SOLICITATION NOTICE
66 -- Positioning tracking system
- Notice Date
- 4/11/2008
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 811219
— Other Electronic and Precision Equipment Repair and Maintenance
- 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-sol-08-1041652
- Response Due
- 4/25/2008
- Point of Contact
- Dominique H Malone, Phone: (301) 827-7227, Leonard D Grant,, Phone: (301) 827-7173
- E-Mail Address
-
dominique.malone@fda.hhs.gov, leonard.grant@fda.hhs.gov
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in 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; a written solicitation document will not be issued. This solicitation is being issued using simplified acquisition procedures. This solicitation is a request for quotation (RFQ). The associated North American Industrial Classification System (NAICS) Code for this procurement is 811219. Food and Drug Administration intends to award a competitive purchase order for a positioning track system. The system is needed for is Food and Drug Administration/Center for Devices and Radiological Health/ Office of Science and Engineering Laboratories/ Ionizing Radiation Measurements Laboratory (FDA/CDRH/OSEL/IRML). A) General Description: A positioning track system is needed for a 320 kV X-ray unit that is used for calibrating radiation monitors for the FDA NVLAP accredited X-ray Calibration Laboratory. B) General Requirements The following Computer Control System and Hardware is needed to interface with an existing FDA 320 kVp Diagnostic X-ray System: 1) Positioning System: (controlled by Computer control system) Computer Controlled 3 Axis positioning system used to position a 0.9 x 0.5 meter platform with an accuracy of ≤ ± 1 mm with a platform load of 100kg. The platform will hold ion chambers, phantoms, or survey meters to insure optimal centering and variability for setup in useful x-ray beam. X-Axis: ~9 meters long and parallel to X-Ray beam through out the full length of travel. (The X-Axis must allow personnel easy access and maneuverability around the track for moving around the room) Y-Axis: 90 cm meter travel, horizontal and perpendicular to X-Ray beam Z-Axis: ~30cm travel, vertical and perpendicular to the X-Ray beam 2) Collimator (aperture) positioning and Filter positioning systems: (Controlled by Computer control system) The Collimator and Filter positioning systems are separate components, but because they both need to be located to insure good beam geometry they are listed together. The Collimator positioning system needs to be located to insure good beam geometry for the filter positioning system, the transmission monitor, and the survey meter or ion chamber. The beam must be collimated enough so that it does not interact with the Filter positioning holder by only hitting the filter material pack. The Vendor can manufacture the Collimator and Filter positioning system as a unit, but they must work independently. Components for the control system include, but may not necessarily be limited to the following: Computer control Collimator positioning system that position ~6 separate lead collimators with apertures diameters of 6, 5, 4, 3, 2, 1cm. Must be easy for FDA personnel to install different apertures, or an alternative that will allow flexibility of optimizing good beam geometry for Computer controlled Filter positioning system that positions ~10 separate filters, and allows easily switching of groups of filters. Vender will need to modify FDAs existing 100 mm square filters to fit in vendor provided filter positioning system. A filter shelf will also be needed for mounting additional filters Bracket that will allow (FDA provided) transmission monitor to be mounted after the beam has exited the filter. 3) Laser alignment system that defines the following: a) the source to probe distance for a point that is defined at the center of the platform cart b) additional variable distance laser that defines a point up to 5 cm in front of the platform cart c) reference center of x-ray beam both vertically and horizontally 4) Computer control system: The control system is focused in the following areas: Equipment communication and positioning set up Ion chamber calibration Exposure rate calculation kVp, mA, and exposure time control Reading of the electrometer Statistical quality control monitoring so that limits of variability for selected or historical parameters are not exceeded Automated calibration report generation for individual test instruments Vendor shall adapt their control system software to FDAs existing techniques and procedures. FDA has ownership and all rights to access and modify any source code that controls the X-Ray calibration system. Adequate documentation will be provided to verify that all requirements are met. The final product will meet ADA requirements. The control system program must be modular in design, allowing