RFP - 75P00123R00032 - Trusted Exchange Framework and Common Agreement.pdf

75P00123R00032- Trusted Exchange Framework and Common Agreement (TEFCA) - Recognized Coordinating Entity (RCE)

SECTION A - Solicitation/Contract Form

TABLE OF CONTENTS

Section Page No. Section Page No.

A 1 H 35 B 2 I 38 C 17 J 53 D 25 K 54 E 26 L 70 F 27 M 75 G 31

SECTION B - Supplies or Services and Prices/Costs

B.1 BRIEF DESCRIPTION OF SERVICES

The U.S. Department of Health and Human Services (HHS) is committed to advancing the interoperability of health information technology (health IT). In the 21st Century Cures Act (Cures Act), Congress identified the importance of interoperability and directed ONC to work with federal agencies within HHS and convene public-private and public-public partnerships to “develop or support a trusted exchange framework, including a common agreement among health information networks nationally.” The Trusted Exchange Framework, Common Agreement, Qualified Health Information Networks (QHINs) and QHIN Technical Framework (QTF) are distinct components of TEFCA. The purpose of this contract is to advance TEFCA in service of improving nationwide interoperability.

Additional details are included in section C.

B.2 TYPE OF CONTRACT

The contract type awarded is a Time and Material.

B.3 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 CLINs.

B.4 CONSIDERATION AND PAYMENT (Time and Material – Severable Services)

In consideration of satisfactory performance of the work as described throughout this contract, the Contractor shall be paid in accordance with the fixed loaded hourly rates as shown herein for the specified categories of labor based on the number of actual hours incurred in the performance of the work specified. Fully loaded rates shall be all inclusive of direct labor, fringe benefits, applicable indirect costs, and any profit for each labor category. Additionally, the contractor shall be reimbursed the actual cost of materials in accordance with FAR 52.212-4; Alt 1. If specifically provided for in the contract, the contractor shall be reimbursed for indirect material costs on a pro-rata basis over the contract performance period at the fixed price specified herein. If the options are exercised funding will be obligated by modification to the contract. The base period and option periods are priced as follows:

B.4.1 CLIN 1 - Base Period – 12 Months:

Labor Categories Loaded Rates Estimated Hours Estimated Total Technical SMEs 3,000 $ Legal SMEs 3,550 $ Policy SMEs 2,000 $ Support Staff 2,000 $ Consultant 1 1,000 $ Consultant 2 400 $ Labor Subtotal $

Travel $ FIXED PRICE Material Indirect Cost $

CLIN Ceiling (Not to Exceed) $

Payment Schedule for Material Indirect Costs Fixed Price: monthly (total fixed price stated above divided by the number of months in the contract period)

B.4.2 CLIN 2 - Base Period – Optional Task #1 (Task 13):

Labor Categories Loaded Rates Estimated Hours Estimated Total Technical SMEs 150 $ Legal SMEs 150 $ Policy SMEs 75 $ Support Staff 75 $ Consultant 1 100 $ Consultant 2 100 $ Labor Subtotal $

Travel $

B.4.3 CLIN 3 - Base Period – Optional Task #2 (Task 14):

Technical SMEs 150 $ Legal SMEs 150 $ Policy SMEs 75 $ Support Staff 75 $ Consultant 1 100 $ Consultant 2 100 $ Labor Subtotal $

Travel $

B.4.4 CLIN 4 - Base Period – Optional Task #3 (Task 15):

Labor Categories Loaded Rates Estimated Hours Estimated Total Technical SMEs 75 $ Legal SMEs 75 $ Policy SMEs 50 $ Support Staff 50 $ Consultant 1 50 $ Consultant 2 50 $ Labor Subtotal $

Travel $

B.4.5 CLIN 5 - Base Period – Optional Task #4 (Task 16):

Technical SMEs 150 $ Legal SMEs 150 $ Policy SMEs 75 $ Support Staff 75 $ Consultant 1 100 $ Consultant 2 100 $ Labor Subtotal $

Travel $

B.4.6 CLIN 6 – Option Period 1 – 12 Months:

Labor Categories Loaded Rates Estimated Hours Estimated Total Technical SMEs 3,090 $ Legal SMEs 3,657 $ Policy SMEs 2,060 $ Support Staff 2,060 $ Consultant 1 1,030 $ Consultant 2 412 $ Labor Subtotal $

Travel $

B.4.7 CLIN 7 – Option Period 1 – Optional Task #1 (Task 13):

Legal SMEs 150 $ Policy SMEs 75 $ Support Staff 75 $ Consultant 1 100 $ Consultant 2 100 $ Labor Subtotal $

Travel $

B.4.8 CLIN 8 – Option Period 1 – Optional Task #2 (Task 14):

Labor Categories Loaded Rates Estimated Hours Estimated Total Technical SMEs 150 $ Legal SMEs 150 $ Policy SMEs 75 $ Support Staff 75 $ Consultant 1 100 $ Consultant 2 100 $ Labor Subtotal $

Travel $

B.4.9 CLIN 9 – Option Period 1 – Optional Task #3 (Task 15):

