Request for Information Pre-solicitation Industry Engagement Announcement Enhanced Pathways Utilizing Data Transport Mechanisms for the Acquisition of Cancer Data for NCI's Surveillance, Epidemiology, and End-Results (SEER) Program

AMENDMENT #1 POSTED 3/7/2023. This AMENDMENT to RFI Notice: HHS-NIH-NCI-RFI-PCPSB-00008-C16 is to provide the presentation and recording of the January 13, 2023 pre-solicitation industry engagement session. The presentation slide deck has been updated (slides 48-50) with government responses to the additional questions received after the January 13, 2023 session from the attendees. Special Notice: Request for Information Pre-solicitation Industry Engagement Announcement Enhanced Pathways Utilizing Data Transport Mechanisms for the Acquisition of Cancer Data for NCI's Surveillance, Epidemiology, and End-Results (SEER) Program RFI Number: HHS-NIH-NCI-RFI-PCPSB-00008-C16 Contracting Office Address Department of Health and Human Services, National Institutes of Health (NIH), National Cancer Institute (NCI), Office of Acquisitions, Rockville, MD. This is a Request for Information (RFI) for any interested vendors to submit questions and attend a pre-solicitation industry meeting. This is NOT a solicitation for proposals or quotations. The purpose of this market research is to share knowledge and information for project planning purposes. Virtual Meeting for Industry Engagement NCI and The Division of Cancer Control and Population Sciences (DCCPS) will host an interchange meeting to give industry an opportunity to communicate with acquisition personnel and program staff. The virtual meeting will be held on Friday, January 13, 2023, from 2:00PM - 4:00PM EASTERN TIME. All interested organizations are highly encouraged to attend this meeting and seek clarification about any of the information discussed below before submitting a response. The virtual meeting will be held via WebEx. The meeting information will be sent to registered participants. Written questions about this notice may be submitted electronically via email to Ms. Michelle Nguyen and Ms. Mary Muir via email: michelle.nguyen2@nih.gov and mary.muir@nih.gov by 5:00 PM EST on December 19, 2022. Purpose The DCCPS and the NCI of the NIH require services to support the transport of cancer data from health care providers, laboratories, diagnostic centers or other health care facilities where cancer is diagnosed and assessed to Surveillance, Epidemiology, and End-Results (SEER) Core Central Cancer registries (SEER Registries). The Contractor(s) shall provide sustainable, streamlined, and scalable mechanisms and pathways to support secure transport of cancer patients clinical data to SEER registries. The Government anticipates that all transport pathway solutions provided under this contract shall comply with regulations as required by 1) individual health facilities and 2) SEER Registry state regulations for public health reporting. Examples of the types of relevant health data that may be transported include pathology, radiology, or genomic reports and other reports and information related to a cancer patients diagnosis, treatments, or outcomes. These data could come from electronic health record (EHR) systems, laboratory information management systems (LIS), or radiology information system (RIS), etc. Because these data are required for public health reporting of cancers[1], patient identifying information must be captured along with the clinical information to permit SEER Registries to consolidate information on the same patient. Key objectives include: Facility Recruitment and Engagement - provide sustainable and expert engagement with U.S. health care facilities or centralized health data aggregators to initiate and support sustained data transfer of information on cancer patients related to the diagnosis, treatment or outcome of their disease to SEER Registries. Vendors would be required to have a strong capability to setup an engagement with facilities and organizations for the purpose of transferring data to SEER Registries; Data Transfer - initiate efficient, secure and sustainable transfer of data from health care facilities (as described above) via mechanism(s) that are potentially scalable to other geographically dispersed health facilities; and Maintenance - employ agile and transparent maintenance and monitoring of the data transfer process, including status and data volume reporting. Background The Surveillance, Epidemiology, and End Results Program of the National Cancer Institute is an authoritative source of information on cancer incidence and survival in the United States. SEER is supported by the Surveillance Research Program (SRP) in NCI's Division of Cancer Control and Population Sciences (DCCPS). Case ascertainment (i.e., identification of all eligible cancer cases to be included in the registry) for the SEER program began on January 1, 1973. Originally there were seven central/regional SEER registries comprising the SEER program. SEER has expanded central cancer registries to additional geographic regions and now covers approximately 48% of the U.S. population (additional information about current registries in SEER available at URL: https://seer.cancer.gov/registries/). There are currently 18 NCI supported SEER registries, each with wide variation in the number of healthcare facilities in their catchment areas. The purpose of the SEER Program is to assemble and report annual estimates of cancer statistics that pertain to incidence, prevalence, and patient survival; monitor trends to identify changes in cancer rates for population subgroups defined by geographic, demographic, and social characteristics; provide information on changes over time in stage of disease at diagnosis and types of therapy, as well as associated changes in cancer patient survival; carry out special studies that provide insight into trends in cancer rates, treatment patterns, and other relevant aspects of cancer control; and provide an infrastructure to support cancer research