Regenstrief COVID-19 NOFO FINAL.pdf

U.S. Department of Health and Human Services

Office of the National Coordinator for Health Information Technology

Notice of Funding Opportunity Accelerating and Expanding LOINC® Development to Support

Public Health Needs

Application Due Date: 09/11/2020

Anticipated Award Date: 09/30/2020

Table of Contents

Executive Summary

A. Program Description/Purpose Structure and Approach Roles and Responsibilities under a Cooperative Agreement Performance Goals/Program Milestones

B. Funding Opportunity Award Information Key Award Parameters Key Dates Roles and Responsibilities Under a Cooperative Agreement

C. Eligibility Information

D. Application and Submission Information Application Package Application Submission Instructions Restrictions on Oral Conversations

E. Application Review Information Screening Review Merit Review Pre-Award Risk Assessment

F. Federal Award Administration Information Award Decisions Notice of Grant Award Terms and Conditions

G. Points of Contact

Appendix A – Tips for Writing a Strong Application Appendix B – Instructions – SF-424 Application for Federal Assistance Appendix C - Instructions – SF-424A, Budget Information for Non-Construction Programs Appendix D – Budget Narrative/Justification Template Appendix E – Letter of Commitment Template

Executive Summary

Logical Observations Identifiers Names and Codes (LOINC®)1 is an open source, universal code system for identifying laboratory and clinical observations produced and copyrighted by the Regenstrief Institute (Regenstrief). LOINC® is used in conjunction with many other standards published by standards development organizations (SDOs), such as Health Level 7 International (HL7®)2, Integrating the Healthcare Enterprise (IHE)3, SNOMED International (SNOMED®)4, and Radiological Society of North America (RSNA®)5. LOINC® provides for semantic interoperability and has been identified by HL7® as the preferred code set for laboratory test names in transactions between health care facilities, laboratories, laboratory testing devices, and public health authorities. LOINC® has also been adopted by the U.S. Department of Health and Human Services (HHS) and incorporated by reference as part of the Office of the National Coordinator for Health Information Technology (ONC)’s 2015 Edition certification criteria6 (see 45 CFR 170.299(o)). LOINC® is also referenced in the annual ONC Interoperability Standards Advisory (ISA)7.

The LOINC® team at Regenstrief maintains the LOINC® database and supporting documentation, processes submissions and edits to the content, develops and curates accessory content (descriptions, hierarchies, other attributes, etc.), develops the Regenstrief LOINC® Mapping Assistant (RELMA®) mapping program (a software that helps users map their local terms or lab tests to universal LOINC® codes), and coordinates LOINC® releases. In addition, Regenstrief continues to cultivate and support the LOINC® community worldwide by increasing and updating the standardized list of LOINC® codes available for the most commonly ordered laboratory tests in ambulatory care settings, the Universal Common Order Codes Value Set (Common Lab Orders).

Laboratories play an essential role in the ability to test and diagnosis patients for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus, using LOINC® codes in the in vitro diagnostics (IVD) SARS-CoV-2 test kits that identify the presence of the SARS-CoV-2 virus (the virus, in the Coronavirus disease 2019 [COVID-19]) in patients suspected of having COVID-19. Since the beginning of the COVID-19 outbreak8, Regenstrief, as the sole owners and stewards of LOINC®, has experienced an overwhelming increase in requests for LOINC® codes to support the lab test kits being used to test and identify patients experiencing symptoms of the virus. As of May 22, 2020, Regenstrief has developed 1,073 new LOINC® “Special Use” codes, codes that are developing in response to an urgent or emergent situation, resulting in substantial resource constraints and need to divert staff from other priorities

The purpose of this Notice of Funding Opportunity (NOFO) is to provide time sensitive additional support to increase the development and pre-release of LOINC® Special Use codes9, and updating of their technical infrastructure in order to support the search ability and rapid dissemination of the codes to IVD manufacturers, laboratories, and other entities both nationally and internationally. This funding opportunity is in the form of a cooperative agreement and is for the purposes of accelerating and expanding LOINC® development to support public health needs as authorized under the Coronavirus Aid, Relief, and Economic Security (CARES) Act (CARES Act) (Pub. L. No. 116-136, March 27, 2020), as well as Section 3011 of the Public Service Health Act (PHSA) Through this funding

1 https://loinc.org/ 2 http://www.hl7.org/index.cfm 3 https://www.ihe.net/ 4 http://www.snomed.org/ 5 https://www.rsna.org/ 6 https://www.healthit.gov/topic/certification-ehrs/2015-edition 7 https://www.healthit.gov/isa/ 8 https://www.who.int/emergencies/diseases/novel-coronavirus-2019 9 https://loinc.org/prerelease/ https://loinc.org/ http://www.hl7.org/index.cfm https://www.ihe.net/ http://www.snomed.org/ https://www.rsna.org/ https://www.healthit.gov/topic/certification-ehrs/2015-edition https://www.healthit.gov/isa/ https://www.who.int/emergencies/diseases/novel-coronavirus-2019 https://loinc.org/prerelease/ opportunity, ONC will award a sole source cooperative agreement in support of the rapid development of LOINC® Special Use codes and the deployment of corresponding technical and educational resources to ensure all affected stakeholders can adequately respond to the COVID-19 pandemic.

