26-007626 - JOFOC.pdf

Justification for Other than Full and Open Competition

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity.

Department of Health and Human Services (HHS) National Institutes of Health (NIH) Clinical Center (CC)

b. Sponsoring organization.

Department of Laboratory Medicine (DLM) Microbiology Service

c. Project Officer information.

• Project Officer name: IJEOMA IKPEAMA

• Mailing address.

Department of Laboratory Medicine Clinical Center National Institutes of Health 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.

The National Institutes of Health (NIH) Clinical Center (CC), Department of Laboratory Medicine (DLM), Microbiology Service proposes to award a sole-source, follow-on reagent rental agreement to Remel, Inc. for the continued use of the currently installed ARIS HiQ Instrument and its associated SWIN Computer System. The proposed action will be executed as a firm-fixed-price contract vehicle for a base period of one (1) year with two option year periods.

a. Acquisition purpose and objectives.

The purpose of this acquisition is to establish a follow-on reagent rental agreement with Remel, Inc. for the ARIS HiQ Instrument and associated SWIN Computer System utilized by the Department of Laboratory Medicine (DLM), Microbiology Service, to perform antimicrobial susceptibility testing (AST).

mailto:ijeoma.ikpeama@nih.gov

The agreement will provide continued access to the existing instrumentation, susceptibility testing panels, reagents, consumables, supplies, software support, technical support, preventative maintenance, corrective maintenance, and applications support necessary to sustain routine AST operations. The agreement will also provide manufacturer-authorized support services required to maintain operational functionality and performance of the ARIS HiQ platform.

The primary objective of this acquisition is to ensure uninterrupted antimicrobial susceptibility testing services across the Bacteriology, Mycology, and Mycobacteriology laboratory sections of the Microbiology Service. Continued operation of the ARIS HiQ platform supports patient care, clinical research protocols, infection prevention activities, and antimicrobial stewardship efforts at the NIH Clinical Center.

b. Project background.

The Microbiology Service currently utilizes the Remel ARIS HiQ Instrument and associated SWIN Computer System to perform antimicrobial susceptibility testing (AST) for bacterial, fungal, and mycobacterial isolates recovered from clinical specimens. The platform supports testing performed within the Bacteriology, Mycology, and Mycobacteriology laboratory sections and is an established component of the laboratory's routine testing operations.

The current reagent rental agreement provides access to the instrumentation, susceptibility testing panels, reagents, consumables, technical support, software support, preventative maintenance, and corrective maintenance necessary to sustain routine AST services. The existing agreement is approaching expiration, and establishment of a follow-on reagent rental agreement is necessary to ensure continuity of testing operations.

The ARIS HiQ platform has been operational within the DLM since 2021 and has been incorporated into validated laboratory workflows, quality management processes, staff training programs, and Laboratory Information System (LIS) reporting processes. Continued support of the existing platform is required to maintain ongoing antimicrobial susceptibility testing services for patients receiving care at the NIH Clinical Center.

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

a. Project title.

Reagent Rental Agreement for the Remel ARIS HiQ Antimicrobial Susceptibility Testing Platform

b. Project description.

The Microbiology Service within the DLM requires a follow-on reagent rental agreement for the existing Remel ARIS HiQ Instrument and associated SWIN Computer System used to perform automated antimicrobial susceptibility testing (AST). The agreement shall provide continued access to the instrumentation, susceptibility testing panels, reagents, consumables, ancillary supplies, technical support, software and firmware updates, preventative maintenance, corrective maintenance, and applications support necessary to sustain routine laboratory operations. Under this arrangement, the Government purchases the reagents and consumables required for clinical testing while the Contractor provides the associated equipment, maintenance, and support services.

The ARIS HiQ platform supports AST testing performed within the Bacteriology, Mycology, and Mycobacteriology laboratory sections and is utilized for the testing of clinically significant bacterial, fungal, and mycobacterial isolates recovered from patient specimens. The platform is an established and validated component of the laboratory's diagnostic testing workflow and supports patient care, clinical research protocols, infection prevention activities, and antimicrobial stewardship efforts at the NIH Clinical Center.

The requested acquisition is a continuation of an existing laboratory capability and is necessary to maintain uninterrupted antimicrobial susceptibility testing services throughout the period of performance. A detailed description of the Government's requirements is provided in the accompanying Statement of Need (SON).

• 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.

Estimated Contract Value:

$276,000

Period of Performance:

Base Year plus 2 option years

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).

Remel, Inc.

