Procurement of Service Support of Rees Scientific Electronic Temperature Monitoring System in DLM

Statement of Work (SOW) / Performance Work Statement (PWS)

This document outlines the requirements for validation and calibration services for the existing Rees NIH160 environmental monitoring system. The objective is to ensure the safety and integrity of products and research samples by maintaining the performance of critical laboratory equipment, meeting regulatory requirements (CAP, cGMP), and ensuring processes have not been compromised.

• Annual qualification and validation of the entire REES system and associated software.

• Calibration and validation of all existing sensors (temperature, humidity, differential pressure, CO2) using NIST traceable instruments.

• Validation and calibration of hardwired and wireless sensors to confirm correct installation and function.

• System upgrade to allow connection to an SQL database using TLS 1.2 encryption and disabling SNMP.

• Installation of the latest Rees Scientific approved version of Apache Web Server with strong cipher suites.

• Validation of the system against 21CFR211.68(a), 21CFR211.68(b), and 21CFR11 requirements, including Design Qualification, Installation Qualification, Operational Qualification, and Performance Qualification.

• Confirmation of sensor readings, calibration, and proper alarm system functionality (local and remote).

• Testing of processor, RAM, PROM, A/D converter, voice chip, phone interface, display interface, and remote panel communications.

• Testing of all output relays.

• Comprehensive yearly IQ/OQ of the system with full documentation.

• Provision of a one-year onsite service plan with 24/7 technical support.

• Delivery of GMP/GLP IQ/OQ validation reports, software validation test reports, calibration certificates, and onsite refresher training.

• All calibrations must be performed using NIST traceable instruments with valid certificates.

• Sensors must be calibrated within acceptable tolerances.

• The system must meet specific CFR requirements for calibration, record retention, change management, audit trails, data backup, electronic signatures, and validation.

• Vendor must have a quality management system similar to or exceeding ISO 9001:2015 and meet ISO/IEC 17025:2017 requirements for calibration laboratories.

• Vendor must establish a change management process and investigate all quality events.

• Personnel performing services must meet specific education, training, and experience requirements.

• Base Period: April 24, 2026, through April 23, 2027.

• Place of Performance: NIH Bldg #10 - DLM, 10 Center Drive, Room 2C324, Bethesda, MD 20892.

• Services must be performed by trained Rees technicians.

• Vendor must have a robust quality management system and qualified personnel.

• Subcontracting requires pre-approval by NIH.

• Calibration stickers must be placed on all calibrated probes/sensors.

• Repairs due to abuse, neglect, vandalism, fire, or water are excluded and will require a separate purchase order.

Other / Unclassified

This document is a Sole Source Justification and Approval for Rees Scientific to provide service support for the National Institutes of Health (NIH) Clinical Center's Department of Laboratory Medicine (DLM) Electronic Temperature Monitoring System (EMS).

This document outlines the specific requirements for an Environmental Monitoring System (EMS) that senses environmental parameters like temperature and humidity. Key features include:

• System Capabilities: Windows-based operation, SQL server compatibility, ability to monitor up to 128 wireless or hardwired sensors (hybrid configuration), and universal sensor compatibility.
• Access Control: 8 levels of access permissions, user name/password control, and options for system-specific or existing Windows passwords.
• Alarming & Notifications: Programmable alarm delays, "Buddy Watch" feature for node health monitoring, MPX Com and Battery alarms, and "Pre-alarm Alert"/"Out of Range" notifications via audible, remote, and email means.
• Data Management: Audit logs for program changes, automatic backup, and individual sensor logging rates.
• Unique Qualifications: Rees Scientific is the only vendor with ISO 9001 certification that meets cGMP and CAP requirements. They also have an established presence and proven security at NIH, with local service technicians.
• Estimated Value: $21,593.43

The document justifies a sole-source procurement based on Rees Scientific's unique qualifications, including ISO 9001 certification and proven performance at NIH, making them the only vendor that satisfies all stringent requirements.