Technical SMEs 75 $ Legal SMEs 75 $ Policy SMEs 50 $ Support Staff 50 $ Consultant 1 50 $ Consultant 2 50 $ Labor Subtotal $

Travel $

B.4.10 CLIN 10 – Option Period 1 – Optional Task #4 (Task 16):

Labor Categories Loaded Rates Estimated Hours Estimated Total Technical SMEs 150 $ Legal SMEs 150 $ Policy SMEs 75 $ Support Staff 75 $ Consultant 1 100 $ Consultant 2 100 $ Labor Subtotal $

Travel $

B.4.11 CLIN 11 – Option Period 2 – 12 Months:

Technical SMEs 3,090 $

Legal SMEs 3,657 $ Policy SMEs 2,060 $ Support Staff 2,060 $ Consultant 1 1,030 $ Consultant 2 412 $ Labor Subtotal $

Travel $

B.4.12 CLIN 12 – Option Period 2 – Optional Task #1 (Task 12):

Labor Categories Loaded Rates Estimated Hours Estimated Total Technical SMEs 100 $ Legal SMEs 100 $ Policy SMEs 50 $ Support Staff 50 $ Consultant 1 50 $ Consultant 2 50 $ Labor Subtotal $

Travel $

B.4.13 CLIN 13 – Option Period 2 – Optional Task #2 (Task 13):

Legal SMEs 150 $

Policy SMEs 75 $ Support Staff 75 $ Consultant 1 100 $ Consultant 2 100 $ Labor Subtotal $

Travel $

B.4.14 CLIN 14 – Option Period 2 – Optional Task #3 (Task 14):

Labor Categories Loaded Rates Estimated Hours Estimated Total Technical SMEs 150 $ Legal SMEs 150 $ Policy SMEs 75 $ Support Staff 75 $ Consultant 1 100 $ Consultant 2 100 $ Labor Subtotal $

Travel $

B.4.15 CLIN 15 – Option Period 2 – Optional Task #4 (Task 15):

Technical SMEs 75 $ Legal SMEs 75 $ Policy SMEs 50 $

Support Staff 50 $ Consultant 1 50 $ Consultant 2 50 $ Labor Subtotal $

Travel $

B.4.16 CLIN 16 – Option Period 2 – Optional Task #5 (Task 16):

Labor Categories Loaded Rates Estimated Hours Estimated Total Technical SMEs 75 $ Legal SMEs 75 $ Policy SMEs 50 $ Support Staff 50 $ Consultant 1 50 $ Consultant 2 50 $ Labor Subtotal $

Travel $

B.4.17 CLIN 17 – Option Period 3 – 12 Months:

Technical SMEs 3,278 $ Legal SMEs 3,879 $ Policy SMEs 2,185 $ Support Staff 2,185 $

Consultant 1 1,093 $ Consultant 2 437 $ Labor Subtotal $

Travel $

B.4.18 CLIN 18 – Option Period 3 – Optional Task #1 (Task 13):

Labor Categories Loaded Rates Estimated Hours Estimated Total Technical SMEs 150 $ Legal SMEs 150 $ Policy SMEs 75 $ Support Staff 75 $ Consultant 1 100 $ Consultant 2 100 $ Labor Subtotal $

Travel $

B.4.19 CLIN 19 – Option Period 3 – Optional Task #2 (Task 14):

Technical SMEs 150 $ Legal SMEs 150 $ Policy SMEs 75 $ Support Staff 75 $ Consultant 1 100 $

Consultant 2 100 $ Labor Subtotal $

Travel $

B.4.20 CLIN 20 – Option Period 3 – Optional Task #3 (Task 15):

Labor Categories Loaded Rates Estimated Hours Estimated Total Technical SMEs 75 $ Legal SMEs 75 $ Policy SMEs 50 $ Support Staff 50 $ Consultant 1 50 $ Consultant 2 50 $ Labor Subtotal $

Travel $

B.4.21 CLIN 21 – Option Period 3 – Optional Task #4 (Task 16):

Technical SMEs 150 $ Legal SMEs 150 $ Policy SMEs 75 $ Support Staff 75 $ Consultant 1 100 $

Travel $

B.4.22 CLIN 22 – Option Period 4 – 12 Months:

Labor Categories Loaded Rates Estimated Hours Estimated Total Technical SMEs 3,377 $ Legal SMEs 3,996 $ Policy SMEs 2,251 $ Support Staff 2,251 $ Consultant 1 1,126 $ Consultant 2 450 $ Labor Subtotal $

Travel $

B.4.23 CLIN 23 – Option Period 4 – Optional Task #1 (Task 13):

Technical SMEs 150 $ Legal SMEs 150 $ Policy SMEs 75 $ Support Staff 75 $ Consultant 1 100 $

B.4.24 CLIN 24 – Option Period 4 – Optional Task #2 (Task 14):

Labor Categories Loaded Rates Estimated Hours Estimated Total Technical SMEs 150 $ Legal SMEs 150 $ Policy SMEs 75 $ Support Staff 75 $ Consultant 1 100 $ Consultant 2 100 $ Labor Subtotal $

