36C10B21R0023_1.docx

36C10B21R0023

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

PHONE:

FAX:

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

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

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

25. ACCOUNTING AND APPROPRIATION DATA

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

ARE

ARE NOT ATTACHED.

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

ARE

ARE NOT ATTACHED

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

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

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

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

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

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

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. 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

36C10B21R0023 06-24-2021 Joseph Pignataro, Contract Specialist 732-795-1115 07-01-2021 2pm, EST Department of Veterans Affairs Technology Acquisition Center 23 Christopher Way Eatontown NJ 07724 x x 541511 $30M N/A N/A X See Delivery Schedule

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

Department of Veterans Affairs Technology Acquisition Center Financial Services Center PO Box 149971 Austin TX 78714-8971 See Section B.

Type of Contract: Firm Fixed Price (FFP) Alternate POC: Kathryn Pantages, 732-440-9717 Period of Performance: 12 months with two 12-month option periods and optional tasks.

Title: Clinical Assessment, Reporting and Tracking System Kathryn Pantages Contracting Officer 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 Order. Commercial license agreements may be made a part of this 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 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 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 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 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 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 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 Order must be made by modification (Standard Form 30) and shall only be made by a warranted Contracting Officer. Nothing in this 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

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

a. CONTRACTOR: TBD

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

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:

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.

Department of Veterans Affairs Technology Acquisition Center Financial Services Center PO Box 149971 Austin TX 78714-8971 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.4 PRICE SCHEDULE

Base Period Period of Performance shall be 12 months.

This is a firm-fixed price contract line item number (CLIN).

Government approval of invoices for payment shall be subject to contractor’s successful completion of task requirements and associated deliverables required by the PWS.

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

Electronic submission to: VA PM, COR, CO Inspection: destination Acceptance: destination

Due the fifth day of each quarter throughout the period of performance.

Subsequent reports are due 15 days following the reporting period.

Electronic submission to: VA PM, COR, CO Inspection: destination Acceptance: destination

Due 3 days after contract award and updated within 3 days when staff changes are made.

Electronic submission to: VA PM, COR, CO Inspection: destination Acceptance: destination

This is firm-fixed price CLIN.

Government approval of invoices for payment shall be subject to contractor’s successful completion of task requirements and associated deliverables required by the PWS.

Due one week prior to the first training session.

Due one week prior to the first training session.

Due one week prior to the first training session.

Due upon completion of each upgrade/enhancement effort throughout the PoP.

This is firm-fixed price CLIN.

Government approval of invoices for payment shall be subject to contractor’s successful completion of task requirements and associated deliverables required by the PWS.

Due 7 days prior to training session.

Electronic submission to: VA PM, COR, CO Inspection: destination Acceptance: destination

Base Period Optional Tasks FAR 52.217-7, Option for Increased Quantity – Separately priced Line Item (MAR 1989) may be exercised at any time and from time to time during the base period up to the quantity set forth in CLIN(S) 0004 - 0007. Work shall not commence until, and unless, a formal modification is issued by the Contracting Officer.

A1 Small (SM)

A2 Medium (M)

A3 Large (L)

A4 Extra-Large (XL)

Option Period 1 This 12-month option period may be exercised in the sole discretion of the Government in accordance with (IAW) FAR 52.217-9 Option to Extend the Term of the Contract. Work shall not commence until, and unless, a formal modification is issued by the Contracting Officer. If exercised, the 12-month option period is to commence immediately upon expiration of the Base Period.

This is a firm-fixed price CLIN.

Government approval of invoices for payment shall be subject to contractor’s successful completion of task requirements and associated deliverables required by the PWS.

Due 30 days DAC and updated monthly thereafter.

Electronic submission to: VA PM, COR, CO Inspection: destination Acceptance: destination

Due 15 days following the reporting period.

Electronic submission to: VA PM, COR, CO Inspection: destination Acceptance: destination

Due 3 days after contract award and updated within 3 days when staff changes are made.

Electronic submission to: VA PM, COR, CO Inspection: destination Acceptance: destination

This is firm-fixed price CLIN.

Government approval of invoices for payment shall be subject to contractor’s successful completion of task requirements and associated deliverables required by the PWS.

