75D301-24-Q-77965_NASN-SBAS Phase 3_Statement of Work.pdf

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75D301-24-Q-77965

NASN-SBAS Phase 3

Statement of Work

Procurement Request #: 1T Period of Performance: 7/26/2024 – 9/25/2025

Title: School-Based Active Surveillance (SBAS) Among School Children for Chronic Conditions with a

Focus on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) – Phase 3

[Running Title: Phase 3 of the SBAS Project for ME/CFS Among School Children]

SECTION 1 – BACKGROUND

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a complex, debilitating multi-system disease and affects about 836,000 to 3.3 million American adults. Estimates of pediatric ME/CFS prevalence vary in different studies from 0.10 to 0.75%. However, about 90% of people with ME/CFS have not been diagnosed by a physician yet. The diagnosis of ME/CFS might not be considered by healthcare professionals because education about this illness is subpar in many medical schools and residency programs across the United States. As a result, only a small number of clinicians truly understand ME/CFS and consider it a legitimate disease. Data on disease burden of ME/CFS in children is lacking; particularly in the national prevalence of ME/CFS and indicators associated with ME/CFS among school children.

Data on chronic conditions among school children, such as asthma, has been collected over the years, but there has been little to no emphasis on ME/CFS in the United States. Chronic conditions among school-aged children likely account for a high proportion of chronic school absenteeism and school withdrawal.

Identifying the clinical diagnoses associated with these children is key to strategize intervention plans that would help ensure their health by balancing school attendance and the need of school accommodation and activity participations. Conducting active surveillance among students using school nurses could expedite the diagnosis and management of children who present with symptoms commonly seen in ME/CFS. This involves educating school nurses about ME/CFS and its related syndromes, how to best approach parents and guardians when suggesting the diagnosis, and how to support the educational success of students with chronic diseases.

In response to both, a needs assessment underscoring state epidemiologists’ need for information on the burden of ME/CFS and a recommendation from the Chronic Fatigue Syndrome Advisory Committee

(CFSAC) of the U.S. Department of Health and Human Services (HHS) calling for HHS to “educate educators and school nurses on ME/CFS affecting children and adolescents”, the CDC ME/CFS Program created a solicitation for a contract to provide technical services in support of conducting a school-based active surveillance (SBAS) of ME/CFS among school children. The National Association of School Nurses

(NASN) was awarded the initial contract in mid-September 2018 for the pilot (first) phase of the SBAS project and a follow-on contract in late-July 2021 for the second phase of the SBAS project. The two phases were to: 1) engage school nurses in the selected school districts from 14 states for school-based surveillance,

2) develop and maintain electronic data platform to facilitate data collection for this surveillance, and 3) educate nursing professionals about ME/CFS including school nurses that participating in this surveillance project.

Active surveillance for pediatric ME/CFS coupled with education of school nurses about ME/CFS could help improve measuring the burden of ME/CFS in children and provide insights for future plans to improve healthcare in children suffering from ME/CFS and other chronic health conditions. In the next phase (Phase

3) of this project, we will expand the active surveillance project to additional schools in those states participating in the first two phases as well as to other states. In this phase, school nurses will continue to receive education and technical assistance. Having baseline data about other chronic conditions, will ultimately help inform the interpretation of future data on ME/CFS and guide interventions to help students experiencing health-related academic challenges.

SUBSECTION A – DEFINITIONS

https://www.cdc.gov/me-cfs/programs/School-Based-Active-Surveillance.html https://www.cdc.gov/me-cfs/programs/School-Based-Active-Surveillance.html

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Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a debilitating, multisystem, chronic disease of unknown etiology and pathogenesis that can affect children, adolescents and adults. ME/CFS is characterized by reduced ability to perform pre-illness activities that lasts for more than 6 months and is accompanied by profound fatigue, which is not improved by rest. A hallmark of ME/CFS is that symptoms can worsen after physical, mental, or emotional effort, a manifestation known as post-exertional malaise

(PEM). Patients with ME/CFS also have unrefreshing sleep. Other common manifestations include orthostatic intolerance, cognitive impairment, and pain.

Postural orthostatic tachycardia syndrome (POTS) is a condition where changing from lying down horizontally to an upright position causes the heart rate to increase to an abnormal degree.

Chronic Fatigue Syndrome Advisory Committee (CFSAC) was charted under the Public Health Service Act of the US and funded by the United States Department of Health and Human Services (HHS). The

Committee was sunset effective September 5, 2018. Before its sunset, CFSAC provided advice and recommendations to HHS on issues related to ME/CFS including patients, research, and clinical education.

