Attachment 0003 - Questions and Answers Discussed at Industry Day_Revised.pdf

Attachment 0003 – Questions & Answers Discussed at Industry Day_Revised

08 MAR 2021

Technical Q&As

1. Question: Does the Government have a preference between molecular (i.e. PCR, isothermal etc.) tests and rapid antigen tests?

Answer: The intention of this effort is to expand laboratory based testing for K-8 schools and underserved populations. As such it is envisioned that laboratory-based molecular tests will be a major component of this effort. However, alternative testing paradigms that involve the use of other testing modalities, including rapid antigen tests, will be considered if they can meet the government’s requirements.

2. Question: Does the government have a preferred test(s) for the laboratories to use?

Answer: While the U.S. Government (USG) contemplated use of a preferred vendor list, it has elected not to provide such a list to potential offerors. The USG does not have a preferred list for tests to be used by laboratories at this time. Please reference the Statement of Objectives and the OTA Announcement for further details.

3. Question: Can RUO/LDT tests be proposed as part of this testing expansion?

Answer: Yes. Testing paradigms utilizing RUO/LDT tests can be proposed, as long as they meet all federal, state and local regulations. It is envisioned in this scenario that reflex testing with an FDA authorized EUA test will be required for all positive specimens prior to reporting results.

4. Question: Can sample pooling be proposed as part of this testing expansion?

Answer: Pooling is a strategy that can be implemented as part of this testing expansion effort, but is not required. Technical proposals should highlight the strengths/weaknesses, risks/mitigations of the pooling approach. Offerors should make special note of FDA and CDC guidance related to the topic, especially around requirements for reportable results for pooled methods.

5. Question: Is there a specific process for collecting samples?

Answer: There is no specific process required for sampling, furthermore sample collection will not be conducted by the Coordinating Center and will be the responsibility of the state, local or school authorities. The Coordinating Center can provide guidance and assistance in implementing a collection protocol that local agencies and schools will perform in order to achieve the desired testing objective.

6. Question: Is there a specific sample type that should be used for testing?

Answer: There are no specifically preferred sample types; however, all proposed sample types should take into consideration compatibility with the approved FDA labeling for the EUA test(s) and/or requirements necessary to carry out other tests (LDT or RUO) that will be utilized.

Coordinating centers will be responsible for communicating with the state, local or school authorities on acceptable sample types for testing.

7. Question: Can sequencing be part of this testing expansion?

Answer: Sequencing strategies can be proposed as part of this effort, but are not required.

Proposals including sequencing should detail technical approaches that will enhance the testing program while maintaining the coordinating center’s ability to meet the USG’s primary requirements.

8. Question: Does testing need to cover all known variants?

Answer: The expectation is that testing will correctly identify clinical samples containing SARS- CoV-2 virus as positive, including samples containing variant strains. There is not currently a USG requirement to specifically identify which variant strain is in the samples.

Requirements Q&As

1. Question: How is sample volume forecasted, distributed, and assigned to the partner labs?

Answer: Coordination centers will conduct outreach to schools and other facilities interested in participating in the testing program, develop detailed testing implementation plans (i.e.

population, volume, frequency, specimen collection and flow, and other pre-analytical and post-analytic aspects) and data reporting structures in consultation with the USG’s Testing and Diagnostics Program Management Team, laboratories, state/county/local school districts, and technical assistance groups. The Testing and Diagnostic Program Management team will set overall testing targets for the region.

2. Question: What are the top objectives of the program specifically related to the delivery model

– i.e. full execution of the end to-end program vs. reliance on multiple partners across the components of the program?

Answer: The coordination center will have the responsibility of coordinating with the states, counties, and/or local school districts on testing efforts for the K-8th grade students, congregate settings like homeless shelters and/or organizations that reach underserved populations within their region, and ensuring proper testing at laboratories as directed by the USG. The coordination center will coordinate with states, counties, and/or local school districts for receipt of specimens for testing from the greatest possible dispersion of locations within a region. The USG Testing and Diagnostics Program Management Team may direct testing of specific locations and/or populations as necessary to assist in maintaining the goal of meeting public health needs as determined by the USG. For further details, please refer to the Statement of Objectives.

3. Question: What populations will the Coordination Centers be expected to test, and how often?

Answer: Coordination centers will conduct outreach to schools and other facilities interested in participating in the testing program, develop detailed testing implementation plans (i.e.

population, volume, frequency, specimen collection and flow, and other pre-analytical and post-analytic aspects) and data reporting structures in consultation with the USG’s Testing and Diagnostics Program Management Team, laboratories, state/county/local school districts, and technical assistance groups.

