SOLICITATION NOTICE
B -- Bio Analytical Testing Services for Clinical Study
- Notice Date
- 6/28/2011
- Notice Type
- Presolicitation
- NAICS
- 541380
— Testing 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-(HG)-2011-237-DLM
- Archive Date
- 7/22/2011
- Point of Contact
- Dorothy Maxwell, Phone: 301-435-0352
- E-Mail Address
-
maxwelld@mail.nih.gov
(maxwelld@mail.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 National Heart, Lung, and Blood Institute (NHLBI) Office of Acquisition (OA) intends to negotiate and award a purchase order on a noncompetitive sole source basis to Bio Analytical Research Corporation (BARC) USA, Inc., 5 Delaware Drive, Suite 2, New Hyde Park, New York 11042-1100 to procure the services outlined below: The sole source determination is based on the fact that National Institute of Health (NIH) is the nation's leading medical research agency and the primary Federal agency conducting and supporting making medical discoveries that improve people's health and save lives. The National Human Genome Research Institute (NHGRI), mission of the Center for Research on Genomics and Global Health (CRGGH) is to investigate the potential role of genetic and environment factors in the development of complex diseases such as Type 2 diabetes, obesity and hypertension. The center has been recruiting participants around the world to better characterize and understand the pathophysiology of these diseases. Even though during the recruitment process, we obtain the medical history of each participant, it remains self-reported and cannot be solely used to conduct the type of analyses required for our understanding of the molecular and cellular processes involved in the complexity of the diseases the center is investigating. Therefore the center has a need to gather quantitative data not only for data analyses purposes but also to have a high- quality measured phenotypes to accurately group and identify the participants in the cohorts. One of the methods validated and commonly used by the health and scientific communities to unmistakably group individuals by specific phenotypes are panels of clinical and biochemical markers. These biochemical panels can be general or specific to a disease. Purpose and Objectives : • The Contractor's laboratory uses the same biochemical assay that CRGGH center has used on all previous samples. This is important to alleviate inter-assay variations. Using the same procedure will also ensure that we can merge the new data with existing data without compromising the quality of our research. • The Contractor has in place a rigorous quality control procedure that allows tracking and identifying the samples throughout the processing of the samples; for sample tracking, labels are printed with the clients provided sample ID. Labels are attached to all processing tubes. • The Contractor has relatively short turnaround time to process samples and makes the results available to CRGGH. • The Contractor has a long standing experience with clinical trials, medical testing, research samples and logistics not only in US but worldwide. • The Contractor's laboratories operate under a global quality assurance system and global standard operating procedures. They are accredited according to international and national quality standards including ISO, CA, and CLIA License. Objectives : 1. Study Set-Up which includes : • Preparation of a study specific database • Review of testing and requirements by clinical pathologist 2. Logistic Support : • Tracking of samples in transit 3. Clinical Lab Testing : • Analysis of the requested tests under stringent quality control (Measurement serum level of Glucose, lipids, uric acid, insulin, renal markers.) • Flagging and reporting of alert values to site and Sponsor representatives • Quality Assurance 4. Clinical Study Support : • Project Manager and Project Assistant as communication interface for study related issues Contractor Requirements : • The Contractor will perform testing within 5 business days of receipt of samples. Special handling or packaging requirements : • Samples will be received by the Contractor in IATA650 compliant shipping materials. • Samples will be stored on-site at -70 C until testing and for a period of 3 months after testing should retesting be required. • For clinical testing, well-conserved specimens are required. Serum or plasma samples should be frozen after separation from the whole blood and kept frozen during transportation. Conventionally, anti-coagulated peripheral blood collected in EDTA, Na-Citrate, or Heparin-containing vacutainers are the sources of serum or plasma. The Biochemistry panel (lipids, glucose, potassium, chloride, sodium, total protein, uric acid, creatinine, and BUN will be run on the Roche Diagnostics platform, Roche modular P. Insulin will be run on Elecsys 2010. Government Responsibilities : • The Government will provide furnished data, property, or facilities to the Contractor. • The Government will be responsible for reviewing and approving reports and similar matters generated. • All results will be provided to the NIH via data transfer upon completion of testing. • The Government will not provide furnished equipment to perform the study. Samples and associate sample documentation (sample ID numbers, descriptions) is provided to the Contractor. Government authorized personnel will be required to review the label information prior to finalization. • The Government will be responsible for retrieving and shipping the samples to the Contractor. Reporting Requirements and Deliverables : 1. The deliverable from the Contractor is to provide a database containing all the measured tests. The Contractor will provide the following reports, upon request or using a predetermined scheduled from the client • Sample inventory reports • Shipping reports • Receiving reports • Invoices • Online results reporting (LabPhone) Program Management and Control Requirements : The Contractor has in place SOPs, worksheets, and batch records to record all manipulations. Analyzer calibrations are performed in compliance with the Contractor's SOP's. Inspection and Acceptance Requirements : • The Contractor will report Thawed samples to the NIH and will be tested. • The Government will accept sample runs from the Contractor based on QC (quality) checks. • The Contractor is required to notify the Government if re-testing is required and communicate to the Government. • All final results will be inspected/accepted by the NIH. Industry Classification (NAICS) Code is 541380, Testing Laboratories, with size standard of $12.5M. 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) 05-52 (May 31, 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 July 7, 2011, 7:30 a.m. 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-(HG)-2011-237-DLM, may be submitted to the National Heart, Lung and Blood Institute, Office of Acquisition, COAC Services Branch, 6701 Rockledge Drive, Suite 6149, Bethesda, Maryland 20892-7902, Attention: Dorothy Maxwell. Response may be submitted electronically to maxwelld@mail.nih.gov. Faxes will not be accepted. Responses will only be accepted if dated and signed by an authorized company representative. Note: In order to receive an award from the NHLBI, contractors must have a valid registration in the Central Contractor Registration (CCR) www.ccr.gov, and ORCA https://orca.bpn.gov/login.aspx.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-CSB-(HG)-2011-237-DLM/listing.html)
- Place of Performance
- Address: Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02484025-W 20110630/110628234546-998828e027d3b4c2e66ed23c202dac51 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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