(S02) 36C10B18Q3124.docx

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TION UNLESS BLOCK IS

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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.

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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

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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. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL

STANDARD FORM 1449

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C10B22R0004 03-22-22 Jamie Valentine 848-377-5091 03-29-22

11:00AM EST

511210 $41.5 Million

N/A

See Delivery Schedule

This solicitation is issued for the Artificial Intelligence (AI)-Based Physical Therapy Application (AIPTA).

See Section B.4 for Price Schedule.

Period of Performance: 12 Months from Date of Award

Points of Contact:

Jamie Valentine 848-377-5091 / Jamie.Valentine@va.gov Contract Specialist

Matthew Newell 848-377-5170 / Matthew.Newell@va.gov Contracting Officer

Matthew Newell, Contracting Officer

Department of Veterans Affairs Technology Acquisition Center Financial Services Center PO Box 149971 Austin, TX 78714-8971 Department of Veterans Affairs Technology Acquisition Center 23 Christopher Way Eatontown, NJ 07724 Department of Veterans Affairs Technology Acquisition Center 23 Christopher Way Eatontown, NJ 07724

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 GOVERNING LAW

Federal law and regulations, including the Federal Acquisition Regulations (FAR), shall govern this Contract/Order. Commercial license agreements may be made a part of this Contract/Order but only if both parties expressly make them an addendum hereto, as permitted by FAR 12.212. If the commercial license agreement is not made an addendum, it shall not apply, govern, be a part of or have any effect whatsoever on the Contract/Order; this includes, but is not limited to, any agreement embedded in the computer software (clickwrap), any agreement that is otherwise delivered with or provided to the Government with the commercial computer software or documentation (shrink-wrap), or any other license agreement otherwise referred to in any document. If a commercial license agreement is made an addendum, only those provisions addressing data rights regarding the Government’s use, duplication and disclosure of data (e.g., restricted computer software) are included and made a part of this Contract/Order, and only to the extent that those provisions are not duplicative or inconsistent with Federal law, Federal regulation, the incorporated FAR clauses and the provisions of this Contract/Order; those provisions in the commercial license agreement that do not address data rights regarding the Government’s use, duplication and disclosure of data shall not be included or made a part of the Contract/Order. Federal law and regulation including, without limitation, the Contract Disputes Act (41 U.S.C. § 7101 et seq.), the Anti-Deficiency Act (31 U.S.C. § 1341 et seq.), the Competition in Contracting Act (41 U.S.C. § 3301 et seq.), the Prompt Payment Act (31 U.S.C. § 3901 et seq.), Contracts for Data Processing or Maintenance (38 USC § 5725), and FAR clauses 52.212-4, 52.227-14, 52.227-19 shall supersede, control, and render ineffective any inconsistent, conflicting, or duplicative provision in any commercial license agreement. In the event of conflict between this clause and any provision in the Contract/Order or the commercial license agreement or elsewhere, the terms of this clause shall prevail. The Contractor shall deliver to the Government all data first produced under this Contract/Order with unlimited rights as defined by FAR 52.227-14. Claims of patent or copyright infringement brought against the Government as a party shall be defended by the U.S. Department of Justice (DOJ) in accordance with 28 U.S.C. § 516; at the discretion of DOJ, the Contractor may be allowed reasonable participation in the defense of the litigation. Any additional changes to the Contract/Order must be made by modification (Standard Form 30) and shall only be made by a warranted Contracting Officer. Nothing in this Contract/Order or any commercial license agreement shall be construed as a waiver of sovereign immunity.

B.2 SOFTWARE LICENSE, MAINTENANCE AND TECHNICAL SUPPORT

(1) Definitions.

a) Licensee. The term “licensee” shall mean the U.S. Department of Veterans Affairs (“VA”) and is synonymous with “Government.”

b) Licensor. The term “licensor” shall mean the Contractor having the necessary license or ownership rights to deliver license, software maintenance and support of the computer software being acquired. The term “Contractor” is the party identified in Block 17a on the SF1449. If the Contractor is a reseller and not the Licensor, the Contractor remains responsible for performance under this Contract/Order.

c) Software. The term “software” shall mean the licensed computer software product(s) cited in the Schedule of Supplies/Services.

d) Maintenance. The term “maintenance” is the process of enhancing and optimizing software, as well as remedying defects. It shall include all new fixes, patches, releases, updates, versions, and upgrades, as further defined below.

e) Technical Support. The term “technical support” refers to the range of services providing assistance for the software via the telephone, email, a website or otherwise.

f) Release or Update. The term “release” or “update” are terms that refer to a revision of software that contains defect corrections, minor enhancements, or improvements of the software’s functionality. This is usually designated by a change in the number to the right of the decimal point (e.g., from Version 5.3 to 5.4). An example of an update is the addition of new hardware.

g) Version or Upgrade. The term “version” or “upgrade” are terms that refer to a revision of software that contains new or improved functionality. This is usually designated by a change in the number to the left of the decimal point (e.g., from Version 5.4 to 6).

