Justification for Other than Full and Open Competition

“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity. HHS. NATIONAL

INSTITUTES OF HEALTH

b. Sponsoring organization. CLINICAL CENTER (CC)/DEPARTMENT OF

LABORATORY MEDICINE (DLM)

c. Project Officer information.

• Project Officer name. IJEOMA IKPEAMA

• Mailing address. 9000 ROCKVILLE PIKE, BLDG 10 RM

2C301, BETHESDA, MD 20892

• E-mail address. ijeoma.ikpeama@nih.gov

• Telephone number. (301) 496-2824

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

a. Acquisition purpose and objectives. This acquisition is for the procurement of a MALDI Biotyper Sirius CA System from Bruker Scientific, LLC. The requested instrumentation will be used by the Microbiology Service within the Department of Laboratory Medicine to support the rapid and accurate identification of pathogenic organisms from clinical patient specimens at the NIH Clinical Center.

b. Project background. The Microbiology Service requires replacement of its existing MALDI Biotyper Smart System, which is approaching the end of its service life and is increasingly requiring maintenance. The current system is the primary platform used for microbial identification from clinical cultures.

Acquisition of the MALDI Biotyper Sirius CA System will ensure continuity of laboratory operations and enable the Department of Laboratory Medicine to continue providing accurate diagnostic results with rapid turnaround times and minimal downtime.

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

a. Project title. Purchase of a MALDI Biotyper Sirius CA System for Use by the Microbiology Service within the DLM

b. Project description. The Microbiology Service requires the MALDI Biotyper Sirius CA System to support the rapid and accurate identification mailto:ijeoma.ikpeama@nih.gov of microorganisms, including bacteria, fungi, and mycobacteria, from clinical cultures.

This system will be used to support diagnostic testing for clinical patient specimens at the NIH Clinical Center. The instrument must support existing laboratory workflows and maintain compatibility with current consumables, reagents, and validated methodologies to ensure continuity of operations and minimal disruption to clinical services.

Additional details are provided in the accompanying Statement of Need.

• 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 (specify): ____________________

• 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 quantity (specify whether indefinite quantity, definite quantity, or requirements): ___________

❑ Other (specify): ___________

❑ Completion Form ❑ Term form

• Acquisition identification number. To be determined.

c. Total estimated dollar value and performance/delivery period. The estimated cost for this acquisition will be $314,207.71. Delivery and installation are anticipated to occur within a timeframe to be determined upon award.

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 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).

Bruker Scientific, LLC 40 Manning Road Billerica, MA 01821

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

The Department of Laboratory Medicine currently utilizes a Bruker MALDI Biotyper Smart System as its primary platform for microbial identification from clinical patient specimens. This system is essential for the identification of bacteria from clinical cultures and is also used for identification of fungi and mycobacteria.

The MALDI Biotyper Sirius CA System, manufactured exclusively by Bruker Scientific, LLC, is the direct successor to the currently deployed platform and is uniquely capable of meeting the Government’s requirements while maintaining continuity of operations. The system must be a direct successor to the existing platform to minimize validation requirements and avoid disruption to clinical laboratory operations.

The Sirius system is compatible with existing consumables, reagents, workflows, and validated methodologies currently in use within the Microbiology Service. Transitioning to a different manufacturer’s platform would require substantial validation and verification of clinical assays to meet regulatory and accreditation requirements, as well as retraining of personnel and modification of laboratory processes. This would result in significant duplication of effort, increased costs, and potential delays in diagnostic testing.

Additionally, the current system is approaching the end of its service life, with manufacturer support scheduled to end in March 2027, and is experiencing increased maintenance needs. Failure to replace the system in a timely manner may result in increased downtime and risk to continuity of laboratory operations.

For these reasons, Bruker Scientific, LLC is the only responsible source capable of providing a system that meets the Government’s requirements without unacceptable delays, duplication of effort, or disruption to mission-critical clinical services.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a SAM.gov Contract Opportunities notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

Market research was conducted to identify potential sources capable of providing microbial identification systems meeting the needs of the Microbiology Service.

While other vendors offer alternative microbial identification technologies, these systems are not compatible with the existing Bruker MALDI Biotyper platform, associated consumables, or validated laboratory workflows.

A notice will be posted to SAM.gov in accordance with FAR Subpart 5.2 to identify any additional capable sources. However, based on current market research, no other vendors are expected to provide a system that meets the Government’s requirements without requiring substantial validation and causing disruption to clinical operations.

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

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.

Market research was conducted through review of commercially available microbial identification systems and vendor capabilities. While multiple vendors offer systems for microbial identification, these systems differ in methodology, workflow, and compatibility with existing laboratory processes.

No alternative vendor was identified that could provide a system compatible with the existing Bruker MALDI Biotyper platform while minimizing validation requirements and avoiding disruption to ongoing clinical laboratory operations.

Based on this research, Bruker Scientific, LLC is the only source capable of meeting the Government’s requirements.

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

In accordance with FAR 6.302-1(b)(1)(i), the required supplies are available from only one responsible source, and no other type of supplies will satisfy agency requirements without unacceptable delays and duplication of effort.

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

The NIH Clinical Center will continue to monitor advancements in microbial identification technologies and reassess future requirements to determine whether competition can be increased in subsequent acquisitions.

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.

Official Name & Title Signature Date

Project Officer Ijeoma Ikpeama, Chief Technologist, Microbiology Service, DLM

Project Officer’s

Immediate Supervisor

Head of the Sponsoring

Program Office

13. Contracting Officer certification.

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.

Official Name & Title Signature Date

Contracting Officer

14. Chief of the Contracting Office and Head of the Contracting Activity signature(s).

Official Name & Title Signature Date

Chief of the

Office

Head of the

Activity

15. Competition Advocate signature.

Official Name & Title Signature Date

Competition Advocate

16. HHS Senior Procurement Executive signature.

Official Name & Title Signature Date

HHS Senior Procurement

Executive