Draft ICATT SoW.docx

Statement of Work

Title: Increase Community Access to Testing (ICATT) Program

SECTION 1 – BACKGROUND

On March 13, 2020, the President declared a national emergency concerning COVID‐19 under section 501(b) of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121‐5207 (the “Stafford Act”). The novel coronavirus (SARS-CoV-2) is a highly contagious pathogen that is responsible for the current worldwide pandemic of COVID-19 disease. To aggressively address this disease, an immediate deployment of critical public health assets and supports was required to decrease transmission of the virus and to provide medical care for impacted communities.

Initially, the federal government implemented new policies to streamline payment for pharmacy testing to more quickly diagnose individuals who may be infected with SARS-COV-2. Early diagnosis has a direct impact on saving lives and reducing the spread of COVID-19 disease. The support provided by the federal government allows private companies to scale operations and dramatically increase COVID‐19 testing access and capacity by removing the complexity and uncertainty associated with billing.

In March 2020, under the Office of the Surgeon General, the US Government established the Community Based Testing Site (CBTS) program to support patient accessibility to no-cost diagnostic testing in pharmacies and community surge testing sites. This program was converted under the inter-agency Testing and Diagnostics Workgroup (TDWG) to the Increasing Community Access to Testing (ICATT) Program. ICATT provides no-cost testing in locations with a high social vulnerability index (SVI), elevated rates of COVID-19 incidence, and/or lower rates of COVID-19 vaccine uptake. Under this contract, patients do not receive a bill for the test and do not pay any fee related to test processing, evaluation, or handling. Evidence shows that when local no-cost opportunities are available there is an increase in the number of individuals who seek and receive testing.

Community pharmacy and surge testing sites are maintained through a public/private partnership with various national pharmacy chains, independent pharmacies, and laboratories. Between April 2020 and November 2021, through various contracting actions, the ICATT program has directly supported the performance of more than 25.5 million SARS-CoV-2 tests through the more than 10,000 pharmacies and community sites in all 50 states, Washington DC, and Puerto Rico. As of November 2021, 53% of the ICATT sites are in high SVI communities, and 40% of all ICATT tests performed are for racial and ethnic minorities. ICATT has support over 790 surge sites since April 2020. As of December 2021, the program has 32 active surge sites. At present, the ICATT program performs an estimated 5% of all national testing and based on a recent Rockefeller Foundation survey, parents indicated that pharmacies are the most favored location for obtaining a test.

SUBSECTION A – DEFINITIONS

· Are located in a moderate or high social vulnerability index (SVI) census tract (SVI rating is greater than 0.5); pharmacy locations that are not located in moderate- or high-SVI census tracts but serve moderate- or high-SVI census tracts are included in this consideration;

· Greater than 36% of the demographic composition of the county identifies as non-white, non-Hispanic

· Are at a greater risk of SARS-CoV-2 transmission due to the 7-day case rate exceeding 25 per 100,000;

· Are located in a testing desert (see definition); and/or

· Are at greater risk of poorer health outcomes resulting from COVID-19 disease where vaccination rates are less than half the national average.

· of loss caused, arising out of, relating to, or resulting from administration or use of countermeasures to diseases, threats and conditions

· determined by the Secretary to constitute a present, or credible risk of a future public health emergency

· to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures

Inactive – Testing site that has not submitted results in HHS Protect for 30 days.

Live – Testing site that is currently providing testing.

Transition/Closed – Testing site identified by Contractor that is no longer providing testing. Contractors cannot bill for testing that occurs after the Close Date for closed sites.

Community – Long term non-pharmacy testing site (may be a brick-and-mortar store or fixed site in a community)

Congregate – Congregate facilities such as nursing homes or schools

Pharmacy – Brick-and-mortar pharmacy testing site

Pop-up/stand-up sites – see surge with management fee

Surge with infrastructure management – Short-term testing site with management fee (fee added when Contractor provides infrastructure such as generator, Wi-Fi, tent, tables, etc.)

Surge without infrastructure management - Short-term testing site without management fee (if another entity provides infrastructure such as a generator, Wi-Fi, tent, tables, etc.)

Community – Long term non-pharmacy testing site (may be a brick-and-mortar store or fixed site in a community)

Congregate – Congregate facilities such as nursing homes or schools

Pharmacy – Brick-and-mortar pharmacy testing site

Pop-up/stand-up sites – see surge with management fee

Surge Testing – Short-term remote testing events (e.g., parking lots or other public venues) that are held in response to an STLT public health agency’s determination that a change in local case rates indicates a greater need increased testing in the area. Surge testing events are typically held for one to two weeks at a time.