Travel $

B.4.25 CLIN 25 – Option Period 4 – Optional Task #3 (Task 15):

Technical SMEs 75 $ Legal SMEs 75 $ Policy SMEs 50 $ Support Staff 50 $ Consultant 1 50 $ Consultant 2 50 $

B.4.26 CLIN 26 – Option Period 4 – Optional Task #4 (Task 16):

Labor Categories Loaded Rates Estimated Hours Estimated Total Technical SMEs 150 $ Legal SMEs 150 $ Policy SMEs 75 $ Support Staff 75 $ Consultant 1 100 $ Consultant 2 100 $ Labor Subtotal $

Travel $

B.4.27 Base and All Options Value: ________________________

B.5 CEILING PRICE

The hours and total price per labor category are for budgeting purposes only. The number of hours actually used for each category may exceed or be less than the estimate by category as long as the ceiling price for the CLIN is not exceeded. The ceiling for each CLIN is identified in Section B. The Government shall not be obligated to pay any amount in excess of this ceiling price nor is the Contractor obligated to continue performance if to do so would exceed this ceiling price. In the event that the Government chooses to exercise optional CLINS, unused funds from a previous CLIN may not be used to fund any services taking place in a subsequent CLIN. The ceiling price may be modified by the Government if it is determined that the estimated hours or estimated materials are insufficient for the work required.

B.6 ADDITIONS AND CHANGES TO LABOR CATEGORIES

It may be necessary to add or change labor categories during performance of this contract in order to carry out the services described in Section C. If new labor categories are added, or existing labor categories revised, the parties will negotiate the labor category(ies) prior to the incorporation into the contract. Any new labor rate proposed will be evaluated for reasonableness in accordance with FAR 15.4.

SECTION C - Description/Specifications/Statement of Work

TITLE: Trusted Exchange Framework and Common Agreement (TEFCA) - Recognized Coordinating Entity (RCE)

C.1 BACKGROUND

The U.S. Department of Health and Human Services (HHS) is committed to advancing the interoperability of health information technology (health IT). In the 21st Century Cures Act (Cures Act), Congress identified the importance of interoperability and directed ONC to work with federal agencies within HHS and convene public-private and public-public partnerships to “develop or support a trusted exchange framework, including a common agreement among health information networks nationally.”

The Trusted Exchange Framework, Common Agreement, Qualified Health Information Networks (QHINs) and QHIN Technical Framework (QTF) are distinct components of TEFCA that are described below:

The Trusted Exchange Framework is a common set of principles designed to facilitate trust between health information networks (HINs) and by which HINs voluntarily elect to abide to enable widespread information exchange. These principles are standardization; openness and transparency; cooperation and non-discrimination; privacy, security, and safety; access; equity; and public health.

The Common Agreement is the legal contract that the RCE will sign with each

QHIN. It defines the baseline legal and technical requirements for secure information sharing on a nationwide scale. The Common Agreement also establishes the infrastructure model and governing approach to enable users in different HINs to securely share clinical information with each other—all under commonly agreed-to expectations and regardless of which network they happen to be in.

A Qualified Health Information Network is a HIN that is a U.S. Entity that has been Designated and is a party to the Common Agreement countersigned by the

RCE.

The QHIN Technical Framework focuses on the technical components for exchange among QHINs, including, but not limited to, patient identity resolution, authentication, and performance measurement. The QHIN Technical Framework is incorporated by reference into the Common Agreement.

In August of 2019, an entity was awarded a four-year Cooperative Agreement to function as the Recognized Coordinating Entity (RCE). ONC published the Trusted Exchange Framework and the Common Agreement Version 1 on January 19, 2022. The RCE released the QHIN Technical Framework Version 1 on January 19, 2022 and released accompanying standard operating procedures (SOPs) throughout 2022 and 2023. The RCE opened the QHIN application process on October 3, 2022. ONC anticipates issuing future subregulatory guidance, regulatory guidance, or both, incorporating certain aspects of these documents and other policies.

C.2 PURPOSE

The purpose of this contract is to advance TEFCA in service of improving nationwide interoperability.

C.3 STATEMENT OF WORK - Severable Services

To achieve the purpose stated above, the Contractor shall perform the tasks listed below. In completing all tasks under this Contract, the Contractor is bound by any ONC guidance documents and applicable regulations that ONC may promulgate, as well as applicable law.

Base Tasks

C.3.1 Task 1 – Project Kickoff Meeting and Program Reporting The Contractor shall set up an introductory kick-off meeting with the COR and any project team members to ensure agreement on the overall project plan and timeline across tasks.

The Contractor shall include, as appropriate, any subcontractors who will work with the Contractor. During the kickoff meeting, the Contractor shall establish with the COR a routine schedule of update reports and meetings.

The Contractor shall conduct regular telephone calls with the COR to provide updates on project task status. Any meetings between the COR and the Contractor shall be arranged jointly by the COR and the Contractor as needed and at mutually convenient times.

The Contractor shall conduct a final meeting with the COR to conclude the period of performance.

