36C10B24R0031 CART.docx

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.

UEI:

EFT:

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

7/29/2024

36C10B24R0031

Dana Seeler dana.seeler@va.gov 848-377-5181 08-05-2024

1:00 PM

EDT

Department of Veterans Affairs Technology Acquisition Center 23 Christopher Way Eatontown, NJ 07724

X

541511 $34 Million

N/A

See Delivery Schedule

Department of Veterans Affairs Technology Acquisition Center 23 Christopher Way Eatontown, NJ 07724

Technology Acquisition Center Financial Services Center

PO BOX 149971

Austin, TX 78714-8971

This Request for Proposal (RFP) is issued for Clinical Assessment, Report and Tracking (CART) Program.

See Section B.4 Price Schedule and B.5 for Performance Work Statement

The Period of Performance shall be one 12-month base period, with two 12-month option periods.

Points of Contact:

Dana Seeler, Contract Specialist dana.seeler@va.gov

Jason King, Contracting Officer jason.king6@va.gov

Period for Questions will close on Wednesday, 08/01/2024, 9:00AM EST. Answers will be posted via Addendum.

Jason King

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 (shrinkwrap), 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/or 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 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 two business days) in resolving software problems will be noted in the Government’s various past performance records on the Contractor (e.g., www.cpars.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:

Name of Company:

Address:

Point of Contact:

Phone Number:

Email Address:

Company Business Size & Status:

Unique Entity Identifier (UEI):

b. GOVERNMENT: Contracting Officer 36C10B, Jason King

Technology Acquisition Center 23 Christopher Way Eatontown, NJ 07724

☒ 52.232-33, Payment by Electronic Funds Transfer—System 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:

with B.4, Price Schedule and in accordance with Section B.5, Performance Work Statement

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:

6. Purchase Order for Billing Purposes: TBD

B.4 PRICE SCHEDULE

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. All questions shall be directed to the Contract Specialist, Dana Seeler, dana.seeler@va.gov, and Contracting Officer, Jason King, jason.king@va.gov prior to the closing date and time specified in the Request for Proposal (RFP).

Any resulting contract will be awarded on a firm-fixed-price basis as defined by Federal Acquisition Regulation Subpart 16.202. Accordingly, the Contractor shall ensure that any and all costs associated with the Contractor’s proposed application(s), software products, software solution, and/or system, shall be included in the Contractor’s proposed firm-fixed price, and shall serve as the Contractor’s firm-fixed price for the life of any resulting contract. No additional costs or fees relative to the Contractor’s proposed application(s), software products, software solution, and/or system including, but not limited to, licensing costs and any associated licensing maintenance required for the development, delivery, integration, operation, and/or maintenance of the Contractor’s proposed solution will be allowed, accepted, and/or paid by the Government.

All deliverables will be destination inspection, acceptance, and F.O.B.

Days used below refer to calendar days unless otherwise stated. Deliverables with due dates falling on a weekend or holiday shall be submitted the following Government workday after the weekend or holiday.

Electronic submission to: VA Project Manager, Contracting Officer, and Contracting Officer’s Representative

Product Service Code for the following CLINs/SLINs is DA01: IT and Telecom – Business Application/Application Development Support Services (Labor)

Base Period The period of performance for this effort shall be 12 months from date of award.

This Firm Fixed Price (FFP) Contract Line Item Number (CLIN) includes all Labor, Materials, Project Management and Deliverables required for successful completion of the services detailed in PWS paragraphs 5.1, 5.2, and 5.3, inclusive of all subparagraphs.

Period of Performance (PoP): 12 months from date of award

Due 30 days after award and updated monthly thereafter

Due the fifth day of each quarter throughout the PoP.

Due 3 days after contract award and updated as required throughout the PoP.

This FFP CLIN includes all Labor, Materials, Project Management and Deliverables required for successful completion of the services detailed in PWS paragraph 5.2 and subparagraphs 5.2.1, 5.2.2.

PoP: 12 months from date of award

Cross-Training of CART Program Personnel IAW with PWS paragraph 5.3

This FFP CLIN includes all Labor, Materials, Project Management and Deliverables required for successful completion of the services detailed in PWS paragraphs 5.3, inclusive of all subparagraphs.

PoP: 12 months from date of award

Due one (1) week prior to the first training session.

Option Period One This 12-month option period may be exercised in accordance with FAR 52.217-9, Option to Extend the Term of the Contract (MAR 2000). Work shall not commence until, and unless, a formal modification is issued by the Contracting Officer. If exercised, this option shall commence immediately after expiration of the Base Period.