Under this sole source cooperative agreement, Regenstrief should work collaboratively with ONC to develop LOINC® codes in coordination with other federal agencies such as the Centers for Disease Control and Prevention (CDC)10, and the Food and Drug Administration (FDA)11, infrastructure upgrades that provide mapping services and corresponding technical support, such as drafting and publishing of content for its partners, external stakeholders, and end users. Regenstrief should collaborate with ONC to ensure efforts align with recommendations made by HHS specific to COVID- 19, and also support expansion of interoperability objectives such as those define in the 21st Century Cures Act (Cures Act) Final Rule.12

The expected outcomes of this cooperative agreement are to 1) support the rapid development of SARS- CoV-2 LOINC® codes and associated mapping services; 2) upgrade technical infrastructure necessary to support IVD manufacturers, laboratories, and other entities in testing efforts; and 3) to standardize the terminology for test order and lab results. Combined, we anticipate these efforts will streamline communication and processes, provide timely support to the LOINC® community, and reduce the number of unnecessary lab orders and erroneous results delivery that is currently being reported.

10 https://www.cdc.gov/ 11 https://www.fda.gov/ 12 https://www.federalregister.gov/documents/2020/05/01/2020-07419/21st-century-cures-act-interoperability-information-blocking-and-the-onc-health-it-certification https://www.cdc.gov/ https://www.fda.gov/ https://www.federalregister.gov/documents/2020/05/01/2020-07419/21st-century-cures-act-interoperability-information-blocking-and-the-onc-health-it-certification https://www.federalregister.gov/documents/2020/05/01/2020-07419/21st-century-cures-act-interoperability-information-blocking-and-the-onc-health-it-certification

A. Program Description/Purpose

In 2018, ONC issued a sole source cooperative agreement, “Enhancing the Logical Observation Identifiers Names and Codes (LOINC®) Standard to Support U.S. Interoperability,” with the Regenstrief Institute (Regenstrief). The goal of this cooperative agreement was to upgrade their underlying technical infrastructure in order to update existing, and develop new LOINC® codes to advance interoperable health IT, and position LOINC® to support the continued evolution of the U.S.

Core Data for Interoperability (USCDI)13.

Through this cooperative agreement, Regenstrief has been able to update their servers; convert, test, and publically deploy their legacy Access-based Multiaxial Hierarchy process to a new set SQLServer stored procedure; upgrade and deploy LHC-Forms14 and LOINC® panel content15; deploy LOINC® Release versions 2.65 and 2.66; and develop tools to support the creation and management of Health Level 7 International’s (HL7®) Fast Healthcare Interoperability Resources (FHIR®) ValueSets16.

The outbreak of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus has increased the number of requests for new LOINC® codes, which are being released in real-time as “Special Use” codes; codes that are developing in response to an urgent or emergent situation. The rapid creation of Special Use codes supporting the coronavirus disease (COVID-19) pandemic has resulted in 1,073 new LOINC® codes as of May 22, 2020.

To objectives under this cooperative agreement award are:

1) To support the rapid development of SARS-CoV-2 LOINC® codes and associated mapping services;

2) Upgrade technical infrastructure necessary to support IVD manufacturers, laboratories, and other entities in testing efforts; and

3) Terminology standardization.

Structure and Approach

The recipient is encouraged objectives to submit a plan to ONC that outlines the methodological approach it intends to take to meet the purpose of the cooperative agreement and collaborate with ONC when developing this plan.

The plan and methodological approach may include, but are not limited to, the following components:

• Term Creation and Mapping Services for SARS-CoV-2 Testing and Other Public Health Needs;

• Technical Infrastructure Upgrades to Support SARS-CoV-2 and Other Public Health Content and Interoperability Development; and

• Standardization of terminology to reduce errors and the need for unnecessary tests, both which help to decrease costs within health care.

Roles and Responsibilities Under a Cooperative Agreement

13 https://www.healthit.gov/isa/united-states-core-data-interoperability-uscdi 14 https://loinc.org/lhc-forms/ 15 https://loinc.org/panels-and-forms/ 16 https://loinc.org/fhir/ https://www.healthit.gov/isa/united-states-core-data-interoperability-uscdi https://loinc.org/lhc-forms/ https://loinc.org/panels-and-forms/ https://loinc.org/fhir/

The funding instrument used for this program will be the cooperative agreement, an assistance mechanism in which substantial ONC programmatic involvement is anticipated during the project period-of-performance. Under the cooperative agreement, the ONC purpose is to support and stimulate the recipient’s activities by involvement in, and otherwise working jointly with, the recipient in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities.

Consistent with this premise, the dominant role and prime responsibility resides with the recipient for the project as a whole. To facilitate appropriate involvement, during the cooperative agreement period-of-performance, ONC and the recipient will be in contact monthly, at minimum, and more frequently when appropriate.

