PKG00247423-instructions.pdf

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Maternal and Child Health Bureau Division of Child, Adolescent and Family Health

Emergency Medical Services for Children Targeted Issues Program

Funding Opportunity Number: HRSA-19-051

Funding Opportunity Type(s): Competing Continuation, New Catalog of Federal Domestic Assistance (CFDA) Number: 93.127

NOTICE OF FUNDING OPPORTUNITY

Fiscal Year 2019

Application Due Date: April 11, 2019

Ensure your SAM.gov and Grants.gov registrations and passwords are current immediately!

HRSA will not approve deadline extensions for lack of registration.

Registration in all systems, including SAM.gov and Grants.gov, may take up to 1 month to complete.

Issuance Date: January 10, 2019

Diane Pilkey, RN, MPH Public Health Analyst, Division of Child, Adolescent and Family Health Telephone: (301) 443-8927 Email: DPilkey@hrsa.gov

Authority: Public Health Service Act, Title XIX, § 1910 (42 U.S.C. 300w-9) mailto:DPilkey@hrsa.gov

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EXECUTIVE SUMMARY

The Health Resources and Services Administration (HRSA) is accepting applications for the fiscal year (FY) 2019 Emergency Medical Services for Children (EMSC) Targeted Issues Program. The purpose of this program is to provide funding for investigator-initiated research of national significance that will demonstrate the link between system readiness improvements within hospital and prehospital emergency medical systems and improved clinical care and better health outcomes among pediatric patients. You must select from one of two categories of systems improvements for which you will assess the impact on pediatric clinical care and health outcomes. Category 1:

Readiness of Emergency Departments (EDs) to Care for Children is based on the guidelines for care of children in the hospital emergency department established by the American Academy of Pediatrics, the Emergency Nurses Association, and the American College of Emergency Physicians. Category 2: System Readiness Improvements in EMSC Performance Measures is based on selected HRSA EMSC Program performance measures for hospital EDs and prehospital Emergency Medical Services agencies.

Funding Opportunity Title: Emergency Medical Services for Children

Targeted Issues Program Funding Opportunity Number: HRSA-19-051 Due Date for Applications: April 11, 2019 Anticipated Total Annual Available FY 2019 Funding:

$1,300,000

Estimated Number and Type of Award(s):

Up to four grants, with a minimum of one award in each of the two categories

Estimated Award Amount: Up to $325,000 per year dependent on the availability of appropriated funds

Cost Sharing/Match Required: No Period of Performance: September 1, 2019 through

August 31, 2023 (4 years)

Eligible Applicants: State governments and accredited schools of medicine.

See Section III-1 of this notice of funding opportunity (NOFO) for complete eligibility information.

Application Guide

You (the applicant organization/agency) are responsible for reading and complying with the instructions included in HRSA’s SF-424 Application Guide, available online at http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf, except where instructed in this NOFO to do otherwise.

http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf

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Technical Assistance

HRSA has scheduled the following technical assistance:

Webinar

Day and Date: Thursday, January 31, 2019 Time: 2 p.m. ET Call-In Number: 1-866-917-4660 Participant Code: 68594605 Weblink: https://hrsa.connectsolutions.com/targeted_issues_nofo/

An archive recording of the call will be available within a week of the call at:

https://mchb.hrsa.gov/fundingopportunities/.

https://hrsa.connectsolutions.com/targeted_issues_nofo/ https://mchb.hrsa.gov/fundingopportunities/

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Table of Contents

I. PROGRAM FUNDING OPPORTUNITY DESCRIPTION

1. PURPOSE

2. BACKGROUND

II. AWARD INFORMATION

1. TYPE OF APPLICATION AND AWARD

2. SUMMARY OF FUNDING

III. ELIGIBILITY INFORMATION

1. ELIGIBLE APPLICANTS

2. COST SHARING/MATCHING

3. OTHER

IV. APPLICATION AND SUBMISSION INFORMATION

1. ADDRESS TO REQUEST APPLICATION PACKAGE

2. CONTENT AND FORM OF APPLICATION SUBMISSION

i. Project Abstract

ii. Project Narrative

iii. Budget

iv. Budget Narrative

v. Program-Specific Forms

vi. Attachments

3. DUN AND BRADSTREET DATA UNIVERSAL NUMBERING SYSTEM (DUNS) NUMBER AND

SYSTEM FOR AWARD MANAGEMENT

4. SUBMISSION DATES AND TIMES

5. INTERGOVERNMENTAL REVIEW

6. FUNDING RESTRICTIONS

V. APPLICATION REVIEW INFORMATION

1. REVIEW CRITERIA

2. REVIEW AND SELECTION PROCESS

3. ASSESSMENT OF RISK AND OTHER PRE-AWARD ACTIVITIES

4. ANTICIPATED ANNOUNCEMENT AND AWARD DATES

VI. AWARD ADMINISTRATION INFORMATION

1. AWARD NOTICES

2. ADMINISTRATIVE AND NATIONAL POLICY REQUIREMENTS

3. REPORTING

VII. AGENCY CONTACTS

VIII. OTHER INFORMATION

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I. Program Funding Opportunity Description

1. Purpose

The Health Resources and Services Administration (HRSA) is accepting applications for the fiscal year (FY) 2019 Emergency Medical Services for Children (EMSC) Targeted Issues Program. The purpose of this program is to demonstrate the link between system readiness improvements within hospital and prehospital1 emergency medical systems and improved clinical care and health outcomes among pediatric patients.

