SOLICITATION NOTICE
66 -- High Frequency Ultrasound System
- Notice Date
- 4/12/2012
- Notice Type
- Combined Synopsis/Solicitation
- 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, Bldg 50 Room 422, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- 1100737
- Archive Date
- 5/8/2012
- Point of Contact
- Nicholas E Sartain, Phone: 870-543-7370
- E-Mail Address
-
nick.sartain@fda.hhs.gov
(nick.sartain@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number is 1100737. This solicitation is issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-56 dated April 2, 2012. Funds are not presently available for this requirement. Award will be subject to if/when appropriated funds are available. The associated North American Industry Classification System (NAICS) Code is- 334510- Electromedical and Electrotherapeutic Apparatus Manufacturing; Small Business Size Standard is 500 employees and is issued as full and open competition. The U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) requires a high frequency ultrasound system with post-warranty service/maintenance options inclusive of all parts, labor and travel for the entire system. The High-Frequency Ultrasound System will be used to image anatomical and physiological features of small animals used as model systems for human disease and injury. The high frequency ultrasound system should enable the researcher to obtain in vivo anatomical, functional, physiological and molecular data simultaneously, in real-time and with resolution down to 30 μm. High frequency transducers • Transducers shall be included capable of frequencies ranging from 15 MHz to 55 MHz • Adjustable focus depths for each transducer. • 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 (rats and mice) on a heated handling table, which maintains the animal's physiological body temperature and overall physiological function. • Integrated platform 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. • ECG and Respiration gating can be controlled by the user. 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 • Should allow the user to steer the sample volume to any angle the user chooses. 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. Targets (for example, tumor growth) can be segmented and volumetric measurements made. • 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 errors. • Range = # of slices x step size. • Maximum number of 500 slices. 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 from one room or lab to another. Post-Warranty Service Agreement The service agreement shall include, at a minimum, the following: • Four (4) 1-year option periods • Minimum of one (1) Preventative Maintenance visit per contract year; • Unlimited on-site preventative maintenance, services, and repairs; • Unlimited Priority Telephone and Email Support; • Peak performance maintenance kits; • Software updates; • Preventative maintenance, services, and repairs performed by an OEM trained and certified technician; • Preventative maintenance, services, and repairs include all labor, travel, and new OEM factory-certified replacement parts, components, subassemblies, etc. (except consumables); • Phone support available from 8am to 5pm Eastern Time, Monday through Friday; • Priority scheduling for requests for service within 24 hrs; and • Absolute adherence to and conformity with OEM specifications, manuals, bulletins, etc. in performing all preventative maintenance, services, and repairs • Service Records and Reports The Contractor shall, commensurate with the completion of each service call or preventative maintenance visit, 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 monthly reports to the FDA COR and Contract Specialist, not later that the 5th work day following the end of each month, summarizing all maintenance and repair activities for the previous month; negative reports are required. FOB Point 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. Payment terms net 30 days after government acceptance of the instrument. Period of Performance Note: Service period start/end dates is dependent on delivery, installation, on-site training and acceptance of the instrument. The estimated date could potentially be as follows: Award of contract- 6/1/12 Instrument delivered, installed, and on-site training conducted and accepted- 90 calendar days ARO 8/30/12. Initial 1-year warranty (minimum) ends on 8/29/13. Option year 1: August 30, 2013 through August 29, 2014. Option year 2: August 30, 2014 through August 29, 2015. Option year 3: August 30, 2015 through August 29, 2016. Option year 4: August 30, 2016 through August 29, 2017. Preventative maintenance and repair visits shall not be scheduled during Federal Holidays or Federal Closures as determined by Executive Orders or WWW.OPM.GOV. Federal holidays are as follows: New Year's Day Martin Luther King, Jr. Washington's Birthday Memorial Day Independence Day Labor Day Columbus Day Veteran's Day Thanksgiving Day Christmas Day Schedule of Items: 1. High Frequency Ultrasound System which includes inside delivery, installation, on-site training as specified above, and a minimum of one year warranty for the fixed price of $____________. 2. Option Year 1:- Service maintenance agreement as described above for the aforementioned High Frequency Ultrasound System. For the service agreement services that the Contractor shall provide, the Government will pay the contractor the fixed price of $___________. 3. Option Year 2:- Service maintenance agreement as described above for the aforementioned High Frequency Ultrasound System. For the service agreement services that the Contractor shall provide, the Government will pay the contractor the fixed price of $___________. 4. Option Year 3:- Service maintenance agreement as described above for the aforementioned High Frequency Ultrasound System. For the service agreement services that the Contractor shall provide, the Government will pay the contractor the fixed price of $___________. 