(2) Software License.

a) Unless otherwise stated in the Schedule of Supplies/Services, the Performance Work Statement or Product Description, the software license provided to the Government is a perpetual, nonexclusive license to use the software.

b) The Government may use the software in a networked environment.

c) Any dispute regarding the license grant or usage limitations shall be resolved in accordance with the Disputes Clause incorporated in FAR 52.212-4(d).

d) All limitations of software usage are expressly stated in the Schedule of Supplies/Services and the Performance Work Statement/Product Description.

(3) Software Maintenance and Technical Support.

a) If the Government desires to continue software maintenance and support beyond the period of performance identified in this Contract/Order, the Government will issue a separate contract or order for maintenance and support. Conversely, if a contract or order for continuing software maintenance and technical support is not received, the Contractor is neither authorized nor permitted to renew any of the previously furnished services.

b) The Contractor shall provide software support services, which includes periodic updates, enhancements and corrections to the software, and reasonable technical support, all of which are customarily provided by the Contractor to its commercial customers so as to cause the software to perform according to its specifications, documentation or demonstrated claims.

c) Any telephone support provided by Contractor shall be at no additional cost.

d) The Contractor shall provide all maintenance services in a timely manner in accordance with the Contractor’s customary practice or as defined in the Performance Work Statement or Product Description. However, prolonged delay (exceeding 2 business days) in resolving software problems will be noted in the Government’s various past performance records on the Contractor (e.g., www.ppirs.gov).

e) If the Government allows the maintenance and support to lapse and subsequently wishes to reinstate it, any reinstatement fee charged shall not exceed the amounts that would have been charged if the Government had not allowed the subscription to lapse.

(4) Disabling Software Code. The Government requires delivery of computer software that does not contain any code that will, upon the occurrence or the nonoccurrence of any event, disable the software. Such code includes but is not limited to a computer virus, restrictive key, node lock, time-out or other function, whether implemented by electronic, mechanical, or other means, which limits or hinders the use or access to any computer software based on residency on a specific hardware configuration, frequency of duration of use, or other limiting criteria. If any such disabling code is present, the Contractor agrees to indemnify the Government for all damages suffered as a result of a disabling caused by such code, and the contractor agrees to remove such code upon the Government’s request at no extra cost to the Government. Inability of the Contractor to remove the disabling software code will be considered an inexcusable delay and a material breach of contract, and the Government may exercise its right to terminate for cause. In addition, the Government is permitted to remove the code as it deems appropriate and charge the Contractor for consideration for the time and effort expended in removing the code.

(5) Manuals and Publications. Upon Government request, the Contractor shall furnish the most current version of the user manual and publications for all products/services provided under this Contract/Order at no cost.

B.3 CONTRACT ADMINISTRATION DATA

(Continuation from Standard Form 1449, block 18A)

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR: TBD

b. GOVERNMENT: Contracting Officer 36C10B, Matthew Newell Department of Veterans Affairs Technology Acquisition Center 23 Christopher Way Eatontown NJ 07724

for Award Management, or

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

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly [ ]

b. Semi-Annually [ ]

c. Other [X] Upon acceptance of deliverables in accordance with

B.4 Price Schedule

4. 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.

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

B.4 PRICE SCHEDULE

NOTE: Vendors are instructed to complete Section B.4: Price Schedule and submit with their quote. Vendors are cautioned that alterations to the line items as specified below may render quotes unacceptable. Undefinitized line items will not be acceptable. All questions shall be directed to the Contract Specialist, Jamie Valentine, Jamie.Valentine@va.gov, 848-377-5091, and Contracting Officer, Matthew Newell, Matthew.Newell@va.gov, 848-377-5170, prior to the closing date and time specified on the solicitation.

Base Period The period of performance for this effort shall be 12 months in accordance with (IAW) Section 4.1 of the Performance Work Statement (PWS)

The Contractor shall deliver project management IAW PWS Section 5.1 and all applicable subparagraphs.

· Due at the receipt of contract

The Period of Performance shall be 12 months from date of award.

The cost of this CLIN shall be included and allocated to CLINS 0002-0004.

The Contractor shall deliver a CPMP that lays out the Contractor’s approach, timeline, and tools to be used in execution of the contract IAW PWS Section 5.1.2.

· Due 30 days after contract (DAC) and updated monthly thereafter.

· Electronic Submission To: VA PM, COR, CO.

Inspection: Destination Acceptance: Destination

0001AB

Weekly Progress Report IAW PWS Section 5.1.3.

· Due noon EST, every Thursday throughout the PoP.

· Electronic Submission To: VA PM, COR, CO.

Inspection: Destination Acceptance: Destination

The Contractor shall submit training certificates for the completion of (1) Privacy and Health Insurance Portability and Accountability Act (HIPAA) training, (2) VA Privacy and Information Security Awareness and Rules of Behavior, and (3) the Contractor Rules of Behavior IAW PWS Section 5.1.5.

