Draft Statement of Work - Severe IAE in PICUs 2627_07Jan2026.pdf

STATEMENT OF WORK

Title: Surveillance of severe influenza-associated encephalopathy and related complications in US children

Short title: Severe IAE

Performance period: Base period: August 1, 2026 – July 31, 2027 Option period 1: August 1, 2027 – July 31, 2028 Option period 2: August 1, 2028 – July 31, 2029 Option period 3: August 1, 2029 – July 31, 2030 Option period 4: August 1, 2030 – July 31, 2031

C.1 – Background and need

Influenza-associated encephalopathy (IAE) is a rare and serious neurologic complication of influenza virus infection. One of the most severe forms of IAE is acute necrotizing encephalopathy (ANE), a condition that disproportionately affects children, has a poor prognosis, and can result in lasting neurologic sequelae or death.

In January 2025, CDC received anecdotal reports of critically ill children with IAE, including deaths with ANE. In response, CDC requested notification of U.S. IAE cases from health departments and clinicians.

Among 192 reports of suspected IAE submitted to CDC, 109 were categorized as IAE, roughly one-third of which were subcategorized as ANE. IAE cases were notable for a high frequency of severe disease, including intensive care unit admission (74% of all IAE cases) and death (19% of all IAE cases and 41% of acute necrotizing encephalopathy cases); over half of cases occurred in previously healthy children.

Given the severity of this complication observed in the 2025 investigation and the lack of existing national surveillance, CDC’s Influenza Division introduced IAE surveillance to two CDC influenza surveillance systems, the Influenza-Associated Pediatric Mortality Surveillance System and the Influenza Hospitalization Surveillance Network, in October 2025. However, these surveillance systems do not comprehensively capture data on critically ill children in the United States, especially given the rarity of IAE, and significant gaps exist in our understanding of IAE. There are no diagnostic criteria or treatment protocols for IAE, and while several forms of IAE have been described, they have not been validated with real-world data. Additional critical gaps in our understanding of IAE include the spectrum of disease, disease course, risk factors for severe disease, and the impact of influenza vaccination and influenza antiviral treatment.

C.2 – Project objective

The purpose of this contract is to conduct surveillance for severe IAE among critically ill hospitalized children and improve understanding of the spectrum of disease, disease course, risk factors for severe disease, optimal management, and the impact of influenza vaccination and influenza antiviral treatment on disease course. Detailed clinical data will be collected for children with IAE admitted to participating ICUs, estimated to be less than 200 cases during a given non-pandemic influenza season. This active surveillance effort would allow for improved understanding of IAE in U.S. children and the public health impact of this severe complication of influenza.

C.3 – Scope of work

The specific goals of this project are to:

1. Perform surveillance for severe IAE in hospitalized children with laboratory-confirmed influenza (age ≤18 years) using standardized case definitions.

2. Collect detailed clinical information on identified IAE cases to assess risk factors for severe disease, describe the disease course and spectrum of disease, and assess the impact of different clinical interventions including influenza vaccination and antiviral medications.

3. Assess influenza vaccination status of patients and other information about the hospital course by conducting medical record reviews and statewide vaccine registry reviews.

The project includes the following optional goals (subject to identification of need and funding):

1. Evaluate neuroradiologic reports of children with severe IAE to allow for disease characterization. Participating healthcare facilities will upload deidentified neuroradiologic images for independent evaluation.

2. Test clinical specimens. Submit residual influenza respiratory specimens for influenza virus subtyping and additional viral pathogen testing. As feasible at some participating healthcare facilities, collect and submit discarded blood/sera and CSF samples to assess pre-treatment and/or post-treatment cytokine, antibody, and autoantibody levels in patients.

3. Evaluate genetic and immunologic risk factors and pathways of severe IAE, including assessment of immune system activation acutely and on follow-up in biologic specimens to be collected, stored, and analyzed.

4. Assess neurodevelopmental and neurocognitive sequelae and quality of life outcomes after hospital discharge among severe IAE case patients, using validated tools and assessments to include neurodevelopmental and neurocognitive quality of life scales.

5. Conduct surveillance of other severe complications of influenza and/or other viral respiratory diseases among critically ill hospitalized children.