5. Option Year 4:- Service maintenance agreement as described above for the aforementioned High Frequency Ultrasound System. For the service agreement services that the Contractor shall provide, the Government will pay the contractor the fixed price of $___________. Contract clauses- The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (FEB 2012), applies to this acquisition. The following addenda have been added to the clause. The following FAR and HHSAR clauses, incorporated by reference, and apply to this acquisition. FAR Clause 52.204-4 Printed or Copied Double-Sided on Recycled Paper.(MAY 2011) FAR Clause 52.204-7 Central Contractor Registration. (FEB 2012) FAR Clause 52.225-8 Duty-Free Entry. (OCT 2010) FAR Clause 52.217-9 Option to Extend the Term of the Contract (MAR 2000) (a)... within 1 day of contract expiration;.... at least 15 days before the contract expires... (c)...shall not exceed the time stated in the schedule. HHSAR Clause 352.202-1 Definitions JAN 2006 HHSAR Clause 352.203-70 Anti-Lobbying JAN 2006 HHSAR Clause 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations OCT 2009 HHSAR Clause 352.223-70 Safety and Health JAN 2006 HHSAR Clause 352.231-71 Pricing of Adjustments JAN 2001 HHSAR Clause 352.242-71 Tobacco-Free Facilities JAN 2006 The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the contracting officer's representative (COR) specified at award. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the contracting officer. Contract Administration a. Contracting Officer/Contract Administrator Nick Sartain, Contracting Officer 3900 NCTR Road HFT-320 Jefferson, AR 72079 Phone: 870-543-7370 Email: nick.sartain@fda.hhs.gov b. Contractor's Point of Contact (To be completed at time of award) Phone: Email: c. Technical Point of Contact-Contracting Officer's Representative The following COR will represent the Government for the purpose of this contact: (To be completed at time of award) Name: Phone: Email: 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 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. Invoice Submission Invoices shall be submitted to the attention of the designated Contract Specialist identified below and contain all necessary information per FAR 52.212-4 (g) in accordance with the following instructions. I. An original and two (2) copies shall be submitted to: Food and Drug Administration Nick Sartain 3900 NCTR Road Building 50, Room 422 Jefferson, AR 72079 Or electrically at nick.sartain@fda.hhs.gov II. One copy to the Contracting Officer Representative (COR) or other program center/office designee, clearly marked "courtesy copy only: To be completed at time of award. The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statues or Executive Orders-Commercial Items (APR 2012) applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: 52.203-6 alt I, 204-10, 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, and 52.232-33. Solicitation provisions Contract Type: Commercial Item-Firm Fixed Price. The provision at FAR 52.212-1 Instructions to Offerors-Commercial Items (FEB 2012) applies to this solicitation. The following addenda have been added to this provision: Addendum Paragraph (c) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm until September 30, 2012. The provision at FAR 52.212-2 Evaluation-Commercial Items is applicable to this solicitation. The specific evaluation criteria to be included in paragraph (a) of that provision are as follows: The Government will award a contract resulting from this solicitation 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 quotes: (i) Technical capability of the items/services offered to meet or exceed the Government's requirement. (ii) Recency and Relevance of 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 and must be affordable. Technical capability will be determined 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 Identify 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. Include the firms DUNS number with quote. (b) 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). (c) 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. The government reserves the right to make an award without discussions. The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (APR 2012), applies to this acquisition. An offeror should complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at http://orca.bpn.gov. One or more of the items under this acquisition is subject to the World Trade Organization Government Procurement Agreement and Free Trade Agreements. FAR and HHSAR Clauses and Provisions incorporated by reference may be obtained at: FAR: https://www.acquisition.gov/far/ HHSAR: http://www.dhhs.gov/asfr/ogapa/acquisition/acquisitionpolicies.html It is the offeror's responsibility to monitor FedBizOpps.Gov for the release of any information related to this acquisition, e.g., questions and answers, amendments, award notice, etc. Offerors that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. All responsible sources may submit an offer, which if timely received, shall be considered. The offer must reference solicitation number 1100737. The offers are due in person, by postal mail or email to the point of contact listed below on or before April 23, 2012 by 13:00 hours (Central Standard Time in Jefferson, Arkansas) at the Food and Drug Administration, FDA/OO/OFBA/OAGS/DAP, Attn: Nick Sartain, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502. For information regarding this solicitation, please contact Nick Sartain at (870) 543-7370, FAX (870) 543-7990 or email nick.sartain@fda.hhs.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/1100737/listing.html)
- Place of Performance
- Address: 8800 Rockville Pike, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02720921-W 20120414/120412235741-90d872ed13fefe759f99845c7c3b0ff6 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |