Synopsis CDC would like to partner with one or more organizations that have the infrastructure, capability, scalability, and safeguards to enable the submission of electronic test orders to public health laboratories and the receipt of test results by clinical partners. This system, once established, could also facilitate electronic submission of public health reportable test results to public health, including during emergencies, by laboratories and hospitals that don’t currently have electronic laboratory reporting systems in place. This is a request for information. It is not a solicitation for proposals or proposal abstracts. Release of this information should not be construed as a commitment to procure items discussed or to incur costs for which reimbursement would be required or sought. 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 activities for laboratory Electronic Test Orders and Results (ETOR) systems. Background Laboratory test results are a critical source of information used by physicians to provide appropriate patient care. Laboratory data, when reported to public health, can also be used for population health and to inform emergency response decisions. ETOR (Electronic Test Orders and Results) is one initiative to modernize informatics capabilities of public health laboratories, and to strengthen the connection between clinical laboratories and public health. ETOR is a collaborative effort with multiple stakeholders to use agreed-upon standards and build upon existing information systems to transmit test orders, specimen information, patient data, and results. Efforts to implement ETOR have been occurring in some public health laboratories, but the lack of a national strategy and federal funding may have prevented many public health laboratories from either initiating ETOR or completing ETOR implementation with the clinical partners in their jurisdictions. An important lesson from the COVID-19 pandemic is the need for public health to quickly obtain both patient information and laboratory test result data from the private healthcare system. Furthermore, the faster laboratories receive and process test orders, the sooner they can provide results back to submitters that are essential for effective clinical decision making or early intervention and response to public health emergencies. ETOR systems can immediately provide clinical and patient demographic data associated with specific laboratory data. In addition, ETOR systems enable the private sector to immediately receive test results back from public health laboratories in an automated way, reducing manual data entry and opportunities for error. Demographic data provided to the laboratory enables more complete electronic laboratory reporting (ELR) to public health departments, accelerating and enhancing contact tracing and public health action during outbreaks and emergencies. Use of appropriate standards for encoding the data in ETOR and ELR messages allows public health departments and CDC to obtain properly coded high-quality data. Ideally, ETOR will enable more widespread and accessible exchange between public health laboratories and the private and commercial sectors to • ensure more complete data is provided with samples submitted to public health laboratories • help testing entities to have timely reporting of results from public health laboratories back to sample submitters • improve overall test result reporting to public health CDC would like to partner with one or more organizations that have the infrastructure, capability, scalability, proven past performance, and safeguards to enable ETOR through seamless integration of public health laboratories and clinical partners, including hospitals, commercial, and clinical laboratories. CDC expects the contractor to be able to accept a variety of data transmissions (including HL7, FHIR, and standardized CSV files), provide basic data validation and any necessary data transformations The expectation is that the routing logic and transformations needed to transmit data in several formats (e.g. HL7, FHIR, etc.) between entities 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 ETOR. Requirement: CDC is seeking information from companies and other organizations about their capability, proven past performance, and capacity to develop and implement a solution to enable ETOR for public health and clinical laboratories. The agency is seeking a brief summary of no more than 10 pages, with two sections: (1) cover page, (2) approach and (3) business information. Section 1: Cover page Respondents are asked to provide a cover page that contains the following information: i. Point of Contact information (email addresses, phone numbers, and mailing address) ii. DUNS number iii. All relevant NAICS Codes iv. Identification as a large or small business. If small, indicate any additional classification. v. Identification of services on any Federal Supply Schedules, if any, and the relevant schedule numbers. Section 2: Approach i. Describe end to end solution, including proposed architecture and diagrams that enables ETOR for every state and local public health laboratory and the clinical partners in its jurisdiction. ii. Description of any existing interfaces to transmit test order and result information, standards for submission data (i.e. HL7, FHIR, standardized CSV files), formats of delivered data, methods of integration (e.g. web portal, EHR to LIS direct) and a list of entities that are users of the interface or other product.. iii. Technical specifications of existing solutions, including APIs, files types and standards supported (e.g. HL7, FHIR, CSV) 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 submitting and receiving entities. iv. Implementation approach, including details of using cloud infrastructure and resultant efficiencies. v. 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. vi. 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 public health laboratories. vii. Any liability issues, constraints and/or concerns to be considered viii. Describe previous experience implementing ETOR solution ix. Testimonials or proof of successful past performance of these capabilities including volume of tests handled. Section 3: Business and pricing model considerations i. Explain product pricing and licensing model, and what level of support is provided, any annual or maintenance fees ii. Describe anticipated funding requirements for infrastructure needs and long-term sustainability costs for nationwide ETOR implementation. iii. Describe any business arrangement models that clarify the costs for CDC and other stakeholders and scalability by number of data feed or volume of messages. iv. Explain ability to use a GSA schedule or other government-wide vehicle 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. Proprietary information, if any, should be minimized and MUST BE CLEARLY MARKED. 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 “Request for Information – Electronic Test Orders and Results” may be submitted electronically via email to the points of contact listed below NO LATER THAN 5:00 PM August 5, 2021. Questions must be submitted NO LATER THAN 5:00 PM July 15,2021). Point of Contact: Contracting Officer: Lauren Peel;
[email protected] Amended July 21, 2021 - answers posted