Clinical chemistry measurements in the Framingham Heart Study

INTRODUCTION: THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Heart, Lung, and Blood Institute (NHLBI) Office of Acquisition (OA) on behalf of the of the Population Sciences Branch/Framingham Heart Study (NHLBI), intends to negotiate and award a purchase order on a noncompetitive sole source basis without providing for full and open competition to Trustees of Boston University, 72 East Concord St, B-606, Boston, MA 02118 to procure the study of Clinical chemistry measurements in the Framingham Heart Study. Procurement: Contractor Requirements: - Contractor will provide metabolite profiling services on 5000 FHS samples plus duplicates for quality assessment. - The Contractor will provide high quality assay results and will provide coefficient of variations for the urinary metabolites. - Quality control measures will be applied by the Contractor and assay results will be accompanied by quality control information reflecting metabolite QC. - Contractor will specify any special packaging, marking, or shipping instructions for sample shipment. - Each sample received will be identified by the Contractor using the identifiers provided by NHLBI. - Contractor shall provide a letter from the manufacturer stating they are in authorized to perform the above services Analytes to be measured are: 1. Cortisol 2. PTH 3. Vitamin D 4. Fructosamine 5. Creatine 6. Albumin Background: Cardiovascular disease (CVD) is the leading cause of death and serious illness in the United States. In 1948, the Framingham Heart Study -- under the direction of the National Heart Institute (now known as the National Heart, Lung, and Blood Institute; NHLBI) -- embarked on an ambitious project in health research. At the time, little was known about the general causes of heart disease and stroke, but the death rates for CVD had been increasing steadily since the beginning of the century and had become an American epidemic. The objective of the Framingham Heart Study was to identify the common factors or characteristics that contribute to CVD by following its development over a long period of time in a large group of participants who had not yet developed overt symptoms of CVD or suffered a heart attack or stroke. The Framingham Heart Study continues to make important scientific contributions by enhancing its research capabilities and capitalizing on its inherent resources. New diagnostic technologies, such as echocardiography (an ultrasound examination of the heart), carotid-artery ultrasound, bone densitometry (for monitoring osteoporosis), and computerized tomography of the coronary arteries, are evaluated and integrated into ongoing protocols. While pursuing the study's established research goals, the NHLBI and the Framingham investigators are expanding their research into other areas such as the role of genetic factors in CVD. Framingham investigators also collaborate with leading researchers from around the country and throughout the world on projects in stroke and dementia, osteoporosis and arthritis, nutrition, diabetes, eye diseases, hearing disorders, lung diseases, and genetic patterns of common diseases. Purpose and Objective: The objective of the Framingham Heart Study was to identify the common factors or characteristics that contribute to CVD by following its development over a long period of time in a large group of participants who had not yet developed overt symptoms of CVD or suffered a heart attack or stroke. The Framingham Heart Study continues to make important scientific contributions by enhancing its research capabilities and capitalizing on its inherent resource. The purpose of this project is to perform a study of urinary and plasma clinical chemistry measurements using the FHS Roche e411 and c501 clinical lab analyzers located in Framingham Massachusetts. Period of Performance: Period of performance is schedule from 9/25/2013-9/24/2014 Government Responsibilities: To provide the necessary supplies for completion of research To provide assay kits in order to conduct the research Reporting Requirements and Deliverables: - Raw data will be cleaned and returned to FHS for data processing - Data will be posted to NIH dbGaP website Justification: Refer to attached Justification and Approval Regulatory Authority: This acquisition is conducted under the authority of the Federal Acquisition Regulations (FAR) Subpart 13.106-1(b) Soliciting from a single source, only one responsible source and no other supplies or services will satisfy agency requirements. ADDITIONAL INFORMATION Industry Classification (NAICS) Code is 541380 and the Small Business Size Standard is $14.0M. The acquisition is being conducted under FAR Part 13, simplified acquisition procedures, therefore the requirements of FAR Part 6 B Competitive Requirements are not applicable (FAR Part 6.001). The resultant Contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-69 (August 1st 2013). This requirement is under the SAT of $150,000.00. This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses must be received by September 13, 2013, 9:00 am eastern standard time and must reference synopsis number HHS-NIH- NHLBI-CSB-(HL)-2013-227-DDC, may be submitted to the National, Heart, Lung and Blood Institute, Office of Acquisition, COAC Services Branch, 6701 Rockledge Drive, Suite 6142, Bethesda, Maryland 20892-7902, Attention: Deborah Coulter. Response may be submitted electronically to coulterd@nhlbi.nih.gov. Faxes will not be accepted. Responses will only be accepted if dated and signed by an authorized company representative. "All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency."