Biorepository and Sample Processing Services For a New Prospective U.S. Cohort Set Within Integrated Health Care Systems

Notice Number: HHS-NIH-NCI-RFI-ETSB-0001-70 Key Dates: Response Due Date: No later than 3:00PM Eastern on May 11, 2018 Issued By: National Cancer Institute (NCI), Office of Acquisitions (OA) General Information: This Request for Information (RFI) is intended to provide source material to formulate a procurement strategy for biorepository and sample processing services to support a prospective cohort set within U.S. integrated health care systems. This RFI should not be construed as a solicitation or as an obligation on the part of the Federal Government, the National Institutes of Health (NIH), and the National Cancer Institute (NCI). The Government does not intend to award a contract on the basis of this solicitation or to otherwise pay for the information solicited except as an allowable cost under other contracts as provided in subsection 31.205-18, Bid and proposal costs, of the Federal Acquisition Regulation. Although "proposal" and "offeror" are used in this Request for Information, your response will be treated as information only. It shall not be used as a proposal. Purpose: The responses to this RFI may guide the NCI in awarding future contracts at an undetermined time. There is no solicitation available at this time; no basis for claims against NCI shall arise as a result of this RFI, responses thereto or the NCI's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. This notice is for market research only to make decisions regarding development of strategies for shipping, processing, storage, management, and retrieval of biospecimens collected in a novel prospective cohort set within U.S. integrated healthcare systems. NAICS Code and Size Standard: In the event a Request for Proposal (RFP) is issued, North American Industry Classification System (NAICS) code 541990 - All Other Professional, Scientific and Technical Services with a size standard of $15M is being considered. Background: The Division of Cancer Epidemiology and Genetics (DCEG) plans to build a new prospective multi-center cohort study of at least 200,000 adult participants enrolled through several integrated health care system institutions in different locations in the United States. Pilot enrollment is expected to begin in the fall of 2019 with an estimated 50,000 participants enrolled each year for 4 years beginning in 2020. Participants will provide an e-consent followed by an online questionnaire, and collection of biological specimens including blood, urine, and others. The new cohort will additionally have all the desirable attributes of a contemporary study including serial samples, tumor tissue, comprehensive data from Electronic Medical Records on elements such as drug prescription, medical conditions and procedures, and repeated surveys combined with reliable passive and long-term follow-up strategies for outcome ascertainment. The cohort infrastructure will be designed to allow enhancements to be added in subsets of the participants at any phase to allow more detailed assessment of certain exposures, collection of additional specimens, and to facilitate patient-centered and health delivery research to improve patient care through evidence-based decisions. There will be a need to process, store, and manage large numbers of biospecimens collected from participants in the cohort study. Blood specimens may be processed locally or may require central processing at the repository within 24-36 hours of collection. Blood will need to be fractionated to its components (serum, buffy coat, plasma, RBCs) before storage. DNA extraction at the time of processing may also be required. Serial biospecimens will be collected, on average, every three years from all participants. In addition to repeated samples of blood and urine to be collected at each follow-up, additional specimen types may be collected from all or a subset of participants for ancillary studies. These may include but are not limited to, blood RNA tubes, other specific blood collection tubes, tissue samples, saliva samples, hair and toenail samples, and collection of clinical discard specimens such as cervical specimens, fecal blood tests, and others. Given the longevity of the cohort, flexibility will be needed to accommodate changes to the number and type of collection tubes and/or storage vials in the future. It will be critical to provide efficient, accurate and timely access to biospecimens for researchers and laboratories at different locations as the study progresses. Anticipated activities for the biorepository services include: 1. Transfer and track specimens from collection sites to central repository. Transfer specimens from collection sites or central laboratories at different integrated healthcare systems across the U.S. to the biorepository within 24-36 hours. These activities require communication with the collections sites and regional centers, real time tracking, and stable cold chains from sample collection to biorepository storage. 