Program Goal Targeted Issues projects are investigator-initiated projects that expand the evidence base in pediatric emergency medicine, resulting in nationally significant findings that inform future efforts to improve emergency medical services for children. Each project will examine how select improvements from one of the two categories below are associated with improved delivery of optimal pediatric clinical care (e.g., adherence to evidence-based clinical guidelines, improved system performance such as reduced time to appropriate medication) and patient health outcomes related to emergency care (e.g., mortality and morbidity, reduced severity of asthma, decreased hospitalization for trauma). Proposed projects must meet an identified need, and relate directly to improving the quality of care of pediatric Emergency Medical Services (EMS). You must propose goals, objectives, and methods that are consistent with the program activities described below.

HRSA will fund at least one project in each category.

Category 1: Readiness of Emergency Departments (EDs) to Care for Children.

Projects in this category will be based on the Joint Policy Statement--Pediatric Readiness in the Emergency Department, established by the American Academy of Pediatrics (AAP), the Emergency Nurses Association (ENA), and the American College of Emergency Physicians (ACEP).2 The proposed projects should include more than one hospital and assess how adoption of these guidelines within EDs is associated with changes in the quality of pediatric clinical care and improved health outcomes.

Category 2: System Readiness Improvements in EMSC Performance Measures Projects in this category will focus on select performance measures (PMs)3 from the HRSA EMSC State Partnership Program. You may select one or more of the PMs below and demonstrate the impact on delivery of optimal clinical care and improved

1 NHTSA Office of EMS. (n.d.). What is EMS? Retrieved September 14, 2018, from https://www.ems.gov/whatisems.html 2 Remick K, Gausche-Hill M, Joseph MM, et al; American Academy of Pediatrics Committee on Pediatric Emergency Medicine and Section on Surgery, American College of Emergency Physicians Pediatric Emergency Medicine Committee, Emergency Nurses Association Pediatric Committee. Pediatric Readiness in the Emergency Department. Pediatrics. 2018;142(5):e20182459. URL accessed 11/1 at:

http://pediatrics.aappublications.org/content/pediatrics/142/5/e20182459.full.pdf 3 A description of the EMSC Performance Measures is available at:

http://www.nedarc.org/performanceMeasures/documents/EMS%20Perf%20Measures%20Manual%20We b_0217.pdf https://www.ems.gov/whatisems.html http://pediatrics.aappublications.org/content/pediatrics/142/5/e20182459.full.pdf http://www.nedarc.org/performanceMeasures/documents/EMS%20Perf%20Measures%20Manual%20Web_0217.pdf

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pediatric health outcomes. Proposed projects should include more than one ED or prehospital Emergency Medical Services (EMS) agency.

1) Pediatric Emergency Care Coordination in Pre-Hospital Settings (EMSC PM 02):

The presence of a designated individual or combination of individuals responsible for key coordination roles focused on improving pediatric care within a local EMS agency.

2) Hospital Recognition for Pediatric Medical Emergencies (EMSC PM 04): Hospitals with an ED that are recognized through a statewide, territorial, or regional standardized program as able to stabilize and/or manage pediatric medical emergencies.

Overarching Objectives and Activities

While proposed objectives and activities will vary depending on the category chosen, successful recipients should plan to complete the following overarching activities:

1) Implement a project aiming to link hospital and/or prehospital system readiness improvements as described in this NOFO with improvements in pediatric clinical care and patient health outcomes. The study design must be sufficiently rigorous to investigate and confirm the presence (or absence) of these links (e.g., case-control, quasi-experiment, random assignment experiment).

2) Establish and maintain access to critical data sources. This includes linking data sources to assess the selected project’s impact on changes to clinical care and outcomes in multiple settings.

3) Secure and maintain critical partnerships (i.e., with hospitals, EMS agencies, medical directors, providers and others) needed to implement the selected project.

4) Apply high quality analytic techniques to derive significant conclusions from the collected data.

5) Maintain active external communications throughout every stage of the research project including, but not limited to:

a. Build and maintain a project webpage to inform EMSC stakeholders about the project design and progress.

b. Develop and submit at least one academic manuscript describing the hypothesis, design, methods, and results of the project for publication in a peer-reviewed journal.

c. Present results from the project to at least one scientific conference attended by emergency care providers.

6) Create and implement a dissemination plan for communicating project findings to EMSC stakeholders, including State Partnership grantees, state EMS officials, hospital administrators, and national stakeholder organizations. Include a webinar accessible to EMSC stakeholders to communicate such findings at least once during the period of performance.

