SOLICITATION NOTICE
R -- Dosimetry and Calibration Issues
- Notice Date
- 4/2/2007
- Notice Type
- Solicitation Notice
- NAICS
- 541511
— Custom Computer Programming 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, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- Reference-Number-R1028076
- Response Due
- 4/5/2007
- Archive Date
- 4/20/2007
- Description
- Requisition 1028076 (Modification #2 HHSF223200610464P) Professional Services Contract Contracting Office Address 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 Period of Performance (UNCHANGED from MODIFICATION 1) February 1, 2006 through September 30, 2007 Contractor Henry T. Heaton, II Address: 21116 Black Rock Road, Hagerstown, MD 21740 Description This is a modification to a previous Sole Source Award for a noncommercial item. This announcement constitutes the only notification of such changes. Due to the changes in the Statement of Work and the additional funding, these changes are being published on FEDBIZOPS. The solicitation number is R1028076. The Government plans to modify the Firm Fixed Purchase Order. Original Sole Source Justification Dr. Thomas Henry Heaton is a former CDRH Calibration Laboratory Manager and current NVLAP Auditor, and has knowledge of all aspects of the laboratory. This expertise is critical for transitioning to the White Oak Facility and preparing for an Audit by NIST?s National Voluntary Laboratory Accreditation Program within the desired timeframe. Amended Sole Source Justification The proposed contractor is a former CDRH Calibration Laboratory Manager and current NVLAP Auditor, and has extensive knowledge of all aspects of the laboratory. This expertise is critical for transitioning to the White Oak Facility and preparing for an Audit by the National Institute of Standards and Technology?s (NIST) National Voluntary Laboratory Accreditation Program within the desired timeframe. Dr. Heaton is an expert in dosimetry and the calibration of radioactive sources. He has performed research in the area and has written many papers on these topics. Dr. Heaton?s help and assistance with dosimetry and calibration issues in this program will have a great impact on the safety of the public health. Professional Services Contract Modification This is a modification to the original statement of work. As stated in the previous statement, Dr. Heaton has been working on a project intended to provide the Division of Reproductive, Abdominal and Radiological Devices (DRARD) with advanced technical expertise in the radiation therapy area. This expertise is not available in the Center. DRARD is required to provide credible reviews of various radiation therapy submissions and without support, the program would be significantly hampered. The work, expertise and background of Dr. Heaton in these areas uniquely qualify him to address specific issues associated with the radiation therapy product line. He will contribute greatly to the medical device review process and to the various matters that are critical to the safety of the public. Without this support, the Division would be placed at a disadvantage in completing its mission. The Center will be pressed for time and might find it impossible to provide knowledgeable reviews of many radiation therapy products including the completion of this dosimetry and calibration project. The result will be the marketing of radiation therapy devices of uncertain safety and effectiveness and the potential for an increased number of adverse results from the use of these devices. Revised Statement of Work The primary purpose of this contract modification is to allow Dr. Heaton the ability to provide technical support to the CDRH Calibration Laboratory Project due to the Center?s move to the White Oak Campus. This part of the project has become more involved and it was determined that someone with a background in calibration and dosimetry was needed. In identifying this project and need, scientific and technical support will be provided in the following areas: * Reestablishing and validating the calibration ranges * Updating the Calibration Quality Manual to reflect the White Oak Facility move and the ISO 17025 format. * Technical support and recommendations for improvement of overall Quality System to prepare for NVLAP Audit at the new facility This project will be completed in three phases. They include: Phase 1 Revise and update Calibration Laboratory Quality Manual to be consistent with the requirements in ISO 17025 and NIST Handbook 150 which is necessary for continued National Voluntary Laboratory Accreditation (NVLAP) accreditation of the CDRH X-ray Calibration Laboratory. Phase 2 Provide guidance, technical assistance, and direction on the measurements necessary to characterize the operational aspects of the CDRH X-ray Calibration Laboratory after the move to the White Oak campus. This includes the measurements necessary to understand the factors that impact calibration of instruments used by FDA inspectors in various compliance programs in x-ray beams from diagnostic and mammographic quality beams and how to account for these influencing quantities in the calibration process. Phase 3 Document the measurements used to characterize the new CDRH X-ray Calibration Laboratory and the associated calibration procedures employed to calibrate various types of instruments. Update and document the uncertainty analysis to reflect the calibration laboratory at the new White Oak campus. Benefits to the Organization This contract would support the retention of the CDRH Laboratory?s accredited status through the National Institute for Standards and Technology?s (NIST) National Voluntary Laboratory Accreditation Program and conformance to the ISO/IEC Standard 17025. This laboratory allows the CDRH to fulfill its responsibilities for monitoring the safety of electronic products that emit potentially hazardous levels of radiation. IRML is continuing to work with OCER in developing a plan to phase out instrument calibration service while maintaining ?for cause? measurement capabilities. The laboratory provides expertise for quantifying radiation emissions from emerging technologies and new products. The laboratory also provides expertise for the development of voluntary standards and guidance documents aimed at limiting the public?s exposure to non-medical x-radiation. Deliverables 1) Dr. Heaton will be able to develop a Calibration Laboratory Quality Manual in the following formats (order of preference): WORD, PDF, HTML 2) Place the manual on the appropriate media storage device (DVD, CD, and Computer System).
- Place of Performance
- Address: 9200 Corporate Blvd, Rockville, MD
- Zip Code: 20850
- Country: UNITED STATES
- Zip Code: 20850
- Record
- SN01264185-W 20070404/070402220243 (fbodaily.com)
- Source
-
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