This FFP CLIN includes all Labor, Materials, Project Management and Deliverables required for successful completion of the services detailed in PWS paragraph 5.4.

PoP: 12 months after expiration of the base period

Due 30 days after exercise of Option Period One and updated monthly thereafter

Due the fifth day of each quarter throughout the PoP.

Updated as required.

PoP: 12 months after expiration of base period

This FFP CLIN includes all Labor, Materials, Project Management and Deliverables required for successful completion of the services detailed in PWS paragraphs 5.3, inclusive of all subparagraphs.

PoP: 12 months after expiration of base period

Due one (1) week prior to the first training session.

Option Period Two This 12-month option period may be exercised in accordance with FAR 52.217-9, Option to Extend the Term of the Contract (MAR 2000). Work shall not commence until, and unless, a formal modification is issued by the Contracting Officer. If exercised, this option shall commence immediately after expiration of Option Period One.

This FFP CLIN includes all Labor, Materials, Project Management and Deliverables required for successful completion of the services detailed in PWS paragraph 5.4.

PoP: 12 months after expiration of the base period

Due 30 days after exercise of Option Period One and updated monthly thereafter

Due the fifth day of each quarter throughout the PoP.

Updated as required.

PoP: 12 months after expiration of base period

This FFP CLIN includes all Labor, Materials, Project Management and Deliverables required for successful completion of the services detailed in PWS paragraphs 5.3, inclusive of all subparagraphs.

PoP: 12 months after expiration of base period

Due one (1) week prior to the first training session.

B.5 PERFORMANCE WORK STATEMENT

PERFORMANCE WORK STATEMENT (PWS)

DEPARTMENT OF VETERANS AFFAIRS

Office of Information & Technology Office of Clinical Assessment, Reporting and Tracking (CART) Program

Clinical Assessment, Report and Tracking (CART) Program

Date: 5/6/2024

VA-24-00011768

PWS Version Number: 2.0

1.0 BACKGROUND

The Department of Veterans Affairs (VA), Office of Information & Technology (OIT), Office of Clinical Assessment, Reporting and Tracking (CART) 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.

Professional society guidelines have recommended that all cardiac catheterization laboratories should participate in procedural registries with structured data reporting to monitor the quality of interventional care as well as to provide benchmarks related to national norms (Journal of American College of Cardiology, 59(24): 2221, 2012 and Journal of American College of Cardiology, 63(23): 2591, 2014).

The CART Program was created to monitor the quality and safety of invasive cardiac procedures within the VA Healthcare System. To do so, the CART Program has led the development of a standalone software application (CART Application Suite [CART-APPS]) that is now fully integrated with the Computerized Patient Record System (CPRS) and Oracle Health. This enables providers to reuse and annotate existing Veterans Health Information Systems and Technology Architecture (VISTA) data including information regarding medical comorbidities and medications. The application also allows for the input of discrete information for pre-procedural assessments, diagnostic coronary procedures and percutaneous coronary interventions. After operators complete this information within the dedicated software application, a standardized procedural report is then automatically created which can be uploaded into the permanent electronic medical record. The application also stores procedural information in a standard relational database that can be easily deployed and migrated to any Structure Query Language (SQL) database system. The application can also be configured to connect via the VA internet to a single national database server that serves all cardiac catheterization laboratories or a series of locally deployed servers with automatic rollup to the national server, giving medical centers the flexibility to choose a deployment structure that best meets the available resources. The data retrieved within the application is then monitored by the CART Program to enhance the quality and safety of invasive cardiovascular procedures. CART was mandated to be a national program for use in all 81 catheterization laboratories in the VA system by the Deputy Undersecretary for Health and is a unique collaborative effort involving Patient Care Services, and the Office of Information, Office of Quality and Performance.

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. 10 U.S.C. § 2224, "Defense Information Assurance Program"

8. 5 U.S.C. § 552a, as amended, “The Privacy Act of 1974”

9. Public Law 109-461, Veterans Benefits, Health Care, and Information Technology Act of 2006, Title IX, Information Security Matters

10. 42 U.S.C. § 2000d “Title VI of the Civil Rights Act of 1964”

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

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

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

14. 36 C.F.R. Part 1194 “Information and Communication Technology Standards and Guidelines,” January 18, 2017

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

16. 32 C.F.R. Part 199, “Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)”

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

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

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

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

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

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

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

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

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

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

27. VA Handbook 6500.11, “VA Firewall Configuration,” August 22, 2017

28. 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

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

30. VA Directive 6508, “Implementation of Privacy Threshold Analysis and Privacy Impact Assessment,” October 15, 2014

31. VA Handbook 6508.1, “Procedures for Privacy Threshold Analysis and Privacy Impact Assessment,” July 30, 2015

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

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

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

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

36. 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

37. 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)

