SOLICITATION NOTICE
Q -- Follow-ON Genetic Testing Services for Undiagnosed Diseases program
- Notice Date
- 3/3/2013
- Notice Type
- Presolicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- 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)-2013-106-DLM
- Archive Date
- 3/22/2013
- 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 FOLLOW-ON. This is a Pre-Solicitation / Notice of Intent synopsis. 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 Emory University, 2165 North Decatur Road, Decatur, Georgia 30033 to provide genetic testing for Undiagnosed Diseases Program for rare and new genetic disorders, specifically, cutting edge analysis of blood, urine and fibroblasts for congenital glycosylation (CDG) and lysosomal storage disorders. 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. PROJECT DESCRIPTION : The Contractor will apply the following test samples and additional samples as needed for this protocol study: TEST SAMPLES (ADDITIONA ADDED AS NEEDED) 1.Lysosomal Enzyme Screening (13 enzyme panel) 2.Coenzyme Q10 Profile, Leukocytes 3.Congenital Disorders of Glycosylation:O‐glycan Profile and Quantification 4.N‐glycan and Carbohydrate Deficient Transferrin Panel for CDG; and 5.Oligosaccharide and Glycan Screening. CONTRACTOR REQUIREMENTS: A.Specific Tasks: 1.The Contractor shall provide cutting edge analysis of blood, urine and fibroblasts for congenital disorders of glycosylation (CDG). 2.The Contractor shall provide specialized lysosomal screening for the 12 most common lysosomal disorders and confirmatory mutation analysis as needed. 3.The Contractor shall add new tests as available 4.The Contractor shall provide a wide-range of tests as outlined in the attachment with family follow up as needed, as well as support the ongoing collaborative research expertise needed by the NHGRI, UDP. 5.The Contractor shall provide unique services specific to complex CDGs and lysosomal disorders meet the program goals of the UDP. 6.The Contractor's shall turn-around-time for UDP to receive results will be 2-4 weeks. 7.The Government will be contacted if any patient results need to be evaluated urgently for impact on caring for patients in the UDP. 8.The Contractor shall supply faxed copies of all patient reports for the study file and medical record. B.Desired Results/Functions/End Items: 1.CLIA-certified test results with qualified interpretations in a timely way given the requirements of the particular test the UDP Clinicians request. 2.Research collaborations will be conducted via Teleconferences, email communications, shared professional presentations, posters and publications. Grand Round presentations at the Contractor's location and the NIH Clinical Center may also occur. C. Technical Specifications/Standards/Methods: 1.The Contractor shall supply CLIA-certified test results with qualified interpretations. D. Special Handling or Handling Requirements: 1.The Contractor shall provide result reports in a secure HIPAA compliant manner. E. Government Responsibilities: The Government will provide to the Contractor : 1.The Government will not furnish any government property to the vendor 2.The Government will provide patient samples will include; isolated DNA, blood, urine, fibroblasts, skeletal muscle or liver tissue as the patient condition and evaluation warrants. 3.The Government will send all patient samples via Fed-Ex overnight to the Contractor for testing. 4.The Government will not furnish any facilities to be used by the vendor. The Government will be responsible for reviewing and approving reports and similar matters generated: 1.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). 2.All confirmed abnormal diagnostic test results will be released to the referring clinician and patient/family. F. Reporting Requirements and Deliverables: 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. Program Management and Control Requirements: •Any internal management and control systems either specified by the Government or to be developed by the contractor. PERIOD OF PERFORMANCE : Base: March 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 30, 2017 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 541712, Research and Development in the Physical Engineering and Life Sciences (Except Biotechnology) 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) 05-66 (February 28, 2013). The determination by the Government to award a purchase order on a sole source on competitive basis for genetic testing to Emory University is based upon the responses to the sources sought synopsis published in the FedBizOpps on [NHLBI-CSB-2013-08-DLM, December 5, 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. 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)-2013-106-DLM/listing.html)
- Place of Performance
- Address: NIH, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03001382-W 20130305/130303233028-f192c22e78dca7b2e86ee61ec6339fd8 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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