SOLICITATION NOTICE
R -- On-Line Training Course
- Notice Date
- 9/17/2005
- Notice Type
- Solicitation Notice
- NAICS
- 611430
— Professional and Management Development Training
- 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
- Reference-Number-1004641
- Response Due
- 9/22/2005
- Archive Date
- 10/7/2005
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a written solicitation will not be issued. This synopsis, identified as No. 1004641, is to notify contractors of the government?s intent to award a purchase order to Radiation Safety LLC under the simplified acquisition procedures. The FDA intends to issue a simplified acquisition on a sole source basis to Radiation Safety LLC, 44 Stelton Road, Suite 115, Piscataway, NJ 08854-2600. There is only one responsible source and no other supplies or services will satisfy agency requirements due to the following reasons: In the spring of 2002, this contractor designed, developed, tested, evaluated, modified, and implemented an online course that provided instruction to potential FDA and State inspectors through distance learning in the fundamental concepts of radiation physics with emphasis on mammography-related aspects. Subsequently, the division has maintained a relationship with the contractor whereby he 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. Benefits to sole sourcing: With the recent assumption of the CDRH Radiological Health Program and in an effort to fulfill the recommendations contained therein, we now need to broaden the scope of the original ?inspector? training offering to include instruction on additional radiation-emitting equipment, including basic radiation physics, diagnostic radiographic and fluoroscopic systems, dental diagnostic systems, computed tomography (CT), radiation therapy systems, and non-medical radiation-emitting equipment, as appropriate. As the leading expert on the content of the existing online training, this contractor understands our targeted audiences, their needs, our goals in expanding the training to encompass a larger array of module-specific instruction and can adapt the existing format and content in a timely, seamless, and efficient manner. His performance on the original contract has been exceptional. He has met all deliverables within the time frames specified and has been extremely responsive to our program, and successfully addresses the needs of our students. These characteristics and our expectations of continued stellar performance are key components to meeting our emerging and increasing training needs. Additionally, by contracting with this sole source, we will save both government time and money by building on the existing course materials that have been well received and appropriate for the training of our cadre of potential inspectors. Additionally, by avoiding unnecessary delays in initiating a new process, we will fulfill our obligations in supporting the radiological health program, meet the demands of our targeted audiences in a timely manner, and invest our resources into prioritizing our remaining training needs. The contractor will use the existing "all inclusive" radiologic introductory physics course as the foundation for the additional modules to meet FDA's prime objective to prepare MQSA and medical imaging surveyors to fulfill the Agency's regulatory responsibilities. As with the original online course, the expanded version will be delivered through on-line and CD-Rom methodologies that allow students to train at their own pace, in the time frames convenient to their program and personal schedules and responsibilities; and to minimize costs and the additional time commitment involved in travel and being away from their respective work sites. This approach has been highly successful and has received favorable evaluations by the students taking this training. Most importantly, the intended training will capitalize on the original format, content, and methodologies by offering new modules, visuals, demonstrations, exercise, and laboratory sessions that provide and prepare students with knowledge and expertise to progress to the next required training. Also included are the necessary pre-testing and testing and registration for up to 30 students to get invaluable feedback. These reasons, considered in their entirety, are why FDA anticipates a sole source award to Radiation Safety LLC, however, other sources may submit descriptive literature that fully demonstrates their capabilities and they will be reviewed to determine if they are considered qualified. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2001-27. The associated NAICS code is 611430 ? Professional and Management Development Training and the small business size standard is $6M. The following are objectives and tasks Radiation Safety LLC will be requested to provide: Background: The Division of Mammography Quality and Radiation Programs (DMQRP) has the responsibility of implementing the Center for Devices and Radiological Health?s (CDRH) radiological health program based on the plan signed by the 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, dental diagnostic systems, computed tomography (CT), and radiation therapy), with long-term inclusion of non-medical radiation products. To accomplish this goal, DMQRP requests the service of Radiation Safety LLC 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. Since 2002, this company has provided DMQRP with an online basic radiological course specific to mammography equipment. As the leading expert on the content of the existing online mammography training, they understand our targeted audiences, their needs, our goals in training these audiences, and the time frames associated with offering this training. Their 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. Scope of Work: DMQRP 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 is a multi-year effort that will be accomplished in a phased-in manner, beginning on the date of award and ending on June 30, 2008. This task also involves the development and expansion of the current MQSA Inspector Course I (CI) online training to include a number of modules specific to radiation areas as specified above and prioritized by DMQRP after it conducts a full needs assessment of radiological health training needs. The ultimate goal of this purchase order is to provide comprehensive, online training for FDA and State personnel in the fundamental concepts of basic radiation physics with additional modules covering instruction in specific diagnostic radiation systems (e.g., mammography, diagnostic radiographic and fluoroscopic systems, dental diagnostic systems, computed tomography (CT) systems, and radiation therapy systems, as appropriate) to allow FDA to fulfill its regulatory responsibilities in monitoring these radiation-emitting devices. 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. There will be deliverables with scheduled due dates. The provision at FAR 52.212-1, Instructions to Offerors?Commercial Items applies to this solicitation. The following agenda have been attached to this provision: None. Offerors shall include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications?Commercial Items. The clause at FAR 52.212-4, Contract Terms and Conditions?Commercial Items applies to this acquisition. The following agenda have been attached to the clause: None. The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders?Commercial Items applies to this acquisition. The following FAR clauses cited are applicable: FAR 52.222-26, FAR 52.222-35, FAR 52.222-36, FAR 52.225-3, FAR 52.225-15, FAR 52.232-33. Clauses and provisions are incorporated by reference and apply to this acquisition. The FDA intends to make award immediately following the response date on this notice. All responsible sources that intend to submit descriptive literature shall submit it by COB on the due date referenced above to the following address or e-mail: Food and Drug Administration, 5630 Fishers Lane, Room 2083, HFA-500, Rockville, Maryland 20857-0001 or Lforgosh@oc.fda.gov. The Government will award a firm-fixed-price purchase order using Simplified Acquisition procedures in accordance with FAR 13.5. For information regarding this solicitation, please contact Lori Forgosh at 301-827-7044, fax 301-827-7106 or e-mail Lforgosh@oc.fda.gov.
- Place of Performance
- Address: 44 Stelton Road, Suite 115, Piscataway, NJ
- Zip Code: 08854-2600
- Country: USA
- Zip Code: 08854-2600
- Record
- SN00897864-W 20050919/050917211533 (fbodaily.com)
- Source
-
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