BD BIOSCIENCE JOFOC CS UPDATE 231PM-MD 12172024 V1 with Corrections_Redacted.pdf

b. Project background.

The Department of Laboratory Medicine provides cutting-edge laboratory testing to support Clinical Center patient care and serves as a hub for excellence in research and training in laboratory medicine. To meet the growing demands of patient care and research testing, it is essential to maintain an adequate supply of resources to support the increasing workload.

Without a sufficient stock of the necessary proprietary reagent kits and supplies, the department would be unable to deliver critical results in a timely and reliable manner, which is crucial for both patient care and research testing.

Previous Purchase Order Number

Period of Performance

Amount Type of Contract

75N90019D00005 01/01/2019- 12/31/2019

$300,000.00 Sole Source

75N90020D00008 01/01/2020 - 12/31/2024

$2,491,000.00 Sole Source

3. Description of the supplies or services required to meet the agency’s needs

(including the estimated value).

a. Project title. BD Biosciences BD FACSLyric™ 3L12C Lease and BD FACSLyric™ Universal Auto Loader Consumables and Maintenance Service

b. Project description.

The comprehensive Lease, Consumables and Service package includes the equipment with options and maintenance. Estimated reagent usage is listed in the below table.

• Requirement type.

Research & development (R&D) R & D support services Support services (non-R&D) X Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify):

• Type of action.

New requirement X 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):

Completion Form Term form

• Acquisition Identification Number. POTS 25-000064

Total estimated dollar value and performance/delivery period.

The total dollar value for this requirement is estimated at $1,250,000.00.

The award is intended to be made for a one-year base period, and four twelve-month option periods. The yearly minimum for each contract period is $250,000.00.

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) 13.501_.

Base Year Period of Performance Cost Option Year 1 01/01/2025-12/31/2025 $250,000.00 Option Year 2 01/01/2026-12/31/2026 $250,000.00 Option Year 3 01/01/2027-12/31/2027 $250,000.00 Option Year 4 01/01/2028-12/31/2028 $250,000.00 Option Year 5 01/01/2029-12/31/2029 $250,000.00

This acquisition is conducted under the authority of section 4202 of the Clinger-Cohen Act of 1996.

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, and Company 2350 Qume Drive San Jose, California 95131-1812, United States Tel: (855) 236-2772

b. Nature of the acquisition and proposed unique qualifications of the contractor(s). A continuation of the current lease for the proprietary BD FACSLyric™ instrumentation is needed for consistency and support of existing protocols. The BD FACSLyric™ Flow Cytometry System is a high-performance, highly sensitive flow cytometer that demonstrates exceptional resolution and improved separation to make dim and rare cell populations easier to resolve. Multiparameter flow cytometry is used routinely to track cell subsets in blood and tissue, flow cytometry is a powerful tool for the single-cell analysis of patient samples Due to the specific reagent consumables required for the FACS Lyric™, BD Biosciences is the only vendor capable of supplying the necessary reagents and supplies that fit the existing instruments in the Department of Laboratory Medicine. The proposed vendor, Becton, Dickinson and Company, is the sole manufacturer, trademark holder and service provider of the BD FACSLyric™. The system is not sold in the US by any distributors or other third parties. These kits are so specific for the existing instrument. Since the supplies are proprietary, there is only one supplier whose products can fit into the instrumentation; any other supply or service could cause the cancellation of the protocol/delays in completion of the protocol. This would cause unwarranted expenditure/waste of very limited Government research funds. Lab results from these instruments are used by health care providers to diagnose and treat patients in a timely manner at NIH.

In some cases, the delay in testing would cause the extended storage of patient samples useless for patient testing as some analytes are not stable in storage.

This would be a waste of time and money not to mention the pain that patients would have to endure due to repeat testing.

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.

To reach as many potential sources as possible, a presolicitation notice of intent to sole source to BD Biosciences was published on SAM.gov from October 31, 2024, to November 14, 2024. No responses were received to this posting, except from the incumbent vendor.

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

Price reasonableness will be determined through evaluation of current pricing of similar types of buys, previous buys (Contract #75N0019D00005 and 75N90020D00008). There is a 1.5% increase in the current price for reagents since 2023 which is line with the current CPI for medical commodities at the rate of 1.6%

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.

To reach as many potential sources as possible, a notice of intent to sole source to BD Biosciences was published on SAM.gov from October 31, 2024, to November 14, 2024. No responses were received to this posting, except from the incumbent vendor, all technical lab experts were consulted for this procurement.

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

None

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

No responses were received in writing for this requirement except from the incumbent vendor, BD Biosciences who responded to the presolicitation notice.

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.

Before any other subsequent actions market research will be performed in accordance with FAR PART 10 to assess any market changes