SOLICITATION NOTICE
B -- Plasma Samples, Detection of Hepatitis C Virus, HCV, RNA
- Notice Date
- 10/29/2004
- Notice Type
- Solicitation Notice
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Research Contracts Br., 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852
- ZIP Code
- 20852
- Solicitation Number
- RFQ-NCI-50003-NG
- Response Due
- 11/29/2004
- Archive Date
- 11/30/2004
- Description
- This is a combined synopsis solicitation for commercial services, prepared in accordance with the format in FAR Part 12.6, as supplemented with additional information included in this notice. THIS ANNOUNCEMENT CONSITUTES THE ONLY SOLICITATION AND A SEPARATE SOLICITATION WILL NOT BE ISSUED. This solicitation includes applicable provisions and clauses in effect through FAR FAC 2001-25 (10/2004). The acquisition is being made in accordance with the test program for using simplified procedures for certain commercial items authorized in FAR Part 13.5. The North American Industry Classification System Code is 621511 and the business size standard is $11.5M. Background information: HCV is an RNA virus that is transmitted by inoculation of blood. It is highly prevalent among persons with hemophilia who were treated with contaminated plasma products prior to 1990. Approximately 20% of HCV infections clear spontaneously, and sustained viral clearance of HCV RNA can be achieve in about half of infected patients with current therapy. Detection of HCV RNA in serum or plasma is the primary measure of chronic HCV infection and thus is fundamental to understanding the natural history and complications of this infection. The purpose and objective is for laboratory testing service, specifically, the Roche Diagnostic Systems COBAS Amplicor Hepatitis C Virus Test, version 2.0, shall be used to test plasma samples from research participants in the National Cancer Institute's Second Multicenter Hemophilia Cohort Study. This test is commercially available and will be used for its intended purpose, as licensed by the Food and Drug Administration. Contract Requirements: A. Experience and laboratory certification: The contractor shall test a maximum of 1000 plasma samples with the Roche COBAS Amplicor Hepatitis C Virus Test, version 2.0. The Roche manufacturer's specifications shall be used for testing the specimens and determining the result: positive for HCV RNA, negative for HCV RNA, or indeterminate. Specimens with indeterminate results shall be repeated once (at no additional cost), with the second result considered final. (1) The contractor shall have tested a minimum of 500 human serum or plasma specimens during the past two (2) years with the Roche COBAS Amplicor Hepatitis C Virus Test, version 2.0. (2) The testing shall be performed by technical laboratory staff, individual members of which have themselves obtained valid (that is, not indeterminate) HCV RNA results with the Roche COBAS Amplicor Hepatitis C Virus Test, version 2.0 on at least 200 serum or plasma specimens, (3) Experience with other HCV assays will not suffice either for the technical staff or the contractor as a whole, (4) The staff shall be supervised by a laboratory director (or the equivalent) who has at least five (5) years experience with one or more HCV molecular assay systems, (5) The Contractor shall be Clinical Laboratory Improvement Act (CLIA) certified to perform the Roche Diagnostic Systems COBAS Amplicor Hepatitis C Virus Test, version 2.0 and, (6) The Contractor shall comply with and summarize its participation in quality and proficiency assurance programs for performance of laboratory assays. B. Description of work to be performed: (1) The laboratory shall receive approximately 400 plasma specimens will be delivered by the Government, via courier or US mail, to the Contractor within the first two (2) months. Thereafter, 50 to 200 frozen plasma specimens from the Government will be delivered every other month (not to exceed 1000 specimens total) and the plasma shall be kept frozen (at or below -20C) until testing; (2) Testing of the specimens shall be completed within 2 months of receipt by the contractor, (3) Any residual plasma remaining in the vials upon completion of testing shall be re-frozen in the original vials and packaged (in compliance with biosafety regulations) for shipment back to the Government repository at the Government's expense. The repository's address is: NCI Repository, BBI Biotech Research Laboratories, 8425 Progress Drive, Frederick, MD 21701 and, (4) each batch of 88 specimens shall be accompanied by an electronic excel spreadsheet file with the sample ID numbers. For each batch, the laboratory shall key each of the 88 test results (HCV RNA positive, negative or indeterminate) in the adjacent column and on the appropriate row of the excel file, provided by the Government, and shall electronically transmit the file with the batch's results to the NCI Project Officer. Minimum Requirements: Contractor shall have current CLIA certification in performing the Roche Diagnostic Systems COBAS Amplicor Hepatitis C Virus Test, version 2.0 and shall have tested a minimum of 500 serum or plasma specimens with this assay within the past 2 years. Government Responsibilities: (1) The Government shall deliver, via courier, the plasma frozen in aliquots of 0.25mL or 0.50mL, and in batches of 88, on dry ice, to the Contractor's testing laboratory in full compliance with biosafety packaging and shipping regulations. Each plasma specimen will be labeled only with a sample identification (ID) number, (2) The Government will provide the electronic excel spreadsheet file to which the laboratory will record the test results and, (3) The Government will pay for delivery (in compliance with biosafety regulations) of residual, re-frozen plasma samples back to its repository. Reporting Requirements and Deliverables: The contractor shall report to the Government one result (HCV RNA positive, negative or indeterminate) per plasma specimen, using the Microsoft Excel file provided, which shall be delivered to the project officer via email attachment within one week of completion of testing each batch of 88 specimens. In the body of the email, the contractor shall include a brief text report that summarizes the results of the batch and shall describe any difficulties or anomalies encountered. The contractor shall be required to store on its premises, for one (1) year, after the