Specific activities may be shared between the recipient and ONC include, but are not limited to:

♦ Providing substantive input and policy direction as appropriate, and collaborate with the recipient to identify and prioritize the types and numbers of underlying technical infrastructure upgrades needed, as well as the timeline in which these upgrades must be completed

♦ Working with the recipient to set the priorities and implementation direction that will be detailed in the Project Implementation Plan and all other deliverables submitted to meet the goals of the project (identified in Deliverable Table)

♦ Providing tactical guidance and feedback during project execution

♦Collaborate with the recipient and other federal agencies to ensure programmatic and policy alignment, awareness, and use of SARS-CoV-2 test orders and results.

♦Collaborate with the recipient to identify and prioritize the types and numbers of underlying technical infrastructure upgrades needed, as well as the timeline by which these upgrades must be completed.

♦Provide substantive input in the development of the terminology standardization pilot projects, including pilot partners and pilot sites.

♦Conduct, on an annual basis reassessments of the state of public health needs, and in collaboration, update the Project Implementation Plan and any other related activities and priorities. The Project Implementation Plan and any other related activities and priorities may also be reassessed and adjusted at any time if deemed necessary by ONC and/or the recipient.

♦ Participating in the selection of key personnel, as deemed necessary.

♦ Releasing funds based on achievement of performance goals/project milestones.

♦ Agency review and approval of substantive provisions of proposed sub-awards or contracts.

♦ Agency review, assessment, and final approval of priorities and deliverables as identified by the recipient.

♦ Engaging with leadership of the recipient’s organization to ensure successful execution of the cooperative agreement.

♦ Ending an activity if performance specifications are not met.

Performance Goals/Program Milestones ONC will measure the success of the projects through applicant reporting of progress on milestones and metrics and how well they advance one of both of the following ONC objectives: advancing the development and use of health IT capabilities, and establishing transparent expectations for data sharing.

The applicant will develop an audit-appropriate process for validating milestone achievement and a measurement process and tools for recording metrics. Applicants must provide baseline measurements and propose performance metrics to demonstrate successful support for the rapid development of Special Use LOINC® codes for SARS-CoV-2. For each milestone and metric, ONC will work with the applicant to determine the appropriate targets and reporting requirements.

The performance goals/program milestones associated with each are of interest in this NOFO, and ensuing award, are as follows:

Objective 1: Prioritize Term Creation and Mapping Services for SARS-CoV-2 Testing and Other Public Health Needs The recipient is able to respond to incoming requests for SARS-CoV-2-related LOINC® codes for test kits and rapidly deploy Special Use codes as they complete development, in addition to mapping services for In Vitro Diagnostics (IVD) manufacturers, laboratories, and other entities with limited impact to the development of non-SARS-CoV-2-related LOINC® codes.

Objective 2: Technical Infrastructure Upgrades to Support SARS-CoV-2 and Other Public Health Content and Interoperability Development The recipient, deploys technical infrastructure improvements that support the new SARS-CoV- 2/COVID-19 related content development, and improve the availability of other public health resources for future interoperability needs.

Objective 3: Terminology Standardization The recipient increases the implementation and use of standardized terminology for SARS-CoV- 2/COVID-19 test ordering and results delivery naming.

Performance Goals shall be tracked and measured by the recipient in order to assess overall programmatic results over the entirety of the cooperative agreement’s period-of-performance and the project’s impact in supporting their response to SARS-CoV-2/COVID-19 and the advancement of public health needs across the health care continuum. Specific objectives, approach, measurement metrics, performance targets, and data source shall be proposed by the recipient within 4-weeks of award date, for discussion with and for approval by ONC. A sample table for measuring progress of specific objective is given below for reference.

Objectives and Goal(s) What are we trying to achieve with this project?

Approach How do we plan to achieve this goal?

Metric/Measure How can we demonstrate that we have achieved the stated goal?

Type of Measure Input, Output, Outcome

Performance Target What is the performance target for the measure and by the end of the 5-year period of performance?

Data Source How will you capture data to measure performance?

New SARS-CoV-2 LOINC Codes

Objectives and Goal(s) What are we trying to achieve with this project?

Approach How do we plan to achieve this goal?

Metric/Measure How can we demonstrate that we have achieved the stated goal?

Type of Measure Input, Output, Outcome

Performance Target What is the performance target for the measure and by the end of the 5-year period of performance?

Data Source How will you capture data to measure performance?

Adoption Level

Stakeholder/SDO Outreach and Engagement

Sample Measurement Table:

New SARS-CoV-2 LOINC Codes Y1 Q1 Actual Y1 Q2 Actual Y1 Q3 Actual Y1 Q4 Actual

Year 1

Baseline - - - -

Q1 Target - - -

Q2 Target - -

Q3 Target -

Q4 Target

B. Funding Opportunity Award Information

Key Award Parameters

Title: Accelerating and Expanding LOINC® Development to Support Interoperable Public Health Reporting

Federal Funding Agency: Department of Health and Human Services Office of the National Coordinator for Health Information Technology

Announcement Type: Cooperative Agreement

Application Type: New

Funding Opportunity Number: COVID-C3-20-004

Catalog of Federal Domestic Assistance (CFDA) Number: 93.346

Eligible Applicants: This is a non-competitive funding opportunity and is restricted to the organization designated below. Organizations not designated as such are not eligible to apply for this opportunity, and therefore should not submit an application. Applications submitted by organizations not designated below will not be considered.