through its data. State cancer reporting regulations require hospitals and all healthcare providers (such as physicians, pharmacists, and laboratories) to report identifiable cancer patient information. The collection of cancer- related information qualifies under HIPAA exemptions as a public health activity (HIPAA-exempt). Public health reporting under the authority of state law is specifically exempted from the HIPAA Privacy Rule regulations (45 CFR 154.512(b)(1)(i)). The SEER Program currently collects and publishes cancer incidence and survival data from population- based cancer registries. Information on more than 9.7 million in situ and invasive cancer cases are included in the SEER database, and approximately 850,000 annual cases are accessioned within the SEER catchment areas. The SEER registries routinely collect data from health facilities (i.e., hospitals, laboratories, or other health entities that provide cancer-related patient diagnostics and treatments) in their state on patient demographics, primary tumor site, morphology, stage at diagnosis, treatment, and follow-up for vital status. The SEER Program is the only comprehensive source of population-based information in the United States that includes stage of cancer at the time of diagnosis and survival rates within each stage. Today, the SEER program has vendors that acquire and transport electronic clinical documents from various facilities across the United States to state and regional registries. The purpose of this acquisition is to acquire vendors services to establish new or enhanced pathways utilizing existing data transport mechanisms for 1) electronic data transfer from new facilities and 2) new types of data from existing facilities. The electronic data to be transported via these proposed solutions shall include but not be limited to: radiology, genomic, pathology reports or other data. The new facilities shall include but not be limited to hospitals, physician offices, laboratories, and radiology facilities. It is not anticipated that any one offeror would transport every data type or cover every facility in a geographical catchment area. The ultimate goal is to establish scalable, sustainable and cost-efficient solutions to enhance the collection and transport of cancer patients data to SEER Registries. Project Requirements & Objectives See Attachment 1 for a draft Statement of Work for a potential multi-year, multiple-award Indefinite Delivery, Indefinite Quantity (IDIQ). The Pre-solicitation Industry meeting will have the Government walk through the requirements and objectives, exchange information with the industry, and answer questions from the vendor community. Information Sought NCI seeks to share knowledge and information about the upcoming procurement during this group session with all interested parties. Vendors can submit questions based on the review of the draft statement of work by the deadline stated above. The Government plans to address the submitted questions during the January 13, 2023 session, and there will be an opportunity to submit additional questions during the Webex call. Industry Day Registration and Question Submission Instructions: Written Questions: All vendors are encouraged to submit questions in advance in regards to the draft Statement of Work (Attachment 1: Statement of Work) which will be addressed during the Pre-solicitation Industry Day meeting. A copy of the draft Statement of Work (SOW), which is subject to revisions, is uploaded as attachment to notice HHS-NIH-NCI-RFI-PCPSB-00008-C16. All questions related to this announcement and Attachment 1 Draft Statement of Work should be submitted electronically to Ms. Michelle Nguyen and Ms. Mary Muir via email: michelle.nguyen2@nih.gov and mary.muir@nih.gov. The subject line must specify - Questions regarding HHS-NIH-NCI-RFI-PCPSB-00008-C16. Question Response Due Date: Electronically submitted questions are due no later than 5:00PM EASTERN TIME, December 19, 2022. Registration and Intent to Attend Due Date: By 5:00PM EASTERN TIME, January 6, 2023. , please email Ms. Michelle Nguyen and Ms. Mary Muir via email: michelle.nguyen2@nih.gov and mary.muir@nih.gov to submit the following information: Intent to Attend Organization Name Main Organization's Point of Contact (name, email address) Organization's website Organization's business size (small business, large business, etc.) Names and emails of the organization's attendees who plan to participate The subject line must specify - Registration Request for Pre-Solicitation Conference -HHS-NIH-NCI-RFI-PCPSB-00008-C16. A Webex invitation will be sent to all registered participants. The participant count will greatly assist us in meeting preparations. 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. 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. The Government, at their sole discretion, may contact interested parties that respond to this inquiry to conduct additional exchange of information and/or market research. THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claim against the NCI shall arise as a result of a response to this Request for Information or the NCI's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement(s). Confidentiality: Respondents shall mark confidential, privileged, proprietary, trade-secret, copyrighted information, data, and materials with appropriate restrictive legends. The Government will not publicly disclose proprietary information obtained as a result of this notice. Unless otherwise marked, the Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. The Government will presume that any unmarked information, data, and materials were furnished with an - unlimited rights license; assumes no liability for the disclosure, use, or reproduction of the information, data, and materials. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). Attachments Draft Statement of Work, 10 pages. [1] Public health reporting to Cancer Registries is Health Insurance Portability and Accountability Act (HIPAA) exempt