2. Laboratory Information Management System (LIMS) and Records Management. The LIMS should have an application programming interface (API) or can be enabled to have API as it will need to interface with the cohort's tracking system to share key specimen-related information and metrics. The shipping company used by the biorepository to manage and track shipment should allow for real-time tracking, communication if shipment should not be sent (for example, due to weather-related delays), reporting and investigation of delays, and packaging to meet International Air Transport Association (IATA) regulations, temperature control, and size requirements. It is critical that the entire life-cycle of each sample is tracked and recorded e.g. storage temperature and any fluctuations, freeze-thaw cycles. 3. Central processing of biospecimens. Receive a variety of human biospecimens, separate and aliquot biospecimens according to Standard Operating Procedures (SOPs), and extract DNA from blood specimens. The infrastructure needs to be available to immediately process and aliquot specimens when they arrive at the receiving facility. Ideally, these activities will be automated and available 7 days a week. The infrastructure should have a well-documented custody chain, sample tracking, and should be automated. Flexibility will be needed to accommodate ancillary studies and future changes to the specimen collection and processing protocol. 4. Long-term storage of biospecimens. Provide safe and efficient long-term storage of biospecimens at a variety of temperatures, predominantly -80C, but also liquid nitrogen storage, 4C storage and room temperature, with humidity control. Biospecimens will be accrued over many years, with approximately 200 samples per day in each of the first two years of recruitment (approx. 2 million aliquots created per year) and 400 samples per day each year thereafter. (approx. 4 million created aliquots per year). Large, expandable storage capacity is required. Storage facilities require alarms, emergency protocols, and redundancy for emergency storage if cooling equipment fails. Ideally, backup storage of a subset of aliquots at a different site should be provided. Long term storage will also be required for other types of samples including DNA, tissue, hair, toenails, cervical specimens, fecal blood tests, and others. 5. Biospecimen retrieval. Retrieve, aliquot, and ship stored samples. Biospecimen retrieval requires a fast turnaround time and should be fully automated to ensure reliability and cost-efficiency. 6. Preparation of biospecimen collection kits. Build various biospecimen collection kits that may be used for home collection (e.g. stool, saliva) or at clinical sites. Information Requested: I. General Information - contact information, including name, institution/organization, telephone and fax numbers and e-mail address; website URL II. Equipment and Capabilities 1. The NCI seeks to understand the methodological and technological capabilities to receive, process, store, and retrieve biospecimens according to the anticipated services described above. a) Complete the table below to indicate your capability in each of the anticipated services. ITEM INDICATOR Is Available (Yes/No) In progress* Automated (Yes/No) 1 Transfer and track specimens from collection sites to central repository. 2 LIMS and Record Management 3 Central processing of biospecimens with capacity for approximately 400 samples/day 4 Long-term storage of biospecimens with capacity for the cohort 5 Biospecimen retrieval. 6 Preparation of biospecimen collection kits. N/A *If you are currently building facilities please indicate when they will be complete and ready to operate. b) Provide a summary describing your capabilities in each of the required services described above. In addition, please describe the degree of automation and specify if any portion of your process is proprietary. 2. Please describe your cost model for providing the above services. For example, rental vs. ownership of equipment; cost per vial or per unit stored; cost model for specimen retrieval; cost model for shipping, tracking and receipt; and cost model for equipment maintenance and replacement. 3. Please identify any portion(s) of a future procurement for these services for which fixed price contracting could not be utilized and provide rationale and an alternative strategy. 4. Provide any other feedback and any other specific areas related to the stated activities you believe are worthy of consideration by NCI. How to Submit a Response: Interested organizations should submit a response to this Request for Information, not to exceed 10 single-sided pages, including all attachments, charts, etc. (single space, 12-point font minimum) that clearly responds to the above questions. Brevity and structured format (such as bulleted items) are encouraged whenever applicable to aid in processing. All proprietary information should be marked as such. Responses will be held in a confidential manner. NCI will provide confirmation of response submission, but respondent will not receive individualized feedback. Number of Copies and Delivery Point: Please submit all your responses, electronically, to Ms. Helen Wesley at helen.wesley@nih.gov. All information furnished must be in writing. All questions must be in writing and emailed to Helen Wesley, Contracting Officer, at helen.wesley@nih.gov. A determination by the Government not to compete this requirement based upon responses to this notice is solely within the discretion of the Government. Please reference number HHS-NIH-NCI-RFI-ETSB-0001-70 on all correspondence.