PWS_CEPHEID GENEXPERT SYSTEM.docx

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CEPHEID GeneXpert Systems
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This document is a Performance Work Statement (PWS) for the maintenance and repair of CEPHEID GeneXpert Systems used by the U.S. Coast Guard Health, Safety, and Work-Life Service Center. The PWS outlines the scope of work, objectives, and performance requirements for the contractor to provide preventative maintenance, software upgrades, and as-needed repairs to the GeneXpert Systems located at Coast Guard clinics in the continental U.S., Hawaii, and Puerto Rico. Key requirements include: using manufacturer-trained personnel, providing 24/7 telephone support, completing annual preventative maintenance visits within 1 day, responding to repair calls within 48 hours, and providing service reports within 5 business days. The period of performance is a 1-year base period with three 1-year option periods. This PWS is related to a pre-solicitation for a federal contract opportunity to provide the CEPHEID GeneXpert Systems and associated maintenance services to the U.S. Coast Guard.

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CEPHEID GENEXPERT SYSTEM MAINTENANCE

FOR THE U.S. COAST GUARD HEALTH, SAFETY, AND WORK-LIFE SERVICE CENTER

PERFORMANCE WORK STATEMENT

1.0 GENERAL.

1.1 Scope: The purpose of this contract is to provide preventative maintenance and as-needed repairs to CEPHEID GeneXpert Systems throughout the U.S. Coast Guard Clinics in the continental United States, Hawaii, and Puerto Rico. The services performed under this contract are non-personal and are not inherently governmental or closely associated inherently governmental services. The Government will not exercise any employer responsibilities or rights over contract personnel performing under this contract. The Contractor is solely accountable and liable for its employees and is obligated to meet all contract terms and conditions. The prime Contractor also retains responsibility for any teaming partner or subcontractor and shall be accountable for their actions and performance. The Contractor is responsible for the performance of the entire scope of work and shall meet all performance standards.

The Contractor shall perform Cepheid GeneXpert System Maintenance in accordance with (IAW) with this PWS for locations within the U.S Coast Guard.

1.2 Background: The Cepheid GeneXpert Systems are highly automated, that provides the detection for a viral and bacterial organisms through polymerase chain reaction. The system provides fast turn-in around times with one hour detection. This system is critical to operation medicine’s SARS-CoV-2, FLU A/B, and RSV for the CG’s afloat and ashore units. The Cepheid GeneXpert Systems were purchased during the height of the COVID pandemic to sustain testing operations, and has since passed its warranty date. The Service agreement which provides repairs and replacements will be essential to keeping the analyzer operational to its max capacity.

1.3 Objectives: The Contractor shall ensure all work accomplished in support of this PWS meets all applicable federal, state, and local laws, regulations, and directives to include safety, environmental, and Occupational Safety and Health Administration (OSHA) procedures.

1.4 Period of Performance: The Period of Performance shall be for one (1) 12-month base period and three (3), 12-month option periods.

1.5 Post Award Conference/Periodic Progress Meetings: The Contractor shall attend any post award conference convened by the contracting activity or contract administration office IAW Federal Acquisition Regulation (FAR) Subpart 42.5. Any required meetings will be conducted virtually through teleconference. The Contracting Officer and other government personnel, as appropriate, may meet periodically with the Contractor to review the Contractor’s performance. At these meetings, the Contracting Officer will apprise the Contractor of how the Government views the Contractor’s performance and the Contractor will apprise the Government of problems, if any, being experienced. The Contractor shall take appropriate action to resolve outstanding issues. These meetings shall be at no additional cost to the Government.

1.6 Hours of Operation: All Laboratory maintenance services and repairs must be accomplished within “normal working hours,” Monday through Friday, between the hours of 7:30 A.M. to 4:30 P.M., local time, excluding federal holidays.

1.7 Recognized Holidays: The Contractor shall not schedule services on federally recognized holidays. The Government observes the following federal holidays:

New Year’s Day Juneteenth Veteran’s Day Martin Luther King Jr. Birthday Independence Day Thanksgiving Presidents Day Labor Day Christmas Memorial Day Columbus Day

1.8 Planned Closures/Other Non-Duty Days: Bases may be closed all or part of the day for declared down days. On those days, the Contractor shall only schedule services during the hours the Government is open.

1.9 Unplanned Closures: During an unplanned closure due to unusual and compelling circumstances (natural disasters, emergencies, severe weather), services will not be required.

1.10 In the event the place of performance is closed (whether planned or unplanned) on a day where services were previously scheduled, the Contractor will have the following option:

1.10.1 Reschedule the work on any day that is mutually satisfactory between the Government and Contractor.

1.11 Security Requirements: All personnel employed by the Contractor in the performance of this contract, or any representative of the Contractor entering a government installation, shall abide by all security regulations of the installation. The Government reserves the right to direct the removal of an employee for misconduct or security reasons. This action does not relieve the Contractor from total performance of the contract tasks specified herein.

1.12 Identification of Contract Employees: Contractor personnel shall present a neat appearance and be easily recognized as a contracted employee. The Contractor employees performing services on the government installation shall identify themselves as contractor personnel by introducing themselves or being introduced as contractor personnel and by displaying distinguishing badges or other visible identification while on a government facility. Contractor personnel shall identify themselves as contractor employees in telephone conversations and in formal and informal written correspondence with government personnel.

1.13 Access Requirements: Installation Access will be coordinated with the installation POC. The contractor will be issued a temporary visitor’s pass to gain access to the Laboratory. The customer shall assist, as needed, in obtaining access passes.