A subsidiary of Thermo Fisher Scientific 12076 Santa Fe Trail Drive Lenexa, KS 66215

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

The Microbiology Service requires continuation of the existing reagent rental agreement for the Remel ARIS HiQ Instrument and associated SWIN Computer System utilized for antimicrobial susceptibility testing

(AST). The platform supports testing performed within the Bacteriology, Mycology, and Mycobacteriology laboratory sections and is used to generate susceptibility results for clinically significant bacterial, fungal, and mycobacterial isolates recovered from patient specimens.

The ARIS HiQ platform has been operational within the DLM since 2021 and is fully integrated into established laboratory workflows. The laboratory has completed validation and verification studies for the AST panels and methodologies currently utilized on the platform and has developed associated standard operating procedures, quality control processes, competency assessment programs, and Laboratory Information System (LIS) configurations necessary to support routine testing operations.

Remel, Inc. is the only source capable of providing the proprietary reagents, susceptibility testing panels, software support, maintenance services, replacement parts, and technical support required to operate the existing ARIS HiQ platform. The Government requires continued support of the existing system to ensure uninterrupted antimicrobial susceptibility testing services.

Competition of this requirement would result in substantial duplication of cost and unacceptable delays in fulfilling the Government's requirements.

Transition to an alternative platform would require removal of existing instrumentation, procurement and installation of replacement equipment, validation and verification of new testing methodologies, redevelopment and validation of LIS interfaces and reporting rules, revision of standard operating procedures, retraining of laboratory personnel, and reassessment of staff competency. These activities would require significant expenditure of Government resources and could adversely affect continuity of testing operations.

In addition to routine diagnostic testing, the Microbiology Service performs specialized antimicrobial susceptibility testing that may require customized testing configurations not routinely available on standard commercial AST systems. The ARIS HiQ platform provides flexibility necessary to support the testing needs of the NIH Clinical Center patient population and ongoing clinical research activities.

Accordingly, Remel, Inc. is the only responsible source capable of providing the products and services required to support the existing ARIS HiQ platform without causing substantial duplication of cost, unacceptable delays, and disruption to ongoing laboratory operations.

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

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 appropriate to the nature of this acquisition.

Because this requirement is for continuation of an existing reagent rental agreement supporting the Remel ARIS HiQ Instrument and associated SWIN Computer System currently utilized by the Department of Laboratory Medicine (DLM), Microbiology Service, the review focused on the availability of alternative sources capable of supporting the existing platform and maintaining continuity of operations.

The review confirmed that Remel, Inc. is the source of the reagents, susceptibility testing panels, software support, maintenance services, replacement parts, and technical support required to operate the existing ARIS HiQ platform. While alternative antimicrobial susceptibility testing (AST) systems are commercially available, the current requirement is for continued support of an established testing platform that has been operational within the DLM since 2021.

The ARIS HiQ platform supports established laboratory workflows, validated testing methodologies, quality control processes, staff competency assessment programs, and Laboratory Information System (LIS) reporting configurations.

Transition to an alternative platform would require procurement and installation of replacement instrumentation, validation and verification of new testing methodologies, redevelopment and validation of LIS interfaces, revision of standard operating procedures, retraining of laboratory personnel, and reassessment of staff competency.

Based on the market research performed and the operational requirements of the Microbiology Service, Remel, Inc. is the only source capable of providing the products and services necessary to support the existing ARIS HiQ platform while maintaining continuity of antimicrobial susceptibility testing operations within the Bacteriology, Mycology, and Mycobacteriology laboratory sections.

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

This acquisition is being conducted in accordance with FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. Remel, Inc. is the only source capable of providing the reagents, susceptibility testing panels, software support, maintenance services, replacement parts, and technical support required to operate the existing ARIS HiQ Instrument and associated SWIN Computer System currently utilized by the Microbiology Service.

Continuation of the existing reagent rental agreement will ensure uninterrupted antimicrobial susceptibility testing services within the Bacteriology, Mycology, and Mycobacteriology laboratories and avoid substantial duplication of cost and unacceptable delays associated with transition to an alternative testing platform.

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.

For future acquisitions, the Government will continue to evaluate emerging antimicrobial susceptibility testing technologies and commercially available testing platforms as part of routine laboratory operations and future acquisition planning. However, the current requirement is for continued support of an existing, validated testing platform that is integrated into laboratory workflows, quality management systems, and Laboratory Information System (LIS) processes.

At this time, no alternative source has been identified that can provide the products and services required to support the existing ARIS HiQ platform without substantial duplication of cost, unacceptable delays, and disruption to ongoing laboratory operations.

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, Supervisory Clinical Laboratory Scientist, 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