26-006555 - Sole Source Memo.docx

Date: April 30, 2026

From: David Ram, Supervisor of Biomedical Engineering—NIH Clinical Center

Subject: SOLE SOURCE JUSTIFICATION AND APPROVAL

To: NIH, CLINICAL CENTER, CONTRACTING OFFICER

1. AGENCY IDENTIFICATION AND CONTRACTING ACTIVITY

David Ram, supervisor of Biomedical Engineering National Institute of Health Clinical Center 9000 Rockville Pike Bethesda, MD 20892 AO’s Name, contact information: Kevin Doty, 301-215-1158

Contracting Activity:

NIH Clinical Center Office of Purchasing and Contracts 6707 Democracy Blvd Bethesda, MD 20892

2. NATURE AND/OR DESCRIPTION OF THE ACQUISITION BEING APPROVED

The Clinical Center needs a full-service contract for their Hamilton ventilators that were purchased in 2020 and one in 2025.

NIH Clinical Center Biomedical Engineering and Instrumentation Service ensure that medical devices in the select inventory are inspected, tested and maintained as scheduled per the manufacturer’s recommendations.

3. DESCRIPTION OF THE SUPPLIES AND SERVICES REQUIRED, INCLUDING THE DELIVERY SCHEDULE AND/OR THE PERIOD OF PERFORMANCE and DOLLAR VALUE OF THE ACQUISITON.

The Clinical Center needs a Full-service contract, base year with four option years, for their Hamilton Ventilators that were purchased in 2020 and one MRI purchased in 2025.

Base Year - 9/25/26-09/24/27 Option one - 9/25/2027-9/24/2028 Option two - 9/25/2028-9/24/2029 Option three - 9/25/2029-9/24/2030 Option four - 9/25/2030-09/13/2031

This Full-Service requirement includes repair service visits, which include labor, travel, and replacement parts required to restore the Equipment to its published operating specifications. This requirement encompasses only OEM parts, manufacturer’s maintenance schedule, recall remediation and software upgrades that are available to the general population. Vendor shall provide expertise to coordinate issues and documentation, is case of adverse patient incidents.

Equipment:

This service agreement

· Two (2) HAMILTON-MR1 (All parts, labor, travel and annual PM included)

· Twelve (12) HAMILTON-T1 Ventilators (All parts, labor, travel and annual PM included)

Procurement cost: Base year: $18,480.00 Total agreement cost: 92,400.00

4. IDENTIFICATION OF STATUTORY AUTHORITY PERMITTING OTHER THAN FULL AND OPEN COMPETITION.

X FAR 13.106-1(b) (1): For purchases not exceeding the simplified acquisition threshold (SAT), contracting officers may solicit from one source if the contracting officer determines that the circumstance of the contract action deem only one source reasonably available (e.g., urgency, inclusive licensing agreements, brand name, or industrial mobilization).

5. DEMONSTRATION THAT THE PROPOSED CONTRACTOR’S UNIQUE QUALIFICATIONS OR THE NATURE OF THE ACQUISITION REQUIRES USE OF THE AUTHORITY CITED

· Usage in the Clinical Center: Hamilton ventilators were purchase by the Clinical Center in 2020. These products have been solely maintained by Hamilton and part of many NIH protocols.

· These machines are used mainly in the ICU. Ventilators are life critical and routinely require real-time clinical and technical support from Hamilton.

· Hamilton Medical repair service, training, service contracts, and service parts are sole source products/service, manufactured, sold, performed and distributed exclusively by Hamilton Medical, Inc.

· No division of Hamilton Medical, nor any other company, offers a similar or competing products/services. These product/services must be purchased directly by institutions from Hamilton Medical, Inc. There are no agents or dealers authorized to represent these products/services.

· Sole Source Impact: If a third-party service provider is introduced to the Clinical Center, the CC would:

· Risk not having the Manufacturer’s clinical and technical support and a guide on integrating technology into care process.

· Be liable to pay Manufacturer for recertification of system before Manufacturer begins service.

· Risk jeopardizing available Manufacturer expert resources.

· Risk having CC staff work through recall remediation and software upgrades that are available to general the public, thus delaying critical uptime of equipment.

· Inconsistency of applications (new contacts, new service providers, no toll free 24/7 access) and a possible new source of infections within the Clinical Center could pose a patient safety issue.

6. A DESCRIPTION OF EFFORTS MADE TO ENSURE THAT OFFERS ARE SOLICITED FROM AS MANY POTENTIAL SOURCES AS PRACTIABLE

This is a sole source item. No other brand can meet the requirements or seamless support.

7. DEMONSTRATION THAT THE ANTICIPATED COST WILL BE FAIR AND REASONABLE

The actual cost of this service is consistent and lower when compared to non-dedicated service providers, when considered clinician level of effort. Cost comparison was measured against past procurements, ECRI market analysis, and industry standards.

8. DESCRIPTION OF MARKET RESEARCH CONDUCTED AND THE RESULTS OR STATEMENT OF THE REASON MARKET RESEARCH WAS NOT CONDUCTED

Researched sources include ECRI equipment comparison and guidance charts; ECRI Select Plus Market Intelligence Reports. Consultation and information gathering from the CC's Standardization Committee members, equipment managers, attendance at AAMI and HIMSS Technology Conference and Expositions.

9. ANY OTHER FACTS SUPPORTING THE USE OF OTHER THAN FULL AND OPEN COMPETITION.

No other supporting documents other than the unique qualifications listed in question 5.

10. LISTING OF SOURCES, IF ANY, THAT EXPRESSED, IN WRITING, AN INTEREST IN THE ACQUISITION.

No other source expressed interest in 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.

There are currently no barriers.

12. ADMINISTRATIVE OFFICER/PROGRAM OFFICIAL CERTIFICATION

“I hereby certify that the information contained in this justification is accurate and complete to the best of my knowledge and belief.”

David Ram, Supervisory Biomedical Engineer, COR

[YOUR NAME, SIGNATURE, AND TITLE]

Administrative Officer or COR

13. CONTRACTING OFFICER’S CERTIFICATION

“I hereby certify that the information contained in this justification is accurate and complete to the best of my knowledge and belief.”.”

[NAME AND SIGNATURE]

Contracting Officer image1.emf image2.png