SECTION 2 – PURPOSE

The purpose of this contract is to build on the work from Contract # 75D30121C12121 for the school-based active surveillance among school children. The new acquisition will consist of 4 main components: 1) engage and educate nursing professionals including school nurses, 2) maintain and enhance the electronic data platform for the active surveillance, 3) increase nurse workforce to help ensure students’ health and data collection for the surveillance, and 4) assess burden of ME/CFS using data from the national rollout active surveillance. The data collection part of this contract will be led by the school nurses at the school districts that are participating in the national rollout phase. The information includes but not limited to: chronic conditions including ME/CFS, and characteristics associated with ME/CFS and other chronic conditions such as school absenteeism, withdrawal, and activity participation.

SECTION 3 – SCOPE OF WORK

Independently and not as an agent of the Government, the Contractor shall provide all personnel, facilities, facilities equipment, materials, and supplies to conduct the national school-based active surveillance for

ME/CFS and other selected chronic conditions (e.g., asthma, diabetes). The Contractor shall provide technical support services in planning, organizing, conducting, and reporting on the national school-based active surveillance for chronic conditions.

Specific Objectives/Expected Outcomes

The expected outcomes for this requirement include the following:

1. Continue the original objectives of engaging the school nurse workforce at multiple levels (e.g., local, district, state, and national levels) to collect data pertaining to chronic conditions, chronic school absenteeism, and school withdrawal as well other relevant data.

2. Increase the number of local schools, school districts, and states involved in school nurse-led active surveillance of chronic conditions, including ME/CFS.

3. Increase the number of participants who take continuing education courses and Data

Champion trainings developed in the prior phases of the SBAS project for ME/CFS and related comorbidities, the active surveillance process, data management, and best practices on supporting students with chronic conditions.

4. Continue to provide technical assistance, support, and training to the school nurse workforce in the project sites to facilitate 1) the data collection using the electronic

75D30124Q77965 – NASN-SBAS Phase 3 – Page 3 of 9 platform developed in pilot phase and 2) the analysis and dissemination of the active surveillance data.

5. Present to interested stakeholders the findings and lessons learned from the implementation of this active surveillance.

6. Develop and publish in collaboration with the funding agency at least one peer-reviewed publication using information collected from this SBAS project.

The contractor shall provide CDC with the national surveillance data from U.S. school districts in at least 10 states during the contract performance period. School districts should include urban, suburban, and rural areas. The contractor will provide the support to their subcontractors or school nurses to assure the completion and quality of surveillance data collection throughout this contract.

SECTION 4 – TASKS TO BE PERFORMED

The contractor shall perform the following tasks:

Task 1. Develop a work plan describing all aspects of the project including nursing professional education, data management, and health education outreach.

The Contractor shall coordinate and facilitate a kick-off meeting so that all parties can understand the statement of work and address any questions. The Contractor shall get acquainted with the findings and lessons learned from the first two phases of the SBAS project. Based on the information from the first two phases, the contractor shall develop an initial work plan that outlines specific steps in the process for stakeholder engagement for the active surveillance, project management, data collection, reporting, and transmission at the national level, nursing professional education and training, and best practices for health education outreach. This plan shall include:

a. Description of data collection, reporting, and transmission at the national level, nursing professional education and training, and best practices for health education outreach.

b. Goals with SMART criteria (Specific, Measurable, Attainable, Relevant, and Time-Bound, etc.) for each of these areas above.

c. Milestones to be achieved in each of these areas.

d. An estimated timeline for achieving these milestones.

e. Data management, data transferring, and reporting plan.

f. Anticipated challenges in the process and suggestions on how to manage them.

Task 2. Conduct data collection, QC, and delivery (to the Government) of school-level data.

The Contractor shall obtain initial and annual local Institutional Review Board (IRB) approval and shall submit one electronic or one hard copy to the CDC Project Officer. Over the performance period, the contractor shall aim to involve school districts in at least 10 states for school-based active surveillance of

ME/CFS and other chronic conditions. The contractor shall strategize the number of states that they will engage at the performance period to complete data collection from school districts in at least 10 states.