2. Background

The HRSA EMSC Program is authorized by the Public Health Service (PHS) Act, Title XIX, § 1910 (42 U.S.C. 300w-9) to support a portfolio of demonstration projects for the expansion and improvement of emergency medical services for children with an injury

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or critical illness requiring emergency care. The program evolved in direct response to a growing recognition that children often have unique needs in emergencies due to physiological, developmental, and psychological differences as compared to adults, and the belief that child health outcomes and survival needed to be improved. The majority of pediatric ED visits occur in community hospitals where fewer than 15 pediatric patients are seen each day.4 In addition, less than 10 percent of prehospital EMS patient encounters involve pediatric patients.5 As a result, many EDs and EMS agencies lack the resources, skills, and training to care for children. The HRSA EMSC Program is the only federal program focused specifically on improving the pediatric components of emergency medical systems. The program’s vision is to ensure that every child receives optimal pediatric emergency care no matter where he/she lives or travels.

Readiness of EDs to Care for Children

In 2009, the AAP, ACEP, and ENA published the revised Joint Policy Statement-- Guidelines for Care of Children in the Emergency Department,6 a comprehensive guide to the essential policies, procedures, and resources necessary for an ED to adequately serve pediatric patients. Multiple stakeholder organizations endorsed the Policy Statement,7 agreeing that adoption of the guidelines would facilitate the delivery of optimal emergency care for children. Based on those guidelines, the HRSA EMSC Program joined with AAP, ACEP, and ENA to establish the National Pediatric Readiness Project (NPRP), a multi-phase quality improvement initiative to increase uptake of key components of the Guidelines. In November 2018, AAP, ACEP, and ENA released an updated guideline: Pediatric Readiness in the Emergency Department. The 2018 guidelines continue to recommend most of the same essential components of pediatric readiness.

This NOFO seeks to build the evidence demonstrating that improved uptake of the guidelines (e.g., having a pediatric emergency care coordinator in the ED, having specific pediatric policies and procedures in place, having specific pediatric medications and equipment) is associated with improved delivery of clinical care and improved health outcomes.

4 Gausche-Hill M, Ely M, Schmuhl P, et.al. A National Assessment of Pediatric Readiness of Emergency Departments. JAMA Pediatr. 2015;169(6):527-534.

5 Data from the National Emergency Medical Services Information System (NEMSIS).

6 American Academy of Pediatrics, Committee on Pediatric Emergency Medicine, American College of Emergency Physicians, Pediatric Committee, Emergency Nurses Association Pediatric Committee. Joint policy statement: guidelines for care of children in emergency departments. Pediatrics. 2009;124:1233- 1243.

7 Joint Policy Statement endorsed by: Academic Pediatric Association, American Academy of Family Physicians, American Academy of Physician Assistants, American College of Osteopathic Emergency Physicians, American College of Surgeons, American Heart Association, American Medical Association, American Pediatric Surgical Association, Brain Injury Association of America, Child Health Corporation of America, Children's National Medical Center, Family Voices, National Association of Children's Hospitals and Related Institutions, National Association of EMS Physicians, National Association of Emergency Medical Technicians, National Association of State EMS Officials, National Committee for Quality Assurance, National PTA, Safe Kids USA, Society of Trauma Nurses, Society for Academic Emergency Medicine, and The Joint Commission.

http://pediatrics.aappublications.org/content/pediatrics/142/5/e20182459.full.pdf

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Assessment of ED Uptake of Guidelines In 2013, over 4,000 hospitals across the country completed the NPRP Assessment, an 83 percent response rate, representing 24 million annual pediatric ED visits. Among the participating EDs, the resulting median weighted pediatric readiness score 8 was 68.9 out of 100 (100 represents that the ED is fully prepared to care for children in emergencies). In addition to generating state and national results, the NPRP Assessment provided a report back to each of the participating EDs. The report included key elements of the Joint Policy Statement as well as the ED’s pediatric readiness score, in order to indicate the ED’s degree of pediatric readiness. The report has served as a tool to measure uptake of the Guidelines and to inform hospital, state, and national efforts to promote pediatric readiness.4 More information about the NPRP, as well as the NPRP Assessment results, can be found at https://www.pedsready.org/.

A new national assessment based on the 2018 guidelines is scheduled to occur in early 2020. A weighted pediatric readiness score will be generated and participating hospitals will receive a summary of their results for their quality improvement efforts, offering an essential data source for the Targeted Issues grants. The current portal to complete the self-assessment based on the 2009 Guidelines will remain open through September 2019 and is available at: https://www.pedsready.org/.

System Readiness Improvements in EMSC Performance Measures

The HRSA EMSC Program has worked to spread uptake of expert- and evidence-informed system readiness improvements in both prehospital and hospital EMS settings. EMSC State Partnership grant recipients are currently working across 58 states and jurisdictions to improve select components of the prehospital and hospital system, defined by the HRSA EMSC Program performance measures (PMs). The EMSC State Partnership work represents the main national effort to standardize and improve the delivery of optimal pediatric emergency care. Recipients of the Targeted Issues grant will work to build the evidence linking the below system readiness improvements (reflected in select EMSC Program PMs) to improved clinical care and health outcomes.

a) Pediatric Emergency Care Coordination in Pre-Hospital Settings (EMSC PM 02):

In its landmark report, Emergency Care for Children: Growing Pains, the Institute of Medicine recommended that EMS agencies and hospital EDs appoint pediatric emergency care coordinators (PECCs) to promote the delivery of quality pediatric care.9 A national study found that hospital EDs with a nurse or physician PECC were more likely to have important pediatric policies in place and have a quality improvement plan that addressed the needs of children, compared with EDs without a PECC.4 In another

8 A subpanel of experts from the NPRP steering committee was assembled to develop weighting criteria for the NPRP Assessment. Based on the results of the expert panel and the California Readiness Project, 24 of the questions were weighted in the national assessment to generate an overall weighted pediatric readiness score for each hospital. The score was normalized to a 100-point scale. The final weighting for each section for the national assessment included 19 points for coordination of care, 10 points for physician/nurse staffing, 7 points for quality improvement, 14 points for patient safety, 17 points for policies/procedures, and 33 points for equipment and supplies.

