HRSA-21-096.pdf

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of Global Health (OGH) Office of the Administrator (OA)

Health Resources and Services Administration (HRSA)

NOTICE OF FUNDING OPPORTUNITY

Fiscal Year 2021

Application Due Date: May 7, 2021

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: March 8, 2021

Tracey Gantt, MSN, RN, PHNA-BC Nurse Consultant, OGH/OA/HRSA Office of the Administrator Telephone: (301) 443-1219 Email: tgantt@hrsa.gov

Authority: Public Law 108-25 (the United States Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 2003) [22 U.S.C. 7601 et seq.], Public Law 110-293 (the Tom Lantos and Henry Hyde United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008), and Public Law 113-56 (PEPFAR Stewardship and Oversight Act of 2013).

Quality Improvement Solutions for Sustained Epidemic Control Project (QISSEC)

Funding Opportunity Number: HRSA-21-096

Funding Opportunity Type: New Assistance Listings (CFDA) Number: 93.266 https://www.hrsa.gov/office-global-health https://www.hrsa.gov/about/organization/key-staff.html https://www.hrsa.gov/ mailto:tgantt@hrsa.gov

HRSA-21-096 i

EXECUTIVE SUMMARY

The Health Resources and Services Administration (HRSA), Office of Global Health (OGH) is accepting applications for fiscal year (FY) 2021 to administer the Quality Improvement Solutions for Sustained Epidemic Control Project (QISSEC). The purpose of this project is to facilitate improvements in quality across the HIV care continuum at the site level (defined as the location where persons diagnosed with HIV receive care and treatment) and within the community. The project attempts to improve the effectiveness, efficiency, patient-centeredness, safety, accessibility, and equity of the HIV services in low to middle-income countries (LMIC) as identified by the U.S.

President’s Emergency Plan for AIDS Relief (PEPFAR) program. FY21 PEPFAR priorities recognize quality health services as essential in order to ensure that optimal health outcomes are met on a daily and routine basis. Therefore, all PEPFAR country programs must incorporate explicit quality management (QM) practices, including both quality assurance (QA) and quality improvement (QI) activities into service delivery and partner management. Focused on building the capacity of countries to sustain and spread QI methodologies, improve documentation of efforts and continuously enhance staff knowledge, QISSEC strives to impact the delivery of quality HIV services, improve health outcomes and support HIV/AIDS epidemic control. This Notice of Funding Opportunity (NOFO) will fund two cooperative agreements in support of the PEPFAR focus on the management of evidence-informed interventions for scale-up and spread.

The successful applicants will facilitate solutions for long-term change management approaches and sustainability of QA and QI activity.

Funding Opportunity Title: Quality Improvement Solutions for

Sustained Epidemic Control Project Funding Opportunity Number: HRSA-21-096 Due Date for Applications: May 7, 2021 Anticipated Total Annual Available FY 2021 Funding:

Up to $20,000,000 funding ceiling

Estimated Number and Type of Award(s): 2 cooperative agreements

Estimated Award Amount: Up to $20,000,000 per year subject to the availability of appropriated funds

Cost Sharing/Match Required: No Period of Performance: September 30, 2021 through September

29, 2026 (5 years) http://www.pepfar.gov/about/strategy/237172.htm

HRSA-21-096 ii

Eligible Applicants:

Domestic or foreign public or non-profit private entities, including schools of medicine, nursing, public health, management and public administration, and academic health centers, community-based organizations, faith-based organizations, and consortia consisting of such organizations, are eligible to apply.

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.

Technical Assistance

HRSA has scheduled the following technical assistance:

Webinar

Date: Friday, March 19, 2021

Time: 1:00 PM – 2:30 PM EST

Adobe Connect URL Weblink: https://hrsa.connectsolutions.com/nofo_pre-application/

Call-In Number: Dial-in: Conference Call 888-730-9136 for all callers (U.S. and international)

Participant passcode 5686097 (U.S. and international)

The webinar will be recorded and should be available for viewing by March 31, 2021. The location of the recording and frequently asked questions (FAQ’s) will be discussed during the webinar.

http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf https://hrsa.connectsolutions.com/nofo_pre-application/