period of performance, all primary data and related documents, and the contractor shall make these available to the Government for resolution of inconsistencies or other types of validation of the transmitted data. Upon the completion of testing 1,000 specimens, the contractor shall submit to the project officer a final report summarizing the results. Inspection and Acceptance Criteria: The project officer will review the reports and will inspect the electronically delivered test results. The project officer will have the test result data merged with other data from the research participants. Within 10 days of receipt, the project officer shall determine that the data are or are in not valid and free of anomalies. The contractor shall submit an invoice upon delivering the data, but the work will not be deemed satisfactorily completed and payment approved until the project officer is satisfied with the validity of the data. Clearances: IRB Protocol Number: 01-C-N-170, OMB approval number: not applicable. Period of Performance: Base Year: December 20, 2004 through December 19, 2005, Option Year 1: December 20, 2005 through December 19, 2006. FAR Clause 52.217-8 Option to Extend Services and 52.217-9 Option to Extend the Term of the Contract apply. BASIS FOR AWARD: Award will be made, subject to available funding and quoter responsibility, to that acceptable quote, the price or cost of which is not necessarily the lowest, but which is sufficiently more advantageous to the Government than the lowest offer so as to justify the payment of additional amounts, based on the evaluation criteria described in this section. FORMAT AND INFORMATION FOR SUBMITING A QUOTE: Please submit ONE (1) original plus two (2) copies of entire quotation. Please submit your quotation by the following: VOLUME 1: Contract and Pricing Documents: (1) Signed SF1449 (page 1, blocks 17a, 21, 22, 23, 24, 26, 30a, 30b, 30c and other pricing information), (2) Signed amendments (if applicable) and, (3) 52.212-3 Completed and signed Representations and Certifications (Commercial Items). VOLUME 2: Technical Proposal: The technical quotation and offeror should clearly and fully demonstrate the offeror's capabilities, knowledge and experience regarding the technical requirements described below. Failure to respond explicitly to each of the categories and subcategories listed below may result in the offeror's quotation being deemed technically unacceptable. Technical Capability (60 Points): The proposed technical solution, shall include, but is not limited to the following: (A) Resume(s) of key laboratory personnel, including laboratory supervisor, or the equivalent, describing experience, not to exceed 2 pages, (B) Copy of the laboratory's CLIA Certification document(s), (C) Summary of participation in Quality and Proficiency Assurance programs, not to exceed 2 pages, (D) Contractor's understanding of the Roche Diagnostic Systems COBAS Amplicor Hepatitis C Virus Test, version 2.0, not to exceed 4 pages: (i) Relationship of HCV Amplicor to other test results and (ii) Technical steps in assay performance including, identification and avoidance of pitfalls. (E) Summary of data handling, entry, validation, reporting, and storage, not to exceed 2 pages. VOLUME 3: Past Performance: Past Performance (40 Points): The past performance shall demonstrate the contractor's background and experience in HCV assay performance. The contractor shall provide: (A) A minimum of two (2) references to include organization name, address, telephone number, a point of contact, a description of services provided, and the contract value (if appropriate), contract number, date of award, and number and type of tests. These references should be directly linked to experience with the Roche Diagnostic Systems COBAS Amplicor Hepatitis C Virus Test, version 2.0. Price (Price will be evaluated but, will not be scored). The Evaluation Process: The Government will award a contract resulting from this quotation to the responsible contractor whose quote conforming to the quotation will be the most advantageous to the government, price and other factors considered. FAR 52.212-1, INSTRUCTIONS TO OFFERORS COMMERCIAL ITEMS and FAR 52.212-3, OFFEROR REPRESENTATIONS AND CERTIFICATIONS - COMMERCIAL ITEMS, along with the DUNS NUMBER ADDENDUM. The resulting contract will incorporate FAR 52.212-4, CONTRACT TERMS AND CONDITIONS - COMMERCIAL ITEMS and FAR 52.212-5, CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS - COMMERCIAL ITEMS. The following FAR Clauses cited in paragraph (b) of the clause at 52.212-5 are applicable to this acquisition. FAR 52.217-5 Evaluation of Options, FAR 52.222-3 Convict Labor; FAR 52.222-19 Child Labor - Cooperation with Authorities and Remedies; FAR 52.222-21 Prohibition of Segregated Facilities; FAR 52.222-26 Equal Opportunity; FAR 52.222-35, Affirmative Action for Disabled Veterans and Veterans of the Vietnam Era; FAR 52.222-36 Affirmative Action for Workers with Disabilities; FAR 52.222-37 Employment Records on Disabled Veterans and Veterans of the Vietnam Era, and Other Eligible Veterans; FAR 52.232.32, Payment by Electronic Funds Transfer - Central Contractor Registration. Note Contractor must be registered with the Central Contractor Registration (CCR) in order to receive an award. Interested offerors may contact Malinda Holdcraft via electronic mail at holdcram@exchange.nih.gov or via fax at 301-402-4513 to receive full text copies of the Representations and Certifications or other cited provisions and clauses. Technical and price quotations, along with a completed Offeror Representations and Certifications- Commercial Items - with DUNS number addendum, must be received in the contracting office no later than 1 PM on November 29, 2004. Please site the solicitation number RFQ-NCI-50003-NG on all correspondence. Quotations can be mailed to address: 6120 Executive Blvd. Room 6072, Rockville, Maryland 20852 attention Malinda Holdcraft. If you have any questions pertaining to this solicitation, they must be in writing via electronic mail or fax. No collect calls will be accepted. No faxed copies or electronic quotations will be accepted.
- Place of Performance
- Address: Contractor location
- Zip Code: 20892
- Country: USA
- Zip Code: 20892
- Record
- SN00700780-W 20041031/041029211646 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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