75P00120R00175 Final 9.2.2020.pdf

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CODE 18a. PAYMENT WILL BE MADE BY

CODE

FACILITYCODE

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

OFFEROR

PSC/FMP/AMS/SLC

SALT LAKE CITY UT 84111

4TH FLOOR

299 SOUTH MAIN STREET

PSC/FMP/AMS/SLC

PSC CODE 16. ADMINISTERED BYCODE

X

X

519190

SIZE STANDARD:

% FOR:SET ASIDE:UNRESTRICTED ORPSC/FMP/AMS/SLC

RFPIFB

10. THIS ACQUISITION ISCODE

RFQ

14. METHOD OF SOLICITATION

13b. RATING

NAICS:

SMALL BUSINESS

09/10/2020 1400 ET385-285-7380DEBBIE HOPE

(No collect calls)

INFORMATION CALL:

FOR SOLICITATION 8. OFFER DUE DATE/LOCAL TIMEb. TELEPHONE NUMBER a. NAME

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

75P00120R00175

5. SOLICITATION NUMBER

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 1. REQUISITION NUMBER PAGE OF

1 72 OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

TELEPHONE NO.

17a. CONTRACTOR/

Bethesda MD 20814 7700 Wisconsin Ave Program Support Center

PSC

15. DELIVER TO

SALT LAKE CITY UT 84111

4TH FLOOR

299 SOUTH MAIN STREET

9. ISSUED BY

7.

2. CONTRACT NO.

EFFECTIVE DATE

$30.00

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DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

11.

SEE SCHEDULEX

12. DISCOUNT TERMS

THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13a.

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

8(A)

PSC/FMP/AMS/SLC

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

24.

AMOUNT

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UNIT PRICE

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UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

TITLE: COVID-19 support for Accelerating Standards Development for the US Realm

This requirement is to support COVID-19 activities and is being conducted under the flexibilities authorized in FAR Part 18 and is a commercial acquisition under FAR Part 12.

This is a sole source acquisition to Health Level Seven International, Inc., a non-profit agency.

Expedited response time is requested in accordance with Section L.6.

(Use Reverse and/or Attach Additional Sheets as Necessary)

HEREIN, IS ACCEPTED AS TO ITEMS:

X

XX

DATED

DEBBIE L. HOPE

. YOUR OFFER ON SOLICITATION (BLOCK 5),

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER

ARE

ARE

31c. DATE SIGNED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (Type or print)

ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL

SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

26. TOTAL AWARD AMOUNT (For Govt. Use Only)

OFFER

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA - FAR (48 CFR) 53.212

ARE NOT ATTACHED.

ARE NOT ATTACHED.

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

30b. NAME AND TITLE OF SIGNER (Type or print)

30a. SIGNATURE OF OFFEROR/CONTRACTOR

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

25. ACCOUNTING AND APPROPRIATION DATA

29. AWARD OF CONTRACT:

REF.

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32c. DATE 32b. SIGNATURE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

40. PAID BY39. S/R VOUCHER NUMBER38. S/R ACCOUNT NUMBER

37. CHECK NUMBER

FINALPARTIAL

36. PAYMENT

FINALPARTIAL

35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER33. SHIP NUMBER

COMPLETE

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

42d. TOTAL CONTAINERS42c. DATE REC'D (YY/MM/DD)

42b. RECEIVED AT (Location)

42a. RECEIVED BY (Print)

41c. DATE41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

STANDARD FORM 1449 (REV. 2/2012) BACK

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AMOUNT

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UNIT PRICE

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21.

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SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

1 Base 5-year period

Fixed monthly support for Accelerating Standards

Development for the US Realm

2 Travel

3 Optional Task 7 (Year 1)

(Option Line Item)

4 Optional Task 8 (Year 2)

(Option Line Item)

5 Optional Task 9 (Year 3)

(Option Line Item)

6 Optional Task 10 (Year 4)

(Option Line Item)

7 Optional Task 11 (Year 5)

(Option Line Item)

32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

72 2 of

RFP: 75P00120R00175

TITLE: COVID-19 support for Accelerating Standards Development for the US Realm

SECTION B - Supplies or Services and Prices/Costs

B.1 BRIEF DESCRIPTION OF SERVICES

This requirement provides support for COVID-19 activities and is being conducted under FAR Part 12.

The purpose of this contract is to support management in standards development and implementation activities for the US Realm. The objectives of this contract are to provide administrative support in the governance of standards development and implementation activities, to facilitate stakeholder outreach and to support development, balloting, and publication of the US Core Implementation Guide and C-CDA standard.

B.3 TYPE OF CONTRACT

The contract type awarded is a firm fixed priced (FFP).

B.4 SEVERABLE SERVICES

The services acquired under this contract are severable services. Funds are only available for use for the contract line item (CLIN) to which they are obligated. Unused funds from one CLIN may not rollover for use in other periods.