Special Skills and Requirements: The contractor must have demonstrated experience in:

1. Serving as the clinical coordinating center (CCC), data coordinating center (DCC), single institutional review board (sIRB), central viral laboratory, and biospecimen repository for an already established observational, multicenter, prospective public health surveillance network comprised of pediatric hospitals, medical centers, and institutes from which to recruit the identified case patients to study influenza-associated encephalopathy in hospitalized children;

2. Identifying and recruiting the type and number of institutions with the “minimum requirements” identified in this requirement;

3. Performing all other tasks as described in C.4 – Tasks to be Performed; and

4. Meeting the critical timelines outlined in this contract, specifically those included in C.9 –

Deliverables/Reporting Schedule

C.4 – Tasks to be Performed

The contractor shall complete the tasks outlined below in accordance with any applicable delivery dates reflected in C.9 – Deliverables/Reporting Schedule:

1. Kickoff Meeting. The Contractor shall schedule a virtual (teleconference) Annual Meeting within thirty (30) business days from the beginning of each performance period (“Start Date”). The Contractor shall send a meeting link and a meeting agenda to the Contracting Officer (CO), the Contracting Officer’s Representative (COR) and CDC Technical SMEs. The purpose of the meeting is to review and clarify the scope of work and delivery schedule for tasks, to delineate roles and responsibilities, and to establish communication protocols for the associated performance period. (Deliverable 1: Kickoff Meeting Agenda)

2. Project Coordination. The Contractor shall communicate (via email, telephone, and/or virtual meetings) as needed to support successful performance of this contract. The primary point of contact for technical discussions related to this contract are the CDC Technical SMEs and primary point of contract for contractual aspects of this contract are the CO and the COR.

Meeting cadence and communication preferences will be discussed at the kickoff meeting.

PHASE I: PRE-SURVEILLANCE

3. Identify and present recommendations for healthcare facilities participating in this project from their already established network. The Contractor shall identify and recommend to CDC a list of a target of forty (40) healthcare facilities within their existing established research network from which patients (“patients” for purposes of this contract are “children from the age of birth to eighteen (18) years”) can be identified and that should support this contract. The healthcare facilities list that the Contractor recommends must:

a. include a dedicated pediatric intensive care unit(s)

b. provide care to patients who are representative of the healthcare facility’s location and be able to capture all microbiologically confirmed viruses of interest at that hospital, medical center or facility.

c. be geographically diverse and representative of the U.S. population and have a diverse population of patients with respect to pediatric age, race, ethnicity, and underlying conditions; and

d. demonstrate a history of conducting active surveillance of complications of viral respiratory disease, including the ability to identify patients in real-time, complete chart reviews, and obtain laboratory and radiologic data, as part of an established network.

The Contractor shall submit to CDC its final list of participating healthcare facilities (Deliverable 2: Final list of Healthcare Facilities participating in this project) for this contract within 30 (thirty) business days from the Start. The final list shall include the name, location, healthcare facility type, and geographic distribution of healthcare facilities.

CDC will review the Contractor’s list of healthcare facilities and advise whether any healthcare facilities may not participate under this contract. The approved healthcare facilities collectively constitute “Healthcare Facilities” and individually are a “Healthcare Facility” under this contract.

In the event that an approved Healthcare Facility leaves or is removed from the project, CDC reserves the right to request that the Contractor replace the Healthcare Facility using the criteria stated above to ensure that the number of Healthcare Facilities stays within the identified range.

4. Create and provide protocol, forms, and data dictionary for active surveillance of severe IAE in critically ill children.

a. The Contractor shall create and revise, as needed, the CDC-approved protocol, data dictionary, instruction manual for data entry, REDCap database for data entry, quality assurance/quality control [QA/QC] plan, and data dictionaries to conduct surveillance in hospitalized children with severe IAE. The following information will be included in these documents:

i. Standardized case definitions for IAE and sub-categories based on clinical and laboratory data.

ii. Data elements to be collected; these include but are not limited to baseline demographics, underlying conditions, vaccination status (including statewide vaccine registry review), clinical course, viral/bacterial/fungal coinfections, antiviral treatment and other therapies, imaging results, laboratory data, and clinical outcomes both during hospitalization and up to 30 days post discharge

b. Within twenty-one (21) business days from the Start, the Contractor shall provide these updated documents to CDC for its review and approval (Deliverable 3: “Draft” Surveillance Protocol). The Contractor shall incorporate CDC’s comments into a final version (Deliverable 4: Final Surveillance Protocol) no later than three (3) business days from receipt of the CDC’s comments. When final and approved, this document will be the “Final Surveillance Protocol”.

c. Within thirty (30) business days from the Start, the Contractor shall provide a data dictionary aligned to this project. (Deliverable 5: Data Dictionary).

5. Institutional Review Board (IRB) approval(s) or non-research determination of the study (including protocols and forms). The Contractor shall prepare IRB documents and share approval with CDC once the Contractor obtains IRB approval or non-research determination.

