36C10X22R0027.docx

36C10X22R0027

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1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

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

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

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

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

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

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

TBD

36C10X22R0027 05-16-2022 Holly.Knott@va.gov

06-30-2022

1PM ET

21703 Strategic Acquisition Center - Frederick Department of Veterans Affairs

5202 Presidents Court, Suite 103 Frederick MD 21703

X

541715 1000 Employees

N/A

36C10X See Task order Performance Work Statement(s) (PWS)

36C10X Strategic Acquisition Center - Frederick Department of Veterans Affairs

VAFSC

U.S. Department of Veterans Affairs Financial Services Center

PO BOX 149971

Austin TX 78714-8917 1-(877)-489-6135

See CONTINUATION Page Veterans Health Administration (VHA) Office of Discovery, Education and Affiliate Networks (DEAN) Accelerating VA Innovation and Learning (AVAIL) Indefinite Delivery Indefinite Quantity (IDIQ) Questions are to be emailed to Melissa.Maloy@va.gov and Holly.Knott@va.gov NLT 1PM ET May 24, 2022

See CONTINUATION Page

Melissa Maloy Contracting Officer

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 SCHEDULE OF SUPPLIES/SERVICES

Task Categories 1-5 of SOW (T&M, LH and FFP): All work ordered on time-and-materials basis under any of the five task categories set forth in the Statement of Work

Orders can be issued any time during five-year ordering period

HOURLY RATES FOR WORK PERFORMED ON LABOR-HOUR OR TIME-AND-MATERIALS BASIS

For all work performed on a labor-hour or time-and-materials basis under this contract, the hourly rates (within the meaning of FAR 52.212-4, Alternate I (NOV 2021)) set forth in the task order pursuant to which such work is ordered and performed shall not exceed the hourly rates set forth in this contract for each of the corresponding labor categories to which such rates apply.

COMMERCIAL LICENSE AGREEMENTS

This contract does not contain or incorporate by reference the terms of any commercial license agreements pertaining to data delivered under the contract, including any such agreements that are provided to VA with such data or otherwise referred to in any document that is not a part of this contract.

APPLICABILITY OF DATA RIGHTS CLAUSES

The version of FAR 52.227-19 (Commercial Computer Software License) that is set forth in this contract applies to any commercial computer software delivered under this contract. The version of FAR 52.227-17 (Rights in Data-Special Works) that is set forth in this contract applies when there is a specific need to limit distribution and use of the data or to obtain indemnity for liabilities that may arise out of the content, performance, or disclosure of the data. The version of FAR 52.227-14 that is set forth in this contract applies when data will be produced, furnished, or acquired under the contract.

When FAR 52.227-14 applies, the applicable task order will expressly set forth any applicable restrictions (within the meaning of 52.227-14(d)(2)) on Contractor’s right to use, release to others, reproduce, distribute, or publish any data first produced or specifically used by the Contractor in the performance of that task order.

B.2 PAYMENT ADMINISTRATION DATA

1. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

2. INVOICES: Invoices shall be submitted in arrears:

3. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

U.S. Department of Veterans Affairs Financial Services Center

PO BOX 149971

Austin TX 78714-8917

Submission - In accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests, all invoices shall be submitted electronically. A copy of all invoices shall be provided to the contracting POC identified above.

Tungsten (fka OB10) ELECTRONIC INVOICE SUBMISSION FSC e-INVOICE PROGRAM THRU AUSTIN PORTAL

FSC MANDATORY ELECTRONIC INVOICE SUBMISSION FOR AUSTIN PAYMENTS

Vendor Electronic Invoice Submission Methods:

Fax, email and scanned documents are not acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically according to the accepted data transmissions below.

· VA’s Electronic Invoice Presentment and Payment System – The Financial Services Center (FSC) in Austin, TX uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission. Please go to this website: http://www.tungsten-network.com/US/en/veterans-affairs/ to begin submitting electronic invoices, free of charge.

· A system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) chartered by the American National Standards Institute (ANSI). The X12 EDI Web site is http://www.x12.org.

Vendor e-invoice Set-up information:

Please contact Tungsten at the phone number or email address listed below to begin submitting your electronic invoices to the VA Financial Services Center in Austin, TX for payment processing. If you have questions about the payment status of a properly submitted invoice, the e-invoicing program, or Tungsten, please contact the FSC at the phone number or email address listed below.

