Draft Performance Work Statement - Mass Serology.docx

Performance-Based Work Statement Title: MASS-C Study New Contract: Multistate Assessment of SARS-CoV-2 Seroprevalence (Commercial Laboratories) Period of Performance:11 months; 10 months of sample testing (5 total testing periods, each of 8 week duration) and 1 month to finalize final report prior to submission.

I. BACKGROUND:

Several U.S. seroprevalence studies have suggested that the majority of persons have not been infected with SARS-CoV-2. However, there has been wide variability in seroprevalence estimates due to several factors including the use of different assays, participant selection methods, time period conducted, and regional differences in the burden of disease. In this work, CDC will enter into a new contract for a repeat cross sectional serologic survey using convenience samples collected from commercial laboratories across the United States.

II. PROJECT OBJECTIVE:

The CDC’s work in this contract will use offeror(s) residual/remnant/excess, deidentified blood specimens to obtain laboratory testing toward determining U.S. seroprevalence by geographic region, pediatric age group, and time period.

III. DESCRIPTION OF WORK (organized by TASK/CLIN):

CDC reserves the right to award multiple contracts to multiple offerors to achieve the geographic reach needed for studying seroprevalence across 50 states, Washington DC and Puerto Rico. Offeror(s) shall complete and include with their technical proposals Attachment A which includes questions on offeror(s) capabilities, geographic coverage, ability to obtain pediatric specimens, ability to monitor and adjust for geographic representativeness of sample, and residual specimen descriptions. Offeror(s) shall include in their technical proposal an appendix of all offered test protocols.

CDC will not be able to provide residual samples to contractors. for the contract includes funds for contractors to subcontract in order to obtain residual samples.

Task 1: COVID-19 panIG ELISA Testing Task 1.1 Residual Specimen Selection

a. Contractor(s) shall identify excess, remnant, or residual blood specimens from remaining volumes of previously obtained blood specimens for non-COVID-19 diagnostic or antibody testing. From this list, the contractor shall choose sufficient samples from each jurisdiction (50 US States, DC, and Puerto Rico) to achieve the target sample size within each age group.

a. Age groups and sample sizes below:

b. Totaling ~650 samples over each 8 week period per jurisdiction

i. Time periods for collection:

b. Collection Period 1: February 28- April 24, 2022

c. Collection Period 2: April 25-June 19, 2022

d. Collection Period 3: June 20- August 14, 2022

e. Collection Period 4: August 15- October 9, 2022

f. Collection Period 5: October 10- December 4, 2022

An option is built into the contract to grant flexibility to extend this work for an additional year (i.e. 6 monthly sampling periods) and/or provide for a round of sampling for all age groups in FY23.

Task 1.2 Residual Sample Testing

a. The Contractor(s) shall test specimens to include CLIA-approved and/or EUA-approved ELISA, COVID-19 IgG and/or IgM serological assays. The required sample matrix and sample volume should be specified for each offered test name. One anti-S quantitative assay and one anti-N qualitative assay will be performed on each specimen

a. Suggested assays to ensure consistency of assay characteristics across labs:

b. Any anticipated remnant handling costs such as accessioning work should be part of the testing cost estimated in the business proposal.

b. The Contractor(s) shall ship any CDC-selected seropositive or seronegative specimens to CDC- designated facilities for reflexive testing described under task 2 (see Task 1.6) if the Contractor(s) cannot perform reflexive testing or was not awarded Task 2.

Task 1.3 Review Meeting

a. Contractor(s) shall schedule meeting for review of new contract and to address any questions

Task 1.4 Data Reporting

a. Contractor(s) shall provide data report to CDC after each sample collection and testing period.

Task 1.5: Identification of Specimens for Reflexive Testing

a. Offeror(s) will identify seropositive specimens from task 1.2 for further reflexive testing. Contractor(s) shall complete testing under task 2.1 or prepare and send shipments under task 1.6 to another offeror(s) facilities. Reflexive testing under task 2.1 should be performed within 5 days of the quantitative anti-S assay performed under Task 1.2 to ensure comparable results. A small subset of seronegative specimens may also be requested for reflexive testing.

