LOINCFinalDraft.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: 08/27/2018

Anticipated Award Date: 09/19/2018

Table of Contents

Executive Summary

A. Program Description/Purpose Structure and Approach Performance Goals/Program Milestones

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 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 through which health information technology (health IT) implementers and users will be able to more easily use LOINC®; and to position the LOINC® terminology standard to support the continued evolution of the draft U.S. Core Data for Interoperability2 (USCDI) (as applicable). 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, 2018, Pub. L. 115-141, Division H, Title II.

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 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 criteria3 (see 45 CFR 170.299(o)). LOINC® is also referenced in the annual ONC Interoperability Standards Advisory (ISA)4.

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).

This funding opportunity announcement seeks to establish a formal collaboration with Regenstrief Institute through a sole source cooperative agreement in order to upgrade their existing underlying technical infrastructure in order to subsequently update existing, and develop new LOINC® codes to advance interoperable health IT, as well as position LOINC® to support the continued evolution of the USCDI (as applicable).

Under this sole source cooperative agreement, Regenstrief will be required to work collaboratively with ONC to establish priorities, update underlying technical infrastructure, identify gaps, and accelerate Regenstrief’s ability to support the LOINC® community by increasing the number of, and updating

1 https://www.congress.gov/114/plaws/publ255/PLAW-114publ255.pdf 2 https://www.healthit.gov/sites/default/files/draft-uscdi.pdf 3 ONC 2015 Edition (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 – October 6, 4 https://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/isa/ existing, LOINC® codes available for use. Specifically, Regenstrief will be required to complete a number of tasks, in close collaboration and with the approval of ONC, which are further detailed below.

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 information technology as authorized under the Consolidated Appropriations Act, 2018, Pub. L. 115-141, Division H, Title II. The Cures Act is targeted to improve health care quality and delivery by ensuring electronic health record (EHR) systems are interoperable for seamless patient care using health IT standards adopted by HHS as part of the ONC Health IT Certification Program. The intended outcome is to allow EHR systems to recognize and aggregate health data from other institutes, 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 a consistent data format 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 with all other systems with which it interacts is impractical.

Utilization of the Common Lab Orders to more comprehensively cover tests commonly ordered in ambulatory care settings and for tests ordered in the public health settings is a critical component in the efforts to advance the interoperable exchange of health information across the care continuum.

To address this issue, stakeholders in the health IT ecosystem have organized themselves under the auspices of SDOs to develop standardized data formats and structures pertaining to specific purposes.

SDOs are primarily responsible for developing and maintaining the technical standards and any accompanying implementation specifications/profiles that provide additional implementation instructions to developers based on the particular purpose for which the standard is intended to be used.

Regenstrief is the exclusive SDO responsible for the development and maintenance of the LOINC® codes and solely governs the processes by which these value sets and accompanying implementation guidance are issued and updated. Attempting to complete these or any future tasks specific to LOINC® codes with another SDO or organization would be time consuming, inefficient, and would still ultimately require an alternative organization to go through Regenstrief to publish a final product. Thus, Regenstrief’s involvement is both fundamental and always necessary to publish an update to LOINC ® codes and associated LOINC® infrastructure components.

As a result, ONC believes that a cooperative agreement with Regenstrief, given its authoritative role as the steward for LOINC®, is the most efficient and effective way to quickly increase the number of, and update existing, LOINC ® codes to advance interoperable health IT, as well as position LOINC® to support the continued evolution of the USCDI (as applicable). First and foremost, Regenstrief will be required to upgrade their technical infrastructure to successfully support the other tasks listed in this funding opportunity. Regenstiref will work closely with ONC in order to identify and prioritize these tasks.

Furthermore, it is ONC’s intent to broadly coordinate with health IT industry stakeholders to improve and advance the technical standards and specifications required for 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 funding opportunity reflects ONC’s intention to work directly with Regenstrief to upgrade their technical infrastructure, expedite improvements in accessing content, and bridge gaps between LOINC® and HL7® FHIR®. Additionally, the work will fund advancing the production deployment of FHIR-based 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 RELMA®.