Designated Organization: Regenstrief Institute

1. Sole Source Justification

Regenstrief Institute (Regenstrief) is a non-profit medical research organization, associated with Indiana University, and is the exclusive standards development organization (SDO) with the ability, authority, and intellectual property rights to develop and maintain the Logical Observation Identifiers Names and Codes (LOINC®), an open source common terminology for laboratory and clinical observations. As a result, Regenstrief is the only organization that can successfully deliver the goals articulated in this funding opportunity. Moreover, Regenstrief members include organizations that are actively engaged in implementing LOINC® codes in health IT systems and standards, and hence can provide necessary feedback in timely manner through a well-established process for consensus standards development. As the field of medicine continues to evolve, there is an ongoing need for Regenstrief to provide new codes in a timely manner. The goals and expected outcomes of this funding opportunity can only be achieved accurately and in a timely manner by Regenstrief, given its authoritative role as the steward for LOINC®. Thus, Regenstrief’s involvement is both fundamental and always necessary to publish an update to LOINC® codes and associated LOINC® infrastructure components. As such, this funding opportunity announcement seeks to establish a formal collaboration with Regenstrief through a sole source cooperative agreement in order to accelerate the development of new LOINC® codes to support SARS-CoV-2 testing, including code development, mapping services, and technical infrastructure upgrades. This project would assist to coordinate with the health care industry to rapidly respond to incoming SARS-CoV-2/COVID-19 related requests, standardize terminology, and improve and advance the technical standards and specifications required for public health interoperability. Working directly with Regenstrief will enable this coordination to be more effective and efficient and will enable broad industry consensus to be more rapidly achieved when done through Regenstrief’s processes.

This NOFO is a new, sole source, 5-year cooperative agreement for a maximum award of $1,500,000.

(Funding Opportunity Number COVID-C3-20-004; Catalog of Federal Domestic Assistance Number 93.346). The eligible applicant must submit an application by 93.346. Subsequent years of funding for this cooperative agreement is contingent on meaningful progress and availability of funds.

HHS grants policy requires that the grant recipient perform a substantive role in the conduct of the planned project or program activity and not merely serve as a conduit of funds to another party or parties. If consortium/contractual activities represent a significant portion of the overall project, the applicant must justify why the applicant organization, rather than the party(s) performing this portion of the overall project, should be the grantee and what substantive role the applicant organization will play.

An incomplete and/or non-responsive application not following instructions given in this NOFO will not be reviewed. Only the review criteria described below will be considered in the review process.

Legislative Authority: Coronavirus Aid, Relief, and Economic Security (CARES) Act (CARES Act)

(Pub. L. No. 116-136, March 27, 2020), as well as Section 3011 of the Public Health Service Act (PHSA)

Approximate Amount of Available Funding (inclusive of direct and indirect costs) : $1,500,000.00

Anticipated Number of Awards: 1

Approximately Amount of Each Award: $1,500,000

Project Period: TBD

Budget Period(s): TBD

Funding of future non-competing continuation awards is conditioned on the availability of funds, satisfactory progress by the recipient, and an awarding office determination that continued funding of the award is in the best interests of the Government.

Cost-Sharing Requirements: There are no cost sharing requirements associated with this award.

Program Income: There are four potential ways in which ONC may require that a recipient apply program income as specified in the Notice of Grant Award (NGA): 1) deduct it from total allowable project/program costs to determine the net allowable costs on which the Federal share of costs is based;

2) add it to funds otherwise available for the project, generally resulting in an increase to the total approved budget; 3) use it to meet a matching or cost sharing requirement; or 4) a combination of these alternatives.

Costs paid by program income generally are subject to the applicable cost principles and other Federal requirements and must be disbursed for project purposes before requesting additional payments of Federal funds. In the event program income remains at the end of the award, the additional income is considered part of the award funding and must be returned to ONC.

Intergovernmental Review This program is excluded from Executive Order 12372

Key Dates

Milestone Date NOFO Released

08/12/2020

Applications Due

09/11/2020

Anticipated Award Date

09/30/2020

Anticipated Project Start Date

09/30/2020

Roles and Responsibilities Under a Cooperative Agreement The funding instrument used for this program will be the cooperative agreement, an assistance mechanism in which substantial ONC programmatic involvement is anticipated during the project period-of-performance. Under the cooperative agreement, the ONC purpose is to support and stimulate Regenstrief’s activities by involvement in, and otherwise working jointly with, Regenstrief in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities.

Consistent with this premise, the dominant role and prime responsibility resides with Regenstrief for the project as a whole. To facilitate appropriate involvement, during the cooperative agreement period-of-performance, ONC and Regenstrief will be in contact monthly, at minimum, and more frequently when appropriate.

