SOW_12.17.24.docx

STATEMENT OF WORK

Service Agreement for QIAcube Connect, serial #1435

Background The Atlanta Human and Animal Food Laboratory (ATLHAFL) owns and operates a QIAcube Connect as part of our molecular biology work, especially WGS analysis. This automated equipment can perform DNA and RNA extraction for a variety of protocol and kits. Since this equipment is used for high priority mission critical samples, is extremely important that keeps a valid service agreement. The service agreement, that includes an annual PM, will assure that the system will get prompt repair or service when needed. Without this, the laboratory will be obligated to cover costly repair cost(s). In addition, the laboratory will need to cover the cost of the yearly PM to follow our ISO accreditation reequipments.

Purpose To procure a new service agreement for the QIAcube Connect, serial # 1435. This will ensure that our high priority mission critical work continues without delays, and we follow the ISO1725 requirements.

Scope Contractor shall provide a QIAcube Connect, full repair service agreement. The Contractor shall ensure the agreement fully covers all costs for repairs, labor, and travel.

Salient Characteristics/ Trade and Service Specifications The Contractor shall provide one (1) Full Repair Service Agreement providing coverage of the QIAcube Connect serial number 1435 for a period of one (1) year with options to extend coverage for an additional four (4) years. The Contractor shall ensure the agreement includes:

· The Contractor shall perform an instrument verification to ensure system is operating according to manufacturer’s specification to ensure accuracy and precision of the instrument.

· Service and repair (to include travel, parts, and labor) of all covered incidents within the contract period

· One yearly Preventative Maintenance Inspection

· A certificate of instrument qualification after every preventative maintenance service or repair service.

· Loaner instrument provided if any required services are offsite. The Contractor shall ensure the loaner instrument is an equivalent QIAcube connect system in working order.

· Response to all inquiries within 48 hours/2 business days.

· The Contractor shall ensure all services are conducted by qualified services personnel that have been trained and possess current/valid OEM certification/recertification for reservice and repairs on QIACUBE Connect instruments. The Contractor shall ensure service personnel present qualifications to the Technical Point of Contract during all service calls.

· The Contractor shall ensure all service calls include verification, calibration and repair if needed of:

· Operating temperature

· Accuracy of pipetting system

· Operating System is up to date

· UV lamp

· Centrifuge

· Shaker

· Protocols and kits are up to date Records and Reports The Contractor shall provide a copy of all service records to the TPOC with in 48hr of completion of service. The Contractor shall ensure the records include, at a minimum, a summary of the work performed and certification that the instrument is operating properly.

Deliverables

Shipping Destinations:

Atlanta Human and Animal Food Laboratory (ATLHAFL) Microbiology Branch 60 8th Street NE Atlanta, GA 30309 POC: Will be identified at time of award.

The Contractor shall provide the Contracting Officer’s Representative (COR), and FDA Technical Point of Contact with at least one (1) week’s written notice prior to delivery of services. Contractor shall coordinate with Technical Point of Contact when scheduling services date.

Service shall occur (Monday – Friday) between the times of 8:00 AM – 2:00 PM, excluding Federal holidays or Federal Closures. Federal holidays are listed below, and specific dates can be found at the following site: https://www.opm.gov/policy-data-oversight/pay-leave/pay-administration/fact- sheets/holidays-work-schedules-and-pay:

Independence Day

Security Guest shall check in with Security and be escorted by lab staff. Security background clearance not required as vendor’s employees will not be provided card reader access to the space.

Period of Performance The Period of Performance runs from the date of contract award for a period of one (1) Base Year plus four (4) Option Years.

Base Year: 02/01/2025-01/31/2026 Option 1: 02/01/2026-01/31/2027 Option 2: 02/01/2027-01/31/2028 Option 3: 02/01/2028-01/31/2029 Option 4: 02/01/2029-01/31/2030