Statement of Work Cepheid Module Activation

Statement of Work (SOW)
1. PROJECT TITLE: Cepheid Module STI & Module Expansion 2. BACKGROUND/PURPOSE: The FPSU Laboratories currently utilize Cepheid instrumentation to provide molecular diagnostic testing services. Demand for sexually transmitted infection (STI) testing has increased, requiring additional testing capacity to maintain acceptable turnaround times and support timely patient diagnosis treatment. The purpose of this procurement is to acquire moderate-complexity Cepheid systems and activate two additional modules on each of our existing Cepheid instruments. This acquisition will expand testing capacity for STI testing and Respiratory illnesses such as COVID/FLU/RSV, while maintaining compatibility with existing laboratory infrastructure, workflows, staff training programs, and quality management systems. The procurement supports continuity of patient care, maximizes utilization of existing government owned equipment, and avoids unnecessary duplication of costs associated with implementation of an alternate testing platform.
3. SCOPE: The agreement is between Fort Peck Service Unit (“Customer”) and the manufacturer, Cepheid. The Contractor shall provide all labor, materials, equipment, software, installation services, training, and technical support necessary to furnish two moderate-complexity Cepheid instruments and activate the additional two modules on each of the existing Cepheid instruments. The system shall be fully compatible with existing Cepheid instrumentation and support FDA-cleared moderate-complexity molecular assays for sexually transmitted infection testing. The contractor shall provide equipment that is new, unused, operational and ready for laboratory verification upon completion of installation. 4. APPLICABLE DOCUMENTS: The plan will meet or exceed Clinical Laboratory Improvement Amendments (CLIA) requirements and performance levels specified by the manufacturer’s operation and service manuals.

5. TASKS:

a. Provide 2 moderate-complexity Cepheid molecular testing systems b. Provide all required hardware, software, licenses, cables, and accessories necessary for operation
c. Replacement of printers, software updates as needed
d. Activate two currently inactive modules on each of the existing Cepheid instruments. (4 modules to activate in total)
e. Verify functionality of activated modules
f. Install and configure the new system
g. Verify proper operation and communication with the system software h. Provide training materials and documentation