SOLICITATION NOTICE
Q -- Metabolic pathway analysis on body fluids from patients in the Undiagnosed Disease Program
- Notice Date
- 7/15/2013
- Notice Type
- Combined Synopsis/Solicitation
- 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)-2013-213-DLM
- Archive Date
- 8/2/2013
- 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
- i. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. ii. The solicitation number is NHLBI-CSB-(HG)-2013-213-DLM and the solicitation is being posted as a request for proposal (RFP). Offerors shall submit their proposals no later than 7:30 a.m. Eastern Standard Time (EST) on July 18, 2013. iii. A statement that the solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-68, June 26, 2013. iv. The associated North American Industry Classification System (NAICS) code for this is 541712, Research and Development in the Physical, Engineering, and Life Sciences (except biotechnology) and small business size standard is 500. PURPOSE : The purpose of this acquisition is to provide metabolic pathway analysis on body fluids from patients in the Undiagnosed Disease Program. This analysis will determine how disease mutations and changes in or accumulation of biomarker compounds elicits patient disease. The Objective is to provide cutting edge methodology for untargeted detection of pathological changes in the lipid glycosylation, protein-glycosylation and metabolic profiles of cerebrospinal fluid from individuals with neurological disorders. v. Background : The National Human Genome Research Institute (NHGRI), Undiagnosed Disease Program (UDP) is a trans-National Institute of Health (NIH) initiative that focuses on the most puzzling medical cases referred to the NIH Clinical Center in Bethesda, Md. It was organized by the National Human Genome Research Institute (NHGRI), the NIH Office of Rare Diseases Research (ORDR) and the NIH Clinical Center. Many medical specialties from other NIH research centers and institutes contribute the expertise needed to conduct the program, including endocrinology, immunology, oncology, dermatology, dentistry, cardiology and genetics, among the dozens of participating senior attending physicians. A longstanding medical condition that eludes diagnosis by a referring physician can be considered undiagnosed and may be of interest to this clinical research program. The Undiagnosed Disease Program (UDP) offers patients the hope of a diagnosis and the possibility of therapeutic strategies. In return, patients provide UDP researchers the opportunity to gain new insights about genetic and biochemical mechanisms of disease and insights into normal cell biology, biochemistry and physiology. So far, UDP researchers have encountered patients with uncommon presentations of known disorders, multi-systemic complex disorders and new disorders that have never been diagnosed. UDP clinical researchers are using advances in DNA sequencing to detect defects in genes that point to known disorders. These tools offer the potential for discoveries about the role of molecular and biochemical events that can cause disease and, eventually, the development of diagnostic and therapeutic approaches for rare and common diseases. CONTRACTOR REQUIREMENTS : A. SCOPE OF WORK : The Contractor must have Clinical Laboratory Improvement Amendments (CLIA) Approval, No Exception and provide a copy of Certification. 1. Contractor shall perform untargeted body fluid organic acid analysis using gas-chromatography mass spectrometry and a deconvolution-separation procedure. • All components in the biological sample must be recognized and spectra be matched to libraries available. • All unrecognized compounds must be analyzed using a combination of gas-chromatography mass-spectrometry and liquid chromatography-tandem mass spectrometry if associated with the patient's disease. 2. Contractor shall perform targeted amino acid analysis using Ultra-Performance Liquid Chromatography on all patient samples. 3. Contractor shall perform a novel UPLC assay on CSF from all patients that can measure down to 1 micromole per liter with a CV of less than 20%. 4. Contractor shall measure glycolipids in the patient samples using LC-MS-MS using a unique assay developed by the Contractor. 5. Contractor shall perform sterol analysis using GC-MS and separation technology. 6. Contractor shall perform untargeted glycomics analysis of CSF measuring free oligosaccharides, N-linked glycan and O-linked glycan profiles using both MALDI-TOF and ESI-QTOF in order to discover undiagnosed glycosylation disease in the patient samples. 7. Contractor shall perform analyses using protocols that are consistent with CLIA-approved patient care by certified technologists. Specific Tasks: 1. Untargeted body fluid organic acid analysis using a gas-chromatography-mass spectrometry (GC-MS) and a deconvolution separation procedure. Unrecognized compounds in a sample will be further analyzed using a combination of GC-MS and liquid chromatography-tandem mass spectrometry (LC-MS-MS) if considered to be associated with the patient's condition. 2. Untargeted glycomics analysis of CSF measuring free oligosaccharides, N-linked glycan and O-linked glycan profiles using both MALDI-TOF and ESI-QTOF technology. 3. Targeted amino acid analysis using Ultra-Performance Liquid Chromatography will be performed on appropriate samples. 4. Measurement of glycolipids using LC-MS-MS on appropriate samples. 5. Sterol analysis by GC-MS on appropriate samples. 6. Coordinate analyses with Dr. Hoppel from Case Western Reserve University. 7. The Contractor shall provide test results in a format that can be integrated with exome sequence variant analysis and support the ongoing collaborative research expertise needed by the UDP. 8. The Contractor shall provide unique services specific to untargeted metabolome and glycome screening of UDP patients as well as appropriate targeted follow-up screening and identification of anomalous compounds deemed associated with the patient's disease. 9. The Contractor's turn-around-time for UDP to receive results will be both untargeted screens on 20 samples per month. 10. The Government will be contacted if any patient results need to be evaluated urgently for impact on caring for patients in the UDP. 11. The Contractor shall supply electronic copies of all reports appropriate for deposition in the UDP process management system and for exome sequence variant analysis. Desired Results/Functions/End Items : 1. Test results with qualified interpretations in a timely way given the requirements of the particular test. 2. Follow-up targeted testing and identification of anomalous compounds will be discussed and mutually agreed upon in a timely manner. 