Attachment 05 Questions and Answers Batch 3.pdf

Question # Question Response

Will manufacturers with EUAs pending (not yet approved) be considered for award?

Are EUA’s allowed?

Tests without an active (not pending) EUA/510k must be treated as RUO until the EUA/510K is granted. 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.

Where does list of preferred lab providers come from? 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.

Will the Coordinating Centers be responsible for performing on site testing in the schools or congregate setting?

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.

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.

256 Can a single organization serve as multiple region’s Coordination Centers? Yes. Please refer to the Other Transaction Authority (OTA) Announcement for more information

How will funds be distributed across the Coordination and partner labs?

The coordination center is responsible for establishing agreements with the partner labs to include funding arrangements. Please refer to the Statement of Objectives (SOO) for additional information.

What is the timeline for the pilot? Why is this being run as a pilot? How long does HHS envision running this program? 6 month and max a year per document?

This is not a pilot, but a prototype seeking innovative solutions to demonstrate the ability to establish regional coordination hub(s) for expanding COVID testing capacity. Please refer to the Other Transaction Authority (OTA) Announcement for more information

What is the funding structure? Is there anything we should be prepared to present in our applications? How does this differ by testing method?

The coordinating center is responsible for determining all labor and material expenses required to execute the Statement of Objectives (SOO). Please refer to the Other Transaction Authority (OTA) Announcement for more information

Please give an example of Organizational Conflict of Interests (OCI) and speak to how this will be addressed.

An Organizational conflict of interest means that because of other activities or relationships with other persons, a person is unable or potentially unable to render impartial assistance or advice to the Government, or the person’s objectivity in performing the contract work is or might be otherwise impaired, or a person has an unfair competitive advantage. It is the offeror's responsibility to identify OCIs, if any, and mitigate them.

How should a lab interested in becoming part of the lab network connect with the vendors who would like to be coordination center(s)?

In order to help facilitate this, the Government released the list of vendors from industry day that wanted their information shared to others that also noted the same. Laboratories are encouraged to reach out to potential coordination center contractors to identify excess capacity.

Is the OTA only intended for coordinating centers, or may a laboratory submit a white paper to be available to coordinating centers?

Only the coordination center should submit white papers. The coordination center is responsible for establishing agreements with the partner labs to include funding arrangements. Please refer to the Statement of Objectives (SOO) for additional information

OTA Notice Section 3.2 "Should an Offeror not have an active registration in SAM, the Offeror shall address its status in registering on the SAM and understand that award of an agreement is contingent on approved registration. This shall allow a proposal submission while registering.”

If an entity submits a response, while pursuing SAM registration, and the SAM registration is not approved either on or before the date on which award determination is made by HHS, will the government provide additional time necessary for the SAM process to finish and subsequently formalize the award to the entity, assuming that’s the entity the government determines to be the winning bidder?

It is anticipated that SAM registration can be completed within the timeframe from proposal submission to award. If not completed by the time the Government makes award, the Government may consider alternative approaches to award the agreement but is not obligated to do so.

OTA Notice Section 3.2 "Should an Offeror not have an active registration in SAM, the Offeror shall address its status in registering on the SAM and understand that award of an agreement is contingent on approved registration. This shall allow a proposal submission while registering.”

If a company has two separate organizational units, at what response milestone must we determine whether entity A or entity B must respond before we no longer can have the flexibility to pick one vs. other. I.e. whitepaper submission, response to proposal post‐invitation, or some other?

If a company would like to be considered for multiple awards (i.e. one to entity A, one to entity B) then separate submissions are required for each milestone. If multiple entities have the capabilities to perform but only one will be determined by the company to actually perform, it should be noted in the submission of each response and the Government will make a determination as to when the performing entity needs to be determined.

Establish Testing Capacity (SOO Objective 5.2): Are the White Paper and RFP processes the sole methods for laboratory selection? If not, what other methods/criteria will be evaluated?

Only the coordination center should submit white papers. The coordination center is responsible for establishing agreements with the partner labs to include funding arrangements. Please refer to the Statement of Objectives (SOO) for additional information.

