A13 JUSTIFICATION AND APPROVAL_Only_One_Source_SAT_ROFAR.pdf

JUSTIFICATION AND APPROVAL

For Other Than Full and Open Competition (Commercial Products or Commercial Services – SAT Level)

1. Contracting Activity U.S. Department of Health and Human Services (HHS), National Center for Health Statistics (NCHS), Division of National Health and Nutrition Examination Surveys

(DHANES).

2. Description of the Action Approval of a sole-source award for commercial services, using simplified acquisition procedures, to SCINOMIX, INC.

3. Description of the Commercial Requirement The Government requires commercial services, as defined in Revolutionary FAR Overhaul Part 12, to support the six Sci-Print VXL/AQ Perform liquid handlers as part of data collection in the National Health and Nutrition Examination Survey (NHANES). The data from the NHANES are used by government agencies, state and community organizations, private researchers, consumer groups, companies, and health care providers. NCHS introduced the Sci-Print VXL/AQ Perform liquid handler in 2025. We maintain seven mobile examination centers (MECs), five of which travel to different locations across the United States every ten weeks. Scheduling participants for examinations starts three weeks before each MEC arrives at its location; the team has two days to set up the equipment. Each MEC has a lab trailer where one Sci-Print VXL/AQ Perform liquid handler allows the Medical Technologists to quickly and effectively process specimen from all NHANES participants. Keeping this same line of product is critical in ensuring the validity of the data over time by supporting consistent and efficient processing, improving turnaround time, preserving specimen integrity, and therefore, safeguarding analyte stability. Only Scinomix is authorized to provide service and maintain the Sci-Print VXL/AQ Perform liquid handler, as they are proprietary equipment. The requirement will provide preventive maintenance, repair, parts, and technical support to ensure ongoing instrument performance and data integrity.

4. Authority for Other Than Full and Open Competition This acquisition is justified under Revolutionary FAR Overhaul 6.103-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

This justification is prepared in accordance with Revolutionary FAR Overhaul Part 6, including Revolutionary FAR Overhaul 6.3, and HHSAR 306.303.

5. Unique Qualifications of the Contractor SCINOMIX, INC is the only responsible commercial source capable of meeting the Government’s minimum requirements because:

• The requirement is for a proprietary or uniquely configured commercial product/service; and

• The contractor controls the intellectual property, technical data, or integration capability necessary to meet the requirement.

No other known commercial sources can provide a functionally equivalent product or service without unacceptable cost, schedule, or performance impact.

The Sci-Print VXL/AQ Perform liquid handler is proprietary equipment of Scinomix.

Scinomix is the only authorized provider capable of performing warranty and post-warranty service, providing OEM parts, and performing certified repairs for this model.

6. Efforts to Obtain Competition Market research was conducted in accordance with Revolutionary FAR Overhaul Parts 10 and 12, including review of commercial sources and prior acquisitions. The research confirmed that only one responsible source is capable of meeting the requirement.

7. Fair and Reasonable Price Determination The Contracting Officer will determine price reasonableness using commercial price analysis techniques in accordance with Revolutionary FAR Overhaul Part 12 and Revolutionary FAR Overhaul Part 15, as applicable.

8. Other Supporting Facts This sole-source determination is based solely on the authority cited in Revolutionary FAR Overhaul 6.103-1. Simplified acquisition procedures do not constitute a competition exception.

9. Certification I certify that this justification is accurate and complete to the best of my knowledge and belief.

Contracting Officer: ________________________ Date: ______

Approving Official: ________________________ Date: ______ (Approval IAW Revolutionary FAR Overhaul 6.304 and HHSAR 306.304)

04/22/2026

04/22/2026