B.5 CONSIDERATION AND PAYMENT (Fixed Price – Severable Services)

In consideration of satisfactory performance of the work as described throughout this contract, the Contractor shall be paid a fixed price for each CLIN (if exercised). If the options are exercised, funding will be obligated by modification to the contract. The base period and option tasks are priced as follows:

CLIN

Task Contract Period Fixed Price Per Month/Task

Total Price

1 Base Tasks 1-6 Year 1 Year 2 Year 3 Year 4 Year 5

2 Travel NTE Years 1-5 $20,000.00 3 Optional Task 7 Year 1 4 Optional Task 8 Year 2 5 Optional Task 9 Year 3 6 Optional Task 10 Year 4 7 Optional Task 11 Year 5

TOTAL CONTRACT AMOUNT

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Payment shall be made upon the delivery and acceptance of the services required in accordance with the following fixed monthly support.

All travel requires approval from the Contracting Officer’s Representative (COR) before commencing.

SECTION C - Description/Specifications/Statement of Work

TITLE: Accelerating Standards Development for the US Realm

BACKGROUND

The Office of the National Coordinator for Health Information Technology (ONC) at the U.S.

Department of Health and Human Services (HHS) is responsible for supporting the adoption of health information technology (health IT) and the promotion of nationwide health information exchange (HIE) to improve health care. As part of this mission, ONC is committed to improving interoperability among health IT systems. The 21st Century Cures Act1 (Cures Act) defines interoperability as enabling “the secure exchange of electronic health information with, and use of electronic health information from, other health information technology without special effort on the part of the user.”

One of the essential ingredients of interoperability is a common “language” for interactions between systems. Health IT standards provide this “language” by defining aspects of IT systems and their interactions, such as information structures, terminologies, and communication protocols. Standards Development Organizations (SDOs) develop and maintain technical standards, as well as implementation guidance to support the implementation and use of the standards.

Founded in 1987, Health Level Seven International (HL7®) is an American National Standards Institute (ANSI) accredited SDO. HL7 is the exclusive SDO with the ability, authority, and intellectual property rights to develop and maintain many of the technical standards for HIE and health IT interoperability. HL7’s portfolio of standards includes HL7 v2,2 v3,3 Consolidated Clinical Document Architecture (C-CDA),4 and Fast Healthcare Interoperability Resources (FHIR®).5 These standards and accompanying implementation guidance support a variety of health care use cases including patient access to health information, clinical decision-making for patient care, quality and public health reporting, and information exchange. HL7 standards are developed through a public, transparent, and collaborative process and made available for use in the public domain.

ONC has historically supported the adoption and use of health IT standards for interoperability. For example, ONC regulations establish the capabilities expected of health IT products and the standards

1 https://www.congress.gov/bill/114th-congress/house-bill/34 2 https://www.hl7.org/implement/standards/product_brief.cfm?product_id=185 3 https://www.hl7.org/implement/standards/product_brief.cfm?product_id=186 4 http://www.hl7.org/implement/standards/product_brief.cfm?product_id=7 5 http://hl7.org/fhir/ javascript:__doPostBack('ctl00$ctl00$body$homebody$RecentDocuments$C$RecentDocumentsControl$PinnedDocumentResults$ctl00$DocumentNumberLink','') https://www.congress.gov/bill/114th-congress/house-bill/34 https://www.hl7.org/implement/standards/product_brief.cfm?product_id=185 https://www.hl7.org/implement/standards/product_brief.cfm?product_id=186 http://www.hl7.org/implement/standards/product_brief.cfm?product_id=7 http://hl7.org/fhir/ that developers must use to provide these capabilities. The ONC Health IT Certification Program6 (Certification Program) tests these capabilities and certifies products that support them. Many of the certification criteria, such as the capability to generate a patient care summary, require the use of HL7 standards. Health care providers must use certified health IT to participate in certain federal programs like the Centers for Medicare & Medicaid Services (CMS) Promoting Interoperability Programs. Thus, ONC policies help establish a baseline set of technical standards and implementation specifications for use across the health care industry in the United States.

ONC also funds HL7 standards development and implementation activities through a cooperative agreement. In addition to supporting HL7’s overarching standards development processes, ONC funding has led to the development of new standards that help health IT developers meet their obligations under the Certification Program. The US Core Implementation Guide,7 for example, defines the minimum conformance requirements for accessing patient data through an application programming interface (API). Likewise, ONC has funded standards to support access to health information for a population of patients. The resulting FHIR Bulk Data Access Implementation Guide8 was recently included in ONC’s Cures Act Final Rule9 as a component of the Certification Program.

Enabling the ONC to effectively monitor and evaluate standards development activities in the US Realm is critical given ONC’s role in enabling interoperability in the US health care system.

However, ONC currently lacks the capabilities to appropriately oversee the large number of standards development activities impacting the US Realm. ONC, for example, does not have a defined methodology for tracking the status and progress of standards development and implementation activities. Simply identifying which projects are underway requires navigating the various websites and processes for more than 40 HL7 workgroups.

Given ONC’s mission to facilitate the adoption, use, and interoperability of health IT in the United States, a more organized US Realm is imperative. The US standards development community, health IT developers, and users of health IT must have the ability to easily identify standards development and implementation activities that impact the US Realm. Up-to-date information about these activities and the overall lifecycle of each must be readily available to support public and private sector efforts to improve the quality, costs, and outcomes of the US health care system through the use of health IT.

