36C10B23Q0520 - Amendment 0001.pdf

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. 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

36C10B23Q0520 9/15/2023

KEVIN ANDUJAR, CONTRACT SPECIALIST 848-377-5264 09-20-2023

4:00PM EDT

Department of Veterans Affairs Technology Acquisition Center

23 Christopher Way Eatontown NJ 07724

X 100

X

339112

1,000 Employees

N/A

See Delivery Schedule

23 Christopher Way Eatontown NJ 07724

Financial Services Center PO Box 149971 Austin TX 78714-8971

SimLEARN National SimVET Center – BD Pyxis MedStation

Contract Specialist:

Kevin Andujar / Kevin.Andujar@va.gov

Contracting Officer:

Peter Lewandowski / Peter.Lewandowski@va.gov

Purchase Order: TBD

All changes to the RFQ are highlighted in yellow.

Peter Lewandowski Contracting Officer

36C10B23Q0520

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 GOVERNING LAW CLAUSE

B.3 SOFTWARE LICENSE, MAINTENANCE AND TECHNICAL SUPPORT:

B.4 PRICE SCHEDULE

B.5 PERFORMANCE WORK STATEMENT

SECTION C - CONTRACT CLAUSES

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

C.2 52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR

INFORMATION SYSTEMS (NOV 2021)

C.3 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (JUN 2023)

C.4 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ... 58

C.5 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC 2022)

C.6 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.7 VAAR 852.211-70 EQUIPMENT OPERATION AND MAINTENANCE MANUALS

(NOV 2018)

C.8 VAAR 852.211-76 LIQUIDATED DAMAGES - REIMBURSEMENT FOR DATA

BREACH COSTS (FEB 2023)

C.9 VAAR 852.212-71 GRAY MARKET AND COUNTERFEIT ITEMS (FEB 2023)

C.10 VAAR 852.219-73 VA NOTICE OF TOTAL SET-ASIDE FOR CERTIFIED

SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESSES (JAN 2023)

(DEVIATION)

C.11 VAAR 852.219-75 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—

CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (JAN 2023)

(DEVIATION)

C.12 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS

(NOV 2018)

C.13 VAAR 852.239-70 SECURITY REQUIREMENTS FOR INFORMATION

TECHNOLOGY RESOURCES (FEB 2023)

C.14 VAAR 852.239-72 INFORMATION SYSTEM DESIGN AND DEVELOPMENT

(FEB 2023)

C.15 VAAR 852.239-73 INFORMATION SYSTEM HOSTING, OPERATION,

MAINTENANCE, OR USE (FEB 2023)

C.16 VAAR 852.239-74 SECURITY CONTROLS COMPLIANCE TESTING (FEB 2023)

C.17 VAAR 852.239-76 INFORMATION AND COMMUNICATION TECHNOLOGY

ACCESSIBILITY (FEB 2023)

C.18 VAAR 852.246-71 REJECTED GOODS (OCT 2018)

C.19 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.3 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)

E.4 52.216-1 TYPE OF CONTRACT (APR 1984)

E.5 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.6 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION

(OCT 2018)

E.7 VAAR 852.239-71 INFORMATION SYSTEM SECURITY PLAN AND

ACCREDITATION (FEB 2023)

E.8 VAAR 852.239-75 INFORMATION AND COMMUNICATION TECHNOLOGY

ACCESSIBILITY NOTICE (FEB 2023)

E.9 BASIS OF AWARD

E.10 QUOTE SUBMISSION

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR: To be determined.

b. GOVERNMENT: Contracting Officer 36C10B

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:

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] 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:

AMENDMENT NO DATE

B.2 GOVERNING LAW CLAUSE

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.3 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.cpars.gov).

e) If the Government allows the maintenance and support to lapse and subsequently wishes to reinstate it, any reinstatement fee charged shall http://www.cpars.gov/ 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.4 PRICE SCHEDULE

CLIN Description Qty U/I Unit Price Total Price

0001 Project Management in accordance with (IAW) Performance Work Statement (PWS) Section

5.1 and all associated subparagraphs.

PSC: 6515

1 Lot

(LO)

0001AA Technical Kick-Off Meeting Agenda

Due within 5 days after contract award.

IAW Section 5.1.1 of the

PWS.

Electronic submission to:

VA, Project Management (PM), Contracting Officer’s Representative (COR), 1 Each

(EA)

NSP NSP

Contract Specialist (CS), and Contracting Officer (CO).

PSC: 6515

0001AB Technical Kick-Off Meeting Minutes

Due three (3) days after Technical Kick-Off Meeting.

Final minutes are due five

(5) days after receipt of Government comments.

IAW Section 5.1.1 of the

PWS.

Electronic submission to: VA PM, COR, CS, and CO.

PSC: 6515

1 LO NSP NSP

0001AC Monthly Progress Report

Due the fifth day of each month throughout the period of performance (PoP).

IAW Section 5.1.2 of the

PWS.

Electronic submission to: VA PM, COR, CS, and CO.

PSC: 6515

12 MO NSP NSP

0002 New Hardware and Software Upgrades IAW Section 5.2 of the PWS

PSC: 6515

1 LO $ $

0002AA BD PAS Integration, Lessons Learned, Future Recommendations and Testing Summary for VA’s desired state EHR

1 LO NSP NSP

Installation and configuration shall be completed no later than 30 days after contract award.

IAW Section 5.2 of the PWS.

Electronic submission to: VA PM, COR, CS, and CO.