Establish Testing Capacity (SOO Objective 5.2): How much weight will individual elements factor into Coordination Center selection of laboratories? (We acknowledge the White Paper Submission and Technical Evaluation Rating Schedule)

The responses to the OTA Announcement will be evaluated holistically to determine which proposal(s) meet or exceed the established requirements to the greatest extent.

Establish Testing Capacity (SOO Objective 5.2): Is there a recommended or required contract template that will be used by Coordination Hubs to contract with laboratories? If so, may this template be shared with laboratories submitting White Papers?

The coordination center is responsible for establishing agreements with the partner labs.

Are graphics held to the 12 point font requirement? (OTA Announcement 3.6.1 Phase I – White Paper Submission Content)

No, but text on graphics should be legible and minimal.

`Is a white paper need for each region if a firm wishes to be considered for each of the regions? (OTA Announcement 3.6.1 Phase I – White Paper Submission Content)

If an entity is interested in more than one (1) region, they may submit one (1) White Paper addressing the region(s) they are interested in.

If an entity proposes on more than one (1) region, a separate proposal for each region shall be submitted.

Where should shipping costs be applied relative to test kit delivery and sample return? (Attachment 0002 – Price Matrix)

Please refer to the Description of CLIN 0003 in the Price Matrix

Where should individual test kit supply costs be applied relative to testing?

(Attachment 0002 – Price Matrix)

Please refer to the Description of CLIN 0003 in the Price Matrix

SOO Objective 5.3 (Procurement of Tests): How are the Coordination Hubs to be funded? Will awarded contracts include funding to set up and begin operations, including hiring? Will Hubs be reimbursed for tests once they are administered or prospectively paid based on assumptions related to number of schools, etc.?

Please refer to the SOO and the description of the CLINs in Attachment 0002 ‐ Price Matrix.

SOO Objective 5.1 (Establish Coordination Centers): If we are interested in being considered for each region, should we submit four different white papers or four price matrixes? Is the ROM completed using the attached price matrix for the white paper? Or is the price matrix submitted only for the full proposal?

Refer to section 3.7.1 of the OTA announcement for requirements if an organization desires to serve as a Coordination Center for multiple regions. The ROM does not need to utilize the price matrix but will be required if an offeror is invited to submit a proposal for Phase II.

SOO Objective 5.1 (Establish Coordination Centers): Do all contractor and subcontractor agreements have to be in place and final for white paper submission?

No.

Establish Coordination Centers: Should offerors include staff and costs for in field sample collection across the region (I.e. plan for deploying, training, recruiting, and paying all sample collection staff)?

All expenses related to execution of the SOO are to be included in the offeror’s proposal. Costs should be appropriately segregated by the offeror if they will be more likely to be incurred in the execution of the general coordination center functions or on a per test basis.

3.7.3 Factor 2‐ Price Proposal Volume‐ Would the government consider alternative pricing/billing structures other than firm fixed price? With such variable and undetermined volume levels, it seems that setting up costs based on volume tiers could achieve better value and outcomes for the government while minimizing the performance and financial risk of the successful awardee(s).

Offerors are to propose in accordance with the OTA Announcement. If alternative arrangements are suggested they may be discussed as part of the white paper and proposal for Government consideration to be discussed during negotiations prior to award.

5.5 Program Management: What is the financial model? i.e. per test administrative fee?

Please refer to the Description of CLIN 0003 in the Price Matrix

1.3 Contractor Support

If one of the contractors listed under 1.3 Contractor Support is unaware of their organization providing evaluation support for this OTA, how can the contractor be removed from the list? If removal is not permitted, is the contractor permitted to submit an OTA response and recuse themselves from evaluating their own submission?

The Government will be issuing an Amendment in the near future removing some of the Contractors from Section 1.3. Additionally, if a contractor on the list desires to submit a proposal, they can request removal from the list and they will not be allowed to be involved in any aspect of this procurement.

Offerors may be interested in submitting bids for multiple regions. How should offerors indicate interest in submitting bids for multiple regions in the White Paper submission? To follow on the preceding question, will the same process apply for full proposal submission for vendors interested in submitting bids for multiple regions?

If an entity is interested in one (1) region, they may submit one (1) White Paper addressing the region(s) they are interested in. If an entity proposes on more than one (1) region, a separate proposal for each region shall be submitted.