Structure and Approach

The tasks listed below are an initial activities for Regenstrief to submit as deliverables under this funding opportunity. The list of tasks can be expanded during the implementation phase; Regenstrief and ONC shall conduct a biannual review based on the planned LOINC® release cycles, to reassess and adjust priorities and implementation activities as necessary.

Deliverable 1:

Kick-Off Meeting Within 1 week of award date, Regenstrief and ONC shall conduct a Kick-Off Meeting to mutually determine priorities, discuss implementation activities and timelines, and establish a mutually agreeable regular meeting time. The Kick-Off Meeting shall also go over all programmatic and financial reporting requirements. Regenstrief attendees must include the Principal Investigator (PI)/Project Director (PD), other subject matter experts (SMEs) and key personnel, including a financial/grants manager.

Deliverable 2:

Environmental Scan Report During the first 6 months of this cooperative agreement, Regenstrief is required to conduct an environmental scan of infrastructure needs and identify infrastructure enhancements to support Application Programming Interface (API) based access to LOINC® services using FHIR® Release 3 and Release 4 standard. Additionally, the environmental scan must identify all the new LOINC® codes that will be required to support the data classes identified in the draft USCDI5 published by ONC. This must also include feedback from LOINC® implementers and standards developers that use LOINC®. This report of findings will inform additional future activities and priorities under this cooperative agreement.

Within 2 weeks of the report submission, ONC and Regenstrief shall convene a working session(s) to review and assess the findings of the Report and mutually establish the priorities for tasks and specific deliverables for the next 6 months of the cooperative agreement. These activities and priorities shall be reassessed and updated on a biannual basis in alignment with the LOINC® release cycle, but may be reassessed and adjusted at any time if deemed necessary by ONC and/or Regenstrief.

Deliverable 3:

Implementation Plan Regenstrief shall submit a draft implementation plan on how the recipient 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 report (“Report”), and based on discussion from the Kick-Off Meeting and subsequent review and assessment of the Report with ONC within 1 month of submitting the Report. The draft implementation plan must also include Regenstrief’s proposed tasks, 5 https://www.healthit.gov/sites/default/files/draft-uscdi.pdf deliverables, timelines, resources, risks and risk mitigation strategy, and a revised estimated budget proposal, if necessary, for each objective, and is subject to final approval by ONC. Once approved by ONC, the Implementation Plan shall be reassessed and updated on a biannual basis in alignment with the LOINC® release cycle, but may also be reassessed and adjusted at any time if deemed necessary by ONC and/or Regenstrief.

Deliverable 4:

Monthly Progress Meetings Regenstrief shall set-up regular check-in meetings, no less than monthly, with ONC at a mutually agreeable time and frequency, for the duration of the cooperative agreement period-of-performance. At the Kick-Off Meeting, ONC and Regenstrief will also establish the medium and format for these monthly progress meetings, including responsibilities for agenda setting and note taking.

Deliverable 5:

Quarterly Progress Reports Quarterly progress reports shall be submitted to ONC during the cooperative agreement period-of-performance regarding the implementation plan. The medium and format for these quarterly progress reports shall be established by ONC prior to the first quarterly report submission.

Deliverable 6:

Technical Artifacts

As applicable, Regenstrief shall submit the following deliverables to ONC for each of the technical enhancements approved in the implementation plan:

• Software design document prior to development for technical infrastructure and tool development/enhancement

• Quality Assurance Plan

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

• Test Scripts and procedures

• Deployment architecture document

• Installation document

• User guide

• Report or link to published LOINC® codes supported by the cooperative agreement

• Publicly accessible link to all the tools and content developed by the cooperative agreement

While we anticipate ONC to identify and approve additional priorities based on the Report, during the duration of the cooperative agreement, below we also identify an initial list of objectives and tasks for planning purposes. Regenstrief can consider the following objectives in developing their initial plans for the cooperative agreement.

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

The objective of this task is to perform necessary software enhancements to existing tools and services maintained by Regenstrief to support LOINC® terminology needs for health information exchange using newer API-based standards.

Regenstrief’s existing LOINC® technical infrastructure needs to be upgraded in order to support the community’s rapid adoption of new health IT standards including FHIR and the use of internet enabled technologies such as JavaScript Object Notation (JSON) and REpresentational State Transfer (REST).

