MODIFICATION
66 -- Dual Energy CT Scanner
- Notice Date
- 6/2/2016
- Notice Type
- Modification/Amendment
- NAICS
- 334510
— Electromedical and Electrotherapeutic Apparatus Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-SS-1162671
- Archive Date
- 6/24/2016
- Point of Contact
- Heather Kinsey, Phone: 2404027591
- E-Mail Address
-
heather.kinsey@fda.hhs.gov
(heather.kinsey@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- General Information: Document Type: Sources Sought - FDA-SS-1162671 Release Date: May 23, 2016 Response Date: June 3,2016 at 12:00pm EST via email to Heather.Kinsey@fda.hhs.gov Contracting Office Address: Food and Drug Administration, 5630 Fisher Lane, Rockville, Maryland 20857; Attn: Heather Kinsey, Contract Specialist Description of Services/Supplies: Dual-Energy Multi-Slice Helical CT Scanner, plus control workstation, image reconstruction, analysis software and service support CONTRACTING OFFICE U.S. Department of Health and Human Services (DHHS) Food and Drug Administration Agency (FDA) / Office of Acquisitions and Grants Services (OAGS) DESCRIPTION This is a SOURCES SOUGHT NOTICE to determine the availability and capability of small businesses (including certified 8(a), Small Disadvantaged, and HUBZone firms; veteran and service-disabled veteran-owned small businesses, and women-owned small businesses) for the purchase of a Dual-Energy Multi-Slice Helical CT Scanner. The Contractor's capability statement shall demonstrate the company's ability to meet the following requirement. Please provide a detailed description of your company's (including its teammates, if applicable) experience and demonstrated abilities to deliver the following: SOW (Statement of Work) The Contractor shall provide the following: The proposed work under this contract shall include the site design, installation, set up, and maintenance of a dual-energy multi-slice spiral CT imaging system and control workstation at the FDA White Oak campus (Bldg. 62) in Silver Spring, MD. User training and instruction materials shall be provided. System Requirements • Dual-energy capability enabling the possibility to acquire two spiral CT data sets with diverse information in the range spanning 80 to 140 kV at the same or nearly the same time. • Dose management software that assesses and documents dose values per scan, scan type, and object scanned. • Automatic exposure control to minimize dose in animal and phantom scans. • Partial scanning capability for evaluation of reduced-exposure protocols. • Data visualization software with generation of axial, sagittal, coronal planes. • Image analysis software for determination of CT number, volumetric analyses, and quantitative tissue characterization. • Slice thickness of 0.625 mm or less. • Rotation time of at least 0.5 sec or better • At least 6 cm coverage per rotation at isocenter. • At least 64 detector rows. • Volume coverage of at least 400 mm/s • Patient table with up to 200 cm scan range. • Bore diameter of at least 78 cm. • Isotropic spatial resolution of 0.5 mm or better. • Physiologic monitoring capable, including ECG-controlled or gated acquisition. • Uninterruptible power supply to protect CT system from power interruption during image acquisition. THE SPECS ABOVE ARE NOT FINAL; SOME ADJUSTMENTS MAY BE MADE PRIOR TO ANNOUNCEMENT PENDING INPUT FROM ALL STAKEHOLDERS. Design Phase - The Design Phase seeks to develop detailed plans for installation of the new CT scanner on the FDA White Oak campus (Bldg. 62), including attention to all necessary considerations related to shielding, x-ray tube cooling and power needs of the scanner. A formal review of the high-level architectural design will be conducted prior to a detailed design of the facilities/system to achieve confidence that the design satisfies the system requirements, is in conformance with any occupational or design standards, to raise and resolve any critical technical and/or project-related issues, and to identify and mitigate project, technical, security, and/or business risks affecting continued detailed design and subsequent activities. During the Design Phase, the development of an initial strategy for necessary training of FDA staff on the operation of the CT imaging system is also begun. Estimates of project expenses are updated to reflect actual costs and estimates for future phases. In addition, the work planned for future phases is redefined, if necessary, based on information acquired during the Design Phase. Installation Phase - During the Installation Phase, the contractor takes the detailed information documented in the previous phase to install the new dual-energy CT scanner. As necessary and appropriate, CT scanner system hardware, CT workstation hardware, networking and telecommunications equipment, and image reconstruction/processing/analysis/visualization/transfer software is installed and configured. Test scans are performed and images are analyzed to verify proper functioning of the installed equipment. Training plans are actualized and user procedures are laid out via instruction manuals. The Installation Phase ends with a Project Advisory Group (PAG) Review to determine if the system is up and running as specified. Maintenance Phase - The contractor shall provide twice-yearly preventive maintenance by contractor service engineers to assure that all relevant components are inspected and tuned to maintain continuous functionality. In the event of an x-ray tube failure, the system is repaired and operation restored. As software updates are made available they are downloaded and installed. Testing • CT number accuracy and uniformity, • temporal and spatial resolution, • noise, • slice thickness, • collimation, • physiological monitoring and gating, • spectral performance • image quality. Deliverables Specific Tasks The Contractor shall provide all necessary labor required to complete the tasks issued by the FDA in support of this contract. The Contractor shall deliver, install, and make operational the CT scanner system and conduct a successful physics testing stage to demonstrate that the system is functioning to specification. At a minimum the contractor shall perform these tasks: • Perform a site review to determine facilities requirements for installation of new CT scanner. • Work with the Contracting Officer Representative (COR) and government staff in the verification and approval of the system installation