Surge with infrastructure management – Surge testing site with management fee. Fee is added when Contractor provides infrastructure such as generator, Wi-Fi, tent, tables, etc. (see section 11)

Surge without infrastructure management – Surge testing site without management fee. Fee is not added if another entity provides infrastructure management (such as a generator, Wi-Fi, tent, tables, etc.)

Confirmatory Testing - Confirmatory POC testing, typically NAAT, is performed to confirm the results of a POC result that mismatches the patient’s symptoms. Used only in certain settings to guide patient care or processing.

Multiplexed Testing – Diagnostic tests which detect two or more targets in a single test; in the context of this document, it refers to two or more pathogens such as SARS-CoV-2 and influenza.

Over-the-counter (OTC) tests – Diagnostic tests that have been authorized by FDA for use without a prescription.

Point-of-care (POC) Testing - Diagnostic tests performed at or near the place of specimen collection Polymerase Chain Reaction (PCR) – Diagnostic tests that detect SARS-CoV-2 genetic material; in the context of this document and other solicitation materials, it includes both reverse transcription polymerase chain reaction and isothermal amplification POC or laboratory-based testing methods..

Pooled Sample Testing - Combining the same type of specimen from several people and conducting one test on the combined pool of specimens to detect SARS-CoV-2. Pooled tests that return positive results require each specimen in the pool to be retested individually to determine which individual(s) are positive. The advantages of pooling include preserving testing reagents and resources, reducing the amount of time required to test large numbers of specimens (increasing throughput), and lowering the overall cost of testing. The optimal pooling strategy depends on the incidence of infection in the community, and pool size need to be adjusted accordingly.

Swab and Send – Self-collection kit for sample collection and testing. Samples are self-collected, packaged in a prelabeled shipping package, and deposited at or mailed to a collection location for testing.

1. New England (Northeast): Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont

2. Mid-Atlantic: Delaware, Maryland, New Jersey, New York, Pennsylvania, and Washington, D.C.

3. South: Alabama, Arkansas, Florida, Georgia, Kentucky, Louisiana, Mississippi, North Carolina, South Carolina, Tennessee, Virginia, and West Virginia

4. Midwest: Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri, Nebraska, North Dakota, Ohio, South Dakota, and Wisconsin

5. Southwest: Arizona, New Mexico, Oklahoma, and Texas

6. West: Alaska, Colorado, California, Hawaii, Idaho, Montana, Nevada, Oregon, Utah, Washington, and Wyoming

7. Other: U.S. territories, protectorates, or freely associated states.

b) A test voucher can also be a piece of paper with a registration number that allows a test taker to register for a test using pharmacy sites that are not funded by the Government. In this way, the government can support testing in pharmacies to populations at higher risk of COVID-19 disease or poorer health outcomes that are not located in high SVI areas or supported by the Government. Using the registration number on the voucher, the test taker can register for a no cost test instead of charging the test to the patient’s health care insurance. The voucher has no monetary value.

1.) Connect patients who receive positive or indeterminant COVID-19 test results with care linkages and/or available therapeutic interventions 2.) Provide COVID-19 vaccination access and informational resources to patients who receive negative COVID-19 test results.

SECTION 2 – PURPOSE

In this effort, the Expansion of Screening and Diagnostics Task force (ESDTF) at the U.S. Centers for Disease Control and Prevention (CDC), which supports the inter-agency TDWG, seeks to increase equitable access to COVID-19 testing through contractual relationships with private sector partners.

SECTION 3 – SCOPE OF WORK

The ICATT program objectives are achieved through three (3) primary efforts:

1.) Testing in pharmacies to ensure equitable access to COVID-19 testing 2.) Establishing surge testing sites and provide testing to provide infection control to populations at elevated risk of SARS-CoV-2 transmission 3.) Establishing community testing sites and provide testing to increase access to COVID-19 testing in under-resourced communities

Additionally, the ESDTF ICATT Program will continue to expand testing outreach, availability, and effectiveness. As needed, the Government shall increase or decrease the number of testing sites supported to adapt to the pandemic response needs. However, at this time it is the intention of the Government to maintain approximately 20,000 ICATT testing sites. The number of sites that the ICATT program will maintain may be subject to change as the response to the COVID-19 pandemic continues to evolve.

The contractor shall sustain surge testing capabilities to deploy to disease outbreak zones, including flexible off-site testing models to rapidly reach communities of interest. Contractors shall use appropriate testing methodologies in accordance with state and federal regulations to provide quality and timely results as described in 4.8.F.

