2023 LOINC NOFO_508.pdf

U.S. Department of Health and Human Services

Office of the National Coordinator for Health Information

Technology

Notice of Funding Opportunity Enhancing the Logical Observation Identifiers Names and Codes

(LOINC®) Standard to Support U.S. Interoperability

Application Due Date: July 05, 2023

Anticipated Award Date: August 08, 2023

Program Contact Anmer Ayala & Sara Armson Office of the National Coordinator 330 C Street SW Washington, D.C., 20201 ONC.Techlab@hhs.gov

Grants Contact Carmel Halloun Office of the National Coordinator 330 C Street SW Washington, D.C., 20201 ONCGrants@hhs.gov mailto:ONC.Techlab@hhs.gov mailto:ONCGrants@hhs.gov

Table of Contents

Executive Summary

A. Program Description/Purpose

Structure and Approach

B. Funding Opportunity Award Information

Key Award Parameters

Key Dates

Roles and Responsibilities Under a Cooperative Agreement

Informational Session

Notice of Intent

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 (with SAMPLE information)

Appendix E – Letter of Commitment Template

Executive Summary

As the nation continues to enhance its interoperability and with the increased expectations set forth by the 21st Century Cures Act of 2016 (Cures Act),1 there is an industry-wide need to ensure that health information can be used in an interoperable manner across the care continuum. The purpose of this Notice of Funding Opportunity (NOFO) is to: update existing and create new Logical Observation Identifiers Names and Codes (LOINC®) terminology standards to improve interoperability; upgrade the underlying technical infrastructure used by health information technology (health IT) implementers and users to more easily use LOINC; and to position the LOINC terminology standard to support the continued evolution of the U.S. Core Data for Interoperability2 (USCDI). This funding opportunity is in the form of a cooperative agreement and is for the development and advancement of interoperable health information technology, as authorized under the Consolidated Appropriations Act, 2023.3

LOINC 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®), Integrating the Healthcare Enterprise (IHE), SNOMED International, and Radiological Society of North America (RSNA®). LOINC provides for semantic interoperability and has been identified by HL7® as the preferred code system 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 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 criteria4 (see 45 CFR 170.299(p)). LOINC® is a required applicable standard for multiple USCDI data elements and is also referenced in the annual ONC Interoperability Standards Advisory (ISA).5

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 web-based search tool (SearchLOINC) and the Regenstrief LOINC Mapping Assistant (RELMA®) mapping program (a tool that help users map their local terms or lab tests to universal LOINC concepts), and coordinates LOINC releases. In addition, Regenstrief continues to cultivate and support the LOINC community worldwide by increasing and updating LOINC content.

ONC is charged under Section 3000 of the Public Health Service Act with the advancement of health information technology (IT) and promotion of nationwide health information exchange to improve health care. This funding opportunity seeks to enable semantic

1 https://www.congress.gov/114/plaws/publ255/PLAW-114publ255.pdf 2 https://www.healthit.gov/sites/default/files/draft-uscdi.pdf

3 https://www.congress.gov/117/bills/hr2617/BILLS-117hr2617enr.pdf 4 2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications Final Rule, 80 FR 62601 (Oct. 16, 2015) 5https://www.healthit.gov/isa/ https://www.congress.gov/114/plaws/publ255/PLAW-114publ255.pdf https://www.healthit.gov/sites/default/files/draft-uscdi.pdf https://www.healthit.gov/sites/default/files/draft-uscdi.pdf https://www.healthit.gov/isa/ interoperability for the exchange of health information through creation and curation of LOINC content, foster improvements to the public technical tooling that enables users to interact with and implement the LOINC code system, and position LOINC to support the continued evolution of the USCDI.

Under this sole source cooperative agreement, Regenstrief should work collaboratively with ONC to establish priorities, update underlying technical infrastructure, identify gaps in LOINC content and services, and accelerate Regenstrief’s ability to support the LOINC community by applying requested changes to existing content and increasing the number of LOINC concepts available for use.

A. Program Description/Purpose

Background Information

This funding opportunity is in the form of a cooperative agreement and is for the development and advancement of interoperable health IT as authorized under the Consolidated Appropriations Act, 2023.

The intended outcome is to allow EHR systems to recognize and aggregate health data from multiple organizations, enabling clinicians and consumers to access clinical data when and where they need it in a standardized manner.

When a computer system receives electronic health information from another system, it needs to be able to process the information without time-consuming human intervention. This can only occur if the sending system has used consistent data format and terminology that is known to – and expected by – the receiving system. Given the vast number of systems that exchange electronic health information, expecting each to negotiate agreed-upon exchange formats and terminology is impractical.