This contract will fund development of HL7 standards and implementation guidance for the US health IT ecosystem including: creating and enforcing guidelines for developing standards and implementation guidance, facilitating stakeholder outreach and engagement, tracking the status of standards development work products, and managing the US Realm balloting and publishing processes. Because HL7 develops the leading content standards for health IT interoperability, contracting HL7 to support the governance of the US Realm activities will enable more strategic, targeted, focused, and timely standards development to accelerate interoperability.

6 https://www.healthit.gov/topic/certification-ehrs/about-onc-health-it-certification-program 7 https://www.hl7.org/fhir/us/core/ 8 https://hl7.org/fhir/uv/bulkdata/ 9 https://www.federalregister.gov/documents/2020/05/01/2020-07419/21st-century-cures-act-interoperability-information-blocking-and-the-onc-health-it-certification javascript:__doPostBack('ctl00$ctl00$body$homebody$RecentDocuments$C$RecentDocumentsControl$PinnedDocumentResults$ctl00$DocumentNumberLink','') https://www.healthit.gov/topic/certification-ehrs/about-onc-health-it-certification-program https://www.hl7.org/fhir/us/core/ https://hl7.org/fhir/uv/bulkdata/ https://www.federalregister.gov/documents/2020/05/01/2020-07419/21st-century-cures-act-interoperability-information-blocking-and-the-onc-health-it-certification https://www.federalregister.gov/documents/2020/05/01/2020-07419/21st-century-cures-act-interoperability-information-blocking-and-the-onc-health-it-certification

PURPOSE

The purpose of this contract is to support standards development and implementation activities for the US Realm. The objectives of this contract include:

• Monitor, manage, and track US Realm standards development.

• Develop and enforce governance policies for US Realm standards development.

• Facilitate stakeholder outreach to coordinate standards development and implementation activities in the US Realm.

• Support development, balloting, and publication of the US Core Implementation Guide and C-CDA standard.

Supporting US Realm standards development and implementation activities in this manner will help establish a foundational level of interoperability for the United States. These standards will enable electronic health records and other health IT applications to communicate and share information more easily. They will provide a consistent and common set of technical capabilities for health IT developers to build around. And they will ensure that patients and doctors can readily access and use the most important clinical information when and where they need it.

STATEMENT OF WORK

To achieve the purpose stated above, the Contractor shall perform but is not limited to the following:

Task 1: Monitor, manage, and track US Realm standards development.

The Contractor shall assist ONC in gathering, organizing, monitoring, and managing work products associated with HL7 standards development and implementation activities for the US Realm.

The Contractor shall develop and implement a methodology for tracking the status of US Realm standards and implementation specifications.

• Contractor shall consult with ONC and representatives of the USR-SC to identify an approach for monitoring, managing, and tracking US Realm standards development.

• Contractor shall provide a written methodology for tracking HL7 standards development.

The methodology shall (1) address how the Contractor will gather, organize, monitor, and manage work products associated with HL7 standards, (2) identify key metrics associated with standards, and (3) provide a transition plan for monitoring and tracking activities after the period of performance concludes. Examples of key metrics include:

o Name & identifier of the work product o Sponsoring workgroup(s) o Whether a Project Scope Statement (PSS) has been submitted and approved o Which workgroup(s) have approved the PSS o Current status/maturity (e.g. pre-ballot, balloted, draft standard for trial use, standard for trial use, normative) o Current version o Whether the standard is cited in federal regulation javascript:__doPostBack('ctl00$ctl00$body$homebody$RecentDocuments$C$RecentDocumentsControl$PinnedDocumentResults$ctl00$DocumentNumberLink','') o Expiration date (i.e. when the standard must be renewed) o Deployment and usage

• Contractor shall implement the tracking methodology and track HL7 standards development in the US Realm. Contractor shall provide ONC with all data collected in the course of monitoring US Realm standards development activities

• Contractor will provide maintenance and support for technical infrastructure supporting the HL7 US Realm standards and implementation specifications.

Task 2: Develop and enforce governance policies for US Realm standards development.

The Contractor shall assist ONC in developing, maintaining, and enforcing governance of US Realm standards and implementation specifications, including but not limited to guidelines for:

• Creating and publishing FHIR profiles, extensions, and implementation guidance.

• Updating the US Core Implementation Guide, including adding new profiles and modifying existing profiles to meet US Realm needs.

• Re-using existing HL7 standards work products for US Realm specific needs, including but not limited to FHIR profiles and C-CDA templates.

• Managing standards produced by the HL7 FHIR Accelerator Program.

The Contractor shall develop a written governance plan for standards development in the US Realm, including but not limited to:

• Recommended guidelines for US Realm standards development.

• Strategies for reviewing new US Realm standards development proposals and enforcing guidelines.

Task 3: Facilitate stakeholder outreach to coordinate standards development and implementation activities in the US Realm.

The Contractor shall assist ONC in engaging the US standards development community to increase awareness of US Realm guidelines and identify strategic priorities for US Realm standards development and implementation activities.

