A01 PERFORMANCE WORK STATEMENT.docx
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- Solicitation number
- 75H71326Q00023
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Summary: Performance Work Statement for Molecular Diagnostic Instrument Maintenance
This Performance Work Statement outlines the requirements for manufacturer-authorized preventive and corrective maintenance services for four Cepheid GeneXpert analyzers located at Indian Health Service (IHS) Portland Area Service Units. The contractor must provide comprehensive support including preventive maintenance, corrective maintenance, technical support, software support, and associated services necessary to maintain operational performance of the instruments. The contract has a one-year base period with four optional one-year renewal periods. Service locations include Fort Hall Service Unit in Fort Hall, Idaho; Warm Springs Service Unit in Warm Springs, Oregon; Western Oregon Service Unit in Salem, Oregon; and Yakama Service Unit in Toppenish, Washington, each with specified serial numbers for the diagnostic equipment.
The primary objective is to ensure continuous operational readiness of the GeneXpert analyzers across all four IHS Portland Area facilities through timely maintenance interventions and technical support. The contractor is responsible for maintaining equipment performance standards and responding to service requests to minimize downtime at these healthcare facilities serving Native American communities. The Department of Health and Human Services Indian Health Service is the contracting federal agency for this maintenance service agreement.
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| File | Type | Posted |
|---|---|---|
| Sole Source Justification Cepheid_redacted.pdf |
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PERFORMANCE WORK STATEMENT (PWS)
1.0 PURPOSE
The Indian Health Service (IHS), Portland Area, requires comprehensive manufacturer-authorized maintenance and support services for designated Cepheid GeneXpert analyzers to ensure continuous operational readiness and reliability for clinical diagnostic testing.
2.0 SCOPE
The Contractor shall provide manufacturer-authorized preventive maintenance, corrective maintenance, technical support, software support, and associated services necessary to maintain the operational performance of Cepheid GeneXpert analyzers located at the following IHS Portland Area Service Units:
2.1 Service Locations
Fort Hall Service Unit – Not-Tsoo Gah-nee Indian Health Center 33 N. Mission Road Fort Hall, ID 83203 Serial Number: 845950 Warm Springs Service Unit – Warm Springs Health & Wellness Center 1270 Kot-Num Road Warm Springs, OR 97761 Serial Number: 844972 Western Oregon Service Unit – Chemawa Indian Health Center 3750 Chemawa Road NE Salem, OR 97305 Serial Number: 844156 Yakama Service Unit – Yakama Indian Health Center 401 Buster Road Toppenish, WA 98948 Serial Number: 810066
3.0 COVERED EQUIPMENT
This requirement covers all active Cepheid GeneXpert analyzers identified in the contract schedule (Contract Line Item Number (CLIN) structure) by Service Unit and serial number.
The Contractor shall provide all services necessary to maintain covered equipment in accordance with manufacturer specifications and performance standards throughout the period of performance.
4.0 PERFORMANCE REQUIREMENTS
4.1 General Requirements
The Contractor shall provide manufacturer-authorized service and maintenance support for all covered GeneXpert analyzers.
Services shall be performed by factory-trained and certified personnel authorized by the equipment manufacturer.
4.2 Technical Support
The Contractor shall:
· Provide twenty-four (24) hours per day, seven (7) days per week technical telephone support for laboratory personnel and biomedical/clinical engineering staff.
· Provide remote diagnostic support capabilities, including Laboratory Information System (LIS) support when applicable.
4.3 Corrective Maintenance
The Contractor shall:
· Provide on-site corrective maintenance Monday through Friday between 8:00 a.m. and 6:00 p.m. local time, excluding Federal holidays.
· Diagnose and repair equipment malfunctions to restore equipment to full operational status.
· Furnish all labor, travel, replacement parts, and materials necessary to complete repairs.
4.4 Preventive Maintenance
The Contractor shall:
· Perform one (1) annual preventive maintenance inspection on each covered system during each contract year.
· Conduct preventive maintenance in accordance with current manufacturer recommendations and service procedures.
· Provide all labor, travel, tools, software, and replacement parts required to complete preventive maintenance activities.
4.5 Software and System Support
The Contractor shall provide:
· Software updates.
