SOLICITATION NOTICE
B -- Special Studies and analysis not R & D
- Notice Date
- 4/22/2005
- Notice Type
- Solicitation Notice
- NAICS
- 622310
— Specialty (except Psychiatric and Substance Abuse) Hospitals
- 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
- NHLBI-PS-2005-083-DDC
- Response Due
- 5/6/2005
- Archive Date
- 5/21/2005
- Point of Contact
- Deborah Coulter, Contract Specialist, Phone (301) 435-0366, Fax (301) 480-3345, - Debra Hawkins, Chief, Procurement Section, Phone (301) 435-0366, Fax (301) 480-3345,
- E-Mail Address
-
dc143b@nih.gov, dh41g@nih.gov
- Description
- THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR A PROPOSAL. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The National Heart, Lung, and Blood Institute intends to negotiate an award of a purchase order on a noncompetitive basis to Suburban Hospital, 8600 Old Georgetown Road, Bethesda, Maryland 20814. NHLBI initiated four (4) protocols on cardiac diseases in which Suburban Hospital is the sole cohort. The NIH does not have a sufficient patient population or skilled research nursing staff essential to assure development of theses protocols. As such, the NIH requires regular access to patient populations that include acute cardiac patients such as those at Suburban Hospital. The protocols also require the service of skilled research nursing support o provide on-site enrollment, processing, and follow-up of patients at Suburban Hospital. It is essential that these resources be in close proximity to the NIH campus to facilitate prompt access to NIH investigators and other available NIH clinical resources that may be required, especially in emergency situations. STATEMENT OF WORK: To further the clinical, applied, and basic research, training, and education components of its activities the National Heart, Lung, and Blood Institute (NHLBI) Division of Intramural Research (DIR) requires access to patient populations that include acute cardiac patients such as those at Suburban Hospital, Bethesda, Maryland. The NHLBI DIR does not have a sufficient patient population or skilled nursing staff essential to conduct multi-center studies and requires these resources to assure protocol development. The NHLBI DIR requires the services of skilled nursing support staff located at Suburban Hospital to enroll and process patients in the multi-center clinical research protocols listed below that have been approved by the NHLBI and Suburban Hospital Institutional Review Boards: Protocol 92-H-0189: Evaluation of patients with known or suspected heart disease (Screening protocol) (NHLBI-Suburban Hospital) The principal mission of the NIH is the conduct of research that elucidates biological mechanisms, pathogenesis, and treatment of disease. Patients with known or suspected cardiovascular diseases are referred to NHLBI cardiologists for consideration of participation in clinical research protocols. However, eligibility for participation is often uncertain from referral information or even after an outpatient evaluation. The purpose of this protocol is to permit inpatient evaluation of patients for whom participation in clinical research protocols is under consideration in order to determine protocol eligibility by means of conventional laboratory and cardiovascular testing. Protocol 03-H-0250: Technical Development of Interventional Cardiovascular Magnetic Resonance Imaging (NHLBI – Suburban Hospital) Cardiovascular interventional procedures are minimally-invasive, catheter-based treatments such as coronary artery angioplasty and stenting. These procedures generally can be conducted on awake patients with few complications, and were developed as alternatives to conventional open surgery. Conventional cardiovascular interventional procedures are conducted by physicians manipulating medical devices inside patients under the guidance of fluoroscopic x-ray. We are developing minimally-invasive cardiovascular interventional procedures using real-time magnetic resonance imaging, also known as MR Fluoroscopy. These procedures have the advantage of excellent imaging without surgery and without radiation exposure or toxic contrast agent. Moreover, because MR Fluoroscopy can produce excellent images of soft tissue, blood, and of three-dimensional structures, it may be possible to guide minimally invasive procedure not possible even with invasive surgery. Purpose: The purpose of the protocol is to develop and test incremental technical advances in patients. Protocol 03-H-0086: Stem Cell Mobilization for Improvement in Vascular Function and Myocardial Perfusion in Patients Undergoing Cardiac Rehabilitation (NHLBI – Suburban Hospital) This study will look at the effect of a cardiac rehabilitation exercise program on release of stem cells from the bone marrow and on heart function. Stem cells are primitive cells produced and released by the bone marrow, circulate in the bloodstream and develop into white blood cells, red blood cells and platelets. Some stem cells may also develop into other kinds of cells, including those that make up heart muscle, especially if the heart has been damaged or is not getting sufficient blood. Stem cells called endothelial progenitor cells (EPCs) are thought to form new blood vessels that can carry blood to areas of the heart muscle that are oxygen-deprived because of clogged arteries. Previous experiments have shown that some EPCs can be forced out of the bone marrow by exercise. This study will examine whether repeated exercise and lifestyle changes increase the number of EPCs released into the bloodstream and if these cells improve heart and blood vessel function. Protocol TG001-03: A Phase 1-2, Multi-center, Randomized, Double-Blind, Placebo Controlled, Prospective Study to Evaluate the Safety and Potential Efficacy