C.3.2 Task 2 – Project Work Plan The Contractor shall deliver a draft Work Plan within 10 business days following the Kickoff Meeting and a final Work Plan within 20 business days following the Kickoff Meeting. The Work Plan shall include a proposed breakdown of the work to be completed, including a detailed schedule of proposed project milestones, schedule of interim deliverables, and listing of any critical dependencies on which the Contractor expects to rely on the government including the dates by which those dependencies should be resolved. The Contractor shall develop and maintain (update regularly, and, as necessary, revise) the Work Plan in an appropriate format and at a level of detail needed to ensure successful completion in a timely manner. The Work Plan and management approach shall prioritize agility and value to the customer.

The Contractor is encouraged to provide a topical outline of the Work Plan to the COR as an interim deliverable for this task prior to submission of the Work Plan.

C.3.3 Task 3 – Program Progress Updates

The Contractor shall participate in monthly calls with ONC and submit quarterly and annual progress reports to ONC.

C.3.4 Task 4 – Update Common Agreement The Contractor shall propose updates/revisions to the Common Agreement at least annually to ONC for approval and implement approved changes as requested by ONC. Additional updates/revisions may be required by ONC. Such updates/revisions may be related to new or existing regulations and subregulatory guidance, new ONC policies, technological advancements, or for any other reason identified by ONC.

C.3.5 Task 5 – Develop and Update SOPs and Common Agreement Resources The Contractor shall develop ten (10) new SOPs and Common Agreement resources and submit to ONC for approval. Additionally the Contractor shall propose revisions to already finalized SOPs and Common Agreement resources to ONC for approval and implement new or revised SOPs and Common Agreement resources as requested by ONC.

The Contractor will publish all SOPs and Common Agreement resources on its publicly available website.

C.3.6 Task 6 – Update TEFCA Technical Documents The Contractor shall propose revisions to two (2) documents: the QHIN Technical Framework (QTF), including updates related to Health Level Seven (HL7®) Fast Health Interoperability Resources (FHIR®) implementation, and propose revisions to the draft FHIR Implementation Guide, and submit both to ONC for approval. Additional updates/revisions may be required by ONC. Upon ONC approval, the Contractor shall publish the updated QTF and FHIR Implementation Guide on its publicly available website.

C.3.7 Task 7 – Public Information Dissemination The Contractor shall work with the COR to convene public informational sessions, on at least a quarterly basis, that will allow the public to provide feedback about TEFCA. The Contractor shall publicize and make the public information sessions available to a broad and diverse array of entities and must encourage a broad array of entities to participate in them. Those represented should include health care systems, payers, purchasers, care providers (e.g., long-term and post-acute care, behavioral health, community-based and safety net providers, and emergency medical services), health IT developers, QHINs, HINs, federal agencies, individuals, and other groups that enable widespread health information exchange to occur. The Contractor shall engage with the public on matters related to TEFCA through webinars; sessions at industry meetings; soliciting feedback on TEFCA topics; and attending at a minimum 5 national, regional, and peer learning meetings as directed by the COR. The Contractor may also host in person feedback sessions in states upon approval from the COR. The Contractor shall maintain a publicly available website for TEFCA.

C.3.8 Task 8 – Review Applications, Conduct Onboarding Activities, and Make QHIN Designation Determinations

The Contractor shall review QHIN applications, conduct activities related to Onboarding1, and provide a designation determination to ONC and the applicant, all in accordance with the Common Agreement, relevant SOPs, ONC regulations and subregulatory guidance, and applicable law. The Contractor shall support ONC’s appeals process for designation determinations, including providing additional information and maintaining documentation that supports the Contractor’s designation determination and providing such information and documentation to the COR upon request. The Contractor will provide to ONC a monthly report on the status of all items in Task 8.

C.3.9 Task 9 – Monitor QHINs and Make Determinations Regarding QHIN Noncompliance The Contractor shall monitor QHINs and make determinations regarding QHIN noncompliance with the Common Agreement and provide ONC with a monthly status report. The Contractor shall follow the processes established in the Common Agreement and relevant SOPs, ONC regulations and subregulatory guidance, and applicable law, for making determinations regarding noncompliance, including suspending or terminating a QHIN. The Contractor shall support ONC’s appeals process for suspension and termination determinations, including providing additional information and maintaining documentation that supports the Contractor’s suspension or termination determination and providing such information and documentation to the COR upon request.

C.3.10 Task 10 – TEFCA infrastructure The Contractor shall develop, maintain, operate, and upgrade key TEFCA infrastructure.

This must include testing and/or piloting activities. This task includes:

Developing and maintaining resources for QHINs, Participants and Subparticipants, including updates to any required technical specifications necessary to support TEFCA infrastructure and maintaining alignment with ONC standards requirements within a timeframe identified by ONC.

Developing, operating, maintaining, and upgrading/updating an endpoint directory, including an implementation guide for directory use.

Developing, operating, maintaining, and upgrading/updating the TEFCA infrastructure required to establish and support technically enforceable trust among participants, including digital certificates.

Any other actions identified by ONC as necessary for the development, maintenance, operation, and upgrading of key TEFCA infrastructure.