Due one week prior to the first training session.

Due one week prior to the first training session.

Due one week prior to the first training session.

Due upon completion of each upgrade/enhancement effort throughout the PoP.

Due 7 days prior to training session.

Electronic submission to: VA PM, COR, CO Inspection: destination Acceptance: destination

Option Period 1 Optional Tasks FAR 52.217-7, Option for Increased Quantity – Separately priced Line Item (MAR 1989) may be exercised at any time and from time to time during Option Period 1 up to the quantity set forth in CLIN(S) 1004 - 1007. Work shall not commence until, and unless, a formal modification is issued by the Contracting Officer.

A1 Small (SM)

A2 Medium (M)

A3 Large (L)

A4 Extra-Large (XL)

Option Period 2 This 12-month option period may be exercised in the sole discretion of the Government in accordance with (IAW) FAR 52.217-9 Option to Extend the Term of the Contract. Work shall not commence until, and unless, a formal modification is issued by the Contracting Officer. If exercised, the 12-month option period is to commence immediately upon expiration of the Option Period 1.

This is a firm-fixed price CLIN.

Government approval of invoices for payment shall be subject to contractor’s successful completion of task requirements and associated deliverables required by the PWS.

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

Electronic submission to: VA PM, COR, CO Inspection: destination Acceptance: destination

Due 15 days following the reporting period.

Electronic submission to: VA PM, COR, CO Inspection: destination Acceptance: destination

Due 3 days after contract award and updated within 3 days when staff changes are made.

Electronic submission to: VA PM, COR, CO Inspection: destination Acceptance: destination

This is firm-fixed price CLIN.

Government approval of invoices for payment shall be subject to contractor’s successful completion of task requirements and associated deliverables required by the PWS.

Due upon completion of each upgrade/enhancement effort throughout the Pop

Due 7 days prior to training session.

Electronic submission to: VA PM, COR, CO Inspection: destination Acceptance: destination

Option Period 2 Optional Tasks FAR 52.217-7, Option for Increased Quantity – Separately priced Line Item (MAR 1989) may be exercised at any time and from time to time during Option Period 2 up to the quantity set forth in CLIN(S) 2004 - 2007. Work shall not commence until, and unless, a formal modification is issued by the Contracting Officer.

A1 Small (SM)

A2 Medium (M)

A3 Large (L)

A4 Extra-Large (XL)

B.5 PERFORMANCE WORK STATEMENT

DEPARTMENT OF VETERANS AFFAIRS

Office of Information & Technology Office of Clinical Systems Development and Evaluation

Clinical Assessment, Reporting, and Tracking (CART) Program Services

Date: 3/17/2021

VA-21-00024380

PWS Version Number: 2.0

1.0 BACKGROUND

The Department of Veterans Affairs (VA), Office of Information & Technology (OIT), Office of Clinical Systems Development and Evaluation 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 Clinical Assessment, Reporting, and Tracking (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 Cath Lab Application) that is now fully integrated with the Computerized Patient Record System (CPRS). 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 2016

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. Carnegie Mellon Software Engineering Institute, Capability Maturity Model® Integration for Development (CMMI-DEV), Version 1.3 November 2010; and Carnegie Mellon Software Engineering Institute, Capability Maturity Model® Integration for Acquisition (CMMI-ACQ), Version 1.3 November 2010

9. 5 U.S.C. § 552a, as amended, “The Privacy Act of 1974”

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

11. 42 U.S.C. § 2000d “Title VI of the Civil Rights Act of 1964”

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

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

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

15. 36 C.F.R. Part 1194 “Information and Communication Technology Standards and Guidelines,” January 18, 2017

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

17. 32 C.F.R. Part 199, “Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)”

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

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

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

21. VA Directive 6500, “VA Cybersecurity Program,” January 24, 2019

22. VA Handbook 6500, “Risk Management Framework for VA Information Systems – Tier 3: VA Information Security Program,” March 10, 2015

23. VA Handbook 6500.2, “Management of Breaches Involving Sensitive Personal Information (SPI)”, July 28, 2016

24. VA Handbook 6500.3, “Assessment, Authorization, And Continuous Monitoring Of VA Information Systems,” February 3, 2014