HRSA-21-096 iii

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. Attachments

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

4. Submission Dates and Times Application Due Date

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

VI. Award Administration Information

1. Award Notices

2. Administrative and National Policy Requirements

3. Reporting

VII. Agency Contacts

VIII. Other Information

HRSA-21-096 1

I. Program Funding Opportunity Description

1. Purpose

This notice announces the opportunity to apply for funding for the Quality Improvement Solutions for Sustained Epidemic Control Project (QISSEC). The purpose of this project is to facilitate improvements in quality across the HIV care continuum at the site level (defined as the location where persons diagnosed with HIV receive care and treatment) and within the community. The project attempts to improve the effectiveness, efficiency, patient-centeredness, safety, accessibility, and equity of the HIV services in low to middle-income countries (LMIC) as identified by the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) program.

FY21 PEPFAR priorities recognize quality health services as essential in order to ensure that optimal health outcomes are met on a daily and routine basis. Therefore, all PEPFAR country programs must incorporate explicit quality management (QM) practices, including both quality assurance (QA) and quality improvement (QI) activities into service delivery and partner management.

Focused on building the capacity of countries to sustain and spread QI methodologies, improve documentation of efforts, and continuously enhance staff knowledge, QISSEC strives to impact the delivery of quality HIV services, improve health outcomes, and support HIV/AIDS epidemic control. This Notice of Funding Opportunity (NOFO) will fund two cooperative agreements in support of the PEPFAR focus on the management of evidence-informed interventions for scale-up and spread. The successful applicants will facilitate solutions for long-term change management approaches and sustainability of QA and QI activity.

The QISSEC shall focus on developing innovative strategies to improve the delivery of HIV quality care and treatment for use by facilities that serve the most vulnerable individuals in PEPFAR-supported LMICs. Using quality improvement methodologies, tools, and techniques, the project will identify gaps in service delivery, and develop culturally and medically appropriate, sustainable interventions targeted to PEPFAR-identified vulnerable and key populations.

Over 18 years PEPFAR https://www.state.gov/pepfar/ has evolved to a complex and high impact program, with mature stakeholders and partners showing that epidemic control is indeed possible. It is in this context that HRSA is renewing its commitment to PEPFAR and specifically seeking to fill gaps as well as to bring targeted and innovative solutions to the remaining barriers to epidemic control around the globe.

The PEPFAR 2021 Country Operational Plan Guidance for all PEPFAR Countries (https://www.state.gov/wp-content/uploads/2020/12/PEPFAR-COP21-Guidance-Final.pdf) suggests all PEPFAR country programs must incorporate explicit quality management practices, including both QA and QI activities, into service delivery and partner management.

2. Background

This program is authorized by Public Law 108-25 (the United States Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 2003) [22 U.S.C. 7601 et seq.], Public Law http://www.pepfar.gov/about/strategy/237172.htm https://www.state.gov/pepfar/ https://www.state.gov/wp-content/uploads/2020/12/PEPFAR-COP21-Guidance-Final.pdf

HRSA-21-096 2

110-293 (the Tom Lantos and Henry Hyde United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008), and Public Law 113-56 (PEPFAR Stewardship and Oversight Act of 2013).

Since its inception, PEPFAR has invested over $85 billion in the global HIV/AIDS response, saving over 18 million lives, preventing millions of HIV infections, and accelerating progress toward controlling the global HIV/AIDS epidemic.

PEPFAR’s investments continue to strengthen the systems that drive client-centered and sustainable health care. These investments create a lasting health system for partner countries to confront other current and future health challenges, enhance global health security, and protect America’s borders. The HIV/AIDS pandemic constantly evolves in every community and country and PEPFAR continually adapts to address new risk groups, new health challenges, and persistent gaps. (https://www.state.gov/about-us-pepfar/).

Under the leadership of the Office of the U.S. Global AIDS Coordinator (OGAC), as part of the U.S. Government’s global HIV response, HRSA has been a significant contributor to PEPFAR’s achievements. HRSA’s work builds on the agency’s domestic and international experience and expertise by improving outcomes along the HIV care continuum for people living with HIV (PLHIV). Domestically, HRSA’s programming includes integrations with other bureaus in the agency, such as the HIV/AIDS Bureau (HAB) and the Bureau of Primary Health Care (BHPC).