If vendors must submit a white paper for each region of interest, please confirm that Vendors should use Attachment B as the basis for the ROM for each region (Coordination Center Setup, Program Management, and Price‐per‐test for 25,000,000 tests total for each region).

If an entity is interested in more than one (1) region, they may submit one (1) White Paper addressing the region(s) they are interested in.

Yes, vendors may use Attachment B as their basis for the ROM for each region, and include a ROM per region and how the ROM is impacted if they were to operate over multiple regions.

002 Monthly cost of Coordination Center program management: Can our monthly overhead cost vary by month, based on the number of schools supported or tests performed, or is it required to be fixed for the full six month period?

CLIN 0002 is based on an overall total of 6 months, but could be variable among each month. If that is the case, the offeror should use the average monthly cost as the unit price.

Will USG permit pass‐through payments for certain cost categories, such as on‐site collections staffing and courier/transportation of specimens? We would plan to bill for these services at cost, and we believe that it is more cost efficient than factoring an estimated volume of service into the total per test fee.

Offerors are to propose in accordance with the OTA Announcement. If alternative arrangements are suggested they may be discussed as part of the white paper and proposal for Government consideration to be discussed during negotiations prior to award.

Would the USG consider using a Cost Reimbursable model due to the undefined SOW and critical need? (On emergency response contracts, i.e. FEMA and HHS, Cost Reimbursable or T&M contracts are used due to the not fully defined Scope of Work and fast evolving requirements in an urgent situation. Pricing this requirement as FFP CLINS places an undue amount of risk onto the contractor.)

Offerors are to propose in accordance with the OTA Announcement. If alternative arrangements are suggested they may be discussed as part of the white paper and proposal for Government consideration to be discussed during negotiations prior to award.

Please clarify what constitutes "a significant extent" for non‐traditional defense contractor or non‐profit participation under 10 USC 2371b(d)(1)(A).

There is no established definition of what constitutes a significant extent and it is a determination made the by Agreements Officer based on the degree to which non‐traditional defense contractors or non‐profit institutions supply a new key technology, product, or process;

supply a novel application or approach to an existing technology, product or process; provide a material increase in the performance, efficiency, quality or versatility of a key technology, product or process; accomplish a significant amount of the prototype project; cause a material reduction in the cost or schedule of the prototype project; or, provide for a material increase in performance of the prototype project.

Given the preference for graphics, and the objectives to be covered, Will the Government extend the White Paper page limitation from 5 to 8 pages? No.

Is tracing and tracking for positive results a component at the school level Coordination Centers are not expected to conduct "contact tracing," but are expected to track specimens received by network laboratories and document associated testing results in a reportable fashion. The Coordination Center shall ensure full compliance with HIPAA and other federal and state privacy laws, as applicable, which includes the storage of data in compliance with those laws.

What type of COVID Test Method should be priced in CLIN 3? (Attachment 0002 – Price Matrix)

Please refer to the Description of CLIN 0003 in the Price Matrix.

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 U.S. Government's requirements.

Data and Reporting: Can you talk more about expectations around collection of personally identifiable information including name, street address, DOB, race, ethnicity and how reporting of that information to state public health departments;

what are the expectations for reporting electronically, timely or complete? Will information about the patient’s school be collected and reported?

Coordination Centers shall ensure full compliance with HIPAA and other federal and state privacy laws, as applicable, which includes the storage of data in compliance with those laws. Additionally, coordination centers are ultimately responsible for ensuring proper administration of the all tests in compliance with the FDA labeling and current guidance. No assumptions shall be made that the U.S.

Government will serve in reaching individual agreements with any of the individual laboratories. Please reference the Statement of Objectives and the OTA Announcement for further details.

What software will be used to route specimen from the coordinating centers to the participating labs in each region

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. Please reference the Statement of Objectives and the OTA Announcement for further details.

Will there be a shared database/LIS to be used across all locations for sample accessioning and resulting?

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. Please reference the Statement of Objectives and the OTA Announcement for further details.

How is the coordination center going to be responsible for the reporting system training at the collection site, when the reporting system is tied to the lab? There will be a lot of different systems, devices, labels and LIS.

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.

Is there additional information available on the initiative to expand sequencing?

