SOLICITATION NOTICE
Q -- Untargeted and Targeted Body Fluid Analysis
- Notice Date
- 7/2/2013
- 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)-2013-198-DLM
- Archive Date
- 7/24/2013
- 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)-2013-198-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 9, 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. A. Background: The National Institute of Health (NIH) is the nation's leading medical research agency and the primary Federal agency conducting, supporting and making medical discoveries that improve people's health and save lives. The National Institutes of Health 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. B. Purpose and Objectives : The purpose of this requirement is to provide cutting edge methodology for untargeted detection of pathological changes in the carnitine species, lipids, isoprostanes and metabolic profiles of fluid from 200 individuals with neurological disorders. The Contractor shall provide comprehensive quantitative analysis of the following : 1. carnitine, acylcarnitine and butyrobetaine species in cerebrospinal fluid, plasma and urine using UHPLC-MS/MS; 2. lipidomic and phospholipid analysis of the cerebrospinal fluid using HPLC-MS; 3. metabolomic analysis of the cerebrospinal fluid and urine using HPLC-MS; and 4. isoprostane species in cerebrospinal fluid, plasma and urine using ChipCube chromatography-MS/MS. C. Scope of Work: Specifically the contractor shall : 1. Provide a validated, UHPLC-MS/MS method for the accurate quantification, resolution of acylcarnitineisomers (e.g. butyryl- and isobutyrylcarnitine; valeryl-, isovaleryl-, 2-methyl-butyryl- and pivaloylcarnitine), remove isobaric contaminants, and use standardized compounds with multiple-point calibration curves. This analytical method allows individual acylcarnitines to be accurately quantitated. Butyrobetaine shall also be analyzed using stable-isotope labeled butyrobetaine as the internal standard. These analyses shall be performed on cerebrospinal fluid, plasma and urine. Unrecognized compounds in a sample will be further analyzed if considered to be associated with the patient's condition. 2. Provide untargeted quantitative lipid and phospholipid analysis of cerebrospinal fluid body using HPLC-MS. Unrecognized compounds in a sample will be further analyzed if considered to be associated with the patient's condition. Also, the Contractor at Children's Hospital of Pennsylvania will be notified of samples with such abnormalities so that she can determine if the abnormal species is a glycolipid. 3. Provide untargeted quantitative analysis of the metabolome of the cerebrospinal fluid and urine using HPLC-MS. Unrecognized compounds in a sample will be further analyzed if considered to be associated with the patient's condition. 4. Provide quantitative analysis ofisoprostane species in cerebrospinal fluid, plasma and urine using ChipCube chromatography-MS/MS. 5. Coordinate analyses with the Contractor's from Children's Hospital of Philadelphia. 6. 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. 7. Provide unique services specific to untargeted metabolome, lipidome and oxidative stress screening of UDP patients as well as appropriate targeted follow-up screening and identification of anomalous compounds deemed associated with the patient's disease. 8. Turn-around-time for UDP to receive results will be both untargeted screens on 20 samples per month. 9. The Contractor shall contact the Government if any patient results need to be evaluated urgently for impact on caring for patients in the UDP. 10. Supply electronic copies of all reports appropriate for deposition in the UDP process management system and for exome sequence variant analysis. D. Other considerations : 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, 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. 5. The Contractor shall supply results with qualified interpretations in formats appropriate to the process management systems and for facilitation of other collaborations. 6. 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. 7. The Government will not furnish any government property to the vendor 8. The Government will provide access to phenotypes and exome data as needed. 9. The Government will provide patient samples including fibroblasts or pellets of cultured fibroblasts, cerebrospinal fluid, urine, and plasma as the research warrants. 10. The Government will send all patient samples via Fed-Ex overnight to the Contractor for testing. 11. The Government will not furnish any facilities to be used by the vendor. 12. Results will be provided electronically to the UDP via secure email, the UDP ftp site or direct deposition into the UDP process management system. 13. Results will also be shared with UDP collaborators as defined mutually 14. The Government will receive all electronic results quarterly. 15. The Government will receive additional reports for any test added-on after the Contractor receives the original specimen. 16. The Government will receive additional reports for any parental or sibling testing done for the clarification of a new genetic disease. E. Anticipated Period of Performance : Twelve (12) months from the date of award. v. NIH/UDP is located at 9 Memorial Drive, Bethesda, Maryland 20892. vi. 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. vii. 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. Provide the following for CSF analysis: a validated quantification of acylcarnitine isomers, untargeted quantitative lipid and phospholipid analysis, untargeted quantitative analysis of the metabolome, quantitative analysis of isoprostane species. 2. Coordinate all analyses with the Contractor's from Children's Hospital of Philadelphia. 3. test results in a format that can be integrated with exome sequence variant analysis and support the ongoing collaborative research of the UDP. 4. Provide reports in a timely fashion and record all experimental data in the UDP laboratory electronic notebook. 5. Have the ability to perform follow-up CLIA certified analyses. 6. Have the ability to integrate analysis of the metabolome, glycome and lipide. A. 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). viii. 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/. ix. FAR clause 52.212-4, Contract Terms and Conditions - Commercial Items applies to this Acquisition. x. FAR clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items applies to this Acquisition. xi. 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 9, 2013. The proposal must reference the RFP Number: NHLBI-CSB-(HG)-2013-198-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)-2013-198-DLM/listing.html)
- Place of Performance
- Address: NIH, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03105887-W 20130704/130702235413-f58301477af1759b32bc81372d6748e7 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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