The Contractor shall provide situational awareness to ONC about other HL7 standards development and implementation activities that may impact the US Realm.

• Contractor shall develop a written stakeholder outreach and engagement plan, including but not limited to:

o Recommendations for key stakeholders or projects to engage. At a minimum, the Contractor shall include other HL7 governance and management workgroups, projects under the HL7 FHIR Accelerator Program, and projects that have been sponsored or funded by US federal agencies.

o Strategies for identifying and evaluating standards development and implementation activities that may impact the US Realm.

o Proposed approach for stakeholder outreach and engagement, including but not limited to methods of contact, frequency of engagement, and procedures for capturing and reporting on the outcomes of outreach and engagement.

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• Contractor shall analyze meetings and work products from other HL7 governance and management groups including but not limited to:

o FHIR Management Group o CDA Management Group o HL7 Terminology Authority o Technical Steering Committee o Standards Governance Board

• Contractor shall engage with project leads from other standards development and implementation projects on at least a quarterly basis to provide information about applicable US Realm guidelines, better understand the purpose and goals of the projects, and identify potential priorities for standards development and implementation in the US Realm. At a minimum, Contractor shall engage with:

o Projects under the HL7 FHIR Accelerator Program o Projects sponsored or funded by US federal agencies

• Contractor shall provide a written update on a quarterly basis detailing insights and analysis from stakeholder outreach and engagement. At a minimum, the update shall include any guidance or directives from other groups, new projects that require US Realm oversight or approval, trends or issues that may impact the US realm, and recommendations (as appropriate) for future standards development and implementation activities.

o Contractor shall present relevant findings from each quarterly update to ONC.

The Contractor shall develop a strategic roadmap for standards development and implementation activities in the US Realm. At a minimum, the roadmap shall:

• Identify strategic goals for HL7 standards development and implementation in the US Realm.

• Identify priority areas in need of additional standards development and implementation to support the interoperable use of health IT.

• Describe an approach for publication of new versions of US Core Implementation Guide and C-CDA Companion Guide based on data elements specified in the latest version of the USCDI approved by ONC for the Standard Version Advancement Process (SVAP).

• Provide recommendations for ensuring that US Realm standards and implementation guidance are appropriately kept “up-to-date” for the duration of the standards lifecycle.

• Measure the adoption, implementation, and use of HL7 US Realm Standards and Implementation Specifications.

Task 4: Lead the development, balloting, and publication of the US Core Implementation Guide and C-CDA standard.

The Contractor shall lead the development of new versions of the US Core Implementation Guide and C-CDA standard (including C-CDA Companion Guide).

• Contractor shall recommend and make updates to the content of the standards and implementation guidance, including written guidance, resources, profiles, extensions, and terminologies as appropriate. Contractor shall base recommendations on the appropriate processes established in HL7 working groups. At a minimum, updates shall reflect any applicable changes in USCDI.

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• Contractor shall facilitate testing of the standards and implementation guidance by identifying pilot implementations, organizing “connectathons”, and soliciting feedback from the HL7 standards community. Contractor shall update the standards and implementation guidance as appropriate based on testing.

• Contractor shall ballot the standards and implementation guidance according to HL7 policies and procedures governing the HL7 standards development process.

• For each version of the standards and implementation guidance balloted by the Contractor during the period of performance, Contractor is responsible for publishing a Standard for Trial Use (STU) according to HL7 policies and procedures. Any such STU shall be licensed per HL7 policies and procedures.

At a minimum, the Contractor shall provide:

• Written recommendations for updates to C-CDA and US Core standards.

• Updated versions of C-CDA and US Core standards, including GitHub repository and online “build”.

• Written proposal for conducting pilot tests of updated versions of C-CDA and US Core standards.

• Written plan for Connectathon tracks to test updated versions of C-CDA and US Core standards.

• Updated version of C-CDA and US Core for ballot, including GitHub repository and online “build”.

• Published STU version of C-CDA and US Core, including GitHub repository and online

“build”.

Task 5: Ensure a high-performing, efficient, and sustainable US Realm.

The Contractor shall implement relevant aspects of the governance plan and strategic roadmap to manage and oversee standards development and implementation activities in the US Realm.

The Contractor shall develop a written report describing how the activities performed under this contract facilitated HL7 standards development and implementation for the US Realm. At a minimum, the report shall:

• Assess the state of US Realm governance, including the impact of any guidelines that have been developed, maintained, and enforced.

• Identify priorities for future activities to support standards development for the US Realm.

• Describe how ongoing and proposed US Realm standards development and implementation activities align with the US Realm strategic roadmap.

• Describe challenges and lessons learned.

Task 6: Project management and administration.

Within one month after the award, the Contractor shall conduct a Kick-off Meeting with the ONC COR and Project Manager to discuss the objectives of the contract, set expectations regarding roles and responsibilities, and identify any related project issues. At a minimum, the outcome of this meeting shall be agreement on a set of high level milestones for which the javascript:__doPostBack('ctl00$ctl00$body$homebody$RecentDocuments$C$RecentDocumentsControl$PinnedDocumentResults$ctl00$DocumentNumberLink','') contract will be oriented and upon which the Work Plan will be focused.

