Statement of Work for VaLogic IQOQ Testing (3).docx

Statement of Work for Service Contract Request

Project Title: VaLogic, LLC Installation, Operational, and Performance Qualification (IQ/OQ/PQ) Services of Cold Temperature Units

Department: NIH Clinical Center, Pharmacy Department

Project Officer: Richard DeCederfelt Section Chief, Pharmacy Business Section Pharmacy Department NIH Clinical Center

1. Background

1.1 The National Institutes of Health (NIH) Clinical Center (CC) is a clinical research hospital providing all medical services for patients participating in human research protocols of the NIH. The CC provides patient facilities and services for clinical investigations by the NIH Institutes, research in related areas and supervises residency and other training programs.

1.2 The NIH Clinical Center Pharmacy Department provides Drug Distribution Services that include concurrent drug use review, preparation and distribution of sterile and non-sterile products, and investigational drug dispensing to inpatients and ambulatory patients. The Investigational Drug Management includes protocol support activities, investigational drug information development, and control and accountability of investigational agents. Moreover, Clinical Programs include participation in drug selection and experimental protocol design and implementation; monitoring patient response to drug therapy; patient education; provision of drug information; drug use evaluation; and patient counseling.

2. Purpose

2.1 Purchase of the VaLogic, LLC IQ/OQ/PQ Qualification Services of Cold Temperature Units (CTU) for the Pharmacy Department.

3. Scope of Work

3.1 The VaLogic, LLC IQ/OQ/PQ Qualification Services of Cold Temperature Units (CTU) will provide initial and follow-up installation, operational, and performance qualifications of new CTUs and follow-up operational and performance qualifications of existing CTUs that have undergone critical repairs coverage for the pharmacy department refrigerators and freezers which are used to store clinical patient study pharmaceutical drugs, sterile and non-sterile products, and investigational drugs used on a daily basis for all NIH study protocols. The cold temperature units are essential medical equipment which provide a critical function in the storage and stability of patient medications for ongoing clinical research studies being conducted in collaboration with NIH institutes. Qualification, maintenance, and repair of all instrument systems is essential in avoiding prolonged interruption of pharmacy services and consequently delaying completion of ongoing NIH clinical studies.

4. Period of Performance

4.1 Qualifications, testing, calibration, and certification services of the Pharmacy Department cold temperature units is expected between November 5, 2025 and will extend until December 31, 2025.

The CPRU expects the following to be included as part of the service warranty plan:

· One comprehensive installation, operation, and performance qualification (IQ/OQ/PQ) service must be included.

· One comprehensive NIST-traceable 3-point calibration of CTU chamber temperature probe of all refrigerated and freezer units.

· Documented evidence of comprehensive installation, operation, and performance qualification of all CTUs

· Comprehensive electronic and paper documentation of all installation, operational and performance qualifications performed on Pharmacy CTUs.

· Testing equipment calibration certification must be completed and available for documentation prior to performing qualification of CTUs.

· Services, labor, and travel should be all inclusive in the service contract.

· Qualification services must be initiated and addressed within 72 hours of initial service call.

· Customer technical support on all refrigerators and freezers qualifications procedures must be available during normal business hours via phone and 24 hours via internet.

· Service engineers must have complete systems-certified annual training on all refrigerated, freezer, and sub-zero systems qualification protocols.