SOLICITATION NOTICE
R -- Genome Transplant Dynamics Antibody Testing
- Notice Date
- 9/8/2016
- Notice Type
- Presolicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- 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-2016-308-KMA
- Archive Date
- 9/29/2016
- Point of Contact
- Kevin Alvarez,
- E-Mail Address
-
kevin.alvarez@nih.gov
(kevin.alvarez@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- INTRODUCTION 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 The Johns Hopkins University, 3400 N Charles St, Baltimore, MD, 21218, to perform HLA and non-HLA antibody testing for Dr. Hannah Valentine's laboratory within NHLBI's Division of Intramural Research. BACKGROUND Dr. Valentine has studied the causes of heart-transplant rejection since the beginning of her clinical medicine career. Her research has led to fundamental discoveries about why heart transplants fail, including the pathogenesis of CAV. She has made significant contributions to areas such as the use of echocardiography for evaluating transplant rejection, the role of insulin sensitivity on cardiac allograft adverse outcomes, clinical testing of next-generation immunosuppressive agents to improve patient outcomes, and most recently, non-invasive methods to monitor transplant rejection. After organ transplantation, some patients produce antibodies against the transplanted organ (graft). A fraction of these patients develop rejection (and may die), while others with the same antibodies do not develop rejection and do just fine. The reason for this observed difference is still not known. The lab suspects that the patients who develop rejection undergo injury on their graft caused by the antibodies. So far, there is no research to show whether or when these antibodies cause injury to the graft. The lab's existing clinical tool for detecting graft injury-biopsy is insensitive and often misses graft injury when it occurs. Attempting to use this tool to characterize when and how these antibodies cause injury has been limited with variable results. The lab has developed a more sensitive tool-cell-free DNA that detects graft injury better and often weeks to months before biopsy. This newer tool is quite sensitive and may provide a mechanism to assess the correlation between these antibodies and graft injury in transplant patients. Thus, we will like to assess whether and when these antibodies cause injury using this new sensitive tool. Several groups have reported two types of antibodies that a patient may produce after transplantation, HLA and non-HLA antibodies. Both of these antibodies are associated with transplant rejection and early death. While most clinical laboratories are able to measure HLA antibodies, only Johns Hopkins University measures the non-HLA antibodies. Measuring only HLA antibodies will miss a subset of transplant patients who only develop anti-HLA antibodies. Additionally, these two antibodies are different and may not have the same significance in transplant patients. Thus, it is critically important to assess the importance of both antibodies using this novel more sensitive tool-cell-free DNA. PURPOSE The purpose of this acquisition is to procure the services of an outside contractor to perform HLA and non-HLA antibody testing for Dr. Hannah Valentine's laboratory within NHLBI's Division of Intramural Research. This testing will assess when and if these antibodies cause injury to the transplanted organ (graft) as a mechanism towards the associated early mortality. JUSTIFICATION The sole source determination is based on the fact that Johns Hopkins University's Immunogenetics Laboratory is the only institution that offers non-HLA antibody testing. We must have this crucial data in addition to the HLA antibody testing in order to receive the most complete data set on which to base future studies. 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 541990, All Other Professional, Scientific, and Technical Services, and the Small Business Size Standard is $15.0 million. 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) 05-89 (August 15th, 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 September 14, 2016 at 9:00AM EST and must reference synopsis number NHLBI-CSB-HL-2016-308-KMA. Responses shall be submitted to the National Heart, Lung, and Blood Institute, Office of Acquisitions, COAC Services Branch, 6701 Rockledge Drive, Room 6127, Bethesda, Maryland 20892-7902, Attention: Kevin Alvarez. Responses may be submitted electronically to kevin.alvarez@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."
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- Record
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