HAB provides a comprehensive system of HIV primary medical care, essential support services, and medications for low-income PLHIV who are uninsured and underserved. More than half of people living with diagnosed HIV in the United States receive services through the Ryan White HIV/AIDS Program each year. That means more than half a million people received services through the program. BHPC oversees the Health Center Program, a national network of health centers that provide comprehensive primary health care services to more than 27 million people nationwide, regardless of a patient’s ability to pay, charging for services on a sliding fee scale.

These health centers play an important role in “Ending the HIV Epidemic” by serving as a key point of entry for people undiagnosed with HIV. Integrating HIV services into primary care delivery is critical for success, both for health centers and for patients living with HIV. They emphasize coordinated and comprehensive care, and have the ability to manage patients with multiple health care needs.

HRSA continues to work with host countries and with other key partners to assess the needs of each country and design a customized program of assistance that fits within the host country’s strategic plan. PEPFAR guidance changes regularly; therefore recipients will consistently monitor, adapt and align their program activities with current PEPFAR guidelines.

II. Award Information

1. Type of Application and Award

Type of applications sought: New

HRSA will provide funding in the form of a cooperative agreement. A cooperative agreement is a financial assistance mechanism where substantial involvement is anticipated between HRSA and the recipient during performance of the contemplated project.

https://www.state.gov/about-us-pepfar/ https://hab.hrsa.gov/ https://bphc.hrsa.gov/ https://www.hrsa.gov/ending-hiv-epidemic

HRSA-21-096 3

HRSA program involvement will include:

• Participate in discussions for planning, implementing, and evaluating program activities, including the identification and selection of additional in-country impact partners.

• Assist in the coordination and collaboration among program partners, such as the Office of the U.S. Global AIDS Coordinator and Health Diplomacy (OGAC), other HHS agencies, the USAID, foreign governments, international donors, and other key stakeholders.

• Participate, as appropriate, in planning and producing meetings or workgroups conducted during the period of performance.

• Maintain an ongoing dialogue with the recipients of this cooperative agreement concerning program plans, policies, and other issues that have major implications for any activities under the cooperative agreement.

• Review and provide comments and recommendations for documents, curricula, program plans, budgets, contracts, personnel (including consultants), revisions of work plans, etc., prior to printing, dissemination, or implementation.

• Support the engagement of relevant stakeholders and assist in developing and periodically reviewing the recipients’ five-year monitoring and evaluation plan (M&E), ensuring compliance with the strategic information guidance established by OGAC.

• Provide technical assistance, as mutually agreed upon, and revise annually during validation of the first and subsequent annual work plans. This could include expert technical assistance and targeted training activities in specialized areas, such as strategic information, project management, confidential counseling and testing, palliative care, treatment literacy, and adult learning techniques.

• Support access to the expertise of HRSA personnel and other relevant resources to the project.

• Participate in the dissemination of project findings, best practices, and lessons learned across the initiative.

The cooperative agreement recipient’s responsibilities will include:

• Collaborate closely with HRSA, country governments, in-country U.S.

Government (USG) teams, and other key stakeholders to gain a greater understanding of the identified LMIC’s situation, root causes for state fragility, short and longer term needs and priorities in order to better mobilize, build consensus, and efficiently plan and coordinate successful interventions for the highest impact.

• Consult with HRSA and field teams as applicable, to inform HRSA on program progress and barriers encountered, identify activities to be planned jointly, and discuss matters that require HRSA input and approval.

• Implement strategies for facilitating scale-up and sustainability of activities supported under this agreement that include building on and strengthening previous and/or existing efforts by governments, local networks, and institutions that benefit the populations served. Strategies should strengthen indigenous capacity in all aspects of the agreement.

HRSA-21-096 4

• Develop and execute a final M&E plan within the first six months of the period of performance, in consultation with HRSA and key stakeholders.

• Support the relevant governmental, academic, and regulatory bodies by partnering with local organizations and providing technical support to the government. The partnerships are expected to expand through the period of performance.

• Support health systems strengthening interventions that are grounded in primary health care and universal health coverage principles and capable of responding to diverse and unexpected challenges that might arise in the future.

• Respond to the health needs of the people of the identified LMICs in their unique political, economic, and health system circumstance. Identifying post-conflict, resource-poor, or policy-poor considerations that possess uniquely complicated characteristics will require a customized approach.