of Single, Increasing Doses of TG100-115 in Subjects Undergoing Percutaneous Coronary Intervention for Acute Anterior ST Elevation Myocardial Infarction (NHLBI – Suburban Hospital) This is an exploratory study designed to obtain preliminary safety and pharmacokinetic date in human subjects with the targeted disease indication. The subjects enrolled into the study will be undergoing percutaneous coronary intervention (PCI) following an acute anterior ST elevation myocardial infarction. The study is a pilot and is not powered to achieve statistical significance but is designed to provide sufficient data for the design of future studies with TG100-115. Therefore a series of endpoints will be used to help define the primary and secondary objectives of future studies. Of particular interest will be the inter-subject variance of infarct size using the two specified methodologies witch will help determine the assessment of infarct size in the pivotal studies. Nuclear imaging studies for this purpose will be conducted at the Clinical Center. Location of Work: Suburban Hospital 8600 Old Georgetown Road, Bethesda, Maryland 20814, Contact Person: Gene Passamani, M.D. Senior Vice President for Medical Affairs, Period of Performance: One (1) year upon award of purchase order. Service to be Performed: Provide nursing support at the site to interview patients for inclusion and/or exclusion, enroll, collect duration of the identified research projects. 2. Develop recruitment strategies to recruit and screen patients for specific studies. Perform telephone screening and/or record reviews of potential study patients to ensure they meet study criteria. 3. Coordinate flow of information regarding cardiology clinical trials from NHLBI Clinical Research Program (CRP) to physicians, staff, patients and appropriate committees at Suburban Hospital in timely and and accurate manner. 4. Obtain patient consent and ensure that informed consent document(s) are understood and signed by subjects and other appropriate parties prior to participation. 5. Serves as a liaison between Suburban and NHLBI CRP physicians and investigators. 6. Determines, with the Principal Investigator and NHLBI lntramural Group, which clinical trials are appropriate to open at Suburban Hospital. 7. Collaborates with Suburban Hospital physicians and staff in order to facilitate patient and physician participation in clinical trials. 8. Obtains and maintains good working knowledge of all Suburban protocols. 9. Determines patient eligibility for studies by reviewing patient history, clinical lab results, pathology, cardiac catheterization and pathology, and radiology reports. 10. Participates in all aspects of data management, including coordinating data collection case report form completion for NHLBI cardiology clinical trials protocols conducted at Suburban Hospital. 11. Maintains/updates regulatory binders for each protocol. Adheres to all protocol requirements to ensure the validity of clinical research patient data. 12. Assists with the maintenance of the research chart each patient. 13.Assists with the development and maintenance of a database of patient & protocol data for all NHLBI protocols conducted at Suburban Hospital. 4. Assists in the development of standard operating procedures for the cardiology research program, including: content & scope of tasks performed by research staff. & specific investigators; data management (abstraction of data from source documents, completion of case report forms, database development & maintenance, quality assurance surveillance, and assurance of patient confidentiality). 15. Assists in conducting quality assurance audits,identifying deficiencies, and proposing resolutions to improve data integrity. 16. Participates in assuring that NHLBI clinical trials conducted through Suburban Hospital are in compliance with the standards of Good Clinical Practice and with the Code of Federal Regulations. 17. Assists in the preparation of required reports for the IRB including applications for new protocols, annual renewals, protocol amendments and revisions, and termination reports. 18. Demonstrates knowledge of techniques, procedures, use of equipment and DHHS, NIH and Suburban policies necessary for job performance. This acquisition is being conducted under simplified acquisition procedures and is exempt from the requirement of Federal Acquisition Regulations (FAR) Part 6, Competition Requirements. The North American Industry Classification System (NAICS) applicable to this requirement is 622310, and Size Standard is $29.0M. This notice of intent is not a request for competitive proposals. Interested parties may identify their interest and capabilities in response to this requirement. The determination by the Government not to compete the proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will be used for informational purposes only. Responses to this announcement, referencing synopsis number NHLBI-PS-2005-0083/DDC, may be submitted by mail to the National Heart, Lung, and Blood Institute, Contracts Operations Branch, Procurement Section, 6701 Rockledge Drive, Rockledge Building 2, Suite 6042, Bethesda, Maryland 20892-7902, Attention: Deborah Coulter. All responsible sources may submit information, which if timely received, shall be considered by the agency. NOTE: THIS NOTICE WAS NOT POSTED TO WWW.FEDBIZOPPS.GOV ON THE DATE INDICATED IN THE NOTICE ITSELF (22-APR-2005); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link to FedBizOpps document.
(http://www.eps.gov/spg/HHS/NIH/NHLBI/NHLBI-PS-2005-083-DDC/listing.html)
- Place of Performance
- Address: BETHESDA MARYLAND
- Record
- SN00794149-F 20050424/050422213017 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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