Entities are encouraged to include in their technical respone any approaches to sequencing that will enhance the testing program while still being capable of meeting the Governments primary requirements in the SOO

Will sequencing be a part of the initial scope or a potential follow‐on scope?

Entities are encouraged to include in their technical respone any approaches to sequencing that will enhance the testing program while still being capable of meeting the Governments primary requirements in the SOO

What type of testing is planned?

Entities will be asked to submit their plans for testing, which may include using EUA, LDT and/or RUO. Impact of variants on EUA is being evaluated and risk assessed by FDA and manufacturers. Labs with RUO and LDT may describe their efforts at addressing impact of variants on their assays.

Would the CHWL currently‐used COVID assay be the one that is expected to be used, or would a different assay be required?

a. If a different assay is required, will assistance be provided in the validation process?

Entities will be asked to submit their plans for testing, which may include using EUA, LDT and/or RUO. Impact of variants on EUA is being evaluated and risk assessed by FDA and manufacturers. Labs with RUO and LDT may describe their efforts at addressing impact of variants on their assays.

How are you defining a laboratory service company?

Offerors may propose, as part of their testing strategy, the inclusion of companies that offer certified laboratory testing as a service. The level or type of certification required will depend on the Offerors proposed use and in accordance this federal and local law and regulations for generating a reportable diagnostic result.

If proposing a pooled testing method, must samples be deconvoluted?

Pooling is a strategy that can be implemented to meet the government requirement but is not required. Technical proposals should highlight the strengths/weaknesses, risks/mitigations relative to the of the approach and how that approach will meet the government requirement. Offerors should make special note of FDA and CDC guidance related to the topic, especially around requirements for reportable results.

Will HHS circulate any presentations or materials from the virtual engagement following the event?

Presentation materials have been shared, and answers to the questions about the program will be shared more broadly soon.

Technical Requirements: 1. Does the vision include a web/mobile application for all the various stakeholders?

Proposals should describe the process for managing information and reporting results to and from individuals/guardians, school districts, and relevant public health agencies. Please reference the Statement of Objectives and the OTA Announcement for further details.

A K‐8 population will likely include a significant percentage of asymptomatic cases among those infected with COVID‐19. In such cases, “rapid tests” in particular may be more likely to produce false negative results. What is the strategy to deploy RT‐PCR, rapid tests and antibody assays for this population?

RT‐PCR, rapid tests and antibody assays each have their own advantages and disadvantages for specific use cases. Technical proposals should highlight the strengths/weaknesses, risks/mitigations relative to the of the approach and how that approach will meet the government requirement.

What is the view on the use of standardized testing across the program to enable scale vs. customization based on the capabilities and/or capacity of the entire network?

Standardized vs customized approaches are both acceptable and each have their pros and cons. Any response to the solicitation should highlight the strengths/weaknesses, risks/mitigations relative to the of the proposed approach and how that approach will meet the government requirement.

302 Is there a plan to survey vaccination effectiveness/immune response? Surveying vaccination effectiveness is not currently within the scope of this request.

How will novel technology solutions such as Pine Trees Health be considered for inclusion in the testing program?

Testing strategies may be proposed by Coordinating Centers for use within their respective laboratory network in compliance with federal and local law and regulations. All discussion of novel technologies should highlight the strengths/weaknesses, risks/mitigations relative to the of the proposed approach and how that approach will meet the government requirement.

Will the government provide the Physician Standing order to establish the testing sites?

The Coordination Center shall ensure full compliance with HIPAA and other federal and state privacy laws, as applicable, which includes the storage of data in compliance with those laws. Additionally, coordination centers are ultimately responsible for ensuring proper administration of the all tests in compliance with the FDA labeling and current guidance. No assumptions shall be made that the U.S.

Government will serve in reaching individual agreements with any of the individual laboratories. Please reference the Statement of Objectives and the OTA Announcement for further details.

Is it contemplated that there will be a universal reporting delivery infrastructure, and/or is it contemplated that results shall be made available to individual students/families or just to their institution?

The Coordination Center shall report all test results in accordance with regulatory and contractual requirements. Please reference the Statement of Objectives and the OTA Announcement for further details.

Will genomic sequencing (variant typing) be utilized to help track and reduce spread of variants across each region?