2. Summary of Funding

HRSA anticipates a funding ceiling of $20,000,000 to be available annually to fund two (2) recipients. You may apply for a ceiling amount of up to $20,000,000 total cost (includes both direct and indirect, facilities and administrative costs) per year. The period of performance is September 30, 2021 through September 29, 2026. Funding beyond the first year is subject to the availability of appropriated funds for QISSEC in subsequent fiscal years, satisfactory recipient performance, and a decision that continued funding is in the best interest of the Federal Government. HRSA may reduce recipient funding levels beyond the first year if a recipient is unable to fully succeed in achieving the goals listed in the application.

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

Grants to foreign organizations and foreign public entities that are performed fully outside of the territorial limits of the U.S. may be paid to support the costs of compliance with federal requirements at a fixed rate of 8 percent of MTDC exclusive of tuition and related fees, direct expenditures for equipment, and subawards in excess of $25,000.

III. Eligibility Information

1. Eligible Applicants

Eligible applicants include domestic or foreign public or non-profit private entities, including schools of medicine, nursing, public health, management and public administration, and academic health centers, community-based organizations, faith-based organizations, and consortia consisting of such eligible organizations.

2. Cost Sharing/Matching

Cost sharing/matching is not required for this program.

3. Other http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=4d52364ec83fab994c665943dadf9cf7&ty=HTML&h=L&r=PART&n=pt45.1.75

HRSA-21-096 5

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.

HRSA will consider any application that exceeds the page limit referenced Section IV.2 non-responsive and will not consider it for funding under this notice.

NOTE: Multiple applications from an organization are not allowable.

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 notice of funding opportunity (NOFO) following the directions provided at http://www.grants.gov/applicants/apply-for-grants.html.

The NOFO is also known as “Instructions” on Grants.gov. You must provide your email address when reviewing or preparing the workspace application package in order to receive notifications including modifications and/or republications of the NOFO on Grants.gov before its closing date. You will also receive notifications of documents placed in the RELATED DOCUMENTS tab on Grants.gov that may affect the NOFO and your application. 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.

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.

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

HRSA-21-096 6

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) You, on behalf of the applicant organization certify, by submission of your proposal, that neither you nor your principals are 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 you are unable to attest to the statements in this certification, an explanation shall be included in Attachment 11: 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:

Project Level Activities Given the diversity of PEPFAR funded countries’ needs for quality improvement technical assistance, this announcement is not intended to be a prescriptive approach to improving quality but rather requires that you support implementation of innovative, evidence-informed practices. PEPFAR priorities stress the importance of successfully operationalizing a quality management program to support programs with fidelity, scale, and quality. HRSA encourages you to offer ideas and strategies, and to incorporate an inter-professional approach or multidisciplinary team-based approach.

The World Health Organization defines inter-professional practice as a collaborative process of communication and decision-making between a multidisciplinary team to influence new knowledge and new skills.

https://www.who.int/hrh/resources/framework_action/en/

HRSA-21-096 7

You are required to:

• Use a sample of PEPFAR-funded countries to illustrate and identify quality improvement gaps across the HIV care continuum, including, but not limited to:

HIV service delivery gaps, adult and pediatric antiretroviral therapy (ART), ART switch confidence, treatment adherence, support of medical case management, retention in care, and viral suppression management. The use of the U.S.

Centers for Disease Control and Prevention Granular Site Management Tool, and SIMS are effective sources of country data.

• Build communities of learning through implementing various QI activities that offer levels of QM, QA, and QI methodologies, tools, and techniques related to any of the above-listed or that are newly identified. Communities of learning have proven to be effective collaborative models.

• Facilitate rapid scale up and dissemination of interventions that:

o Are ministries of health (MOH) and stakeholder vetted o Are targeted and time-limited o Extend across country programs, and across distinct technical areas to facilitate the spread of new knowledge

• Assess the impact of implementation on health outcomes through demonstrated plans of monitoring and evaluation, revealing outcome and impact data. You must use the results of the assessment, as presented in an M&E plan, throughout the project to continuously modify interventions for sustainability.

Principles of QISSEC

Integrate the following principles in the overall approach to the QISSEC project:

• HIV care continuum approach

• Integrated design

• Documentation

• Evidence-based QI

• Institutionalization of QI and sustainability

• Evaluation of QI

HIV care continuum approach

The HIV care continuum includes the diagnosis of HIV, linkage to HIV medical care, retention in HIV medical care, prescription of ART, and, ultimately, HIV viral suppression.

