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FBO DAILY ISSUE OF SEPTEMBER 28, 2007 FBO #2132
MODIFICATION

R -- Medical Product Safety Network (MedSun) Adverse Reporting Feedback Program

Notice Date
1/24/2007
 
Notice Type
Modification
 
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
2/7/2007
 
Point of Contact
Jennifer Fagan , Contract Specialist , Phone 301-827-7183, Fax 301-827-7101
 
E-Mail Address
jennifer.fagan@fda.hhs.gov
 
Description
The Food and Drug Administration intends to make a single award for professional services to support the MedSun program. MedSun is a medical device adverse event reporting network. It is comprised of a primary network and several sub-networks. The primary network collects information on radiological devices generally, while the sub-networks collect information about specific classes of devices. The program involves investigation of the adverse events reported and providing feedback to the clinical community about the events and possible remedies thereto. Currently 350 hospitals participate in the MedSun program, providing reports to both the primary network and sub-networks. The purpose of the intended contract is twofold: to obtain assistance in the continued development of the program, and to process incoming reports and to analyze the data. With respect to program development, the contractor shall recruit and train participating sites, develop incentives plans to retain participating sites, and increase participation in sub-networks. The contractor shall also maintain and market the MedSun websites, and administer, update and test the MedSun database. The development of communication plans, small scale compliance evaluations, and rapid response surveys is also required. Additionally, the contractor shall advise the FDA on program related issues. With respect to the processing of reports and data analysis, the contractor shall process incoming reports. Processing the reports is not solely a clerical function, but requires the expertise to understand the reported events from a clinical and biomedical perspective. The contractor shall also code the reports, analyze the reports, meet with the FDA to review reports, and perform follow-up to the reports as requested. Additionally, the contractor shall assist the FDA in evaluating the impact of the MedSun program and shall develop methods to link data received to the demographics of the participating hospitals. The contract is expected to consist of a one year base period, with four one year option periods. The deliverables called for under the contract shall be provided according to the schedule set forth therein. Some contractor employees will be required to work on-site at the FDA? facility located at 1350 Piccard Dr Rockville, MD 20850 ? others may work off-site. It is anticipated that a written solicitation will be released on or about June 4, 2007. Award will be made on or before September 21, 2007. All responsible sources may submit an offer, and the FDA will consider all offers submitted. All contractors doing business with the Federal Government must be registered in the Central Contractor Registration (CCR) database. The website for registration is www.ccr.gov. ng-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. 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 7, 2007. NOTE: THIS NOTICE MAY HAVE POSTED ON FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (24-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
 
Record
SN01422442-F 20070928/070926230533 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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