Statement of Work for REES Sensor Upgrade Specialty Services (1).docx

Statement of Work for REES Sensor Upgrade Specialty Services Purchase Request

Project Title: Purchase of REES Scientific Resistance Temperature Detector Probes for Pharmacy Department Cold Units

Department: NIH Clinical Center, Pharmacy Department

Project Officer: Richard DeCederfelt Service Chief Pharmacy Business Management Services 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 at the NIH. The CC provides patient facilities and services for clinical investigations conducted at the NIH Institutes, which includes 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 REES Scientific, Inc. Resistance Temperature Detector (RTD) probes to replace existing Thermocouple Cable (TPT) probes for improved sensitivity and reliability of 24/7 CTU temperature monitoring.

3. Scope of Work

3.1 The REES Scientific, Inc. purchase and installation package specialty service will include replacing existing TPT probes with RTD probes for designated control temperature units (CTU) in the pharmacy department. The RTD temperature probes will be installed, tested, and calibrated with a 3-point calibration protocol that includes provision of a calibration certificate for each installed and calibrated RTD temperature probe. The REES Scientific RTD probes are used to monitor CTU chamber temperature for all pharmaceutical investigational products stored in the pharmacy and used on currently ongoing patient clinical research studies. The RTD temperature probes are essential medical instruments that provide critical environmental monitoring of clinical study pharmaceutical products which facilitate the progress of all human investigative research studies being conducted at NIH.

4. Period of Performance

4.1 Installation, testing, calibration, and certification services of the REES Scientific RTD temperature probes will begin March 15, 2026 and will extend until May 15, 2026. Installation, testing, calibration, and certification of the REES Scientific RTD temperature probes should be completed during this period and should not extend past the end date.

The Pharmacy Department expects the following to be included as part of the specialty service:

1. Remove existing TPT temperature probes from existing cold units and update REES software monitoring systems as well as computer workstation software communications.

2. Install new RTD temperature probes at existing locations where TPT temperature probes were located and update REES software monitoring systems, computer workstation software, and communications applications.

3. All new RTD temperature probes are required to be tested, calibrated, and certified.

4. Three-point Calibration of RTD temperature probes is required for each new sensor probe.

5. Calibration certificates will be generated for each RTD temperature probe and provided to the Pharmacy Quality Assurance (QA) section for Quality Control (QC) and QA documentation.

6. Deploy all RTD temperature probe for immediate use and environmental monitoring in all pharmacy sections that store investigation clinical study pharmaceutical products.

7. Customer technical support on the RTD temperature probe and monitoring system must be available during maintenance, testing, and certification.

8. Software applications support on the RTD temperature probe and monitoring system must be available during maintenance, testing, and certification.

9. Service engineers must have complete systems-certified training on all REES Scientific instruments, devices, and software manager clients.

10. Service support specialists must be available during business hours via phone.