Biospecimen Collection and Biobanking Services

SOURCES SOUGHT FOR ALL POTENTIALLY CAPABLE, INTERESTED SOURCES TO PROVIDE SUPPORT FOR THE BIOSPECIMEN COLLECTION AND BIOBANKING SERVICES (BCBS) CONTRACT INTRODUCTION The National Cancer Institute, Office of Acquisitions (NCI OA) on behalf of the National Cancer Institute's, Division of Cancer Treatment and Diagnosis (DCTD) is issuing this sources sought synopsis as a means of conducting market research to identify any/all parties, to include large and small businesses, having an interest in and the resources to support the requirements for Biospecimen Collection and Biobanking Services to conduct and support cancer research by providing specialized expertise to identify and manage clinical sites across the United States to engage and enroll cancer patients onto NCI's biospecimen collection protocols, collect biospecimens and associated medical data, and to provide biorepository services. The intention is to procure these specialized service areas on a competitive basis. BASED ON THE RESPONSES TO THIS SOURCES SOUGHT NOTICE (MARKET RESEARCH), FOR THIS REQUIREMENT All Small Business Set-Aside categories will be considered. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions. PLACE OF PERFORMANCE It is anticipated that performance for this effort will primarily consist of conducting services at the Contractor(s) and/or subcontractor(s) facility on a full-time basis. DISCLAIMER: - THIS SOURCES SOUGHT IS FOR INFORMATIONAL PURPOSES ONLY. THIS IS NOT A - REQUEST FOR PROPOSAL (RFP) TO BE SUBMITTED. IT DOES NOT CONSTITUTE A SOLICITATION AND SHALL NOT BE CONSTRUED AS A COMMITMENT BY THE GOVERNMENT. RESPONSES IN ANY FORM ARE NOT OFFERS AND THE GOVERNMENT IS UNDER NO OBLIGATION TO AWARD A CONTRACT AS A RESULT OF THIS ANNOUNCEMENT. NO FUNDS ARE AVAILABLE TO PAY FOR PREPARATION OF RESPONSES TO THIS ANNOUNCEMENT. ANY INFORMATION SUBMITTED BY RESPONDENTS TO THIS TECHNICAL DESCRIPTION IS STRICTLY VOLUNTARY. RESPONSES WILL NOT BE RETURNED TO THE RESPONDER. NOT RESPONDING TO THIS NOTICE DOES NOT PRECLUDE PARTICIPATION IN ANY FUTURE REQUEST FOR QUOTE (RFQ) OR INVITATION FOR BID (IFB) OR RFP, IF ANY ISSUED. IF A SOLICITATION IS RELEASED, IT WILL BE SYNOPSIZED ON THE GOVERNMENT-WIDE POINT OF ENTRY (GPE). THE GPE IS LOCATED AT https://www.sam.gov. IT IS THE RESPONSIBILITY OF POTENTIAL OFFERORS TO MONITOR THE GPE FOR ADDITIONAL INFORMATION PERTAINING TO THIS REQUIREMENT. PROGRAM BACKGROUND The National Cancer Institute (NCI) uses biospecimens, including tissues, blood, and other bodily fluids donated by research participants, as part of scientific research to develop novel diagnostics and therapies for cancer. The Contractor(s) shall be responsible for providing services to identify and engage clinical sites in conducting NCI biospecimen collection studies and to provide biorepository services for concurrent multi-disciplinary studies with diverse study designs. Biospecimens and associated data of known quality are a critical resource for research that investigates the causes, biology, diagnosis, prevention, and treatment of cancer. The NCI requires biospecimens for research that may include, but is not limited to, the following activities: development of patient-derived models; characterization of tumors using clinical- and research-grade sequencing; proteomics studies; pharmacodynamic studies; development and validation of clinical assays; performance of clinical testing and return of clinical test results to providers and patients; and development of research reserves of biospecimens for future research use. REQUIRED CAPABILITIES The objective of this contract is to obtain specialized services for the identification and coordination of clinical sites in the management of NCI biospecimen collection studies, and the collection, processing, storage, and distribution of biospecimens and associated data for current and future cancer research. For specific details under each Service Area please reference the draft Statement of Work (SOW) attached to this announcement (Attachment 1). The Government encourages and appreciates any feedback from respondents in their capability submissions (i.e., comments, suggestions, recommendations) on the draft Statement of Work that would improve the understanding of requirements/capabilities for this anticipated acquisition. NCI is seeking the following information from respondents regarding strategies and explicit examples of how they would propose to support NCI initiatives in one or more of the following services areas: TECHNICAL SERVICE AREA CAPABILITY REQUIREMENTS: SERVICE AREA A: COORDINATION OF BIOSPECIMEN COLLECTION STUDIES AT CLINICAL SITES 1) Ability to provide hands on support and expertise to coordinate Clinical Sites that engage and enroll cancer patients in NCI-sponsored biospecimen collection research studies. 2) Ability to provide hands on support and expertise for study activation, training, coordination, and assistance at each Clinical Site; track Clinical Sites progress through regulatory requirements related to human subjects research; provide appropriate regulatory and legal documentation. 3) Ability to provide hands on support and expertise with study-designated data collection teams to assess completeness and quality of data entry and data transmission by Clinical Sites as needed, to determine appropriate reimbursement to sites. ? SERVICE AREA B: BIOSPECIMEN KIT DEVELOPMENT/MANAGEMENT 1) Ability to provide biospecimen collection kit development, management, shipment, and tracking. SERVICE AREA C: COMPREHENSIVE BIOREPOSITORY SERVICES WITHOUT THE REQUIREMENT TO OPERATE UNDER THE CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) 1) Ability to provide biospecimen kit management services as described under SERVICE AREA B. 2) Information technology support dedicated to biobanking operations, to include data and information collection, management, quality control and analysis. 3) Accreditation by the College of American Pathologists (CAP) Biorepository Accreditation Program (BAP). 4) Ability to provide hands-on support for anatomic pathology and histology services including a board-certified anatomic pathologist on site. 5) Ability to provide expertise in tracking of pre-analytical variables and detailed inventory management for all biorepository activities per CAP/BAP requirements, using an existing data management solution. 6) Ability to provide scientific expertise and leadership in biobanking activities including but not limited to appropriate processing of biospecimens into molecular analytes and appropriate biospecimen and analyte storage. 