(Deliverable 9: IRB Approval Letters or email confirmation from site PIs of non-research determination by their site IRB.)

6. Steering Committee: The Contractor shall define a steering committee structure with CDC to include all Contractor and CDC principal investigators aligned to this contract. The Contractor shall provide a list of members, including their names, titles, project affiliation, emails, and phone number.

PHASE II: SURVEILLANCE

7. Surveillance. The Contractor shall conduct surveillance based on the Final Surveillance Protocol.

a. IAE surveillance: Cases will include patients hospitalized with laboratory-confirmed influenza in the ICU. Target case count goals for severe IAE surveillance database in the Base Period may be up to 200 infants and children. The severe IAE surveillance database will be maintained in the Option Periods

b. Healthcare Facilities will identify patients that meet the surveillance definition, consent to participate in the study if determined to be necessary, and meet other criteria to be identified by CDC and the Contractor. Patients must be between “0 and 18 years old”.

c. The Contractor will prepare and provide for CDC a bimonthly case count dashboard of all case patients detected, including key variables such as influenza vaccination history (Deliverable 10: Bimonthly Surveillance Dashboard)

d. The Contractor will prepare and provide for CDC a quarterly quality assurance/quality control (QA/QC) report including case counts and completeness of data (Deliverable 11:

Quarterly QA/QC Reports).

e. The Contractor shall submit one mid-way dataset from the data reporting tool to the CDC Technical SMEs and CDC COR in addition to the final dataset (Deliverable 12: Midterm Interim Dataset). Datasets shall be exports of the data and will include patient demographics, data from medical chart abstractions, testing results, influenza vaccination history ascertainment (vaccination status by interview only, verified through medical records or state vaccine registry), and influenza antiviral receipt ascertainment (by interview, medical records, and other potential sources).

PHASE III: POST-SURVEILLANCE

8. Final Electronic Dataset(s). The Contractor will complete the electronic datasets on all case patients and deliver to CDC within two (2) weeks of completing surveillance and data collection, and no later than ten (10) days prior to the end of each performance period (Deliverable 13: Final Complete Dataset). The datasets will include demographic, clinical, and viral testing data.

a. The Contractor shall ensure the data is clean for the final datasets.

b. Only the Healthcare Facility surveillance sites will have the link between the patient study ID and the patient identity.

9. Data analysis. The Contractor will provide support as needed to CDC with data analysis and development of manuscripts.

OPTIONAL TASKS.

Tasks #A, #B, #C, #D, and #E (listed below) are included as Optional Tasks for the Base Period, and all Option periods. They will be separately priced as noted in Section B for all performance periods and by each optional task. The Government may elect to exercise one or both these tasks per the terms of Section B if the Government identifies a bona fide need and identifies available funding.

1. OPTIONAL TASK #A: Evaluation of neuroradiologic reports of children with severe IAE.

Consensus definitions for infection-triggered encephalopathy syndromes associated with influenza with defined neuroimaging patterns have been described but require real-world validation. No consensus standardized diagnostic criteria exist for IAE and the role of neuroimaging in guiding diagnosis and clinical management is unclear. Obtaining and validating neuroimaging to fit into previously described infection-triggered encephalopathy neuroimaging patterns, or recognizing novel neuroimaging patterns associated with IAE, will significantly contribute to the development of diagnostic definitions for IAE and can potentially guide clinical management. In performing this task, the Contractor shall conduct the following activities:

a. Develop a neuroradiologic analysis plan and study protocol to evaluate and categorize neuroradiologic imaging patterns in patients with severe IAE (Deliverable 14:

Neuroimaging analysis protocol);

b. Update all data collection instruments, including forms and databases;

c. Draft any standard operating procedures necessary for Healthcare Facilities to implement this task;

d. Upload de-identified primary neuroradiologic images and reports for patients with severe

IAE to a secure central data repository for independent evaluation

e. Provide neuroimaging expertise to independently review and categorize neuroimaging;

f. Facilitate coordination of this activity;

g. Provide midterm Neuroradiologic Characterization Datasets to CDC (Deliverable 15:

Midterm Neuroradiologic Characterization Datasets).

h. Provide final Neuroradiologic Characterization Datasets to CDC (Deliverable 16: Final complete Neuroradiologic Characterization Datasets).

2. OPTIONAL TASK #B: Evaluation of influenza virus subtype and inflammatory markers from clinical specimens. While IAE has been described frequently during influenza A(H1N1) predominant seasons, data generally support that encephalopathy is a complication of influenza unrelated to virus type or subtype. Evaluation of influenza virus subtype to assess for associations of disease frequency or severity with influenza subtype will contribute to the evidence base.