C.3.11 Task 11 – Evaluate TEFCA

1 The Common Agreement defines Onboarding as “the process Signatory, a Participant, or a Subparticipant must undergo to become a QHIN, Participant, or Subparticipant and operational in the production environment under the Framework Agreement to which it is a party. For Signatory, the Onboarding requirements shall be set forth in the Onboarding & Designation SOP addressing the process toward Designation as a QHIN. For a Participant, the Onboarding requirements shall be set forth in the Participant- QHIN Agreement. For a Subparticipant, the Onboarding requirements shall be set forth in the Subparticipant Agreement or the Downstream Subparticipant Agreement, as applicable.”

The Contractor shall evaluate TEFCA by monitoring the effectiveness of QHINs through collection of data, metrics, and reports, which will demonstrate the progress of exchange through TEFCA. The Contractor shall evaluate, on at least a quarterly basis (i.e., at least four times each year), trends in the volume of TEFCA exchange and participation in TEFCA, impacts on equity, stratified by identified demographics. The Contractor will provide various raw data, including data derived from the RCE directory to the COR, who could combine that data with other data to generate new insights on the status of nationwide interoperability.

Optional Tasks

C.3.12 Task 12 – Sustainability of TEFCA The Contractor shall propose a plan that an RCE could employ to sustain TEFCA at a national level. The Contractor shall submit a sustainability plan and revise the sustainability plan per ONC feedback.

C.3.13 Task 13 – Develop and Update Additional, Future SOPs and Common Agreement Resources

In addition to Task 5, the Contractor shall provide up to approximately five (5) new SOPs and/or Common Agreement resources per year, and submit those for ONC approval. The Contractor will publish all SOPs and Common Agreement resources on its publicly available website.

C.3.14 Task 14 – Additional, Future Technical Documents (e.g., Implementation Guides)

In addition to Task 6, the Contractor shall provide up to three (3) additional technical documents (e.g., additional implementation guides) throughout the period of performance, and submit them to ONC for approval. The Contractor shall publish the updated technical documents on its publicly available website.

C.3.15 Task 15 – Additional Public Information Dissemination

In addition to Task 7, the Contractor shall perform additional activities to engage with the public on matters related to TEFCA through additional webinars; additional sessions at industry meetings; additional solicitations of feedback on TEFCA topics; and attending at an additional 5 national, regional, and peer learning meetings as directed by the COR.

C.3.16 Task 16 – Pilots to Test TEFCA Requirements for Implementation

The Contractor must develop a pilot plan and perform up to four (4) pilots from the following categories:

1. TEFCA Standard Operating Procedures, as described in Task 5;

2. Common Agreement Resources, as described in Task 5;

3. QTF, as described in Task 6; and/or

4. TEFCA FHIR IG, as described in Task 6.

Prior to performance, the Contractor must receive ONC approval on the pilot plan and the pilot’s specific focus.

C.4 HHS SECTION 508 AND ACCESSIBILITY STANDARDS

Section 508 of the Rehabilitation Act, as amended by the Workforce Investment Act of 1998 (P.L. 105-220) requires that when Federal agencies develop, procure, maintain, or use information and communication technology (ICT), it shall be accessible to people with disabilities. Federal employees and members of the public who have disabilities must have access to, and use of, information and data that is comparable to people without disabilities.

All products, platforms and services delivered as part of this work statement that are ICT, or contain ICT, must conform to the Revised 508 Standards, which are located at 36 C.F.R. § 1194.1 & Apps. A, B, C & D, and available at https://www.access-board.gov/ict/.

All requirements are applicable to support services and documentation deliverables. All functional performance criteria apply when using an alternative design or technology that achieves substantially equivalent or greater accessibility and usability by individuals with disabilities, than would be provided by conformance to one or more of the requirements in Chapters 4-6 of the Revised 508 Standards, or when Chapters 4-6 do not address one or more functions of ICT.

For each proposed product or platform, a fully completed Accessibility Conformance Report (ACR) using the Voluntary Product Accessibility Template (VPAT) (https://www.itic.org/policy/accessibility/vpat) must be submitted. Evaluation will be on an Acceptable/Unacceptable basis.

Prior to acceptance of deliverables, the offeror must demonstrate conformance to the HHS Section 508 requirements via HHS Section 508 checklist(s) (https://www.hhs.gov/web/section-508/accessibility-checklists/index.html). The government reserves the right to perform testing on required ICT items to validate the offeror’s Section 508 conformance claims. If the government determines that Section 508 conformance does not meet the HHS Section 508 requirements, the government shall, at its option, require the offeror to remediate the item, at no additional cost to the government, to align with the HHS Section 508 conformance requirements prior to acceptance.

The contractor shall ensure all deliverables are produced in a way that is accessible to individuals with disabilities. Section 508 compliance is an iterative process consisting of several rounds of audit and fix cycles until the audit indicates that the content is free of errors. The contractor shall use both automated and human checking to ensure the specified reports, briefs, analyses, data, charts, tables, diagrams, graphics, pictures and other products and deliverables are 508 compliant. It is not sufficient to run an automated Section 508 checker or other automated program. Human audits are required to ensure the information presented for individuals with disabilities accurately reflects the information contained in the deliverable. The contractor shall consider Section 508 conformance in assessing options to present information, particularly information contained in complex charts and other data visualizations, audio and video. The contractor shall include Section 508 conformance as a milestone in all project plans and schedules for deliverables for all products required to be 508 compliant. In addition to the contractor’s internal process for ensuring all work produced is Section 508 conformant, the contractor shall plan for at least three cycles of audits and fixes with the Department over a period of 4 to 6 weeks to ensure final products meet the Department’s standards for Section 508 conformance.