for easy modifications to the system. C) Detailed Description 1) Positioning System The 320KV X-Ray beam centerline is 1.65 meter above and parallel to the floor. The Positioning System shall facilitate mounting and positioning instruments and phantoms in a stable, repeatable (±1mm) fashion in the center of the X-Ray beam. The system must be level and sturdy for the entire travel length, to insure positioning reproducibility for all axes. The positioning system needs to hold 100kg without significant deflection and have a minimum of backlash and side-play. The mounting platform needs to be a flat plate with an alignment grid engraved (1 cm grid). Mounting holes that are Ό-20 SAE drilled and tapped in the plate in 10 cm intervals (starting 5 cm from the platforms edge) to allow jigs to be bolted to the platform. Platform size needs to be approximately ~ 90 cm x 50 cm. The Platform will need to support the 100kg without deflection. The positioning track shall be configured as a three axis system with a positioning accuracy of ± 1 mm designed primarily for positioning ion chambers for calibration. Each axis shall be operated via computer control from the control console and jog switches on the Positioning System (jog switches will be located on the right side of the Y-Axis assembly). (Note: The right side is from the perspective of the 320 kV X-Ray tube). Each axis will include a metric scale with an applicable axis pointer to manually confirm positioning. The X-Axis scale will need to be referenced to the Focal Spot of the X-Ray tube. Because the Positioning Track System will move up to 8.5 meters (X-Axis) and 0.9 meter (Y-Axis), a method for controlling the cables (data/control/signal/power) will be required. The cable management system must allow FDA personnel to easily add and/or remove cables as needed. Note: Not required but would be nice: the use of Absolute Encoders in the positioning circuit, so the positioning system would not have to seek a home (reference) switch with the loss of power. X-Axis: The X-Axis needs to allow the travel of the Y-Axis up to 8.5 meters away from the X-Ray source. Because the X-Axis travel utilizes most of the length of the room, the design must allowing easy personnel maneuverability. One Example that would work is tracks/rail that is mounted close to the floor (≤15cm). The system must be level, sturdy, and centered to the useful beam for the entire length of travel, to insure positioning reproducibility and good beam geometry without having to readjust the y or z axis and by only changing collimation. The system will need to be aligned to keep the platform precisely leveled with the beam centerline. Overall track/rail length will be 9 meters; allowing 8.5 meters of Y-Axis (platform) positioning travel. This also allows space for the x-ray cabinet at one end. The Y-axis moves along the X-axis and is controlled via computer control from the control console and jog switches located on the right side of the Y-Axis frame. The X-Axis positioning accuracy needs to be ≤ ± 1 mm (referenced from the X-Ray tube focal Spot). Y-Axis: The Y-Axis is a framework that moves on the X-Axis and is designed to places the Y-axis system (track/rails) approximately 40cm under the beam centerline. The Z-Axis platform is mounted to the Y-Axis system (tracks/rails). The Y-axis is ~2m long. The platform size shall be 0.9 m x 0.5 m. The Y-axis travel must provide adequate travel so that any part of the (Z-Axis) 0.9 m wide platform can be placed in the beam centerline. The bottom of the Y-Axis framework will have a shelf with minimum of 30cm vertical clearance. Located near the shelf will be 115 VAC 60 Hz 15A outlet or power strip connected to building power/outlet. The right side of the Y-Axis framework will include a method for mounting alignment Laser(s) to position the laser light horizontal and perpendicular to the X-Ray beam center line (~1.65 meters from the floor). (Note: The right side is from the perspective of the 320 kV X-Ray tube). The lasers will need to be able to be positioned up to 5cm in front of the platform and mark the full 40cm depth of the platform. The Y-Axis movement is controlled via computer control from the control console and jog switch located on the right side of the Y-Axis frame. The Y-Axis positioning accuracy needs to be ≤ ± 1 mm to accurately indicate the distance from the referenced X-Ray source to the reference spot on the platform). Z-Axis: The Z-Axis moves on the Y-Axis rails and is positioned so that with the Z-Axis fully raised, will position the Platform 10cm below the X-Ray beam center line. With the Z-Axis fully lowered, it will position the Platform 40cm below the X-Ray beam center line. The vertical axis provides 30 cm of vertical movement for the Platform. Z-axis is controlled via computer control from the control console and jog switch located on the right side