· Tungsten e-Invoice setup information: 1-877-489-6135

· Tungsten e-Invoice email: VA.Registration@tungsten-network.com

· FSC e-Invoice contact information: 1-877-353-9791

· FSC e-Invoice email: vafsccshd@va.gov

· http://www.fsc.va.gov/einvoice.asp

COMMUNICATIONS:

· https://www.federalregister.gov/articles/2012/11/27/2012-28612/va-acquisition-regulation-electronic-submission-of-payment-requests

· http://fcw.com/articles/2012/11/27/va-epayments.aspx?s=fcwdaily

Submission of Proper Invoice - The following data must be included in an invoice for it to constitute a proper invoice:

a. Name and address of the contract

b. Invoice date and number

c. Item number, description, quantity, unit of measure, price, extended price and a total of supplies delivered or services performed.

1. Cumulative billing (per line item and total)

1. Final invoices must be marked ‘FINAL INVOICE’

1. Proof of supplies delivered or services performed MUST also be provided. Signature, printed name and title of Government receiving official and date of delivery or performance period must be included.

INVOICES THAT DO NOT COMPLY WITH THESE REQUIREMENTS SHALL BE REJECTED.

4. ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.3 CONTRACT ADMINISTRATION

Strategic Acquisition Center - Frederick Department of Veterans Affairs

The CO reserves the right to designate Contracting Officer’s Representatives (COR) for the contract and/or for individual task orders issued hereunder. The CO will issue designation letters to any CORs and to the contractor that set forth in writing the extent of the COR’s authority to act on behalf of the CO, the limitations on the COR’s authority, and the period covered by the designation. In no event will any COR possess authority to make any commitments or changes that affect price, quality, quantity, delivery, or other terms and conditions of the contract or any task orders issued hereunder nor in any way direct the contractor or its subcontractors to operate in conflict with the terms and conditions of the contract or any task order.

B. Task Order Procedures All future task orders, beyond TOPR 7, will be posted to the Acquisition Task Order Management System (ATOMS). The contractors shall utilize this site when competing for and/or receiving issuance of task orders.

1. The IDIQ Task Orders, beyond TOPR 7, will follow ordering procedures as outlined in FAR 16.505. In accordance with FAR 16.505(b)(2), the CO will provide all awardees a fair opportunity to be considered for all awards under the IDIQ which exceed the micro-purchase threshold, unless one of the following exceptions applies:

0. The agency need for the supplies or services is so urgent that providing a fair opportunity would result in unacceptable delays;

0. Only one awardee is capable of providing the supplies or services necessary at the level of quality required because the supplies or services ordered are unique or highly specialized;

0. The order must be issued on a sole-source basis in the interest of economy and efficiency because it is a logical follow-on to an order already issued under the contract, provided that all awardees were given a fair opportunity to be considered for the original order; or

0. It is necessary to place an order to satisfy a minimum guarantee.

0. For orders exceeding the simplified acquisition threshold, a statute expressly authorizes or requires that the purchase be made from a specified source.

0. In accordance with section 1331 of Public Law 111-240 (15 U.S.C. 644(r)), contracting officers may, at their discretion, set aside orders for any of the small business concerns identified in 19.000(a)(3).

When utilizing these exceptions, the CO will proceed with a sole source acquisition or limit the awardees provided an opportunity to be considered, as applicable. Justifications for exceptions to fair opportunity will be generated, approved, and disseminated when and as required by FAR 16.505.

1. When an exception to fair opportunity is not utilized, the CO will determine the evaluation factors for that task order competition and issue a solicitation, labeled a Task Order Proposal Request (TOPR), to all awardees. While the contractor is not required to submit a proposal in response to all TOPRs to which it is eligible to respond, it nevertheless must submit proposals in response to at least 50% of TOPRs to which it is eligible to respond during each consecutive one-year period following contract award. Failure to comply with this obligation will negatively impact past performance evaluations. If the contractor will not be submitting a proposal in response to a TOPR, it shall submit a “no-bid” response to the CO with a brief, yet specific, explanation.

1. Each TOPR shall include, at a minimum:

2. The due date and instructions for proposal submission;

2. A Statement of Work (SOW), Statement of Objectives (SOO), or Performance Work Statement (PWS) with a description of the requirements, including deliverables, and all other applicable information;

2. The place and period of performance; and

2. Any additional information deemed necessary by the CO.

1. Each TOPR will also set forth the basis upon which the award will be made. Evaluation factors, with the exception of price, will be assigned an adjectival rating. Proposals will be evaluated by analysis of the following factors:

3. Technical Capability: The contractor will be asked to discuss their plan for accomplishing the work of the requirement. This factor may include subfactors such as a management plan, staffing plan, or key personnel.