During the performance period, the contractor shall deliver interim data at 50%, and 100% of the data collection in analyzable data format via secured data transferring systems (e.g., encrypted FTP). Additionally, the contractor shall perform data scrubbing quality assessment and quality management. The contractor shall deliver the final data files and the final report at the end of each performance period. Rather than individual-level data collection, the school-level information collection shall include but not limited to the following data elements for information related to chronic absenteeism and school withdrawal at each participating school:

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a. Number of students chronically absent or withdrawn for any reason and for health reasons

b. Number of families contacted for students with chronic absenteeism

c. Number of undiagnosed students with symptoms related to ME/CFS

d. Number of students referred to a provider for possible ME/CFS

e. Types of nursing interventions, and nursing diagnoses for students who are chronically absent

Task 3. Conduct training for nurse workforce data champions.

The Contractor shall provide training for the nurse workforce data champions, state data coordinators who provide data assistance for school nurses. The training shall address topics including electronic data collection platform, data fidelity, data sharing agreements, and messaging to school nurses regarding initiating or continuing engagement with data collection and other surveillance efforts. The Contract shall conduct the aforementioned training types at least 4 times during the performance period in the mixed method of in-person, virtual, or online formats. The Contractor shall provide a single report at the end of the first performance period that summarizes the training for the nurse workforce data champions.

Task 4. Provide online education to nursing professionals about chronic illness conditions including

ME/CFS and Long COVID ME/CFS-like illness.

Increasing knowledge for ME/CFS and other post-acute infection illnesses could help identifying probable cases for further active case ascertainment to be included in the data collection for this school-based active surveillance. The Contractor shall work with CDC experts to identify topic areas for the recording of online courses and make them available on NASN’s training platform to nurses about chronic illness conditions including ME/CFS, Long COVID ME/CFS-like, and conditions that could be comorbidities in people with

ME/CFS. These online courses shall offer continuing education credits such as Continuing Nursing

Education (CNE) or Nursing Continuing Professional Development (NCPD). At least one course shall be made available as a first priority to nurses participating in the active surveillance effort but may also be made more widely available to nurses in private and other school settings as well as to members of the public who are registered on NASN’s learning portal but are not NASN members. Additionally, the contractor shall plan to develop at least one new course in ME/CFS to extend the content from the Phase 2 course.

Task 5. Support the conduct of school-based active surveillance data collection activities for original sites and newly added sites.

The Contractor shall provide technical assistance to the school nurses that participating in this active surveillance project in the following areas:

a. Maintain and update the online data platform

b. Provide trouble shooting for the data platform issues

c. Statistical or data management

The Contractor shall provide a report at the end of each performance period that summarizes the conduct of surveillance data collection activities by the school nurse workforce nationwide. This report shall contain a summary section for the performance period.

Task 6. Summarize completed tasks and next steps at in-person or virtual meetings with CDC

Technical Monitor and other invited staff.

The Contractor shall coordinate and facilitate an in-person or virtual meeting with the CDC ME/CFS Team at the end of each performance period. This meeting may include school nurses from school districts that are participating in the data collection for school-based surveillance. The Contractor shall summarize the meeting discussion and action assignments. The Contractor shall provide the summary report to the Contracting

Officers Representative (COR) and Technical Monitor. The contractor shall distribute the agenda and any relevant documentation agreed upon by the Contracting Officer’s Representative (COR) and Technical

Monitor before the meeting. These meetings shall consist of:

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1. Review of the milestones reached and to be reached and deliverables completed and to be completed.

2. Review of data for active surveillance and trainings.

3. Discussion of any successes, challenges, and lessons learned to date and any risk mitigation actions that can be taken.

4. Record of the meeting discussion and action assignments provided to the Contracting

Officers Representative (COR) and Technical Monitor.

Task 7. Disseminate the following information to stakeholders in the format of a final report and a webinar: the findings and lessons learned from the implementation of national active surveillance in schools.

The Contractor shall provide information to interested stakeholders regarding the process of, findings from, and lessons learned from implementing national active surveillance in schools through publications. In addition to preparing a final report, the Contractor shall prepare at least one webinar which shall be posted on a website available to both the school nurse workforce, other stakeholders, and the general public.

REPORTING REQUIREMENTS

The Contractor shall provide the progress reports, draft, and final report as follows:

Progress Reports

The progress report shall contain, at a minimum, the following information:

1. A brief description of requirements.

2. Accomplishments during the reporting period and significant events regarding the task order.

3. Deliverables submitted, progress on deliverable products.

4. Any current and anticipated problems and solutions, stakeholder participation and issues, communications with persons, groups, organizations, and agencies and the nature of those communications.