References:

Section 508 Standards: https://www.access-board.gov/ict/ HHS Policy on Section 508 Compliance and Accessibility of Information and Communications Technology (ICT):

https://www.hhs.gov/web/governance/digital-strategy/it-policy-archive/department-of-health-and-human-services-hhs-policy-on-section- 508-and-accessibility-of-technology.html

HHS Accessibility and Section 508 Compliance Checklists:

https://www.hhs.gov/web/section-508/accessibility-checklists/index.html

C.5 RESTRICTIONS ON DISCLOSURE OF INFORMATION AND RIGHTS IN

DATA

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 employee 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.

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. 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 that provides for greater rights to the Contractor.

C.6 POST AWARD ORGANIZATIONAL CONFLICT OF INTEREST (OCI)

a. General: The Contractor shall have policies, processes, and programs in place to identify, report, and mitigate actual and potential conflicts of interest for itself, its employees, subcontractors and consultants. The existence of such policies, processes, and programs and the disclosure of known actual or potential conflicts are material performance requirements of this contract.

b. Disclosure: The Contractor shall report all actual and potential conflicts of interest pertaining to this contract to the Contracting Officer, including those that would be caused by a contemplated modification to this contract or another contract. Such reports shall be in writing (including by email). Upon request, the Contractor shall respond to a Contracting Officer's request for an OCI analysis and/or mitigation plan.

c. Resolution: In the event the Contracting Officer determines that a conflict of interest exists, based on disclosure from the Contractor or from other sources, the Contracting Officer shall take action which may include, but is not limited to, requesting a mitigation plan from the Contractor, terminating part or all of the contract, modifying the contract or obtaining a waiver in accordance with applicable law, including FAR 9.503 as applicable.

SECTION D - Packaging and Marking

D.1 PACKAGING AND MARKING

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 FAR clause 52.212-4, 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.1.1 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.1.2 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 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

The period of performance of the task order shall be for a Base period of twelve (12) months plus 4 Option Periods of twelve (12) months. The program funding for Option Periods is dependent on availability of funds, required work, satisfactory completion of tasks, and a determination that continued funding is in the best interest of the federal government and the public.

Base Period: September 1, 2023 through August 31, 2024 Option Period 1: September 1, 2024 through August 31, 2025 Option Period 2: September 1, 2025 through August 31, 2026 Option Period 3: September 1, 2026 through August 31, 2027 Option Period 4: September 1, 2027 through August 31, 2028

Option periods may be exercised in accordance with FAR Clause 52.217-9 entitled "Option to Extend the Term of the Contract."

Note: Actual Period of Performance depends on date of award.

F.2 PLACE OF PERFORMANCE

The work performed under this task order shall be performed at the Contractor’s site.

F.3 DELIVERABLES AND DELIVERY 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. The government will review deliverable documents, provide comments back to the Contractor, and approve or disapprove the deliverable (s). The Contractor will have a maximum of ten

(10) business days from the day ONC 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.

Deliverables (ongoing Tasks as specified above not listed here) Task Deliverable Due Date Base Tasks C.3.2 Task 2 – Project Work Plan

Project Work Plan including Staffing Plan

Draft – 10 business days after meeting Final – 20 business days after meeting

C.3.3 Task 3 – Program Support and Engagement

Quarterly and Annual Progress Reports

Every 3 months from the start of the award (quarterly) and at the end of each Period of Performance (annual)

C.3.4 Task 4 – Update Common Agreement

Common Agreement V2 Draft – December 31, 2023 Final – March 31, 2024

C.3.5 Task 5 – Develop and update Standard Operating Procedures (SOPs) and Common Agreement Resources

New SOPs Revised SOPs Common Agreement Resources

30 days following COR approval

C.3.6 Task 6 – Update Technical Documents

QTF V2

Updates to FHIR Implementation Guide

QTF Draft – December 31, 2023 QTF Final – March 31, 2024 FHIR IG updates – 30 days following COR approval

C.3.8 Task 8 – Review Applications, Conduct Onboarding Activities, and Make QHIN Designation Determinations

Monthly reports on the status of all items in Task 8

Monthly

C.3.9 Task 9 – Monitor QHINs and Make Determinations Regarding QHIN Noncompliance

Monthly status reports Monthly

C.3.10 Task 11 – Evaluate TEFCA

Metrics outlined in Task 10 Quarterly

Optional Tasks C.3.11 Task 12 – Sustainability of

TEFCA

Sustainability Plan Final Report due prior to the end of Option Year 3

C.3.13 Task 13 – Develop and Update Additional, Future SOPs and Common Agreement Resources

New SOPs Revised SOPs Common Agreement Resources

30 days following COR approval

C.3.14 Task 14 – Additional, Future Technical Documents (e.g., Implementation Guides)

QTF

Implementation Guides

30 days following COR approval

C.3.16 Task 16 – Pilots to Test TEFCA Requirements for Implementation

Pilot Plan

Conduct Pilots

30 days following execution of Optional Task.