The Contractor shall deliver a draft Work Plan within one month of the Kick-off Meeting, and a final Work Plan based on feedback from ONC within one month thereafter. At a minimum, the Work Plan shall include a detailed schedule of proposed project milestones, a schedule of deliverables and their estimated cost, and a listing of any critical dependencies which may impact successful completion of milestones and the dates by which those issues should be resolved.

The Contractor shall meet with the ONC COR and Project Manager at least monthly to provide status updates for the tasks outlined in this SOW. In addition, the Contractor shall:

• Ensure the timely delivery of all deliverables and work products associated with this contract.

• Provide appropriate administrative, clerical, documentation, and other related functions for the successful management and administration of this contract.

• Manage the Work Plan, schedules, and resources for the tasks outlined in this SOW.

• Promptly communicate with the ONC COR and Project Manager verbally and in writing, any changes to the estimated resources (e.g., time, money, materials) required to complete the tasks under this contract.

• Ensure that activities conducted by the Contractor’s personnel, including but not limited to research, stakeholder outreach and engagement, and coordination with the HL7 standards development community, are directly relevant to and necessary for completing the tasks outlined in this SOW.

• Maintain high standards of employee competency, conduct, professionalism, and integrity.

The Contractor shall provide written documentation to the ONC COR and Project Manager at least monthly describing the activities performed to complete the tasks under this SOW. The Project Status Report shall include, at a minimum:

• Objectives met, work completed, and work outstanding per the Work Plan

• Hours used/hours remaining per assigned individual(s)

• Notable achievements (as applicable)

• Issues or obstacles impeding progress and recommended solutions (as applicable)

• Status of deliverable/milestones

• Resource planning/status (as applicable)

• Risks to the quality of deliverables and work products (as applicable)

Optional Task 7 (year 1): Lead development, balloting, and/or publication of additional US Realm standards and implementation guidance.

Subject to the availability of funding, ONC anticipates exercising this optional task to conduct standards development activities in accordance with health IT priorities and needs identified by other federal agencies. ONC anticipates at least one “release” of a standard or implementation guidance for this task.

The Contractor shall develop, ballot, and publish standards and implementation guidance that javascript:__doPostBack('ctl00$ctl00$body$homebody$RecentDocuments$C$RecentDocumentsControl$PinnedDocumentResults$ctl00$DocumentNumberLink','') provide additional sets of profiles, extensions, terminologies, protocols, and/or technical guidance for use in future standards development and implementation activities in the US Realm.

All standards and guidance developed for this task must be balloted in accordance with HL7 standards development policies and procedures.

• Contractor shall develop and submit to ONC, recommendations of identified priorities for standards development, balloting, and publication, based on input and feedback from the USR-SC, and other stakeholders as appropriate.

The scope of a standard or implementation guidance may vary depending on the needs of the federal agency. In general, standards or implementation guidance development under this task involves:

• Gathering information about the scope and requirements of the standard or implementation guidance.

• Drafting new or updating existing standards or implementation guidance.

• Testing the new or updated standard or implementation guidance through Connectathons and pilot implementations.

• Incorporating lessons learned from testing and other feedback from the HL7 community to update the draft specification.

• Balloting the draft specification according to HL7 standards development policies and procedures.

• Performing ballot reconciliation and updating the draft specification.

• Publishing an STU version of the standard or implementation guidance.

At a minimum, for each “release” of a standard, the Contractor shall provide:

• A written plan for developing, updating, balloting, and/or publishing the standard or implementation guidance.

• Draft and final versions of US Realm standards or implementation guidance, including GitHub repository and online “build”.

• A written transition plan for maintaining any new standards or implementation guidance beyond the period of performance. At a minimum, the plan shall identify a potential “owner” that is responsible for ongoing maintenance of the standard or implementation guidance, anticipated risks or challenges associated with maintaining the standard in the future, and recommendations for mitigating such risks or challenges.

Optional Task 8 (year 2): Lead development, balloting, and/or publication of additional US

Subject to the availability of funding, ONC anticipates exercising this optional task to conduct standards development activities in accordance with health IT priorities and needs identified by other federal agencies. ONC anticipates at least two “releases” (e.g. two standards with one release each or one standard with two releases) of a standard or implementation guidance for this task.

The Contractor shall develop, ballot, and publish standards and implementation guidance that provide additional sets of profiles, extensions, terminologies, protocols, and/or technical guidance for use in future standards development and implementation activities in the US Realm.

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All standards and guidance developed for this task must be balloted in accordance with HL7 standards development policies and procedures.

• Contractor shall develop and submit to ONC, recommendations of identified priorities for involves:

• Gathering information about the scope and requirements of the standard or implementation guidance.

• Drafting new or updating existing standards or implementation guidance.

• Testing the new or updated standard or implementation guidance through Connectathons and pilot implementations.

• Incorporating lessons learned from testing and other feedback from the HL7 community to update the draft specification.

• Balloting the draft specification according to HL7 standards development policies and procedures.

implementation guidance.