Integrated design

HRSA expects that this project will focus on large scale, country-specific activities designed to introduce or expand and enhance modern quality improvement as an integral part of health care. Funding allocations are made to align with PEPFAR priorities, country specific epidemiological information, and other data. Recipient(s) should plan to assist HRSA in preparation for annual portfolio reviews and subsequent funding allocations consistent with program needs and supported by evidence of https://www.state.gov/wp-content/uploads/2020/10/FY21-SIMS-4.1-Implementation-Guide_15Aug2020.pdf https://www.state.gov/wp-content/uploads/2020/10/FY21-SIMS-4.1-Implementation-Guide_15Aug2020.pdf https://www.hiv.gov/federal-response/policies-issues/hiv-aids-care-continuum

HRSA-21-096 8

impact. QISSEC country programs will generally be designed to be supported by an office established and staffed by the recipient(s) in each host country or within a region.

Staff in the field is not an explicit requirement, but consistent support and access to a virtual platform is optimal.

Documentation

The documentation of QI changes in both quantitative and qualitative indicators will be used to monitor the results of QI activities, how the teams produced these results, and how QI interventions were implemented. For example, the development of a QI knowledge hub provides access to resources and tools in support of dissemination and spread of QI knowledge for replication.

Evidence-Informed QI

Evidenced-informed improvement science offers an approach to improving quality that includes the measurement of change in relation to well-defined, appropriate indicators.

Specifically, improvement science suggests supporting the testing of changes in health care processes, and then measuring the impact of these changes using indicators that capture the performance of that process or its outcome.

Institutionalization of QI and Sustainability

The QISSEC seeks to make quality improvement a permanent and an integral part of delivering health services in QISSEC countries. To achieve this goal, the project must build the capacity of host country institutions to carry out effective improvement interventions without external assistance. As a result of this institutionalization, the project will support the development of improvements in health care processes that endure over the long term rather than improvements that depend on external support or on a level of effort that cannot be sustained by the health system of the host country.

Evaluation of QI

The central purpose of evaluation under QISSEC is to contribute to the development of more cost effective QI activities that are fully institutionalized and sustainable components of the provision of health services. The primary focus should be on the assessment of implementation through demonstrated plans of monitoring and evaluation, revealing outcome and impact data. These efforts will contribute to improving the design of QI programs and evaluations that measure the impact of QI programs HIV service delivery gaps.

i. Project Abstract See Section 4.1.ix of HRSA’s SF-424 Application Guide.

Please include a summary of the proposed activities; a description of the impact of the proposed activities; and indicate the funding amount requested for the period of performance. The project abstract should not exceed one page.

HRSA-21-096 9

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.

Successful applications will contain the information below. Please use the following section headers for the narrative:

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

Briefly describe the purpose of the proposed project. Summarize the existing service gaps, design and rationale of the proposed program, and evolving public health considerations. Discuss how the program will engage and collaborate with stakeholders to collectively develop practical, effective, and innovative solutions.

Describe your organization’s responsibility for carrying out activities and abilities related to the project activities. Describe your organization’s role/contribution and that of each potential partner as it relates to priorities identified by PEPFAR for LMICs. Include a discussion that exhibits an expert understanding of the issues related to the activities included in this funding opportunity announcement among the applicant’s internal and consulting staff, as well as any partner organizations.

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

Outline the understanding of the needs of diverse LMICs in which you propose to work. Select three sample LMIC PEPFAR-supported countries to discuss the overall state of quality in PEPFAR-supported countries, followed by a description of the specific needs. Provide examples if possible to enhance understanding and address provider compliance with clinical guidelines and other priority areas in the discussion.

The needs assessment should demonstrate a summary of the following:

• A brief description of the sample countries’ HIV/AIDS epidemic

• A brief description of leadership and resources available for HIV care and

QI activities

• A brief relevant history of QI interventions and identified gaps in QI activities (for example, performance measurement)

Briefly describe your understanding of the contributing factors of incidence and prevalence rates for HIV in the sampled LMIC countries.

Use and cite demographic and epidemiologic data as presented by the sampled countries for the last two quarters. Data sources may include surveillance and epidemiology reports, Ministry of Health reports, and other programmatic data.