3. Past Performance: The contractor will be asked to provide narratives of recent and relevant references and past performance questionnaires which confirm a level of quality. The CO may consider relevant performance on task orders previously issued under this contract and any other information available from Government sources.

3. Price: The Government will evaluate price reasonableness using price analysis techniques as prescribed in FAR 15.404-1(b). With regard to work that is to be performed on a labor hour or time and materials basis, the contractor must propose labor rates that are equal to or lower than those listed in the contract. The Government will ensure that rates are not reduced to a level that risks nonperformance by requiring justification for the reduced rate at the time of proposal

3. Any other factors as determined appropriate by the CO.

1. The CO is not required to prepare formal evaluation plans or engage in discussions or negotiations with offerors.

1. The proposals will be evaluated, and award (if any) will be made, in accordance with the process and basis for award set forth in the TOPR. The CO reserves the right to cancel TOPRs after their issuance. In such event, the contractor will be notified, via email, of the TOPR cancellation.

1. Any task orders awarded to the contractor will be issued via email to the contractor.

1. The CO will provide post-award notifications and debriefings, in the manner required by FAR 16.505(b)(6), when the total price of a task order exceeds $10 million.

1. The Task orders can include Firm Fixed Price (FFP), Labor Hours (LH) or Time and Materials (T&M) Contract Line Items (CLINs). For all work performed on a labor-hour or time-and-materials basis under this contract, the hourly rates (within the meaning of FAR 52.212-4, Alternate I (NOV 2021)) set forth in the order pursuant to which such work is ordered and performed shall not exceed the hourly rates set forth in this contract for each of the corresponding labor categories to which such rates apply.

C. Minimum Guaranteed Amount and Maximum Value

1. The minimum quantity of work that VA will order under this contract is $2,500.00. The Government has no obligation to order any work exceeding the minimum quantity specified herein.

1. The maximum quantity of work that VA may order under this contract is $650,000,000.00.

D. Options When inclusion of options is determined appropriate pursuant to FAR subpart 17.2, VA may include options in task orders issued under this contract, provided their inclusion is determined appropriate in accordance with FAR. Inclusion of options at the task order level will be properly documented and approved in accordance with FAR and agency procedures and will be clearly stated in the TOPR.

E. On-Ramping/Off-Ramping VA may “off-ramp” contractor(s) through contract termination. The contractor is required to submit proposals for at least 50% of the TOPRs for which it is eligible during each consecutive one-year period following contract award. Failure to comply with this requirement constitutes grounds to terminate the contract for cause pursuant to FAR 52.212-4(m). Alternatively, VA may terminate the contract for convenience pursuant to FAR 52.212-4(l) whenever such termination is determined to be in the best interests of the Government.

VA reserves the right to “on-ramp” additional contractors throughout the ordering period to ensure adequate competition for each task order. Should VA exercise this right, a new solicitation with identical requirements, terms, and conditions will be issued via the Governmentwide Point of Entry. Awardees will be added to the pool of contractors for future competitions. The “on-ramping” process will not extend the ordering period.

“On-ramping” and “off-ramping” processes may occur independently and are not guaranteed as a result of the other.

36C10X22R0027

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B.4 STATEMENT OF WORK

1.0 INTRODUCTION

This statement of work describes the general scope, nature, complexity, and purposes of the services and property that may be procured under this Contract.

2.0 BACKGROUND

The Department of Veterans Affairs (VA), Veterans Health Administration (VHA) is America’s largest integrated health care system with over 1,700 sites of care, serving 8.76 million Veterans each year.

For decades, the Veterans Health Administration has been a pioneer and leader in healthcare innovation. Today, wearable technologies, big data, machine learning and artificial intelligence, 3-D printing, and telehealth capabilities are driving significant and growing segments within the healthcare market. These emerging technologies, which are poised to transform care experience and service, can require enormous up-front investments and if not carefully designed, developed, and validated and/or tested in real-world settings, can yield little value to healthcare system or the patients it serves.

