet NIAID’s minimal technical requirements for these maintenance services. In conclusion, the market research supports a sole source award to Becton, Dickinson, and Company as the only source available to the Government for this requirement.

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

Becton, Dickinson and Co., is the manufacturer of the cytometers and lasers in use by FCS/RTB.

BD provides a dedicated team of service professionals ensuring each instrument provides optimum performance and results regardless of its application and where it is located. BD has many local service engineer/technicians available immediately to provide repair services for the various flow cytometers and lasers. This will minimize down time in the busy facility of the FCS, RTB. Fully functional equipment is critically important due to the nature of the work in the FCS, RTB. If a flow cytometer or laser malfunctions and cannot be repaired within reasonable hours, experiments can be lost. The CS verified with BD that they are the only manufacturer who can perform maintenance and services on their OEM equipment, and that there are no authorized third-party vendors that they authorize to perform the maintenance and services on BD equipment. Furthermore, using another vendor other than BD, could lead to the instruments becoming non-functioning and unrepairable causing the Government to spend additional funds to repurchase needed equipment for the labs experimenting processes.

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

NIAID received no response from the NOI.

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.

It is the policy of NIAID to promote the use of competitive procedures whenever and wherever possible. In an effort to remove or overcome barriers to competition in the future, the market will be scanned frequently for new companies and products that could satisfy the Government’s requirement. The FCS, RTB staff meets periodically to discuss various changes to scientific products and processes. Vendor, trade magazines, and scientific publications are scanned for new, open scientific changes that can satisfy various on-going protocols. The agency will continually re-evaluate the instruments functionality and will continue to research the various manufacturers and products that could be in the Government’s best interest. The current situation requires Becton, Dickinson, and Company to satisfy agency requirements so no further actions will be undertaken to overcome barriers for this acquisition.

12. Program Officer 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.

1 CUBE 640-40 Red Lsr NO-SERIAL-5029

1 Cube 405-100 SORP Lsr NO-SERIAL-5030

1 MPB 532-1000 SORP Green Lsr NO-SERIAL-5031

1 G4 355-60 UV Lsr NO-SERIAL-13342

1 FACS Flow Supply System N3492775936

1 FACSAria III 5 Laser System P28200155

1 FACSymphony A5 R66096400118

1 SAPPHIRE 488-400 Blue Lsr No-SERIAL-13986

1 MPB 628-1000 3mm Red Lsr No-SERIAL-13987

1 OBIS 405-100 LX Violet Lsr NO-SERIAL-13988

1 G4 355-60 w/BD UV Lsr NO-SERIAL-13989

1 MPB 532-1000 SORP Green Lsr NO-SERIAL-13999

1 FACS Flow Supply System N3492775770

1 HTS R647701000623

1 FACSAria Fusion 5 Laser System P656700000115

1 Service Contract S6 (no lasers) R66293700039

1 SAPPHIRE 488-200 Blue Lsr NO-SERIAL-16068

1 SAPPHIRE 561-200 Yellow Lsr NO-SERIAL-16069

1 G4 355-60 UV Lsr NO-SERIAL-16070

1 OBIS 405-200 LX Violet Lsr NO-SERIAL-16071

1 MPB 628-200 Red Laser NO-SERIAL-16072