SDOs develop and maintain the technical standards and implementation specifications that provide implementation instructions to developers. Regenstrief is the exclusive standards development organization (SDO) with the ability, authority, and intellectual property rights to develop and maintain LOINC. Regenstrief’s LOINC team solely governs the processes by which the concepts and accompanying implementation guidance are issued and updated. Regenstrief maintains the LOINC website, which is the only authoritative source for public access to the latest versions of the LOINC standard. Regenstrief also provides a public terminology server to enable systems to access LOINC within technical workflows.

LOINC technical infrastructure, which supports the creation and curation of LOINC content, enables Regenstrief to respond to public feedback and publish new releases of LOINC twice per year.

It is ONC’s intent to broadly coordinate with the health IT industry to improve and advance the technical standards and specifications required for interoperability. As a result, this cooperative agreement with Regenstrief, given its authoritative role as the steward for LOINC, will advance interoperable health IT through development and enhancements of LOINC content and technical tools. Regenstrief can work closely with ONC to identify and prioritize these tasks.

This funding opportunity reflects ONC’s intention to work directly with Regenstrief to upgrade LOINC technical infrastructure, expedite improvements in accessing content, and bridge gaps between LOINC and HL7® FHIR®. Additionally, the cooperative agreement will advance the production deployment of FHIR Terminology Services for LOINC, support LOINC content developers as they develop new content that supports USCDI, and update tools maintained by Regenstrief for LOINC implementers, including SearchLOINC and RELMA. All the tools and content developed under the cooperative agreement must be publicly accessible.

https://fhir.loinc.org/

Structure and Approach

ONC has identified the following objectives for this cooperative agreement. The recipient must accomplish these objectives under the cooperative agreement. ONC has also identified a list of activities that the recipient can consider in order to meet the objectives.

Objective 1: Technical Infrastructure Updates to Support Expanding Health Information Exchange Needs

Because of advancements of technology, updates to regulations, and recognition of the benefit to health outcomes, the health information exchange ecosystem continues to grow and evolve. This objective is for the recipient to perform necessary software enhancements to existing tools and services maintained by Regenstrief to support LOINC terminology needs for the evolving health information exchange ecosystem and to responsively meet the needs of the interoperability community through user-friendly tools.

Regenstrief’s existing LOINC technical infrastructure should continue to evolve in order to support the community’s rapid adoption of new health IT standards including FHIR implementation guides and FHIR-based terminology services. Additionally, LOINC content grows in response to submissions from submitters, and the LOINC team facilitates the submission process with tooling built on the LOINC technical infrastructure. These LOINC submission tools should also continue to advance to provide a transparent and efficient process for LOINC content requests.

Objective 2: Developing LOINC® Content in Support of USCDI and Improving Content Use This objective is for the recipient to increase the use of the LOINC® standard in healthcare information exchange by expanding LOINC content for the USCDI data elements that have LOINC identified as the applicable vocabulary standardnd providing user-centric tools for users to interact with LOINC concepts.

As the owner and overall steward of the LOINC terminology standard, Regenstrief, via its LOINC team, maintains and provides the LOINC content and tools via a public website.6 Part of this objective is for Regenstrief to expand the number of existing LOINC concepts to support the interoperability needs of ONC certified health IT. ONC can provide Regenstrief input on the implementation plan and concepts that will be developed and updated to align with USCDI.

6 www.loinc.org http://www.loinc.org/

Activities that that the recipient can consider in order to achieve the objectives of the cooperative agreement.

• Environmental Scan Report Regenstrief could conduct an environmental scan to identify the needs and enhancements necessary to support the objectives above. The scan could include feedback from LOINC implementers and standards developers that use LOINC.

• Implementation Plan Regenstrief could prepare an implementation plan for how it will achieve the objectives of this cooperative agreement. An implementation plan could describe how project staff will meet the objectives and deliverables as described in this funding opportunity, including additional gaps or areas identified for improvement as determined by the environmental scan. An implementation plan could also include proposed tasks, deliverables, timelines, resources, risks and a risk mitigation strategy. An implementation plan could also address how LOINC content creation will continue to support new and updated data elements and data classes for new versions of USCDI.

• Technical Infrastructure Activities Regenstrief could consider the following activities to update technical infrastructure, consistent with Objective 1:

Implement LOINC technical tooling improvements to support rapid content development and publication.

Upgrade LOINC’s technical infrastructure to improve the ease of use for those requesting updates to existing LOINC terms and new LOINC concepts, including the ability to leverage application programming interfaces (APIs) such as FHIR, and upgrades to RELMA as needed, to meet the needs of the health IT community.