To provide patients access to wrap-around services in addition to testing provided under ICATT, the Contractor shall integrate ICATT testing services with other related COVID-19 vaccination and therapeutics delivery services to the greatest degree possible at each testing site to create a single point of access. These wrap-around services are intended to help reduce morbidity and transmission of this disease. The Contractor shall maintain the capability to provide wrap-around services under this contract. Distribution of informational resources shall be required. Actual distribution of therapeutics if required during performance will be added via a bilateral modification.

The Contractor shall track and report testing site and test performed data that enhances the analysis of HHS testing data and complements federal disease surveillance and research activities. Unless otherwise state herein, all data collected by the Contractor will be entered into HHS Protect.

The Contractor shall adapt and implement strategies in collaboration with the government to respond to the changing pandemic environment, employ maintenance strategies to ensure testing capabilities are up to date and relevant, and implement efficiencies over time for cost and timeliness of services provided.

SECTION 4 – TASKS TO BE PERFORMED

1. General Tasks and Responsibilities The Contractor shall provide the below tasks/services in locations that have been approved by the Government to address the COVID testing needs of individuals in communities of interest covered under the ICATT program. All services shall be provided at no cost to the patient.

A. The Contractor, in accordance with the relevant laws and regulations of state Departments of Health and other state agencies, officials or community partners related to specific site, shall perform the following:

i. Provide full end-to-end processing of tests including patient registration/scheduling, application of screening criteria, ordering of the test by a licensed healthcare practitioner, operation of the testing site, transportation/delivery of test sample to lab (if needed based on testing model), conduct the test or arrange for the conducting of the test, notification of results to patients, input required HHS Protect system data, and report positive and negative cases as directed by the relevant state and local Departments of Health. See “Specific Tasks” for more details.

ii. Test according to specific criteria determined by the Centers for Disease Control & Prevention (CDC) unless otherwise agreed to by the Government: https://www.cdc.gov/coronavirus/2019-ncov/lab/index.html.

iii. Coordinate with state and local government and law enforcement to ensure security is present when Contractor personnel are on site and the site complies with state and local laws.

iv. Implement standard diagnostic testing quality assurance and controls per test kit manufacturer guidelines.

Unless otherwise waived, the Contractor shall abide by all Federal and State guidelines, (e.g., Health Insurance Portability and Accountability Act (HIPAA)), needed to protect personal identity information.

2. Program Management and Staffing

A. The Contractor shall provide program management for the operation of the contract and shall provide organization, control systems, quality assurance and reporting procedures.

B. The Contractor shall ensure all necessary communication on at least a weekly basis with ICATT program representatives on all aspects of the testing locations regarding site status changes, inventory and key staffing and leadership updates, site needs, testing metrics, and risks and issues.

C. The Contractor shall ensure adequate testing materials are available for operations.

D. The Contractor shall provide, maintain, and use all information technology (IT) systems necessary for the full discharge of activities required under this contract. Such systems include patient screening and registration, scheduling, chain of custody of specimens and tests, fulfilling public health reporting obligations, patient notification of test results, logistical support (e.g., timely delivery of all required testing related supplies), and capacity to report on all elements described in Attachments 1 “Data Reporting Requirements” and 2 “Invoice Reporting Requirements.”

E. Contractor shall report all elements described in Attachment 1 “Data Reporting Requirements” on at least a daily basis.

F. Contractor shall report Over-the-Counter (OTC) test sales on at least a weekly basis, in accordance with Attachment 1 “Data Reporting Requirements”, Section E.

G. When partnering with another entity (e.g., state and local stakeholders, bases, etc.) in providing surge site infrastructure management and operations of event sites, the Contractor shall work with the state and/or local stakeholders to determine the appropriate testing strategies, logistics, site management, and implementation timelines, and operating hours for the sites. The Contractor may coordinate with the state/local Department of Health or other state/local agencies for the purposes of setting up and operating the site to accomplish any of the following: scheduling patients, site logistics, augmenting personnel, augmenting supplies, and augmenting security.

H. For the purposes of establishing and operating approved sites for scheduling patients, site logistics, augmenting personnel, augmenting supplies, and augmenting security, the Contractor shall coordinate with appropriate state/local Department of Health or other governing state/local agencies to determine the required policies and regulations for conducting ICATT services within their jurisdictions. It is the Contractor’s responsibility to assure all services under this contract comply to these policies and regulations.