Other viruses, such as SARS-CoV-2 and HHV-6, are also associated with infection-triggered encephalopathy syndromes such as ANE. Research testing for additional viruses allows for better understanding of contributors to disease. Additionally, characterization and description of pre-treatment cytokine and other inflammatory markers for IAE is limited in the data; this information could guide the development of diagnostic and treatment parameters.

The contractor shall submit residual influenza respiratory specimens for subtyping and additional viral pathogen testing. As feasible at some participating healthcare facilities, collect and submit discarded blood/sera and CSF samples to assess pre-treatment cytokine, antibody, and autoantibody levels in patients. In performing this task, the Contractor shall conduct the following activities:

a. Draft any standard operating procedures necessary for Healthcare Facilities to implement this task;

b. Collect upper respiratory specimens (residual or active collection) and discarded serum/plasma and CSF samples as feasible at some participating healthcare facilities on a subset of patients with severe IAE and test them at a centralized facility or facilities, in quarterly batches (to be determined between Contractor and CDC) (Deliverable 17:

Quarterly Specimen Collection Testing and Results Report);

c. Update all data collection instruments, including forms and databases;

d. Facilitate coordination of this activity;

e. Provide midterm Clinical Specimen Datasets to CDC (Deliverable 18: Midterm

Specimen Collection Testing and Results Reporting Clinical Specimen Datasets);

f. Provide final Clinical Specimen Datasets to CDC (Deliverable 19: Final complete

Clinical Specimen Datasets).

3. OPTIONAL TASK #C: Evaluation of genetic and immunologic risk factors for severe IAE

(Immunobiology Task). ANE has been associated with pathogenic variants in genes such as RANBP2, but underlying mechanisms are not well understood or characterized, and many cases of ANE do not have any known genetic predispositions to developing ANE. Understanding of genetic risk factors for severe IAE other than ANE are limited. Genetic characterization of severe cases of IAE can improve understanding of risk factors for severe disease and support the development of prevention and treatment strategies. Additionally, development of IAE appears to be related to a systemic inflammatory response to influenza virus infection of the respiratory tract. Characterization of this response can improve understanding of disease progression and risk factors for disease severity.

The contractor shall investigate genetic/immunologic/rheumatologic risk factors and pathways of severe IAE including data/specimen collection, laboratory testing (including immunologic / immunophenotyping analyses), and analysis to evaluate host immunologic parameters for severe IAE patients. In performing this task, the Contractor shall conduct the following activities:

a. Develop an immunologic specimen collection and analysis plan and study protocol to evaluate genetic/immunologic/rheumatologic risk factors for severe IAE (Deliverable 20:

Immunobiology protocol);

b. Update all data collection instruments, including forms and databases;

c. Draft any standard operating procedures necessary for Healthcare Facilities to implement this task;

d. Identify a biostatistical support at the Contractor’s site to support data cleaning and basic analyses of severe IAE risk factor/immunologic studies and laboratory evaluation (with bioinformatics support);

e. Facilitate coordination of this activity;

f. Provide interim Clinical Specimen Datasets to CDC (Deliverable 21: Immunobiology

Midterm Preliminary Results Report);

g. Provide final Clinical Specimen Datasets to CDC (Deliverable 22: Final Complete

Immunobiology Datasets).

4. OPTIONAL TASK #D: Evaluation of neurodevelopmental and neurocognitive sequelae among children with severe IAE (Neurologic/Cognitive Task). Children with ANE can have lasting neurologic sequelae. Long-term follow-up studies on outcomes for severe IAE are limited;

this follow-up can help understand the implications of severe IAE on neurologic, cognitive, and educational outcomes and overall quality of life.

The Contractor shall investigate neurodevelopmental and neurocognitive sequelae and quality of life outcomes among severe IAE patients using validated tools and assessments to include brain MRIs and patient/parent-reported neurodevelopmental and neurocognitive quality of life scales.

In performing this task, the Contractor shall:

a. Establish or maintain a cohort of children aged 0-18 years with severe IAE to understand long-term neurologic sequelae and quality of life;

b. Develop a study protocol, data collection instruments, and data dictionary (Deliverable 23: Updated Neurologic Study Protocol, Data Collection Instruments, and Data Dictionary);

c. Facilitate coordination of this activity;

d. Provide quarterly reports (Deliverable 24: Neurologic Quarterly Reports with Enrollment

Updates);

e. Provide final Clinical Specimen Datasets to CDC (Deliverable 25: Final complete Immunobiology Datasets).

