THIS RFI HAS BEEN AMENDED TO POST QUESTIONS AND ANSWERS . I. Background The Increasing Community Access to Testing (ICATT) program, implemented by the Centers for Disease Control and Prevention (CDC) in partnership with state and private sector partners, provides no-cost COVID-19 testing. The ICATT program focuses on communities that are at greater risk of COVID-19, under-resourced, uninsured, considered socially vulnerable, and/or have been disproportionately impacted by the pandemic. The ICATT program established a network of vendors performing testing in pharmacies and other testing surge sites nationwide, providing expanded community testing in response to a sudden increase in COVID-19 transmission. The ICATT testing sites include pharmacies offering full-service and drive-through test administration of point of care (POC) and sample collection for laboratory-resulted polymerase chain reaction (PCR) tests; kiosk, mail order and community site distribution of unobserved self-swab collection kits followed by laboratory-resulted PCR testing; and limited distribution of over-the-counter (OTC) tests. As the US recovers from the pandemic, the ICATT program infrastructure will transition from an active response program to a minimum sustainable testing program, maintaining a warm-base level of testing that could be activated in the event of another Public Health Emergency (PHE). Warm base is defined as the minimum sustainable level of testing to maintain preparedness for rapid response to a future PHE. The term “warm base” is derived from the Army , US Senate , and others who use warm base to reflect the minimum resources or capacity to maintain workload and manufacturing readiness for greater responsiveness. Warm base is traditionally referred to in the context of the manufacture of tests, components and consumables, and strategies for warm base testing services has not been well defined. In March of 2020, the federal government declared a PHE to encourage broad testing of COVID-19 in non-traditional testing facilities by easing testing regulations. As the pandemic wanes and the PHE expires, federal regulatory agencies will reinstate traditional testing regulations that will impact the current testing performed in pharmacies and other non-traditional testing locations. CDC’s approach to warm base testing will also include strategies to overcome challenges posed by the expiration of the PHE. II. Purpose This request for information (RFI) seeks input on possible post-PHE strategies to maintain diagnostic testing infrastructure (i.e.., policies, procedures, funding, and minimal operations to maintain services, approved tests, staff to deliver services, etc.) that can rapidly scale up (or surge) testing to meet the demands of the next PHE. OBJECTIVE: The CDC seeks information to create a strategy to reduce the scale of ICATT testing services to the lowest possible level required to maintain testing capabilities, data systems, and the ability to respond to future PHE. Elements of the strategy should encompass: • Minimum level of diagnostic testing services that can rapidly scale to meet the demand of future public health threats (e.g., variants, novel pathogens) • An optimized range of test types (i.e., tests for any PHE, not exclusive to COVID-19), resources, systems, and sites to sustain cost-effective access to testing for disproportionately affected people who live in communities with a high social vulnerability index • An optimized range of infrastructure and services (e.g., policies, partnerships, contracts, inventory/reserves, innovation, etc.) to reduce risk and enable readiness to rapidly scale up diagnostic testing • Legislative authorities, government policies, regulatory rules, and standard procedures that impede continuation of diagnostic testing services (e.g., COVID-19 and related testing services) after the PHE QUESTIONS: Please provide warm base strategy recommendations to continue diagnostic testing services after the COVID-19 PHE expires. 1. Describe approaches to provide warm base testing services. Please elaborate your organization’s capacity to implement the following approaches in a warm base: a. Feasible minimum capacity level to sustain cost-effective diagnostic testing and maintain preparedness to rapidly expand b. Broad geographic coverage of a minimal testing footprint c. Optimized types of tests, including routine tests or testing services d. Insurance billing capabilities for a no-cost test offering (e.g., public/private insurance) e. Sustainability and preparedness costs for testing (e.g., partnership costs, inventory, staff retention, appointment availability, automated reporting, forecasting demand, systems, etc.) 2. Identify the top three main concerns or challenges faced to execute diagnostic testing during past surge responses (e.g., supply chain, staffing, logistics, etc.), and describe how these obstacles could be mitigated in a future response. 3. Provide three innovations currently employed, or that could be employed to maintain diagnostic testing preparedness. 4. Provide recommendations to maintain testing access for uninsured patients and at-risk communities (e.g., moderate to high SVI locations, remote locations, racial and ethnic minority populations, etc.). 5. Provide recommendations to mitigate disruption of testing due to post PHE legislative and regulatory changes. Please consider: a. Criteria for testing b. Availability of COVID-19 testing kits with 510(k) marketing clearance versus emergency use authorization (EUA) c. Level of authority for pharmacists (e.g., order and perform CLIA-waived COVID-19 POC testing by pharmacists) d. Testing oversight and procedures e. Testing cost reimbursement capabilities via private insurance, Medicare, and Medicaid 6. What type of coordination is needed from the CDC to transition to a warm base testing strategy? III. Instructions: Responders to this RFI may include commercial or not-for-profit organizations, including teaming arrangements/partnerships or joint ventures. Please provide the following information on page 1 of your response: a. Unique Entity Identification Number b. Company Name c. Company Address d. Company Point of Contact, phone number and email address e. Type of company under North American Industry Classification System (NAICS), as validated via the SAM. Additional information on NAICS codes can be found at www.sba.gov. Any potential government contractor must be registered on the SAM located at http://www.sam.gov/index.asp General Capabilities Statements will not be accepted. Please submit a detailed responses (e.g., not standard marketing materials and general capability statements) that meet the RFI objectives. The informative nature of response is anticipated to address complex topics and possible strategies to achieving the objectives. The goal of the RFI responses is compile an enhanced understanding of strategic inputs. Product capability statements are not being sought. Do not send information that requires a non-disclosure agreement or sensitive business information. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions. Answer all questions that are relevant or most meaningful to your organization’s operations. Please denote questions that are not applicable or intentionally skipped. The page limit is not to exceed 5 pages. Responses should be single-spaced in Times New Roman 12-point font. Specify whether these responses are for USG access only by writing “[For US Government Use Only]” at end of response. Please submit your final responses to this RFI no later than (date) by 5:00 PM ET on December 16th ,2022 with questions due by November 23rd, 2022. Submit responses electronically, with subject “RFI Response National Diagnostic Testing Service Delivery Capability: [Company Name]” to
[email protected] Submit general questions relating to the RFI via email to
[email protected]. All information received in response to the RFI that is marked as proprietary will be handled accordingly. IV. Disclaimer : In accordance with FAR 15.201 (e), this RFI is for market research only and does not commit the Government to issue a solicitation, make an award, or pay any costs associated with responding to this RFI. The information submitted in all responses will be utilized to help the Government further define its requirements and develop acquisition strategies. All submitted information shall remain with the Government and will not be returned.