SOLICITATION NOTICE
66 -- PAP-8E Aggregometry System Test Tubes / Cells / Stir Bars
- Notice Date
- 2/12/2016
- Notice Type
- Presolicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- 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-2016-085-JML
- Archive Date
- 3/5/2016
- Point of Contact
- Jonathan M. Lear,
- E-Mail Address
-
john.lear@nih.gov
(john.lear@nih.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION. The National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA), intends to negotiate and award a purchase order on a noncompetitive sole source basis to Bio/Data Corporation, 155 Gibraltar Road, Horsham, PA 19044-2303, to provide the PAP-8E Aggregometry System Test Tubes / Cells / Stir Bars to the NHLBI Division of Intramural Research (DIR). BACKGROUND The Population Sciences Branch (PSB) in the Division of Intramural Research (DIR) of the National Heart, Lung, and Blood Institute (NHLBI), is involved in the study of blood diseases and genetic associations for measurable blood traits. Part of the branch is particularly focused on the biology of platelet reactivity and population variation and associations with such measures. As part of the research, the laboratory requires collection of new Platelet Reactivity and Blood Cell count data in the NHLBI Framingham Heart Study. PURPOSE The laboratory will test both platelet rich plasma (PRP) aggregometry and whole blood based aggregometry using three (3) different systems. These systems are tested separately because whole blood provides the context of platelet reactivity / function when in the environment of other cell types (e.g., white cells). Platelet reactivity data collected at population scales (i.e., thousands of samples) is rare in research studies. These data will provide Government scientists a valuable resource to make new genetic and epidemiological discoveries relating to Platelet biology, a system that is targeted for many pharmaceutical interventions. A known issue of major importance in the platelet reactivity field that must be addressed is batch to batch variation in platelet agonists, as well as inconsistencies across different suppliers of the same agonists (these are the critical reagents that induce platelet reactivity). Thus, to ensure the validity of data across all three (3) testing systems, the lab requires a contractor that can provide dedicated Lots / Batches of platelet agonists to test ~2,000 samples over 1.5 years. This contractor must have a track record for providing high quality agonists. They must also be able to store at their site dedicate Lots for our project for an extended period of time and deliver subsets of these lots on demand over the period of performance. The lab also requires test cells, stir bars, and test kits that are specifically manufactured for the PAP-8E equipment in order to conduct this research. PROCUREMENT The contractor shall provide the PAP-8E Aggregometry Test Tubes / Cells / Stir Bars with the following quantities: - Micro Test Tubes, Siliconized (100 pcs.) (Qty. 180) - Micro Stir Bars (50 pcs.) (Qty. 320) - ADP (3x0.5mL) (Qty. 70) - Arachidonic Acid (3x0.5mL) (Qty. 40) - Collagen (3x0.5mL) (Qty. 120) - Epinephrine (3x0.5mL) (Qty. 70) - AggRecetin (1.0-1.5mg/mL) (Includes 2.0 mL diluent) (Qty. 60) - TRAP-6 amide kit (50 tests per vial) (Qty. 40) - U46619 (1mg) (Qty. 7) - LTA Check Performance Test Kit (2 Tests per Year) (Qty. 3) - LTA Check Software (Qty. 1) JUSTIFICATION The sole source justification is based on the fact that there are very few contractors that provide equipment for platelet reactivity testing. The lab has previously purchased the Bio/Data Corporation PAP-8E aggregometer. In order to use the system for data acquisition, the lab requires specific test tubes / cells and stir bars that fit the PAP-8E system. The lab also requires test diagnostic kits to ensure the system is running properly. These items are all specific to the PAP-8E system and are not available from any other manufacturer. Bio/Data Corporation has proven capability to produce and provide a wide range of platelet agonists in large quantities and at high quality. For this project the lab requires the manufacture / delivery of seven (7) different platelet agonists from Bio/Data (ADP, Arachidonic Acid, Collagen, Epinephrine, Ristocetin, TRAP-6 amide, U46619). A known issue of major importance in the platelet reactivity field that must be addressed is batch-to-batch variation in platelet agonists, as well as inconsistencies across different suppliers of the same agonists (these are the critical reagents that induce platelet reactivity).Thus, Bio/Data is able to manufacture large lots of all seven (7) agonists that will be dedicated mostly to the lab's needs to reduce the impacts of batch-to-batch variation. They must store and deliver on demand subsets of dedicates Lots to the lab over a period of ~2 years so that we can conduct high quality testing of ~2,000 samples. Bio/Data has a track record for providing high quality agonists and tests the integrity of each batch and reports quality control metrics so the lab can adjust protocols accordingly. Bio/Data is also able to store dedicated Lots at their site for this project for an extended period of time and deliver subsets of these lots on demand over the period of performance. Furthermore, Bio/Data can supply calf-tendon derived Type I collagen agonist, whereas some contractors supply equine-tendon derived Type I collagen. The properties and activities of calf-derived and equine-derived collagen are known to be quite different, and thus dramatically effect research outcomes (as NHLBI has previously showed in genetic studies: Johnson et al. 2010 Nature Genetics). The lab has also acquired the BioData PAP-8E aggregometer and so BioData will stand by and guarantee the quality of the delivered agonists since they know the lab will largely employ them on their own system. The lab previously collected platelet reactivity data from ADP, Epinephrine and Type I calf-tendon derived Collagen using BioData supplied agonists in a different sample (Framingham Gen2 sample, ~1991-1995). In order to increase the potential to compare new results with this historical Framingham data, the best option is to once again use BioData supplied agonists (e.g., calf-derived collagen) for this award. 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 (for purchases not exceeding the simplified acquisition threshold) and only one responsible source and no other supplies or services will satisfy agency requirements. ADDITIONAL INFORMATION Industry Classification (NAICS) Code is 334516, Analytical Laboratory Instrument Manufacturing, and the Small Business Size Standard is 500. The acquisition is being conducted under FAR Part 13, Simplified Acquisition Procedures, therefore the requirements of FAR Part 6, Competitive Requirements, are not applicable (FAR Part 6.001). The resultant award will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-86 (February 1, 2016). 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 February 19, 2016 at 3:00PM EST and must reference synopsis number NHLBI-CSB-(HL)-2016-085-JML. Responses shall be submitted to the National Heart, Lung, and Blood Institute, Office of Acquisitions, COAC Services Branch, 6701 Rockledge Drive, Room 6151, Bethesda, Maryland 20892-7902, Attention: Jonathan Lear. Responses may be submitted electronically to john.lear@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."
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-CSB-HL-2016-085-JML/listing.html)
- Place of Performance
- Address: National Institutes of Health / NHLBI, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN04019430-W 20160214/160212234406-0dd43774b2ae4bea8b8c04d1b6d83bd5 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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