Procurement of DNA, RNA, Transformed Lymphocytes, and Lymphoblastoid Lines for Genetic Studies

Sources Sought Notice No.: SS-ETSB-100711-56 This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business concern; (2) whether they are small business; HUBZone small business; service-disabled, veteran-owned small business; 8(a) small business; veteran-owned small business; woman-owned small business; or small disadvantage business; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. The NAICS code for this project is 541990. The small business size standard is $7.0 million in annual receipts. Background The mission of the Division of Cancer Epidemiology and Genetics (DCEG) is to conduct population and multidisciplinary research to discover the genetic and environmental determinants of cancer and new approaches to cancer prevention. Most studies from the Division have molecular biology components that require the isolation of biomolecules from a variety of material types, such as whole blood, transformed lymphoblastoid cells, buccal cells, paraffin-embedded tissue, tumor tissue, etc. The availability of high quality preparations of cellular biomolecules from these sources has contributed to a wealth of information regarding the discovery of genetic and environmental determinants of cancer. These findings have come from family, population, clinical and translational studies undertaken by investigators in many DCEG branches including the Genetic Epidemiology Branch (GEB), Clinical Genetics Branch (CGB), Occupational and Environmental Epidemiology Branch (OEEB), and the Infections and Immunoepidemiology Branch (IIB). There are a variety of biological materials that are important for estimating levels of biomarkers that may fluctuate with disease status. Examples include biomarkers of immune response, profiles of cytokines and characterization of other cellular phenotypes. Many of these assays, as well as other biomarker measurements, require the isolation and cryopreservation of peripheral blood mononuclear cells (PBMCs) and other cell types as source materials for these assays. The ability to isolate cellular components from fresh biospecimens received from clinical and field sites is essential in order for many of these downstream analyses to be performed. In order to perform these isolations, specimens must be processed before they are frozen, and once processed, must be frozen or "cryopreserved" under carefully controlled circumstances. Purpose and Objectives The purpose of this project is to provide support for the processing of fresh biological specimens from field and clinical settings by receiving whole blood and other biospecimens, isolating peripheral blood mononuclear cells (PBMCs), immortalizing cell lines with Epstein-Barr virus (EBV), isolating nucleic acids, and cryopreserving a variety of cell types, as needed. The processing is essential in order for the processed biomaterials to be available for genetic, immunological, and other analyses based on DNA, RNA and protein composition. The studies to be supported by this project have been designed to understand the etiology of certain rare diseases, family-based cancers and other large population based initiatives. Project requirements Major tasks required of the Contractor include the following: 1. Specimen Processing: a) Receipt and processing of fresh whole blood and other biospecimens such as serum, plasma, buccal cells, bone marrow, tumor and non-tumor tissue, lymphocytes/leukocytes, culture fibroblasts: b) Isolation of peripheral blood mononuclear cells (PBMCs) for subsequent nucleic acid isolation, transformation with Epstein-Barr virus (EBV): c) Transformation of lymphocytes and/or cryopreserved whole blood to lymphoblastoid cells using the Epstein-Barr virus (EBV): d) Cryopreservation of PBMCs, granulocytes, bone marrow cell preparations as well as other material types: e) Expansion of lymphoblastoid or other types of cell lines up to gram quantities: f) Extraction of nucleic acids from fresh specimen and some frozen specimens, as needed. Biospecimens required in the performance of the above tasks will be provided by the Government. 2. Transfer of Biospecimens: a) Supply service to pick up specimens from medical care facilities or other laboratories in the Washington, DC area or at area transport centers (airports): b) Specimens shall be protected from temperature extremes by use of acceptable means and a portable liquid nitrogen container for transport of frozen cells or tumor specimens: c) Monitor shipment of biospecimens and track their progress in transit: d) Ensure the prompt and accurate transfer of end-products (e.g. cell cultures, PBMC preparations, or DNA) to the Long-Term storage repository. 3. Maintain a Biospecimen Processing Laboratory and a Short Term Repository: a) In accordance with industry best practices: b) maintain a safety and health program for good laboratory practices and for the handling of human biological materials: c) Use labeling and barcoding technologies, all specimens shall have a 2-D barcode: d) Have in place a quality control/assurance program: e) Provide short term storage for specimens that shall be monitored visually and electronically: f) Facility shall be equipped with fire and smoke alarms, manned 24-hours a day, 365-days a year: g) Provide backup generator for mechanical freezer and emergency reserve source of liquid nitrogen for liquid nitrogen freezers in the event of power failure. 4. Utilize the Biospecimen Inventory System (BSI): a) Enter information to track and control biospecimens into BSI from Contractor's site: b) Utilize all relevant BSI-generated inventory and tracking reports: c) Ensure the accuracy of data entered into the BSI system by following quality control/assurance procedures: d) Protocols for all quality control/assurance procedures shall be available to the COTR for review when requested. 5. Communication with the COTR and DCEG Investigators: a) Consult with the COTR on ongoing testing, as well as any other aspect of the contract effort: b) Provide guidance to DCEG Investigators on specific issues identified by the COTR: c) Advise and make recommendations regarding innovative, cutting edge approaches to specimen collection and processing. 6. Initial and Final Transition Plan: a) Ensure the orderly, efficient and safe transition of all contract activities and biospecimen materials within a pre-determined period of time. As part of the work under this potential contract quarterly and final technical report are expected. In addition, Queue, Cost Accounting System (CAS), Emergency Response and Specimen Damage reports are expected. Other important considerations This work requires the Contractor to have the capability of receiving and processing fresh whole blood, as well as fresh lymphocytes tumor samples, or other types of fresh specimens each weekday from Monday through Thursday. As little as three hours or four hours notice may be given (routine submission of samples may be scheduled several days in advance). This work requires the Contractor to have the capability to receive and process any fresh specimens within 24 hours after the specimen has been received. Specimens requiring immediate processing may number 10 or fewer on a typical weekday (more samples may be received on occasional exceptions on a pre-scheduled date). All biological materials delivered will need to be packaged in appropriate containers and delivered according to Department of Transportation regulations. Anticipated period of performance The anticipated period of performance for this requirement is one year, with four one-year options. Capability statement/information sought. Interested qualified small business organizations should submit a tailored capability statement for this requirement, not to exceed 20 single-sided pages (including all attachments, resumes, charts, etc.) presented in single-space using a 12-point font size minimum, that clearly details the ability to perform the aspects of the notice described above. Statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement, as well as the eligible small business concern's name, point of contact, address and DUNS number. Information submission instructions All capability Statements sent in response to this SOURCES SOUGHT notice must be submitted electronically (via email) to Juana A. Diaz, Contract Specialist, at diazj@mail.nih.gov in MS Word or Adobe Portable Document Format (PDF), by October 21, 2011, 3:30PM, EST. All responses must be received by the specified due date and time in order to be considered. Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. Respondents will be added to the prospective offerors list for any subsequent solicitation. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary information in any resultant solicitation(s).