The Office of Healthcare Innovation and Learning (OHIL) leads VHA efforts to design, develop, and test new healthcare solutions, services (including funding models) and care models of care that can advance VHA’s mission to provide world class care and experience to Veterans. The office consists of three core programs: SimLEARN, including the National Simulation Center; The VHA Innovation Ecosystem; and The Center for Care and Payment Innovation. Collectively, these offices create a synergistic and advanced collaborative team which has successfully designed, developed, tested, and scaled multiple healthcare innovations used throughout the American healthcare system.

The Office of Healthcare Innovation and Learning is also part of VHA DEAN – Discovery, Education and Affiliate Networks – in which it shares a common mission with its sister offices, Office of Academic Affiliate and Office of Research and Development, to advance VHA’s urney to excel as a learning organization that amplifies innovation.

The AVAIL – Accelerating VA Innovation and Learning – contract serves as an opportunity to further VA’s long-standing tradition as a pioneer in medical innovation and VHA’s journey towards excelling as a learning organization by offering VHA, and the Office of Healthcare Innovation and Learning, the availability to augment its ongoing design, development and testing efforts around healthcare innovation. The Office of Healthcare Innovation has identified 5 major innovation task categories or “growth areas” in which ongoing efforts are focused on: (1) Personalized Care; (2) Data Transformation; (3) Digital Care; (4) Immersive Technology; and (5) Care and Service Delivery Models. AVAIL will augment VHA and OHIL’s capacity, through subject matter expertise, to design, develop and test novel solutions and accompanying care and service models in a real-world setting (in this case, the Veterans Health Administration), ensuring that solutions create meaningful value for VHA clinicians, administrators, caregivers, and most importantly, Veterans, before being scaled into clinical production.

3.0 SCOPE

Except as may be expressly stated in this Contract or orders issued hereunder as furnished by the Government, the Contractor shall provide all management, labor, materials, equipment, facilities, and other resources necessary to perform work ordered in any of the five Task Categories set forth in Section 6.0.

Orders may be issued for any work within the general scope of this Contract. VA may order work that is limited in scope to just one component of a single Task Category or Task Group, or VA may order work that spans multiple Task Categories and/or Task Groups. Work ordered under the Contract can encompass matters other than specific examples provided in Section 6.0. Decisions regarding what work will be ordered will be made by VA after award of this Contract and throughout its ordering period.

Work within the general scope of this Contract does not encompass production deployment and/or development of solutions which may require dedicated IT development on the part of VHA and/or VA OI&T.

4.0 OTHER DIRECT COSTS (ODCs)

If and when VA orders work on a time-and-materials basis, reimbursement for other direct costs, if any such reimbursement is authorized, will be in accordance with FAR 52.212-4 Alternative I (Nov 2021). The applicable order will identify the other direct costs, if any, for which VA will reimburse the Contractor pursuant to FAR 52.212-4(i)(1)(ii) Alternative I (Nov 2021).

5.0 PERFORMANCE DETAILS

5.1 Period of Performance/Ordering period

The ordering period for this Contract will be five years from the date of contract award.

5.2 Type of Contract

This is an indefinite-delivery indefinite-quantity contract. The contract pricing type for orders issued under this Contract will be firm-fixed-price, labor-hour, and/or time-and-materials. An order may consist of line items that are all of the same contract pricing type (e.g., an order under which all line items are time-and-materials, or an order under which all line items are firm-fixed-price) or it may contain different line items that are priced on different basis’s (e.g., an order encompassing certain firm-fixed-price line items, certain labor-hour line items, and certain time-and-materials line items). Any work within the scope of this Contract may be ordered utilizing any of the foregoing three contract pricing types.

5.3 Place of Performance

Performance under this Contract shall occur at the contractor’s facility unless otherwise provided in the applicable order issued under this Contract. VA expects that some work will necessitate performance by contractor personnel at specific VA facilities located in the continental United States, and any such requirements regarding place of performance will be identified at the order level.

Any work performed at VA facilities shall not take place on Federal holidays (actual or observed) or weekends unless directed by the Contracting Officer (CO). If any Federal holiday falls on a Saturday, then Friday shall be observed as a holiday. Similarly, if one falls on a Sunday, then Monday shall be observed as a holiday.

6.0 TASKS

The task categories and groups set forth in this section constitute a high-level narrative summary of the types of work that VA may order under this Contract. Any examples provided in this section (including but not limited to parentheticals containing a prefatory “e.g.”) do not limit the scope of the subject matter of which they are an example and shall not be interpreted as limiting the intended meaning of the terms describing that subject matter. Specific services and/or property required by VA will be detailed in any orders issued under this Contract.