Continue to deploy and enhance FHIR-based terminology services to align with FHIR Release 4 and Release 5.

• LOINC Content Activities

• Regenstrief could consider the following activities to update LOINC content, consistent with Objective 2:

Regenstrief could create new or update existing LOINC content available to users based on findings from the report, which includes input from interested parties. Additional content needs may be reassessed and updated on a biannual basis in alignment with the LOINC release cycle.

Regenstrief could enhance the usability of publicly available LOINC resources to improve users’ ability to search for LOINC concepts.

• Creation of Technical Artifacts Regenstrief could create technical artifacts, which could include:

• A user guide (or enhancements to existing LOINC User Guide regarding LOINC content with

USCDI)

• Software design documents

• Software code published in an open-source code repository used by Regenstrief

• Test scripts and procedures

• A deployment architecture document

• An installation document

• Summary of Activities

Regenstrief could create a publicly available summary of activities that describe for the interoperability community the enhancements to LOINC tooling that support expanding health information exchange needs and development of LOINC content in alignment with the evolution of USCDI. This could include environmental scan findings, a summary of an implementation plan, a review of technical upgrades and impacts of the upgrades on the LOINC community, lessons learned, and recommendations for future activities that would further support known interoperability needs of the LOINC community.

B. Funding Opportunity Award Information

Key Award Parameters

Title: Enhancing the LOINC® Standard to support U.S. Interoperability

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

Announcement Type: Cooperative Agreement - A cooperative agreement is a support mechanism used when there will be substantial Federal involvement.

Application Type: New

Funding Opportunity Number: NAP-AX-23-001

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 achieve the objectives articulated in this funding opportunity. As the field of medicine continues to evolve, new implementation guides are developed, or novel requirements emerge (e.g., COVID-19), there is an ongoing need for Regenstrief to provide new concepts in a timely manner. The objectives of this funding opportunity can only be achieved by Regenstrief, given its authoritative role as the steward for LOINC. Regenstrief’s involvement is both fundamental and always necessary to publish an update to LOINC concepts and associated LOINC infrastructure components. This funding opportunity announcement seeks to establish a formal collaboration with Regenstrief through a sole source cooperative agreement to upgrade Regenstrief’s existing underlying technical infrastructure, update existing and develop new LOINC concepts to advance interoperable health IT, and to support the continued evolution of the USCDI through the development and maintenance of LOINC. This project will facilitate coordination with the health IT industry to improve and advance the technical standards and specifications required for interoperability.

This work is integral to supporting the health IT community in its next phase of interoperable exchange.

The period of performance for this award is 5 years. Pending the availability of funds, subsequent years will focus on additional concept development (including revisions), testing, quality assurance, and publication work that aligns with ONC’s priorities and federal regulations relating to the interoperable exchange of electronic health data.

SDOs develop and maintain health IT technical standards as well as any accompanying implementation specifications that provide implementation instructions for developers. Regenstrief is the single organization responsible for the development and maintenance of the LOINC concepts and solely governs the processes by which the concepts and accompanying implementation guidance are issued and updated. Thus, Regenstrief’s involvement is both fundamental and necessary to publish an update to LOINC concepts, implementation guidance, and associated LOINC infrastructure components.

Legislative Authority: Consolidated Appropriations Act, 2023.

Approximate Amount of Available Funding (inclusive of direct and indirect costs) : $500,000

Anticipated Number of Awards: 1

Approximately Amount of Each Award: $500,000

Project Period: August 08, 2023-August 07, 2028

Budget Period(s): August 08, 2023-August 07, 2024

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 interest 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.

For the purpose of this award, ONC requires the additional cost alternative of program income, which allows for the program income to further eligible project or program objectives. 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 from the Payment Management System. In the event program income generated during the period of performance 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

June 06, 2023

Applications Due

July 05, 2023

Anticipated Award Date

August 08, 2023

Anticipated Project Start Date

August 08, 2023

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, ONC’s 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, primary responsibility, or a dominant role in the activities.

Consistent with this premise, the dominant role and primary responsibility resides with Regenstrief for the project.

In a cooperative agreement, ONC staff is substantially involved with the project activities, above and beyond routine grant monitoring. ONC activities for this project include:

• Providing tactical guidance and feedback during project execution;

• Providing substantive input and policy direction as appropriate, in the development, deployment, and augmentation of FHIR-based terminology services. ONC may also ask for testing demonstrations of these services throughout this cooperative agreement;

• Providing substantive input and policy direction as appropriate, in the prioritization of LOINC concepts that Regenstrief develops, updates, or both, and makes available for public use. ONC may also ask for testing demonstrations of these throughout this cooperative agreement;

• 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.