· Certificates of Completion due 1 week after contract award

· Electronic submission to: VA PM, COR, CO

Inspection: Destination Acceptance: Destination

The Contractor shall utilize HCD principles and evaluations as part of all product development and/or operations efforts for reporting any interfaces that provide information to or from users and/or associated systems IAW PWS Section 5.2.

The Period of Performance shall be 12 months from date of award.

· Due 45 days after contract award and updated monthly thereafter

· Electronic submission to: VA PM, COR, CO.

Inspection: Destination Acceptance: Destination

· Due 45 days after contract award and updated monthly thereafter

· Electronic submission to: VA PM, COR, CO.

Inspection: Destination Acceptance: Destination

The Contractor shall provide a data source agnostic XAI driven digital physical therapy application for assessing foot/ankle musculoskeletal disorders IAW PWS Section 5.3.

The Period of Performance shall be 12 months from date of award.

· 12 Compatible tablets/footbeds are due at the onset of Phase I

· 10 additional compatible tablets/footbeds are due at the onset of phase II Contractor shall provide a data-enabled tablet. This does not have to be an iPad. It merely must be a tablet-device that is compatible with the AIPTA system. VA will not take ownership of these devices. They will only be used for the pilot.

The Contractor shall test AIPTA software, hardware and wearables, orientation, training, and workflow processes to assess and improve functionality/system performance, scalability, usability, physical therapist information needs, Veteran engagement, potential for clinical usefulness and all applicable paragraphs IAW PWS Section 5.3.2.1.

· Due 14 days after the end of Phase 1a.

· Electronic submission to: VA PM, COR, CO.

Inspection: Destination Acceptance: Destination

The contractor shall provide 12 compatible tablets/footbeds and associated connection at the at the onset of Phase I

The Contractor shall identify and correct any issues associated with the AIPTA functionality/system performance, scalability, usability, physical therapist information needs, Veteran engagement, potential for clinical usefulness and all applicable paragraphs IAW PWS Section 5.3.2.1.

· Due 14 days after the end of Phase 1b.

· Electronic submission to: VA PM, COR, CO.

Inspection: Destination Acceptance: Destination

The Contractor shall assess the same variables as in Phase 1 using improved processes and the AIPTA app with the larger population provided by engaging two sites (Tampa and Cincinnati) simultaneously and all other applicable requirements detailed IAW PWS Section 5.3.2.2.

· Due 14 days after the end of Phase 2.

· Electronic submission to: VA PM, COR, CO.

Inspection: Destination Acceptance: Destination

The contractor shall provide 10 additional compatible tablets/footbeds and associated connection at the at the onset of Phase II

The Contractor shall document lessons learned from Phase 2 and provide to the VA, at a minimum, orientation and training reference materials, any data or documentation first produced for VA and workflow/provisioning processes and all other applicable requirements detailed IAW PWS Section 5.3.2.2.

· Due 14 days after the end of Phase 2.

· Electronic submission to: VA PM, COR, CO.

Inspection: Destination Acceptance: Destination

The Contractor shall prescreen all personnel requiring access to the computer systems to ensure the appropriate background investigation is collected and maintained IAW PWS Section 6.2.2.

· Due 3 days after contract award and updated throughout the period of performance.

· Electronic submission to: VA PM, COR, CO.

Inspection: Destination Acceptance: Destination

The Period of Performance shall be 12 months from date of award.

B.5 PERFORMANCE WORK STATEMENT

PERFORMANCE WORK STATEMENT (PWS)

DEPARTMENT OF VETERANS AFFAIRS

Veterans Health Administration Office of Research and Development National Artificial Intelligence Institute (NAII)

AI-Based Physical Therapy App (AIPTA)

Date: March 9, 2022

VA-21-00092373

PWS Version Number: 1.8

1.0 BACKGROUND

The Department of Veterans Affairs (VA), Veterans Health Administration, Office of Research and Development, National Artificial Intelligence Institute (NAII), and the Office of Information & Technology (OIT) strives to provide high quality, effective, and efficient Information Technology (IT) services to those responsible for providing care to the Veterans at the point-of-care as well as throughout all the points of the Veterans’ health care in an effective, timely and compassionate manner. VA depends on Information Management/Information Technology (IM/IT) systems to meet mission goals.

Physical therapy, and Musculoskeletal (MSK) rehabilitation is challenging. A VA HSR&D study indicates that 50% - 60% of Veterans report chronic musculoskeletal pain with high co-prevalence rates of medical, mental health and substance use disorder. The physical therapists only see their patients for a brief period and most of the opportunities for re-injury occur outside of the clinic. With the AIPTA pilot, Artificial Intelligence (AI) models shall provide physical therapists with insights, recommendations, notifications, reports, and rationale, while providing Veterans with biofeedback, notifications, and progress reports during and after performing their physical therapy exercises. Physical therapists can assess Veteran engagement and progress data, remotely manage a Veteran’s training plan, and intervene in between clinical visits.