The following is a glossary of defined terms used throughout the following task categories:

1. Applied research: process to respond to specific questions aimed at solving practical problems to develop objectives in the form of products, procedures, or services.

1. Applied research techniques: methodology and formulating a research problem or topic leading to a project in researching the proper explanations or understanding to the issue or topic under investigation.

1. Consideration of alternatives: a comparison of the operational effectiveness of alternatives.

1. Data gathering and analysis: collection and synthesizing of information from a variety of stakeholders and sources in an objective, unbiased manner to reach a conclusion, goal, or judgment, and to enable strategic and leadership decision making.

1. Design: use applied research techniques to support problem definition, market analysis, consideration of alternatives, initial data gathering and analysis, ideation, and solution proposal.

1. Develop: perform experimental development and/or prototyping of a minimal viable product),

1. Evaluate: analysis of completed goals, objectives, and activities to determine whether the project has produced planned results, delivered expected benefits, and made desired change.

1. Experimental development: creative and systematic work, drawing on knowledge gained from research and practical experience, which is directed at producing new products and/or processes, or improving existing products or processes.

1. Market analysis: assessment of a market within a specific industry such as volume and value, potential customer segments, competition, and other important factors.

1. Minimal viable product: a new product is introduced with basic features, but enough to get the attention of the end users.

1. Problem definition: identified difference between the expected state and the actual state commonly defined in project management by identifying: Who, What, Where, When, Why and How?

1. Processes: procedure for the planning and control of the services or the implementation of a project.

1. Ideation: process where ideas and solutions are generated through sessions such as Sketching, Prototyping, Brainstorming, Brainwriting, Worst Possible Idea, and a wealth of other ideation techniques.

1. Innovative: combination of the management of innovation processes and change management. It refers to products, services, business processes, and accompanying transformational needs, whereby the organization must change the way they conduct their business.

1. Solution proposal: technical solution to be provided by the organization in response to the requirements and the objectives of the project.

1. Test: activities designated for investigating and examining progress of a given project to provide stakeholders with information about actual levels of performance and quality of the project.

1. Validation: documented process of demonstrating that a system or process meets a defined set of requirements of the solution against a Veteran population and/or in the context of health care delivery by and within VHA.

6.1 Task Category 1: Innovation in Personalized Healthcare

6.1.1 Task Group 1.1: Advanced Manufacturing in Healthcare

If and as ordered by VA, the Contractor shall design (i.e., use applied research techniques to support problem definition, market analysis, consideration of alternatives, initial data gathering and analysis, ideation, and solution proposal), develop (i.e., perform experimental development and/or prototyping of a minimal viable product), and test and/or evaluate (i.e., perform validation of the solution against a Veteran population and/or in the context of health care delivery by and within VHA) innovative personalized medical devices developed utilizing advanced manufacturing techniques (e.g., 3D printing, injection molding, milling). Work ordered and performed within this task group will be limited to one or more of the following five major categories: (1) anatomical models for pre-surgical planning; (2) personalized prosthetics (e.g., customized lower limb sockets), orthotics, and surgical instruments (e.g., patient-matched surgical cutting guides); (3) personalized dental devices and equipment; (4) personalized assistive technology; and (5) bio-fabrication. Activities may pertain to a single medical device, or they may pertain to multiple such devices (e.g., a line or “suite” of related devices). VA will determine the specific personalized medical devices based on Veteran need, organizational priorities, and relevant market considerations (e.g., technological developments, or market shortages of needed medical devices or solutions).

Contractor performance of work ordered within this task category will consist of provision of support to VA during one or more of the following steps in the process that VA generally follows when engaging in research and development pertaining to personalized medical devices that are developed utilizing advanced manufacturing techniques:

· Step 1: Initiation: assessment of device idea, opportunity, and impact.

· Step 2: Planning: detailed scoping and planning of user needs, device requirements, funding, device risks, testing, and transfer to manufacturing.

· Step 3: Development: development of device specifications; risk analysis; design and process development activities including but not limited to bench testing, design of experiment, and process development; quality control requirements; and establishment and documentation of all processes necessary for product realization.

· Step 4 Validation: authorship, execution, and validation report of design and process validation requirements per the master validation plan.

Contractor production of medical devices pursuant to this task group is limited to prototyping and does not encompass production for clinical use or large-scale manufacturing.

