A05 - SOW Cepheid Module Activation.docx

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

i. Provide manufacturer warranty coverage

j. Provide technical support resources and service contract information

k. Provide installation records, user documentation, warranty information, and software licensing information

6. DELIVERABLES AND DELIVERY SCHEDULE: The contractor shall provide two moderate-complexity Cepheid instruments, activation of two currently inactive modules on both of the existing Cepheid instruments, all required software and licenses, installation services, operator training, warranty coverage, and all associated documentation necessary for operation of the system. The contractor shall deliver the equipment within the thirty calendar days after contract award. Installation module activation, and operational verification shall be completed following delivery. Training and required documentation shall be provided at the time of installation. Warranty coverage shall begin upon Government acceptance of the equipment and services. Government acceptance shall occur upon successful completion of delivery, installation, activation of the two modules on both of the existing systems, verification of system functionality, and receipt of all required documentation.

7. GOVERNMENT-FURNISHED EQUIPMENT AND INFORMATION: The Government will provide access to the existing government-owned Cepheid instruments for the purpose of activating the currently inactive modules and verifying functionality.(POPLAR ANALYZER SN: 110003233 & WOLF POINT ANALYZER SN: 110003186) The Government will provide reasonable access to the installation location and existing laboratory infrastructure necessary to complete the work. The Government will provide information necessary to support installation, module activation, and system implementation, including applicable laboratory contact information, equipment identification information, installation site requirements, and scheduling information.

8. PLACE OF PERFORMANCE: Fort Peck Service Unit:

9. PERIOD OF PERFORMANCE: 30 days from date of award.

10. SECURITY: Work does not require IT clearance. Vendor will check in with Administration and receive a visitor’s badge at the time of arrival while performing service.