I. Contractor shall maintain sufficient staffing capacity sufficient to maintain hours of operation and service capacity described to meet applicable requirements of sections 4.1 and 4.2.

J. Contractor shall ensure that sites currently providing no-cost testing supported by other federal agencies and programs (e.g., HRSA and/or ELC) will be excluded from ICATT-participation.

K. Contractor shall provide services:

i. Perform diagnostic tests in compliance with Clinical Laboratory Improvement Amendment (CLIA) (including CLIA Certificates or Certificates of Waiver, or CLIA violations and Food and Drug Administration (FDA) regulations (including FDA EUA submissions or amendments).

ii. Ensure that the test used has appropriate FDA Emergency Use Authorization (EUA) for any laboratory tests used in approved sites.

iii. Comply with any regulatory barriers or requirements required for successful performance of services (including FDA EUA submissions or amendments, CLIA Certificates or Certificates of Waiver, or CLIA violations at proposed sites).

iv. Implement the conversion to private/public insurance reimbursement as summarized in Section 8.

L. The contractor shall provide monthly reports on the above activities including any challenges to implementation.

M. The contractor shall provide ad hoc reports in order to clarify testing data as required by the changing nature of the response.

N. The contractor shall complete a final report at the completion of each period of performance. The final report shall include total testing numbers for the period of performance, the report should highlight areas of interest, trends, quality issues, and continuous improvement metrics. The final reports should also include any challenges in the implementation of Section 8 of the statement of work.

3. Testing Site Locations A. The testing locations are sites that have been determined to benefit from enhanced access to testing, including pharmacies, community sites, and surge sites. It is the Government’s desire to establish and maintain up to 20,000 approved test sites at locations covered by the ICATT program. From time to time, the Government may identify locations to be added, changed, and/or removed. When the Government requests a change and it is within the Contractor’s locations covered under this Contract, the Contractor shall be required to make the change and/or add the location unless the Contractor immediately notifies the Government there are circumstances beyond its control which prevents the requested change to be accomplished, otherwise, as provided in the contract the requested change shall be completed by the Contractor. The Contractor shall operate and sustain a minimum of 1,000 pharmacy, community and / or retail testing sites concurrently. While due to budget constraints and program needs the Government may permit Contractor to operate fewer than 1,000 sites, the Contractor shall be able to scale up to this level with two weeks’ notice if operating below the minimum at the direction of the Government. These sites shall meet the following criteria:

i. A minimum of 200 sites shall be in each of any three US regions or a minimum of 100 sites in each of the contiguous U.S. regions (regions one through six; see “US Regions” in definitions)

ii. At least 50% of sites should be located in intermediate to high social vulnerability index census tract areas or, if not feasible, at least 500 sites should be located in such areas

iii. At least 10% of sites shall operate under extended hours based on testing demand. The Government defines extended hours as at least 3 hours before 9 AM or after 5 PM. These sites may provide any test method

iv. During regular operations, the Contractor shall be prepared to meet a site capacity of at least 28 ICATT testing appointments per day

v. At sites where appointments are not offered, during regular operations, the Contractor shall be prepared to meet a site capacity of at least 28 ICATT tests per day, and

vi. For pharmacy sites, testing hours shall coincide with pharmacy hours.

B. The Contractor shall have the ability to expand testing capacity to at least 42 ICATT tests per day in mutually agreed locations with two weeks’ notice by modifying testing strategies, which may include extending operating hours, increasing the number of appointments per hour, and utilizing additional no-cost testing methodologies.

C. The Contractor shall also have the capability to conduct testing for periods of shorter duration (e.g., a couple of weeks) at offsite locations such as parking lots, aggregate settings, and population dense areas within two weeks of request and in inclement weather (temperate rain, heat, cold, wind), but not severe conditions where Contractor would be required to enact emergency actions plans as required under 29 CFR 1910.38 (https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.38).

D. The Contractor shall abide by all federal and state scope of practice laws, regulations, and policies.

E. The Contractor shall provide inside and outside communications/signage indicating that HHS funds the no-cost testing program instructing patients how they should proceed to be tested

4. Site Selection of Testing Sites A. The Government must approve Contractor-recommended site locations and hours of operation before the Contractor begins testing to ensure appropriate distribution and prevent duplication with other Contractors. The Government will review Contractor-recommended site locations and hours within seven days of submitting recommended sites within HHS Protect for review and approval.

B. The Contractor shall use the Facility ID #, as provided by HHS Protect for each site location, when reporting in HHS Protect.