5. Activities scheduled for the next reporting period.

6. Key personnel changes.

7. A brief summary of activity planned for the next reporting period.

Draft and Final Project Report

The final report shall contain, at a minimum, the following information:

1. Submit a draft Final Report.

2. Summarize the project and its findings in narrative and figurative format. The final report shall include sections on recommendations, future funding, and potential stakeholders to partner with to advance surveillance in schoolchildren.

3. The COR or designee will respond with feedback, if any, on the draft final report within two weeks of its receipt.

Submit a final report that includes all of the feedback received from the draft final report submitted.

SECTION 5 – GOVERNMENT FURNISHED MATERIALS

All travel shall be in accordance with the Federal Travel Regulations. Travel will be reimbursed for cost only.

It is anticipated for in-person meetings to review work progress at the Centers for Disease Control and

Prevention (CDC) campus, 1600 Clifton Road, Atlanta, Georgia 30333. The projected meetings will be discussed and approved by the Contracting Officer (CO) and Contracting Officer’s Representative (COR)

75D30124Q77965 – NASN-SBAS Phase 3 – Page 6 of 9 before any travel arrangements are made. ***Travel may be put on hold due to the pending travel restrictions. Virtual Meetings may be utilized in lieu of in-person meetings.

SECTION 6 – PERIOD OF PERFORMANCE

This is a fixed performance-based contract. The estimated period of performance for this requirement is July

26, 2024 through September 25, 2025.

Place of Performance: The work to be performed at the Contractor’s facility.

Any education material products can be printed at CDC’s facility based on availability. If CDC’s facility is not available for in-person meetings, the contractor will identify an appropriate location. *** Virtual

Meetings may be utilized in lieu of in-person meetings.

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SECTION 7 – DELIVERABLES/REPORTING SCHEDULE

Performance Period: 07/26/2024 to 09/25/2025 (14-months)

Task No. Description of the

Deliverable

Quantity/Format Delivery

Date(s)

Deliver To

1 Kick-off Meeting Minutes One (1) MS Word document (email)

Two (2) weeks after award

COR and

Technical Monitor

1 Work Plan One (1) MS Word document (email)

4 weeks after award draft work plan

COR and

Technical Monitor

2 Data Delivery and Report –

50%

Analyzable Format

(e.g., EXCEL)

9 months after award

Technical Monitor

2 Data Delivery and Report –

100% for at least 8 states

Analyzable Format

(e.g., EXCEL)

16 months after award

Technical Monitor

3 1st Draft Data Champion

Training Report

One (1) MS Word document (email)

Eight (8) months after award

COR and

Technical Monitor

3 Final Data Champion

Training Report

One (1) MS Word document (email)

2 weeks after draft returned to

Contractor

COR and

Technical Monitor

4 Outline of Online Education

Course

One (1) MS Word document (email)

6 weeks after award

COR and

Technical Monitor

4 Posting of Online Education

Course

One course posted on the website

6 months after award

COR and

Technical Monitor

5 1st Draft Technical

Assistance Report

One (1) MS Word document (email)

Two (2) month before 1st

Performance

Period Meeting

COR and

Technical Monitor

5 2nd Draft Technical

Assistance Report

One (1) MS Word document (email)

2 weeks after draft returned to

Contractor

COR and

Technical Monitor

7 In-person or Virtual 1st

Performance Period Meeting

Minutes/Final Report

One (1) MS Word document (email)

Two (2) weeks before the end of the contract period

COR and

Technical Monitor

Progress Reports One (1) MS Word document (email)

15th of every month with about 10-11 progress reports due each period

COR and

Technical Monitor

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*Note: All tasks and deliverables will also be monitored closely through monthly reports and calls occurring at least monthly. The final delivery of items notated with double asterisks (above) is dependent on CDC clearance.

‡ All deliverables are due to CDC COR and Technical Monitor, respectively.

SECTION 8 – REFERENCE MATERIALS

Reference Materials for this requirement:

1. Institute of Medicine. 2015. Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome:

Redefining an Illness. Washington, DC: The National Academies Press.

https://doi.org/10.17226/19012.