Include in the summary a comprehensive understanding of the types of QI activities that support and facilitate sustainable increases of retention in care and viral suppression. Address key challenges and barriers, such as stigma, infrastructure, and the potential impact of social determinants of health. Include specific cultural considerations, linguistic differences, and health literacy skills

HRSA-21-096 10

essential to build scalable, sustainable efforts.

• METHODOLOGY -- Corresponds to Section V’s Review Criterion #2

QISSEC Requirements

A. Objectives of the Project

The objectives of the QISSEC include four core components:

1. Identify Quality Improvement Gaps in the service delivery of HIV care and treatment across the HIV care continuum. You must accomplish this in collaboration with host MOH, stakeholders such as staff directly delivering HIV care and treatment, vulnerable and key populations, and other civil society stakeholders. This objective will establish a clear plan of action that will support facility level capacity and enhancements to infrastructure, while maximizing evidenced-informed quality improvement interventions. This is a core component of the project.

2. Implement Quality Improvement Interventions at the site level, using evidence-informed methodologies and best practice approaches that focus on a range of well-defined innovative strategies for HIV service delivery along the HIV care continuum that increase measurable health outcomes (improved retention in care or enhanced viral suppression). Focused on the development of interventions for country-identified gaps in retention in HIV care and treatment and HIV viral suppression, this core component will support communities of learning.

3. Disseminate/Spread Quality Improvement Tools and Resources that are supportive, rapid and scalable, user-friendly, and replicable at the facility level.

“Spread” in this context is defined as the transfer of knowledge beyond the dissemination point. This transfer can be achieved through traditional face-to-face methods or ideally through a cost-effective virtual platform. This core component will facilitate the widespread dissemination of tools and resources, and supports indigenous organizations to sustain the monitoring and implementation of QI programs.

4. Measure and Evaluate the Impact of Activities that contribute to scalable and sustainable interventions. This core component will demonstrate the appropriateness of identifying the most urgent gaps for quality improvement activities; will highlight the most effective implementation of quality improvement interventions; and acknowledge the most cost-effective and scalable activities for dissemination and spread of quality improvement tools and resources.

Propose methods that you will use to achieve the project’s objectives, goals, and intended outcomes. Objectives should be specific, measurable, realistic, and achievable within the project period. Clearly relate the project objectives and goals to the program expectations outlined in Section I of this NOFO.

Highlight those activities linked to the goals outlined in PEPFAR. Describe your proposed approach for improving access to and the quality of services for HIV, other communicable and non-communicable diseases, and other priority health areas. This section must include a plan for identifying gaps, implementation of interventions, dissemination, spread, and sustainability of efforts.

HRSA-21-096 11

• How you, in collaboration with consortium partners, will build and maintain effective strategic partnerships with relevant government agencies, education institutions, regulatory bodies, health management teams, civil society organizations, other USG-funded programs, and other stakeholders to ensure relevant, appropriate, and timely technical assistance.

• How you will ensure that plans are in alignment with identified LMIC’s national strategic plans and current PEPFAR priorities.

• How the proposed approach will work to strengthen the interprofessional approach to care and treatment.

• How the proposed approach will ensure up-to‐date knowledge and skills in HIV/AIDS, TB, malaria, and other communicable and non-communicable diseases in response to local health priorities, and addresses the specific needs of low-income youth, women, and men, and targeted key populations.

• How strategies for facilitating scale-up and sustainability of activities will include building on and strengthening previous and/or existing efforts by the individual governments, USG, or other donors.

• How choices will be made to balance between immediate impact or longer-term, more sustainable interventions.

• How your experience in the design and management of health management information systems and/or the capacity to assist institutions in using data to inform decisions is a benefit to PEPFAR-supported LMICs.

• How you will maintain consistency with national plans, specific groups or categories of beneficiaries targeted, and mechanisms for coordination with similar activities that are supported by other funding sources.

• How you will develop the process you will use to manage and monitor subrecipients. Describe the subaward process from initiation to approval, with the corresponding timelines. Describe the approach for working collaboratively with other partners including USG, other implementing partners, donors, and Ministries. You must demonstrate a strong capacity to understand, manage, and leverage different types of relationships to implement the QISSEC project.

