RECOVERY - Biospecimen Core Resources (BCR) Providing Biospecimen Processing Services to The Cancer Genome Atlas (TCGA) Program

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 sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your response 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. A determination by the Government not to compete this requirement as a set-aside based upon responses to this Notice is solely within the discretion of the Government. Interested parties are expected to review this Notice and the draft Statement of Work to familiarize themselves with the requirements of this project; failure to do so will be at your firm's own risk. Background: The Biospecimen Core Resource (BCR) serves as a biospecimen processing center as outlined in the draft Statement of Work (SOW) (See attachment) for The Cancer Genome Atlas (TCGA) program. TCGA is a comprehensive, collaborative effort led by the National Institutes of Health (NIH) to accelerate our understanding of the molecular basis of cancer through the application of genome analysis technologies. The National Cancer Institute (NCI) and the National Human Genome Research Institute (NHGRI) launched TCGA as a 3-year pilot in 2006. The second phase of the project is to study at least 20 additional cancers over five (5) years. This project aims to systematically explore the entire spectrum of genomic changes involved in human cancer. This project is designed to comprehensively analyze DNA copy number changes, including large and small scale rearrangements, transcription profiles, epigenetic modifications, sequence variation, and sequence in both tumor tissue and case-matched germline DNA. To successfully generate comprehensive data, TCGA will acquire in excess of 40,000 biospecimens over the course of this project. In the pilot project the TCGA utilized one (1) BCR. This project will utilize two (2) BCR's. Purpose and Objectives: The purpose of this Small Business Sources Sought Notice (SBSS) is to identify qualified small business concerns including HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses, veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses that are interested in and capable of performing the work described herein. The NCI does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information submitted. As a result of this SBSS Notice, the NCI may issue a Request for Proposal (RFP). THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NCI shall arise as a result of a response to this Small Business Sources Sought Notice or the NCI's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. If a RFP is issued, the NCI anticipates that multiple awards may result from the issuance of the RFP. The specific purpose of this project is to establish two (2) Biospecimen Core Resource(s) (BCRs) sites for receiving tissue and data from the multiple the Tissue Source Site (TSS) networks for storage, quality control, processing into molecular analyses, and other research support efforts as outlined in the draft SOW. Project Requirements: The contractor shall posses the requisite personnel, material, equipment and facilities to provide a centralized facility to uniformly process tissues and associated data for any one cancer being studied and distribute standardized sets of biomolecule aliquots to multiple TCGA sites performing genomic characterization. Specifically, the contractor shall: 1. Provide biospecimen and associated data procurement support in accordance with requirements of Section 1 of the draft Statement of Work. 2. Provide total support of biospecimen management and bioreposotry operations in accordance with the requirements identified in Section 2. of the draft SOW. 3. Provide biospecimen pathology review support as outlined in Section 3 of the draft SOW. 4. Provide support services to process biospecimen into molecular analytes in accordance with Section 4 of the draft SOW. 5. Comply with all the informatics support services requirements as outlined in the Section 5 of the draft SOW. 6. Provide for project management in accordance with Section 6 of the draft SOW. 7. Comply with all standard operating procedures and QA requirements as outlined in Section 7 of the draft SOW. Anticipated Period of Performance: The period of performance for this requirement is five (5) years, consisting of an eighteen (18) month base period, plus three (3) one-year options and one six (6) month option. The anticipated start date is on/or about May 1, 2010. It is anticipated that the eighteen (18) month base period will be funded utilizing American Recovery and Reinvestment Act (ARRA) Funding. The option periods, if exercised will be supported by appropriated funds. Other Important Considerations: Draft Statement of Work: A copy of the draft Statement of Work (SOW), which is subject to revisions, may be accessed on the NCI Office of Acquisitions Website at URL: http://rcb.nci.nih.gov/ . Once there, click on Current Requests for Proposals. NAICS Code and Size Standard: In the event an RFP is issued, North American Industry Classification System (NAICS) code 541990 with a size standard of $7.0 million dollars is being considered. Capability Statement/Information Sought: Sources are expected to have the expertise, personnel, protocols, systems, and technology to meet requirements of the draft SOW. Tailored Capability Statements shall demonstrate a clear understanding of all tasks specified in the draft Statement of Work (SOW). Tailored Capability Statements for this requirement shall also address the following four (4) areas: 1. Demonstrate through its technical approach and corporate experience a clear understanding of the draft SOW. Specifically address the following: a. Overall plan for meeting objectives outlined in the Statement of Work and Technical Proposal Preparation instructions b. Documented capability for high-throughput, state-of-the-art histopathological processing technologies and the clinical informatic approaches necessary for analysis, data integration and data sharing with the rest of the TCGA Research Network through the Data Coordinating Center. c. Feasibility of plan to ensure a minimum resource level can maintain the baseline operating capacity at all times with the capability of scaling to maximal capacity (200 cases/month). d. Documentation of experience in histopathological processing of samples including, but not limited to, experience in processing different types of cancers, macrodissection, sample portioning and tissue imaging. e. Feasibility of proposed plan with regards to bioinformatics and IT capacity including: documentation provided that demonstrates ability to integrate own data with that of the other BCR Contractor(s) under this project and documented efficiency and security of system proposed to store, update, backup, track and release data. Demonstrated capability and agreement to collaborate and share data. f. Documented experience in utilizing standard operating procedures (SOPs) to extract molecular analytes from tumor and normal samples and serve as a centralized source to distribute analytes to other laboratories. g. Demonstration of understanding of quality control needs and protocols used to increase reproducibility, efficiency, scalability, capacity and success rate. Experience incorporating technical advances to significantly increase the rate of the tissue processing pipeline. 