9 Institute of Medicine. Committee on the Future of Emergency Care in the US. (2007). Emergency Care for Children: Growing Pains. Washington, DC: National Academy Press.

https://www.pedsready.org/ https://www.pedsready.org/

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study, having a PECC, as well as a designated pediatric area in the ED and a quality improvement plan with pediatric specific components, has been associated with improved patient triage, pain management, and asthma management for children.10

However, more validation is needed to strengthen the connection between having a PECC and improved clinical care and outcomes, especially in the prehospital EMS agency setting. This EMSC PM seeks to expand the presence of PECCs in prehospital EMS agencies, which represents a unique opportunity to examine expansion of PECCs and related pediatric outcomes. The PECC measure recommends that one individual has designated leadership on care coordination roles; yet it could be a team of individuals within the EMS agency or region. Some key roles of the PECC include ensuring that the pediatric perspective is included in the development of EMS protocols;

ensuring that fellow providers follow pediatric clinical practice guidelines; and promoting pediatric continuing education opportunities. More information about key roles and responsibilities of the PECC is available at http://www.nedarc.org/performanceMeasures/documents/EMS%20Perf%20Measures% 20Manual%20Web_0217.pdf.

b) Hospital Recognition for Pediatric Medical Emergencies (EMSC PM 04): The HRSA EMSC Program promotes the use of a standardized statewide, territorial, or regional recognition program to designate a hospital’s capacity to stabilize and/or manage pediatric medical emergencies. Pediatric facility recognition programs work to ensure EDs meet the pediatric standards set in the aforementioned AAP/ACEP/ENA Joint Policy Statement through quality improvement initiatives and additional reinforcement through onsite verification.11 Having a facility recognition program is associated with improved pediatric readiness and increased alignment with evidence-based practices (i.e., reduced use of radiation scans and improved pain management).12,13,14 However, more scientifically rigorous studies are needed showing the link between hospital recognition and clinical outcomes.

Investments under this NOFO are expected to advance the HRSA EMSC Program’s mission by demonstrating that system readiness improvements and increased preparedness to care for children by EMS agencies and hospital EDs lead to improvements in pediatric patient outcomes.

10 Oakley E, Crellin D, Barty N, Braitberg G, Young S. (2004). Improving emergency care for children: A model of collaboration between emergency departments. Emergency Medicine Australia, 16, 417-424.

11 Information on an EMSC medical facility recognition Quality Improvement Collaborative is available at:

https://emscimprovement.center/collaboratives/facility-recognition-collaborative/ 12 Rice A, Dudek J, Gross T, St Mars T, Woolridge D. (2017). The impact of a pediatric emergency department facility verification system on pediatric mortality rates in Arizona. The Journal of Emergency Medicine, 52(6), 894-901.

13 Ball JW, Sanddal ND, Mann NC, et al. (2014). Emergency department recognition program for pediatric services: Does it make a difference? Pediatric Emergency Care, 30(9), 608-612.

14 Remick K, Kaji AH, Olson L, et al. (2016). Pediatric readiness and facility verification. Annals of Emergency Medicine, 67(3), 320-328.

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II. Award Information

1. Type of Application and Award

Type(s) of applications sought: Competing Continuation, New

HRSA will provide funding in the form of a grant.

2. Summary of Funding

HRSA expects approximately $1,300,000 to be available annually to fund four recipients. You may apply for a ceiling amount of up to $325,000 total cost (includes both direct and indirect, facilities and administrative costs) per year. The period of performance is September 1, 2019 through August 31, 2023 (4 years). Funding beyond the first year is dependent on the availability of appropriated funds for the HRSA EMSC Program in subsequent fiscal years, satisfactory recipient performance, and a decision that continued funding is in the best interest of the Federal Government.

All HRSA awards are subject to the Uniform Administrative Requirements, Cost Principles and Audit Requirements at 45 CFR part 75.

III. Eligibility Information

1. Eligible Applicants

Eligible applicants include domestic state governments or accredited schools of medicine in states and jurisdictions.

Under § 2(f) of the PHS Act (42 U.S.C. 201(f)), the term “state,” except as otherwise noted, includes, in addition to the several states, only the District of Columbia, Guam, the Commonwealth of Puerto Rico, the Northern Mariana Islands, the Virgin Islands, American Samoa, and the Trust Territory of the Pacific Islands. The Trust Territory of the Pacific Islands encompasses the Federated States of Micronesia, the Republic of the Marshall Islands, the Republic of Palau, and the Commonwealth of the Northern Mariana Islands.