Additionally, the use of FHIR-based terminology services has exponentially expanded the number and types of stakeholders that have traditionally been the users of LOINC®. This has rapid adoption has created both new requirements for performance and new ways of content delivery including the use of API-based terminology services. For example, the FHIR standard has specified API-based terminology services 6 to meet the needs of its developer community.

List of Activities:

Task 1: Conduct biannual review of analyses of the needs of the LOINC® community and implement LOINC® technical infrastructure improvements during planned release cycles (no less than 2 times per year) to support rapid content development and publication.

Task 2: Upgrade LOINC®’s technical infrastructure to improve the ease of use and searchability of LOINC® terms by LOINC® implementers, 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 developer community.

Task 3: Develop, deploy, and augment FHIR-based terminology services to align with FHIR Release 3 and Release 4.

Objective 2: Increasing LOINC® Content and Improving Content Use

The objective of this task is to increase the use of the LOINC® standard in healthcare information exchange by expanding LOINC® content and providing user-centric tools for users to interact with LOINC® codes.

As the owner and overall steward of the LOINC® vocabulary standard, as well as the exclusive SDO for LOINC®, the LOINC® team at Regenstrief maintains and provides the LOINC® content and tools via public website7. Under this cooperative agreement, Regenstrief is expected to expand the number of existing LOINC® codes in a timely manner to continue supporting the interoperability needs of ONC-certified health IT. ONC and Regenstrief shall mutually establish a reasonable number of codes that will be developed and/or updated during each release cycle and shall be detailed in the Implementation Plan.

Additionally, Regenstrief will develop new tools or update existing tools with ONC approval, based on the biannual environmental scan.

List of Activities:

Task 1: Increase and/or update the publication of LOINC® codes available to users based on findings from the Report, which includes stakeholder input and final input and approval by ONC. The number of increased and/or updated LOINC® codes shall be reassessed and updated on a biannual basis in alignment with the LOINC® release cycle, but may be reassessed and adjusted at any time if deemed necessary by ONC and/or Regenstrief.

6 http://hl7.org/fhir/terminology-service.html 7 www.loinc.org http://www.loinc.org/ http://hl7.org/fhir/terminology-service.html

Task 2: Regenstrief shall work with SDOs to ensure that each of the data classes and their constituent data elements specified in the draft USCDI8 are provided with appropriate LOINC® codes in a timely manner as needed to support their addition into health IT exchange standards. The specific data classes shall be identified by Regenstrief and included in their Report, and are subject to review and approval by ONC. The initial number of data classes to be supported under this Task shall be detailed in the initial Implementation Plan and shall be reassessed and updated on a biannual basis in alignment with the LOINC® release cycle, but may be reassessed and adjusted at any time if deemed necessary by ONC and/or Regenstrief.

Task 3: Perform usability enhancement of the LOINC® website for improved searchability of LOINC® codes by users and improved navigation of the web site.

Deliverable 7:

Final Report and Associated Artifacts The Final Report will contain the following:

1. Summary of the work conducted under the cooperative agreement;

2. Summary of Environmental Scan findings;

3. Initial activities and priorities submitted in the Implementation Plan;

a. Subsequent additions/adjustments made to the Implementation Plan based on the biannual assessments

4. Documented list of all technical infrastructure upgrades made using funds from this cooperative agreement, and any known impacts (positive and negative) that it had on the LOINC® developer and user community;

a. Report or link to published LOINC® codes supported by the cooperative agreement

b. Publicly accessible link to all the tools and content developed by the cooperative agreement

5. Summary of findings, outcomes/deliverables, and lessons learned, and recommendations for future activities that would further support known interoperability needs of the LOINC® community.

Performance Goals/Program Milestones A performance goal/program milestone is a target level of performance expressed as a tangible, measurable objective, against which actual achievement can be compared. The performance goals/program milestones associated with this funding opportunity, and ensuing award, are listed in the table below.

Deliverable Table The deliverable table consists of expected deliverables which will be produced in support of execution of the cooperative agreement and the due date by which they will be delivered to ONC. The specific details and associated tasks for the final deliverables are described above under Structure and Approach, and will be further detailed by Regenstrief in the Implementation Plan.

