SOURCES SOUGHT
R -- Medical Product Safety Network (MedSun) Adverse Reporting Feedback Program
- Notice Date
- 1/22/2007
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical 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
- 20857-0001
- Solicitation Number
- FDA-SOL-07-00155
- Response Due
- 2/5/2007
- Point of Contact
- Jennifer Fagan , Contract Specialist , Phone 301-827-7183, Fax 301-827-7101, - Karen Gamble, Contract Specialist, Phone 301-827-3366, Fax 301-827-7101
- E-Mail Address
-
jennifer.fagan@fda.hhs.gov, karen.gamble@fda.hhs.gov
- Description
- Sources Sought This announcement constitutes a Sources Sought Synopsis. Responses to this publication are solicited to identify qualified sources. Qualified sources are limited to 8(a), Hubzone, and small businesses including service disabled veteran owned small businesses, veteran owned small businesses and women owned small businesses. Those parties that have an interest and ability to provide FDA's Center for Devices and Radiological Health (CDRH) with the services detailed below should SUBMIT CAPABILITY STATEMENTS. The capability statement and supporting data that clearly illustrate/exhibit the contractor's ability to perform the specified requirement, such as previous similar services performed or resumes, must be submitted no later than February 5, 2007. An electronic copy and four hard copies of the capability statement and each supporting document shall be sent to the contact listed in this announcement. This IS NOT a request for proposals. This synopsis seeks to identify the interest from prospective contractors to assist FDA in the ongoing research, development, and implementation of CDRH's Medical Product Safety Network (MedSun). Project Description: MedSun is a CDRH adverse event reporting/feedback pilot program that has been funded since 2002 under a Task Order contract. That contract expires in August 2007. The MedSun program currently includes 350 hospitals and nursing homes which report on-line to CDRH about problems with the use of medical devices. The program involves investigation of those problems, creating solutions to those issues, and providing feedback to the clinical community about the problems and the solutions. Educational tools are developed to teach clinicians how to recognize device problems, how to write quality reports about those problems, and how to improve the safe and effective use of devices. This development is a creative, ongoing process. The program requires specific, advanced technical capabilities and knowledge. The technical capabilities include: understanding and experience with sociological research, understanding and experience of surveys and sampling methodologies, experience with a wide array of large health data bases and national health care organizations, techniques for quality assurance, understanding of trend analysis, sound judgment about data quality and usefulness, and development of outcome measures. Technical capabilities also include a wide array of research techniques for special studies to understand the use of medical devices in the clinical community, the ability to present technical materials in written and graphical form to non-technical audiences, and a staff of nurses, physicians, and engineers highly knowledgeable of the use of medical devices in all areas of hospitals. In addition to these technical capabilities, a detailed understanding of federal and state policies related to collection of health care data and medical device adverse events is critical, as well as a detailed understanding of the medical device related statutes of the Food, Drug, and Cosmetic Act, and the associated medical device regulations. Because the MedSun program is an ongoing program, there can be no time lag in transitioning the current program from the current contractor to a new contractor. Therefore, a prospective candidate must have the in-house capability to be able to assume the full project and provide seamless workflow from the beginning of the new Task Order contract. Describe in detail your proven capability and current in-house capacity to perform all the following required capabilities, as well as those cited in the Project Description paragraph, above: Experience in recruiting a representative sample of acute-care hospitals for participation in long-term research efforts. Experience in training hospital staff in use of electronic reporting system to report device-related events and providing technical support to more than 1000 system users. Experience in maintaining on-going cooperation from health-care provider organizations in a national, large-scale patient safety reporting effort. Demonstrated ability to maintain high level of data security handling sensitive data collected from health provider organizations; credibility with hospital community regarding collection and handling of organizationally sensitive data. Capability to provide programming and systems support to FDA in maintaining and performing enhancements on secure on-line patient safety reporting system. Demonstrated ability to obtain project participation of nationally-known patient safety experts in an advisory capacity. Demonstrated ability to produce useful multi-media educational tools designed to teach clinicians to recognize and report problems with medical devices. Project management staff with knowledge of medical technology and experience in managing a clinically trained staff. On-board staff, or plans to bring staff on board, with clinical training and hospital-based experience in biomedical engineering and nursing in device-intensive settings with experience in root-cause analysis. On-board staff, or plans to bring staff on board, with experience in developing device problem codes, and in coding adverse event reports with patient and device problem codes. Experience in conducting web-based rapid response organizational surveys. Experience in subcontracting to major medical institutions to conduct research relating to device safety. Experience in planning, organizing and conducting conferences for 300 to 400 hospital-based staff involved with device safety (such as risk managers and biomedical engineers). THIS SYNOPSIS IS FOR INFORMATION AND PLANNING PURPOSES AND IS NOT TO BE CONSTRUED AS A COMMITMENT BY THE GOVERNMENT. THIS IS NOT A SOLICITATION ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR ANY COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO THIS ANNOUNCEMENT AND ANY FOLLOW-UP INFORMATION REQUESTS. RESPONDENTS WILL NOT BE NOTIFIED OF THE RESULTS OF THE EVALUATION. ALL INFORMATION SUBMITTED IN RESPONSE TO THIS ANNOUNCEMENT MUST ARRIVE ON OR BEFORE THE CLOSING DATE. THE CLOSING DATE FOR RESPONSES IS FEBRUARY 5, 2007. NOTE: THIS NOTICE MAY HAVE POSTED ON FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (22-JAN-2007). IT ACTUALLY APPEARED OR REAPPEARED ON THE FEDBIZOPPS SYSTEM ON 26-SEP-2007, BUT REAPPEARED IN THE FTP FEED FOR THIS POSTING DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link to FedBizOpps document.
(http://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SOL-07-00155/listing.html)
- Place of Performance
- Address: Rockville, Maryland
- Zip Code: 20857
- Country: UNITED STATES
- Zip Code: 20857
- Record
- SN01422450-F 20070928/070926230739 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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