2.0 APPLICABLE DOCUMENTS

In the performance of the tasks associated with this Performance Work Statement, the Contractor shall comply with the following:

1. 44 U.S.C. § 3541-3549, “Federal Information Security Management Act (FISMA) of 2002”

2. “Federal Information Security Modernization Act of 2014”

3. Federal Information Processing Standards (FIPS) Publication 140-2, “Security Requirements for Cryptographic Modules”

4. FIPS Pub 199. “Standards for Security Categorization of Federal Information and Information Systems,” February 2004

5. FIPS Pub 200, “Minimum Security Requirements for Federal Information and Information Systems,” March 2006

6. FIPS Pub 201-2, “Personal Identity Verification of Federal Employees and Contractors,” August 2013

7. 5 U.S.C. § 552a, as amended, “The Privacy Act of 1974”

8. 42 U.S.C. § 2000d “Title VI of the Civil Rights Act of 1964”

9. VA Directive 0710, “Personnel Security and Suitability Program,” June 4, 2010, https://www.va.gov/vapubs/index.cfm

10. VA Handbook 0710, “Personnel Security and Suitability Program,” May 2, 2016, https://www.va.gov/vapubs/index.cfm

11. VA Directive and Handbook 6102, “Internet/Intranet Services,” August 5, 2019

12. 36 C.F.R. Part 1194 “Information and Communication Technology Standards and Guidelines,” January 18, 2017

13. Office of Management and Budget (OMB) Circular A-130, “Managing Federal Information as a Strategic Resource,” July 28, 2016

14. NIST SP 800-66 Rev. 1, “An Introductory Resource Guide for Implementing the Health Insurance Portability and Accountability Act (HIPAA) Security Rule,” October 2008

15. Sections 504 and 508 of the Rehabilitation Act (29 U.S.C. § 794d), as amended, January 18, 2017

16. Homeland Security Presidential Directive (12) (HSPD-12), August 27, 2004

17. VA Directive 6500, “VA Cybersecurity Program,” February 24, 2021

18. VA Handbook 6500, “Risk Management Framework for VA Information Systems VA Information Security Program,” February 24, 2021

19. VA Handbook 6500.2, “Management of Breaches Involving Sensitive Personal Information (SPI),” March 12, 2019

20. VA Handbook 6500.5, “Incorporating Security and Privacy into the System Development Lifecycle,” March 22, 2010

21. VA Handbook 6500.6, “Contract Security,” March 12, 2010

22. VA Handbook 6500.8, “Information System Contingency Planning,” April 6, 2011

23. VA Handbook 6500.10, “Mobile Device Security Policy,” February 15, 2018

24. OIT Process Asset Library (PAL), https://www.va.gov/process/ . Reference Process Maps at https://www.va.gov/process/maps.asp and Artifact templates at https://www.va.gov/process/artifacts.asp

25. One-VA Technical Reference Model (TRM) (reference at https://www.va.gov/trm/TRMHomePage.aspx)

26. VA Handbook 6510, “VA Identity and Access Management,” January 15, 2016

27. VA Directive and Handbook 6513, “Secure External Connections,” October 12, 2017

28. VA Directive 6300, “Records and Information Management,” September 21, 2018

29. VA Handbook, 6300.1, “Records Management Procedures,“ March 24, 2010

30. NIST SP 800-37 Rev 2, “Risk Management Framework for Information Systems and Organizations: A System Life Cycle Approach for Security and Privacy,” December 2018

31. NIST SP 800-53 Rev. 5, “Security and Privacy Controls for Federal Information Systems and Organizations,” September 23, 2020 (includes updates as of 12/10/2020)

32. VA Directive 0735, “Homeland Security Presidential Directive 12 (HSPD-12) Program,” October 26, 2015

33. VA Handbook 0735, “Homeland Security Presidential Directive 12 (HSPD-12) Program,” March 24, 2014

34. OMB Memorandum 05-24, “Implementation of Homeland Security Presidential Directive (HSPD) 12 – Policy for a Common Identification Standard for Federal Employees and Contractors,” August 5, 2005

35. OMB Memorandum M-19-17, “Enabling Mission Delivery Through Improved Identity, Credential, and Access Management,” May 21, 2019

36. OMB Memorandum, “Guidance for Homeland Security Presidential Directive (HSPD) 12 Implementation,” May 23, 2008

37. Federal Identity, Credential, and Access Management (FICAM) Roadmap and Implementation Guidance, December 2, 2011, (NOTE: Part A of the FICAM Roadmap and Implementation Guidance, v2.0, was replaced in 2015 with an updated Architecture (https://arch.idmanagement.gov/#what-is-the-ficam-architecture)

38. NIST SP 800-116 Rev 1, “Guidelines for the Use of Personal Identity Verification (PIV) Credentials in Facility Access,“ June 2018

39. NIST SP 800-63-3, 800-63A, 800-63B, 800-63C, “Digital Identity Guidelines,” updated March 02, 2020

40. NIST SP 800-157, “Guidelines for Derived PIV Credentials,” December 2014

41. VA Memorandum, VAIQ #7100147, “Continued Implementation of Homeland Security Presidential Directive 12 (HSPD-12),” April 29, 2011 (reference https://www.voa.va.gov/documentlistpublic.aspx?NodeID=514)