Specific activities may be shared between Regenstrief and ONC include, but are not limited to:

♦ Providing substantive input and policy direction as appropriate, and collaborate with Regenstrief to identify and prioritize the types and numbers of underlying technical infrastructure upgrades needed, as well as the timeline in which these upgrades must be completed

♦ Working with Regenstrief to set the priorities and implementation direction that will be detailed in the Project Implementation Plan and all other deliverables submitted to meet the goals of the project (identified in Deliverable Table)

♦ Providing tactical guidance and feedback during project execution

♦Collaborate with Regenstrief and other federal agencies to ensure programmatic and policy alignment, awareness, and use of SARS-CoV-2 test orders and results.

♦Collaborate with Regenstrief to identify and prioritize the types and numbers of underlying technical infrastructure upgrades needed, as well as the timeline by which these upgrades must be completed.

♦Provide substantive input in the development of the terminology standardization pilot projects, including pilot partners and pilot sites.

♦Conduct, on an annual basis reassessments of the state of public health needs, and in collaboration, update the Project Implementation Plan and any other related activities and priorities. The Project Implementation Plan and any other related activities and priorities may also be reassessed and adjusted at any time if deemed necessary by ONC and/or Regenstrief.

♦ Participating in the selection of key personnel, as deemed necessary.

♦ Releasing funds based on achievement of performance goals/project milestones.

♦ Agency review and approval of substantive provisions of proposed subawards or contracts.

♦ Agency review, assessment, and final approval of priorities and deliverables as identified by Regenstrief.

♦ Engaging with leadership of the recipient’s organization to ensure successful execution of the cooperative agreement.

♦ Ending an activity if performance specifications are not met.

Informational Session An Informational Session will not be conducted.

Letter of Intent A notice of intent is not required for this award.

C. Eligibility Information

See Section B, Funding Opportunity Award Information, for eligibility, cost-sharing, and other key award information.

D. Application and Submission Information

Application Package The following documents comprise, as applicable, the application package. Additional information regarding each of these documents is further provided.

• Project Abstract

• Project Narrative

• Form SF-424, Application for Federal Assistance

• Form SF-424A, Budget Information for Non-Construction Programs

• Form SF-424B, Assurances for Non-Construction Programs

• Form SF-LLL, Disclosure of Lobbying Activities

• Budget Narrative

• Letters of Commitment

• Proof of Non-Profit Status (if applicable)

• Indirect Cost Agreement(s) – including recipient, sub-recipient, and contractors agreements (if applicable)

Appendix A, Tips for Writing a Strong Application, can be used as a resource.

The Project Narrative and Budget Narrative sections of the application must be double-spaced, on 8-1/2” X 11” plain white paper with 1” margins on all sides, and use either Cambria or Times New Roman font size of not less than 11 point. Smaller font sizes may be used to fill in the Standard Forms, exhibits, and figures, though all text in forms, exhibits, and figures must not be smaller than 8 point font.

Project Abstract Applicants shall include a one-page abstract that is no more than 500 words. This abstract is often distributed to the public and Congress and represents a high-level summary of the project. As a result, applicant should prepare a clear, accurate, concise abstract that can be understood without reference to other parts of the application and that provides a description of the proposed project, including: the project’s goal(s), objectives, overall approach, anticipated outcomes, products, and duration.

The applicant shall place the following information at the top of the Project Abstract (this information is not included in the 500 word maximum):

• Project Title

• Applicant Name

• Physical Address

• Contact Name

• Contact Phone Numbers (Voice, Fax)

• E-Mail Address

• Web Site Address, if applicable

Project Narrative The project narrative provides is the most substantive information regarding the proposed project in a clear and concise manner. To that end, the project narrative should address the elements articulated in the Program Description/Purpose and Structure and Approach sections of this NOFO. The project narrative should also align with the Performance Goals/Program Milestones and Merit Review Evaluation criteria presented in this NOFO (e.g. organizational experience, past performance etc.).

The Project Narrative must be double-spaced, formatted to 8 ½” x 11” (letter-size) pages, 1” or larger margins on all sides, and a font size of not less than 11 point. The maximum length allowed for the Project Narrative is 30 pages. A Project Narrative that exceeds the 30 page limit will not be accepted.

Resumes of Key Personnel, if requested, are not counted as part of the Project Narrative and are not included in the 30 page limit.

Your project narrative should include the following components. These components will be counted as part of the page limit. The suggested lengths of the sections, given below, are guidelines to help applicants create a balanced document, and not mandatory restrictions.