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 currenly a Government requirement to specifically identify which variant strain is in the samples.

Do you expect testing that covers all of the known variants?

The expection is that testing will correctly identify clinical samples containing SARS‐CoV‐2 virus as positive, including samples containing variant strains. There is not currenly a Government requirement to specifically identify which variant strain is in the samples.

Will there be a requirement for variant identification?

The expection is that testing will correctly identify clinical samples containing SARS‐CoV‐2 virus as positive, including samples containing variant strains. There is not currenly a Government requirement to specifically identify which variant strain is in the samples.

Is there a preference between dry swab pooling onsite by teachers and saliva pooling at the lab or is that going to vary based on geography?

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.

Will customers be able to select which type of test is performed (i.e. can a specific school request an antigen test or saliva‐PCR test)? Or, will customers be required to use a test offered by the coordination center/lab regardless of the customer’s preference?

There is no specifically preferred sample collection methods/types. Proposed sample types should take into consideration invasiveness, the operational challenges of sampling large groups of children, and compatibility with the approved FDA labeling for the EUA test(s).

Given the ease of saliva sampling, especially with children, will there be a requirement for a certain percentage of all tests to be saliva‐based?

There is no specifically preferred sample collection methods/types. Proposed sample types should take into consideration invasiveness, the operational challenges of sampling large groups of children, and compatibility with the approved FDA labeling for the EUA test(s).

When students are screened for coronavirus and have a positive result, they likely do not need another test and a molecular test may be positive for some time. Has the Administration thought about the right test and the right time for the right patients?

How will this be controlled so that students who are not contagious can return to school?

To the best of the governments understanding there are no FDA authorized tests available on the market that quantify or stratify levels of contagiousness. The government does acknowledge the challenge of individuals that are peristently positive by molecular testing methods after clearing of live culturable virus.

If an EUA has an age cutoff (e.g. 14 years or older for self‐use), will HHS help manufacturers to expand the test label?

Within the scope of this effort, no assumptions shall be made that the U.S. Government will serve in expanding claims of a test.

Since the goal is to open K‐8 quickly should the coordination hub be ready to launch at large scale in schools immediately in early April? Does that include the hub being able to train teachers and staff, take parental consents, etc, across many schools on Day 1 ?

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. 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. We are targeting to have the first coordinating center stood up by April. The base Period of Performance (PoP) will be six (6) months from the initial operating capability of the coordination center to completion of the testing effort.

Can you clarify how (e.g., data systems and processes) you anticipate tracking laboratory capacity and testing demand?

Coordinating centers shall provide an implementation plan for matching these schools and community organizations with unfulfilled demand to testing capacity (including test and instrument supply, testing‐related supply, staffing resources) and proposed processes for managing the testing process, delivery, collection and reporting.

If a specimen is positive during testing, will the coordination center be responsible for ordering follow‐up diagnostic COVID‐19 testing with the CLIA certified laboratory

Coordinating centers will ensure all individuals with positive test results during surveillance testing are referred to a CLIA‐certified laboratory for diagnostic testing or results from original sample are validated by a CLIA‐certified laboratory.

Can you further clarify the coordinating center's role in follow‐up testing after a positive screening test (e.g., pooled testing), compared to the role of the school, relevant public health authority, diagnostic laboratory etc.

Coordinating centers will ensure all individuals with positive test results during surveillance testing are referred to a CLIA‐certified laboratory for diagnostic testing or results from original sample are validated by a CLIA‐certified laboratory.

Will one software platform be used for patient ordering, pre‐registration, and resulting?

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.

The coordinating center shall report all test results to relevant state health authorities in accordance with 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. They will ensure diagnostic test results compliant with HIPAA and CLIA within 24 hours from collection or reflex from a prior screening surveillance test, and report all confirmatory EUA test results and CLIA‐certified testing results to public health authorities within 48 hours of obtaining a result using a harmonized, electronic format, and in compliance with federal, state, and local law and regulations.

What types of reporting and data analytics has this initiative identified as being a focus for measuring effectiveness and best practice services? Would this committee seek to jointly identify best measurement approaches with the contracted entities?

Data reporting and analytics requirements will be concretely determined as we get further along this process.