2. The CDC ME/CFS website, http://www.cdc.gov/me-cfs/

3. The CFSAC website archive, https://wayback.archive-it.org/org-

745/20190128204246/https://www.hhs.gov/ash/advisory-committees/cfsac/index.html

4. Jones JF, Nisenbaum R, Solomon L, Reyes M, Reeves WC. Chronic fatigue syndrome and other fatiguing illnesses in adolescents: a population-based study. J Adolesc Health. 2004;35(1):34-40.

doi:10.1016/j.jadohealth.2003.09.007

5. Jordan KM, Huang CF, Jason LA, et al. Prevalence of pediatric chronic fatigue syndrome in a community-based sample. Journal of Chronic Fatigue Syndrome. 2006;13(2-3):75-78.

doi:10.1300/J092v13n02_04

6. Rowe P. C., Underhill R. A., Friedman K. J., Gurwitt A., Medow M. S., Schwartz M. S., Speight N., Stewart J. M., Vallings R., Rowe K. S. (2017). Myalgic encephalomyelitis/chronic fatigue syndrome diagnosis and management in young people: A primer. Frontiers in Pediatrics, 5(121), 2.

https://doi.org/10.3389/fped.2017.00121

7. Jason L. A., Katz B. Z., Sunnquist M., Torres C., Cotler J., Bhatia S. (2020). The prevalence of pediatric myalgic encephalomyelitis/chronic fatigue syndrome in a community-based sample. Child

& Youth Care Forum, 49(4), 563–579. https://doi.org/10.1007/s10566-019-09543-3. Epub 2020 Jan

23. PMID: 34113066; PMCID: PMC8186295

8. Maughan ED, Thompson ME, Walsh CA, Issa A, Lin J-MS. Feasibility Assessment of a School

Nurse-Led Approach Using Chronic Absenteeism to Establish the School-Based Active Surveillance

Process. The Journal of School Nursing. 2023;39(2):105-113. doi:10.1177/10598405221144259

9. NASN Active Surveillance Manual, https://www.pathlms.com/nasn/courses/24594

SECTION 9 – POINT OF CONTACT INFORMATION

The Point of Contact (POC) for this procurement is:

Contracting Officer (CO): Nathan R. Amador;

wlv7@cdc.gov; 770.488.2690

Preferred method of communication: Email

SECTION 10 – PAYMENT TERMS

Payment terms are based on federal acquisition regulations.

http://www.cdc.gov/me-cfs/ https://wayback.archive-it.org/org-745/20190128204246/https:/www.hhs.gov/ash/advisory-committees/cfsac/index.html https://wayback.archive-it.org/org-745/20190128204246/https:/www.hhs.gov/ash/advisory-committees/cfsac/index.html https://doi.org/10.3389/fped.2017.00121 https://www.pathlms.com/nasn/courses/24594 mailto:wlv7@cdc.gov

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SECTION 11 – MINIMUM VENDOR QUALIFICATIONS AND LEVEL OF EFFORT

The contractor shall meet the following minimum qualifications:

1. Communicate effectively with scientists, researchers, healthcare providers, epidemiologists, and other public health officials.

2. Provide staff with at least two (2) years of prior experience with working with the school nurse workforce in at least 10 states to collect and submit data pertaining to the standardized definitions for chronic illnesses and other measures related to school health.

3. Demonstrated expertise and ability to train and provide technical assistance to nursing professionals

(e.g., school nurses) across the country and shall be able to provide future continuing nursing education (CNE) regarding ME/CFS and available resources to students with chronic conditions.

SECTION 12 – EVALUATION FACTORS

1. Technical Approach. Includes the contractor’s response to tasks as described and a program management plan for the overall contract.

a. Explain technical approach to recruiting the proposed number of states for school districts that they will involve for this project.

b. Demonstrate the engagement plan to ensure the completion of the surveillance data collection.

c. Demonstrate willingness to obtain data related to ME/CFS, other chronic conditions, and associated characteristics on students at school-level.

d. Demonstrate that the applicant has access to equipment necessary for fulfilling the contract requirements including providing electronic copies of required data forms and sending data via secure data transferring system.

2. Experience

a. Demonstrate an understanding of ME/CFS and experience with school-based active surveillance.

b. Demonstrate capacity for research project management including management of data collections, recruitment of school nurses, and education outreach.

c. Demonstrate any prior experience in term of program evaluation for surveillance activities.

d. Provide curriculum vita(e) to document training, credentials and experience.

e. Document any prior experience with successfully conducting school-based surveillance and education outreach to nursing professional; in particular, school nurses in the United States.

3. Staffing Plan. Address personnel availability to complete the deliverables described in the SOW by providing or obtaining appropriate staff.

a. A data management coordinator is essential, and curriculum vita(e) documenting relevant training, qualifications, and experience should be provided.

b. Staff responsible for preparing IRB submission, updating and maintaining electronic data collection platform, ensuring completeness of information and quality of data collection.

c. Qualified staff for education outreach such as planning educational events and training required for ensuring the high quality of data captured on the electronic data platform.