1. Understanding the Requirements (20 Points)

2. Proposed Approach (40 Points)

3. Project Team and Staffing Qualifications (15 Points)

4. Project Management (15 Points)

5. Reasonableness of the Budget Narrative (10 Points)

The applicant demonstrates knowledge and understanding of the need to rapidly deploy a dedicated team focused on SARS-CoV-2 LOINC® requests, upgrade their underlying technical infrastructure to successfully support the codes and support services to LOINC® implementers, and the need for standardized terminology for test ordering and results naming. (2-3 pages)

The applicant provides guidance that specifies solutions to overcome currently known gaps both in their underlying technical infrastructure and in LOINC® codes and other support services as detailed above in this NOFO, and their proposed strategy to efficiently and effectively implement these solutions. The applicant’s approach is succinct and logical in format and demonstrates methods consistent with the activities to be accomplished. The applicant must propose a clear and detailed actionable plan which includes specific list of activities to achieve the objectives and deliverables specified in the NOFO. (10-18 Pages)

3. Project Team and Staffing Qualifications (15 Points)

The applicant must demonstrate and provide evidence of the following:

a. Experience for identifying, assessing, determining and implementing improvements necessary to effectively and efficiently upgrade their underlying technical infrastructure.

b. Experienced and knowledgeable technical experts to develop new and/or update existing

LOINC® codes.

c. Knowledgeable about HL7® FHIR® and the standards development process, as well as the ability to successfully engage with SDOs and other industry stakeholders for purposes of advancing interoperable health IT using LOINC®.

d. Experienced and knowledgeable technical experts to develop new and/or update existing FHIR-based terminology services.

e. The ability to successfully manage projects of similar size, on time, and within the proposed budget.

All evidence of their past work must be provided in the personnel resumes in the appendix of the applicant’s proposal. (2-3 Pages)

This section should include a clear delineation of the roles and responsibilities of the principal investigator (PI), project staff, and collaborating organizations, and how they will contribute to achieving the research objectives and outcomes. If the application includes sub-awards recipients with contractual relationships, plans for coordinating these activities across multiple organizations should be described. This section should specify who would have day-to-day responsibility for key activities such as: leadership of project; monitoring the project’s on-going progress, preparation of reports; communications with other collaborating organizations, and ONC. Recipients will be required to maintain information relevant to achieving proposed milestones and performance-based outcomes. The application should describe the approach that will be used to assess project performance and monitor and track progress toward meeting key milestones. The application should include a detailed project timeline that incorporates those milestones. The project timeline will not count towards the narrative page limit. It should also include an organizational chart that reflects roles and responsibilities. The organizational chart will not count towards the narrative page limit. (2-3 Pages)

The applicant must provide a detailed breakdown on how they plan to spend the allotted resources to complete the activities detailed in the NOFO. (2-3 Pages)

Appendices

Applicants may submit no more than 30 pages of appendix material. Appendix material should be used to provide additional materials (for example, key papers or reports or excerpts) that will be of assistance in evaluating the merit of the application. Do not use the Appendix to circumvent the page limitations of the Project Narrative component. Applications that use appendix material as a mechanism to exceed the page length limitations of the project narrative will not be considered for award.

Form SF-424, Application for Federal Assistance Appendix B provides line-by-line instructions to complete the form. Please note that the SF-424 is used for a wide variety of Federal grant programs, and Federal agencies have the discretion to require some or all of the information on these forms. Accordingly, when completing the form, please use the instructions in Appendix B in lieu of the standard instructions attached to SF-424.

Form SF-424A, Budget Information for Non-Construction Programs Appendix C provides line-by-line instructions to complete the form. Please note that the SF-424A is used for a wide variety of Federal grant programs, and Federal agencies have the discretion to require some or all of the information on these forms. Accordingly, when completing the form, please use the instructions in Appendix C in lieu of the standard instructions attached to SF-424A. All direct and indirect costs must be allowable, allocable, reasonable and necessary.

Form SF-424B, Assurances for Non-Construction Programs This form contains laws and other assurances applicants must comply with under the discretionary funds programs administered by the Office of the National Coordinator for Health Information Technology.

Please note that a duly authorized representative of the applicant organization must certify that the organization is in compliance with these assurances.

Form SF-LLL, Disclosure of Lobbying Activities This form contains the name and address of lobbying registrants. Please note that a duly authorized representative of the applicant organization must sign the disclosure form. Failure to complete and sign the form may result in civil penalties ranging from $10,000 to $100,000.

Budget Narrative The budget narrative describes how the proposed budget, as articulated in the SF-424A, aligns with the applicant’s project narrative. That is to ensure that costs are realistic (not artificially too low) and reasonable (not inflated) in view of programmatic requirements. Appendix D provides a template to complete the budget narrative populated with sample information.

When more than 33% of a project’s total budget falls under a contractual expense, a detailed budget narrative/justification must be provided for each sub-contractor or sub-recipient. Applicants requesting funding for multi-year grant programs are required to provide a combined multi-year budget narrative/justification, as well as a detailed budget narrative/justification for each year of potential grant funding. A separate budget narrative/justification is also required for each potential year of grant funding requested.

The full Budget Narrative/Justification should be included in the application immediately following the SF 424 forms. The Budget Narrative must be double-spaced, formatted to 8 ½” x 11” (letter-size) pages, 1” or larger margins on all sides, and a font size of not less than 11 point.