plan. • After system installation plan is approved, install the new CT scanner according to the agreed-upon system installation plan. • Complete a successful physics evaluation and PAG data review to demonstrate the full operation of the installed CT system according to performance specifications. • Draft User Manual, Training Plan and Preventive Maintenance Plan as directed by the COR. • Work with the COR and government staff in the verification and approval of the user training and maintenance plans. • Train users and provide user training materials. • Coordinate the appropriate resources on the project and coordinate task planning and execution. • Maintain system in operational status through twice-yearly preventive maintenance and software updates. • Repair or replace x-ray tube in the event of x-ray tube failure. Phase Gate Review Phase Gate Reviews are required at the end of each phase to provide for independent review and approval of key elements of the project's phases. Phase Gate Reviews consist of an independent confirmation by the PAG that all documents and contract deliverables are satisfactorily produced and adequately meet all exit criteria for the phase to permit advancement to the next phase. The contractor shall be required to produce all required documentation and perform all activities necessary to complete the phase. In addition, the contractor shall be responsible for providing documentation of known issues and plans to mitigate the risks, if any, and facilitate the preparation and execution of the phase. The emphasis of Phase Gate Reviews is on: • The successful accomplishment of the phase objectives. • The plans for the next phase. • The risks associated with moving into the next phase. Phase Gate Reviews also address the availability of resources to execute the subsequent phases. The results of the review by the PAG are provided with recommended action to the CO and COTR for decision. Period of performance The Period of Performance for this contract and its tasks shall be 6 months from the onset of the contract. Location The contractor will be required to interact with FDA staff in multiple locations in the Silver Spring, Maryland area. Work is to be performed at the contractor's facilities and the FDA White Oak campus in Silver Spring, MD. Staffing The Contractor is responsible for obtaining the management, technical and subject matter expertise required to accomplish the activities and prepare the deliverables identified in this Statement of Work. Security and Privacy • Contractor personnel performing work under this contract shall satisfy all requirements for appropriate security eligibility in dealing with access to FDA facilities, information and information systems. • The contractor agrees that contractor personnel will not divulge or release data or information developed or obtained in connection with the performance of the resulting contract, unless made public by FDA or upon written approval of the Government. Responses to this notice shall be limited to 5 pages, and must include: 1. Company name, mailing address, e-mail address, telephone and FAX numbers, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives. 2. Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated capabilities identified in the responses. 3. Business size for NAICS 334510 (size standard of 500 employees) and status, if qualified as an 8(a) firm (must be certified by SBA), Small Disadvantaged Business (must be certified by SBA), Woman-Owned Small Business, HUBZone firm (must be certified by SBA), and/or Service-Disabled Veteran-Owned Small Business (must be listed in the VetBiz Vendor Information Pages). 4. DUNS number, CAGE Code, Tax Identification Number, and company structure (Corporation, LLC, partnership, joint venture, etc.). Companies also must be registered in the System for Award Management (SAM) to be considered as potential sources. 5. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and contract number and SINs that are applicable to this potential requirement are also requested. 6. If the company has a Government approved accounting system, please identify the agency that approved the system. 7. Evidence of experience in work similar in type and scope to include contract numbers, project titles, dollar amounts, points of contact and telephone numbers 8. Past performance references with points of contact and telephone numbers. At least three references are requested. Please submit copies of any documentation such as letters or certificates to indicate the firm's status (see item #3, above). Teaming arrangements are acceptable, and the information required above on the company responding to this announcement, should also be provided for each entity expected to be teammates of the respondent for performance of this work. To the maximum extent possible, please submit non-proprietary information. Any proprietary information submitted should be identified as such and will be properly protected from disclosure. This notice is for planning purposes only, and does not constitute an Invitation for Bids, Request for Proposals, Solicitation, Request for Quotes, or an indication the Government will contract for the items contained in this announcement. This request is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this request. The Government will not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this announcement. Responses to this notice must be received via email to Contract Specialist Heather Kinsey at Heather Kisney@fda.hhs.gov no later than 12:00 PM Eastern time on Friday June 3, 2016 for consideration. Responses to this announcement will not be returned, nor any ensuing discussions or debriefings of any responses. However, information obtained as a result of this announcement may be reflected in the subsequent solicitation, and the FDA may contact one or more respondents for clarifications and to enhance the Governments understanding. This announcement is Government market research, and may result in revisions in both its requirements and its acquisition strategy based on industry responses.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SS-1162671/listing.html)
- Place of Performance
- Address: Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN04136848-W 20160604/160602235222-63f2d921a4b74e0331ad406042e7a4b8 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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