Ongoing

All written deliverables must be accessible by Microsoft Word 2007. Any electronic spreadsheets submitted must be accessible by Microsoft Excel 2007. All audio files submitted on CDs must be playable by the latest version of Windows Media Player.

F.4 DELIVERABLES OWNED BY THE GOVERNMENT

Documents, records and data shall be documented in deliverable reports (electronically).

Any databases/code shall be delivered electronically and become the sole property of the United States Government.

All deliverables become the sole property of the United States Government and the Contractor has no right, title or interest in or to any deliverables produced under this award.

The Government, for itself and such others as it deems appropriate, will have unlimited rights under this contract to all information and materials developed under this contract and furnished to the Government and documentation thereof, reports and listings, and all other items pertaining to the work and services pursuant to this agreement including any copyright.

Unlimited rights under this contract are rights to use, duplicate, or disclose data, and information, in whole or in part in any manner and for any purpose whatsoever without compensation to or approval from the provider. The Government will at all reasonable times have the right to inspect the work and will have access to and the right to make copies of the above-mentioned items. All digital files and data, and other products generated under this contract, shall become the property of the Government.

This includes, but is not limited to:

Common Agreement;

QHIN Technical Framework;

SOPs;

Project Work Plan;

List of the participating QHINs;

Copies of executed Common Agreements and all amendments or attachments thereto;

Materials received or developed in relation to QHIN Applications and the

Onboarding, and Designation process, including QHIN Applications and the QHIN applicant's written plan for achieving the requirements of the Common Agreement, written documentation of QHIN Application approval, written documentation of QHIN Designation;

Materials received or developed in relation to making determinations regarding QHIN noncompliance with the Common Agreement, including information and documentation that supports the Contractor’s suspension or termination determinations;

Any ongoing corrective action plans with QHINs;

Other Deliverables developed during the Contract (Deliverables includes all materials developed under this contract whether in partial or final form);

F.5 PAYMENT FOR UNAUTHORIZED WORK

No payments will be made for any unauthorized supplies and/or services or for any unauthorized changes to the work specified herein. This includes any services performed by the Contractor of their own volition or at the request of an individual other than a duly appointed Contracting Officer. Only a duly appointed Contracting Officer is authorized to change the specifications, terms, and conditions under this effort.

F.6 GOVERNMENT FURNISHED PROPERTY

No Government Furnished Property or Equipment will be issued. The Contractor shall furnish all the necessary services and qualified personnel, material, equipment, and facilities, as needed to perform the requirements of this task order in a timely manner.

Any new equipment that the Contractor purchases under the other direct costs line item of this task order for the purpose or intent of accomplishing the objectives of this task order with resources provided through this agreement shall become the property of the government at the conclusion of the task order.

SECTION G - Contract Administration Data

G.1 PROVISIONS APPLICABLE TO MATERIAL COSTS

Unless otherwise expressly provided elsewhere in the contract or in any modification thereto, the cost of the following items or activities shall be unallowable as material costs:

1. Acquisition by purchase or lease, of any interest in real property.

2. Special rearrangement or alteration of facilities;

3. Purchase or lease or rental of any item of general purpose; office furniture or office equipment (including data tapes);

4. Travel to foreign countries; and

5. Food and beverage costs unless part of per diem expenses paid in accordance with the Federal Travel Regulations.

Any equipment having a unit acquisition cost in excess of $1,000.00, of which the Contractor wishes to be reimbursed as a material cost, shall not be acquired by the Contractor without the specific advance written approval of the Contracting Officer.

G.2 CONFERENCE EXPENSES

Unless the Contracting Officer provides explicit written approval for conference expenses, conference expenses are not allowable under this contract. For purposes of this contract, conference and conference expense are defined in the HHS Policy on Promoting Efficient Spending, specifically Attachment 1, Use of Appropriated Funds for Conferences and Meeting Space dated January 23, 2015. The attachment also provides a list of typical HHS meetings and events that are not considered conferences at Exhibit 2. The policy and associated attachments are located at the following site:

http://www.hhs.gov/grants/contracts/contract-policies-regulations/index.html)

G.3 AUTHORITIES OF GOVERNMENT PERSONNEL

Notwithstanding the Contractor's responsibility for total management during the performance of this contract, the administration of this contract will require maximum coordination between the Government and the Contractor. The following individuals will be the Government's points of contact during the performance of this contract:

Contracting Officer Lydina Battle U. S. Department of Health and Human Services Division of Acquisitions 1 (DA1) Office of the Assistant Secretary for Administration Office of Acquisitions Management Services Email: Lydina.Battle@psc.hhs.gov

All communications pertaining to contractual and/or administrative matters under this contract shall be sent to:

Contract Specialist Keith R. Harding U. S. Department of Health and Human Services Division of Acquisitions 1 (DA1) Office of the Assistant Secretary for Administration Office of Acquisitions Management Services Email: Keith.Harding@psc.hhs.gov

Contracting Officer's Representative Name: TBD U. S. Department of Health and Human Services Office of the National Coordinator for Health Information Technology Email: TBD Phone: TBD

Note: The Contracting Officer is the only individual authorized to modify the contract.