42. IAM Identity Management Business Requirements Guidance document, May 2013, (reference Enterprise Architecture Section, PIV/IAM (reference https://www.voa.va.gov/documentlistpublic.aspx?NodeID=514)

43. VA Memorandum “Personal Identity Verification (PIV) Logical Access Policy Clarification,” July 17, 2019, https://www.voa.va.gov/DocumentView.aspx?DocumentID=4896

44. Trusted Internet Connections (TIC) 3.0 Core Guidance Documents, https://www.cisa.gov/publication/tic-30-core-guidance-documents

45. OMB Memorandum M-19-26, “Update to the Trusted Internet Connections (TIC) Initiative,” September 12, 2019

46. OMB Memorandum M-08-23, “Securing the Federal Government’s Domain Name System Infrastructure,” August 22, 2008

47. Sections 524 and 525 of the Energy Independence and Security Act of 2007, (Public Law 110–140), December 19, 2007

48. Section 104 of the Energy Policy Act of 2005, (Public Law 109–58), August 8, 2005

49. Executive Order 13834, “Efficient Federal Operations,” dated May 17, 2018

50. Executive Order 13221, “Energy-Efficient Standby Power Devices,” August 2, 2001

51. VA Directive 0058, “VA Green Purchasing Program,” July 19, 2013

52. VA Handbook 0058, “VA Green Purchasing Program,” July 19, 2013

53. Office of Information Security (OIS) VAIQ #7424808 Memorandum, “Remote Access,” January 15, 2014, https://www.voa.va.gov/DocumentListPublic.aspx?NodeId=28

54. “Veteran Focused Integration Process (VIP) Guide 4.0,” January 2021, https://www.voa.va.gov/DocumentView.aspx?DocumentID=4371

55. VA Memorandum “Proper Use of Email and Other Messaging Services,” January 2, 2018, https://www.voa.va.gov/DocumentListPublic.aspx?NodeId=28

56. “DevSecOps Product Line Management Playbook” version 2.0, May 2021, https://www.voa.va.gov/DocumentView.aspx?DocumentID=4946

57. NIST SP 500-267B Revision 1, “USGv6 Profile,” November 2020

58. OMB Memorandum M-21-07, “Completing the Transition to Internet Protocol Version 6 (IPv6),” November 19, 2020

59. Social Security Number (SSN) Fraud Prevention Act of 2017 Section 240 of the Consolidated Appropriations Act (CAA) 2018, March 23, 2018

3.0 SCOPE OF WORK

The Contractor shall provide all external resources (to include loaned equipment, software, models and staffing) necessary to accomplish the requirements described in this PWS. The Contractor shall provide a Commercial-off-the-Shelf (COTS) external data source agnostic explainable artificial intelligence (XAI) solution, herein referred to as the AI-Based Physical Therapy App (AIPTA), which predicts and mitigates repetitive stress and over-exertion injuries by using an external adaptive user interface capable of receiving input from a variety of non-VA owned wearable technology. The AIPTA shall complement existing VA physical therapy (PT) protocols in preventing and treating chronic ankle/foot musculoskeletal injuries, identifying root causes, and shall provide users with recommendations, biofeedback, notifications, adaptive training plans, reports, and rationale facilitated by wearables and non-VA owned smart technology (compatible tablets and wearable ankle/foot sensors).

The AIPTA does not interface with the VA Network, and shall not be integrated into any VA Healthcare System (VAHCS) information and communications technology, (ICT) systems and shall be a standalone system to include Contractor provided hardware and software, models, devices and wearable sensors.

The Period of Performance (PoP) shall be proposed by the Contractor but shall not exceed 12 months.

Any work at the Government site shall not take place on Federal holidays or weekends unless directed by the Contracting Officer (CO).

There are 11 Federal holidays set by law (USC Title 5 Section 6103) that VA follows:

Under current definitions, four are set by date:

If any of the above 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.

The other six are set by a day of the week and month:

4.2 PLACE OF PERFORMANCE

Tasks under this PWS shall be performed both at Contractor facilities and at VA rehabilitation clinics in Cincinnati, Ohio and Tampa, Florida. The Contractor shall identify the Contractor’s place of performance in their proposal submission.

AI Model modification/installation will occur at Contractor facilities.

On-site tasks include, but are not limited to, testing, provisioning, orientation, training, usability assessments, and initial technical support. Observational studies and intermediate usability studies shall also occur at VA facilities. The Contractor shall have a physical presence at the VA facilities as needed to meet these requirements, however there is no requirement for full time, on-site staffing at VA facilities. It is anticipated that the Contractor’s physical presence may take place during the first 1-2 weeks full time on-site for each phase at each facility throughout the PoP for the kickoff of each phase and to check usability, clinical usefulness, Veteran volunteer engagement, and other related activities, barring any unforeseen facility requirements related to COVID.

