A01 PERFORMANCE WORK STATEMENT.docx

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MAINTENANCE SERVICE AGREEMENT FOR MOLECULAR DIAGNOSTIC INSTRUMENT, PORTLAND AREA
Solicitation number
75H71326Q00023
Issued by

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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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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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