4. Question: What are the main responsibilities of coordinating centers? Will they be required to handle coordination of specimen collection and/or matching capacity and availability of testing?

Answer: The coordination center will have the responsibility of coordinating with the states, counties, and/or local school districts on testing efforts for the K-8th grade students, congregate settings like homeless shelters and/or organizations that reach underserved populations within their region, and ensuring proper testing at laboratories as directed by the USG. The coordination center will coordinate with states, counties, and/or local school districts for receipt of specimens for testing from the greatest possible dispersion of locations within a region. The USG Testing and Diagnostics Program Management Team may direct testing of specific locations and/or populations as necessary to assist in maintaining the goal of meeting public health needs as determined by the USG. For further details, please refer to the Statement of Objectives.

5. Question: Will each coordination center have the same methodology and approach?

Answer: No – The Coordinating Center is responsible for developing a plan that meets the testing goals for the region. The exact plans and implementation will vary across local agencies, communities, schools. We do not expect a one-size-fits-all approach. Coordination centers will conduct outreach to schools and other facilities interested in participating in the testing program, develop detailed testing implementation plans (i.e. population, volume, frequency, specimen collection and flow, and other pre-analytical and post-analytic aspects). Different methodologies and approaches across regions is somewhat expected so that the overall program can succeed and get to the best solution.

6. Question: How will laboratories be selected for participation, i.e., Department of Health, Academic, Private, etc.? Will the criteria be the same for each type of laboratory? Have these labs already been identified? If so, can you share?

Answer: The coordinating center is responsible for identifying and entering into appropriate contractual relationships with as many laboratories as necessary (e.g. ten) to complete the testing requirement within the designated region to complete increasing testing capabilities and capacities. Coordinating center partner entities may include, but are not limited to, large universities, commercial laboratories, consortium of laboratories, or non-profit entities and, if not CLIA-certified, would greatly benefit from partnering with traditional clinical, CLIA-certified laboratories.

7. Question: Are the 25 million tests per months per Coordinating Center or overall?

Answer: In aggregate, we expect laboratories and other entities to perform up to 25M tests per month across all the coordination centers. Each coordination center shall oversee a total of 1.5M or more tests per week across the designated region for the intent of both surveillance and screening efforts. The USG may also direct additional surge testing in excess of 1.5M tests per week as necessary to meet the USG's need for testing within the region.

8. Question: Will testing implementation follow CDC’s tiered approach and three levels of decision-making related to school-based testing (i.e., which schools, which persons in those schools, which testing strategies)?

Answer: The USG encourages, but does not require, coordinating centers and laboratories to follow CDC guidance. However ultimately the coordination centers are responsible for conducting outreach to schools and other facilities interested in participating in the testing program, developing detailed testing implementation plans (i.e. population, volume, frequency, specimen collection and flow, and other pre-analytical and post-analytic aspects) and data reporting structures in consultation with the Testing and Diagnostics Program Management Team, laboratories, state/county/local school districts, and technical assistance groups sufficient to meet the USG’s objectives.

9. Question: Could you please clarify/further define what you mean by ‘matchmaking’ capabilities (section 2.c. in the statement of objectives)?

Answer: The capability to match testing capacity (including test and instrument supply, testing-related supply, staffing resources) to areas with unfulfilled testing demand.

10. Question: Who is responsible for the training of the reporting system at the collections sites?

Answer: The coordinating center will ensure it provides the appropriate management and resources to ensure overall success of the program is achieved, including maintaining schedule, training, quality, program management, and reporting.

11. Question: How is reimbursement for services provided contemplated in this model?

Answer: Please refer to the OTA Announcement.

12. Question: APHL has concerns that the dire need for this expanded testing may be past, however we see value in putting this system in place and evaluating it for use in future emergencies.

Please comment.

Answer: The USG is committed to doing everything it can to strategically expand the nation’s testing capacity and ensure a swift and full national recovery, which will include students’ access to in person education and safe operations for essential businesses and sectors of the economy.

This program would initiate and formalize a national network of laboratories and supporting facilities useful in slowing the COVID-19 pandemic, as well as curbing future outbreaks, resurgences, and future pandemics. Further, with the vaccine available, there is a real opportunity to get to zero transmission and stay there, but to do so, we need to increase testing capacity to continue to identify and stop spread. Maintaining high levels of testing, as vaccination rolls out and transmission decreases, is critical to controlling this pandemic, and to preventing another wave.

