Attachment 0001 - Statement of Objectives (SOO)_08 Mar 2021.pdf

Expansion of U.S. Testing

Capacity Using Coordination Hubs

Statement of Objectives (SOO)

Department of Health and Human Services

08 March 2021

Contents

1. Overview

2. Background

3. Scope

4. Data Obligations

5. Expansion of Testing Capacity Objectives

5.1. Objective 1: Establish Coordination Center

5.2. Objective 2: Establish Testing Capacity

5.3. Objective 3: Procurement of Tests

5.4. Objective 4: Report Test Results

5.5. Objective 5: Program Management

5.6. Objective 6: Subcontract Management

5.7. Objective 7: Compliance Requirements

6. Government Provided Resources

6.1. General Technical Assistance

6.2. Technical Assistance

7. Attachments

7.1. A

7.2. B .......................................................................................................... Error! Bookmark not defined.

7.3. C .......................................................................................................... Error! Bookmark not defined.

1. Overview The overall objective of this initiative is to expand testing opportunities for K-8 schools and underserved populations and congregate settings, such as homeless shelters, across the nation. As opposed to the use of a statement of work (SOW) which is specifically prescriptive and directive of what a potential contractor will do, a SOO has been utilized to solicit from industry recommended approaches to satisfy the requirements of this effort. The intent of this SOO is to provide the basic objectives and requirements of this initiative while allowing the contractor flexibility in establishing their approach to meeting those objectives, ultimately leading to the award of one or more agreements under 10 U.S.C. 2371b other transaction authority.

2. Background Since the start of the COVID-19 pandemic, over 300 million tests have been reported complete in the United States. There are currently an estimated 2 million laboratory-based tests completed per day (about 60 million per month) and another approximate 4 million point-of-care tests daily.

There is potential capacity to conduct more than 150 million more tests per month if the existing supply was supplemented through increased manufacturing, distribution, and utilization.

The additional testing capacity could be used more strategically, for example, to help schools safely reopen, reduce the opportunities for transmission in non-health care congregate settings such as shelters for individuals experiencing homelessness, and reach communities that are underserved or struggle to consistently access testing capacity. Effectively used testing strategies will help to identify and proactively minimize silent transmission, curtail broader community transmission, prevent outbreaks in institutional and community settings, and protect vulnerable individuals and populations. The federal government is committed to doing everything it can to strategically expand the nation’s testing capacity. This program would initiate and formalize a national network of testing facilities useful in slowing the COVID-19 pandemic, as well as curbing future outbreaks and resurgences. The primary goal of this requirement is to help safely re-open K-8 schools by establishing regional coordination and oversight of testing supplies, coordinating testing, and reporting results to public health. The Department of Health and Human Services (HHS) is partnering with the Department of Defense (DOD) to expand testing opportunities for K- 8 schools, underserved communities, and congregate settings, such as homeless shelters, directly through new coordination “hubs.”

3. Scope The objectives under this SOO are expected to be executed and fulfilled through the prototyping of up to four coordination hubs (each a “coordination center”), optimized to best support the population of the United States. It is anticipated that each coordination center will be awarded on a different agreement. The overall concept of this organizational paradigm is illustrated within the below graphic:

Different types of entities could qualify to be a coordination center, 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.

These coordination centers will provide testing, which may include point-of-care and other testing modalities as appropriate to schools, shelters and to underserved communities using available testing capacity including partnering with about 10 laboratories to facilitate collecting specimens, perform the tests, and report the testing results to public health. In aggregate, we expect laboratories and other entities to add up to 25 million tests per month across all the coordination centers in a hub and spoke concept. Surveillance testing may also be included in the coordination center’s activities, provided that the coordination center is able to define how those tests will be reported to public health authorities and how presumptive positive test results might be reflexed for additional testing that supports notification of an infected individual. It is acceptable for an offeror to serve as the coordination center and to fulfill some or all of the laboratory functions within a given network, provided that doing so would not diminish the offeror’s existing capacity to perform testing and ability to achieve the full testing volume desired by the federal government.

The tests to be performed will be (1) tests that have received FDA Emergency Use Authorization (EUA), premarket approval, or 510(k) clearance for use in high- or moderate-complexity laboratories; (2) laboratory-developed tests (LDT); (3) research use only (RUO) testing; or (4) any combination of 1, 2, and 3. As discussed below, provided that the contractor is able to achieve USG objectives, testing may be performed in laboratories that are certified under Clinical Laboratory Improvement Amendments (CLIA), as well as those that are not CLIA certified.

