SOLICITATION NOTICE
66 -- HIGH FREQUENCY ULTRASOUND SYSTEM - Package #1
- Notice Date
- 4/4/2013
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA_13-223-SOL-1115929
- Archive Date
- 5/18/2013
- Point of Contact
- Yolanda T. Peer, Phone: 8705437479
- E-Mail Address
-
yolanda.peer@fda.hhs.gov
(yolanda.peer@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Combined Synopsis/Solicitation for a High-Frequency Ultrasound System with three (3) 1-year Post-Warranty Maintenance Option periods. Document Type: Combined Synopsis/Solicitation Solicitation Number: FDA_13-223-SOL-1115929 Posted Date: April 4, 2013 Response Date: May 3, 2013 Set Aside: Full and Open Competition NAICS Code: Small Business Size Standard: 334516 500 Employees Contracting Office Address FDA/OO/OFBA/OAGS/DAP National Center for Toxicological Research (NCTR) 3900 NCTR Road Jefferson, AR 72079 Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6 "Streamlined Procedures for Evaluation and Solicitation for Commercial Items", as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; offers are being requested, and a written solicitation document will not be issued. The Government intends to issue a Purchase Order in accordance with FAR Part 13.106 for the attached requirement using Simplified Acquisition Procedures. This solicitation number is FDA_13-223-SOL-1115929. This solicitation is issued as a Request for Quote (RFQ). Funds are not presently available for this requirement. Award will be subject to it/when appropriated funds are available. The solicitation document and incorporated provisions and clauses are those in effect through the Federal Acquisition Circular FAC 05-66 dated February 28, 2013. The associated North American Industrial Classification System (NAICS) code for this procurement is 334516 - Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 employees. This combined synopsis/solicitation is Full and Open competition. The U.S. Food and Drug Administration (FDA) is seeking quotes that can provide the Center for Biologics Evaluation and Research (CBER) with a High-Frequency Ultrasound System with three (3) 1-year Post-Warranty Maintenance Option periods. Background The High-Frequency Ultra-Sound System will be used to image anatomical and physiological features of small animals used as a model systems for human disease and injury. The system must enable the researcher to obtain in vivo anatomical, functional, physiological and molecular data simultaneously, in real-time and with resolution down to 30 μm. Specifications: High frequency transducers • At least 3 transducers should be included with frequencies ranging from 15 MHz to 55 MHz • Each transducer should have adjustable focus depths • Each high frequency transducer should be able to deliver a usable frame rate of 300-400 frames per second Integrated imaging station • Allows secure positioning of the animal on a heated handling table, which maintains the animal's physiological body temperature and overall physiological function. • Platform should be integrated with an isoflurane-based anesthesia system that can be connected to oxygen or air. Monitoring of physiological function and data • ECG, heart rate, temperature and respiration should be recorded and displayed on the monitor screen alongside the images. This information should be able to be exported and saved. M-Mode • M-Mode imaging should produce quantifiable images to characterize moving anatomy, such as a cardiac wall motion, by selecting a line of the B-Mode image and observing it over time. • Should be able to sample volume size down to 50 microns • M-Mode cine loop with a maximum length of 30 seconds. • Should allow the user to steer the sample volume to any angle they choose. Doppler Mode Capabilities • The equipment should be capable of using Color Doppler Imaging to produce an image of directional flow in blood vessels. The system should overlay colors on the image of the blood vessels to represent the speed and direction of blood flow through the vessels. • In Pulsed-wave Doppler (PW) Mode, the transducer should be able to detect motion and then show the readings on screen in a spectral display. • The sampling rate for PW Doppler should range from 1-2 kHz to 125 kHz; and be able to detect velocities from a few mm/s to approximately 6 m/s. •The sweep speed parameter should be selectable within a range from 0.25 seconds at 4000 Hz to 5.1 seconds at 200 Hz. • 3D Power Doppler Mode will collect Power Doppler data during a 3D-Mode acquisition and be able to reconstruct a 3D volume that is integrated with the surrounding B-Mode 3D volume. 3D Imaging • 3D-Mode imaging should provide tools to create and manipulate three-dimensional renderings and make volumetric measurements of objects viewed with high-resolution ultrasound. • Acquires a series of 2-dimensional "slices" (as small as 10 μm) and assembles them into a 3D data set that can then be visualized and manipulated. • 3D imaging can be used in B-Mode, Power Doppler Mode or Contrast mode imaging procedures. • 3D acquisition functionality allows for precise control of step size, range and slice thickness. This functionality can be integrated with ECG and respiration gating to suppress heart and respiratory artefacts. • Range = # of slices x step size. • Maximum number of 500 slices. • Range: min value = 0.5 mm; max value = 60 mm • Step Size: min value = 0.03175 mm; max value = 0.5 mm; Contrast Imaging • A suite of software analysis and quantification tools should be provided that enables perfusion imaging and targeted/molecular imaging research applications. • Software tools should allow quantification of relative blood volume, blood perfusion and vascular density. • Should be capable of molecular imaging studies: visualization and quantification of endothelial cell markers involved in angiogenesis and inflammation in vivo, in real-time • Should be capable of detecting contrast agents such as microbubbles. Post-processing tool for perfusion and targeted signal analysis • Perfusion parameters are derived from a curve fitting algorithm for both bolus kinetics and replenishment kinetics following destruction reperfusion • Perfusion parameters include a series of calculations for amplitude, time and combination of amplitude and time • Spatial rendering is available in the form of parametric maps • Data can be exported in TIFF, BMP, video files and CSV formats Portability of system • The system should be portable. 3 (1-year Post-Warranty Maintenance Options) • Minimum of one (1) preventative maintenance visit for each coverage period. • Inclusive of all parts, labor, and travel for all Ultrasound equipment including high frequency transducers. • Provide telephone and email-based technical and application support. • Minimum of one (1) year Warranty of System. Award Date: 6/1/2013 Option Year 1: August 31, 2014 through August 30, 2015 Option Year 2: August 31, 2015 through August 30, 2016 Option Year 3: August 31, 2017 through August 30, 2018 Schedule of Items FOB Destination: To be delivered, installed and on-site training no later than 90 calendar days after receipt of order (ARO) FOB Point of Delivery for Services and Supplies will be the FDA/CBER located at 8800 Rockville Pike, Bethesda, MD 20892. Contract Type: Firm Fixed Price Base Period: CLIN DESCRIPTION QTY *UNIT PRICE TOTAL PRICE 0001 High Frequency 1 tiny_mce_marker_______ tiny_mce_marker__________ Ultra Sound System Catalog/Item/Part Number:_____________ **Option Year 1: Post-Warranty Service maintenance agreement for the High Frequency Ultra Sound System (immediately following expiration of warranty) For the Preventive Maintenance (PM) services listed above, the Government will pay the contract the fixed price of tiny_mce_marker______________. **Option Year 2: Post-Warranty Service maintenance agreement for the High Frequency Ultra Sound System (for 1 year following Option Year 1) For the Preventive Maintenance (PM) services listed above, the Government will pay the contract the fixed price of tiny_mce_marker______________. **Option Year 3: Post-Warranty Service maintenance agreement for the High Frequency Ultra Sound System (for 1 year following Option Year 2) For the Preventive Maintenance (PM) services listed above, the Government will pay the contract the fixed price of tiny_mce_marker______________. Total Price, Base Year and Options: tiny_mce_marker____________ *Pricing shall be FOB Destination, inclusive of all shipping, handling, inside delivery, installation, setup, clean-up of area and freight charges. **Proposed price increases beyond Option Year 1 must be explained and supported in the offer. Actual dates will be established once the system is accepted. Place of Performance FDA/CBER 8800 Rockville Pike, Bethesda, MD 20892 Clauses and Provisions: The full text of FAR and HHSAR provisions and clauses may be accessed electronically at http://acquisition.gov/far/index.html or http://www.hhs.gov/policies/hhsar/. CLAUSES FAR 52.212-4 Contract Terms and Conditions-Commercial Items (FEB 2012) The following FAR 52.212-4 addenda apply: FAR 52.204-4 Printed or Copied Double-Sided on Recycled Paper (MAY 2011) FAR 52.204-7 Central Contractor Registration (DEC 2012) FAR 52.217-9 Option to Extend the Term of the Contract (MAR 2000) (a) "...one (1) calendar day of contract expiration;.....30 calendar..." (c) "...three (3) years, exclusive CLIN 0001." HHSAR 352.202-1 Definitions (JAN 2006) HHSAR 352.203-70 Anti-Lobbying (JAN 2006) HHSAR 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (JAN 2010) HHSAR 352.223-70 Safety and Health (JAN 2006) HHSAR 352.231-71 Pricing of Adjustments (JAN 2001) HHSAR 352.242-71 Tobacco-Free Facilities (JAN 2006) The Contractor shall submit one (1) original copy of each invoice to FDA/OC/OA/OFO/OFS, Attn: Division of Payment Services, 3900 NCTR Road, HFT-324, Building 50, 6th floor Suite 616, Jefferson, AR 72079, Fax 870-543-7224. Alternatively, an electronic invoice can be emailed to nctrinvoices@fda.hhs.gov. The Contractor shall submit one (1) original copy of each invoice to FDA/OC/OA/OFO/OFS, Attn: Division of Payment Services, 3900 NCTR Road, HFT-324, Building 50, 6th floor Suite 616, Jefferson, AR 72079, Fax 870-543-7224. Alternatively, an electronic invoice can be emailed to nctrinvoices@fda.hhs.gov. The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) Direct or negotiate any changes in the statement of work; (2) Modify or extend the period of performance; (3) Change the delivery schedule (4) Authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) Otherwise change any terms and conditions of this contract. The Contracting Officer for this order is: XXXXX, Contracting Officer 3900 NCTR Road HFT-320 Jefferson, AR 72079 Phone: (870) 543-XXXX Email: xxxxxx@fda.gov The COR is responsible for: (1) Monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) Interpreting