4.3 TRAVEL

The Government anticipates travel under this effort to perform the tasks associated with the effort. Include all estimated travel costs in your firm-fixed price line items. These costs will not be directly reimbursed by the Government.

The total estimated number of trips in support of the tasks for this effort is 12, (3 persons for 4 trips). Anticipated locations include the following, estimated at 1-2 weeks per trip in duration:

1. Cincinnati VA Medical Center 3200 Vine Street Cincinnati, OH 45220-2213

2. James A. Haley Veterans’ Hospital 13000 Bruce B. Downs Boulevard Tampa, FL 33612-4745

5.0 SPECIFIC TASKS AND DELIVERABLES

The Contractor shall perform the following:

5.1 PROJECT MANAGEMENT

5.1.1 PROJECT MANAGER

The Contractor shall provide a Contractor Project Manager (CPM) who shall provide oversight of all efforts. The CPM is responsible for prompt response to VA project related inquiries. The CPM shall attend the Kickoff Meeting as well as the weekly teleconference to discuss the project approach, schedules, milestones, recurring (weekly) meetings and provide Contractor points of contact (POC).

The Contractor shall make every effort to ensure that issues raised by VA staff are addressed in a timely manner. The CPM shall work with the VA Project Manager / COR to ensure successful execution of the Pilot and to address any issues that may arise.

5.1.2 CONTRACTOR PROJECT MANAGEMENT PLAN

The Contractor shall deliver a Contractor Project Management Plan (CPMP) that describes the Contractor’s approach, timeline, and tools to be used in execution of the contract. The CPMP should take the form of both a narrative and graphic format that displays the schedule, milestones, risks, and resource support. The CPMP shall also include how the Contractor shall coordinate and execute planned, routine, and ad hoc data collection reporting requests as identified within the PWS. The initial baseline CPMP shall be concurred upon and updated in accordance with Section B of the contract. The Contractor shall update and maintain the VA PM approved CPMP throughout the PoP.

Specifically, the CPMP shall include:

Weekly Schedule Management – The development, management, and control of project schedules, to include a project workflow Risk Management – The planning, identification, analysis, monitoring, and control of and responses to program risk.

Communication Management – The timely and appropriate generation, collection, distribution, storage, retrieval, and disposition of program information.

Staffing Plan - Details on staffing levels, resources, etc., for both Contractor and Subcontractor personnel.

Quality Assurance Plan - Detailed quality control and oversight plan for all work performed. This plan shall, at a minimum, address how the Contractor shall do the following:

Ensure VA information (paper and electronic) is not compromised.

Account for all records/information from the point of receipt through return whether on-site or off-site; and, Ensure proper indexing of records

Deliverable:

A. Contractor Project Management Plan

5.1.3 REPORTING REQUIREMENTS

The Contractor shall provide the COR with Weekly Progress Reports in electronic form in Microsoft Word and/or PowerPoint formats (or in a format convertible to Word and/or PowerPoint. The report will capture the content of the weekly teleconference. The report shall include detailed instructions/explanations for each required data element, to ensure that data is accurate and consistent. These reports shall reflect data as of the last day of the preceding Week.

The Weekly Progress Reports shall cover all work completed during the reporting period and work planned for the subsequent reporting period. The report shall also identify any problems that arose and a description of how the problems were resolved. If problems have not been completely resolved, the Contractor shall provide an explanation including their plan and timeframe for resolving the issue. The report shall also include an itemized list of all Information and Communication Technology (ICT) deliverables and their current Section 508 conformance status. The Contractor shall monitor performance against the CPMP and report any deviations. It is expected that the Contractor will keep in communication with VA accordingly so that issues that arise are transparent to both parties to prevent escalation of outstanding issues.

The Contractor and the COR will have a weekly teleconference call to discuss, progress, key issues, developments or any other topic affecting the project.

Deliverable:

A. Weekly Progress Report

5.1.4 KICKOFF MEETING

A kickoff meeting shall be held within 10 days after TO award. The Contractor shall coordinate the date, time, and location (can be virtual) with the Contracting Officer (CO), as the Post-Award Conference Chairperson, the VA PM, as the Co-Chairperson, the Contract Specialist (CS), and the COR. The Contractor shall provide a draft agenda to the CO and VA PM at least five calendar days prior to the meeting. Upon Government approval of a final agenda, the Contractor shall distribute to all meeting attendees. During the kickoff-meeting, the Contractor shall present, for review and approval by the Government, the details of the intended approach, work plan, and project schedule for each effort via a Microsoft Office PowerPoint presentation. At the conclusion of the meeting, the Contractor shall update the presentation with a final slide entitled “Summary Report” which shall include notes on any major issues, agreements, or disagreements discussed during the kickoff meeting and the following statement “As the Post-Award Conference Chairperson, I have reviewed the entirety of this presentation and assert that it is an accurate representation and summary of the discussions held during the kickoff meeting for the AIPTA effort. The Contractor shall submit the final updated presentation to the CO for review and signature within three calendar days after the meeting. The Contractor shall also work with the CS, the Government’s designated note taker, to prepare and distribute the meeting minutes of the kickoff meeting to the CO, COR and all attendees within three calendar days after the meeting. The Contractor shall obtain concurrence from the CS on the content of the meeting minutes prior to distribution of the document.