C. Contractor shall report new sites and site updates in accordance with Attachment 1, section D.

D. The Contractor shall notify the government and provide a list of sites that are added or no longer testing each week via email or other electronic reporting system as agreed between the Contractor and Government.

E. The Contractor shall ensure that HHS Protect records sites statuses, site locations, site number, site metadata, and ICATT participation status correctly with the Government monthly as described in Attachment 1, Section F. All status changes are reported to HHS Protect, COR, and the project manager.

F. The Contractor shall notify the Government seven calendar (7) days in advance before closing a site.

G. The Contractor shall update their testing sites with Castlight Health and Google on a biweekly basis with additions and closures as appropriate to ensure the public can locate testing sites.

5. Patient Registration and Consent A. The Contractor shall provide an online platform which is smartphone compatible where patients can perform initial registration. The website shall be section 508 compliant. The website shall provide:

i. Clear step by step description of the testing process. Each step shall be described using clear and simple language that a member of the general public would be able to understand.

ii. Align with CDC national testing priorities: https://www.cdc.gov/coronavirus/2019-ncov/lab/index.html

iii. Provide detailed guidelines for applicable testing scenarios, such as testing due to travel, employment, school attendance, exposure, or illness

iv. Clear eligibility criteria

v. Detailed guidance on no-cost testing

vi. Acknowledgement of HHS funding support

vii. A testing site map showing testing type, appointment availability, and operating hours for each testing location

viii. Answers to frequently asked questions (developed and maintained by the Contractor)

ix. Type of testing available at each location

x. How and when results will be returned

xi. Requirements for testing children

xii. Toll free point of contact for additional information

xiii. Explanation if a pharmacy rejects testing according to CDC guidance

xiv. Whether a doctor’s referral is necessary for testing B. Through the registration process or at the testing site, the Contractor shall request patient information through a screening process compliant with Attachment 1, Exhibit A, and an informed consent for testing services.

C. The Contractor shall implement screening criteria as provided by the Government (see Attachment 1, Exhibit A, for current screening questions). The Contractor shall adopt a screening protocol that is consistent with the CDC priorities and guidelines for COVID-19 testing. The Government may change the criteria for testing; however, the Contractor shall have a reasonable amount of time to design, test, and implement new or revised screening questions in electronic interface used by the Contractor. The Contractor shall obtain approval from the Government to change any criteria. CDC publishes priorities for COVID-19 testing. This guidance can change periodically. It is the Contractor’s responsibility to check the CDC website periodically for updates.

D. If the screening criteria are met, the Contractor shall arrange for a licensed healthcare practitioner to review and order the test. The Contractor shall have an integrated system for collecting information, tracking specimens, and reporting test results. The Contractor may offer a standing order for tests if it complies with all federal and state laws and regulations.

E. The Contractor shall be capable of uploading a group of test takers from a digital list when testing in congregate settings.

F. The Contractor’s registration process shall be available and efficient for walk-up test takers.

G. In addition to an electronic registration process, the Contractor shall provide for a paper registration process to allow for testing in environments where the electronic registration process would be less expedient than a paper registration process (e.g., registration of foreign nationals for whom the electronic registration process in English may present a barrier). The Contractor is responsible for subsequently capturing paper registrations in their electronic system.

H. The Contractor shall provide clear website communications that publicize the availability of no cost testing. All materials should be shared with HHS for review and acknowledge HHS as the funder.

6. Site Preparation A. The Contractor may coordinate or enter into an agreement with state and local governments to supply items necessary to fulfill testing site needs, including supportive infrastructure.

B. When providing full-service testing sites (such as congregate settings, federally support, or surge site testing as described in sections 4.11, 4.12, and 4.13), the Contractor shall have prepared all necessary equipment (e.g., swabs, personal protective equipment (PPE), traffic flow management, and tents) prior to test takers’ arrivals.

C. For all new locations or sites where testing has not been performed for over one (1) week, the Contractor shall undergo a testing dry run where a small number of test takers or the testing staff are tested, prior to operating at full capacity. Any site preparation or testing performance issues not resolved during the testing dry run shall be communicated to the Government by the end of the business day.

D. Sites shall have the ability to properly store and monitor the storage of testing supplies to assure quality.

7. Patient Verification A. The Contractor shall be responsible for matching patients that arrive to the testing location to the correct laboratory requisition documentation. After verification, Contractor staff shall provide the FDA EUA authorized or fully approved testing kit that is appropriately linked to the patient.

B. The Contractor shall implement processes that allow for sample tracking and transfer of sample collection kits to the laboratories (if required) while preventing or severely limiting, to the extent practicable, direct interaction between the Contractor testing staff and the patient.

