Statement_of_Work_HFP_2025_127610.pdf

ALP: HFP-2025-127610

Attachment 1, Statement of Work Sterilizer and Washer Preventative Maintenance

STATEMENT OF WORK

1. PURPOSE

To obtain a service contract for the preventative maintenance and technical support of four (4) STERIS washing and sterilizing systems.

2. BACKGROUND

Scientists working at the Gulf Coast Seafood Laboratory (GCSL) require clean and sterile media and labware to perform their experiments. Biowaste is accumulated as a result of these studies.

The glassware washer and each of the steam sterilizers are necessary to clean and sterilize the labware, media, and biowaste involved in the experimental process. Steris washers and sterilizers meet the stringent quality control requirements implemented by Human Foods Program (HFP) and the National Shellfish Sanitation Program (NSSP), to prepare media and labware and ensure precise and accurate results. The Steris sterilizers for labware, media, and biowaste here at the GCSL ensure the destruction of all living microorganisms, preventing contamination in sample processing. Due to the necessity of clean and sterile components throughout the experimental process and the complexity of the equipment, multiple inspections and preventative maintenance is imperative to ensure quality results.

3. SCOPE

The Contractor shall provide a Total Care Connect maintenance service agreement for two (2) STERIS sterilization systems (SN# 011640507, 030041917), and Labor Care service agreement for one (1) STERIS washer system (SN# 3603410009) and one (1) STERIS sterilization system (SN# 11549214) for excellent operational condition.

Service agreement shall include:

• Total Care Connect:

o Parts, labor, travel and accommodation for the planned maintenance services and remedial services during the contract period, o Preventative maintenance (PM) services in accordance with OEM recommendations, with delivery on all systems in the same visit to reduce downtime, o All services shall be performed by OEM factory-trained and certified (or OEM equivalent compliant) technicians and engineers, using OEM made or OEM-equivalent certified parts and equipment, o Warranty on workmanship for a minimum of sixty (60) days, o Interior surface cleaning of the sterilizers using OEM approved chemicals and equipment, o National Institute of Standards and Technology (NIST) traceable on-site calibration, o Priority Technical Support in addition to Remote Monitoring (if the covered equipment is capable and enabled with this technology), o Access to eservice.steris.com to schedule/track service requests and obtain service reports, o Unlimited calls to the STERIS service hotline - calls related to STERIS equipment shall be placed ahead of calls related to equipment that is not registered for Priority

Support coverage and STERIS shall route all calls to the appropriate Technical Support resource based on the equipment serial number, o Response to requests within one (1) business day for service and repairs.

• Labor Care:

o Labor, travel and accommodation for the planned maintenance services and remedial services during the contract period, o Preventative maintenance (PM) services in accordance with OEM recommendations, with delivery on all systems in the same visit to reduce downtime, o All services shall be performed by OEM factory-trained and certified (or OEM equivalent compliant) technicians and engineers, using OEM made or OEM-equivalent certified parts and equipment, o Warranty on workmanship for a minimum of sixty (60) days, o Interior surface cleaning of the sterilizers using OEM approved chemicals and equipment, o National Institute of Standards and Technology (NIST) traceable on-site calibration, o Unlimited calls to the STERIS service hotline - STERIS shall route all calls to the appropriate Technical Support resource based on the equipment serial number, o Response to requests within one (1) business day for service and repairs.

4. SPECIFIC TASKS

4.1 Task 1 – Yearly Preventative Maintenance

• A (OEM) Factory-trained and certified (or OEM equivalent compliant) engineer/technician shall travel to site to perform scheduled preventative maintenance on all systems listed in the SOW the number of times yearly as recommended by the OEM. During the service visit, any maintenance needed to keep or bring the systems to fully functional status with adequate calibration results consistent with OEM operating requirements shall be done.

The technician shall also clean and calibrate the sterilizer systems as recommended by the OEM and according to NIST standards.

• All chemicals/reagents, equipment, parts, travel (and accommodations) and labor shall be included.

• Shall use only OEM made parts or OEM-equivalent certified parts for the service.