Coordinating centers maintain the optionality to include point-of-care, at-home, over-the-counter (nucleic acid amplification test or antigen) tests as part of the centers’ activities. In addition, the U.S. Government will require coordination centers and laboratories to make every effort to procure test kits, reagents and supplies from manufacturers the USG has identified as having excess capacity or from sources the coordination center can confirm will bear minimal impact on current national testing efforts. The intent of the project is to increase national testing capacity while minimizing disruptions to the existing supply chain to the extent possible.

To aid the contractor(s) who are selected to serve as coordination centers, the USG anticipates providing certain resources. First, USG contracted coordination centers will deliver materials and one-time startup equipment to the laboratories with an emphasis on expansion of fully operationalized testing platforms. Second, to support the efforts of the coordination centers and their associated laboratories, one or two USG or USG contracted laboratory-expert groups will provide laboratory systems technical assistance in areas of laboratory workflow, human resources, data and information management, and state and federal regulatory requirements in implementing the testing objectives of this SOO.

Period and Place of Performance:

The prototype project is for six months. Upon a determination that the competitively awarded prototype project(s) has been successfully completed in accordance with the criteria set forth in the respective agreements awarded, and subject to the availability of funds, the prototype project(s) may result in the award of a follow-on contract or transaction without the use of competitive procedures of a quantity and duration sufficient to meet the continued public health needs, which is expected to be a period of 6 or more months at comparable or greater quantity of testing that is set forth in this Project Announcement. Place of performance will vary depending upon the solution proposed by the offeror.

4. Data Obligations The coordination center and laboratories must maintain all data, including but not limited to documents, administrative data, support data, billing data, and any data containing Protected Health Information (PHI), at all times in servers located in the United States or in servers of which the operation and maintenance are subject only to the laws of the United States. Data transmitted must only be subject to disclosure pursuant to U.S. Federal law and not the laws of any other jurisdiction or foreign nation. IAW applicable law, the Contractor will report certain data to the USG, including aggregated data and number of tests as a reporting and resupply obligation, in addition to reporting required by law to other federal and state health agencies.

5. Expansion of Testing Capacity Objectives The following is a list of objectives and requirements that must be met by the contractor as part of the response to the solicitation:

5.1. Objective 1: Establish Coordination Center

The contractor shall establish a coordination center within one or more of the regions as outlined by the Government in Section 3. The coordination center will have the responsibility of coordinating testing efforts, including receipt of specimens for testing. This coordination will be done within their region with the states, counties, and/or local school districts for K-8th grade students, with congregate settings like shelters for individuals experiencing homelessness, and/or with organizations or entities that reach underserved populations (as defined by the CDC social vulnerability index), as directed by the USG. Government program management may direct testing of specific locations and/or populations as necessary to assist in maintaining this goal.

Starting no later than six weeks after award, the 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 Government may also request additional surge testing in excess of 1.5M tests per week as necessary to meet the USG’s need for testing within the region.

The coordination center will ensure the following goals are met:

1) Provide an outreach plan and a process to demonstrate commitments from schools, shelters, and organizations in underserved communities to partner with the proposed coordinating center contractor;

2) Provide an implementation plan for matching these schools and community organizations with testing capacity and proposed processes for managing the testing process, delivery, collection and reporting;

3) Provide a monthly report on test by type (diagnostic, screening, or surveillance) and site (e.g., school, shelter, underserved community) by jurisdiction down to the county level within the coordinating center’s region;

4) Provide a testing plan to illustrate specimen flow and volume, along with pre-analytical and post-analytic aspects, all consistent with state and local plans;

5) Provide structure and process for delivery of test results with an objective of 48 hours and a threshold of 72 hours from specimen collection; diagnostic test results compliant with Health Insurance Portability and Accountability Act (HIPAA) and Clinical Laboratory Improvement Amendments (CLIA) within 24 hours from specimen collection or reflex from a prior screening surveillance test;

6) Provide reportable result from the coordination center to relevant state health authorities in less than 48 hours in accordance with applicable federal, state, and local regulations;

7) 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;

8) 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;

9) Establish a plan to use novel and innovative approaches that will result in measurable efficiencies (e.g., pool testing, Next Generation Sequencing) under a surveillance modality (RUO or LDT), coupled with ensured, documented referral or reflex pathways for CLIA-certified medical diagnostic testing for individuals in a positive pool; and

10) Establish a sustainability plan, based in part on a formal evaluation (done in collaboration with coordination center and possibly third-party technical assistance) including overhead costs, so that testing capacity will continue after federal support ceases.

