SOLICITATION NOTICE
Q -- 24 Hour Urine Collection
- Notice Date
- 2/17/2011
- Notice Type
- Presolicitation
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-CSB-(HL)-2011-085-DDC
- Archive Date
- 3/10/2011
- Point of Contact
- Deborah - Coulter, Phone: (301) 435-0368
- E-Mail Address
-
dc143b@nih.gov
(dc143b@nih.gov)
- Small Business Set-Aside
- N/A
- 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 COAC Services Branch, Office of Acquisitions, DERA, National Heart, Lung, and Blood Institute (NHLBI), NIH, intends to negotiate with Litholink Corporation, 2250 West Campbell Park Drive, Chicago Illinois 60612, for the following services outline in the statement of work.. Background Information: Cardiovascular disease (CVD) is the leading cause of death and serious illness in the United States. The objective of the Framingham Heart Study is 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. Chronic kidney disease is a major public health problem and biomarkers to identify early renal injury are limited. This project will capitalize on prior work of Dr. Caroline Fox to identify new markers of kidney function to better identify individuals at risk for disease. Purpose and Objectives: The purpose and objectives of this project is to obtain 24-hour urine information from the Framingham Heart Study. Electrolyte status offers physiologic insight into the metabolic health of individuals. The quantification of 24-hour urinary electrolytes provides more information regarding the total physiologic balance of electrolyte metabolism within the individual. Urinary electrolytes offer novel insight into renal and metabolic heath, and may help identify individuals at risk for vascular disease risk factors before the development of overt clinical disease. This project will be implemented with the Litholink Company. Contractor Requirements: a. The Contractor shall provide electrolyte assay services to measure a panel of urinary electrolytes in 510 urine samples, and all NHLBI samples are to be processed at the contractor's location. b. The Contractor is required to provide high quality assay results with CVs generally less than 10% c. Quality control measures shall be applied by the contractor and assay results will be accompanied by quality control information reflecting intra- and inter-assay CVs. d. The contractor shall specify any special packaging, marking, or shipping instructions for sample shipment e. The contractor is required to identified each urine sample received by using the identifiers provided by NHLBI f. The contractor shall aliquot off a separate tubule of urine for each participant, totaling 10 cc and shall be frozen at -80 degrees C. g. The contractor is to include a flier created by the Framingham Heart Study n the 24-hour urine kits h. The contractor is responsible for sending the required urinary kits with detailed instructions (for both test completion and return mail) to each participant in the study Reporting Requirements and Deliverables: a. Assay results will be returned by Contractor to NHLBI in a standard format in a nonproprietary database in which each analyte is identified by a standard name b. Return of assay results by the Contractor will be accompanied by summary quality control measures for each analyte c. Assay results will be returned to NHLBI within 10 business days of receipt of urine samples Program Management and Control Requirements: No special management or control systems are required under this contract Government Responsibilities: The government (NHLBI Framingham Heart Study Participants) will provide to the Contractor urine in tube via mail per the instructions in the urinary kits received by each participant from the Contractor. The study participants will have 3 business days to return the urine samples to the Contractor via mail according to the instructions specified by the Contractor. In addition, the Government will provide a list of identifiers for urine samples Period of Performance: The period of performance shall be from March 15, 2011 -September 30, 2011 not to exceed six months. The sole source determination is based on the results 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 metabolic risk factors in the pathogenesis of CVD. Chronic kidney disease (CKD) is an important risk factor for CVD and an important public health problem. The most severe stage of CKD, dialysis or transplantation, affects over 500,000 patients in the United States. Earlier stages of CKD are common, affecting 13% of adults in the United States, and 16 million individuals have reduced kidney function (CKD stages 3-5). In addition to increasing the risk for end-stage renal disease and a range of complications including anemia and bone disease, CKD increases the risk of cardiovascular disease and all-cause mortality. Electrolyte status offers physiologic insight into the metabolic health of individuals. We have shown that genome-wide association of serum magnesium,10 calcium,11 phosphorous, and uric acid can identify many important transporters in the kidney associated with maintaining electrolyte balance. However, serum electrolytes are an imperfect measure of electrolyte metabolism, as many analytes are maintained within narrow, physiologic ranges in the serum. Thus, the quantification of 24-hour urinary electrolytes may provide more information regarding the total physiologic balance of electrolyte metabolism within the individual. Urinary electrolyte status has already been shown to be associated with body mass index, hypertension, and kidney stones. Urinary creatinine obtained from 24-hour urines are a good measure of total body lean mass and a strong predictor of mortality. Despite this, there has been relatively little exploration of 24-hour urine data in large population-based studies. This project involves the contractor performing the 24-hr urine assessment in the first year of the Offspring 9 and Omni exam 4 exams. This project involves the contractor performing the 24-hour urine collection and quantification on 510 individuals, and promptly returning the data within 30 days to the Framingham Heart Study, located at 73 Mt. Wayte Avenue, Framingham, MA. 01702. The notice of intent is not a request for competitive proposals. Only one responsible source and no other supplies or services will satisfy agency requirements. Industry Classification (NAICS) Code is 621511, Medical Laboratories with size standard of $13.5 million; this is a small business set-aside.. 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) and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-49 (January 24, 2011). This notice of intent is not a request for competitive proposals. Interested parties may identify their interest and capabilities in response to this synopsis, by February 23, 2011, 7:30am Eastern Standard Time. 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 normally be considered solely for the purpose of determining whether to conduct future competitive procurement. Inquires to this announcement, referencing synopsis number NHLBI-CSB-(HL)-2011-085-DDC, may be submitted to the National Heart, Lung and Blood Institute, Office of Acquisition, Procurement Branch, 6701 Rockledge Drive, Suite 6042, 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.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-CSB-(HL)-2011-085-DDC/listing.html)
- Place of Performance
- Address: NIH, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02382894-W 20110219/110217234742-b29f68f51eab36b0f25bad59d5e80bac (fbodaily.com)
- Source
-
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