5. OPTIONAL TASK #E: Expand surveillance to other complications of influenza and/or other viral respiratory diseases. In future surveillance periods, enhanced surveillance activities for IAE may change or expand to address surveillance for other complications of influenza and/or illness associated with other respiratory pathogens, at the discretion of the Steering Committee leads. In performing this task, the Contractor shall follow similar tasks and deliverables as with the primary task of the Contract:

a. Develop and provide to CDC a study protocol, instruction manual for data abstraction, REDCap database for data entry, quality assurance/quality control [QA/QC] plan), and data dictionaries (Deliverable 26: Final surveillance protocol and forms);

b. Facilitate coordination of this activity with identified participating Healthcare Facilities;

c. Prepare and provide for CDC quarterly QA/QC reports (Deliverable 27: Quarterly

QA/QC Reports);

d. Submit one mid-way dataset from the data reporting tool to the CDC Technical SMEs and CDC COR in addition to the final dataset (Deliverable 28: Midterm interim dataset).

Datasets shall be exports of the data and will include patient demographics, data from medical chart abstractions, testing results, influenza vaccination history ascertainment (vaccination status by interview only, verified through medical records or state vaccine registry), and influenza antiviral receipt ascertainment (by interview, medical records, and other potential sources) (Deliverable 29: Final dataset).

C.5 – Reference Materials

1. Fazal A, Reinhart K, Huang S, et al. Reports of Encephalopathy Among Children with Influenza- Associated Mortality — United States, 2010–11 Through 2024–25 Influenza Seasons. MMWR Morb Mortal Wkly Rep 2025;74:91–95. DOI: http://dx.doi.org/10.15585/mmwr.mm7406a3

2. Fazal A, Harker EJ, Neelam V, et al. Pediatric Influenza-Associated Encephalopathy and Acute Necrotizing Encephalopathy — United States, 2024–25 Influenza Season. MMWR Morb Mortal Wkly Rep 2025;74:556–564. DOI: http://dx.doi.org/10.15585/mmwr.mm7436a1

3. Silverman A, Walsh R, Santoro JD, et al.; Influenza-Associated Acute Necrotizing Encephalopathy (IA-ANE) Working Group. Influenza-associated acute necrotizing encephalopathy in US children. JAMA 2025;334:692–

701. https://doi.org/10.1001/jama.2025.11534

4. Sakuma H, Thomas T, Debinski C, et al. International consensus definitions for infection-triggered encephalopathy syndromes. Dev Med Child Neurol 2025;67:195–207.

https://doi.org/10.1111/dmcn.16067 PMID:39143740

5. Mizuguchi M. Influenza encephalopathy and related neuropsychiatric syndromes. Influenza Other Respir Viruses 2013;7(Suppl 3):67–71. https://doi.org/10.1111/irv.12177

6. Mizuguchi M, Abe J, Mikkaichi K, et al. Acute necrotising encephalopathy of childhood: a new syndrome presenting with multifocal, symmetric brain lesions. J Neurol Neurosurg Psychiatry 1995;58:555–61. https://doi.org/10.1136/jnnp.58.5.555

7. Okuno H, Yahata Y, Tanaka-Taya K, Arai S, Satoh H, Morino S, Shimada T, Sunagawa T, Uyeki TM, Oishi K. Characteristics and Outcomes of Influenza-Associated Encephalopathy Cases Among Children and Adults in Japan, 2010-2015. Clin Infect Dis. 2018 Jun 1;66(12):1831-1837.

doi: 10.1093/cid/cix1126.

C.6 – Government Furnished Materials http://dx.doi.org/10.15585/mmwr.mm7406a3 http://dx.doi.org/10.15585/mmwr.mm7436a1 http://doi.org/10.1001/jama.2025.11534 https://doi.org/10.1111/dmcn.16067%20PMID:39143740 http://doi.org/10.1111/irv.12177 http://doi.org/10.1136/jnnp.58.5.555

1. Upon contract award and signature of any required nondisclosure agreements, CDC will provide the Contractor with the most current CDC-approved, protocols and other documents developed with CDC to leverage in the performance of the tasks in this contract.

2. Contractor Request for Government Furnished Materials. If the Contractor needs any additional government-furnished items to perform the work described in this PWS, the Contractor should identify such additional government-furnished items in the Contractor’s proposal.

