SOLICITATION NOTICE
Q -- Genetic Testing Services (Follow-On)
- Notice Date
- 2/13/2013
- 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
- HHS-NIH-NHLBI-CSB-(HG)-2013-083-DLM
- Archive Date
- 3/6/2013
- 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
- INTRODUCTION: 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. This is a pre-solicitation / notice of intent synopsis for a sole source noncompetitive award to Medical Neurogenetics for genetic testing. The National Heart, Lung, and Blood Institute (NHLBI) Office of Acquisition (OA) on behalf of the National Human Genome Research Institute, (NHGRI), intends to negotiate and award a purchase order on a noncompetitive sole source basis to Medical Neurogenetics, One 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 (CSF), including neurotransmitters, mitochondrial and inflammatory markers to diagnosis disorders of brain chemistry. BACKGROUND : This is a follow-on requirement. The 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 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, Clinical Trial Number: NCT00369421 is connected to this clinical testing, which began in 2008 as a vehicle for admitting patients with broader range of inborn errors of metabolism. Under this observational protocol study, 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. The UDP program has made 47 diagnoses, which is about 20% of the total number of patients seen in this protocol to date. The Researchers in the Protocol study intend on diagnosing and treating certain inborn errors of metabolism. By doing this, researchers hope to expand their knowledge about these disorders and provide access to patients of interest for research, teaching, and clinical experience. Patients enrolled in this protocol have been referred with a known or suspected inborn error of metabolism, heritable disorder, or genetic predisposition. Patients participating in this study will be examined and treated on an outpatient basis, if practical. However, patients requiring specialized tests or treatments will be admitted to the NIH Clinical Center as necessary. Researchers will use only accepted medical procedures in diagnosing (medical history, physical examinations, X-ray studies, eye examinations, blood tests, and urine tests) and treating the patients involved in this study. PERIOD OF PERFORMANCE : Base: February 2013 through September 30, 2013 Option Year One: October 1, 2013 through September 30, 2014 Option Year Two: October 1, 2014 through September 30, 2015 Option Year Three: October 1, 2015 through September 30, 2016 Option Year Four: October 1, 2016 through September 20, 2017 PROJECT DESCRIPTION: The Contractor will apply the following test samples and additional samples as needed for this protocol study: CSF Amino Acids; CSF Lactate; CSF 5-Methyltetrafolate; CSF Tetrahydrobiopterin-Neopterin Profile; CSF Neurotransmitters; CSF 5-Phosphate; CSF Succinyladenosine; CSF Sialic acid; CSF Alpha-Aminoadipic semialdehyde; GCH1 Enzyme Analysis; Aicardi-Goutieres Full Gene Sequencing Analysis Panel (5 genes); and GTP Cyclohydrolase Enzyme Assay. Objectives: • The Contractor shall provide state-of-the art testing of cerebral spinal fluid (CSF) for disorders of brain chemistry; and • The Contractor shall provide Clinical Laboratory Improvement Amendments (CLIA) - certified biochemical testing for patients within the National Human Genome Research Institute (NHGRI), Undiagnosed Disease Program (UDP). Specifically, this laboratory provides highly specialized testing of CSF including neurotransmitters, mitochondrial and inflammatory markers to diagnosis disorders of brain chemistry and supports the research needs of the UDP by collaborating on clinically identified new and rare diseases. CONTRACTOR REQUIREMENTS : A. Specific Tasks: 1. The Contractor shall provide cutting edge analysis of cerebrospinal fluid (CSF) for disorders of brain chemistry. 2. The Contractor shall provide highly specialized analysis of CSF markers of systemic mitochondrial and/or inflammatory disorders. 3. The Contractor shall add new tests as available. B. Desired Results/Functions/End Items : 1. The Contractor shall provide CLIA-certified test results with qualified interpretations in a timely way given the requirements of the particular test the UDP Clinicians request. 2. The Contractor's research collaborations will be conducted via Teleconferences, email communications, shared professional presentations, posters and publications. Grand Round presentations at the Contractor's and in-house may also occur. C. Technical Specifications/Standards/Methods : • The Contractor shall supply CLIA-certified test results with qualified interpretations. D. Special Handling or Handling Requirements : • The Contractor shall provide Result Reports in a secure HIPAA compliant manner. E. Government Requirements : • The Government will appropriately handle packaging and shipping of specimens per requirements of the particular test the UDP Clinicians order and the terms of outlined by the Contractor for the given test. F. Reporting Requirements and Deliverables : 1. The Contractor shall supply CLIA-certified test results with qualified interpretations in a timely way given the requirements of the particular test the UDP Clinicians request. The Government will receive within 2-4 weeks depending on the test ordered. 2. Research collaborations will be ongoing as new disorders are identified or confirmed by the Contractor. JUSTIFICATION: This requirement cannot be competed because of the proposed contractor's unique qualifications. This is a follow on requirement that involves the DIR-NHGRI-Undiagnosed Diseases program (UDP) protocol 76-HG-0238, Clinical Trial Number: NCT00369421. REGULATORY AUTHORITY: This acquisition is conducted under the authority of 41 U.S.C. 253(c) as set forth in FAR Part 6.302-1(b), only one responsible source and no other supplies or services will satisfy agency requirements. ADDITIONAL INFORMATION: Industry Classification (NAICS) Code is 621511, Medical Laboratories and the Small Business Size Standard is $13.5M Per Annum. The resultant Contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-65 (January 29, 2013). The determination by the Government to award a purchase order on a sole source on competitive basis for genetic testing to Medical Neurogenetics is based upon the responses to the sources sought synopsis published in the FedBizOpps on [HHS-NIH-NHLBI-CSB-2013-045-DLM, December 11, 2012, Genetic Testing Services]. Any information received as a result of this pre-solicitation / notice of intent will be considered solely for the purpose of determining whether to conduct any future competitive procurements. Responses to this notice shall contain sufficient documentation to establish the interested parties' bona-fide capabilities for fulfilling the requirement. This notice of intent is not a request for competitive proposals. 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. In order to receive an award from NIH/NHLBI, contractors must be registered and have a valid CCR and ORCA on-line at https://www.sam.gov/portal/public/SAM/. If you have any questions, please submit 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.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHS-NIH-NHLBI-CSB-(HG)-2013-083-DLM/listing.html)
- Place of Performance
- Address: NIH, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02986946-W 20130215/130213234501-ca6ed797a7a4e78152b8f67f54b84e05 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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