Letters of Commitment (If Applicable) Include letters of commitment confirming the support to the project (should it be funded) made by key collaborating organizations and agencies. Any organization that is specifically named to have a significant coordination role in carrying out the project should be considered an essential collaborator such as interstate, intrastate, and regional partners. At a minimum, the letter must explain the demonstrated commitment to the project and how they will advance coordination and collaboration among critical stakeholders. See Appendix E for an example letter of commitment.

Applicants will also provide a letter of commitment from entities that will be responsible for generating reports based on transactional data (e.g. health information service providers, technology vendors, or others). These entities should have the capacity and resources to produce required reports on adoption and use in a timely manner. See Appendix E for an example letter of commitment.

These letters should not be considered as part of the page limit. Signed letters of commitment should be scanned and included as attachments.

Proof of Non-Profit Status Non-profit applicants must submit proof of non-profit status. Any of the following constitutes acceptable proof of such status:

• A copy of a currently valid IRS tax exemption certificate.

• A statement from a state taxing body, state attorney general, or other appropriate state official certifying that the applicant organization has a non-profit status and that none of the net earnings accrue to any private shareholders or individuals.

• A certified copy of the organization’s certificate of incorporation or similar document that clearly establishes non-profit status.

Indirect Cost Agreement(s) Applicants that have included indirect costs in their budgets must include a copy of the current indirect cost rate agreement approved by the Department of Health and Human Services or another federal agency. This is optional for applicants that have not included indirect costs in their budgets. Further, if any sub-contractors or sub-recipients are requesting indirect costs, copies of their indirect cost agreements must also be included with the application.

Application Submission Instructions

1) You must access the electronic application for this program via http://www.grants.gov. You can search the downloadable application page by the Notice of Funding Opportunity Number COVID-C3- 20-004 or CFDA number 93.346

2) Applicants will be able to download a copy of the application packet and complete it off-line. In order to complete the application, an organization must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number. A DUNS number can be obtained via http://fedgov.dnb.com/webform and typically takes 1 to 2 business days. Please plan accordingly.

3) Completed applications are uploaded into Grants.gov. APPLICATIONS WILL NOT BE

ACCEPTED THROUGH ANY OTHER WEBSITE, AND WILL NOT BE ACCEPTED THROUGH

PAPER MAIL, COURIER, OR DELIVERY SERVICE.

In order to upload applications into Grants.gov:

a) An applicant must be registered in the System for Award Management (SAM), at sam.gov, which requires having a DUNS number. The SAM registration process takes 7 to 10 business days so please plan accordingly. If you have already registered with SAM, but have not renewed your registration in the last 12 months, you will need to renew your registration.

The following website depicts the SAM registration process:

http://www.grants.gov/web/grants/applicants/organization-registration.html

b) An applicant must be registered in Grants.gov which can take several days. To that end, applicants are strongly encouraged to register and test Grants.gov logins and passwords well in advance of the application deadline date. For assistance with www.grants.gov, please contact them at support@Grants.gov or 1-800-518-4726. Resources are available 24 hours a day/7 days a week.

A depiction of the Grants.gov application process can be found at http://www.grants.gov/web/grants/applicants/apply-for-grants.html

4) After electronically submitting your application, www.grants.gov will generate an email a tracking number and date of receipt verification confirming that the application was received, the date and time the application was received, and a tracking number. This notification does not ensure that your application could be opened and read -- only that the application was received.

http://fedgov.dnb.com/webform http://www.grants.gov/web/grants/applicants/organization-registration.html http://www.grants.gov/web/grants/applicants/apply-for-grants.html http://www.grants.gov/

5)

The deadline for the submission of applications under this Funding Opportunity is 5:00 P.M. Eastern Standard Time on 09/11/2020. Applications that fail to meet the application deadline will not be reviewed and will receive no further consideration.

Restrictions on Oral Conversations

This funding announcement is subject to restrictions on oral conversations during the period of time commencing with the submission of a formal application by an individual or entity and ending with the award of the competitive funds. Federal officials may not participate in oral communications initiated by any person or entity concerning a pending application for a competitive grant or other competitive form of federal financial assistance, whether or not the initiating party is a federally registered lobbyist.

This restriction applies unless:

• The communication is purely logistical

• The communication is made at a widely attended gathering

• The communication is to or from a federal agency official and another federal Government employee

• The communication is to or from a federal agency official and an elected chief executive of a state, local, or tribal government, or to or from a federal agency official and the Presiding Officer or Majority Leader in each chamber of a state legislature

• The communication is initiated by the federal agency official

E. Application Review Information

Screening Review

Applicants that do not meet the following screening criteria will be eliminated and will not be sent forward for merit review:

• The applicant meets the eligibility criteria

• The application is received by the required deadline through http://www.grants.gov

• The application contains all required components (e.g. Project Abstract, Project Narrative, SF-424 etc.)

• The application meets the formatting and length requirements. The Project Narrative must not exceed 30 pages. The Project Abstract and biosketches do not count as part of the Project Narrative length limitation.