8. Patient Testing A. When self-swab specimen collection is not be feasible, the Contractor shall collect the testing specimen via nasopharyngeal or via other swab administered by Contractor staff.

B. The patient/test taker will be responsible for conducting self-swab testing. The Contractor shall ensure the swabbing process is overseen by a healthcare practitioner (e.g., a licensed pharmacist) or a trained professional in accordance with CLIA regulations with the ability to contact a healthcare professional. The Contractor’s personnel shall be responsible for ensuring the patient conducts the FDA authorized self-swab in accordance with designated swab procedures. If the patient cannot perform a self-swab, the Contractor shall ensure that a member of Contractor staff perform the swabbing procedure. Contractor may include a telehealth option for specimen collection observation.

C. The Contractor shall ensure all tests are performed according to FDA and CMS regulations, guidelines, and Frequently-Asked-Questions available from the CDC, FDA, and CMS websites.

D. The Contractor shall maintain a safe distance between Contractor testing staff and patients as per CDC guidance. In the event a safe distance cannot be maintained, the Contractor shall ensure that contractor personnel are equipped with the necessary PPE to safely perform testing.

E. The Contractor shall provide allocation for patients to deposit self-collected specimens that meets the test manufacturer’s specimen storage criteria and is in accordance with federal and state regulations.

F. The Contractor shall provide the following test methods, as appropriate to the testing site, as proposed by the Contractor and approved by the Government at the point of site registration in HHS Protect; in limited circumstances as described 4.8.E.h, the Contract shall provide OTC tests. While many tests listed below are optional to propose, the Contractor is encouraged to apply a broad mix of tests and sites to ensure resource and test manufacturing limitations do not impact contract performance. See Test Crosswalk Table below. (see 1.A definitions)

a. Swab and send testing

i. The Contractor shall provide specimen collection kits at agreed-upon testing sites for the patient or Contractor to perform sample collection, and then the Contractor shall send the specimen to a laboratory for testing.

ii. Self-collection kits may be provided by the Contractor, test site partner, state/local government, or the federal government. The source of test will be decided at the sole discretion of the Government. Contractor shall include pricing structure for test administration when the test kit is provided by the Government

b. Point-of-Care (POC) testing (Optional to propose)

i. The Contractor shall provide POC testing at agreed-upon testing sites.

ii. Test kits may be provided by the Contractor, test site partner, state/local government, or the federal government. The source of test will be decided at the sole discretion of the Government based on response needs and market conditions. Contractor shall include pricing structure for test administration when the test kit is provided by the Government.

c. Home sample collection & testing

i. The Contractor shall provide self-collection kits for the patient to pick-up at agreed-up on sites or receive by mail, and then the patient returns the specimen to either the pick-up location or mails it directly to a laboratory for testing. If returned to the pick-up location, the Contractor shall send the specimen to a laboratory for testing.

ii. Self-collection kits may be provided by the Contractor, test site partner, state/local government, or the federal government. The source of test will be decided at the sole discretion of the Government. Contractor shall include pricing structure for test administration when the test kit is provided by the Government

d. Confirmatory POC testing (Optional to propose)

i. The Contractor shall provide POC testing at agreed-upon testing sites.

ii. Test kits may be provided by the Contractor, test site partner, state/local government, or the federal government. The source of test will be decided at the sole discretion of the Government based on response needs and market conditions. Contractor shall include pricing structure for test administration when the test kit is provided by the Government.

iii. Confirmatory testing is performed in specific settings, i.e. Federally Supported Testing, to confirm the result of a POC test to expedite patient management and processing.

e. Multiplexed testing (Optional to propose)

i. The Contractor shall provide multiplexed SARS-CoV-2 diagnostic tests which also include influenza and/or other respiratory pathogen targets at agree-upon sites. Multiplexed testing will be implemented at the sole discretion of the government based on the pandemic environment. Multiplex testing may be used in place of a singleplex test.

f. Pooled Testing (Optional to propose)

i. Upon determination by the Government that pooling is the preferred testing approach, the Contractor may provide laboratory testing services for pooling of 5 to 10 samples or more. Pooled sample testing being performed under an FDA EUA shall be performed according to CDC, FDA, and CMS regulations and guidance. Pooled testing may be optionally awarded in support of congregate setting sample collection and testing or in federally supported testing arrangements (reference sections 4.12 and 4.13)

ii. Pooled testing may take the form of diagnostic, screening, or surveillance testing. Laboratories that conduct diagnostic or screening testing for COVID-19 shall also comply with Clinical Laboratory Improvement Amendments (CLIA) regulations. Laboratories should use an existing authorized nucleic acid assay.