• Draft and final versions of US Realm standards or implementation guidance, including GitHub repository and online “build”.

• A written transition plan for maintaining any new standards or implementation guidance beyond the period of performance. At a minimum, the plan shall identify a potential “owner” that is responsible for ongoing maintenance of the standard or implementation

Optional Task 9 (year 3): Lead development, balloting, and/or publication of additional US

Subject to the availability of funding, ONC anticipates exercising this optional task to conduct standards development activities in accordance with health IT priorities and needs identified by other federal agencies. ONC anticipates at least two “releases” (e.g. two standards with one release each or one standard with two releases) of a standard or implementation guidance for this task.

The Contractor shall develop, ballot, and publish standards and implementation guidance that provide additional sets of profiles, extensions, terminologies, protocols, and/or technical guidance for use in future standards development and implementation activities in the US Realm.

All standards and guidance developed for this task must be balloted in accordance with HL7 javascript:__doPostBack('ctl00$ctl00$body$homebody$RecentDocuments$C$RecentDocumentsControl$PinnedDocumentResults$ctl00$DocumentNumberLink','')

• Contractor shall develop and submit to ONC, recommendations of identified priorities for involves:

• Gathering information about the scope and requirements of the standard or implementation guidance.

• Drafting new or updating existing standards or implementation guidance.

• Testing the new or updated standard or implementation guidance through Connectathons and pilot implementations.

• Incorporating lessons learned from testing and other feedback from the HL7 community to update the draft specification.

• Balloting the draft specification according to HL7 standards development policies and procedures.

implementation guidance.

• Draft and final versions of US Realm standards or implementation guidance, including GitHub repository and online “build”.

• A written transition plan for maintaining any new standards or implementation guidance beyond the period of performance. At a minimum, the plan shall identify a potential “owner” that is responsible for ongoing maintenance of the standard or implementation

Optional Task 10 (year 4): Lead development, balloting, and/or publication of additional US Realm standards and implementation guidance.

Subject to the availability of funding, ONC anticipates exercising this optional task to conduct standards development activities in accordance with health IT priorities and needs identified by other federal agencies. ONC anticipates at least two “releases” (e.g. two standards with one release each or one standard with two releases) of a standard or implementation guidance for this task.

The Contractor shall develop, ballot, and publish standards and implementation guidance that provide additional sets of profiles, extensions, terminologies, protocols, and/or technical guidance for use in future standards development and implementation activities in the US Realm.

All standards and guidance developed for this task must be balloted in accordance with HL7 javascript:__doPostBack('ctl00$ctl00$body$homebody$RecentDocuments$C$RecentDocumentsControl$PinnedDocumentResults$ctl00$DocumentNumberLink','') involves:

• Gathering information about the scope and requirements of the standard or implementation guidance.

• Drafting new or updating existing standards or implementation guidance.

• Testing the new or updated standard or implementation guidance through Connectathons and pilot implementations.

• Incorporating lessons learned from testing and other feedback from the HL7 community to update the draft specification.

• Balloting the draft specification according to HL7 standards development policies and procedures.

implementation guidance.

• Draft and final versions of US Realm standards or implementation guidance, including GitHub repository and online “build”.

• A written transition plan for maintaining any new standards or implementation guidance beyond the period of performance. At a minimum, the plan shall identify a potential “owner” that is responsible for ongoing maintenance of the standard or implementation

Optional Task 11 (year 5): Lead development, balloting, and/or publication of additional US Realm standards and implementation guidance.

Subject to the availability of funding, ONC anticipates exercising this optional task to conduct standards development activities in accordance with health IT priorities and needs identified by other federal agencies. ONC anticipates at least two “releases” (e.g. two standards with one release each or one standard with two releases) of a standard or implementation guidance for this task.

The Contractor shall develop, ballot, and publish standards and implementation guidance that provide additional sets of profiles, extensions, terminologies, protocols, and/or technical guidance for use in future standards development and implementation activities in the US Realm.

All standards and guidance developed for this task must be balloted in accordance with HL7 javascript:__doPostBack('ctl00$ctl00$body$homebody$RecentDocuments$C$RecentDocumentsControl$PinnedDocumentResults$ctl00$DocumentNumberLink','') involves:

• Gathering information about the scope and requirements of the standard or implementation guidance.

• Drafting new or updating existing standards or implementation guidance.

• Testing the new or updated standard or implementation guidance through Connectathons and pilot implementations.

• Incorporating lessons learned from testing and other feedback from the HL7 community to update the draft specification.

• Balloting the draft specification according to HL7 standards development policies and procedures.

implementation guidance.

• Draft and final versions of US Realm standards or implementation guidance, including GitHub repository and online “build”.

• A written transition plan for maintaining any new standards or implementation guidance beyond the period of performance. At a minimum, the plan shall identify a potential “owner” that is responsible for ongoing maintenance of the standard or implementation

RESTRICTIONS ON DISCLOSURE OF INFORMATION AND RIGHTS IN DATA

DISCLOSURE OF INFORMATION

Information made available to the contractor by the Government for the performance or administration of this effort shall be used only for those purposes and shall not be used in any other way without the written agreement of the Contracting Officer.