Notice 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 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).

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.

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.

The duration of this award is for a maximum of 5 years. The budget and justification must reflect the costs for the initial 12- month budget period.

The budget proposal must include:

1.An explanation of how the proposed budget supports the proposed Project and is reasonable to meet the Project’s needs;

2.How proposed costs support Project activities; and 3.A description of how the proposed expenditures align with Project Plan.

Please see the Budget Detail in Appendix B for instructions for completing the SF424, and Appendices C through E for instructions for completing the SF424A, Budget Narrative, Justification, and other required forms. A non-competing continuation application is a financial assistance request (in the form of an application or performance/progress report) for a subsequent budget period within a previously approved project period for which a recipient does not have to compete with other applicants. Approval of this application will allow the recipient to continue implementing their project plan and to receive its next 12-month increment of funding. Non-competing continuation applications should be submitted no later than 90 days before the end of the current budget period (i.e., if the budget period will end on August 31, submit the non-competing continuation application by May 10). Exact due dates will be laid out in the terms and conditions that accompany each recipient’s Notice of Grant Award.

Continued funding throughout the 5-year project period will be contingent on timely submission of the non-competing continuation application, strong performance during the previous budget period(s), funding availability, and the recipient’s ability to continue meeting all eligibility requirements laid out in this NOFO. Due to their non-competitive nature, continuation applications will not be reviewed or scored by an Objective Review Committee. Instead, all continuation applications will be reviewed by ONC staff.

Strong performance during the previous budget period(s) will be evaluated by looking at a) the recipient’s ability to meet their performance metrics, b) the quality and timeliness of its report submissions, c) the recipient’s compliance with the terms and conditions provided with their Notice of Award including compliance with all applicable statutory and regulatory requirements, and d) the recipient’s ability to communicate with and respond in a timely manner to requests from its project officer throughout the project period.

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.

Subject to the exceptions in 45 CFR 75.414(f), nonfederal Entities (NFE) that have never received a negotiated indirect cost rate can charge a de minimis rate of 10% of modified total direct costs (MTDC).

Please see 45 CFR 75.414(f) for further guidance.

Application Submission Instructions

1) Applicants must access the electronic application for this program via http://www.grants.gov.

Applicants can search the downloadable application page by the Notice of Funding Opportunity Number NAP-AX-23-001 or CFDA number 93.346.

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 shall have a Unique Entity Identifier (UEI). A UEI can be obtained via registering at http://SAM.gov and typically takes 7 to 10 business days. Please plan accordingly.

2) 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.

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 UEI. The SAM registration process takes approximately 7 days so please plan accordingly. If the applicant has already registered with SAM but has not renewed their registration in the last 12 months, the applicant will need to renew their 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

3) After electronically submitting the application, 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 the application could be opened and read -- only that the application was received.

The deadline for the submission of applications under this Funding Opportunity is 12:00 P.M. Eastern Standard Time July 05, 2023. 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 http://www.grants.gov/web/grants/applicants/organization-registration.html

E. Application Review Information

Screening Review

The applicant must meet the following screening criteria in order for the application to 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 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.

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:

• Understanding the Requirement (30 Points)

• Technical Approach (40 Points)

• Staffing Qualifications (15 Points)

• Reasonableness of the Budget Narrative (15 Points)

Understanding the Requirements (30 Points) The applicant demonstrates knowledge and understanding to update LOINC technical tools to support expanding health information exchange, develop LOINC content for USCDI data elements to indicate LOINC as the applicable standard, and improve the use of LOINC.

(Not To Exceed 4 pages)

Technical Approach (40 Points) The applicant identifies solutions to overcome known gaps both in their underlying technical infrastructure and in LOINC concepts and other support services as detailed above in this NOFO. Its proposes a strategy efficiently and effectively implement these solutions. The applicant’s approach is succinct and logical in format and demonstrates methods consistent with the objectives to be accomplished. The applicant must propose a clear and detailed actionable plan which includes specific list of activities to achieve the objectives specified in the NOFO.

(Not To Exceed 20 pages) http://www.grants.gov/ http://www.grants.gov/

Staffing Qualifications (15 Points) The applicant must demonstrate and provide evidence of the following:

a. Experience 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 update existing LOINC concepts.

c. Knowledge of HL7 FHIR and the standards development process, as well as the ability to successfully engage with SDOs for purposes of advancing interoperable health IT using

LOINC.