iii. If a pooled test result is negative, then all specimens can be presumed negative with the single test and reported as such. If the pooled test result is indeterminate or positive, each of the samples in the pool will need to be tested individually to determine which sample(s) tested positive, and individual results should be reported accordingly. Individual diagnostic retests shall be billed to the Government as a separate test at the corresponding individual diagnostic test rate.

g. Diagnostic Sequencing (Optional to propose)

i. As a function of public health activities in response to changing dynamics of the COVID-19 pandemic response (e.g., surveillance of The Contractor shall reflex a subset of samples for next generation sequencing for diagnostic purposes conducted under CLIA or other laboratory quality management systems. Sequencing shall be completed and data reported within one (1) week of request from the Government.

ii. Samples may come from sites at which the Contractor currently obtains specimens from its pharmacy-based testing and surge testing sites as well as from other third-party state testing sites as designated by the HHS and agreed on by the parties.

iii. The Contractor shall provide:

1. Data and metadata management

2. Secured delivery of genomic data to local, state, or federal partners

3. The uploading of genomic data and associated metadata (provided in bulk upload format by the sample submitter) to GenBank, according to CDC’s minimum data requirements from the Genomic Sequencing Laboratory.

iv. Upon request, the Contractor shall ship a subset of samples to a designated state or federal public health laboratory within 48 hours of request for further testing.

v. The Contractor shall provide accessioning services for samples submitted directly by surveillance partners. Sample submitters are responsible for providing metadata to the testing laboratory in a bulk upload format.

h. Over-the-Counter Self-Testing (Optional to propose)

i. To enhance access to COVID-19 testing and offer more options to those who choose not to get tested at sites or to focus testing on specific populations, the Contractor shall distribute self-testing over-the-counter kits for testing at home. Self-Testing over-the-counter kits are those where the patient completes both the specimen collection and the testing of the specimen at home or other location using an approved specimen collection kit and testing device.

ii. The Contractor track the number of tests distributed and the distribution location and send the data to the government using HHS Protect or other secured digital means as directed by the Government. If required by state regulations and not exempt by PREP Act or other federal authority, the Contractor shall ensure a licensed healthcare provider capable of providing guidance for the use of tests is available as part of the distribution of self-testing kits.

iii. The Contractor shall develop a standard procedure to execute this task that may be optimized to suit different test distribution scenarios. The Contractor shall develop a plan, informational document, and playbooks for self-testing to be shared publicly. All such documents shall belong to the Government. Contractors shall have the right to unlimited access and use.

G. It is the contractor’s responsibility to ensure that the tests and products purchased under this contract are TAA-compliant (see 1.A definition). Comment by Bennett, Robert D (CDC/OCOO/OCIO/OD): OAS to confirm

9. Specimen Security/Preparation, Storage, Shipping, and Testing A. After the patient has deposited the used test kit in the collection area, the Contractor shall ensure that test kits are placed in appropriate storage and stored until processing in accordance with manufacturer instructions.

B. The Contractor shall be responsible for ensuring all collected samples are tested in compliance with Center for Medicare and Medicaid Services’ (CMS) Clinical Laboratory Improvement Amendments (CLIA). Consistent with the site selection and approval process identified in section 4.4.A, above, review of approval request shall occur with seven days of request submission.

C. If testing is done at an off-site commercial lab subcontractor, the Contractor shall abide by all shipping and handling guidance when shipping specimens to its commercial lab subcontractor. The Contractor is responsible for all contracts, relationships, and payment with commercial lab subcontractors.

10. Notification of Results A. The Contractor shall be responsible for ensuring that individuals are timely and accurately notified of their test results. The Contractor shall provide individuals with their POC test results within 24 hours and laboratory-based test results within 48 hours.

i. Test results should be communicated to test takers (or their legal guardians) either at the site, or in a manner approved by the relevant STLT Departments of Health.

ii. Test results should be in writing: a handout provided at the testing site, email, text, or through the registration portal/application are acceptable. Phone calls are acceptable to provide results immediately but shall be followed up in writing.

B. As described in section 21, the Contractor shall link any patient with a positive test result to relevant information about COVID-19 therapeutics. The Contractor shall link any individual with a negative test result to relevant information about COVID-19 vaccination. The Contractor shall regularly update therapeutics and vaccination information in their test results.