G.4 CONTRACTING OFFICER'S REPRESENTATIVE (COR) AUTHORITY

(a) Performance of work under this contract must be subject to the technical direction of the Contracting Officer's Representative identified above, or a representative designated in writing. The term "technical direction" includes, without limitation, direction to the contractor that directs or redirects the labor effort, shifts the work between work areas or locations, fills in details and otherwise serves to ensure that tasks outlined in the work statement are accomplished satisfactorily.

(b) Technical direction must be within the scope of the specification(s)/work statement.

The Contracting Officer's Representative does not have authority to issue technical direction that:

(1) Constitutes a change of assignment or additional work outside the specification(s)/statement of work;

(2) Constitutes a change as defined in the clause entitled "Changes";

(3) In any manner causes an increase or decrease in the contract price, or the time required for contract performance;

(4) Changes any of the terms, conditions, or specification(s)/work statement of the contract;

(5) Interferes with the contractor's right to perform under the terms and conditions of the contract; or

(6) Directs, supervises or otherwise controls the actions of the contractor's employees.

(c) Technical direction may be oral or in writing. The Contracting Officer's Representative shall confirm oral direction in writing within five work days, with a copy to the Contracting Officer.

(d) The contractor shall proceed promptly with performance resulting from the technical direction issued by the Contracting Officers, Representative. If, in the opinion of the contractor, any direction of the Contracting Officers, Representative, or his/her designee, falls within the limitations in (b), above, the contractor shall immediately notify the Contracting Officer no later than the beginning of the next Government work day.

(e) Failure of the contractor and the Contracting Officer to agree that technical direction is within the scope of the contract shall be subject to the terms of the clause entitled "Disputes."

G.5 INVOICES

Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP)

• All Invoice submissions for goods and or services delivered to facilitate payments must be made electronically through the U.S. Department of Treasury’s Invoice Processing Platform System (IPP).

• Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in the applicable Prompt Payment clause included in the contract, or the clause 52.212-4 included in commercial items contracts. The IPP website address is: https://www.ipp.gov.

• The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 – 5 business days of the contract award for new contracts or date of modification for existing contracts.

• Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov.

Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

• The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

• If your company is already registered to use IPP, you will not be required to re-register.

• If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

Additional Office of Acquisition Management Services (OAMS) requirements:

(i) The contractor shall submit invoices under this contract once per month. For indefinite delivery vehicles, separate invoices must be submitted for each order.

(ii) Invoices must break-out price/cost by contract line item number (CLIN) as specified in the pricing section of the contract.

(iii) Invoices that include time and materials or labor hours CLINS must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable).

(iv) Invoices submitted to IPP are limited to 10MB. Backup support should be sent to the contracting officer, contract specialist, and COR in the event it causes the file size to exceed the limit.

G.6 TRAVEL RELATED COSTS

The Contractor will be reimbursed for all domestic travel as described below, incurred directly and specifically in the performance of this contract, claimed by the Contractor and accepted by the Contracting Officer.

Domestic travel expenses incurred by the Contractor in direct performance of the contract shall be reimbursed provided such travel is necessary for the performance of this contract and the cost does not exceed:

a. The lowest customary standard, coach, or equivalent airfare offered during normal business hours for air travel except when such accommodations: 1) require circuitous routing, 2) require travel during unreasonable hours, 3) excessively prolong travel, 4) result in increased costs that would offset transportation savings, 5) are not reasonably adequate for the physical or medical needs of the traveler, or 6) are not reasonably available to meet mission requirements. In order for costs in excess of customary standard or coach airfare to be considered allowable, the applicable exception must be documented and justified.

b. Costs of rail travel by most direct route, coach-class accommodations.

c. The prevailing mileage rate set forth in the Federal Travel Regulation (FTR) or reasonable actual expenses for travel by motor vehicle. Travel by motor vehicle, including rented automobile, shall be reimbursed on a reasonable actual expense basis, or at the Contractor's option, on a mileage basis at the prevailing FTR rate, plus any toll or ferry charges.

d. The prevailing rates set forth in the FTR for lodging, meals and incidental expenses.

SECTION H - Special Contract Requirements

H.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE. (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): http://www.acquisition.gov/far/

H.2 PROHIBITION AGAINST PERSONAL SERVICES

The Contractor shall not perform personal services under this contract. Contractor personnel are employees of the Contractor or its subcontractors and are under the administrative control and supervision of the Contractor. A Contractor supervisor must give all individual Contractor employee assignments and daily work direction. The Government will not supervise or direct Contractor employees in the performance of their assignments.

If at any time the Contractor believes that any Government action or communication has been given that would create a personal service relationship between the Government and any Contractor employee, the contractor shall promptly notify the Contracting Officer of this communication or action. The Contractor shall not perform any inherently-governmental functions under this contract.