of the Y-Axis frame. The Z-Axis positioning accuracy needs to be ≤ ± 1 mm (referenced to the X-Ray beam horizontal center line) 2) Collimator (aperture) positioning and Filter positioning systems: (Controlled by Computer control system) Collimator (aperture) positioning system: The Collimator (Aperture) assembly must be designed to modify the beam diameter of the X-ray beam to provide good beam geometry for the various beam configurations required for calibrating and testing ion chambers, radiation monitors, survey meters, and phantoms. The computer controlled collimator positioning system positions ~6 separate lead collimators for energies up to 300 kV with apertures diameters of 6, 5, 4, 3, 2, 1cm with a minimum positioning accuracy of ±1 mm. Individual apertures must be easy for FDA personnel to replace with different apertures. Filter positioning system: The filer is used to modify the spectral characteristics of the X-ray beam to meet the various beam codes required for calibrating instruments. The Computer controlled Filter positioning system positions the approximate center of the filter material in the center of the X-Ray beam. Filter thickness ranging from 0.1mm to 15mm in thickness. We are looking for a system that will position at least 10 filters and will allow easy switching of all ten 10 filters. Example: disk with 10 filter, remove current disk and insert separate disk with 10 different filters. Vender will need to modify FDAs existing 100 mm square filters to fit in vendor provided filter positioning system. Note: After a filter is positioned, only the filter material shall be in the X-Ray beam path. None of the positioning system or material used to secure the filter material can be in the X-Ray beam path. (~7 cm diameter clearance is required) 3) Laser alignment system: (self leveling) Allows technicians to determine the following: Fixed Cross hair laser, assist technician to position instrument on the platform Movable Cross hair laser that defines a point up to 5 cm in front of the platform Two line lasers that form a cross hair down the center of the X-Ray beam path. (Located on or near the filter positioning system) 1st line laser to the side of X-Ray beam, mounted so the laser line is horizontal and down the center of the X-Ray beam path, this will indicate the X-Ray beams vertical center (~1.65 meters) 2nd line laser above or below the X-Ray beam, mounted so the laser line is vertical and down the center of the X-Ray beam path, this will indicate the X-Ray beams horizontal center 4) Description of Control System The vendor shall provide a rack mounted state of the art computer with necessary software and hardware to run the control system and program. Vendor shall interface their software to FDAs existing techniques and procedures. The control software is powerful yet designed to be simple to use. The core program shall be a PC Windows-based program. It shall be very easy for an operator to use on a routine basis. Only information for routine use shall be presented to the operator, but easily available to the operator upon demand. Selection of options shall be clear and unambiguous. Status of all system components shall be shown in a concise display. The control software shall be designed on a modular approach for functions. The program shall have the ability to generate and print customer calibration reports on demand for calibrated test instrument with logo and letterhead, customer information and identification, and selected parameters relevant to each calibration point. Example of Reference field measurement Read the following parameters: o kV o mA o filter o yield o exposure rate o exposure time (or total exposure) o reference IC position o reference IC calibration factor o reference IC ID o collimator Set generator o set kV o set mA o display settings Move probe table Set filter Set collimator Preset exposure time Shutter routine o read environmental parameters (T, P, RH) o verify kV, mA ��if beyond limits prompt operator and reset o zero reference IC and TM electrometers o check current leakage ��calculate limits ��read electrometers ��if beyond limits prompt operator and repeat o open shutter o at shutter close read reference IC and TM electrometers o calculate exposure rate o compare to expected rate, if beyond limits prompt operator for input o store exposure rate & TM reading for run Repeat shutter routine n times Perform statistical test. There shall be a visual indicator if parameters are outside of preset limits. Example of Test instrument measurement Read parameters o T correction (y/n) o P correction (y/n) o integrated exposure (or preset time) o units o electrometer to read o test IC position Move probe table Preset exposure time Shutter routine o read T, P, RH o verify kV, mA ��if beyond limits prompt operator and reset o zero TM electrometer and test IC electrometer if needed