26-007378 - Sole Source Memo.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

This is a follow-on contract to add 426 RTLS tags to the NIH awarded Conexus contract, PO #: 75N90022F00105. (NIH/CC is seeking a system consisting of Real Time Location System (RTLS) with 802.11(WI-FI) and Stationary RFID Fixed Readers to create a record as RFID-tagged items are “seen” when they pass under the Reader antenna. The CC is looking to monitor "real time" locations of about 2,000 portable medical devices and about 30,000 devices on a fix reader system). 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:

· 421 RTLS/Wi-Fi Asset Tag with Cradle, Plexus Licensing & Tag Activation

· 421 Pc. RTLS Tag Cradle Set with Tap

Procurement cost: $74,938.00

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 2018, the CC did a pilot on the Stanley-Aeroscout asset tracking system on the 3rd and 5th floor of the Clinical Research Building

· In 2020, the CC introduced an RTLS employee location feature as part of the Rauland Responder 5 Patient Call.

· In 2022, the Property Management Branch of NIH is piloting a Sunflower stationary RFID Fixed Reader system

· In 2022, the NIH awarded an RFID and RTLS system to Conexus

· In 2024, The NIH bought 428 additional RTLS tags

Sole Source: Conexus, Inc. is the only brand that meets the requirements needed for this contract.

No other brand can provide:

· Conexus is the only company authorized to connect RTLS tags to the Plexus asset tracking system. The Securitas RTLS tag is the verified RTLS used by Conexus.

· The Asset Tracking solution is assessed and authorized to operate (ATO) on a DoD network with the Defense Health Agency. The process, which is based on the National Institute of Standards and Technology (NIST) Risk Management Framework (RMF), follows a strict adherence to security from software design to implementation, and requires ongoing reviews, updates, and assessments to ensure that the system has sufficiently designed around and/or mitigated for past, current, and future.

· Mobile scanner that can scan 1,000 ft2 (93m2) per x Span unit with Monza R6 based tags, up to 30ft distance from scanner

· Mobile scanner capable of scanning a coverage area of a 10,000 sq. Ft. in less than 5 minutes with minimal to no room entry or patient disturbance

· The System integrates Barcode, Passive RFID and Active Wi-Fi technologies into a single unified platform. RTLS utilizes the site’s 802.11n (or later) network.

· The System uses a combination of Web, Client, Fixed and Mobile devices capable of communicating real-time asset location across a collection of facilities that can make up a campus of facilities. Connection can be delivered by using the campus LAN or can be done using an authorized HTTPS secure internet connection across disparate networks.

· Demonstrated Third-Party Interface Capability. Ability to Bi-directionally interface with large government databases such as the Defense Medical Logistics Standard Support (DMLSS), which is the master record of accountability throughout Defense Health Agency (DHA).

· RFID Location-Aware – automated scanning of RFID tags that will recognize which room in the facility they are located, rather than the person having to determine the room manually. Capability of assigning a “home” location for an asset. When scanning with RFID (Handheld, Cart or Fixed Reader), it will recognize the location and will assess the items that are present and are NOT present. If an asset is expected to remain in a home location, and the scan determines the asset is not in the home location, that data can be reported.

· System conforms to the prevailing Federal Information Processing Standard (FIPS) data encryption process each time that a data file is prepared for distribution.

· Supports the use of the OEM’s serial number and other equipment control numbers that may be part of the customer’s legacy system.

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