Will the laboratories integrate into an HHS / ACC‐RI database so the results are held in one repository and then distributed from that repository?

Data reporting and analytics requirements will be concretely determined as we get further along this process.

Will each Coordinating Center establish a set of best metrics and methods for measuring project success (section 4 of the Statement of Objectives) or will metrics be shared across the 4 Coordinating Centers?

Data reporting and analytics requirements will be concretely determined as we get further along this process. Please refer to the OTA announcement.

Will regional coordinating hubs be purely governmental or will they perhaps be a partnership between government and private industry ‐ possibly based on capabilities of private entities based on assessment of their proposals?

Different types of entities could qualify to be a coordination centers, including but not limited to: a test manufacturer, a commercial or academic laboratory, a services company, or any healthcare related non‐profit or not for profit group that is organized on a local, state, or national level. 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.

Can a testing center be a state lab?

Different types of entities could qualify to be a coordination centers, including but not limited to: a test manufacturer, a commercial or academic laboratory, a services company, or any healthcare related non‐profit or not for profit group that is organized on a local, state, or national level. 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.

What level of oversight will the U.S. Government implement with each of the Coordinating Centers?

Health and Human Services will establish a Testing and Diagnostics Program Management Team to engage with the technical assistance team and provide government direction and oversight to coordination centers in order to execute the government’s concept of operations to expand testing. The numbers and skill sets are being finalized but expect it to consist of approximately one dozen personnel or two personnel for each coordination site (a lead and alternate), contracting interface (and alternate), data analyst, and overall program management director. This will provide adequate oversight and engagement as well as compensate for time zone differences. This team will not only include the Agreements Officer Representative (AOR) and an alternate AOR but will consist of government experts that will be available to engage and monitor the coordination centers and technical assistance team to ensure they perform the duties outlined in the agreement as well as strategic direction provided by senior leaders in Health and Human Services. The Program Management Team will be based in the Hubert Humphreys Building, Washington DC and will liaison with the DoD contracting team as required. The Testing and Diagnostics Program Management Team will assist in identifying testing kit suppliers who have indicated that they have excess testing kits available. Additional technical assistance from CDC, CMS, and FDA may be provided as necessary. The coordinating centers shall also have a single point of contact for coordination with the Government Program Management Office. Each coordination centers is expected to maintain an open line of communication with this office to discuss changes.

What level of changes are within this oversight?

Health and Human Services will establish a Testing and Diagnostics Program Management Team to engage with the technical assistance team and provide government direction and oversight to coordination centers in order to execute the government’s concept of operations to expand testing. The numbers and skill sets are being finalized but expect it to consist of approximately one dozen personnel or two personnel for each coordination site (a lead and alternate), contracting interface (and alternate), data analyst, and overall program management director. This will provide adequate oversight and engagement as well as compensate for time zone differences. This team will not only include the Agreements Officer Representative (AOR) and an alternate AOR but will consist of government experts that will be available to engage and monitor the coordination centers and technical assistance team to ensure they perform the duties outlined in the agreement as well as strategic direction provided by senior leaders in Health and Human Services. The Program Management Team will be based in the Hubert Humphreys Building, Washington DC and will liaison with the DoD contracting team as required. The Testing and Diagnostics Program Management Team will assist in identifying testing kit suppliers who have indicated that they have excess testing kits available. Additional technical assistance from CDC, CMS, and FDA may be provided as necessary. The coordinating centers shall also have a single point of contact for coordination with the Government Program Management Office. Each coordination centers is expected to maintain an open line of communication with this office to discuss changes.

What level of authority/oversight will the HHS technical assistance team have on the daily operations of the coordination centerss?

Health and Human Services will establish a Testing and Diagnostics Program Management Team to engage with the technical assistance team and provide government direction and oversight to coordination centers in order to execute the government’s concept of operations to expand testing. The numbers and skill sets are being finalized but expect it to consist of approximately one dozen personnel or two personnel for each coordination site (a lead and alternate), contracting interface (and alternate), data analyst, and overall program management director. This will provide adequate oversight and engagement as well as compensate for time zone differences. This team will not only include the Agreements Officer Representative (AOR) and an alternate AOR but will consist of government experts that will be available to engage and monitor the coordination centers and technical assistance team to ensure they perform the duties outlined in the agreement as well as strategic direction provided by senior leaders in Health and Human Services. The Program Management Team will be based in the Hubert Humphreys Building, Washington DC and will liaison with the DoD contracting team as required. The Testing and Diagnostics Program Management Team will assist in identifying testing kit suppliers who have indicated that they have excess testing kits available. Additional technical assistance from CDC, CMS, and FDA may be provided as necessary. The coordinating centers shall also have a single point of contact for coordination with the Government Program Management Office. Each coordination centers is expected to maintain an open line of communication with this office to discuss changes.