the statement of work and any other technical performance requirements; (3) Performing technical evaluation as required; (4) Performing technical inspections and acceptances required by this contract; and (5) Assisting in the resolution of technical problems encountered during performance. The COR for this order is: to be completed at time of award. Other Terms and Conditions Maintenance and Repair All maintenance and repair activities (including warranty work) shall be accomplished in accordance with the Original Equipment Manufacturer (OEM) specifications. Service Records and Reports The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. In addition, the Contractor shall provide a written report to the FDA COR and Contract Specialist, not later than the 5th work day following the end of each month, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair activities for the previous month; negative reports are required. FAR 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders (AUG 2012) The following FAR 52.212-5(b) clauses apply: 52.203-6 Alt I, 52.204-10, 52.209-6, 52.219-4, 52.219-8, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.222-40, 52.222-51, 52.223-15, 52.223-16, 52.223-18, 52.225-5, 52.225-13, 52.232-33 Clauses and provisions incorporated by reference can be obtained at https://www.acquisition.gov/far/. PROVISIONS The following solicitation provisions apply to this acquisition: FAR 52.212-1 Instruction to Offerors-Commercial Items (FEB 2012) The following FAR 52.212-1 addenda applies: The offeror agrees to hold the prices firm until September 30, 2013. The Defense Priorities and Allocations System (DPAS) and assigned rating are not applicable to this solicitation notice. It is the offeror's responsibility to monitor the internet site for the release of an amendment to the combined synopsis/solicitation (if any). Offerors that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. In accordance with the Debt Collection Improvement Act of 1996, in order to be considered for an award of a Federal contract, the contractor must be registered in the System for Award Management (SAM), a free web site that encompasses the capabilities of the - Central Contractor Registry (CCR); Federal Agency Registration (Fedreg); Online Representations and Certifications Application (ORCA); Excluded Parties List System (EPLS); and the Catalog of Federal Domestic Assistance. The Contractor is responsible for the accuracy and completeness of the data within the SAM database, and for any liability resulting from the Government's reliance on inaccurate or incomplete data. To remain registered in the SAM database after the initial registration, the Contractor is required to review and update on an annual basis from the date of initial registration or subsequent updates its information in the SAM database to ensure it is current, accurate and complete. Updating information in the SAM does not alter the terms and conditions of this contract and is not a substitute for a properly executed contractual document. To access the SAM website go to: https://www.sam.gov/portal/public/SAM/ FAR 52.212-2 Evaluation-Commercial Items (JAN 1999) The provision at FAR 52.212-2 Evaluation-Commercial Items is applicable to this solicitation. The specific evaluation criteria to be included in paragraph (1) of that provision are as follows: The Government will award the purchase order to the responsible offeror whose offer conforming to the solicitation will be the most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: (i) Technical capability of the items/services offered to meet or exceed the Government's requirement (ii) Past Performance (iii) Price Technical and past Performance, when combined, are significantly more important when compared to price in determining the best value to the Government; however, price remains a significant factor. Technical capability will be determined and evaluated by review of information submitted by the offeror, which must provide sufficient technical information necessary for the Government to conclusively determine that the offered instrument and components meet the technical requirements identified above. Offerors shall specifically address the specifications stated above as well as technical specifications, descriptive material, literature, brochures and other information which demonstrates the capabilities of the offeror. Past Performance will be determined and evaluated by the identification of federal, state, local Government, or private contracts for which the offeror has, in the past three (3) years, performed work similar to the requirement for the same brand of instruments. Provide name, telephone number, email address, contract number and description of services with dollar amount. The Government is not responsible for locating or securing any information, which is not identified in the proposal, however the Government reserves the right to obtain information for use in the evaluation from any and all sources including sources outside of the Government. Offeror's shall include the firms DUNS number with quote. Price proposed must be detailed and represent the offeror's response to the schedule of services above. Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). The following FAR 52.212-2 addenda applies: A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. FAR 52.212-3 Offerors Rerepresentations and Certifications-Commercial Items (APR 2012). An offeror shall complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically via http://www.acquisition.gov/. If an offeror has not completed the annual representations and certifications electronically at the ORCA website, the offeror shall complete only paragraphs (c) through (o) of this provision. Addendum to Paragraph (b) (8) Representations and Certifications- In addition to completing the representations and certifications at FAR 52.212-3(b), the Contractor's quote shall also clearly show that the Contractor has selected the appropriate certification under FAR 52.222-48. Note: This solicitation is being issued under the premise that the Contractor will certify that the combination of equipment/service it will propose to fulfill this requirement is exempt from the Service Contract Act per the conditions set forth in FAR 52.222-48 & FAR 22.1003-4(c). If this is the case and the Contractor certifies that is exempt under the terms and conditions of 52.222-48, then clause 52.222-51 will flow per usual from this solicitation to the resulting order. In the event that a Contractor does not make this certification, traditional Service Contract Act clauses 52.222-41, and 52.222-43 shall be included in the resulting order award as well as Wage Determination WD 05-2103 (Rev.-12: http://www.wdol.gov/wdol/scafiles/std/05-2103.txt?v=12 The provision at FAR 52.222-48, Exemption from application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment Certification (Feb 2009), applies to this acquisition: (a) The offeror shall check the following certification: CERTIFICATION The offeror does ___ does not ____ certify that- (1) The items of equipment to be serviced under this contract are used regularly for other than Government purposes, and are sold or traded by the offeror (or subcontractor in the case of an exempt subcontractor) in substantial quantities to the general public in the course of normal business operations; (2) The services will be furnished at prices which are, or are based on, established catalog or market prices for the maintenance, calibration, or repair of equipment. (i) An "established catalog price" is a price included in a catalog, price list, schedule, or other form that is regularly maintained by the manufacturer or the offeror, is either published or otherwise available for inspection by customers, and states prices at which sales currently, or were last, made to a significant number of buyers constituting the general public. (ii) An "established market price" is a current price, established in the usual course of trade between buyers and sellers free to bargain, which can be substantiated from sources independent of the manufacturer or offeror; and (3) The compensation (wage and fringe benefits) plan for all service employees performing work under the contract are the same as that used for these employees and equivalent employees servicing the same equipment of commercial customers. (b) Certification by the offeror as to its compliance with respect to the contract also constitutes its certification as to compliance by its subcontractor if it subcontracts out the exempt services. If the offeror certifies to the conditions in paragraph (a) of this provision, and the Contracting Officer determines in accordance with FAR 22.1003-4(c)(3) that the Service Contract Act- (1) Will not apply to this offeror, then the Service Contract Act of 1965 clause in this solicitation will not be included in any resultant contract to this offeror; or (2) Will apply to this offeror, then the clause at 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements, in this solicitation will not be included in any resultant contract awarded to this offeror, and the offeror may be provided an opportunity to submit a new offer on that basis. (c) If the offeror does not certify to the conditions in paragraph (a) of this provision- (1) The clause in this solicitation at 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements, will not be included in any resultant contract awarded to this offeror; and (2) The offeror shall notify the Contracting Officer as soon as possible, if the Contracting Officer did not attach a Service Contract Act wage determination to the solicitation. (d) The Contracting Officer may not make an award to the offeror, if the offeror fails to execute the certification in paragraph (a) of this provision or to contact the Contracting Officer as required in paragraph (c) of this provision. (End of provision) The offer must reference solicitation FDA_13-223-SOL-1115929. Offers are due in person, by postal mail or email to the point of contact listed below on or before May 3, 2013 by 1:00 PM, (Local Time Jefferson, Arkansas) at the Food and Drug Administration, OO/OFBA/OAGS/DAP, Attn: Yolanda Peer, 3900 NCTR Road, HFT-320, Building 50 - Room 420, Jefferson, AR 72079-9502 or yolanda.peer@fda.hhs.gov. For information regarding this solicitation, please contact Yolanda Peer at yolanda.peer@fda.hhs.gov.
- Web Link
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FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA_13-223-SOL-1115929/listing.html)
- Place of Performance
- Address: FDA/CBER, 8800 Rockville Pike, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03029497-W 20130406/130404235424-82e3abf4f08889b55bb0adc5885d66bb (fbodaily.com)
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