The term “school of medicine” for the purpose of this funding opportunity (and under 42 U.S.C. 300w-9(c)) has the same meaning as set forth in § 799B(1)(A) of the PHS Act (42 U.S.C. 295p(1)(A)).15

Pursuant to § 1910(a) of the PHS Act, no more than three awards under this authority may be made in a state (to a state or a school of medicine in such state). HRSA will not provide funds to more than three award recipients within each state in a given fiscal year. HRSA will make competitive awards under this NOFO in accordance with the rank order established by the objective review committee, but if awarding funds to the next ranking applicant would result in a fourth award to any state, HRSA must skip

15 See definition at: https://www.law.cornell.edu/uscode/text/42/295p http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=4d52364ec83fab994c665943dadf9cf7&ty=HTML&h=L&r=PART&n=pt45.1.75 https://www.law.cornell.edu/uscode/text/42/295p

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that applicant and make the award to the next eligible applicant, ensuring compliance with this statutory restriction.

2. Cost Sharing/Matching

Cost sharing/matching is not required for this program.

3. Other

HRSA will consider any application that seeks funding for both categories of systems improvements to be non-responsive. HRSA, at its discretion, may return the application for an election as to which of the two categories the applicant desires to seek funding or HRSA may decline to consider the application for funding under this notice.

HRSA will consider any application that exceeds the ceiling amount non-responsive and will not consider it for funding under this notice.

HRSA will consider any application that fails to satisfy the deadline requirements referenced in Section IV.4 non-responsive and will not consider it for funding under this notice.

If for any reason (including submitting to the wrong funding opportunity number or making corrections/updates) an application is submitted more than once prior to the application due date, HRSA will only accept your last validated electronic submission, under the correct funding opportunity number, prior to the Grants.gov application due date as the final and only acceptable application.

IV. Application and Submission Information

1. Address to Request Application Package

HRSA requires you to apply electronically. HRSA encourages you to apply through Grants.gov using the SF-424 workspace application package associated with this NOFO following the directions provided at http://www.grants.gov/applicants/apply-for-grants.html.

If you’re reading this notice of funding opportunity (NOFO) (also known as “Instructions” on Grants.gov) and reviewing or preparing the workspace application package, you will automatically be notified in the event HRSA changes and/or republishes the NOFO on Grants.gov before its closing date. Responding to an earlier version of a modified notice may result in a less competitive or ineligible application. Please note you are ultimately responsible for reviewing the For Applicants page for all information relevant to desired opportunities.

https://www.grants.gov/ http://www.grants.gov/applicants/apply-for-grants.html http://www.grants.gov/applicants/apply-for-grants.html https://www.grants.gov/web/grants/applicants.html

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2. Content and Form of Application Submission

Section 4 of HRSA’s SF-424 Application Guide provides instructions for the budget, budget narrative, staffing plan and personnel requirements, assurances, certifications, and abstract. You must submit the information outlined in the Application Guide in addition to the program-specific information below. You are responsible for reading and complying with the instructions included in HRSA’s SF-424 Application Guide except where instructed in the NOFO to do otherwise. You must submit the application in the English language and in the terms of U.S. dollars (45 CFR § 75.111(a)).

See Section 8.5 of the Application Guide for the Application Completeness Checklist.

Application Page Limit The total size of all uploaded files may not exceed the equivalent of 80 pages when printed by HRSA. The page limit includes the abstract, project and budget narratives, attachments, and letters of commitment and support required in the Application Guide and this NOFO. Standard OMB-approved forms that are included in the workspace application package do not count in the page limit. Indirect Cost Rate Agreement and proof of non-profit status (if applicable) do not count in the page limit. We strongly urge you to take appropriate measures to ensure your application does not exceed the specified page limit.

Applications must be complete, within the specified page limit, and validated by Grants.gov under the correct funding opportunity number prior to the deadline to be considered under this notice.

Debarment, Suspension, Ineligibility, and Voluntary Exclusion Certification

1) The prospective recipient certifies, by submission of this proposal, that neither it nor its principals is presently debarred, suspended, proposed for debarment, declared ineligible, or voluntarily excluded from participation in this transaction by any federal department or agency.

2) Failure to make required disclosures can result in any of the remedies described in 45 CFR § 75.371, including suspension or debarment. (See also 2 CFR parts 180 and 376, and 31 U.S.C. 3321).

3) Where the prospective recipient is unable to attest to the statements in this certification, an explanation shall be included in Attachments 10-15: Other Relevant Documents.

See Section 4.1 viii of HRSA’s SF-424 Application Guide for additional information on all certifications.

Program-Specific Instructions In addition to application requirements and instructions in Section 4 of HRSA’s SF-424 Application Guide (including the budget, budget narrative, staffing plan and personnel requirements, assurances, certifications, and abstract), include the following:

i. Project Abstract See page 34, Section 4.1.ix of HRSA’s SF-424 Application Guide. At the top of the abstract include the information requested in the Guide. Clearly indicate whether you http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf

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are applying for Category 1: Readiness of EDs to Care for Children or Category 2:

System Readiness Improvements in EMSC Performance Measures. Prepare the abstract so that it is clear, accurate, concise, and without reference to other parts of the application because it is often distributed to provide information to the public and Congress. In addition to the information requested in the SF-424 Application Guide, include the following: problem, goals and objectives, proposed activities and methodology, anticipated products, coordination, plans for evaluation, and key words.

ii. Project Narrative This section provides a comprehensive framework and description of all aspects of the proposed project. It should be succinct, self-explanatory, consistent with forms and attachments, and well organized so that reviewers can understand the proposed project.