The contractor agrees to assume responsibility for protecting the confidentiality of Government records, which are not public information. Each contractor or employee of the contractor to whom information may be made available or disclosed shall be notified in writing by the contractor that such information may be disclosed only for a purpose and to the extent authorized herein.

LIMITED USE OF DATA

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Performance of this effort may require the contractor to access and use data and information proprietary to a Government agency or Government contractor which is of such a nature that its dissemination or use, other than in performance of this effort, would be adverse to the interests of the Government and/or others.

Contractor and/or contractor personnel shall not divulge or release data or information developed or obtained in performance of this effort, until made public by the Government, except to authorized Government personnel or upon written approval of the Contracting Officer (CO). The contractor shall not use, disclose, or reproduce proprietary data that bears a restrictive legend, other than as required in the performance of this effort. Nothing herein shall preclude the use of any data independently acquired by the contractor without such limitations or prohibit an agreement at no cost to the Government between the contractor and the data owner which provides for greater rights to the contractor.

No protected health information (PHI) or personally identifiable information (PII) will be shared between ONC and the contractor. In addition, the work performed under this contract will not have any connections to HHS information technology systems.

COPYRIGHT

52.227-14 Rights in Data-General (c)Copyright- (1)Data first produced in the performance of this contract.

(i)Unless provided otherwise in paragraph (d) of this clause, the Contractor may, without prior approval of the Contracting Officer, assert copyright in scientific and technical articles based on or containing data first produced in the performance of this contract and published in academic, technical or professional journals, symposia proceedings, or similar works. The prior, express written permission of the Contracting Officer is required to assert copyright in all other data first produced in the performance of this contract.

(ii)When authorized to assert copyright to the data, the Contractor shall affix the applicable copyright notices of 17 U.S.C. 401 or 402, and an acknowledgment of Government sponsorship (including contract number).

(iii)For data other than computer software, the Contractor grants to the Government, and others acting on its behalf, a paid-up, nonexclusive, irrevocable, worldwide license in such copyrighted data to reproduce, prepare derivative works, distribute copies to the public, and perform publicly and display publicly by or on behalf of the Government. For computer software, the Contractor grants to the Government, and others acting on its behalf, a paid-up, nonexclusive, irrevocable, worldwide license in such copyrighted computer software to reproduce, prepare derivative works, and perform publicly and display publicly (but not to distribute copies to the public) by or on behalf of the Government.

SECTION D - Packaging and Marking

D.1 PACKAGING AND MARKING

javascript:__doPostBack('ctl00$ctl00$body$homebody$RecentDocuments$C$RecentDocumentsControl$PinnedDocumentResults$ctl00$DocumentNumberLink','') http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3

All deliverables shall be delivered to the Contracting Officer’s Representative (COR) identified in Section G and shall be marked as follows:

1. Name and address of the Contractor;

2. Contract Number;

3. Description of item contained therein; and

4. Consignee's name and address.

D.2 PAYMENT OF POSTAGE AND FEES

All postage and fees related to submitting information including forms, reports, etc. to the Contracting Officer or COR shall be paid by the Contractor.

SECTION E - Inspection and Acceptance

E.1 INSPECTION AND ACCEPTANCE

Pursuant to the appropriate inspection clause, all work described in Section C to be delivered under this contract is subject to final inspection and acceptance by an authorized representative of the Government. The authorized representative of the Government is the Contracting Officer’s Representative (COR), who is responsible for inspection and acceptance of all services, materials, or supplies to be provided by the Contractor.

E.2.1 Inspection and Acceptance Criteria Final inspection and acceptance of all work performed, reports and other deliverables will be performed at the place of delivery by the COR.

E.2.2 General Acceptance Criteria General quality measures, as set forth below, will be applied to each work product received from the Contractor under this Statement of Work.

• Accuracy - Work Products shall be accurate in presentation, technical content, and adherence to accepted elements of style.

• Clarity - Work Products shall be clear and concise. Any/all diagrams shall be easy to understand and be relevant to the supporting narrative.

• Consistency to Requirements - All work products must satisfy the requirements of this

Statement of Work.

• File Editing - All text and diagrammatic files shall be editable by the Government.

• Format - Work Products shall be submitted in hard copy and electronic copy. The electronic copy must be in a format as indicated in the Deliverables Table.

SECTION F - Deliveries or Performance

F.1 PERIOD OF PERFORMANCE – Severable Services javascript:__doPostBack('ctl00$ctl00$body$homebody$RecentDocuments$C$RecentDocumentsControl$PinnedDocumentResults$ctl00$DocumentNumberLink','')

The period of performance shall be for a base period of 5-years from the date of award, as follows:

Base Period: TBD

Optional task(s) may be exercised in accordance with FAR Clause 52.217-7 entitled "Option for Increased Quantity-Separately Priced Line Item."