5.1.5 TRAINING – PRIVACY AND HIPAA TRAINING

The Contractor shall submit VA Talent Management System (TMS) training certificates for the completion of Privacy and Health Insurance Portability and Accountability Act (HIPAA) training (TMS 10203) and VA Privacy and Information Security Awareness and Rules of Behavior (TMS 10176) and provide signed copies of the Contractor Rules of Behavior in accordance with Section 9, Training, from Appendix C of the VA Handbook 6500.6, “Contract Security”.

Contractor personnel can register for an account and receive access to the training at https://www.tms.va.gov/SecureAuth35/ and click on the “Create New User” link on the TMS 2.0 site to gain access.

Deliverables:

A. VA HIPAA Certificate of Completion B. VA Privacy and Information Security Awareness and Rules of Behavior Training Certificate C. Signed Contractor Rules of Behavior

5.2 HUMAN CENTERED DESIGN (HCD)

The Contractor shall utilize Human Centered Design (HCD) principles as part of all product development and operations efforts. While engaging in the following HCD activities, the Contractor shall:

1. Follow the United States Digital Service value: “Design with users, not for them.”;

2. Provide expert guidance on user experience (UX) design direction and strategy; and

3. Create and maintain documentation for all activities, recommendations, and VA decisions.

At the start of the AIPTA project, conduct a product development kick-off meeting with government Product Owner and designated stakeholders to establish desired outcomes.

Product Lifecycle Activities The Contractor shall support HCD activities for the AI Based PT App throughout its lifecycle by engaging in the following activities:

A. Conduct discovery activities on existing AI Based PT App as well as internal and external business process flows and functions. Work closely with VA customers to understand their needs and how those needs map to VA capabilities. Collect available data, user feedback, and VA stakeholder feedback and capture in a Discovery Report.

B. Maintaining a product plan/roadmap that includes comprehensive list of the AI Based PT App’s functionality that needs to be built or updated and prioritization of these based on Discovery that has happened, as well as product Key Performance Indicators (KPI). These product’s KPIs shall be established in concert with the VA Product Owner and key stakeholders, as well evaluation KPI methodologies. All KPIs shall be designed to allow the team to effectively and objectively evaluate the product against user needs throughout the life of the product.

C. Participate in VA stakeholder meetings, some of which will be in-person at VA facilities, to plan building and integrating the services and change management activities including but not limited to managing agendas, minutes, action items, and collaboration tool management meetings.

D. Mock proposed AI Based PT App to receive feedback from potential consumers and iterate on designs quickly prior to beginning software development.

Deliverables:

A. Discovery Report B. Product Plan/Roadmap and KPIs

5.3 XAI BASED PHYSICAL THERAPY SOLUTION (AIPTA)

The AIPTA shall be a data source agnostic XAI driven digital physical therapy application for assessing foot/ankle musculoskeletal disorders. The application shall provide physical therapists with an independent assessment of patients and patient rehabilitation plan during clinical visits and guides patients through rehabilitation exercises outside of the clinical setting. The application shall provide physical therapists notifications on patient adherence and progress. The application also shall provide the patient with feedback during exercises to assist the patient in optimizing their form and adherence motivation. VA retains the right, for all compatible tablets that process VA data for this effort, to retain the hard drives of these devices in accordance with Section B3.

The Contractor shall provide the sensored footbed required for the Pilot.

5.3.1 FUNCTIONAL REQUIREMENTS

The AIPTA shall have the following key capabilities and characteristics:

1. Provides a data source agnostic XAI model that predicts and mitigates repetitive stress/over-exertion injuries.

2. Uses an adaptive user interface.

3. Interoperable with a range of wearables and databases. This pilot shall be limited to sensored footbeds, however the system shall have the capability to accept different inputs (e.g., iPad camera data).

4. Does not interfere with existing VA PT activities in preventing and treating chronic ankle/foot musculoskeletal injuries and identifying root causes.

5. Provides users with insights, recommendations, biofeedback, notifications, adaptive training plans, reports, and rationale.

6. Transmits data by encrypted cellular connections using a private Access Point Name and Virtual Private Network between the sensors and the compatible tablet.

7. All data shall be de-identified, fragmented, and isolated across multiple dedicated physical servers.

8. Is a standalone system and as a result shall not be integrated into any VAHCS information or ICT systems.

Deliverables:

A. Compatible tablet with Data Plan with Footbeds.

5.3.2 IMPLEMENTATION

The pilot program shall be broken into two phases spread across two VA sites. The Contractor shall have a physical presence at each site during the pilot program, as described above. At a minimum, the Contractor shall visit each site to ensure each phase commences successfully. Any necessary modifications to the AIPTA shall be pushed electronically as updates to both Veterans (off-site) and physical therapists (on-site).