o check current leakage (needs discussion) ��calculate limits ��read electrometers ��if beyond limits prompt operator and repeat o open shutter o at shutter close read TM electrometer and test IC electrometer (test electrometer reading is usually operator input) o calculate test exposure rate o compare TM reading to reference value, prompt operator if outside limits o store test exposure rate & TM reading for run Repeat shutter routine n times Perform statistics o average test exposure rate o standard deviation of test exp rate o standard deviation of TM o if beyond limits prompt operator for action o calculate and display calibration factor (or cal coefficient if not unitless) Store raw data in temporary storage Store reduced data Perform statistical test. There shall be a visual indicator if parameters are outside of preset limits. Yield Determination for Individual Beam Qualities. An automated program shall exist that collects the electrometer reading, determines and stores exposure rates for distance, kV, mA, and beam qualities along the positioning track. The source code will have the ability to code these values into the software control program. The automatic set up routine shall have the capability to configure the track position, exposure rate, time, and exposure. ADA Requirements Subpart B -- Technical Standards § 1194.21 Software applications and operating systems. (a) When software is designed to run on a system that has a keyboard, product functions shall be executable from a keyboard where the function itself or the result of performing a function can be discerned textually. (b) Applications shall not disrupt or disable activated features of other products that are identified as accessibility features, where those features are developed and documented according to industry standards. Applications also shall not disrupt or disable activated features of any operating system that are identified as accessibility features where the application programming interface for those accessibility features has been documented by the manufacturer of the operating system and is available to the product developer. (c) A well-defined on-screen indication of the current focus shall be provided that moves among interactive interface elements as the input focus changes. The focus shall be programmatically exposed so that assistive technology can track focus and focus changes. (d) Sufficient information about a user interface element including the identity, operation and state of the element shall be available to assistive technology. When an image represents a program element, the information conveyed by the image must also be available in text. (e) When bitmap images are used to identify controls, status indicators, or other programmatic elements, the meaning assigned to those images shall be consistent throughout an application's performance. (f) Textual information shall be provided through operating system functions for displaying text. The minimum information that shall be made available is text content, text input caret location, and text attributes. (g) Applications shall not override user selected contrast and color selections and other individual display attributes. (h) When animation is displayed, the information shall be displayable in at least one non-animated presentation mode at the option of the user. (i) Color coding shall not be used as the only means of conveying information, indicating an action, prompting a response, or distinguishing a visual element. (j) When a product permits a user to adjust color and contrast settings, a variety of color selections capable of producing a range of contrast levels shall be provided. (k) Software shall not use flashing or blinking text, objects, or other elements having a flash or blink frequency greater than 2 Hz and lower than 55 Hz. (l) When electronic forms are used, the form shall allow people using assistive technology to access the information, field elements, and functionality required for completion and submission of the form, including all directions and cues. Subpart C -- Functional Performance Criteria § 1194.31 Functional performance criteria. (a) At least one mode of operation and information retrieval that does not require user vision shall be provided, or support for assistive technology used by people who are blind or visually impaired shall be provided. (b) At least one mode of operation and information retrieval that does not require visual acuity greater than 20/70 shall be provided in audio and enlarged print output working together or independently, or support for assistive technology used by people who are visually impaired shall be provided. (c) At least one mode of operation and information retrieval that does not require user hearing shall be provided, or support for assistive technology used by people who are deaf or hard of hearing shall be