26-008236 - Sole Source Justification.docx

Date: June 19, 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- 301-496-5314

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

With the establishment of the new Pediatric Intensive Care Unit (PICU), the CC needs to add one PrisMax Continuous Renal Replacement Therapy (CRRT) machine to their existing fleet of 5 Prismax CRRT. The CC successfully integrated the PrisMax with the hospital’s EHR, CRIS in 2020.

PrisMax Systems are intended for:

· Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload.

· Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where fluid removal of plasma components is indicated.

· The TherMax Blood Warmer Accessory is indicated for warming returning blood flow.

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

Procurement is for:

· One (1) PrisMax V3 US

· One (1) TherMax Blood Warmer

· One (1) PrisMax Warmer Arm Kit Total cost: $32,868.25

3. 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).

4. 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:

· In 2019, the CC purchases 5 Prismax with Thermax warmers. These 5 machines are the only CRRT machines exclusively used in the hospital for CVVH therapy.

· In early 2020, during activation, the CC successfully integrated the PrisMax with the hospital’s EHR, CRIS.

Sole Source: Vantive is the owner and sole proprietor of the PrisMax CRRT machines.

The PrisMax System delivers multiple modes of continuous renal replacement therapy (CRRT) without the need for additional equipment

· The PrisMax CRRT has an existing interface with the hospital’s CRIS HER

· CVVHDF: continuous veno-venous hemodiafiltration

· CVVHD: continuous veno-venous hemodialysis

· CVVH: continuous veno-venous hemofiltration

· SCUF: slow continuous ultrafiltration

· There is no other CRRT machine that matches the use cases of the PrisMax such as CVVHDF therapy.

Sole Source Impact:

· Inconsistent equipment, features, supplies and operations will prevent researchers to follow NIH Protocols. Protocol based care requires absolute consistency and reproducibility in equipment and processes. If any other equipment is considered, the CC will incur risks

· Consistency of applications within the Clinical Center could pose a patient safety issue. Inconsistency of applications also includes a huge increase in labor, time and cost for IT applications and cyber-security reviews and management

· NIH CC safe practice and culture of Standardization of equipment, supplies, user training, maintenance and contract management

· Develop new policy and procedures for implementation, including equipment cleaning and recall/alerts management

· Review the long-term risk of a possible new source of infection

· Review the incompatibility with the current equipment and supplies

5. 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 provide the requirements listed in question 5.

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

The actual cost of this device is consistent and lower when compared to non-dedicated systems. Cost comparison was measured against past procurements, ECRI market analysis, and industry standards.

7. 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.

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

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

No other source expressed interest in acquisition.

10. 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

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