Applications must contain the information below. Please use the following section headers for the narrative:

• Introduction

• Needs Assessment

• Methodology

• Work Plan

• Resolution of Challenges

• Evaluation and Technical Support Capacity

• Organizational Information

Each section corresponds with a review criterion as follows:

INTRODUCTION -- Corresponds to Section V’s Review Criterion #1.

Briefly describe the purpose of the proposed project that is consistent with Category 1 or Category 2 in this NOFO described in Section I. Purpose of this

NOFO.

NEEDS ASSESSMENT -- Corresponds to Section V’s Review Criterion #1.

This section must help reviewers understand the scientific importance of the project. Include specificity on how your project will build the evidence base that links improvements in emergency care systems to pediatric patient health outcomes, and its national significance.

• Identify which specific Category (i.e., Category 1: Readiness of EDs to Care for Children or Category 2: System Readiness Improvements in EMSC Performance Measures described in Section I. Purpose of this NOFO), your project will address and associated improvements in the delivery of pediatric clinical care and the health outcomes to be assessed.

• Describe and document current evidence, the evidence gap, and the populations you are addressing. Include demographic data of these populations, citing relevant literature.

• Demonstrate a thorough knowledge and understanding of pediatric emergency care research in ED and/or prehospital EMS agency settings.

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METHODOLOGY -- Corresponds to Section V’s Review Criteria # 2 and #4.

This section should include a detailed description of the methods used to implement the project.

• Describe your proposed study design and how that design is sufficiently rigorous to investigate and confirm the presence (or absence) of the links between your proposed project and improvements in patient care and outcomes.

• Include a list of goals and objectives to be accomplished during the funding period that demonstrate the successful implementation of the project and the ability to obtain outcome data related to improvements in delivery of clinical care and pediatric health outcomes. Objectives should be specific, measurable, attainable, realistic, and time-bound (SMART).

• Identify sub-activities for each objective that are consistent with the overarching required activities in Section I. Background of this NOFO.

• Describe your plan to access data sources; link data systems as appropriate; secure data, and collect, analyze, and track data to measure process and outcome/impact metrics. Explain how the data and results will be used to inform project development, enhance service delivery, and improve patient outcomes.

• Describe how findings from the proposed project will be of national significance.

• Create and implement a dissemination plan for communicating project findings to EMS stakeholders during or after the project period to include:

o At least one manuscript describing the results of the project suitable for publication in an academic journal, o At least one scientific presentation, and o At least one webinar for HRSA EMSC Program grantees and stakeholders during the period of performance

• Human Subjects Protection: If you are proposing a project that may utilize human subjects or data from human subjects, you should consult your Institutional Review Board (IRB). Address the timeline to obtain IRB approval and provide proof of consultation with the IRB as well as review schedules for their institution in Attachment 9. Note: Successful applicants will be required to submit proof of IRB approval within 30 days of award.

Therefore, it is recommended (but not required) that you submit your project to the IRB at the time of application.

WORK PLAN -- Corresponds to Section V’s Review Criteria #2 and #4.

• Include a Work Plan (Attachment 1) which describes and sequences the activities that you will use during the entire period of performance to achieve each of the objectives proposed in the Methodology section.

• Include a Timeline (Attachment 2) that describes each activity and identifies responsible staff.

• Include Letters of Agreement and/or Description(s) of Proposed/Existing Contracts (Attachment 3).

• Include relevant letters of support (LOS) from key partners. LOS should describe the expertise the stakeholder brings to the project and scope/focus of future engagement around project activities. Should the inclusion of LOS exceed the page limit, provide a list of the LOS available with a summary of

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the details requested in each. The HRSA Project Officer overseeing this project may contact you for copies of the LOS at a later date for additional consideration of your proposal.

o LOS from the HRSA EMSC Program State Partnership and the State Partnership Regionalization of Care16 award recipients in your state (if there are any) are required and should demonstrate integration throughout the project (Attachment 4).

• Include a Logic Model (Attachment 8): A logic model is a one-page diagram that presents the conceptual framework for a proposed project and explains the links among program elements. While there are many versions of logic models, for the purposes of this NOFO, the logic model should summarize the connections between the:

o Goals of the project;

o Assumptions (e.g., beliefs about how the program will work and support resources). Base assumptions on research, best practices, and experience;

o Inputs (e.g., organizational profile, collaborative partners, key staff, budget, other resources);

o Demographic data about the target population (i.e., the individuals to be served);

o Activities (e.g., approach, key intervention(s) if applicable);

o Outputs (i.e., direct products or deliverables of program activities); and o Outcomes (i.e., results of the program, typically describing a change in people or systems or improved health outcomes that can be attributed to the application of the program intervention(s).

See Section VIII. Other Information for more background on Logic Models.

RESOLUTION OF CHALLENGES -- Corresponds to Section V’s Review Criterion # 3.

• Discuss challenges that you are likely to encounter in designing and implementing the activities described in the work plan, and approaches that you will use to resolve such challenges.

