SPECIAL NOTICE
A -- United States Renal Data System - Coordinating Center
- Notice Date
- 3/27/2006
- Notice Type
- Special Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Nat'l Institute of Diabetes, Digestive, & Kidney Diseases, 2 Democracy Plaza, Suite 700W 6707 Democracy Blvd., MSC 5455, Bethesda, MD, 20892-5455
- ZIP Code
- 20892-5455
- Solicitation Number
- 06-01
- Response Due
- 4/5/2006
- Archive Date
- 4/20/2006
- Description
- The National Institutes of Health, National Institutes of Diabetes and Digestive and Kidney Diseases is conducting a market survey to determine the availability and technical capability of qualified small business, veteran-owned small business, service-disabled veteran-owned small business or HUBZone small businesses capable of serving as the Coordinating Center (CC) for the United States Renal Data System (USRDS) to provide the biostatistical, epidemiological, data management and analytical expertise necessary to maintain and update the existing USRDS database. The CC also coordinates, scientifically manages, develops and expands; prepares and releases subset(s) of the database to support investigator-initiated research; publishes papers and reports of scientific findings based on USRDS data; and provides data to support research performed by Special Studies Centers (SSCs). This request is for interested firms with the capablitiy of providing the required services to submit a capability statement along with projected pricing, to assist the Government in determining in accordance with Federal Acquisition Regulation (FAR) 19.502-2(b) whether or not this procurement will be set-aside for any of the programs described above. The intended procurment will be classified under North American Industrial Classification (NAICS) code 541710 with a size standard of 500 employees. All respondents are requested to identify their firm's size and type of business. The Contractor shall perform all tasks set forth in the Statement of Work for the Coordinating Center, and shall be involved in all aspects of the project. The work shall be performed according to the following defined tasks. a. TASK ONE: Three-Month Transition Period b. TASK TWO The Contractor shall perform characterization of the ESRD patient population, including the distribution of demographic variables or attributes, and the geographic distribution of patients across the several modalities of ESRD treatment and the serial changes over time. 1) The Contractor shall work in collaboration with the SSCs, the DKUHD NIDDK and CMS-OCSQ and OSP, CMS ESRD Networks, and the Steering Committee to coordinate all functions pertaining to all aspects of the USRDS Coordinating Center=s use of the existing USRDS database, and updating of the database from the various sources. 2) The Contractor shall design and implement a structure and a system within the Coordinating Center that will provide biostatistical and analytical expertise, and effective data management. 3) The Contractor shall have the primary responsibility for assembling the master Manual of Operations and the Forms Manual for the CC. 4) The Contractor shall edit all CMS PMMIS/REBUS/SIMS, CPM, MDS, five percent Medicare sample, OPTN, Census, and MEDSTAT (or equivalent) data in the yearly update, and incorporate new data into the current USRDS database. Update of data shall be accomplished on an annual basis (in January/March of each year). Developing of data warehousing capabilities with CMS will be a major objective of the CC during the term of the contract. The Contractor shall develop a contingency plan for conducting regular updates of data on at least a yearly basis, based on access to CMS data files. 5) The Contractor shall characterize the Chronic kidney disease patient population: cause of renal disease, comorbid conditions, demographic variables, treatment regimen, and geographic distribution. 6) The Contractor shall continue production of the USRDS Annual Data Reports (ADRs) outlining the descriptive epidemiology of the ESRD patient population. These reports shall incorporate suggested changes from previous reports, and must be of the highest quality. The Co-Project Officers will obtain assistance from the Steering Committee, the EAC, and other appropriate consultants in reviewing drafts of the reports before final production. 