Task 1.6 Specimen Shipping

a. If the remnant/excess/residual specimens selected under task 1.1 exceeds the Contractor(s)’ specimen testing capacity under task 2.1, the Contractor(s) shall ship the selected residual specimens that exceed its testing capacity to another testing facility designated by CDC.

b. Contractor(s) with any COVID-19 seropositive specimens identified from task 1.2 and selected for reflexive testing in tasks 2.1 shall ship those samples to a CDC designated facility for reflexive testing, if different than the facility where specimens were tested under task 1.2, meaning that the Contractor(s) cannot perform reflexive testing or was not awarded Task 2.

c. In general, Contractor(s) should pack and ship suspected and confirmed SARS-CoV-2 specimens, as UN 3373 Biological Substance, Category B, in accordance with the current edition of the International Air Transport Association (IATA) Dangerous Goods Regulations and U.S. Department of Transportation’s (DOT) Transporting Infectious Substances Safely. Personnel must be trained to pack and ship according to the regulations and in a manner that corresponds to their function-specific responsibilities.

a. The estimated sample volume to plan for reflexive testing is 0.5 mL

b. The estimated shipping temperature to plan for this work is -20 ˚C

c. The U.S. shipping address for reflexive testing will be provided within 4 weeks of contract award

Task 1.7 Draft Final Report and Review Meeting

a. Contractor(s) shall create and submit a sample final report and schedule a draft final report meeting with CDC to discuss. The draft final report should be submitted at least _10 days in advance of the meeting.

Task 1.8 Final Report

a. Contractor(s) shall create and submit a final report

Task 2 Reflexive COVID-19 Microneutralization Assay Testing Task 2.1

a. The Contractor(s) shall provide microneutralization testing for seropostitive specimens. Specimens from individuals from whom a date of previous positive PCR are available are preferred. Reflexive testing under task 2.1 should be performed within 5 days after the quantitative assay performed under Task 1.2. Tests (with specific test names) will be selected from offeror(s) proposals and identified in the contract award. Sample sizes for this task by age group are:

a. Positive serology samples: 200 samples tested per 4 week testing period

i. 100 samples from persons aged 0-11

ii. 100 samples from persons aged 12-17

iii. As many samples as possible with a previous positive PCR date should be selected (20-50% of specimens undergoing microneutralization testing should be from individuals from whom there is a dated prior positive PCR result for SARS-CoV- 2 infection, unless that sample size is not available from specimen pool)

b. The Contractor(s) shall provide microneutralization testing for a small number of seronegative specimens (up to 30/month) if requested

c. As needed, the Contractor(s) may use specimens identified in Task 1.2, or they may identify excess, remnant, or residual blood specimens from samples submitted for COVID-19 antibody testing. Any anticipated remnant handling costs such as accessioning work should be part of the testing cost estimated in the business proposal. If residual specimens are not available, the contractor(s) will test specimens shipped from CDC or other contracted labs.

Task 2.2 Draft Data Report and Meeting

a. Contractor(s) shall create sample draft data report and schedule meeting for review

Task 2.3 Data Reporting

a. Contractor(s) shall provide data report bi-weekly to CDC.

Task 2.4 Draft Final Report and Review Meeting

a. Contractor(s) shall create and submit a sample final report and schedule a draft final report meeting with CDC to discuss. The draft final report should be submitted at least _10_days in advance of the meeting

Task 2.5 Final Report

a. Contractor(s) shall create and submit a final report

IV. DELIVERABLES:

See Attachment B for Deliverables Table. Offeror(s) should also use the list of deliverables provided in Attachment B as a guide for the preparation of technical and business proposals in addition to the PWS. Offeror may propose revised language for the Deliverables Table and attach as an appendix to their proposal

Laboratory Reporting

In accordance with deliverables and tasks as listed, the Contractor(s) shall transmit data to CDC within 2 weeks following every 8 week data collection period by either a CDC-designated secure email or SFTP. The Contractor(s) shall submit aggregate information on age and gender by jurisdiction for all samples available for selection for this study. Additionally, labs shall submit sample-level data for all tested specimens. Files will be submitted as 1) a locked Excel file, 2) an unlocked Excel file, and 3) a .CSV file. In addition to the specimen information requested in Attachment A, the following data elements (if available) are wanted at the sample level and should also be included in the data report deliverables described in Attachment B:

· Race and ethnicity (if available)

· 5-digit zip code of patient residence; provider zip code if residence not available

· The name of the original laboratory test (e.g. basic metabolic panel, lipid panel)

· ICD10 diagnosis associated with the original laboratory test

· Results (including collection date) of any previous COVID-19 testing on the same patient, including previous PCR testing for SARS-CoV-2 infection or previous testing for SARS-CoV-2 antibodies (antibody assay type should be included, if available)

· Information on if the specimen came from an outpatient or inpatient facility (if available)

· Information on payer by category (e.g., private insurer/HMO, Medicaid, Medicare, self-pay, military health system), if available

· Unique patient identifier to allow for deduplication of sample results from the same patient

Time Schedule The proposed time schedule for this work is as follows. Offerors must clarify whether testing can begin on the first sample cycle start date in their technical proposal.

Period (numbered continuously from previous study for clarity)

Start date

VII. SPECIAL REQUIREMENTS/CLAUSES:

HUMAN SUBJECTS

The test results are not intended to be used as a diagnostic tool and instead identify a marker for past infection with SARS-CoV-2 at some previous undetermined time. It will not be useful to the health or well-being of any individual. Remnant/excess/residual specimens will have all personal identifying information removed. Final results will be presented in aggregate, stratified by location and age group, and it will not be possible to link results to an individual.

PAPERWORK REDUCTION ACT OF 1995

“The Paperwork Reduction Act of 1995 (PRA): Offeror should be advised that any activities involving information collection (i.e., posing similar questions or requirements via surveys, questionnaires, telephonic requests, focus groups, etc.) from 10 or more non-Federal entities/persons, including States, are subject to PRA requirements and may require CDC to coordinate an Office of Management and Budget (OMB) Information Collection Request clearance prior to the start of information collection activities. This would also include information sent to or obtained by CDC via forms, applications, reports, information systems, and any other means for requesting information from 10 or more persons; asking or requiring 10 or more entities/persons to keep or retain records; or asking or requiring 10 or more entities/persons to disclose information to a third-party or the general public.”

SECTION 508 OF THE REHABILITATION ACT OF 1973

HHSAR Provision, 352.239-73: Electronic and Information Technology Accessibility Notice

(a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all electronic and information technology (EIT) supplies and services developed, acquired, or maintained under this contract or order must comply with the "Architectural and Transportation Barriers Compliance Board Electronic and Information Technology (EIT) Accessibility Standards" set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the "Access Board") in 36 CFR part 1194. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of Section 508 Final Provisions can be accessed athttp://www.access-board.gov/sec508/standards.htm.

(b) The Section 508 accessibility standards applicable to this contract or order are identified in the Statement of Work or Specification or Performance Work Statement. The contractor must provide any necessary updates to the submitted HHS Product Assessment Template(s) at the end of each contract or order exceeding the simplified acquisition threshold (see FAR 2.101) when the contract or order duration is one year or less. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(c) The Section 508 accessibility standards applicable to this contract are: 1194.

502 Inoperability with Assistive Technology 504 Authoring Tools 602 Support Documentation 603 Support Services

(d) In the event of a modification(s) to this contract or order, which adds new EIT supplies or services orrevises the type of, or specifications for, supplies or services, the Contracting Officer may require that the contractor submit a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found under Section 508 policy on the HHS Web site: (http://hhs.gov/web/508). If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the services to the level of conformance specified in the contract will be the responsibility of the Contractor at its ownexpense.

(e) If this is an Indefinite Delivery contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include EIT supplies or services will define the specifications and accessibility standards for the order. In those cases, the Contractor may be required to provide a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found at http://hhs.gov/web/508. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.