Data deliverables required in connection with work ordered within this task category may include, but are not limited to: reports on work performed, including but not limited to lessons learned and/or results achieved (e.g., with regard to design engineering and/or prototyping work performed by the Contractor); and/or design files (e.g., STL files) that the Contractor is tasked with developing for medical devices identified by VA. Developing and delivering such design files is expected to constitute a significant component of the work ordered and performed pursuant to this task category.

6.1.2 Task Group 1.2: Precision Medicine

If and as ordered by VA, the Contractor shall design (i.e., use applied research techniques to support problem definition, market analysis, consideration of alternatives, initial data gathering and analysis, ideation, and solution proposal), develop (i.e., perform experimental development and/or prototyping of a minimal viable product), and test and/or evaluate (i.e., perform validation of the solution against a Veteran population and/or in the context of health care delivery by and within VHA) innovative precision medicine solutions. Work ordered and performed within this task group will be limited to designing, developing, testing, and/or evaluating precision medicine solutions in one or more of the following areas: 1) genomic disease risk assessment, 2) pharmacogenomics, and 3) precision oncology.

Precision medicine solutions within the scope of this task group will be required to utilize and/or interface with: relevant VA data and analytics platforms (e.g., BI – business intelligence, VA Arches, VA Rockies, VA Common Operating Platform, Synthetic Patient Data Platform); VA Lighthouse and Fast Health Interoperability Resources (FHIR) based Application Programming Interfaces (API); and relevant VA data sets (e.g., Patient-Generated Health Data, Corporate Data Warehouse data, Financial Services Center Resource and Claims data). When designing and/or developing precision medicine solutions, the Contractor will be required to ensure such solutions are designed and/or developed in a manner that accounts for, accommodates, and facilitates utilization of specific clinical decision support tools designed and developed pursuant to work performed under task group 2.1 and specific digital twin solutions designed and developed pursuant to work performed under task group 3.3. Testing and evaluation of personalized health care models will include utilization of methods to objectively measure the impact of use of the precision medicine solution using specific metrics identified by VA, including clinical, operational, and financial metrics. Such testing and evaluation will also include assessment of the precision medicine solution’s compatibility with, and feasibility of integration into, existing VA workflows and health IT and clinical information systems.

Data deliverables required in connection with work ordered within this task group may include, but are not limited to: reports on work performed, including but not limited to lessons learned and/or results achieved (e.g., with regard to design engineering and/or prototyping work performed by the Contractor); and/or design files, including any relevant source code, that the Contractor is tasked with creating for the applicable precision medicine solutions(s) identified by VA.

6.2 Task Category 2: Innovation in Data Transformation

6.2.1 Task Group 2.1: Advanced Clinical Decision Support

If and as ordered by VA, the Contractor shall design (i.e., use applied research techniques to support problem definition, market analysis, consideration of alternatives, initial data gathering and analysis, ideation, and solution proposal), develop (i.e., perform experimental development and/or prototyping of a minimal viable product), and test and/or evaluate (i.e., perform validation of the solution against a Veteran population and/or in the context of health care delivery by and within VHA) innovative clinical decision support solutions. Work ordered and performed within this task group will pertain to utilization of clinical decision support solutions for purposes of improving care or service in one or more of the following clinical areas and patient populations: (1) chronic disease management (e.g., diabetes, brain health, chronic kidney disease, heart failure, long COVID); (2) high risk, high utilizer patient populations (e.g., multiple chronic conditions, cancer, frequent utilization of emergency or urgent care); (3) vulnerable or underserved patient populations (e.g., homeless, food insecure); and (4) acute conditions (e.g., sepsis).

Advanced clinical decision support tools within the scope of this task group will be required to utilize and/or interface with: relevant VA data and analytics platforms (e.g., BI – business intelligence, VA Arches, VA Rockies, VA Common Operating Platform, Synthetic Patient Data Platform); VA Lighthouse and FHIR-based APIs; and relevant VA data sets (e.g., Patient-Generated Health Data, Corporate Data Warehouse data, Financial Services Center Resource and Claims data). When designing and/or developing clinical decision support solutions, the Contractor will be required to ensure such tools are designed and/or developed in a manner that accounts for, accommodates, and facilitates utilization of specific artificial intelligence and machine learning solutions designed and developed pursuant to work performed under task group 2.2 and specific application program interface (API) solutions designed and developed pursuant to work performed under task group 3.2. Testing and evaluation of advanced clinical decision support solutions within the scope of this task group will include utilization of methods to objectively measure the impact of use of the tools using specific metrics identified by VA, including clinical, operational, and financial metrics. Such testing and evaluation will also include assessment of the solution’s compatibility with, and feasibility of integration into, existing VA workflows and health IT and clinical information systems.