C.7 – Period of Performance

The performance period for this requirement is:

Base Period Services Base Period Optional Task A Base Period Optional Task B Base Period Optional Task C Base Period Optional Task D Base Period Optional Task E

Month 1 through Month 12 from date of award (12 Months)

Option Period 1 Services Option Period 1 Optional Task A Option Period 1 Optional Task B Option Period 1 Optional Task C Option Period 1 Optional Task D Option Period 1 Optional Task E

Month 13 through Month 24 from date of award (12 Months)

Option Period 2 Services Option Period 2 Optional Task A Option Period 2 Optional Task B Option Period 2 Optional Task C Option Period 2 Optional Task D Option Period 2 Optional Task E

Month 25 through Month 36 from date of award (12 Months)

Option Period 3 Services Option Period 3 Optional Task A Option Period 3 Optional Task B Option Period 3 Optional Task C Option Period 3 Optional Task D Option Period 3 Optional Task E

Month 37 through Month 48 from date of award (12 Months)

Option Period 4 Services Option Period 4 Optional Task A Option Period 4 Optional Task B Option Period 4 Optional Task C Option Period 4 Optional Task D Option Period 4 Optional Task E

Month 49 through Month 60 from date of award (12 Months)

C.8 – Place of Performance

1. The work to be performed under this contract will be performed at the Contractor’s facility and associated academic, healthcare or research facilities as required.

2. No CDC onsite work is required.

C.9 – Deliverables/Reporting Schedule

All deliverables shall be in written form (i) delivered electronically, or such other manner as the contract requires, to the CDC Technical SME (see Section 12 below), the COR and such other parties as included below, or to whom the COR may designate to the Contractor in writing; and (ii) be formatted in Microsoft Word, Excel, or other editable formatting approved by the COR. All deliverables must be prepared in consideration of all applicable security, confidentiality, and architecture compliance requirements.

IMPORTANT NOTES:

• All deliverables are calculated using a 12-month term with the Contractor being provided with an additional 6 months for each performance period for non-technical reasons.

• Unless otherwise noted, the reference to “days” in this contract are to “calendar” days and not “business” days.

The Contractor shall deliver the following in accordance with the PWS:

# C.4 Task Reference

Deliverable (See “Important Note” above)

Quantity and/or Frequency (Numbers are for each performance period unless otherwise noted; see “Important Note” above)

Due Date (See “Important Note” above)

Deliver to

1 1 – Kickoff Meeting

Kickoff Meeting Agenda

1 Within thirty (30) business days of the Start Date

CDC Technical SME

COR

2 3 – List of healthcare facilities participating in this project

Final list of Healthcare Facilities participating in this project

1 Within thirty (30) business days of the Start

CDC Technical SME

COR

3 4 – Create and provide protocol and forms to conduct active surveillance

“Draft” Surveillance Protocol

1 Within twenty-one (21) business days of the Start

CDC Technical SME

COR

4 4 – Create and provide protocol and forms to conduct active surveillance

Final Surveillance Protocol

1 Within three

(3) business days of the receipt of CDC’s comments to

CDC Technical SME

COR

Deliverable

5 4 – Create and provide protocol and forms to conduct active surveillance

Data Dictionary 1 Within thirty (30) business days from the Start Date

CDC Technical SME

COR

6 4 – Create and provide protocol and forms to conduct active surveillance

Instruction Manual for data entry

1 Within thirty (30) business days from the Start Date

CDC Technical SME

COR

7 4 – Create and provide protocol and forms to conduct active surveillance

Final database 1 Within thirty (30) business days from the Start Date

CDC Technical SME

COR

8 4 – Create and provide protocol and forms to conduct active surveillance

QA/QC plan 1 Within thirty (30) business days from the Start Date

CDC Technical SME

COR

9 5 – Institutional Review Board (IRB) approval(s) or non-research determination of the study (including protocols and forms)

IRB Approval Letters or email confirmation of non-research determination

1 Upon receipt

CDC Technical SME

COR

10 7 – Surveillance Bimonthly Surveillance Dashboard

Every eight

(8) Weeks

Starting within thirty

(30) days from Start Date and continuing every two weeks until the end of the performance period

CDC Technical SME

11 7 – Surveillance Quarterly QA/QC Reports

4 First report due within three (3) Months from Start Date and due every three (3) Months until the end of the performance period

12 7 – Surveillance Midterm Interim Dataset

4 Midway through the first option period

13 8 – Final Electronic Datasets

Final Complete Dataset

1 Within two

(2) weeks of completing case reporting and data collection;

Final datasets should be sent to CDC no later than ten (10) days prior to the end of the performance