You must also propose a plan for project sustainability after the period of performance ends. HRSA expects recipients to sustain key elements of their projects (e.g., strategies or services and interventions) which have been effective in improving practices and those that have led to improved outcomes for the target population.

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

Describe the activities or steps that you will use to achieve each of the objectives proposed during the entire period of performance in the Methodology section.

Discuss how these goals and objectives directly relate to the requirements and expectations of the project requirements outlined in Section 1. Provide a work plan that demonstrates how the outcomes, strategies, activities, timelines, and staffing will take place over the course of the award. Include a detailed work plan for the first year of the project and a high-level plan for the four subsequent years.

The work plan should include goals, objectives, and outcomes that are SMART

HRSA-21-096 12

(specific, measureable, achievable, realistic, and time-measured). Include all aspects of planning, implementation, and evaluation, along with the role of key staff involved in each activity. The work plan must relate to the needs identified in the needs assessment and to the activities described in the project narrative with a minimum of the following;

• Identify the QI intervention for each goal

• Identify the QI activities for each intervention

• Identify the responsible staff to complete or monitor each activity

• Identify the anticipated timeline for activity, intervention and goal completion

The work plan should include as much detail as possible with the understanding that the work plan will be revised after the cooperative agreement is awarded and after initial consultations with HRSA and in-country stakeholders. Include the project’s work plan as Attachment 1. This section is often best presented and/or summarized in a chart format.

• RESOLUTION OF CHALLENGES -- Corresponds to Section V’s Review Criterion

#2

Discuss challenges that you are likely to encounter in designing and implementing the QISSEC activities described in the needs assessment and work plan sections of the narrative, and provide reasonable and actionable solutions to address these barriers. Discuss the strength of your methodology in identifying and responding to these challenges. Discuss approaches that you will use to resolve such challenges.

• EVALUATION AND TECHNICAL SUPPORT CAPACITY -- Corresponds to

Section V’s Review Criteria #3 and #4

You must describe the plan for the program performance evaluation that will contribute to scalable and sustainable interventions. Describe your capacity to monitor program goals and objectives. Describe plans to track and quantify the utilization of tools, systems, and strategies developed. Describe methods and measures that you will use to evaluate the system-level impacts of the overall project and demonstrate the effectiveness of project activities.

Describe how the performance plan will link with expenditure reporting for the proposed project. The plan should also include a well-defined set of yearly milestones for the proposed activities. Such milestones should conform to the proposed timeline described in the work plan. The plan should outline indicators that will demonstrate timely achievement of milestones. Milestones will be reconsidered on an annual basis. The successful recipient, in consultation with HRSA, will work with relevant stakeholders to co-develop the M&E plan.

Describe the methods you plan to use to collect data. Describe current experience, skills, and knowledge, including individuals on staff, materials

HRSA-21-096 13

published, and previous work of a similar nature. As part of this section, discuss the effectiveness of methods proposed to monitor and evaluate the project and project results, and include any developed evaluation tools as Attachment 10 (optional).

• ORGANIZATIONAL INFORMATION -- Corresponds to Section V’s Review

Criterion #5

In this section, provide an organizational description and project organizational chart, an outline of the management and staffing plan, and an outline of key collaborators and partners. Each element is described in more detail below. Include as Attachment 8 a list of experience with global health grants, cooperative agreements, and/or contracts, source of funding including the name of project director/principal investigator; institution holding the award; grant, cooperative agreement, or contract number; total amount of award; and end date. This may present well in table form.

You must also include as Attachment 9, up to three past performance references (required). Consortium partners may provide up to three past performance references from the last three years for contracts, grants and/or cooperative agreements of similar size, scope, and complexity.

Project Structure and Project Organizational Chart

Provide your current mission and structure, scope of current activities, and history of developing and promoting health system strengthening activities.

You must demonstrate at least three years of experience successfully implementing health programs in the international setting.

Describe previous projects that reflect the expertise of proposed personnel in working collaboratively with Ministerial, education institutions, regulatory bodies, health management teams, civil society organizations, other USG-funded programs, and stakeholders.

Describe the proposed organizational structure of the international consortium, and the plans for administering, managing, tracking, and coordinating its activities.

Describe the consortium’s implementing and technical partners’ prior experience and performance with USG grants. Describe the necessary processes and systems in place to comply with the requirements identified at 45 CFR Part 75.