· Firmware updates.
· Security patches.
· Manufacturer-required upgrades and enhancements necessary to maintain supported system functionality and manufacturer support eligibility.
4.6 Service Notifications
The Contractor shall notify the designated Laboratory Supervisor and Biomedical/Clinical Engineering representative prior to arrival for any scheduled or unscheduled on-site service visit.
4.7 Service Documentation
The Contractor shall provide a service report for each maintenance activity performed.
At a minimum, the service report shall include:
· Date of service
· Equipment identification and serial number
· Description of work performed
· Parts replaced
· System status upon completion
· Name of service technician Service documentation shall be provided to the Laboratory Supervisor and designated Biomedical/Clinical Engineering representative within forty-eight (48) business hours following completion of service.
4.8 Cybersecurity Requirements
Any mobile media, service laptops, removable storage devices, or other electronic tools used in support of covered equipment shall be scanned and verified in accordance with applicable IHS cybersecurity requirements prior to connection to any Government-owned system or network.
5.0 PERFORMANCE STANDARDS
| Performance Objective |
| Performance Standard |
| Acceptable Quality Level (AQL) |
| Surveillance Method |
| Technical Support Availability |
| 24/7 technical support available |
| 100% availability |
| Review of service records |
| Preventive Maintenance |
| Annual preventive maintenance completed on each covered system |
| 100% compliance |
| Review of maintenance reports |
| Corrective Maintenance |
| Contractor responds and performs service within contract requirements |
| 95% compliance |
| Service ticket review |
| Service Documentation |
| Service reports submitted within 48 business hours |
| 100% compliance |
| Review of submitted reports |
| System Availability |
| Covered equipment remains operational and supported |
| Minimum 98% uptime |
| Review of maintenance and downtime records |
6.0 DELIVERABLES
| Deliverable |
| Description |
| Due Date |
| Preventive Maintenance Report |
| Documentation of annual preventive maintenance service |
| Within 48 business hours after service completion |
| Corrective Maintenance Report |
| Documentation of repair and corrective maintenance activities |
| Within 48 business hours after service completion |
| Software/Firmware Update Documentation |
| Documentation of updates and upgrades performed |
| Within 48 business hours after completion |
| Uptime and Service Records |
| Documentation supporting performance requirements upon request |
| As requested by the Government |
7.0 GOVERNMENT RESPONSIBILITIES
The Government shall:
· Provide reasonable access to covered equipment and service locations.
· Identify authorized points of contact for laboratory operations and biomedical/clinical engineering support.
· Coordinate facility access requirements for Contractor personnel.
8.0 PERIOD OF PERFORMANCE
The period of performance shall consist of one (1) twelve-month Base Period and three (3) twelve-month Option Periods.
Base Period July 1, 2026 – June 30, 2027 Option Period One July 1, 2027 – June 30, 2028 Option Period Two July 1, 2028 – June 30, 2029 Option Period Three July 1, 2029 – June 30, 2030 Exercise of option periods shall be at the sole discretion of the Government in accordance with FAR 52.217-9, Option to Extend the Term of the Contract.
9.0 SECTION 508 ACCESSIBILITY REQUIREMENTS
All Information and Communication Technology (ICT) deliverables provided under this contract shall comply with:
· Revised Section 508 Standards (36 CFR Part 1194)
· Web Content Accessibility Guidelines (WCAG) 2.1 Level AA
· Section 255 Guidelines, as applicable The Contractor shall:
1. Submit an Accessibility Conformance Report (ACR) using the current Voluntary Product Accessibility Template (VPAT®) version 2.5, or complete applicable HHS Section 508 Accessibility Checklists.
2. Ensure all electronic documents, software, applications, websites, multimedia content, and other ICT deliverables meet applicable accessibility requirements.
3. Correct and remediate identified accessibility deficiencies at no additional cost to the Government.
4. Comply with applicable HHSAR clauses 352.239-73 and 352.239-74, which shall be incorporated into the solicitation and resulting contract.
10.0 PLACE OF PERFORMANCE
Services shall be performed at the Service Unit locations identified in Section 2.1 and remotely as required to provide technical support, diagnostics, software maintenance, and related services.
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