C. The Contractor must comply with all state and local laws regarding reportable conditions, including but not limited to reporting to the relevant public health authorities with all data elements required by jurisdiction for submission of reportable results. The contractor shall ensure this compliance flows down to all subcontractors.

11. Surge Site Infrastructure Management (Optional to Propose) A. The Contractor shall be equipped to provide site management in the event that surge site partners (such as state, local governments, or federal agencies) are not able to provide these services. The Government will identify surge sites and provide surge site testing authorization based on ICATT program needs.

B. A mutual agreement between Contractor and the Government as to whether surge site infrastructure management is needed shall be made on a site-by-site basis. Federal and state partners will remain responsible for State/Federal Government Responsibilities in Section 4.12.F C. Contractor surge site management responsibilities include:

i. Biohazardous waste management and disposal (e.g., gloves, masks)

ii. Physical management of the site to include:

1. Site interaction with site point of contact for all logistics coordination

2. Clinical staffing; site security; traffic control within site; managerial staffing

3. Nonmedical equipment including tents, cones, tables, chairs, electric power

4. Storage of specimens in accordance with manufacturer instructions

iii. Provision of laptops; printers; supplies for printing

iv. Subject Matter Expert (SME) on technology platform for registration, technology, and troubleshooting

v. Office supplies including Sharpies, pens, paper

vi. Wi-Fi access hot spots

vii. Printed informational materials (as needed)

viii. Managing storage; inventory/reporting and redistribution of supplies (laptops, test kits, PPE) from storage location to sites when required

ix. Coordination of returning unused supplies at the end of surge site events

x. Assignment of a POC per site for shipping or courier service driver/dispatch to contact upon arrival

xi. Daily dropping off specimens at FedEx stores that accept class B substances when a site is not at a physical street address (e.g., a park and ride) or in rural areas that do not have regular pickups

xii. Staffing for registration/check-in for onsite patient registration

xiii. Designated clinical staff assigned to be on point for medical emergencies

xiv. On-site advertising of the event D. Surge sites established in the US Affiliated Pacific Islands and Territories may incur additional management fees due to increased logistical challenges with sample processing.

12. Federally Supported Testing (Optional to Propose) A. The Contractor shall perform POC or equivalent using an authorized diagnostic test at agreed-upon federally supported locations.

B. POC tests may be provided by the Contractor, test site partner, state/local government, or the federal government. The source of test will be decided at the sole discretion of the Government. Contractor shall include pricing structure for test administration when the test kit is provided by the Government. If the test provided by the government requires additional testing platform equipment (e.g. readers), the Government will supply this equipment as government-furnished property; the list of equipment will need to be confirmed as necessary by the government prior to procuring it.

C. The Contractor shall perform confirmatory POC testing to confirm rapid POC-positive tests in all people and negative tests in symptomatic people. The Contractor shall follow any other CDC recommendations for confirmation of POC tests (https://www.cdc.gov/coronavirus/2019-ncov/lab/). Confirmatory POC tests can be purchased by the Contractor or provided by the government; the source of the confirmatory test will be decided at the sole discretion of the government. If provided by the government, $25 will be subtracted from the cost of this provision of testing. Requirements for Confirmatory testing in this high-density setting are:

i. Rapid time to results (<30 minutes)

ii. Portable handheld instrument/reader/device that can be taken to the patient, rather than transport of specimen or patient to other testing location, appropriate for use as confirmatory test (no presumptive results).

D. The Contractor shall provide availability of staff and necessary equipment to conduct 24 hour, 7 days a week testing at agreed-upon federally supported locations. In the event the government is unable to provide a fixed structure where the testing will be performed, the Contractor shall provide an appropriate facility or unit for testing that is cost-beneficial to the government. Staff will be on call for screening testing at all hours and capable of testing at least 100 people per hour within one (1) hour of notification.

E. Specimens shall not be shipped; test results shall be available rapidly to make the quarantine decisions promptly. Tasks described in section 4.11.C will be included in the cost of Federally Supported Testing.

F. State/Federal Government Responsibilities:

i. Selection and coordination of site POC for logistics coordination of site locations; including any necessary permits

ii. Biohazardous waste management and disposal (e.g., gloves, masks)

iii. Media relations

iv. Identification of state and local POCs

v. Testing hours/days

vi. Go live/closing dates

vii. Identification of number of tests to be performed in total

viii. Storage location for supplies

13. Congregate Setting Sample Collection and Testing (Optional to Propose) A. The Contractor shall observe the self-collection of samples for those patients doing self-collection per manufacturer’s instructions, and the Contractor shall perform collection of samples for…