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

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

40. 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

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

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

43. 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)

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

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

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

47. NIST SP 800-164, “Guidelines on Hardware-Rooted Security in Mobile Devices (Draft),” October 2012

48. Draft National Institute of Standards and Technology Interagency Report (NISTIR) 7981, “Mobile, PIV, and Authentication,” March 2014

49. 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)

50. 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)

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

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

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

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

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

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

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

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

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

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

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

62. Clinger-Cohen Act of 1996, 40 U.S.C. §11101 and §11103

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

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

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

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

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

68. Social Security Number (SSN) Fraud Prevention Act of 2017

69. Section 240 of the Consolidated Appropriations Act (CAA) 2018, March 23, 2018

70. CATH/PCI Registry: https://www.ncdr.com/webncdr/cathpci

71. ACC NCDR ICD Registry: https://www.ncdr.com/webncdr/icd

72. ACC/NCRD PVI Registry: https://www.ncdr.com/webncdr/pvi

73. ACC/NCDR STS/ACC TVT Registry: https://www.ncdr.com/TVT/Home/Default.aspx

3.0 SCOPE OF WORK

The Contractor shall be responsible for the maintenance and support of the existing CART Application Suite, as well as incorporating enhancements to add new functionality to support clinical care of Veterans.

4.0 PERFORMANCE DETAILS

4. PERFORMANCE PERIOD

The Period of Performance (PoP) shall be one 12-month base period, with two (2) 12-month Option Periods.

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:

4.1 PLACE OF PERFORMANCE

Tasks under this PWS shall be performed at remote locations with prior approval of the Contracting Officer’s Representative (COR).

4.2 TRAVEL

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

5.0 SPECIFIC TASKS AND DELIVERABLES

The Contractor shall perform the following:

5.1 PROJECT MANAGEMENT

The Contractor shall participate with the CART Program personnel during regular conference calls and face-to-face meetings with the CART Program personnel at least three times per week, as well as biweekly one-on-one meetings with the Program Director regarding progress on deliverables.

5.1.1 CONTRACTOR PROJECT MANAGEMENT PLAN

The Contractor shall deliver a Contractor Project Management Plan (CPMP) that lays out 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.

Deliverable:

A. Contractor Project Management Plan

5.1.2 REPORTING REQUIREMENTS

The Contractor shall provide the COR with a Quarterly Progress and Maintenance Report. The Quarterly Progress and Maintenance Reports shall cover all work completed during the reporting period, work planned for the subsequent reporting period, and note any updates or changes to the initial CPMP. Sections of this report shall include: Clinical/Technical Tradeoff Analysis Report; Clinical/Technical Prioritization Report; Implementation Plan, Regression Testing Plan, Autotest Updates and Autotest Tracking Report, and a Deployment Scheduling and Tracking Report. 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 Contractor shall monitor performance against the CPMP and report any deviations. 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 shall also include the status of all Government Furnished Equipment (GFE) in each Quarterly Progress and Maintenance Report.

The Contractor shall coordinate changes involved with these modifications and enhancements with the VA CART Clinical Program Director, the VA CART Database Manager and the CART National Site manager as appropriate.

The Contractor shall participate in the weekly CART Program meetings for ongoing project management review with VA Program Director and staff.

Deliverable:

A. Quarterly Progress and Maintenance Report

5.2 CART MAINTENANCE, MODIFICATIONS AND ENHANCEMENTS

5.2.1 MAINTENANCE AND SUPPORT

The Contractor shall provide maintenance for the existing Clinical Assessment Reporting and Tracking Application Suite (CART-APPS), and ensure CART-APPS is operational 99% of the time at all installed sites listed in ADDENDUM C – CART INSTALLATION LOCATIONS. CART-APPS is built on top of an object-relational model-driven infrastructure using dynamic late binding of application specifications to run-time objects. Maintenance shall include updating the CART-APPS interfaces, using the Delphi and SQL Data programming languages, including: VA VistA Remote Procedure Call (RPC) Broker for access to VistA databases, VA Decision Support System (DSS) for workload and costing and the new VA Real-Time Locator Services (RTLS) for supply chain management of products such as devices and supply items used in the VA Cath labs. CART-APPS is currently being used by over 2,000 users nationally across 81 locations to facilitate the work of the CART Program. The Contractor shall be available 24X7 to provide support for the CART-APPS and respond via e-mail or phone within four (4) hours of being contacted by the CART Program. Support shall include defect fixes for the applications and related databases including:

1. Trouble shooting

2. Coding or configuration to resolve or fix errors and defects

3. Testing/verification of fixes

4. Adaptation and testing with new MS Windows versions (such as Windows 10)

5. Deployment of new versions

The Contractor shall ensure maintenance for the CART-APPs software under this task does not change the salient characteristics of the CART-APPs. The salient characteristics of the CART-APPs software are:

1. The software leverages a powerful object-relational model-driven dynamic late-binding run-time architecture to manage all the internal data, data relationships, report generation, and user inputs.

