SOLICITATION NOTICE
Q -- Genetic Testing Services
- Notice Date
- 3/31/2011
- 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-(HG)-2011-153-DLM
- Archive Date
- 4/20/2011
- 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 Medical Neurogenetics, 1 Dunwoody Park, Suite 250, Atlanta, Georgia 30338-6723 to provide genetic testing for Undiagnosed Diseases Program for rare and new genetic disorders, specifically, cerebral spinal fluid. The sole source determination is based on the fact that National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary Federal agency conducting and supporting medical discoveries that improve people’s health and save lives. The National Human Genome Research Institute (NHGRI), Undiagnosed Disease Program (UDP) is a pilot program designed to address the needs of persons with debilitating medical conditions for which no diagnosis has been found despite an extensive workup. The goals of the UDP include finding accurate diagnoses and discovering new diseases that provide insight into human physiology and genetics. The UDP was established to evaluate participants who have undiagnosed medical conditions. UDP participants have generally received extensive diagnostic workups before traveling to the NIH and often have numerous and/or complex medical problems. The UDP program makes use of a diverse set of diagnostic and research techniques both to attempt to find a diagnosis and to generate research projects to advance medical knowledge. The DIR-NHGRI- Undiagnosed Diseases program (UDP) protocol 76-HG-0238 are connected to this clinical testing. Under this protocol, patients with long-standing, complex undiagnosed diseases are admitted to the NIH Clinical Center for comprehensive evaluation to discover new genetic disorders and/or potential treatments. To date, the Undiagnosed Diseases program has made 47 diagnoses, which is about 15% of the total number of patients seen in this protocol to date. Ongoing research continues to find diagnosis on the other patients who have been seen in the UDP to date. Medical Neurogenetics Laboratories (MNG) is a CLIA-certified biochemical and molecular laboratory providing expert interpretations, and prompt reporting of rare or new genetic disorders, specifically found only in cerebral spinal fluid (CSF). Medical Neurogenetics (MNG) is a diagnostic laboratory functioning as an independent lab, research and clinical facility. MNG has devoted its efforts exclusively to providing biochemical and molecular testing for genetic disorders and inborn errors of metabolism found only in CSF for clinical and research programs around the country. Most of the programs MNG interacts with have complex clinical trials and/or patients with uncharacterized disorders like the patients seen here in the Undiagnosed Diseases program (UDP). Accordingly, the MNG organization, staff, facilities, and work methods have been developed for the purpose of supporting clinical diagnostics and research, resulting in a high level of specialized expertise. MNG supports the goals of the UDP and are unique because they have developed assays for CSF and can perform complex biochemical and molecular testing for a large range of genetic disorders across the lifespan with particular attention to research and diagnosis of CSF diseases that is not offered elsewhere in the United States. Contractor Requirements: 1. The Contractor will provide a wide-range of tests as outlined in the attachment with family follow up as needed, as well as supports the ongoing collaborative research expertise needed by the NHGRI, UDP. 2. The Contractor will provide unique services specific to complex mitochondrial disorders as well as deletion and duplications studies for multiple rare biochemical disorders that meets the program goals of the UDP. 3. The Contractor’s turn-around-time for UDP to receive results will be 2-4 weeks. 4. The Government will be contacted if any patient results need to be evaluated urgently for impact on caring for patients in the UDP. 5. The Contractor will supply faxed copies of all patient reports for the study file and medical record. Government Responsibilities: List of Government-furnished data, property, or facilities to be provided to the vendor. a. The government will not furnish any government property to the vendor. b. Patient samples will include; CSF primarily and isolated DNA or fibroblasts as needed for confirmatory testing, as the patient condition and evaluation warrants. c. We will send all patient samples via Fed-Ex within 1 week of obtaining the samples to MNG for testing d. The government will not furnish any facilities to be used by the vendor The Governments responsibility for reviewing and approving reports and similar matters generated. a. Abnormal results will be provided via phone, with follow up fax, directly to the ordering Clinician who can plan appropriate follow up with other members of UDP caring for the patient/family impacted by the result(s). b. All confirmed abnormal diagnostic test results will be released to the referring clinician and patient/family. Reporting Requirements and Deliverables: Itemize all progress, management, financial and fiscal or other reporting requirements and the frequency of their generation, or specific dates when due. 1. The Government will receive all written results of patient samples within 2-4 weeks of MNG receiving the patient samples. 2. The Government will receive additional reports for any test added-on after MNG receives the original specimen. 3. The Government will receive additional reports for any parental or sibling testing done for the clarification of a new genetic disease. Program Management and Control Requirements Any internal management and control systems, either specified by the Government or to be developed by the vendor/contractor. Industry Classification (NAICS) Code is 621511, Medical Laboratories, with size standard of $13.5M. 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) 05-50 (March 16, 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 April 5, 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)-2011-153-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)-2011-153-DLM/listing.html)
- Place of Performance
- Address: NIH, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02414532-W 20110402/110331235015-fa63473c9f2e13dd11110817c578d9d7 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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