14 Optional Task A – Evaluation of neuroradiologic reports

Neuroimaging analysis protocol

1 Within twenty-one (21) business days of the Start

CDC Technical SME

COR

15 Optional Task A – Evaluation of neuroradiologic reports

Midterm Neuroradiologic Characterization Datasets

1 Midway through the performance

16 Optional Task A – neuroradiologic reports

Final complete Neuroradiologic Characterization Datasets

1 No later than twenty

(20) days prior to the end of the performance period

17 Optional Task B – Testing of clinical specimens

Quarterly Shipments of Respiratory and Serum Specimens from cases (with spreadsheet of shipment contents)

4, or more if periodic deliverables are received

Periodically, but no less than quarterly with the last shipment being made at least fourteen

(14) days before the end of the performance period

CDC Technical SME

18 Optional Task B – Testing of clinical specimens

Midterm Specimen Collection Testing and Results Reporting

1 First report due within six (6) Months from Start Date

CDC Technical SME

19 Optional Task B – Final Clinical Specimen Datasets

Final Complete Clinical Specimen Datasets

1 No later than twenty

(20) days prior to the end of the performance period

CDC Technical SME

COR

20 Optional Task C - Evaluation of genetic and immunologic risk factors for severe

IAE

Immunobiology protocol

1 Within twenty-one (21) business days of the Start

CDC Technical SME

COR

21 Optional Task C - Evaluation of genetic and immunologic risk factors for severe

IAE

Immunobiology Midterm Preliminary Results Report

4 First report due within six (6) Months from Start Date

CDC Technical SME

COR

22 Optional Task C – Final Immunobiology Datasets

Final Complete Immunobiology Datasets (including limited results of research assays)

1 No later than twenty

(20) days prior to the end of the performance period

23 Optional Task D -neurodevelopmental and neurocognitive sequelae among children with severe

IAE

Updated Neurologic Study Protocol, Data Collection Instruments, and Data Dictionary

1 Forty (40) days from the Start Date after exercising this optional task

CDC Technical SME

COR

24 Optional Task D - Evaluation of neurodevelopmental and neurocognitive sequelae among children with severe

IAE

Neurologic Quarterly Reports with Enrollment Updates

4 First report due within three (3) Months from Start Date and due every three (3) Months until the end of the performance period

CDC Technical SME

COR

25 Optional Task D – Final Neurologic Datasets

Final Complete Neurologic Datasets

1 No later than twenty

(20) days prior to the end of the performance period

CDC Technical SME

COR

26 Optional Task E – Surveillance of other complications of influenza and/or other viral respiratory diseases

Final surveillance protocol and forms

1 Within thirty (30) business days of the Start

CDC Technical SME

COR

27 Optional Task E – Surveillance of other complications of influenza and/or other viral respiratory diseases

Quarterly QA/QC Reports

4 First report due within three (3) Months from Start Date and due every three (3) Months until the end of the performance period

CDC Technical SME

COR

28 Optional Task E – Surveillance of other complications

Midterm interim dataset

1 Midway through the of influenza and/or other viral respiratory diseases performance period

29 Optional Task E – Surveillance of other complications of influenza and/or other viral respiratory diseases

Final dataset 1 No later than twenty

(20) days prior to the end of the performance period

C.10 – Travel

This contract does not include travel.

C.11 – Special Considerations (Clearance Requirements)

1. Information Security and Privacy – Clearance language not required for this acquisition:

2. Human Subjects Protections in Research (HSC Clearance Requirement).

3. Paperwork Reduction Act (PRA). Paperwork Reduction Act. Projects that involve the collection of information from ten (10) or more individuals and are funded by a contract will be subject to review and approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA). While PRA is not applicable, NCIRD must submit a separate PRA determination for each information collection activity upon the award of funds.

4. Information, Communications, and Technology (ICT) (Section 508) (Deliverable 21(j)).

Electronic and Information Technology Accessibility Notice

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.accessboard. gov/sec508/standards.htm.

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

205 WCAG 2.0 Level A & AA Success Criteria

302 Functional Performance Criteria

502 Inoperability with Assistive Technology

503 Applications http://www.accessboard/

504 Authoring Tools

602 Support Documentation

603 Support Services

In order to facilitate the Government's determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and documentation detail - whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS Web site http://hhs.gov/web/508.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If an offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(e) Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html.

Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

(End of Provision)

5. Publications. Any publications issued as a result of funding under this contract must comply with the CDC publication clearance requirements.

6. Data. [Please see applicable language in the requirement as defined above and the Data Rights Clause included in Section I.]

