Ortho-Clinical Diagnostics Inc

The Naval Medical Logistics Command intends to negotiate on a sole source basis (IAWFAR 13.501) with Ortho-Clinical Diagnostics Inc, 100 Indigo Creek Drive Rochester, NY 14626 as the only responsible source that can provide the Maintenance for the Ortho Periodic Maintenance and that meets the requirements of the government. In addition, Only the manufacturer or designer of the equipment is capable of furnishing components or parts that will be compatible with existing equipment. This vendor has ready access to OEM parts and has the premier capability to respond to unscheduled and urgent maintenance requirements with its staff of specially trained technicians. USNS MERCY is on perpetual high alert status to respond to any medical contingency mission and must be ready to sail with full capabilities in just five days. If the contract is awarded to a vendor other than the manufacturer, the vendor may have a difficult time obtaining OEM parts and be unable to complete maintenance in the required timeframe. This could seriously degrade Mercy's ability to carry out its vital mission of saving lives. Regulatory Requirements: The system and all of the components, shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. This acquisition is being conducted under simplified acquisition procedures FAR 13.501 under the authority of the test program for commercial items (section 4202 of the Clinger-Cohen Act of 1996). There are not set-aside restrictions for this requirement. The intended procurement will be classified under North America Industry Classification System (NAICS) 334510 with a Small Business Size Standard of 500. This notice of intent is not a request for competitive proposals and no solicitation document exists for this requirement. However, parties interested in responding to this notice will need to submit technical data, including cost, sufficient to determine capability in providing the same product. All capability statements received by the closing date of this synopsis will be considered by the Government. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. Capability statements shall be submitted by email only as a MS Word or Adobe PDF attachment to Jaime Belletto at [email protected]. Statements are due by 4PM EST 25 March 2010. No phone calls accepted DESCRIPTION/SPECIFICATION/WORK STATEMENT ORTHO-CLINICAL DIAGNOSTICS Statement of work This contract shall provide for preventive maintenance services to Department of Defense owned equipments. It shall include all systems, subsystem components, and assemblies that were part of the original system purchased. All maintenance provisions shall apply to hardware, firmware, and software, as appropriate, unless otherwise stated. 1. General a. The Contractor shall comply with Federal, State, Local laws, and Federal Regulations as applicable to the performance of this contract. b. The Contractor shall not accept any instructions issued by any person employed by the U. S. Government, other than: the Contracting Officer (KO), or Biomedical Engineering Division (BME), all acting within the limits of their authority. 2. Scope of Work a. The Contractor shall provide trained, experienced, English speaking personnel, labor, tools, diagnostic equipment, software, test phantoms, material, supplies, transportation, parts and equipment necessary to perform Preventive Maintenance (PM), Calibration (CAL), Safety testing (ST) and corrective maintenance. b. The Contractor shall provide telephonic communications with the Government to discuss technical matters relating to the performance of this contract. A systems operator will be made available to answer technical questions regarding system operations and applications. c. Equipment listed in this contract will be maintained to meet the original equipment manufacturer's (OEM's) specifications. d. The Contractor Point of Contact (POC). The Contractor shall provide in writing the name and telephone number of a primary and alternate English speaking individual to act as their representative for the scheduling and coordination of service calls, and to be responsible for the coordination of the contract with the Government. 3. Government furnished property, Materials and Services. a. Any equipment found to be inoperable during this preventive maintenance would be repaired using a separate purchase order. The government certifies that the equipment to be maintained under this contract will be in good operating condition on the effective date of this contract. For the purpose of this contract, the clause, "good operating condition" means the conditions necessary for the equipment to function as intended without corrective maintenance. The Contractor agrees to leave the equipment in good operating condition at the expiration of this contract. b. The government will be responsible for maintaining the proper environment, including utilities and site requirements necessary for the system to function properly as specified by the OEM. c. The Government will operate the system in accordance with the instruction manual provided by the OEM. d. The Government will not be responsible for the damage or loss due to fire, theft, accident, or other disaster of Contractor supplies, materials, or for the personal belongings brought onto Government property by Contractor's personnel. 4. Contractor Furnished Property and Material. The Contractor shall provide all service literature, reference publications, laptop computers and diagnostic software to be used by the contractor service technicians and as required for the completion of the services in accordance with this contract. 