7) Ability to provide administrative, program and project support by performing administrative duties to provide continuity for office operations and procedures. SERVICE AREA D: COMPREHENSIVE BIOREPOSITORY SERVICES OPERATING UNDER THE CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA). 1) Ability to provide comprehensive Biorepository services as described in SERVICE AREA C and in the Statement of Work (Attachment 1). 2) Ability to provide technical expertise in conducting Biorepository activities in facilities that are certified and as specified by the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations, and that are authorized by the New York State Department of Health to support clinical testing specifically for New York research participants. The facility must also hold a license as required by the State of California to support clinical testing for California research participants. SERVICE AREA E: LEGACY PHASE. 1) The ability to arrange for the physical and operational transfer of biospecimen collections. 2) The ability to provide periodic quality evaluation of selected samples and biospecimen retrieval, evaluation, processing, and distribution to approved researchers. 3) The ability to collaborate and coordinate with other awardee contractors under the anticipated Multi-award Indefinite Delivery Indefinite Quantity contract for efficient coordination and operation of biospecimen collection activities, as required. If your organization has the potential capacity to perform any and/or all these contract services, please provide the following information: 1) Organization name, address, email address, Web site address, telephone number, and size and type of ownership for the organization; and 2) Tailored capability statements addressing the particulars of this effort, with appropriate documentation supporting claims of organizational and staff capability. If significant subcontracting or teaming is anticipated to deliver technical capability, organizations should address the administrative and management structure of such arrangements. The Government will evaluate market research information to ascertain potential market capacity to: 1) provide services consistent, in scope and scale, with those described in this notice and otherwise anticipated; 2) secure and apply the full range of corporate financial, human capital, and technical resources required to successfully perform similar requirements; 3) implement a successful project management plan that includes: compliance with tight program schedules; cost containment; event and tracking performance; hiring and retention of key personnel and risk mitigation; and 4) provide specialized support services under a service acquisition contract. SPECIAL REQUIREMENTS: SERVICE AREA C: The Contractor shall be accredited by the College of American Pathologists (CAP) Biorepository Accreditation Program (BAP). ELIGIBILITY The applicable NAICS code for the predominance of this requirement is 541380, - Testing Laboratory and Services, with a Small Business Size Standard of $19M and 621511, - Medical Laboratories, with a small business size standard of $41.5M. The anticipated Product Service Code's (PSC) applicable to this effort and technical Service Areas A through E are as follows: a.Q301 - Laboratory Testing Services - Predominance of services b. 8071 - Medical Laboratories c. 8734 -Testing Laboratories ADDITIONAL INFORMATION AND SUBMISSION DETAILS (CAPABILITIES STATEMENT) A draft Statement of Work is attached for review (Attachment 1) Interested parties are requested to submit a capabilities statement of no more than ten (10) pages in length in Times New Roman font of not less than 10 pitch. The deadline for response to this request is no later than 2 pm, Eastern Daylight Time (EDT), August 11, 2024. This documentation must address at a minimum the following items: 1) What type of work has your company performed in the past in support of the same or similar requirements? 2) Can or has your company managed task(s)described herein? If so, please provide details. 3) Provide details of existing or past partnerships and established relationships with Clinical Sites, if applicable. 4) Can or has your company managed a team of subcontractors before? If so, please provide details. 5) What specific technical skills does your company possess which ensure capability to perform the tasks? 6) Provide a statement including current small/large business status, company name and address, CAGE, Tax Identification numbers and company profile to include number of employees, annual revenue history, office locations, Unique Entity Identification (UEI) number, etc. 7) Respondents to this notice also must indicate whether they qualify as a Small, Small Disadvantaged, Women-Owned, HUBZone, or Service-Disabled Veteran-Owned Small Business Concern. 8) Include in your response your ability, if applicable, to meet the CLIA requirements under Service Area D. 9) Please provide additional information that you believe we should know about your company in support of this Sources Sought. If a contract is solicited/awarded, the estimated Period of Performance will consist of five years. The contract type is anticipated to be a hybrid of Cost-plus Fixed Fee (CPFF) and Firm-Fixed-Price (FFP) task orders. Upon evaluation of the capability statements, if it is determined that this requirement will be an unrestricted competition, the Government intends to evaluate the Small-Business responses and conduct further market research to identify a subcontracting goal. Your response to this Sources Sought, including any capabilities statement, shall be electronically submitted to the Contracting Officer, Sheila Ramos, in either Microsoft Word or Portable Document Format (PDF), via email at sheila.ramos@nih.gov . All data received in response to this Sources Sought that is marked or designated as corporate or proprietary will be fully protected from any release outside the Government. No phone calls will be accepted. All questions must be submitted to the Contracting Officer identified above. The Government is not committed nor obligated to pay for the information provided, and no basis for claims against the Government shall arise because of a response to this Sources Sought. Respondents to this Sources Sought may be requested to provide an onsite briefing to DCTD personnel to further define capabilities.