F.3 PLACE OF PERFORMANCE

Work will be performed at the Contractor’s primary place of performance at: CONTRACTOR’S PRIMARY PLACE OF PERFORMANCE), but the contractor is not prohibited from allowing its employees to telework in accordance with the contractor’s policies if the work and required level of performance can be completed successfully in accordance with the contract requirements. The Contractor shall coordinate employee telework in advance with the Contracting Officer’s Representative.

F.4 REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE

The contractor shall submit all required report(s)/deliverables in accordance with the following schedule: All reports shall reference and cite the contract number.

F.4.1 DELIVERABLES SCHEDULE

In fulfillment of this effort, the Contractor shall provide the following deliverables. All deliverables shall be submitted to the COR, unless otherwise agreed upon. Unless otherwise specified, the Government will have a maximum of ten (10) business days from the day the draft deliverable is received to review the document, provide comments back to the contractor, approve or disapprove the deliverable(s). The Contractor will also have a maximum of ten (10) business days from the day comments are received to incorporate all changes and submit the final deliverable to the Government. All days identified below are intended to be business days unless otherwise specified.

Acceptable formats for written deliverables include Word, Excel, or Powerpoint, subject to approval by ONC.

Deliverables Task Deliverable Due Date Format Task 1: Tracking methodology

Written methodology including:

• How the Contractor will gather, organize, monitor, and manage work products associated with HL7 standards development

• Key metrics associated with standards

Within 1 month after approval of Work Plan

To the COR as Word, Excel, or Powerpoint javascript:__doPostBack('ctl00$ctl00$body$homebody$RecentDocuments$C$RecentDocumentsControl$PinnedDocumentResults$ctl00$DocumentNumberLink','') development

• Transition Plan for continued monitoring and tracking after the period of performance concludes

Task 1: HL7 work product tracking

Format TBD (e.g. Excel, Confluence)

Ongoing To the COR, format TBD by

COR

Task 2: US Realm governance plan

Written governance plan addressing guidelines and enforcement for US Realm standards development

TBD by

COR

To the COR as Word, Excel, or Powerpoint

Task 3:

Stakeholder engagement plan

Written stakeholder outreach and engagement plan

Within 1 month after approval of Work Plan

To the COR as Word, Excel, or Powerpoint

Task 3: Quarterly updates

Written update and presentation including:

• Guidance or directives from other groups

• New projects that require US Realm oversight or approval

• Trends or issues that may impact the US realm

• Recommendations for future standards development

Quarterly To the COR as Word, Excel, or Powerpoint

Task 3: US Realm roadmap

Written US Realm standards development roadmap including:

• Strategic goals

• Priorities for standards development

• Aligning standards to regulatory changes

• Supporting the standards developing lifecycle

TBD by

COR

To the COR as Word, Excel, or Powerpoint

Task 4:

Recommendations for updates to standards

Written recommendations for updates to C- CDA and US Core

TBD by

COR

To the COR as Word, Excel, or Powerpoint

Task 4: Updated standards

Updated versions of C-CDA and US Core, including GitHub repository and online “build”

TBD by

COR

To the COR as URL to GitHub repository and build

Task 4: Pilot testing proposal

Written proposal for conducting pilot tests of updated versions of C-CDA and US Core

TBD by

COR

To the COR as Word, Excel, or Powerpoint

Task 4:

Connectathon plan

Written plan for Connectathon tracks to test updated versions of C-CDA and US Core

TBD by

COR

To the COR as Word, Excel, or Powerpoint

Task 4: Balloted Updated version of C-CDA and US Core for TBD by To the COR as javascript:__doPostBack('ctl00$ctl00$body$homebody$RecentDocuments$C$RecentDocumentsControl$PinnedDocumentResults$ctl00$DocumentNumberLink','') standard ballot, including GitHub repository and online “build”

COR URL to GitHub repository and build

Task 4: Published

STU

Published STU version of C-CDA and US Core, including GitHub repository and online “build”

TBD by

COR

To the COR as URL to GitHub repository and build

Task 5: Final US Realm Report

Written report describing the state of the US Realm including:

• State of US Realm governance and impact of guidelines for US Realm standards development

• Future priorities

• Alignment of activities with US Realm roadmap

• Challenges and lessons learned

One month prior to conclusion of the period of performance

To the COR as Word, Excel, or Powerpoint

Task 6: Work Plan

Written Work Plan, including:

• Project milestones

• Deliverables/cost

• Critical dependencies

Within 1 month of Kick-off Meeting

To the COR as Word, Excel, or Powerpoint

Task 6:

Programmatic report

Written programmatic report, including:

• Objectives met, work completed, and work outstanding

• Hours used/hours remaining

• Notable achievements

• Issues and resolutions

• Status of deliverable/milestones

• Resource planning/status

• Quality risks

Monthly To the COR as Word, Excel, or Powerpoint

Task 7 [Optional]:

Standards development plan

Written plan for developing, updating, balloting, and/or publishing US Realm standards or implementation guidance

TBD by

COR

To the COR as Word, Excel, or Powerpoint

Task 7 [Optional]:

Published standards

Published versions of US Realm standards or implementation guidance, including GitHub repository and online “build” as appropriate

TBD by

COR

To the COR as URL to GitHub repository and build

Task 7…