7) The Contractor shall conduct the necessary existing data analyses for support of the ADR. c. TASK THREE The Contractor shall provide appropriate selected national samples of patients to support focused clinical studies by the SSCs. One major special study per SSC will be performed during the duration of the contract. The CC shall provide baseline existing data from the USRDS database to the SSCs, as directed by the Co-Project Officers, for the SSCs performance of existing data analyses. Two (2) major existing data studies per SSC will be performed each year during the duration of the contract. d. TASK FOUR The Contractor shall provide data to the scientific research community for the support of government programs, and individual investigator-initiated biomedical and economic research. The Contractor shall aggregate, analyze and release data to the scientific community. This data release will not require specific prior approval from the Co-Project Officers, if such request will require less than two hours of combined computer and personnel time and it meets other requirements established for patient confidentiality. It is estimated that 800 such requests will be carried out each year. The Contractor shall track the number of such requests and report this information in the Quarterly Technical Progress Report. e. TASK FIVE At the direction of the Co-Project Officers, the Contractor shall aggregate, analyze and release data for the use of the Government. Such data requests may require greater than two hours of combined computer and personnel time. Forty (40) such requests are expected each year. f. TASK SIX At the approval of the Co-Project Officers, the Contractor shall aggregate data in a specified manner for release to investigators for the support of biomedical and/or economic research. Such data release shall conform to the prescribed "Policy on USRDS Data Release to Investigators" (see appendix B of the 2005 ADR). The Contractor shall track the number of such requests and report this information in the Quarterly Technical Progress Report. Copies of all correspondence with investigators shall be provided to the Co-Project Officers. g. TASK SEVEN 1) The Contractor shall administratively assist in managing the logistics of the following committees: the Steering Committee, the External Advisory Committee, and the DRRC. 2) The Contractor shall provide logistical and administrative support for meetings necessary to achieve the objectives of the program. Approximately 6 to 9 face-to-face meetings will be required per year. 3) No commitments to represent the USRDS shall be made by the CC to any society or organization without the prior written approval of the Co-Project Officers. The Co-Project Officers may call on CC staff to deliver all or part of such presentations. 4) The Contractor shall prepare manuscripts (deliverables of data analysis) for publication in collaboration with the NIDDK and CMS staff, describing the research findings from the existing data studies. A minimum of one manuscript is expected from each of the existing data studies. The Contractor shall prepare all manuscripts in accordance with the USRDS Publication Policy (revised 2002). 5) The Contractor shall maintain appropriate database and data files. In addition the Contractor=s data system shall have the ability to transmit and receive data electronically to and from CMS. 6) The CC shall explore the possibility of incorporating into the USRDS database data from other relevant national sources such as data bases from large dialysis organizations (LDOs), major insurers, or HMOs. The CC shall inform the Co-Project Officers of such additional sources, and the Co-Project Officers will initiate the process of such incorporation subject to cost limitations. The status of each data incorporation shall be reported by the Contractor in the Quarterly Technical Progress Report. h. TASK EIGHT The Contractor shall receive primary patient identifiable data generated by the SSCs in the conduct of the Special Studies and incorporate these data into the master USRDS database. These data shall be used to form a Special Studies Standard Analysis File, containing data merged with the demographic, treatment, and other data available on the specific patients included in that special study. One year after completion of special study data collection, the special study data base will be made into standard analysis files (SAFs) for the research community. Each SSC will be instructed by the Co-Project Officers to provide the primary data from each Special Study to the CC in a format that allows systematic and timely incorporation of the Special Study data with the rest of the USRDS Database. Interested firms responding to this market survey msut provide (a) capablity statment demonstrating their experience, skills and capability to fulfill the Government's requirements for the above. The capablity statment shall be in sufficient enough detail, but not to exceed 10 pages, so that the Government can determine the experience and capability of your firm to provide the requirements above. Your capablity statement, not to excced 10 pages, should include references, key personnel and teaming arrangements. A copy of the capablilty statement must be received at the address identified in this synopsis by no later than close of business (5:00pm local time at designated location) on April 5, 2006. Responses by fax or e-mail WILL NOT BE ACCEPTED. This synopsis is for information and planning purposes and is not to be construed as a committment by the Government, nor will the Government pay for information solicited.
- Place of Performance
- Address: Bethesda, MD
- Zip Code: 20817
- Country: USA
- Zip Code: 20817
- Record
- SN01015265-W 20060329/060327211718 (fbodaily.com)
- Source
-
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