EVALUATION AND TECHNICAL SUPPORT CAPACITY -- Corresponds to

Section V’s Review Criteria #3, #4, and #5.

• Include a program performance evaluation plan that describes how you will monitor and track project activities, performance, and progress towards achieving the project’s goals and objectives in addition to continuous monitoring of program performance to inform continuous program improvement efforts.

o For each described objective, include at least one evaluation measure.

o Describe how you will respond to obstacles to implementing the evaluation plan.

• Include an evaluation timeline that is consistent with the work plan.

16 State Partnership grantees exist in 58 states, territories, and the District of Columbia. State Partnership Regionalization of Care grants are currently in three states (New Mexico, California, and Montana).

Contact information for EMSC grantees is available at: https://emscimprovement.center/emsc-grantee-contact-list/ https://emscimprovement.center/emsc-grantee-contact-list/ https://emscimprovement.center/emsc-grantee-contact-list/

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• Detail how you will establish the lines of communication with partner organizations or agencies to ensure consistent, timely, high quality work.

• Describe project staff leadership and management skills, as well as experience and expertise in directing the activities in the proposed project.

Experience should demonstrate ability to perform the work described in this NOFO. This experience should include evidence of prior successful collaboration with stakeholders, government and non-government entities, and national organizations in integrating healthcare system readiness improvements and pediatric considerations into the nation’s healthcare system.

• Describe current experience, skills, and knowledge related to pediatric emergency care, including key individuals on staff, materials published, and previous work of a similar nature.

• Provide a staffing plan and job descriptions for key personnel (Attachment 5).

• Provide summary curriculum vitae (Biographical Sketch), maximum of two pages, for each key professional or technical staff member (Attachment 6).

ORGANIZATIONAL INFORMATION -- Corresponds to Section V’s Review

Criterion #5.

• Succinctly describe your organization’s current mission, structure, and scope of current activities. Highlight how these elements all contribute to your organization’s ability to conduct the program requirements and meet program expectations.

• Outline the plan for the project’s management, including an explanation of the roles and responsibilities of project personnel, project collaborators, and consultants.

• Discuss how your organization will follow the approved project plan, as outlined in the application; properly account for the federal funds; and document all costs to avoid audit findings.

• Include an organizational chart (Attachment 7).

• Describe established lines of communication to ensure efficient management and completion of the project.

• Describe the systems and processes that will support your organization's ability to report progress on proposed project objectives, including a description of how the organization will collect and manage and secure data (e.g., assigned skilled staff, data management software, data security) in a way that allows for accurate and timely reporting of performance outcomes and continuous monitoring of program performance.

• Provide information about the data sources from EDs and EMS agencies that will be participating in your project.

o For EDs, include the following:

Total number pediatric ED visits;

Characteristics of these visits (demographics, percent trauma versus medical, other available statistics); and Pertinent information on the ED, such as trauma or pediatric facility recognition.

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o For EMS agencies, include the following:

Total population served;

Total population under age 18;

Square miles of catchment area;

Number of annual EMS calls;

Number and percent of annual pediatric calls; and Highest level of care, overall number of EMS providers by level and by volunteer/ career status and number by part time/ full time status, number of paramedics and average number per shift

NARRATIVE GUIDANCE

To ensure that you fully address the review criteria, this table provides a crosswalk between the narrative language and where each section falls within the review criteria.

Narrative Section Review Criteria

Introduction (1) Need

Needs Assessment (1) Need

Methodology (2) Response and (4) Impact

Work Plan (2) Response

Resolution of Challenges (3) Evaluative Measures

Evaluation and Technical Support Capacity

(3) Evaluative Measures; (and

(5) Resources/Capabilities

Organizational Information (5) Resources/Capabilities

Budget and Budget Narrative (below)

(6) Support Requested – the budget section should include sufficient justification to allow reviewers to determine the reasonableness of the support requested.

iii. Budget

See Section 4.1.iv of HRSA’s SF-424 Application Guide. Please note: the directions offered in the SF-424 Application Guide may differ from those offered by Grants.gov.

Follow the instructions included in the Application Guide and the additional budget instructions provided below. A budget that follows the Application Guide will ensure that, if HRSA selects the application for funding, you will have a well-organized plan and by carefully following the approved plan can avoid audit issues during the implementation phase.

Reminder: The Total Project or Program Costs are the total allowable costs (inclusive of direct and indirect costs) incurred by the recipient to carry out a HRSA-supported project or activity. Total project or program costs include costs charged to the award and costs borne by the recipient to satisfy a matching or cost-sharing requirement, as applicable.

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The Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 (P.L. 115-245), Division B, § 202 states, “None of the funds appropriated in this title shall be used to pay the salary of an individual, through a grant or other extramural mechanism, at a rate in excess of Executive Level II.” See Section 4.1.iv Budget – Salary Limitation of HRSA’s SF-424 Application Guide for additional information. Note that these or other salary limitations may apply in the following FY, as required by law.

iv. Budget Narrative See Section 4.1.v. of HRSA’s SF-424 Application Guide.

Travel: List travel costs according to local and long distance travel. For local travel, the mileage rate, number of miles, reason for travel and staff member/consumers completing the travel should be outlined.