13. Question: What is the targeted turnaround time expectation?

Answer: The coordinating center shall report all test results to relevant state health authorities in accordance with legal, regulatory, and contractual requirements, and be expected to provide structure and process for delivery of test results with an objective of 48 hours and a threshold of 72 hours from specimen collection.

14. Question: Are hubs envisioned to provide training, education, process consulting and/or services to schools?

Answer: Coordination centers will conduct outreach to schools and other facilities interested in participating in the testing program, develop detailed testing implementation plans (i.e.

population, volume, frequency, specimen collection and flow, and other pre-analytical and post-analytic aspects) and data reporting structures in consultation with the Testing and Diagnostics Program Management Team, laboratories, state/county/local school districts, and technical assistance groups. A coordination center needs to ensure it provide the appropriate management and resources to ensure overall success of the program is achieved, including maintaining schedule, training, quality, program management, and reporting.

15. Question: Will testing be divided evenly among the testing centers within a hub?

Answer: Not necessarily - Coordination centers will conduct outreach to schools and other facilities interested in participating in the testing program, develop detailed testing implementation plans (i.e. population, volume, frequency, specimen collection and flow, and other pre-analytical and post-analytic aspects) and data reporting structures in consultation with the Testing and Diagnostics Program Management Team, laboratories, state/county/local school districts, and technical assistance groups. The TDWG program management team can direct testing to certain parts of the region in response to public health needs.

16. Question: Why limit the focus of testing to K-8 – why not K-12?

Answer: This is the current administration's direction and goal. Studies suggest K-8 can safely reopen with appropriate mitigation strategies, whereas grades 9-12 appear to be more prone to increased transmission. K-8 students are also less likely to recognize symptoms and quarantine and likely won’t be approved for the vaccine until Fall 2021. Additionally, K-8 students are not as likely as their high school counterparts to succeed in a virtual environment, struggling with concentration and self-study. For these reasons, the initial priority is on teachers, students, and staff at K-8 schools. We will also focus on underserved congregate settings, such as homeless shelters. As the networks become more established and the testing demand from schools decreases, expansion to reach other vulnerable and underserved populations will be possible.

Contracting Q&As

1. Question: Will the coordinating center be able to work with partners (subcontractors) if necessary?

Answer: Yes. Please refer to the Statement of Objectives (SOO) for additional details.

2. Question: Is this expected to be a multiple award IDIQ contract? [Related: Is it expected the Government will make 4 awards, or will government issue separate awards to coordination centers and laboratories?]

Answer: The USG anticipates making up to four awards, with one for each region/coordination center. There is a potential for the USG to award multiple regions to one contractor. Additional details will be included in the Other Transaction Agreement (OTA) Announcement.

3. Question: What compensation methodology is anticipated?

Answer: The anticipated agreement structure will be a firm fixed price OTA Agreement for each coordination center. Additional details will be included in the OTA Announcement.

4. Question: What expenses are expected to be covered through these contracts (i.e. – lab operating expenses, lab capital buildout, related infrastructure)? [Related question: Will Program management services be billable? Will we be required to bill any services to insurance or other third parties, or will all services be billed to coordinating centers and they then bill HHS directly?][Related: what amount, if any, of financial or other resource support to you expect to offer the Testing Laboratories themselves in order to expand their capacity and customized tests and their accessioning protocols to better suit Educational and other under-served community support]

Answer: All expenses related to execution of the SOO are to be included in the offeror’s proposal. All billing will be through the prime contractor for each OTA Agreement. No third parties, such as insurance, shall be billed. Additional billing instructions and timelines will be included as part of the agreement between the selected offeror(s) and the USG.

5. Question: What are the criteria to be selected?

Answer: The selection criteria will be included as part of the OTA Announcement.

6. Question: What is the duration of the contract?

Answer: The anticipated duration of the contract is 6 months, with a potential for a non-competitive follow-on negotiated agreement or contract to follow. Additional details are included as part of the OTA announcement

7. Question: Will this be released as an RFP? (Related: When?)

Answer: The USG will be releasing an OTA Announcement in the near future. Please continue to monitor the USG’s notices regarding this procurement at beta.SAM.gov

8. Question: Will a potential RFP be “full and open” or will there be any small or disadvantaged requirements at either the Prime or Sub/lab level?

Answer: All proposals must meet the criteria the be eligible for award under 10 USC 2371b(d)(1)(A), (B), or (C). Beyond those statutory requirements, there are no further restrictions or requirements for participation involving small or disadvantaged businesses.