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

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

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

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

29. OI&T 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

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

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

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

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

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

35. VA Directive 6300, Records and Information Management, September 21, 2018

36. VA Handbook, 6300.1, Records Management Procedures, March 24, 2010

37. NIST SP 800-37 Rev 1, Risk Management Framework for Information Systems and Organizations: A System Life Cycle Approach for Security and Privacy, December 2018

38. NIST SP 800-53 Rev. 4, Security and Privacy Controls for Federal Information Systems and Organizations, January 22, 2015

39. OMB Memorandum, “Transition to IPv6”, September 28, 2010

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

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

42. OMB Memorandum M-06-18, Acquisition of Products and Services for Implementation of HSPD-12, June 30, 2006

43. OMB Memorandum 04-04, E-Authentication Guidance for Federal Agencies, December 16, 2003

44. 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

45. OMB memorandum M-11-11, “Continued Implementation of Homeland Security Presidential Directive (HSPD) 12 – Policy for a Common Identification Standard for Federal Employees and Contractors, February 3, 2011

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

47. Federal Identity, Credential, and Access Management (FICAM) Roadmap and Implementation Guidance, December 2, 2011

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

49. OMB Memorandum M-07-16, Safeguarding Against and Responding to the Breach of Personally Identifiable Information, May 22, 2007

50. NIST SP 800-63-3, 800-63A, 800-63B, 800-63C, Digital Identity Guidelines, December 2017

51. NIST SP 800-157, Guidelines for Derived PIV Credentials, December 2014

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

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

54. 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)

55. 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)

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

57. Trusted Internet Connections (TIC) Reference Architecture Document, Version 2.2, Federal Interagency Technical Reference Architectures, Department of Homeland Security, June 19, 2017, https://www.dhs.gov/sites/default/files/publications/TIC_Ref_Arch_v2.2_2017.pdf

58. OMB Memorandum M-08-05, “Implementation of Trusted Internet Connections (TIC), November 20, 2007

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

60. VA Memorandum, VAIQ #7497987, Compliance – Electronic Product Environmental Assessment Tool (EPEAT) – IT Electronic Equipment, August 11, 2014 (reference Document Libraries, EPEAT/Green Purchasing Section, https://www.voa.va.gov/documentlistpublic.aspx?NodeID=552)

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

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

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

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

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

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

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

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

69. “Veteran Focused Integration Process (VIP) Guide 3.2”, December 2018, https://www.voa.va.gov/DocumentView.aspx?DocumentID=4371

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

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

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

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

74. 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 system to include enhancements to add new functionality to existing CART applications.

4.0 PERFORMANCE DETAILS

4.1 PERFORMANCE PERIOD

The Period of Performance (PoP) shall be a 12-month base period, with two, 12-month option periods and optional tasks for enhancements.

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

There are ten 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 in VA facilities located in CART Program Offices, Denver VAMC (Denver CO, 80220). Work may be performed at remote locations with prior approval of the Contracting Officer’s Representative (COR).

4.3 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 National 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), such that CATH/Percutaneous Coronary Intervention (PCI) module, and ensure CART-APPS are operational 99% of the time at all installed sites listed in ADDENDUM C. 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 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 (like 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 VA Cardiology department 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 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 submitted to the FDA’s 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 Program 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 predictive analytics into CART-APPS, three models

1. Integration of a revised structural heart module (CART-Struct)

1. Enhancement of a user-management module for CART-APPS access

1. RTLS Level-2 data integration with CART-APPS (Note: Applies only to CART sites with Wavemark RTLS setup) 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.

Deliverables:

A. Updated Requirements Specification Document B. Updated Software Design Document C. Updated Test Plan/Procedures Document D. 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 to five people, to build a robust team to provide ongoing maintenance, support and development of the CART system. 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 minor guidance by the end of year 1 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 1

The Contractor shall provide all the tasks and services identified in Sections 5.1 and 5.2.1 throughout Option Period 1. 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)

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

3. Integration of predictive analytics into CART-APPS, three models

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 2

The Contractor shall provide all the tasks and services identified in Sections 5.1 and 5.2.1 throughout Option Period 2. 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)

2. RTLS Level-3 data integration with…