2. Demonstrate the ability to provide knowledgeable and experienced professionals to meet the objectives of the attached draft SOW. Specifically, addressing the following: a. Expertise of proposed personnel is demonstrated in each of the following areas: histopathology, molecular biology, basic imaging, tissue processing and database management. Additional description of proposed administrative structure/management necessary for successful oversight, budgetary operations and communication with other potential sequencing sources and the NCI. b. Documented capability at time of award to provide a cost effective solution tissue collection, processing and analyte distribution and plans for additional personnel for scaling up the project, as needed. c. Documented track record of senior personnel to improve technology and/or methodology including, but not limited to, experience in developing optimized SOPs. d. Documented expertise of personnel to follow all regulatory policies and ethical guidelines for clinical research involving human subjects, including experience in adapting protocols for past regulatory changes and capacity for amending protocols for any future regulatory challenges. e. Demonstrate the capacity for training personnel to accomplish tasks described in SOW and understanding the ethical and regulatory aspects of research involving human subjects. f. Expertise of the Pathology Operation Director to screen histopathological samples from tumors to provide the review described in the Biospecimen Pathology Review. g. Documentation of project management experience from team leaders, including the Principal Investigator, the BCR Project Manager, the Pathology Operations Director, the Laboratory Operations Director, the TCGA GCC and GSC coordinator and the Quality Manager. h. Documented experience in developing and implementing a quality assurance program to facilitate both internal and external evaluation. i. Documented experience in working with collaborators or other partners to receive tissues and execution of Material Transfer Agreements (MTAs). j. Documented experience in working with collaborators, partners and/or other laboratories to develop and optimize Standard SOPs that minimize variability at all points in the tissue processing pipeline. k. Contingency plans for replacing Project Key Personnel due to turnover. l. Demonstrate the ablity to meeting the staffing requirements outlined in Section 6.3 of the draft SOW 3. Demonstrate the ability to meet the facilities, equipment and systems requirements as outlined in the draft SOW. Specifically, addressing the following: a. Provide documentation of current facilities and equipment available at time of award to be used under this contract at the prime contractor and any subcontractor's site (if applicable). b. Clearly demonstrate the current capability and past experience in managing a biorepository including biospecimen storage management, tracking and logistics, shipping and receiving, analyte distribution, request processing and recipient feedback capture to the level as required in the SOW. c. Documented informatics capacity to track the status of potential and incoming samples ("supply chain"), quality control metrics and common data elements required for each sample through a Laboratory Information Management System (LIMS). Feasibility of offerors approach for a failsafe system that will ensure patient privacy with regards to specific data elements related to clinical informatics. d. Demonstrate the adequacy of physical space to house service components in close proximity. e. Clearly demonstrate the availability and acceptability of equipment to perform the work scope including robotics, computers for informatics and data management, and appropriate sample storage. Contingency plans regarding need to replace equipment or for maintenance and repair of equipment. f. Provide details on plans for making facilities and equipment available for this project, including time requirements. 4. Demonstrate corporate experience and capabilities to meet the requirements of the draft SOW. Specifically addressing the following; a. The offeror must clearly demonstrate, via documentation experience in tissue processing at the pace specified in the SOW. b. The offeror must demonstrate the ability to provide project management, including ability to meet deadlines and re-assign staff. c. Provide a detailed description of the priority of this project in relation to other corporate projects. d. Provide clear evidence of required Clinical Laboratory Improvement Amendments (CLIA) laboratory accreditation. Information Submission Instructions: 1. Page Limitations: Interested qualified small business organizations should submit a tailored capability statement for this requirement not to exceed twenty (20) single sided pages including all attachments, resumes, charts, etc. (single spaced, 12 point font minimum) that clearly details the firm's ability to perform the aspects of the notice described above and in the draft SOW. Tailored capability 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 (preferable placed under the eligible small business concern's name and address) as well as the eligible small business concern's name, point of contact, address and DUNS number. 2. Number of Copies: All capability Statement sent in response to this SMALL BUSINESS SOURCES SOUGHT notice must be submitted electronically (via e-mail) to James D. Carder, Contracting Officer, at carderj@mail.nih.gov in MS Word, WordPerfect or Adobe Portable Document Format (PDF). The e-mail subject line must specify HHS-NIH-NCI-SBSS-TSB-07013-64. Facsimile responses will not be accepted. 3. Common Cut-off Date: Electronically submitted tailored capability statements are due no later than 2:00PM (Eastern Prevailing Time) on January 29, 2010. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT 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 this 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. 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 technical information in any resultant solicitation(s).