4.2 Task 2 – Technical Support

• Shall provide priority technical support during normal business hours, and remote features for troubleshooting and monitoring (if capable, enabled, and needed) for equipment covered under Total Care Connect.

• Priority technical support via internet, phone, or in person shall be provided during the contract period.

• Quick response within four hours by phone, and onsite service within 48 hours.

4.3 Task 3 – Repairs

• Services and repairs shall be provided by (OEM) Factory-trained and certified (or OEM equivalent compliant) engineer/technician and using OEM approved diagnostic tools, for efficient diagnosis and performance.

• Shall cover dispatch charges, travel, labor, accommodations.

• Shall cover parts for equipment covered under Total Care Connect or equivalent.

• Shall use only OEM made parts or OEM-equivalent certified parts for the service.

• Service shall be provided on regular workdays.

• All workmanship shall be warranted for at least sixty (60) days.

5. DELIVERABLES

• Contractor shall provide chemicals/reagents, equipment, and parts needed for maintenance and repair of the instruments.

• Planned maintenance services shall be scheduled during the contract period per OEM recommendations.

• Contractor shall provide service and support for instruments located at the Gulf Coast Seafood Laboratory, 1 Iberville Drive, Dauphin Island, AL 36528.

• Contractor shall provide a signed, detailed report of maintenance and repair, clearly identifying all work performed, delivered as paper copy and/or email in PDF form to COR and Contract

POC.

6. SECURITY

• This position does not require a badge or access to FDA’s network. Contractor needs to provide photo identification for security pass.

• COR/Contract POC/Technical POC will monitor the contractors while on-site.

• A minimum of two (2) days prior to arrival, the contractor shall contact the contract Point of Contact (POC) or Technical Point of Contact (TPOC) to schedule an appointment to visit the system site for any work. Upon arrival, the contractor shall alert security guard on duty, at the gate, with their purpose and a contact name, when visiting the system site. The Contractor shall sign in at the front desk, provide any additional forms or identification required for entry, and obtain a visitor’s pass. When departing, the Contractor shall “check out” with the guard and return the visitor’s pass. The risk level is non-sensitive.

• During the contractor’s visit/appointment, the Contractor shall abide by all policies and procedures in place at the system site.

7. PLACE OF PERFORMANCE

The task shall be performed at FDA GCSL, 1 Iberville Drive, Dauphin Island, AL. Work shall be conducted Monday through Friday, excluding federal holidays. Unless otherwise directed, the Contractor shall adhere to standard work hours, working no more than forty (40) hours per week, and observe all U.S. Government holidays. The on-site Contractor shall maintain continuous service during the hours at the facility identified above.

8. HOLIDAYS AND GOVERNMENT CLOSURES

The Contractor is not required to provide on-site services on the days that are official Federal Holidays.

In the event of inclement weather when the Federal government is closed, the Contractor is not required to provide on-site service. The Contractor is required to follow, as a minimum, other directives issued by the U.S. Office of Personnel Management or other such official for late arrivals due to inclement weather (unless otherwise specified in the Contract).

In the event the Federal Government is closed by order of the President of the United States or the U.S. Office of Personnel Management for any reason, or the agency, the center or the building is closed for administrative or safety reasons, the Contractor shall follow directives issued by responsible officials concerning reporting for work.

The Contractor may not bill the Government for any hours that Contractor employees did not work due to any Government closure (e.g., applicable under a Labor Hour contract).

For on-site support at the FDA facility, unless otherwise directed, the Contractor should adhere to standard work hours, working no more than forty (40) hours per week. If more than 40 hours per week are required, then the hours should be billed at normal rates/straight time. Any necessary overtime shall be authorized in advance by the Contracting Officer.

9. PERIOD OF PERFORMANCE

The contract is a base year of 12 months and four (4) 12-month option periods. The period of performance dates are shown in the contract document.

10. PERSONNEL QUALIFICATIONS

Engineers/Technicians who will be servicing the instrument shall be OEM factory trained and certified (or OEM equivalent compliant)