Deliverable No. Deliverable Due Date Deliverable 1 – Kick- Off Meeting Conduct a Kick-Off Meeting with ONC

Regenstrief shall conduct a Kick-Off Meeting with ONC in order to set priorities, discuss implementation, assess the gaps, and set expectations

No Later Than (NLT) one

(1) week from award date

8 https://www.healthit.gov/sites/default/files/draft-uscdi.pdf

Deliverable No. Deliverable Due Date Deliverable 2 – Environmental Scan Conduct environmental scan of gaps in LOINC® content and technical infrastructure

Regenstrief shall conduct an environmental scan of infrastructure needs and LOINC® codes and submit a report to ONC.

NLT six (6) months from award date

Deliverable 3 – Detailed Implementation Plan Draft implementation plan for review and approval by ONC

A draft implementation plan on how the recipient will meet the objectives and deliverables as described in this NOFO, including gaps or areas identified for improvement as determined by the environmental scan report, and based on discussion from the Kick-Off Meeting with ONC. Draft implementation plan must also include Regenstrief’s proposed individual goals for each objective

NLT one (1) month from receiving feedback from ONC on Deliverable 2

Deliverable 4 – Monthly progress meetings with ONC Establish regular monthly meetings with ONC to provide progress updates

Set-up regular check-in meetings, no less than monthly, with ONC at a mutually agreeable time and frequency, for the duration of the cooperative agreement period-of-performance. At the Kick-Off Meeting, ONC and Regenstrief will also establish the medium and format for these monthly progress meetings

Monthly; TBD at a mutually agreeable time between ONC and Regenstrief NLT one (1) week from award date

Deliverable 5 – Quarterly Progress Reports

Quarterly progress reports submitted to ONC during the cooperative agreement period-of-performance

Quarterly

Deliverable 6 – Technical Artifacts

• Software design document prior to development

• Quality Assurance Plan

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

• Test Scripts and procedures

• Deployment architecture document

• Installation document

• User guide

• Report or link to published LOINC® codes supported by the cooperative grant

• Publicly accessible link to all the tools and content developed by the cooperative grant

All tasks for initial objectives (1 and 2) completed NLT 12 months after approval by ONC.

Subsequent tasks to be based on approved implementation plan.

Deliverable 7 – Report Final Report and Associated Artifacts

Final Report, containing:

• Summary of the work conducted under the cooperative agreement during the period of performance:

• Summary of Environmental Scan findings

NLT September 6, 2023

Deliverable No. Deliverable Due Date

N/A

• Initial activities and priorities submitted in the Implementation Plan o Subsequent additions/adjustments made to the Implementation Plan based on the biannual assessments

• Documented list of all technical infrastructure upgrades made using funds from this cooperative agreement, and any known impacts (positive and negative) that it had on the LOINC® developer and user community

• Summary of findings, outcomes/deliverables, and lessons learned as well as recommendations for future activities that would further support known interoperability needs of the LOINC® community

N/A

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 but are not limited to:

a. Conduct regular meetings with Regenstrief;

b. Review Environmental Scan Report, provide 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 of which these upgrades must be completed by;

c. Provide substantive input and policy direction as appropriate, in the development, deployment, and/or augmentation of FHIR-based terminology services. ONC may also request testing demonstrations of these services in the duration of this cooperative agreement;

d. Provide substantive input and policy direction as appropriate, in the prioritization and number of LOINC® codes that Regenstrief shall develop and/or update and make available for public use. ONC may also request testing demonstrations of these services in the duration of this cooperative agreement;

e. Provide substantive input and policy direction as appropriate, in the prioritization and number of data classes specified in current and publically available USCDI document that Regenstrief will provide terminology support services for;

f. Conduct, on a biannual basis in alignment with LOINC®’s release cycle, a reassessment and, in collaboration, update the Implementation Plan and any other related activities and priorities. The 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; and

g. Engage with Regenstrief leadership as necessary to ensure successful execution of the cooperative agreement.

