SOLICITATION NOTICE
Q -- Genetic Testing Services
- Notice Date
- 3/24/2011
- Notice Type
- Presolicitation
- NAICS
- 621111
— Offices of Physicians (except Mental Health Specialists)
- 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)-2011-145-DLM
- Archive Date
- 4/13/2011
- 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 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), 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. Baylor Genetic Laboratories (BGL) is a CLIA-certified biochemical and molecular tests, expert interpretations, and prompt reporting of rare or new genetic disorders, specifically mitochondrial disorders. BGL is a diagnostic laboratory functioning as part of the Baylor academic medical center in Houston, TX. BGL has devoted its efforts exclusively to providing biochemical and molecular testing for genetic syndromes, inborn errors of metabolism, and mitochondrial diseases for clinical and research programs around the country. Most of the programs Baylor interacts with have complex clinical trials and/or patients with uncharacterized disorders like the patients seen here in the Undiagnosed Diseases program (UDP). Accordingly, BGL 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. BGL support the goals of the UDP. BGL are unique because they have developed assays for multiple tissues (blood, urine, fibroblasts, muscle, liver and heart tissue), can perform complex biochemical and molecular testing for a large range of genetic disorders across the lifespan, plus have particular research and diagnostic expertise in mitochondrial diseases that is not offered elsewhere in the United States. Contractor Requirements 1. The Contactor 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 Contractor will contact the UDP 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: The Government will provide to the Contractor: a. The government will not furnish any government property to the vendor. b. Patient samples will include; isolated DNA, blood, urine, fibroblasts, skeletal muscle or liver tissue as the patient condition and evaluation warrants. c. The Government will send all patient samples via Fed-Ex within 24 hours of obtaining the samples to Contractor for testing d. The Government will not furnish any facilities to be used by the vendor The Governments will be responsible 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 the Contractor receiving the patient samples. 2. The Government will receive additional reports for any test added-on after the Contractor 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. Industry Classification (NAICS) Code is 621111, Office of Physicians (except Mental Health Specialists), with size standard of $10.0M. 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 March 28, 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)-2011-145-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)-2011-145-DLM/listing.html)
- Place of Performance
- Address: NIH, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02408860-W 20110326/110324234854-84d8f49a94ede1bbd9576e12f833fcc9 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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