Memo-BD FACSCanto II Service Agreement 2026.docx

MEMORANDUM

Date: Feb 18, 2026 From: Abiy Getaneh, Lead Clinical Laboratory Scientist, DLM/CC/NIH Subject: Justification and Approval for Other than Full and Open Competition IAW FAR 6.302-2 To: Procurement

AGENCY IDENTIFICATION AND CONTRACTING ACTIVITY

The National Institutes of Health (NIH), Clinical Center (CC), has a need to approve a "Justification for Other Than Full and Open" requirement in accordance with FAR 6.3, Other Than Full and Open Competition.

This is a sole-source request in accordance with FAR 13.103-1 and 6.302-1. The request is based on the need to procure maintenance services for a BD FACSCanto II Flow Cytometry Cell Analyzer, attached FACSLoader instrument with one computer station.

NATURE AND/OR DESCRIPTION OF THE ACQUISITION BEING APPROVED

The Clinical Center (CC), Department of Laboratory Medicine (DLM), plans to procure maintenance services for a BD FACSCanto II Flow Cytometry Cell Analyzer, attached FACSLoader instrument with one computer workstation on a sole source basis from Becton Dickinson Company, 155 North McCarthy Boulevard Milpitas, California 95035.

DESCRIPTION OF THE SUPPLIES AND SERVICES REQUIRED TO MEET THE AGENCY'S NEEDS

Svc Cont FACSLyric 3 laser (5 day, Monday through Friday,8:00 AM to 5:00 PM Customer Time)

Customer material#: 338960 Serial#: V96100699

Coverage includes the BD FACSCanto II with one Computer Workstation (excluding printers) three lasers for labor, travel expenses and parts (excluding consumable items), or the following:

- 2 Preventive Maintenance Inspections to be performed during a twelve-month period, including 2 PM Kits.

- 24-hour guaranteed response to a request for emergency on-site service, Monday through Friday coverage, excluding BD Biosciences holidays. If we fail to meet our commitment, a $500 Response Time Credit will be issued per our Terms and Conditions.

- Software Revisions released during the Agreement term.

- Unlimited service visits during the term of this Agreement five (5) days per week. Unlimited telephone support for instruments, reagents and applications will be provided at no additional charge.

- Workstation printers are not covered.

Service Contract - FACSLoader 5 Day

Customer material#: 342065 Serial#: F06500302

This plan covers the FACSLoader for labor, travel expenses and parts (excluding consumables), for the following:

- Unlimited service visits, Monday-Friday, excluding BD Biosciences holidays.

- Unlimited telephone support for instruments, reagents and applications will be provided at no additional charge.

Total Cost for renewal - $25,617.60

IDENTIFICATION OF STATUTORY AUTHORITY

The requirement will be solicited under citation 10 U.S.C. 13.103-1. 6.302-1 Single/sole source DEMONSTRATION THAT THE PROPOSED CONTRACTOR'S UNIQUE QUALIFICATIONS OR THE NATURE OF THE ACQUISITION REQUIRES USE OF THE AUTHORITY CITED Becton Dickinson is the manufacturer and sole source provider for maintenance service for a BD FACSCanto II Flow Cytometry Cell Analyzer, attached FACSLoader, and one host Computer Workstation will best meet the clinical testing requirements of DLM.

A DESCRIPTION OF EFFORTS MADE TO ENSURE THAT OFFERS ARE SOLICITED FROM AS MANY POTENTIAL SOURCES AS PRACTIABLE No other vendor can supply this service with the associated patient testing analyzer to meet the clinical testing requirements of DLM.

DEMONSTRATION THAT THE ANTICIPATED COST WILL BE FAIR AND REASONABLE

The Government anticipates that the proposed cost will be fair and reasonable in accordance with FAR 15.404-l (b) (ii) and (v). As noted, no other vendor can provide these services.

DESCRIPTION OF MARKET RESEARCH CONDUCTED AND THE RESULTS OR STATEMENT OF THE REASON MARKET RESEARCH WAS NOT CONDUCTED Market research has been performed with other manufacturers. It is critical that that identical instrument service be in use to ensure that test systems already validated in lab can be smoothly maintained, allowing standardization across many test systems and instruments in lab.

OTHER FACTS SUPPORTING

In accordance with FAR 6,303-2(iii), the nature of harm that would be brought to NIH CC patients may result in delayed diagnosis and treatment. Having validated test systems available in the department is an asset but only insofar as the adequacy of the associated supplies and the purpose they serve. Scientists and physicians alike depend on the efficiency and proficiency at which we test for the patients who come here from around the world with the trust that our NIH CC clinicians can assess and treat patients thoroughly and at the highest clinical expertise.

ADMINISTRATIVE OFFICER/PROGRAM OFFICIAL CERTIFICATION

"I certify that the facts and representations under my cognizance and which are included in this Justification and Approval are accurate and complete to the best of my knowledge and belief."

Abiy Getaneh, Lead Clinical Laboratory Scientist, Hematology-Flow cytometry, DLM/CC/NIH

H. CONTRACTING OFFICER'S CERTIFICATION

"I certify that the facts and representations under my cognizance and which are included in this Justification and Approval are accurate and complete to the best of my knowledge and belief."

Susan Nsangou, Contracting Officer