At a minimum, the following travel is required:

• Travel funds allocated for two individuals, including the Principal Investigator

(PI), to attend a HRSA EMSC Program meeting (held on Years 2 and 4) in Washington, DC. The HRSA EMSC Program requires the PI and another individual with a designated role in the project to attend these meetings. A three-night trip should be budgeted.

It is also recommended that travel for presentation at scientific meetings and other training meetings be budgeted for as appropriate.

v. Program-Specific Forms Program-specific forms are not required for application.

vi. Attachments Provide the following items in the order specified below to complete the content of the application. Unless otherwise noted, attachments count toward the application page limit. Indirect cost rate agreements and proof of non-profit status (if applicable) will not count toward the page limit. You must clearly label each attachment

Attachment 1: Work Plan

Attach the work plan for the project that includes all information detailed in Section IV. 2.ii. Project Narrative. If you will make subawards or expend funds on contracts, describe how your organization will ensure proper documentation of funds.

Attachment 2: Timeline

The timeline should link activities to project objectives and should cover the 4 years of the period of performance.

Attachment 3: Letters of Agreement, Memoranda of Understanding, and/or Description(s) of Proposed/Existing Contracts (project-specific)

Provide any documents that describe working relationships between your organization and other entities and programs cited in the proposal. Documents that confirm actual or pending contractual or other agreements should clearly

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describe the roles of the contractors and any deliverable. Make sure any letters of agreement are signed and dated.

Attachment 4: Letters of Support from Key Stakeholders Letters of support must be dated and specifically indicate a commitment to the project/program (in-kind services, dollars, staff, space, equipment, etc.).

Attachment 5: Staffing Plan and Job Descriptions for Key Personnel (see Section 4.1. of HRSA’s SF-424 Application Guide)

Keep each job description to one page in length as much as possible. Include the role, responsibilities, and qualifications of proposed project staff. Also, include a description of your organization’s timekeeping process to ensure that you will comply with the federal standards related to documenting personnel costs.

Attachment 6: Biographical Sketches of Key Personnel

Include biographical sketches for persons occupying the key positions described in Attachment 5, not to exceed two pages in length per person. In the event that a biographical sketch is included for an identified individual not yet hired, include a letter of commitment from that person with the biographical sketch.

Attachment 7: Project Organizational Chart Provide a one-page figure that depicts the organizational structure of the project.

Attachment 8: Logic Model

While there are many versions of logic models, for the purposes of this NOFO, the logic model should include the components described in Section IV. 2. ii. Project Narrative.

Attachment 9 (Only required if human subjects research involved):

Include the timeline to obtain IRB approval and provide proof of consultation with the IRB as well as review schedules for your institution.

Attachments 10 – 15: Other Relevant Documents.

Include here any other documents that are relevant to the application.

3. Dun and Bradstreet Data Universal Numbering System (DUNS) Number and System for Award Management

You must obtain a valid DUNS number, also known as the Unique Entity Identifier, for your organization/agency and provide that number in the application. You must also register with the System for Award Management (SAM) and continue to maintain active SAM registration with current information at all times during which you have an active federal award or an application or plan under consideration by an agency (unless the applicant is an individual or federal agency that is exempted from those requirements under 2 CFR § 25.110(b) or (c), or has an exception approved by the agency under 2 CFR § 25.110(d)).

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HRSA may not make an award to an applicant until the applicant has complied with all applicable DUNS and SAM requirements and, if an applicant has not fully complied with the requirements by the time HRSA is ready to make an award, HRSA may determine that the applicant is not qualified to receive an award and use that determination as the basis for making an award to another applicant.

If you have already completed Grants.gov registration for HRSA or another federal agency, confirm that the registration is still active and that the Authorized Organization Representative (AOR) has been approved.

The Grants.gov registration process requires information in three separate systems:

• Dun and Bradstreet (http://www.dnb.com/duns-number.html)

• System for Award Management (SAM) (https://www.sam.gov)

• Grants.gov (http://www.grants.gov/)

For further details, see Section 3.1 of HRSA’s SF-424 Application Guide.

UPDATED SAM.GOV ALERT: For your SAM.gov registration, you must submit a notarized letter appointing the authorized Entity Administrator. The review process changed for the Federal Assistance community on June 11, 2018. Read the updated FAQs to learn more.

If you fail to allow ample time to complete registration with SAM or Grants.gov, you will not be eligible for a deadline extension or waiver of the electronic submission requirement.

4. Submission Dates and Times

Application Due Date The due date for applications under this NOFO is April 11, 2019 at 11:59 p.m. Eastern Time. HRSA suggests submitting applications to Grants.gov at least 3 days before the deadline to allow for any unforeseen circumstances.

See Section 8.2.5 – Summary of emails from Grants.gov of HRSA’s SF-424 Application Guide for additional information.

5. Intergovernmental Review

The Targeted Issues Program is not a program subject to the provisions of Executive Order 12372, as implemented by 45 CFR part 100. See Section 4.1 ii of HRSA’s SF- 424 Application Guide for additional information.

http://www.dnb.com/duns-number.html https://www.sam.gov/ http://www.grants.gov/ http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf http://sam.gov/ https://www.fsd.gov/fsd-gov/answer.do?sysparm_kbid=d2e67885db0d5f00b3257d321f96194b&sysparm_search=kb0013183…