• Appendices and attachments are not used as a mechanism to exceed page limits of the Project Narrative http://www.grants.gov/

Merit Review

An independent review panel, of at least three individuals, will evaluate applications that meet the screening criteria identified above. These reviewers will be experts in their field from academic institutions, non-profit organizations, and local and Federal government agencies. Reviewers will review, evaluate, and score applications, in accordance with the criteria identified below:

Applications are scored by assigning a maximum of 100 points across five criteria:

3. Project Team and Staffing Qualifications (15 Points)

Understanding the Requirements (20 points)

• How well does the application understand the current challenges and address the purpose and objectives of this NOFO? To what extent is the proposed project parallel NOFO goals?

• The extent to which the applicant describe how the project and expected outcomes and results will inform the field and future health IT development, public health and emergency preparedness, and semantic interoperability.

Proposed Approach (40 Points)

• The extent to which the proposed approach will address the challenges on a proposed timeline within the parameters of a self-contained five-year project period-of-performance.

• The extent to which the proposed approach specifies solutions to known gaps, in a reasonable, efficient, and timely manner.

• The extent to which the proposed approach plans to engage industry stakeholders. Specifically:

o Reaching consensus on standardized terminology; and o Approach to pilot projects

• The extent to which the plan describes a project management approach for ensuring project success within and across collaborators

• Extent to which the proposed approach are specifically stated, adequately developed, well-integrated, well-reasoned, and appropriate to the goals/objectives of the project.

• The extent to which the applicant proposes a clear and detailed implementation plan with a specific list of activities and deliverables to achieve the objectives proposed.

Project Team and Staffing Qualifications (15 Points)

• Strength of evidence that the project brings an appropriate level of technical knowledge and expertise, for the project and strength of evidence that the project will integrate the efforts of those team members. Specifically:

• Are the PD/PI, collaborators, and other key project team members appropriately trained and well-suited to carry out this work?

• Do the PD/PI and project team bring complementary and integrated expertise to the project?

• Is there adequate PD/PI support allocated throughout the project period-of-performance?

• Does the application demonstrate the investigators’ aptitude to identify and address weaknesses encountered during the conduct of the project?

• Does the application demonstrate that the project team will have adequate administrative structure and processes in place to oversee the successful conduct of the proposed study?

• Did project team members describe and justify their proposed role and why their experience and qualifications make them well-suited for this role?

• Did team members for whom biographical sketches are not required, describe their proposed role and why their experience and qualifications make them well-suited for this role in the in the Budget Justification?

• Extent to which the proposed activities bring all the resources necessary to perform the proposed work and the identification of proposed strategies to complete activities within a five-year time frame?

Project Management (15 Points)

• The extent to which the applicant describes a sound project management approach that adequately tracks project activities, project budget, project reporting, milestones and deliverables, and project outcomes.

• The extent to which the applicants describes their approach to managing and tracking standardized terminology pilot projects.

Budget, Level of Effort, and Justification (20 points)

• Is the use of consultants and/or subrecipients, if applicable, appropriate and adequate to advance the project in accordance with the timelines?

• Extent to which the budget is justified with respect to the adequacy and reasonableness of resources requested, and the amount of the budget allocated to administration is minimized while still allowing coherent management of an integrated project.

Pre-Award Risk Assessment ONC is required to conduct a risk assessment to assess the risk posed by a potential recipient, prior to issuing an award. In doing so, ONC will take into account the applicant’s financial stability, quality of management systems, history of performance, reports and findings from audits, and the applicant’s ability to effectively implement statutory, regulatory, or other requirements imposed on non-Federal entities. To facilitate this assessment, ONC may review information available in systems, such as the Excluded Parties List System, review documentation, such as previous audits, and/or desk reviews or site visits conducted from previous awards. ONC may elect not to fund applicants with management or financial instability that directly relates to the organization’s ability to implement statutory, regulatory or other requirement s (45 CFR Part 75.205.)

F. Federal Award Administration Information

Award Decisions The final award decision will be made by the National Coordinator for Health Information Technology taking into consideration several factors such as the results of the merit review process, results of the pre-award risk assessment, compliance with programmatic and grants management requirements; the reasonableness of the estimated costs, available funding, geographical dispersion, program priorities;

and the likelihood that the proposed project will result in the benefits expected. All applicants will receive a summary of the objective review panel’s assessment of the application’s strengths, weaknesses, and score.

Notice of Grant Award Successful applicants will receive a letter of notification acknowledging that an award was funded, but does not provide authorization for the applicant to begin performance and expend funds associated with the award.

Following this notice, successful applicants will receive a Notice of Grant Award (NGA). The NGA will include, at a minimum, the following:

• Legal name and address of the organization or institutions to whom ONC has issued an award

• Award number assigned by ONC

• Project period, specifying the amount of time ONC intends to support the project without requiring re-competition for funds

• Total amount of financial assistance approved by ONC during the project period

• Budget period, specifying the increments in which the project will be funded, subject to the availability of funds

• Applicable award terms and conditions

• Performance goals, indicators, milestones, or expected outcomes (such as outputs, or services performed or public impacts of any of these) with an expected…