Data deliverables required in connection with work ordered within this task group may include, but are not limited to: reports on work performed, including but not limited to lessons learned and/or results achieved (e.g., with regard to design engineering and/or prototyping work performed by the Contractor); and/or design files, including any relevant source code, that the Contractor is tasked with creating for the applicable clinical decision support solutions(s) identified by VA.

6.2.2 Task Group 2.2: Artificial Intelligence (AI) and Machine Learning (ML) If and as ordered by VA, the Contractor shall design (i.e., use applied research techniques to support problem definition, market analysis, consideration of alternatives, initial data gathering and analysis, ideation, and solution proposal), develop (i.e., perform experimental development and/or prototyping of a minimal viable product), and test and/or evaluate (i.e., perform validation of the solution against a Veteran population and/or in the context of health care delivery by and within VHA) innovative AI and/or ML solutions. Work ordered and performed within this task group will be limited to AI and ML solutions intended for use in improving care in one or more of the following clinical areas and patient populations: (1) chronic disease management (e.g., diabetes, brain health, chronic kidney disease, heart failure, long COVID); (2) high risk, high utilizer patient populations (e.g., multiple chronic conditions, cancer, frequent utilization of emergency or urgent care); (3) vulnerable or underserved patient populations (e.g., homeless, food insecure); and (4) acute conditions (e.g., sepsis).

AI and ML solutions within the scope of this task group will be required to utilize and/or interface with: relevant VA data and analytics platforms (e.g., BI – business intelligence, VA Arches, VA Rockies, VA Common Operating Platform, Synthetic Patient Data Platform); VA Lighthouse and FHIR-based APIs; and relevant VA data sets (e.g., Patient-Generated Health Data, Corporate Data Warehouse data, Financial Services Center Resource and Claims data). When designing and/or developing AI and/or ML solutions, the Contractor will be required to ensure such solutions are designed and/or developed in a manner that accounts for, accommodates, and facilitates utilization of: specific precision medicine solutions designed and developed pursuant to work performed under task group 1.2; specific synthetic data models or data sets designed and developed pursuant to work performed under task group 2.3; and specific digital care solutions designed and developed pursuant to work performed under task group 3.1. Testing and evaluation of AI and ML solutions will include utilization of methods to objectively measure the impact of use of the solutions using specific metrics identified by VA, including clinical, operational, and financial metrics. Such testing and evaluation will also include assessment of the solutions’ compatibility with, and feasibility of integration into, existing VA workflows and health IT and clinical information systems.

Data deliverables required in connection with work ordered within this task group may include, but are not limited to: reports on work performed, including but not limited to lessons learned and/or results achieved (e.g., with regard to design engineering and/or prototyping work performed by the Contractor); and/or design files, including any relevant source code, that the Contractor is tasked with creating for the applicable AI or ML solutions(s) identified by VA.

6.2.3 Task Group 2.3: Synthetic Data

If and as ordered by VA, the Contractor shall design (i.e., use applied research techniques to support problem definition, market analysis, consideration of alternatives, initial data gathering and analysis, ideation, and solution proposal), develop (i.e., perform experimental development and/or prototyping of a minimal viable product), and test and/or evaluate (i.e., perform validation of the solution against a Veteran population and/or in the context of health care delivery by and within VHA) innovative synthetic data models or data sets. Work ordered and performed within this task group will be limited to synthetic data models and data sets intended for use in improving care in one or more of the following clinical areas and patient populations: (1) chronic disease management (e.g., diabetes, brain health, chronic kidney disease, heart failure, long COVID); (2) high risk, high utilizer patient populations (e.g., multiple chronic conditions, cancer, frequent utilization of emergency or urgent care); (3) vulnerable or underserved patient populations (e.g., homeless, food insecure); and (4) acute conditions (e.g., sepsis).

Synthetic data models and datasets will be produced utilizing VA’s synthetic data generator, which is a component of the Arches cloud-based data analytics environment. When designing and/or developing synthetic data models or data sets, the Contractor will be required to ensure such data models or data sets are designed and/or developed in a manner that accounts for, accommodates, and facilitates utilization of specific AI and/or ML solutions designed and developed pursuant to work performed under task group 2.2. Testing and evaluation of synthetic data solutions and data sets will include utilization of methods to objectively measure the impact of use of the data solutions and data sets using specific metrics identified by VA, including clinical, operational, and financial metrics. Such testing and evaluation will also include assessment of the data solutions’ and data sets’ compatibility with, and feasibility of integration into, existing VA workflows and health IT and clinical information systems.

