Description
Synopsis CDC would like to partner with one or more organizations that have the infrastructure, capability, scalability, and safeguards to enable centralized public health laboratory data reporting from testing entities to state and large local health departments, with a focus on multi-state, large regional, and state-wide reporting entities. This is a request for information. It is not a solicitation for proposals or proposal abstracts. The purpose of this notice is to Determine the level of interest that exists in the market for providing the needed services; Obtain information, needs, capabilities, constraints, capacities, and requirements of those potential providers of the needed service; and Make use of this information to inform potential acquisition strategies that may be used to support emergency public health response activities, and maintaining on-going public health laboratory data reporting from commercial, private, and other non-traditional sectors. Background The U.S. public health response to COVID-19 depends on the reporting of comprehensive SARS-CoV-2 testing data. The Coronavirus Aid, Relief, and Economic Security (CARES) Act requires every testing entity to report results of every test it performs to detect SARS-CoV-2 or to diagnose a possible case of COVID-19. Authorized assays for viral testing include those that detect SARS-CoV-2 nucleic acid or antigen. In certain situations, serologic assays may be used to support clinical assessment of persons who present late in their illnesses when used in conjunction with viral detection tests[1]. New guidance released June 4th, 2020 to accompany the CARES Act Section 18115, specifies what data must be reported to comply with the COVID-19 laboratory reporting requirement. It also requires facilities and providers ordering laboratory tests to gather more complete patient demographic information and send it to state and large local public health departments, who will then send deidentified data to U.S. Centers for Disease Control and Prevention (CDC) and U.S. Department of Health and Human Services (HHS). Over 200 large-scale and multi-state testing entities (includes large chain drug stores, pharmacies, private laboratory networks, healthcare providers and healthcare networks, pharmacy data aggregators) have inquired about options for centralized reporting of results as opposed to developing individual or using multiple reporting solutions. COVID testing entities have communicated they are challenged by the reporting requirements to individual state, local, and county health departments. Some organizations stated they provide daily reporting of test results to over 70 public health departments, each differing in format and elements required. Under Section 18115, there are 31 data elements to be reported by the testing entity. These data elements include basic patient identifiers for jurisdictional follow-up, critical testing details, demographic data (including race and age), and ask-on-entry questions to assess individual risk. These data may be reported by the testing entity in three ways. Submission of laboratory testing data directly to state or local public health departments, as required by state and/or local law or policy. These entities will then submit de-identified data to the CDC on a daily basis using either Health Level 7 (HL7) messaging or the CDC-provided CSV format. Submission of laboratory testing data to state and local public health departments through a centralized platform where such data will then be routed to the appropriate state and local authorities and routed to CDC after removal of elements to achieve de-identification according to applicable rules and regulations. Submission of laboratory testing data through a state or regional Health Information Exchange (HIE) to the appropriate state or local public health department and to the CDC as directed by the state. Ideally, a centralized platform will enable more widespread and accessible reporting from the private and commercial sectors to ensure more complete reporting of testing data, help testing entities more efficiently report testing data, and transmit these critical data to state and large local health departments promptly so that the health departments can plan and execute timely COVID-19 control and mitigation efforts. CDC would like to partner with one or more organizations that have the infrastructure, capability, scalability, proven past performance, and safeguards to enable centralized public health reporting from testing entities to state and large local health departments. CDC expects the contractor to be able to accept a variety of data transmissions (including HL7, FHIR, and standard CSV flat files), provide basic data validation to testing entities, any necessary data transformations, and secure storage and retrival capability for jurisidcitional health departments. CDC will follow up with testing entities to improve the quality and completeness of data, and with receiving entities to ensure successful transmission and ingestion of data. Data should be provided by secure transmittal of identified data to state and large local health departments on a real-time or daily basis. The expectation is that the routing logic and transformations needed to transmit data from reporting entities to state and local authorities will be made public through application program interfaces (APIs) and machine readable data formats. Ideally any software code developed for the project should be released under an open-source license. If the solution is not open-source, any software code developed is expected to be government-owned or full rights to the code granted to CDC. The expectation is that this platform will be immediately used to support COVID-19 testing reporting, including for point-of-care testing, but will be expanded in the future to include other reportable conditions and other data streams (e.g. immunizations, admission-discharge-transfer (ADT), electronic case reporting (eCR) and other electronic health record (EHR) data). Requirement: CDC is seeking information from companies and other organizations about their capability, proven past performance, and capacity to leverage a secure and scalable cloud-based platform to accept and transmit testing data from testing entities to relevant state and large local health departments, with a focus on multi-state, large regional, and state-wide reporting entities. The agency is seeking a brief summary of no more than 10 pages (this excludes cover page and business information), with three sections: (1) cover page, (2) approach and (3) business information. Section 1: Approach o Description of any existing interfaces to collect testing data, standards of submission data (i.e. HL7, FHIR, standard CSV flat files), formats of delivered data, list of states and large locals reporting will be provided to. Please include a description of the needed describe changes needed to existing solutions or products to ensure compliance with the requirements of Section 18115. o Technical specifications of existing solutions, including APIs, secure file transfer options, minimal and optional data validation, data transformation, and transmission monitoring services, help desk resources, data storage, analysis and dashboarding functionality for testing entities and health departments. o Implementation details of using cloud infrastructure and resultant efficiencies. o Description of privacy, security, and insurance measures to ensure PII is protected and systems maintain HIPAA compliance. Description of data ownership and methods to deidentify data. Ability to adhere to all applicable health data regulations, HIPAA, and privacy standards. o Description of ability to track data through the transmission process, and ability for submitters to verify and track what has been submitted and received by jurisdictions. o Any liability issues, constraints and/or concerns to be considered o Testimonials or proof of successful past performance of these capabilities Section 2: Business and pricing model considerations o CDC funding is anticipated for platform infrastructure needs and possibly on-going costs for COVID-19 centralized reporting to health departments. o Business arrangement models that clarify the costs for CDC and other stakeholders (e.g. testing entities and submitters, state health departments), and scalability by number of data feed or volume of messages. o Provide recommendations for a pricing model that might attract large portions of the provider market, including large and smaller volume testing entities. o These models should include pricing for reporting that expands beyond COVID-19, to other reportable conditions and other data streams (e.g. immunizations, ADT, eCR and other EHR data). Submission Instructions Respondents are asked to provide only the most pertinent information, data, and materials necessary to adequately convey a declaration of capability in line with this notice. Respondents are asked to provide a cover page that contains the following information: All Point of Contact information (email addresses, phone numbers, and mailing address) DUNS number All relevant NAICS Codes Identification as a large or small business. If small, indicate the classification. Identification of services on any Federal Supply Schedules, if any, and the relevant schedule numbers. Proprietary information, if any, should be minimized and MUST BE CLEARLY MARKED. To aid HHS, please segregate and clearly mark proprietary information. Please be advised that all submissions become the property of the Government and will not be returned. This REQUEST FOR INFORMATION is in accordance with FAR 52.215-3 Request for Information or Solicitation for Planning Purposes (Oct 1997), as such, any information received will be for the purpose of planning only. Responses to this REQUEST FOR INFORMATION notice, along with a firm’s capability statement referencing “Centralized National Reporting Mechanism for COVID19 test results” may be submitted electronically via email to the points of contact listed below NO LATER THAN 5PM EST NOVEMBER 30TH, 2020. [1] U.S. Centers for Disease Control and Prevention. (2020, October 21). Overview of Testing for SARS-CoV-2 (COVID-19). Web site: https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html.