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-18-004

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 to upgrade their existing underlying technical infrastructure to subsequently update existing, and develop new LOINC® codes to advance interoperable health IT, as well as position LOINC® to support the continued evolution of the USCDI (as applicable). This project would assist to coordinate with health IT industry stakeholders to improve and advance the technical standards and specifications required for 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 work is integral to supporting the health IT community in its next phase of interoperable exchange.

This funding opportunity would establish a relationship with Regenstrief and ensure substantial involvement from ONC in the LOINC® code development work. Regenstrief will be able to pay for

SMEs and any other infrastructure necessary to prioritize and expedite these efforts. The period-of-performance for this award is expected to be 5 years. In the first year of the cooperative agreement, Regenstrief will be required to upgrade their underlying technical infrastructure to support LOINC® content developers and enhance LOINC® tools to improve usability by the end user and successfully support the other tasks listed in this funding opportunity, of which they will work closely with ONC in order to identify and prioritize. These additional tasks include, but are not limited to: (i) increasing the number of, and/or updating existing LOINC® codes published for LOINC® implementers; (ii) advancing the production, deployment, and/or augmentation of of FHIR-based terminology services;

(iii) increasing terminology support for data classes specified in current and publically available USCDI;

and (iv) implementing other activities and priorities as identified in the Environmental Scan Report, or as determined by ONC. Pending the availability of funds, subsequent years will focus on additional code development, testing, quality assurance, and publication work that aligns with ONC’s priorities and federal regulations relating to the interoperable exchange of electronic health data, as determined during the biannual assessment in alignment with the LOINC® release cycle.

The primary responsibility of SDOs are the development and maintenance of health IT technical standards as well as any accompanying implementation specifications that provide additional implementation instructions for developers. Regenstrief is the single organization responsible for the development and maintenance of the LOINC® codes and solely governs the processes by which these value sets and accompanying implementation guidance are issued and updated. Attempting to complete these or any future tasks specific to LOINC® codes with another SDO or organization would be time consuming, inefficient, and would still ultimately require an alternative organization to go through Regenstrief engagement to ballot and to publish a final product. Thus, Regenstrief’s involvement is both fundamental and always necessary to publish an update to LOINC® codes, terminologies or implementation guide, and associated LOINC® infrastructure components. Furthermore, it is ONC’s intent to broadly coordinate with health IT industry stakeholders to improve and advance the technical standards and specifications required for 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.

Legislative Authority: Consolidated Appropriations Act, 2018, Pub. L. 115-141, Division H, Title II and 21st Century Cures Act, Pub. L. No: 114-255, Division A, Title IV

Approximate Amount of Available Funding (inclusive of direct and indirect costs) : $600,000

Anticipated Number of Awards: 1

Approximately Amount of Each Award: $600,000

Project Period: 09/19/018 to 09/18/2023

Budget Period(s): 09/19/2018 to 09/18/2019

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

07/26/2018

Applications Due

08/27/2018

Anticipated Award Date

09/19/2018

Anticipated Project Start Date

09/19/2018

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 tasks and 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 of which these upgrades must be completed

♦ Working with Regenstrief to set the priorities and implementation direction that will be detailed in the 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

♦ Providing substantive input and policy direction as appropriate, in the development, deployment, and/or augmentation of FHIR-based terminology services. ONC may also request testing demonstrations of these services in the duration of this cooperative agreement and request changes as deemed necessary to align with and support HHS’ programmatic priorities and regulations

♦ Providing substantive input and policy direction as appropriate, in the prioritization and number of LOINC® codes to that Regenstrief shall develop and/or update and make available for public use. ONC may also request testing demonstrations of these services in the duration of this cooperative agreement and request changes as deemed necessary to align with and support the agency’s programmatic priorities and regulations

♦ Providing substantive input and policy direction as appropriate, in the prioritization and number of data classes specified in current and publically available USCDI that Regenstrief will provide terminology support services for

♦ Conducting, on a biannual basis in alignment with LOINC®’s release cycle, a reassessment and, in collaboration, update the Implementation Plan and any other related activities and priorities. The 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.

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.

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 NAP-AX-18- 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.

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, 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.

The deadline for the submission of applications under this Funding Opportunity is 11:59 P.M. Eastern Standard Time August 27, 2018. Applications that fail to meet the application deadline will not be reviewed and will receive no further consideration.

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

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…