1.14 Contractor Furnished Items and Responsibilities:

The Contractor shall furnish all services to include all labor, parts, tools, materials, and transportation required to perform work under this contract.

All personnel needed to meet the requirements of this PWS shall be provided by the Contractor.

1.15 Location of the GeneXpert Systems where the service will be performed: Location where the GeneXpert systems are located will be provided through the COR.

2.0 Services Required:

The contractor shall provide repairs and maintenance in accordance with the below requirements:

2.1 All services shall be conducted using manufacturer trained and authorized personnel. Maintenance of GeneXpert systems, to include repairs shall be performed IAW manufacturer requirements. Original equipment manufacturer parts shall be used.

2.2 All GeneXpert system maintenance services and repairs shall be accomplished within “normal working hours,” Monday through Friday, between the hours of 7:30 A.M. to 4:30 P.M., local time, excluding federal holidays.

2.3 The Contractor shall provide 24 hours-per-day, 7 days-per-week telephone support.

2.4 Preventative Maintenance: The Contractor shall provide on-site preventative maintenance of the GeneXpert system equipment listed in TE 3. Maintenance shall be provided annually, one (1) time per year for each covered location. Preventative maintenance shall include replacing worn module ejectors, lubricating moving parts, replacing fan filters, brushing clean module optics, replacing automation batteries, and an Xpert check to check the optical system, verify the thermal system, and perform system-level tests to ensure full system functionality.

2.5 Software upgrades.

2.6 Repair Services and Customer Support: The Contractor shall provide as-needed repair services during normal working hours. The Contractor shall respond to repair service calls within 48 hours.

2.7 Service Reports: Upon completion of each service, preventative maintenance and/or repairs, the Contractor shall provide a service report to the COR. The service report shall document the work performed and results, to include detailing their findings of the damage, wear, tear, and overall condition of the instrument. The service report shall be provided within five (5) workdays after service completion.

Technical Exhibit 1

PERFORMANCE REQUIREMENTS SUMMARY

The following performance objective acceptable quality levels (AQLs) for minimum quality levels of service are required on this contract:

PERFORMANCE OBJECTIVE
PWS PARAGRAPH
AQL
SURVEILLANCE METHOD
The Contractor shall provide one (1) annual scheduled preventive maintenance visit.
2.4
Maintenance service is completed within one (1) working day 100% of the time.
Periodic Inspection

Monthly Performance

The Contractor shall respond to repair service calls within 48 hours.

2.5

Response is completed within 48 hours 100% of the time.

Periodic Inspection Monthly Performance

Upon completion of each service, preventative maintenance and/or repairs, the Contractor shall provide a service report to the COR. The service report shall document the work performed and results, to include detailing their findings of the damage, wear, tear and overall condition of the instrument. Service report shall be provided within five (5) work days of service completion.

2.6
Report is completed within four (4) working days 90% of the time. Remaining 10% completed within five (5) working days.
Periodic Inspection

Monthly Performance

Technical Exhibit 2

CONTRACT DELIVERABLES SCHEDULE

Deliverable
Frequency
Number Required
Format
Provided To
Contract Manager Contact Information
NLT 10 business days after performance start date
1
Electronic copy via email
CO and COR
Service Report
NLT 5 business days after each service visit
1
Electronic copy via email
COR

Technical Exhibit 3

GENEXPERT EQUIPMENT INFORMATION

Location
Item Number
Serial Number
Government POC
USCG
900-0513
838445
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110004289
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
838306
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
843997
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
841008
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110004286
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
837950
HSWL SC Chief Laboratory Officer or designee
USCG
900-0511
845155
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110004256
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110004257
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110004287
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110004288
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110004282
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110004284
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110004280
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110004283
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110008193
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110008195
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110008196
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110008197
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110008199
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110008200
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110008201
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110008202
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110003565
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110003560
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
842741
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110003563
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110004230
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110004235
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
844836
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110008151
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110004251
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110004252
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110004253
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110004255
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
844839
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110004259
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110004239
HSWL SC Chief Laboratory Officer or designee
USCG
900-0511
838034
HSWL SC Chief Laboratory Officer or designee
USCG
900-0511
842984
HSWL SC Chief Laboratory Officer or designee
USCG
900-0511
842983
HSWL SC Chief Laboratory Officer or designee
USCG
900-0511
842979
HSWL SC Chief Laboratory Officer or designee
USCG
900-0511
838032
HSWL SC Chief Laboratory Officer or designee
USCG
900-0511
842977
HSWL SC Chief Laboratory Officer or designee
USCG
900-0511
842978
HSWL SC Chief Laboratory Officer or designee
USCG
900-0511
842981
HSWL SC Chief Laboratory Officer or designee
USCG
900-0511
838033
HSWL SC Chief Laboratory Officer or designee
USCG
900-0511
842980
HSWL SC Chief Laboratory Officer or designee
USCG
900-0511
837952
HSWL SC Chief Laboratory Officer or designee
USCG
900-0511
842976
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
838299
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110004254
HSWL SC Chief Laboratory Officer or designee
USCG
900-0511
842975
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
846942
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110003564
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110004281
HSWL SC Chief Laboratory Officer or designee
USCG
900-0511
817107
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110003561
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110004285
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
844830
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110003569
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110004238
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110004234
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110003562
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110004236
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110004350
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110008198
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110003566
HSWL SC Chief Laboratory Officer or designee
USCG
900-0513
110008194
HSWL SC Chief Laboratory Officer or designee

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