Suggested example of a work flow for sample collection, analysis, and reporting of data within the testing network; the contractor may provide additional approaches for USG evaluation.

5.2. Objective 2: Establish Testing Capacity

The contractor (serving as the coordination center) shall identify and enter into appropriate contractual relationships with as many laboratories as necessary (e.g., ten) to complete the testing requirement identified in Objective 5.1, within the designated region to complete increasing testing capabilities and capacities. Testing laboratories’ approaches may include pooled testing.

Coordination center partner entities may include, but are not limited to, large universities, commercial laboratories, a consortium of laboratories, or non-profit entities and, if not CLIA-certified, would greatly benefit from partnering with traditional clinical, CLIA-certified laboratories. The contractor may supplement laboratory capacity and deploy point-of-care testing or antigen testing to meet objective 5.1. The contractor shall ensure that laboratories identify validation protocols and ongoing quality assurance programs to support the testing requirements as well as a sustainability model for continuation after the period of performance. Contractors must ensure that laboratories provide a contingency plan in the event they experience an inability to process and test samples due to an event detrimental to the testing process.

Depending on starting infrastructure and capacity, this is an opportunity for laboratories to augment additional technologic diversity and capacity, including in next generation sequencing, due to the increased need for genetic surveillance of SARS-CoV-2. Laboratories will participate in a collaborative approach with an assigned coordination center and local public health authorities. They will commit to a formal evaluation of their work performed in partnership with third parties, their performance as founders in a national emergency network, and their ability to coordinate with existing networks such as CDC’s Laboratory Response Network (LRN).

The testing conducted at an individual laboratory may include public health surveillance testing, screening, medical diagnostic testing, or a combination to suit local needs in coordination with the assigned coordination center. To ensure the best use of resources, CLIA-certified laboratories should not participate in public health surveillance testing that can be performed by non-CLIA laboratories, and only CLIA-certified laboratories should participate in screening and medical https://www.cdc.gov/coronavirus/2019-ncov/lab/faqs.html#Testing-Strategies-for-SARS-CoV-2 https://www.cdc.gov/coronavirus/2019-ncov/lab/faqs.html#Testing-Strategies-for-SARS-CoV-2 diagnostic testing. Any laboratory with appropriate medical staff must utilize FDA-authorized tests in strict accordance with the test’s labelling. Applicants must document procedures and describe plans to ensure adherence to all local, state, and federal laws and regulations on testing and laboratory practice, including use of LDT, EUA, 510(k), or ROU tests and public health reporting. The procedures must address referral, reflex, and confirmatory testing; record keeping; and quality control.

5.3. Objective 3: Procurement of Tests

The intent of the USG is for the contractor to use suppliers with known areas of excess capacity when procuring tests and equipment for laboratories. For each suggested supplier(s) of EUA, 510(k), LDT, or RUO tests, the contractor must provide justification that demonstrates excess U.S.

test capacity for USG evaluation. The USG retains the right to approve or disapprove any proposed test suppliers.

5.4. Objective 4: Report Test Results

The contractor shall report all test results in accordance with regulatory and contractual requirements.

5.5. Objective 5: Program Management

The contractor shall have a single point of contact for coordination with the Government Program Management Office; successfully integrate and coordinate all activity needed to execute this SOO;

effectively manage all laboratories and other subcontractors; 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; and maintain professional and ethical behavior of all contractor personnel. All Other Transaction Agreements Data Requirements Lists (OTADRLs) should be adhered to and completed as required in Attachment 0001 – OTADRLs of this SOO.

5.6. Objective 6: Subcontract Management

The contractor shall be responsible for any subcontract management necessary to integrate work performed on this requirement and shall be responsible and accountable for subcontractor performance on this requirement. The prime contractor will manage work to ensure there are no Organizational Conflict of Interests (OCI) and related considerations are taken into account. The contractor shall ensure its personnel and all subcontractors it employs in this effort have the appropriate security clearances, training, and qualifications.

5.7. Objective 7: Compliance Requirements

The contractor 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.

6. Government Provided Resources

6.1. General Technical Assistance

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, expected to include: two personnel for each coordination site (a lead and alternate), a contracting interface (and alternate), a data analyst, and an overall program management director.

This team 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.

6.2. Technical 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.

7. Attachments Attachment 0001 – Other Transaction Agreements Data Requirements Lists (OTADRLs)