SOLICITATION NOTICE
U -- ON-LINE X-RAY RADIOLOGICAL HEALTH TRAINING
- Notice Date
- 7/17/2006
- Notice Type
- Solicitation Notice
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, MD, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-1019257
- Response Due
- 8/1/2006
- Archive Date
- 8/16/2006
- Small Business Set-Aside
- Total Small Business
- Description
- ON-LINE X-RAY RADIOLOGICAL HEALTH TRAINING This is A NOTICE OF INTENT TO AWARD to a sole source for commercial service prepared in accordance with the format in FAR 5.207 AND FAR 12.603 as supplemented with additional information included in this notice. . This reference number is FDA-1019257, and is issued as a NOTICE TO THE PUBLIC The contract will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2001-27. The North American Industry Classification (NAICS) Code is 541690 with a small business size standard of $6.5M. This acquisition is being conducted using Simplified Acquisition Procedures in accordance with FAR Part 13. The government intends to award the requirement to a small business set aside (FAR 13 and FAR 19). R.J. TOKARZMEDICAL IMAGING RADIATION SAFETY CORP. 44 STELTON ROAD, STE 115 PISCATAWAY, NJ 08854-2663 The Food and Drug Administration (FDA) requires the services to design, develop, pilot test, evaluate, and offer a fundamental course on basic radiation physics that includes modules specific to radiological health areas as specified Background: The U.S. Food and Drug Administration (FDA) has the responsibility of implementing the radiological health program based on the plan signed by the Center for Devices and Radiological Health (CDRH) Director in May 2005. One of the goals outlined in the plan involved providing meaningful and appropriate training to FDA and State inspectors to properly, efficiently, and effectively perform surveys of medical diagnostic products (e.g., mammography, diagnostic radiographic and fluoroscopic systems with long-term inclusion of other medical and non-medical radiation products. The ultimate goal of this order is to provide comprehensive, online training for FDA and State personnel in the fundamental concepts of basic x-ray health radiation physics with additional modules covering instruction in specific diagnostic radiation systems to allow FDA to fulfill its regulatory responsibilities in monitoring these radiation-emitting devices. Scope of Work: FDA is requesting the expansion of the existing online training to capitalize on the user-friendly format, the fundamental basic radiation information contained in the currently used training, and the expertise previously tapped to develop this training. This task involves the development and expansion of online training to include a number of modules specific to x-ray radiological health areas prioritized by FDA after it conducts a full needs assessment of radiological health training needs. The contractor will preserve the content and format of the original online training and continue to make available to FDA-approved student nominations. Instruction will be delivered through on-line and CD-ROM methodology through modules, visuals, demonstrations, exercises and laboratory sessions providing and preparing the students with knowledge and expertise to progress to the next appropriate level as required. Helpdesk and maintenance support will be provided as well throughout the duration of the project. Deliverables In designing, developing, testing, evaluating, and implementing the broadened training, the contractor will complete the following tasks with the overall goal of creating and offering additional modules in basic radiation systems to include those areas mentioned above, as appropriate: FY 06: Submit a timeline for training design, development, testing, and implementation thereof, including deliverables Initiate required instruction on basic radiology physics to include specified basic radiation materials for the basic x-ray field testing course specific to FDA ?for cause? survey requirements) (Module 1) Provide helpdesk/maintenance support Preserve the module and offer to FDA-approved registrants FY 06: Complete development of Module 1 Pilot test/evaluate/modify Module Present final Module 1 product ( Date to be specified by Project Officer) Offer module 1 online NLT (Date to be specified by Project Officer) Cover registrations for up to 30 FDA and state students* *over the duration of the period of performance Initiate the design/ development of Module 2 (above-table radiographic (AR) x-ray field inspections) Provide helpdesk/maintenance support The FDA views any newly developed and expanded online training to be unique, no longer specific to MQSA, and the property of the Agency for its use as appropriate. As the contractor develops these new training modules, he may offer it to the public at large, charging an enrollment fee and providing course materials and maintenance and hotline support as needed. The FDA will perform the following tasks: Review/accept deliverables list and due dates Provide the contractor with course materials/outlines specific to each radiation modality and regulatory requirements, as appropriate Review, test, and provide feedback to the contractor on modules as appropriate Accept modules Provide the contractor with names of subject matter experts Provide the contractor with names of FDA-approved student nominations Pre-test developed materials before going online for access by FDA-approved student nominations Period of Performance: Beginning August 1, 2006 and ending on September 30, 2007 Qualifications: Since 2002, Tokarz Imaging, Inc. has provided FDA with an online basic radiological course specific to mammography equipment. As the leading expert on the content of the existing online mammography training, he understands our targeted audiences, their needs, our goals in training these audiences, and the time frames associated with offering this training. His sustained quality performance has provided students with a resource to ask questions regarding the course materials and the use of the software used for this online instruction. Over the past several years, Tokarz Imaging, Inc., has designed, developed, tested, evaluated, modified, and implemented an online radiological health course that can provide instruction to FDA and State inspectors through distance learning in the fundamental concepts of radiation health physics. FDA has maintained a relationship with the contractor whereby Tokarz Imaging, Inc., revises and supports the course materials as needed to accommodate feedback from students and changes in our program, as warranted, and provides helpdesk assistance for questions that surface from accessing this training. Therefore, Tokarz Imaging, Inc. has extensive experience and knowledge of the our online training system and demonstrates a unique capability to perform the required services with no learning curve, Additionally, to obtain these services from another vendor with similar knowledge and experience or to train a vendor with less experience and knowledge would take significantly more effort and would be more costly on the part of the government. Evaluation Criteria will be based on the qualifications and requirements as stated above. This is a notice of intent and not a request for competitive proposals. However, interested vendors capable of furnishing the government with the service specified in this notice may identify their interest and respond to the requirements by submitting their response to the below address. All responses will be due fifteen (15) calendar days from the publication date of this synopsis. The quotation must reference the Solicitation number FDA-1019257. The government reserves the right to issue an award without further notice.
- Place of Performance
- Address: 11919 Rockville Pike, Rockville, MD
- Zip Code: 20852
- Country: UNITED STATES
- Zip Code: 20852
- Record
- SN01090654-W 20060719/060717220222 (fbodaily.com)
- Source
-
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