SOLICITATION NOTICE
Q -- Laboratory Testing Services of Chromosome Breakage Analyses for the
- Notice Date
- 3/24/2015
- Notice Type
- Presolicitation
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
- ZIP Code
- 20852
- Solicitation Number
- N02CP52552-76
- Archive Date
- 4/9/2015
- Point of Contact
- Catherine Muir, Phone: (240) 276-5434
- E-Mail Address
-
muirca@mail.nih.gov
(muirca@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Contracting Office Address: Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E144, Bethesda, MD 20892, UNITED STATES Description: National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Clinical Genetics Branch (CGB), plans to procure on a sole source basis the services for chromosome breakage analyses testing from the Oregon Health & Science University, OHSU Patient Business Services, P.O. Box 3595, Portland, OR 97201. This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1) and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 621511 and the business size standard is $32.5M. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price, Indefinite Delivery Indefinite Quantity (IDIQ) type contract. The period of performance of the IDIQ contract is sixty (60) months from date of award. It has been determined there are no opportunities to acquire green products or services for this procurement. The Division of Cancer Epidemiology and Genetics (DCEG) is a research program of the National Cancer Institute (NCI), one of the National Institutes of Health (NIH). The Division is the world's most comprehensive cancer epidemiology research group. Its renowned epidemiologists, geneticists, and biostatisticians conduct population and multidisciplinary research to discover the genetic and environmental determinants of cancer and new approaches to cancer prevention. The Division's research impacts public health policy in the United States and around the world. The Clinical Genetics Branch (CGB), Division of Cancer Epidemiology and Genetics (DCEG), National Cancer Institute (NCI), National Institutes of Health (NIH) is engaged in an ongoing clinical genetics study of inherited bone marrow failure syndromes. Fanconi anemia is the prototype disease, and families with this syndrome comprise the majority of patients seen on this particular study. CGB has a need to obtain the results of the Fanconi anemia chromosome breakage test in order to appropriately classify family members as affected or unaffected by this disease. The samples will be derived from individuals who are members of families in which there is a clinical basis to suspect the diagnosis of Fanconi anemia. There will also be samples from individuals with other types of inherited bone marrow failure syndromes, in order to document that Fanconi anemia has been ruled out. This particular study is part of a comprehensive, multidisciplinary, intramural research program within DCEG's Human Genetics Program which is focused upon elucidation of the entire spectrum of scientific and clinical issues related to familial and hereditary forms of cancer. This is an ongoing study, and this submission is a continuation of that work and not new work. This study is an integral part of the NCI protocol 02-C-0052. Contractor shall perform the following tasks: • The Contractor will receive samples of heparinized peripheral blood, or lymphoblastoid or fibroblast cell lines, or freshly obtained skin biopsies, with coded identification numbers, from CGB investigators for chromosome breakage analysis, or with identifiers from some patients. If the Contractor is blinded to identifying information pertaining to the individuals from whom these specimens were derived, the Contractor will be prohibited from seeking such information. Therefore, from the Contractor's perspective, those samples shall be anonymous. A maximum of eighty-five (85) samples anticipated annually. • The Contractor must be a CLIA-certified laboratory, so that the results can be conveyed to the patient for use in clinical management. • The specimens will consist of peripheral blood, or lymphoblastoid cell lines, or skin fibroblasts. For the latter, a fresh skin biopsy may be provided which the Contractor will need to culture followed by chromosome breakage analysis. Alternatively, CGB may submit previously cultured skin fibroblast cells for direct analysis. • The cells derived from these samples shall be exposed to diepoxybutane (DEB) and mitomycin-C (MMC) [Cervenka et al, Am J Med Genet 15:211-223, 1983] in the laboratory, using standard testing protocols, to determine whether the cells are more sensitive than normal cells to the chromosome-damaging effects of these DNA cross-linking agents. • The Contractor shall provide a written report which includes the number of cells with X number of chromosome breaks (X = 0 to X = >8) as breaks per metaphase cell, and the number of cells with radial forms ranging from 0 to 8 radials per metaphase. The report should also indicate the % of cells with any break, and % of cells with any radial. This information shall be reported for each patient specimen, and for the control samples that are run. • Include a milestone or performance schedule. The written report for blood samples shall be returned to the Contracting Officer's Representative (COR) within twenty-one (21) business days from specimen receipt, except in the case of unusual problems requiring additional investigation. These exceptions must be negotiated directly via telephone discussion with the COR. If the specimen is a fresh skin biopsy, which requires culture prior to breakage analysis, then the time for results to be released needs to be discussed on a case-by-case basis. • Progress Meetings. In lieu of meetings, the Contractor will provide an updated cumulative excel file at 6 month intervals, containing the data discussed above under requirements, for all samples received prior to that date. The dates will be January and July, for the preceding six (6) months to be added to the file. This laboratory testing service is provided by the Oregon Health and Science University, Knight Cancer Institute, Knight Diagnostic Laboratories. The proposed source is the only known laboratory that can perform all the studies required in the SOW. OHSU uses two different clastogenic chemicals, at various concentrations, and report the level of details that CGB requires for this project. There have been no errors in CGB's prior work over the past 14 years of the on-going study. They are uniquely experienced in both blood and fibroblast analyses, which is required. CGB has used their data for peer-reviewed publications, and to properly classify patients and distinguish those with Fanconi anemia from their healthy relatives and from patients with other disorders. The assay is both sensitive and specific, and is critical for proper classification of CGB's patients, and is imperative for the integrity and continuity of the on-going study. This notice is not a request for competitive quotation. However, if any interested party, especially small businesses, believes it can meet the above requirement, it may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow the NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 12:00PM EDT, on April 8, 2015. All responses and questions must be in writing and faxed (240) 276-5401 or emailed to Catherine Muir, Contracting Officer via electronic mail at muirca@mail.nih.gov. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No collect calls will be accepted. In order to receive an award, Contractors must be registered and have valid, current Entity Record, including current Representations and Certifications, in the System for Award Management (SAM) through SAM.gov. Reference: N02CP52552-76 on all correspondence.
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