The Contractor shall provide technical support remotely via voice, chat, web, and email. Upon pilot commencement, the Contractor shall provide remote (virtual) support, available online and telephonically, to include onboarding new users and configuring user experiences to ensure Veteran and Physical Therapist engagement with the AIPTA and proper functionality. The Contractor support shall be available 9:00AM to 4:30PM local time, Monday thru Friday (excluding federal holidays or other days where the PT facilities are closed) for each location, and shall include troubleshooting and resolving technical issues, issues with the functionality, and to respond to requests for assistance from Veteran and Physical Therapist users.

The Contractor shall perform the requirements in each of the following phases in support of the implementation of the AIPTA.

Participants in the pilot will consist of physical therapy residents and mentors and Veterans with chronic lower extremity musculoskeletal pain, more precisely, foot/ankle pain. During the pilot, the Contractor shall provide and maintain, for Veteran participants: XO-sole sensored footbeds, compatible tablet (with the AIPTA app pre-installed), tablet stand, tablet cover, and cellular connectivity.

The Contractor shall provide physical therapists with an compatible tablet with the AIPTA pre-installed, tablet cover, and cellular connectivity. The Contractor shall also provide and maintain at each site, an tablet (with the AIPTA app pre-installed) and a stand for group use when a physical therapist is performing Veteran participant functional tests.

Any communication between Veterans and Physical Therapist staff shall go through pre-existing VA channels and not through any equipment issued in conjunction with this pilot.

5.3.2.1 PHASE 1 – PROOF OF CONCEPT

Duration: 2 - 3 months Locations: Tampa and Cincinnati VAMCs

Phase 1 shall consist of two parts (Phase 1a and Phase 1b) and shall test AIPTA software, hardware and wearables, and orientation, training, and workflow processes to assess and improve functionality/system performance, scalability, usability, physical therapist information needs, Veteran engagement, and potential for clinical usefulness. The Contractor provided system training shall include reference materials for the participants.

Phase 1 shall be highly iterative, integrating participant feedback throughout the Phase in an effort to generate a strong and positive participant experience.

Phase 1a

Participants: Maximum of 10 Volunteer physical therapy staff (residents and mentors) with a minimum of 2 participants per site.

Purpose: The purpose of Phase 1a is to identify and correct any issues associated with functionality/system performance, scalability, usability, volunteer physical therapist information needs, workflow integration, orientation, training. Physical Therapists will act as surrogate patients assessing Veteran adoption of the digital physical therapy system providing feedback on the potential issues that may affect volunteer Veteran engagement.

The Contractor shall provide the COR with a Phase 1a Assessment Report at the end of this phase of the project. The Phase 1a Assessment Report shall be due prior to moving to the next phase and shall include, at a minimum, feedback from participants, lesson learned, recommendations, and proposed next steps. Phase 1a lessons learned shall be integrated into the pilot prior to starting Phase 1b.

Phase 1b

Participants: Maximum of 15 Volunteer Veterans (Veteran participants constrained by the number of available sensored footbeds) and a commensurate number of physical therapy residents.

Purpose: The purpose of Phase 1b is to identify and correct any issues associated with functionality/system performance, scalability, usability, physical therapist information needs, workflow integration, orientation, training, physical therapist and Veteran engagement, and clinical usefulness.

Phase 1 shall end when any major bugs and improvements have been identified, there was consensus on solutions and they have been resolved, and the potential for clinical usefulness has been assessed. Metrics and baselines for evaluating Phase 1 shall be jointly developed by the Contractor, COR and VA subject matter experts and shall use, where available, pre-pilot scores for existing metrics that measure clinical processes, Veteran engagement, and Physical Therapist performance. The pilot stakeholders will identify additional metrics, metrology, and target scores where appropriate and feasible.

The Contractor shall provide the COR with a Phase 1b Assessment Report at the end of this phase of the project. The Phase 1b Assessment Report shall be due prior to moving to the next phase and shall include, at a minimum, feedback from participants, lesson learned, issues resolved include the method by which they were resolved, recommendations, and proposed next steps.

Phase 1 shall not include integration into any VAHCS information or ICT systems.

Deliverables:

Phase 1a Assessment Report Phase 1b Assessment Report

5.3.2.2 PHASE 2 – FEASIBILITY

Duration: 3 - 4 months Locations: Tampa and Cincinnati VAMCs

Participants: Physical therapy residents and mentors; a maximum of nine Veterans per site (Veteran participants limited by the number of available Xonano sensored footbeds). There is a minimum of four participants per site.

The Contractor shall send the sensored footbeds used in Phase 1 for refurbishment for use in Phase 2 while Phase 1 lessons learned are being integrated into the pilot for Phase 2 by the Contractor.

Phase 2 shall assess the same variables as in Phase 1 using improved processes and the AIPTA app with the larger population provided by engaging two sites (Tampa and Cincinnati) simultaneously.

Phase 2 shall evaluate the objectives such as; functionality/system performance, scalability,…