PMA/OQ Agreement for Vantage Liquid Handler System

The Contractor shall be capable of providing both the Service Agreement and Qualification Service for the system specified in the Statement of Work to ensure uninterrupted performance within manufacturer’s specification. Minimum Performance Requirements Preventative Maintenance (PM) & Repair: The Contractor shall provide at least one (1) preventative maintenance inspection (PMI) service visit during each 12-month period of performance for each instrument. The Technical Point of Contact (TPOC) will contact the Contractor to schedule the PMI. All visits will be scheduled by the TPOC at least seven (7) business days in advance. The Preventative Maintenance Service shall be performed in accordance with the specifications contained in the original equipment manufacturer’s service manual. The Preventative Maintenance shall include all consumables, parts, labor, and travel for remedial repair. The Contractor shall obtain all new parts required for all repairs and maintenance which meet the original equipment manufacturer’s specifications at no additional cost to the Government. The Contractor shall repair or replace any part or parts which prove to be defective at no additional charge to the government. The Contractor shall make arrangement for the fastest delivery and will resume work upon receipt of parts within 48 hours or a mutually agreed upon timeframe. The Contractor shall provide documentation of preventative maintenance duties performed. (See Deliverables/ Service Reports) Minimum Performance Requirements Qualification Service The Contractor shall provide Qualification Service after the planned PM and after any other repairs of the system. The Qualification Service shall include Operation Qualification/Performance Verification (OQ/PV). The Contractor shall perform at least one (1) annual OQ/PV for the MicroLab Hamilton VANTAGE Automated Liquid Handling System during the one (1) year period of performance that is equal to or exceeds the qualification requirements of the original equipment manufacturer. The OQ/PV service shall be performed by a qualified engineer. The Contractor shall provide documentation that the system is functioning according to the original equipment manufacturer specifications. The OQ/PV must include all supplies needed to perform the service. Both the OQ/PV shall be scheduled at a date approved by the TPOC or Alternate TPOC. If at any point during the Qualification Service, the system fails a test, the Contractor shall provide onsite service to remedy the failure and re-execute the Qualification Service to demonstrate to the TPOC that the system passed all the Functional Requirements Specification and the system is operating in accordance with OEM specifications. If parts are needed to re-execute the OQ, the Contractor shall schedule delivery of the necessary parts and perform a return service visit within 48 hours or a mutually agreed upon timeframe. Service Calls The Contractor shall respond within two (2) business days after receipt of a service call from the TPOC. The Contractor shall provide unlimited telephone and email access to instrument technical support Monday – Friday between the hours of 9-5 p.m. EST. All repairs must result in the instrument(s) serviced meeting the original manufacturer specifications. All repairs must use factory new replacement parts. The Contractor shall perform a diagnostic test results or narrative summary demonstrating that the instrument is meeting the manufacturer’s specifications. Any parts or components removed for replacement shall be returned to the FDA unless the TPOC approves in writing for the parts or components to be disposed. The Contractor shall remove the parts from the site at the time of the service call or provide shipping instructions and return shipping information so that the FDA may return the parts to the Contractor at no additional cost to the Government, no later than three (3) business days after the service visit is completed. The Contractor shall assume all charges and liability for all shipments. Service Conditions To the maximum extent practicable, service must be rendered on-site at the FDA. The Contractor is responsible for cleanup and removal of all shipping/packing materials at the time of service. Some shipping and packing material cannot be placed in the facility dumpster (e.g. pallets and/or crates) and must be removed by the contractor and at no additional cost to the Government. In the event a part needs to be repaired off-site, the Contractor shall be responsible for all packaging, shipping, and transportation costs as well as liability for the shipment to and from the FDA, 60 8th ST.NE, Atlanta, GA. The Contractor shall be responsible for providing a “Return Authorization Number” or other information authorizing return of the shipment to their facility prior to the shipment. The Contractor shall also provide a shipping account number to pay for the shipment. The Contractor shall only employ tools, parts, instruments, test apparatus, methodologies, techniques, and practices approved for use by Hamilton with the VANTAGE Automated Liquid Handling System. Warranty The Contractor shall provide warranty on all labor, replacement parts and components (excluding consumables) of the system for at least a 12-month period.