SOURCES SOUGHT
A -- Interagency Registry of Mechanical Circulatory Support for End-Stage Heart Failure
- Notice Date
- 2/4/2004
- Notice Type
- Sources Sought
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung, and Blood Institute, Contracts Operations Branch 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, MD, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- Reference-Number-SS-NHLBI-HV-05-08
- Response Due
- 2/20/2004
- Archive Date
- 3/6/2004
- Point of Contact
- Douglas Frye, Deputy Chief, Contracts Operations Branch, Phone (301) 435-0330, Fax (301) 480-3338, - Pamela Lew, Chief, HLV Section, Phone (301) 435-0340, Fax (301) 480-3338,
- E-Mail Address
-
df23a@nih.gov, pl116x@nih.gov
- Description
- The National Heart, Lung, and Blood Institute (NHLBI) is interested in soliciting capability statements from qualified small business offerors for a possible small business set aside program. The program that is being considered is to establish a data and clinical coordinating center (DCCC) to manage a registry of patients receiving a mechanical circulatory support device (MCSD) for the treatment of heart failure. The purpose of the registry is to collect and analyze clinical and laboratory data from 60 to 70 participating clinical centers in the United States concerning patients who are receiving newly approved MCSDs as destination therapy for end-stage heart failure. Data on patients receiving MCSDs for bridge to transplantation will also be collected and analyzed. It is anticipated that the DCCC will need to have the capacity to collect blood and tissue samples and data on approximately 2,000 patients per year for a period of 5 years. Specifically, the DCCC will: a) develop the study protocols to collect data, blood and tissue samples, develop study policies, a manual of operations, study forms and informed consent documents in collaboration with a steering committee and the NHLBI, b) collect, format and store data, c) provide statistical analysis of the data and develop necessary software for this analysis, d) establish methods and procedures for tissue collection and storage, and e) facilitate interaction among the participating centers and provide administrative and logistical support for publication and dissemination of findings. As a minimum, prospective offerors must document capabilities in the following areas which would evidence the potential to successfully complete the work of the registry. 1. Demonstrated past experience in and current capability to perform in collaborative biomedical clinical projects. Specifically, offerors must provide a description of previous multi-center research projects in which the organization and proposed personnel have participated. 2. Experience in and knowledge of cardiovascular and critical care medicine including the use of MCSDs as a treatment method for patients presenting with end-stage heart failure. Physician experience in interpretation of serious adverse events in the setting of critically ill patients with multiple organ damage is also considered essential. In this regard, it is expected that at least one physician with this expertise will be available on a daily basis to monitor the quality and completeness of the data collected and the analyses performed. It is anticipated that a physician?s time commitment of at least 16 hours per week will be required for this program. A curriculum vitae must be provided which details the qualifications of the physician(s), and a statement of availability to work on this program. 3. Offerors must possess experience in biostatistics. It is anticipated that at least one full-time biostatistician will be required for the program in addition to the efforts of other required personnel such as computer programmers and record analysts. Offerors must describe the experience and other qualifications of the individuals who would be assigned to work on this program. 4. Offerors must have experience in conducting site visits to assess site performance, adherence to program procedures, accuracy and timeliness of data collection, and complete audits of study records and transmitted data. Appropriate personnel and staff such as a research nurse and data technician should be available. Offerors must describe the experience and qualifications of person(s) assigned to work on the program 5. Offerors must also have experience in working with device manufacturers and complex bioengineering devices such as the MCSD. Understanding device reliability, modes of failure, and quality control is needed to provide quality and safety monitoring for this program. 6. Facilities available for receiving, processing, storing, and retrieving medical data accurately and efficiently should be described, including any equipment to automate the processing of data forms. This is not a request for proposals (RFP) and the Government is not committed to award a contract pursuant to this announcement. Small business concerns that believe they possess the capabilities necessary to undertake this study should submit complete documentation of their capabilities to the attention of the Contracting Officer at the above address. Three copies of the capabilities statement must be received at this address fifteen (15) days from the publication date of this Notice. When submitting this information, please reference Sources Sought Notice No. SS-NHLBI-HV-05-08. If this program is approved for implementation and it is determined to be a small business set aside, then a competitive RFP will be set aside for small business concerns. The RFP will be available at the FedBizOpps Website: http://www.fedbizopps.gov and at the NHLBI Website: http://www.nhlbi.nih.gov/funding/inits/index.htm#rfp. The North American Industry Classification System (NAICS) code is 541710 with a business size standard of 500 employees. Interested organizations submitting a capability statement are required to identify their size status.
- Record
- SN00515574-W 20040206/040204211930 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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