5. Replacement Parts. a. The Contractor shall have ready access to unique and/or high mortality replacement parts. All parts supplied shall be compatible with the existing system. b. The Contractor shall at their expense, replace all worn or defective parts necessary to restore the equipment to 100% operational condition as specified by the OEM. c. Contractor installed replacement parts shall become the property of the Government and the replaced malfunctioning part shall become the property of the Contractor. d. Freight, postage, and storage charges associated with shipment and receipt of replacement parts, and the return of parts shall be the responsibility of the Contractor. e. The Contractor shall use only new or warranted replacement parts where the quality is equal to or better than the OEM's original part. When discrepancies occur, the Government will make the final determination on whether a replacement part is of equal or better quality. f. The Contractor must include software revisions and upgrades (field service changes) which are required due to FDA or manufacturer announced safety-hazard recall, to include FDA Year 2000 Compliance Directive, as part of the contract at no additional cost to the Government. Specific Tasks. 6. Contractor Report Requirements. a. During normal duty hours, Contracted Field Service Engineer (FSE) personnel shall check-in with the Biomedical Engineering Division upon arrival at the Government site and again prior to departure. The Contractor FSEs shall personally notify Biomedical Engineering (BME) of problems that result in the equipment being left disabled upon their departure. After normal duty hours, Contractor FSEs shall notify the Officer of the Day Desk and the systems operator designated by (BME). b. The Contractor shall provide to (BME) a full service report within two (2) days after completion of all service performed. The service report shall include, but not be limited to: contract number, contractor's log number, detailed description of the service(s) performed, replacement part(s) information (part number, part value, nomenclature, unit price, manufacturer, if not OEM, and whether the part is new/used/reconditioned), the completion date and time, man-hours expended and the hourly rate normally charged for the type of service performed, model and serial numbers, and the name of the FSE performing the service. 7. Contractor Responsibility. The Contractor shall be responsible for the repair/replacement of damaged Government owned equipment and property due to the negligence of the Contractor or his representatives. All such replacement or repair shall be at the Contractor's expense and shall be inspected to the satisfaction of the KO or appointed representative. 8. Preventive Maintenance Services. a. In accordance with Naval Medical Logistics Command (NAVMEDLOGCOM) Risk Assessment Criteria. Preventive maintenance shall be performed during the length of this contract. b. The government reserves the right to change the PM schedule to meet unscheduled operational commitments. c. All test equipment used in the performance of this contract will be within calibration shall be in compliance with Joint Commission on Accreditation of Healthcare Organization (JCAHO), Original Equipment Manufacturer (OEM) and Federal Drug Administration (FDA) standards. 9. Removal of Government Property a. Whenever the repair of equipment cannot be performed at the Government site as determined by the Contractor, the Contractor shall notify (BME) who will make arrangements for the Contractor to remove the item to the Contractor's designated site. The Contractor may be required to sign a Government form accepting responsibility for the Government equipment. b. All charges resulting from a Contractor determined requirement to transport Government owned property, covered by this contract, to and from an alternate repair location shall be the responsibility of the Contractor. 10. Equipment Modification Upgrades a. The Contractor shall only incorporate OEM specified modifications, alterations and upgrades. Approval shall be obtained from (BME) prior to the Contractor installation of any modification, alteration, or upgrades. b. The Contractor shall maintain contact with the OEM to determine the requirement for field modifications and to ensure accomplishment of these modifications in accordance with the time schedule set forth by the OEM. c. The Government shall not alter the system without prior notification to the Contractor. d. The contractor at no additional cost shall provide software upgrade to the Government. Installation of upgrades will be left to the discretion of the Government. 12. Service beyond the Scope of the Contract a. The Contractor shall immediately, but not later than 24 consecutive hours after discovery, notify (BME), in writing, of the existence or the development of any defects in, or repair required to the scheduled equipment which the Contractor considers they are not responsible for under the terms of this contract. b. At the same time of the notification, the Contractor shall furnish (BME) with written estimate of the cost to make the necessary repairs. Repairs considered by the Contracting Officer to be outside the scope of this contract shall not be covered under this contract, but shall be ordered under a separate purchase order.