provided. (d) Where audio information is important for the use of a product, at least one mode of operation and information retrieval shall be provided in an enhanced auditory fashion, or support for assistive hearing devices shall be provided. (e) At least one mode of operation and information retrieval that does not require user speech shall be provided, or support for assistive technology used by people with disabilities shall be provided. (f) At least one mode of operation and information retrieval that does not require fine motor control or simultaneous actions and that is operable with limited reach and strength shall be provided. Subpart D -- Information, Documentation, and Support § 1194.41 Information, documentation, and support. (a) Product support documentation provided to end-users shall be made available in alternate formats upon request, at no additional charge. (b) End-users shall have access to a description of the accessibility and compatibility features of products in alternate formats or alternate methods upon request, at no additional charge. (c) Support services for products shall accommodate the communication needs of end-users with disabilities. 5) Delivery, Shipping and Installation Vendor shall provide and include cost for the following: Delivery to FDA White Oak Facility Be responsible for the moving and installation of all parts. Training of multiple users on the use of the x-ray system and simple instructions for source code modifications Warranty: Minimum of 1 year warranty of all parts and labor after installation. D) Additional Requirements : 1) Vendor will provide manuals, schematics, drawings, and supporting documentation for all equipment installed. 2) Vendor must provide training for operation and maintenance of the equipment. The first will cover the general operation of the equipment and will be given to those personnel who will operate the equipment. The second type of training is much more in depth and will cover: review of source code and software structure; detailed review of electrical schematics; troubleshooting; and maintenance. 3) Vendor bid must include all overhead costs including but not limited to the following: Travel, Lodging, Per-Diem, Transportation, Delivery, Equipment installation, Interface with FDA equipment which include (but not limited to) the 320 kVp X-ray generator system, Shutter controller, electrometers, environmental monitors Site testing and training for five FDA IRML personnel on the use and maintenance of equipment and limited software modification instructions for calibration report generation 4) The equipment must be connected to the existing building system. Electrical requirements must be presented to insure that existing building system can handle all equipment. Vendor must also state floor loading requirements, and any other requirements that are needed within the existing FDA building system. 5) Vendor must submit customer list of accredited diagnostic x-ray calibration laboratories as references. Vendor must also operate under an ANSI NQA-1 quality assurance plan (or equivalent plan). This project must be conducted under the QA plan and cover engineering design, purchase of components, system integration, and testing. A test plan must be used to verify that all equipment is fully operational and complies with the specifications. E) Period of Performance: The period of performance shall start upon acceptance of the contract. The FDA is requiring that review, acceptance of proposal and schedule, shipping, installation, training, and site acceptance shall occur within 120 days of purchase order receipt. F) ADDITIONAL REQUIREMENTS/ INSTRUCTIONS FOR SUBMITTING QUOTATIONS RESPONSES TO FDA: 1.BUSINESS INFORMATION -- a.DUNS: b.COMPANY NAME c.COMPANY ADDRESS d.Type of Company (i.e., large/small business, 8(a), woman owned, veteran owned, etc.) as validated via the CCR. All Offerors must register on the Central Contractor Registration located at http://www.ccr.gov/index.asp. Note: To receive an award under this Request for Quotation, all Offerors must be CCR registered, referencing the NAICS of 811219. e.COMPANY POINT OF CONTACT, PHONE AND EMAIL ADDRESS f.GSA SCHEDULE CONTRACT NUMBER (IF APPLICABLE) 2.EMAIL YOUR QUOTES TO THE CONTRACT SPECIALIST, DOMINIQUE.MALONE@FDA.HHS.GOV ON OR BEFORE APRIL 25, 2008 BY 2:00 PM EASTERN STANDARD TIME. NOT WITHSTANDING, ANY FIRM THAT BELIEVES IT IS CAPABLE OF PROVIDING THE REQUIRED SERVICE AS STATED HEREIN MAY SUBMIT A QUOTE WITH TECHNICAL SPECIFICATIONS TO DOMINIQUE.MALONE@FDA.HHS.GOV. ALL RESPONSES OR QUESTIONS REGARDING THIS POSTING MUST BE IN WRITING AND MUST BE SENT VIA EMAIL. NO PHONE CALLS WILL BE ACCEPTED. SUBMISSION MUST BE RECEIVED BY 2:00 P.M. EST ON, APRIL 25, 2008.
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- Zip Code: 20993
- Zip Code: 20993
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