C.11 – Performance & Quality Assurance

1. Quality Assurance. The Government will annually evaluate the Contractor’s performance under this Contract in accordance with FAR 42.15. For those tasks listed on the Performance Matrix, the COR will follow the method of surveillance specified in Contract.

2. CPARS. For acquisitions over the simplified acquisition threshold, the Government will provide and record Past Performance Information of the Contractor’s performance in the Contractor Performance Assessment Reporting System (CPARS). The CPARS process allows contractors to view and comment on the Government's evaluation of the Contractor's performance before it is finalized.

Contractors are required to register in the CPARS, so that Contractor’s may review and comment on past performance reports submitted through the CPARS. The CPARS website is https://www.cpars.gov/.

3. Performance-Based Matrix: The Performance-Based Matrix describes a list of the contractual requirements that will be verified as contractually compliant by the Government. Each requirement includes a Government-determined performance standard and the resource that is used to perform the verification. Surveillance of any functional area that does not have critical requirements will be accomplished through surveillance of the Contractor’s Quality Control Program or periodic evaluation.

http://hhs.gov/web/508

a) 100% Inspection: One Hundred Percent Inspection is exactly what the title implies – inspecting a requirement every time it occurs.

b) Customer Complaints: Customer complaints will be investigated to ensure compliance with the Performance/Deliverables Matrix prior to being transmitted to the Contractor.

Deliverable or Service Required

Measures of Success Indicators

Standards-Criteria for Acceptable Quality

Level Method of Surveillance

Communications • Accurate bimonthly updates

• Timely delivery of the Agenda

• Scheduling call to include key stakeholders

• Directing communications to the appropriate CDC staff

95% accuracy Customer review of deliverables and content of the calls and communications

Written Reports • Compliance to Contract

• Timeliness

• Functionality

• Completeness

95% compliance with the government requirement and Contract

Government inspection and acceptance

Healthcare Facility List • Alignment to contract’s selection criteria

• Timeliness

• Completeness

• Quality

95% compliance with the government requirement and Contract

Government inspection

Final Study Protocol, Forms and Tools

• Compliance to Contract

• Timeliness

• Functionality

• Completeness

95% compliance with the government requirement and Contract

• Comparison of protocol to contract requirements

• Government inspection

Institutional Review Board (IRB) Approvals

• Compliance to Contract

• Ensure adherence to ethical requirements for research with human subjects

100% compliance with government requirement and Contract

• Issuance by IRB of either an approval or an exemption

• Government inspection and acceptance

Data – Collection & Quality

• Compliance to Contract

• Timeliness

• Quality

• Functionality

• Completeness

95% compliance with the government requirement

• Comparison of case information to contract requirements

• Government inspection and acceptance

If Optional Task B is exercised, collection of biospecimens

• Compliance to Contract

• Timeliness

• Quality

• Completeness

95% compliance with the government requirement

• Comparison of collection information to contract requirements

• Random sampling

Interim and Final Datasets • Compliance to Contract

• Timeliness

• Quality

• Complete and accurate documentation

• <5% data fields with errors upon CDC review of interim delivery

• Interim dataset <6 months from study launch

• Final dataset per final project delivery schedule

• 95% adherence to data dictionary and data requirements

• No more than 2 revisions before final acceptance by CDC

• Comparison of interim and final dataset to the contract requirement

• Random sampling

If Optional Task C is exercised, evaluation of genetic and immunologic risk factors for severe

IAE

• Compliance to Contract

• Timeliness

• Quality

• Functionality

• Completeness

95% compliance with the government requirement

• Comparison of data exports in alignment to the task description

• Random sampling

If Optional Task D is exercised, evaluation of neurodevelopmental and neurocognitive sequelae among children with severe IAE

• Compliance to Contract

• Timeliness

• Quality

• Functionality

• Completeness

95% compliance with the government requirement

• Government inspection and acceptance

• Comparison of updated study protocol, data collection instruments and data dictionary to contract terms

• Random sampling

If Optional Task E is exercised, surveillance of other complications of influenza and/or other viral respiratory diseases

• Compliance to Contract

• Timeliness

• Quality

• Complete and accurate documentation

• <5% data fields with errors upon CDC review of interim delivery

• Interim dataset <6 months from study launch

• Final dataset per final project delivery schedule

95% compliance with the government requirement

• Comparison of protocol to contract requirements

• Comparison of interim and final dataset to the contract requirement

• Random sampling

C.12 – Points of Contact (POC)

COR: Pamela Pagano (CDC/DDID/NCIRD/DVD/RVB), fzu7@cdc.gov, 770-488-0933