SOLICITATION NOTICE
66 -- Stereotactic Radiosurgery and Software
- Notice Date
- 7/17/2008
- Notice Type
- Presolicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd., EPS Suite 600, Rockville, Maryland, 20852
- ZIP Code
- 20852
- Solicitation Number
- NCI-80128-NG
- Archive Date
- 8/12/2008
- Point of Contact
- Malinda L Holdcraft,, Phone: (301) 402-4509, Caren N Rasmussen,, Phone: (301) 402-4509
- E-Mail Address
-
holdcram@exchange.nih.gov, cr214i@nih.gov
- Small Business Set-Aside
- N/A
- Description
- The National Cancer Institute (NCI) plans to procure as a sole source a Maintenance Agreement for Stereotactic Radiosurgery and Software with Integra LifeSciences Corporation, 311Enterprise Drive, Plainsboro NJ 08536 This acquisition will be conducted under the procedures for acquiring commercial items authorized in FAR Part 12 and under the authority to use simplified procedures for commercial requirements as provided in FAR 13.501. The North American Industry Classification System code is 811219 and the business size standard is $6.5M. Period of Performance shall be for twelve (12) months from date of award with two (2) one (1) year options. Only one (1) award will be made as a result of this solicitation. Contractor shall provide: 1) one (1) annual on-site preventive maintenance inspection for the Sterotactic Radiosurgery hardware; 2) unlimited emergency repair within twenty-four (24) hours of first call; 3) furnish all required replacement parts with the exception of consumable parts at no additional cost to the Government; and 4) provide free software upgrades. Contractor personnel shall have a minimum of two (2) years specialized factory training within the last five (5) years in order to perform service to these instruments. Contractor shall provide current software updates. Justification: The Radiation Oncology Branch, CCR, NCI treats cancer patients with complex distributions of high-energy x-rays. The most demanding of these treatments is stereotactic radiosurgery/radiotherapy, which requires positioning the patient and delivering treatments with sub-millimeter accuracy. This treatment requires custom fabricated applicators, applicator mounts, patient alignment and positioning devices and quality assurance equipment. It also requires a specialized treatment planning system utilizing proprietary software. The system (hardware and software) constitutes a medical device, which is regulated by the FDA. Integra LifeSciences Corporation is the Original Equipment Manufacturer (OEM) of the XKnife radiosurgery hardware, as well as the developer of the specialized treatment planning software, such as XKnife RT and ImageFusion. ROB requires a service contract on this equipment to provide for rapid response, emergency repair, periodic quality assurance of mechanical components to ensure that they are within tolerances, software updates and support in cases where unforeseen complications arise in clinical treatment planning. The system requires periodic and emergency maintenance to ensure the accuracy of treatment delivery, as well as periodic software updates containing product improvements and correcting any deficiencies. Integra LifeSciences Corporation is the only source known to the NCI which has proprietary rights of the hardware and software. Statutory Authority Statute: This justification has been prepared under the authority of 41 U.S.C. 253 (c)(1) as set forth in 13.106-1 (b)(2) and 13.501(a)(1). (b) Soliciting from a single source. (2) For sole source acquisitions of commercial items in excess of the simplified acquisition threshold conducted pursuant to subpart 13.5, the requirements at 13.501(a) apply. Integra LifeSciences Corporation is the OEM of the stereotactic radiosurgery system currently in clinical use by ROB. This includes patented treatment hardware and copyrighted software. The hardware and software have received 510K approval by the FDA as a medical device. Sole-source acquisition of this service contract is requested to maintain operability of this vital, mission critical equipment. This notice is not a request for competitive quotation. However, if any interested party believes it can meet the above requirement, it may submit a statement of capabilities. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. No faxed or emailed capability statements will be accepted. Contractor shall provide one (1) original and one (1) copy of the capability statement. Capability statements must be received in the contracting office by 11:00 AM ET, by July 28, 2008. All questions must be in writing and can be faxed or emailed to: Malinda Holdcraft, Contract Specialist via electronic mail at holdcram@exchange.mail.gov or fax to 301-402-4513. It is the vendors’ responsibility to ensure all questions have been received in the contracting office. A determination by the Government not to compete this proposed requirement based upon 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. No collect calls will be accepted. In order to receive an award, contractors must be registered and have valid certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA). Reference: NCI-80128-NG on all correspondence.
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- Record
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