1. The software uses a configuration specification to provide information about how the application should function to the architecture, allowing changes to be made through simple specification changes instead of changing the source code associated with the software.

1. The software collects data relevant to the CART Program and the National Cardiology Program Office as identified by industry standards, current research, and VA Clinician feedback on all Cardiology procedures performed in the VA and produces a nationally standardized set of reports for inclusion in patient medical history.

1. The software is tightly integrated with the VISTA/CPRS system as well as Oracle Health and uses it for patient selection, security, data import and data upload.

1. The software complies with all the rules, regulations, and security protocols mandated by VA, Federal Law, and health care oversight organizations, such as The Joint Commission (JACO) authorized by the VA, and must adjust to any new requirements by any of these organizations within a reasonable timeframe.

1. The software interfaces with the VA’s Real Time Locator System (RTLS) and imports information about devices tracked by RTLS that are used during procedures to provide more accurate accounting of devices and reduce the amount of data entry required by users of the application.

1. The software is implemented to permit multiple release versions of the software to operate against the same database. This permits the software upgrade process to happen as each individual hospital approves the update instead of requiring all sites to update simultaneously.

1. The software facilitates procedure coding by mapping all procedures performed into Clinical Procedure Type (CPT) codes.

1. The software produces a list of problems encountered with devices used so that this information can be submitted to the Food and Drug Administration’s (FDA) Device Surveillance program.

1. The software automatically provides alerts when major complications are encountered during procedures and forwards these alerts to a clinical patient safety review team for investigation.

1. The software incorporates feedback from the VA, VA Clinicians, and other end users into the design and implementation of new features.

1. The software provides security roles that limit the scope of the data that users can view and modify, and these security roles also limit access to management features that allow each individual software installation to manage their own location’s settings and users.

1. The software uses a sharing and protection mechanism to reuse data elements from previous reports whenever possible to avoid creating duplicated data and to prevent adjustments to shared data.

1. The software logs key user actions and any error messages produced by the application into a database table to facilitate support and maintenance of the application.

1. The software includes specialized graphical controls and control contents that are dynamically generated based on the contents of key reference tables in the database, so that changes in reference tables will automatically generate graphical control changes and changes in graphical control content without requiring source code or programming changes.

1. The software provides the ability to calculate and display health status scores and analytic measurements based on data collected by the software.

1. The software produces a data dictionary based on the internal application model and current application specification that provides a baseline for published data dictionary updates for software users.

1. Maintenance of the CART application includes:

17. Telephone and email support that is available during normal business hours.

17. Examination of application and database log files

17. Routine Backups of the CART database based on VA Policies and Procedures

17. Routine patching of CART servers based on VA Policies and Procedures

17. Activating and deactivating users

17. Adjusting user roles and permissions

17. Installing upgrades to the application at each hospital

5.2.2 ENHANCEMENTS

The Contractor shall develop and install enhancements to existing CART-APPS per feedback from the CART Clinical Director and CART Clinical Advisory subcommittee. This shall include assistance with prioritization, developing time and resource estimates, implementation and testing of modifications to the CART-APPS and the database and the deployment to all installed sites.

Enhancements to the CART-APPS and database are defined as being within the existing CART system, CART applications and database platform and require no changes to the underlying architecture and infrastructure.

The Contractor shall provide the following enhancements to the CART system:

1. Integration of alternative data fields into CART-APPS, as dictated by CART Program leadership (up to 20 fields)

1. Integration of a revised coronary intervention module

1. Enhancement of an electrophysiology module

1. Enhancement of a cardiac implantable electronic device module

The Contractor shall provide Updated Requirement Specification Document (RSD), Updated System Design Document (SDD), and Updated Test Plans/Procedures (TP/P), and the Modified/Enhanced CART System/Applications Software.