3. In combination with the work of the Contractor, Contractor will collaborate with Case Western University (Dr. Charles Hoppel); UDP will achieve an integrated and comprehensive analysis of the metabolome, glycome, and lipidome of the CSF of UDP patients with neurological problems. 4. Research collaborations will be conducted via Videoconferences, email communications, shared professional presentations, posters and publications. Grand Round presentations at the Contractor's location and the NIH Clinical Center may also occur. Technical Specifications/Standards/Methods : 1. The Contractor shall supply results with qualified interpretations in formats appropriate to the process management systems and for facilitation of other collaborations. Special Handling or Handling Requirements : 1. The Contractor shall provide result reports and record methods and materials as appropriate to the highest scientific standards. These materials, methods and results will be shared with agreed upon UDP collaborators to enable diagnosis of UDP patients. Government Responsibilities : 1. The Government will not furnish any government property to the vendor. 2. The Government will provide access to phenotypes and exome data as needed. 3. The Government will provide patient samples including fibroblasts or pellets of cultured fibroblasts, cerebrospinal fluid, urine, and plasma as the research warrants. 4. The Government will send all patient samples via Fed-Ex overnight to the Contractor for testing. 5. 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. Results will be provided electronically to the UDP via secure email, the UDP ftp site or direct deposition into the UDP process management system. 2. Results will also be shared with UDP collaborators as defined mutually. Reporting Requirements and Deliverables : 1. The Government will receive all electronic results quarterly. 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. OTHER CONSIDERATIONS : The Contractor shall provide: 1. untargeted body fluid organic acid analysis using a gas-chromatography-mass spectrometry (GC-MS) and a deconvolution separation procedure; 2. untargeted glycomics analysis of CSF measuring free oligosaccharides, N-linked glycan and O-linked glycan profiles using both MALDI-TOF and ESI-QTOF technology, and as appropriate targeted analysis of; 3. glycolipids using LC-MS-MS; 4. sterol analysis by GC-MS, and 5. amino acids using Ultra-Performance Liquid Chromatography. Anticipated Period of Performance : Twelve (12) months from the date of award. vi. NIH/UDP is located at 9 Memorial Drive, Bethesda, Maryland 20892. vii. The FAR Provision 52.212-1, Instructions to Offerors -- Commercial, applies to this acquisition and is hereby incorporated by reference. All Federal Acquisition Regulations (FAR) clauses may be viewed at http://acquisition.gov/comp/far/index.html. viii. EVALUATION OF PROPOSALS: The Government will evaluate proposals that are determined technically acceptable in accordance with the Technical Evaluation factors. The Government intends to award a single contract from this solicitation. The Government reserves the right not to award a contract. Evaluation of Proposals : The Government reserves the right to make an award without discussions based solely upon initial proposals. EVALUATION FACTORS : 1. Ability to perform untargeted body fluid organic acid analysis using gas-chromatography mass spectrometry and a deconvolution-separation procedure. 2. Ability to perform targeted amino acid analysis using Ultra-Performance Liquid Chromatography on all UDP patient samples. 3. Ability to perform untargeted glycomics analysis of CSF measuring free oligosaccharides, N-linked glycan and O-linked glycan profiles using both MALDI-TOF and ESI-QTOF technology 4. Ability to provide metabolomics studies for UDP in conjunction with the Palmieri Metabolic Disease Laboratory at Children's Hospital of Philadelphia. 5. The Laboratory must be CLIA Certified, certificate submitted. (i) Price (This will be Firm-Fixed Price): An evaluation of the offeror's price proposal will be made to determine if proposed prices are realistic for the work to be performed, reflect a clear understanding of the requirements, and are consistent with the technical proposal. Reasonableness determinations will be made by determining if competition exists, by comparing proposed prices with established commercial or GSA price schedules (if applicable), and/or by comparing proposed prices with the Independent Government Cost Estimate (IGCE). ix. In accordance with FAR Clause 52.212-3, Offeror Representations and Certifications - Commercial Items, offerors must complete annual representations and certifications on-line at https://www.sam.gov/portal/public/SAM/. x. FAR clause 52.212-4, Contract Terms and Conditions - Commercial Items applies to this Acquisition. xi. FAR clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items applies to this Acquisition. xii. The Defense Priorities and Allocations System (DPAS) and assigned rating does not apply to this acquisition. Offerors shall submit their proposals no later than 7:30 a.m. Eastern Standard Time (EST) on July 18, 2013. The proposal must reference the RFP Number: NHLBI-CSB-(HG)-2013-213-DLM. All responsible offerors may submit a proposal, which if timely received, shall be considered by the agency. Proposals can be emailed to the Contracting Specialist, Dorothy Maxwell at maxwelld@nhlbi.nih.gov; Quotations shall not be deemed received by the Government until the quotation is entered into the e-mail address inbox set forth above. Faxed proposals will NOT be accepted. Offerors' proposals shall not be deemed received by the Government until the proposal is entered into the e-mail address inbox set forth above. All quotes shall contain the following: 1. Name of Contracting Organization; 2. Contract Number (for subcontracts, provide the prime contract number and the subcontract number); 3. Contract Type; 4. Total Contract Value and Discounts; 5. Description of Requirement; 6. Contracting Officer's Name and Telephone Number; 7. North American Industry Classification System (NAICS) Code; and 8. DUNS Number. Offerors must complete annual representations and certifications on-line at https://www.sam.gov/portal/public/SAM/.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHS-NIH-NHLBI-CSB-(HG)-2013-213-DLM/listing.html)
- Place of Performance
- Address: NIH, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03116068-W 20130717/130715234352-247c1975f98a899cc443c72290b23ae1 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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