Describe the estimated percentage of your total organizational budget that funding from this cooperative agreement would comprise.

Provide a project organizational chart as Attachment 5. The organizational chart should be a one-page figure that depicts the organizational structure of your consortium, including impact and technical partners, as well as any collaborating entities, and lines of authority for staff.

Note: If the application includes sub-agreements, describe separately your organization’s experience with establishing and administering sub-agreements.

Management and Staffing Plan https://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75&rgn=div5

HRSA-21-096 14

Include as Attachment 2 the Staffing Plan and Job Descriptions for Key Personnel.

Provide a staffing plan including key personnel and core technical staff, inclusive of a management plan for project implementation. Indicate and justify the FTE proposed for each. Demonstrate responsibilities and lines of authority. The management plan must describe how the project will relate to and respond to HRSA and to in-country USG. You must describe capacity for rapid start-up of the project, including plans for rapidly accessing and deploying key personnel and essential technical staff to support program implementation.

The staffing plan must also indicate staff who are already employed by the organization and the level of effort.

Include biographical sketches, not to exceed two pages in length, for only key personnel on the project as Attachment 3. Include a description of the staff experience; knowledge of PEPFAR priorities, and PEPFAR-supported LMICs. If a biographical sketch for an individual not yet hired is included, you must attach a letter of commitment signed by the individual. Describe the qualifications of the Project Director (by training and experience) that demonstrate their ability to lead a project of similar size and scope. Include a description of publications and funded research in the specialty with appropriate academic preparation, clinical expertise, and experience as an educator.

Key personnel, at a minimum, should include:

• Principal Investigator (PI) should possess a clinical/healthcare background degree.

• A Program Director (PD) with fiscal and programmatic authority for the management of the program who will be the contact person for OGH staff.

The Program Director should have experience in project management, working with federal grants and cooperative agreements, and have the skills and requirements addressed under the Organization Information in Section IV. 2. This position must be responsible for the administration of the cooperative agreement, and 1) provides vision, 2) directs the strategic planning, operations, and capacity, 3) has the technical expertise in quality improvement, 4) supervises key tasks and staff, 5) clearly delineates staff responsibilities and roles, 6) creates the work plan and timelines, and 7) oversees program management.

• A program evaluator with impact evaluation expertise.

Describe your and your consortium partners’ resources, and capabilities to support the provision of culturally and linguistically competent training and capacity development services. See the USG National Standards for Culturally and Linguistically Appropriate Services.

Key Collaborators and Partners (Letters of Support) Describe how you will collaborate with key stakeholders. Describe how you will https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53 https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53

HRSA-21-096 15

liaise and coordinate with the partner government(s) as well as with other district and local government partners, USG partners and other stakeholders working across PEPFAR program areas. If you plan to collaborate with other organizations or government agencies for the implementation of the proposed activities, outline the services each such agency or organization will provide. State whether you have any existing relationships with the proposed partner(s) and, if so, include the MOUs in Attachment 4.

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. Any attachments referenced in a narrative section may be considered during the objective review.

Narrative Section Review Criteria

Introduction (1) Need

Needs Assessment (1) Need

Methodology (2) Response

Work Plan (2) Response and (4) Impact

Resolution of Challenges (2) Response

Evaluation and Technical Support Capacity

(3) Evaluative Measures and

(5) Resources/Capabilities

Organizational Information (5) Resources/Capabilities

Budget and Budget Narrative (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.

HRSA-21-096 16

In addition, the QISSEC program requires the following:

• Provide a program-specific line item budget for each year of the five-year period of performance using the object class categories in the SF-424A. List personnel separately by position title and the name of the individual for each position title, or note if position is vacant. The line item budget for each of the five years is uploaded as an attachment to the application as Attachment 6.

The budget allocations on the line item must relate to the activities proposed in the project narrative, including the work plan. The line item budget requested for each year must not exceed the total funding ceiling amount. In addition, the amounts requested on the SF-424A and the amounts listed on the line item budget must match.

• Indirect costs on grants awarded to foreign organizations and performed outside of the territorial limits of the United States may be paid to support the costs of compliance with federal requirements at a fixed rate of eight (8) percent of modified total direct costs exclusive of tuition and related fees,…