Service Agreement for Equipment Maintenance Agreement for Spectra Equipment

This is a notice of intent, not a request for quotation. A solicitation document will not be issued and quotations will not be requested. The National Institues of Health, Clinical Center (CC) intends to award a fixed price purchase order to Terumo BCT, Lakewood, CO 80215 on a sole source basis to a proprietary service agreement for Equipment Maintenance Agreement for Spectra Equipment. Terumo BCT, is the only company that manufacturers these instruments. These instruments are used to perform extracorporeal therapy in which the blood of donors or patients is passed through the device to separate out blood components. Numerous regulatory authorities, specifically the Food and Drug Administration (FDA) and American Association of Blood Bank (AABB), set policy and enforce this policy for care and maintenance of equipment that is used in support of donors and patients. This acquisition is being conducted using policies unique to the acquisition of commericial items prescribed in FAR Part 12, in conjunction with the policies and procedures for the competition requirements of Part 6. The notice of intent is not a request for competitive proposals. Interested parties may identify their interest and capabilities in response to this posting. The determination by the Government not to compete the proposed requirement based upon responses to this notice is solely within the discretion of the Government. Comments referencing this posting may be submitted to the Clinical Center, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Andre' Moody, Contract Specialist, moodya@cc.nih.gov by the due date and time marked for closing. STATEMENT OF WORK COBE Spectra Cell Separator The subject contract shall cover maintenance, support and emergency servicing for the 5 COBE Spectra Cell Separator instruments and 4 Spectra Safe Sealers located in the Blood Services Section of the Department of Transfusion of the Clinical Center at NIH. The Preventative maintenance (PM) is required to comply with 21CFR211.67. The Cell separators are used in the collections of peripheral blood stem cells and therapeutic exchanges on patients. It has the ablility to collect granulocytes for use in either the research setting or for therapeutic transfusions. Mononuclear cells can be collected on donors to support reserach for patient. Therapeutic exchanges and cellular collections support patient's undergoing protocols which support our mission of providing high-quality patient care, and hospital services in support of NIH Clinical research programs. Included in this contract will be one regular preventative maintenance visit, emergency servicing, spare/replacement parts, and support for each device. Work to be performed Independently, and not as an agent of the Government, the Contractor shall provide all necessary personnel, supplies and services to perform the work by this contract as set forth in this sections. The contractor shall perform the following: Preventative Maintenance (PM) The contractor shall provide scheduled preventive maitnenance twice in the 12 month period. The PM will be scheduled by a qualified service representative and 30 days in advance of the scheduled due date. Instrumentation Calibration and preventative mainenance each performance assurance inspection will include a complete inspection and calibration of each unit as described in the Preventative Maintenance Section of the current associated equipment Service Manual. Following the performance assurance inspection, the CUSTOMER will be provided with a copy of the completed checklist and a calibration sticker. Emergency Service Emergency serivce visits and repair services to include labor and all replacement parts (except disposables) for the equipement as required, except for any service or replacement parts which COMPANY determines are are required as a result of the CUSTOMER'S failure to used the equipment in accordance with the COMPANY'S Operator Manual. All maintenance will be performed in accordance with establised procedures, as outlined in the current revision of the assoicated service manual. PARTS/SUPPLIES The contractor shall supply all parts and supplies needed for service and maintenance. Labor and Travel The contractor shall provide all labor and travel at no additional cost for the duration of the contract. Emergency Visits The contractor shall provide full service coverage and telephone support to correct all equipment malfunctions. The contract shall respond within 1 hour. The on-site response for emergency should be within 24 hours. Service Calls Request for service has no designation individuals. Any employee assigned to a specific work area, can report a malfunction to one of the devices by calling the 800 number. Contract Duration: October 24, 2014 thru October 23, 2015.