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

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

Reasonableness of the Budget Narrative (15 Points) The applicant must provide a detailed breakdown on how it plans to spend the allotted resources to complete the objectives detailed in the NOFO. (Not To Exceed 2 pages)

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 requirements (45 CFR § 75.205.)

For any Federal award issued under a Notice of Funding Opportunity (NOFO), if the HHS awarding agency anticipates that the total Federal share will be greater than the simplified acquisition threshold on any Federal award under a notice of funding opportunity may include, over the period of performance (see § 75.2 Simplified Acquisition Threshold), this section shall also inform applicants: i. That the HHS awarding agency, prior to making a Federal award with a total amount of Federal share greater than the simplified acquisition threshold, is required to review and consider any information about the applicant that is in the designated integrity and performance system accessible through SAM (currently FAPIIS) (see 41 U.S.C. 2313); ii.

ONC is required to review and consider any information about the applicant that is in the Federal Awardee Performance and Integrity Information System (FAPIIS), www.fapiis.gov/, before making any award in excess of the simplified acquisition threshold over the period of performance. An applicant may review and comment on any information about itself that a federal awarding agency has previously entered into FAPIIS. ONC will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgment about the applicant's integrity, business ethics, and record of performance under federal awards when completing the review of risk posed by applicants, as described in 45 CFR § 75.205(a)(2) HHS awarding agency review of risk posed by applicants.

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.

Notice of Grant Award The recipient will receive a letter of notification acknowledging that an award was funded, but that letter 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 timeline for accomplishment

The Authorized Representative will receive the NGA electronically from ONC. The recipient accepts the award by drawing down funds. By accepting an ONC award, the recipient assumes legal, financial, administrative, and programmatic responsibility for administering the award in accordance with the terms and conditions of the award, as well as applicable laws, rules, regulations, and Executive Orders governing HHS assistance awards, all of which are to be incorporated into the award by reference. Failure to comply with these requirements may result in suspension or termination of the awards and/or ONC’s recovery of award funds.

Non-Discrimination Legal Requirements for Recipients of Federal Financial Assistance

Applicants who successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the applicant agrees, as a condition of receiving the grant, to administer the programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to the programs or activities by limited English proficient individuals, see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.

• For information on the specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html.

• For guidance on administering the project in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws, see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Terms and Conditions

Incorporated by Reference: Administrative and National Policy Requirements Awards issued under this announcement are subject to 45 CFR Part 75 - Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of award, and applicable statutory provisions. The Code of Federal Regulations (CFR) is available at www.ecfr.gov. Funded organizations are responsible for ensuring that their activities comply with all applicable federal regulations.

HHS Grants Policy Statement The HHS Grants Policy Statement (HHS GPS) is the Department of Health and Human Services' single policy guide for discretionary grants and cooperative agreements. ONC grant awards are subject to the requirements of the HHS GPS, which covers basic grants processes, standard terms and conditions, and points of contact, as well as important agency-specific requirements. The general terms and conditions in the HHS GPS will apply as indicated unless there are statutory, regulatory, or award specific requirements to the contrary that are specified in the Notice of Award (NOA). The HHS GPS is available at https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf Specific terms and conditions are further delineated below due to their importance in terms of integrity, achieving programmatic objectives, and/or sound financial stewardship of federal funds.

https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html https://www.lep.gov/ http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html https://www.hhs.gov/conscience/conscience-protections/index.html https://www.hhs.gov/conscience/religious-freedom/index.html https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

Non-Discrimination Legal Requirements for Recipients of Federal Financial Assistance Per Executive Order (E.O.) 13985 entitled Advancing Racial Equity and Support for Underserved Communities Through the Federal Government (Jan. 20, 2021), Applicant will administer the project in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age, and comply with applicable conscience protections. Applicant will comply with applicable laws that prohibit discrimination on the basis of sex, which includes discrimination on the basis of gender identity, sexual orientation, and pregnancy. Compliance with these laws require taking reasonable steps to provide meaningful access to persons with limited English proficiency and providing programs that are accessible to and usable by persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

Specific terms and conditions, incorporated by reference above, are further delineated below due to their importance in terms of integrity, achieving programmatic objectives, and sound financial stewardship of federal funds.

Performance Reporting ONC Program Progress Reports (PPR) are due quarterly. The PPR will address to the extent applicable:

• degree to which performance goals were attained (actual performance versus targeted performance)

• data source and validation method for performance measures

• opportunities to address performance deficiencies

• accomplishments

• next steps

• challenges/barriers

• recommendations to address challenges and barriers

ONC will provide specific guidance regarding the…