5.3 CROSS-TRAINING OF CART PROGRAM PERSONNEL

The Contractor shall provide technical cross-training to CART Program personnel, approximately two (2) to five (5) people, to build a robust team to provide ongoing maintenance, support and development of the CART Application Suite. This training shall take place in small, informal, on-the-job sessions. Initial training shall enable CART Program team members to perform development and support tasks (listed below) with minimal guidance by the end of the base period and progress through the life of the contract whereby the CART Program team will be able to perform these tasks without guidance by the end of this contract. These development and support tasks include:

1. Add new applications and perform application enhancements.

2. Adaptation to new MS Windows versions.

3. CERNER-CART-APPS integration development and support.

4. Support deployment of new CART versions.

5. Handle all other CART support issues.

The Contractor shall provide a detailed CART Training Manual that shall cover the overall CART system, maintenance and system update requirements.

Deliverable:

A. CART Training Materials

5.4 OPTION PERIOD ONE

The Contractor shall provide all the tasks and services identified in Sections 5.1 and 5.2.1 throughout Option Period One. The Contractor shall also perform all of the tasks and services for sections 5.2.2 for the enhancements specified below and for 5.3 for the training requirements listed below:

From section 5.2.2 Enhancements:

1. Integration of alternative data fields into CART-APPS, as dictated by CART Program leadership (up to 20 fields) to enhance the coronary interventional module.

2. RTLS Level-2 data integration with CART-CL, CART-EP and CART-PVI (Note: Applies only to CART sites with Wavemark RTLS setup).

From section 5.3 Cross training of CART Program Personnel:

1. Add new applications and perform application enhancement without guidance.

2. Adaptation to new MS Windows version without guidance.

3. CPRS RPC broker support without guidance.

4. Support deployment of new CART versions without guidance.

5. Handle all other CART support issues without guidance.

6. Perform difficult trouble shooting task with minor guidance.

5.5 OPTION PERIOD TWO

The Contractor shall provide all the tasks and services identified in Sections 5.1 and 5.2.1 throughout Option Period Two. The Contractor shall also perform all of the tasks and services for sections 5.2.2 for the enhancements specified below and for 5.3 for the training requirements listed below.

From section 5.2.2 Enhancements:

1. Integration of alternative data fields into CART-APPS, as dictated by CART Program leadership (up to 20 fields) to enhance the electrophysiology and cardiac implantable electronic device modules

2. RTLS Level-3 data integration with CART-CL, CART-EP and CART-PVI (Note: Applies only to CART sites with Wavemark RTLS setup).

From section 5.3 Cross training of CART Program Personnel:

1. Perform all development and support tasks without guidance.

2. Add new applications and perform application enhancement without guidance.

3. Adaptation to new MS Windows version without guidance

4. CPRS RPC broker support without guidance

5. Support deployment of new CART versions without guidance

6. Handle all other CART support issues without guidance.

7. Perform difficult trouble shooting task with minor guidance.

6.0 GENERAL REQUIREMENTS

6.1 ENTERPRISE AND IT FRAMEWORK

6.1.1 VA TECHNICAL REFERENCE MODEL

The Contractor shall support the VA enterprise management framework. In association with the framework, the Contractor shall comply with OIT Technical Reference Model (VA TRM). The VA TRM is one component within the overall Enterprise Architecture (EA) that establishes a common vocabulary and structure for describing the information technology used to develop, operate, and maintain enterprise applications. Moreover, the VA TRM, which includes the Standards Profile and Product List, serves as a technology roadmap and tool for supporting OIT. Architecture & Engineering Services (AES) has overall responsibility for the VA TRM.

6.1.2 FEDERAL IDENTITY, CREDENTIAL, AND ACCESS MANAGEMENT (FICAM)

The Contractor shall ensure Commercial Off-The-Shelf (COTS) product(s), software configuration and customization, and/or new software are Personal Identity Verification (PIV) card-enabled by accepting HSPD-12 PIV credentials using VA Enterprise Technical Architecture (ETA), https://www.ea.oit.va.gov/EAOIT/VA_EA/Enterprise_Technical_Architecture.asp, and VA Identity and Access Management (IAM) approved enterprise design and integration patterns, https://www.oit.va.gov/library/recurring/edp/index.cfm. The Contractor shall ensure all Contractor delivered applications and systems comply with the VA Identity, Credential, and Access Management policies and guidelines set forth in VA Handbook 6510 VA Identity and Access Management, VA Handbook 0735 Homeland Security Presidential Directive 12 (HSPD-12) Program, and align with the Federal Identity, Credential, and Access Management Roadmap and Implementation Guidance v2.0.

The Contractor shall ensure all Contractor delivered applications and systems provide user authentication services compliant with the National Institute of Standards and Technology (NIST) Special Publication (SP) 800-63-3, VA Handbook 6500 Appendix F, “VA System Security Controls”, and VA IAM enterprise requirements for direct, assertion based authentication, and/or trust based authentication, as determined by…