More detail on the role of the Government Program Management Office would be appreciated.

Health and Human Services will establish a Testing and Diagnostics Program Management Team to engage with the technical assistance team and provide government direction and oversight to coordination centers in order to execute the government’s concept of operations to expand testing. The numbers and skill sets are being finalized but expect it to consist of approximately one dozen personnel or two personnel for each coordination site (a lead and alternate), contracting interface (and alternate), data analyst, and overall program management director. This will provide adequate oversight and engagement as well as compensate for time zone differences. This team will not only include the Agreements Officer Representative (AOR) and an alternate AOR but will consist of government experts that will be available to engage and monitor the coordination centers and technical assistance team to ensure they perform the duties outlined in the agreement as well as strategic direction provided by senior leaders in Health and Human Services. The Program Management Team will be based in the Hubert Humphreys Building, Washington DC and will liaison with the DoD contracting team as required. The Testing and Diagnostics Program Management Team will assist in identifying testing kit suppliers who have indicated that they have excess testing kits available. Additional technical assistance from CDC, CMS, and FDA may be provided as necessary. The coordinating centers shall also have a single point of contact for coordination with the Government Program Management Office.

Which government entity would be overseeing the program and how?

Health and Human Services will establish a Testing and Diagnostics Program Management Team to engage with the technical assistance team and provide government direction and oversight to coordination centers in order to execute the government’s concept of operations to expand testing. The numbers and skill sets are being finalized but expect it to consist of approximately one dozen personnel or two personnel for each coordination site (a lead and alternate), contracting interface (and alternate), data analyst, and overall program management director. This will provide adequate oversight and engagement as well as compensate for time zone differences. This team will not only include the Agreements Officer Representative (AOR) and an alternate AOR but will consist of government experts that will be available to engage and monitor the coordination centers and technical assistance team to ensure they perform the duties outlined in the agreement as well as strategic direction provided by senior leaders in Health and Human Services. The Program Management Team will be based in the Hubert Humphreys Building, Washington DC and will liaison with the DoD contracting team as required. The Testing and Diagnostics Program Management Team will assist in identifying testing kit suppliers who have indicated that they have excess testing kits available. Additional technical assistance from CDC, CMS, and FDA may be provided as necessary.

If schools/public health have challenges with specimen collection, will this program provide assistance?

HHS will establish a testing and diagnostics technical assistance contract with one or more organizations. These organizations will provide technical advisors (TA) that will be prepared to support at the school, lab, and coordination center level as needed in regards to logistical support, information, technology, regulatory, quality assurance and other areas related to collection, handling, processing, resulting, and final disposition of specimens.

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.

How can this group help clear administrative hurdles related to paper consents, medical record keeping at the school, test oversight, sample logistics, and CLIA Waivers?

HHS will establish a testing and diagnostics technical assistance contract with one or more organizations. These organizations will provide technical advisors (TA) that will be prepared to support at the school, lab, and coordination center level as needed in regards to logistical support, information, technology, regulatory, quality assurance and other areas related to collection, handling, processing, resulting, and final disposition of specimens.

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.

Is a specific testing algorithm similar to that deployed with LTCFs based on local prevalence being considered?

HHS will not provide any testing model. 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 Testing and Diagnostic Program Management team will set overall testing targets for the region.

Is there an existing model being considered to roll out testing to underserved populations or is the RFI requesting industry to provide input on the model? Could HHS describe the model?

HHS will not provide any testing model. 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 Testing and Diagnostic Program Management team will set overall testing targets for the region.

Are the 25 million tests per months per Coordinating Center or overall?

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.

What is the expected number of individuals tested per area?

In aggregate, we expect laboratories and…