Data deliverables required in connection with work ordered within this task group may include, but are not limited to: reports on work performed, including but not limited to lessons learned and/or results achieved (e.g., with regard to design engineering and/or prototyping work performed by the Contractor); and/or design files, including any relevant source code, that the Contractor is tasked with creating for the applicable synthetic data solutions(s) identified by VA.

6.3 Task Category 3: Innovation in Digital Health

Glossary of Definitions Specific to Task Group 3.1

· Asynchronous care solutions: Also referred to as remote patient monitoring (RPM) or the use of medical information exchanged from one site to another via electronic communication to be reviewed at a different time by the care team to help guide changes to a patient’s care plan.

· Hardware and/or wearables: broad category that includes connected sensor technologies (i.e., ‘wearables’), biometric monitoring technologies, and/or internet of medical things (e.g., smart scales, blood pressure cuffs, etc.). May also include ‘ingestibles’ (e.g., smart pills) and/or ‘implantable’ such as pacemakers and subdermal wearables.

· On-demand synchronous care solutions: Includes traditional telehealth services (i.e., use of digital technologies to deliver real-time medical care, health education, and public health services by connecting users in separate locations) and is often referred to as ‘virtual care’ or ‘virtual care delivery.’

· Digital care-backed clinical decision support solutions: Clinical decision support (CDS) solutions provide clinicians and healthcare staff with contextually relevant knowledge and patient-specific information that is intelligently presented at the point-of-care at appropriate times to enhance health care delivery. Specific examples include automated computerized alerts and reminders, clinical guidelines, condition-specific order sets, and diagnostics.

· Digital therapeutics: digital care solutions where both clinical evidence and real-world outcomes are required; evidence must be cleared or certified by the requisite regulatory bodies to support any claims of risk, efficacy or intended use.

6.3.1 Task Group 3.1: Digital Care Solutions

If and as ordered by VA, the Contractor shall design (i.e., use applied research techniques to support problem definition, market analysis, consideration of alternatives, initial data gathering and analysis, ideation, and solution proposal), develop (i.e., perform experimental development and/or prototyping a minimal viable product), and test and/or evaluate (i.e., perform validation of the solution against a Veteran population and/or in the context of health care delivery by and within VHA) innovative digital care solutions. The types of digital care solutions within the scope of this task group are: digital therapeutics; FDA-regulated (i.e., medical) and non-FDA regulated (i.e., consumer) hardware and/or wearables; on-demand synchronous care solutions; asynchronous care solutions; digital care-backed clinical decision support solutions; and custom applications. Work ordered and performed within this task group will be limited to digital care solutions intended for use in clinical quality improvement efforts in one or more of the following clinical areas and patient populations: (1) chronic disease management (e.g., diabetes, brain health, chronic kidney disease, heart failure, long COVID); (2) high risk, high utilizer patient populations (e.g., multiple chronic conditions, cancer, frequent utilization of emergency or urgent care); (3) vulnerable or underserved patient populations (e.g., homeless, food insecure); and (4) acute conditions (e.g., sepsis).

Digital care solutions within the scope of this task group will be required to utilize and/or interface with: relevant VA data and analytics platforms (e.g., BI – business intelligence, VA Arches, VA Common Operating Platform, MDClone, Rockies); VA FHIR-based APIs; and relevant VA data sets (e.g., Patient-Generated Health Data, Corporate Data Warehouse data, VistA data, Cerner EHR data, Community Care data, Financial Services Center resource and claims data, Social Determinants of Health data). When designing and/or developing digital care solutions, the Contractor will be required to ensure such solutions are designed and/or developed in a manner that accounts for, accommodates, and facilitates utilization of specific API solutions designed and developed pursuant to work performed under task group 3.2 and specific digital twin solutions designed and developed pursuant to work performed under task group 3.3. Testing and evaluation of digital care solutions will include utilization of methods to objectively measure the impact of use of the solutions using specific metrics identified by VA, including clinical, operational, and financial metrics. Such testing and evaluation will also include assessment of the digital care solutions’ compatibility with, and feasibility of integration into, existing VA workflows and health IT and clinical information systems.

Data deliverables required in connection…