Sole Source Memo VaLogic.docx

Date: October 14, 2025

From: Raúl Alfaro Pharmacy Dept., Quality Assurance Section National Institutes of Health, Clinical Center

Subject: SOLE SOURCE JUSTIFICATION AND APPROVAL

To: NIH, CLINICAL CENTER, CONTRACTING OFFICER

1. AGENCY IDENTIFICATION AND CONTRACTING ACTIVITY

Raúl Alfaro Pharmacy Dept., Quality Assurance Section National Institutes of Health, Clinical Center 10 Center Drive 1C-166 Bethesda, MD 20892

Susan Nsangou Contracting Officer National Institutes of Health, Clinical Center Office of Purchasing and Contracts 6707 Democracy Blvd Suite 106 Bethesda, MD 20892

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

VaLogic Bio IOQ/PQ/RQ Qualification specialty services for Pharmacy Department Cold Temperature Unit (CTU) including refrigerators/freezers/sub-zero freezers.

DESCRIPTION OF THE SUPPLIES AND SERVICES REQUIRED, INCLUDING THE DELIVERY SCHEDULE The selected source is based on availability and certified training on equipment Good Manufacturing Practices (GMP) qualification and validation of various manufacturer cold temperature units (CTU). VaLogic Bio will provide the specialty service to pharmacy cold temperature units with the capacity to specifically perform Installation Operational Qualifications (IOQ), Performance Qualifications (PQ), and Re-qualifications (RQ) to the Pharmacy Department cold temperature units and their respective electronic control components, unit temperature probes, and mechanical components.

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

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

The selected source is based on current service coverage by Valogic Bio, Inc. via the Office of Research Services and Compliance (ORSC) contract with VaLogic (Contract #75N90021D00025, Task Order #75N90021F00001). VaLogic Bio, Inc. will perform IOQ/PQ/RQ testing, calibration, and validation of pharmacy cold temperature units that will require qualification testing. The sole source is also based on the availability to provide GMP/GLP qualifications to all new and existing Pharmacy Department Cold Temperature Unit (CTU) with the capacity to service various manufacturer cold temperature units from Follet, Panasonic, ThermoFisher, and Stirling. Because of the existing VaLogic contract with ORSC as well as the specific IOQ/PQ/RQ validation training and expertise, only one (1) source will be solicited. All other sources have been exhausted due to the service technician specific training, certification, database access, and knowledgebase of manufacturer refrigerator, freezer, and sub-zero equipment as well as the software/firmware that are directly applicable to the operation and management of each CTU.

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

The certified training of VaLogic Bio, Inc. technicians on Follet, Panasonic, Helmer, ThermoFisher, K2 Scientific, and Stirling model cold temperature units which includes specific cold temperature unit manufacturer training, service certification and access to the latest technical developments, repair procedures knowledge base access, updated instrument schematics database access, software & firmware updates, and planned maintenance procedures of multiple manufacturer refrigerator, freezer, and sub-zero units compels the solicitation of only one (1) source. Additionally, since VaLogic has provided qualification, validation, and certification services for various Pharmacy department biomedical equipment and aseptic facilities for the past eight (2) years and currently holds the existing service contract through ORSC, no other solicitations will be made. These specific requirements will not permit competition to the maximum extent possible. Competition will be sought by oral solicitation procedures and no resultant synopsis in FBO will be published. (FAR 5.202 (a) (2))

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

Based upon price analysis and comparison of maintenance, service, and repair of all Pharmacy Department biomedical equipment and cold temperature units, the price of the selected specialty service contract will be considered reasonable.

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

Only one service provider was sought by oral solicitation procedures due to the service provider specialized certification which includes calibration, validation, and qualification of biomedical equipment for Aseptic Processing Facilities (APF). Additionally, VaLogic Bio, Inc. held the service contract #75N90021D00025, Task order #75N90021F00001 for specialty qualifications services through the clinical center ORSC section. Moreover, the service provider is local and provides GMP validation services for all pharmacy department aseptic processing facility biomedical equipment as well as cold temperature units. The aforementioned specifications were targeted based on market capabilities.

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

Competition will be limited to vendors that respond to the oral solicitation.

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

The selected vendor will be based on availability to provide the service product. VaLogic Bio, Inc.

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.

Because this is a continuing service contract of the Pharmacy Department cold temperature units that are currently operating on site and which store critical pharmaceutical products used for investigational clinical study protocols, the NIH Clinical Center Pharmacy department will continue to seek competition through oral solicitations. A blanket purchase agreement (BPA) may be considered if there is sufficient need for such a contract mechanism.

11. 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.”

Richard DeCederfelt, COR Pharmacy Department

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.”

Susan Nsangou Contracting Officer image1.png