PSC: 6515

0002AB BD Pyxis ES-323 AMDC, Q- 6 Drawer, Pyxis ES 5 cubic feet Refrigerator, Medical Label Module Integration, Lessons Learned, Future Recommendations and Testing Summary for VA’s current state EHR

Installation and configuration shall be completed no later than 270 days after EHR integration is completed.

IAW Section 5.2 of the PWS.

Electronic submission to: VA PM, COR, CS, and CO.

PSC: 6515

1 LO NASP NSP

0003 Biomedical Engineering Requirements IAW Section

5.3 of the PWS

PSC: 6515

1 LO $ $

0003AA Power and Conditioning Report

Draft report is due 120 days after contract award; Final report is due 5 days after receipt of Government comments.

IAW Section 5.3 of the PWS.

Electronic submission to: VA PM, COR, CS, and CO.

PSC: 6515

0003AB Acceptable Cleaning and Disinfecting Chemistries Report

Due 120 days after contract award.

IAW Section 5.3 of the PWS.

Electronic submission to: VA PM, COR, CS, and CO.

PSC: 6515

1 EA NSP NSP

0003AC Copies of Service Literature

Due 90 days after contract award.

IAW Section 5.3 of the PWS.

Electronic submission to: VA PM, COR, CS, and CO.

PSC: 6515

2 EA NSP NSP

0003AD Training Manual and Quick Start User Guide

Due 90 days after contract award.

IAW Section 5.3 of the PWS.

Electronic submission to: VA PM, COR, CS, and CO.

PSC: 6515

1 LO NSP NSP

0003AE Monthly Patching Instructions

Due the fifth day of each month throughout the period of performance (PoP).

IAW Section 5.3 of the PWS

Electronic submission to: VA PM, COR, CS, and CO.

PSC: 6515

0003AF 24 Month Summary of PIC iX Rev. C Recalls, Safety Alerts, and Field Engineering Change notices over the past 24 months

Due 90 days after contract award.

IAW Section 5.3 of the PWS.

Electronic submission to: VA PM, COR, CS, and CO.

PSC: 6515

1 EA NSP NSP

0003AG Electromagnetic Interference Report

Draft report is due 90 days after contract award. Final report is due 5 days after receipt of Government comments.

IAW Section 5.3 of the PWS.

Electronic submission to: VA PM, COR, CS, and CO.

PSC: 6515

1 LO NSP NSP

0004 Annual Software Maintenance IAW Section

5.4 of the PWS

Period of Performance: 12 months upon completion of installation and configuration.

PSC: 6515

1 EA $ $

BASE PERIOD TOTAL $

OPTION PERIOD ONE

Period of Performance: 12 Months

This option period may be exercised IAW 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 period shall commence immediately after expiration of the Base Period.

1001 Annual Software Maintenance

Period of Performance: 12 Months from Option Exercise.

IAW Section 5.4 of the

PWS.

PSC: 6515

OPTION PERIOD 1 TOTAL $

OPTION PERIOD TWO

This option period may be exercised IAW 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 period shall commence immediately after expiration of Option Period 1.

2001 Annual Software Maintenance

Period of Performance: 12 Months from Option Exercise.

IAW Section 5.4 of the

PWS.

PSC: 6515

OPTION PERIOD 2 TOTAL $

OPTION PERIOD THREE

Period of Performance: 12 Months

This option period may be exercised IAW 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 period shall commence immediately after expiration of Option Period 2.

3001 Annual Software Maintenance

Period of Performance: 12 Months from Option Exercise.

IAW Section 5.4 of the

PWS.

PSC: 6515

EA 1 $ $

OPTION PERIOD 3 TOTAL $

OPTION PERIOD FOUR

This option period may be exercised IAW 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 period shall commence immediately after expiration of Option Period 3.

4001 Annual Software Maintenance

Period of Performance: 12 Months from Option Exercise.

IAW Section 5.4 of the

PWS.

PSC: 6515

OPTION PERIOD 4 TOTAL $

GRAND TOTAL $

B.5 PERFORMANCE WORK STATEMENT

1.0 DESCRIPTION OF SERVICES

Automated Medication Dispensing Cabinets (AMDC) with a narcotics drawer are widely used in acute care settings. The Becton Dickinson (BD) Pyxis MedStation ES-323 and Pyxis Anesthesia System (PAS) are AMDCs that are biomedical device integration (BMDI) capable and can automatically document any medications administered within a patient's electronic health record (EHR), record drug accountability data, and allow clinical personnel to focus on the patient not on a computer screen or keyboard. Automation of the medication dispensing cabinet process can substantially reduce medication errors, automatically track medication inventory, and prevent narcotic diversion. Acquiring this device will allow SimVET to assist the Veterans Health Administration (VHA) to become a fully digital environment and enable us to simulate state-of-the-art patient care workflows for systems testing, workflow optimization, and training.

Automated medication dispensing cabinets have improved greatly over the past 10 years and are critical to the delivery of both inpatient and outpatient care. Most importantly, these cabinets are capable of BMDI–a process where a medical device automatically documents clinical data, such as vital signs or medications given, in the desired state (Oracle/Cerner Millennium) simulated EHR and current state (VistA/CPRS) simulated EHR. Thus, allowing healthcare personnel to focus on simulated clinical care not on looking at a screen or typing on a keyboard.

Incorporating these automated medication dispensing cabinets into the simulated Emergency Department, simulated Operating Room, and simulated Intensive Care simulation areas will greatly increase the fidelity of our simulations and enable SimVET to provide realistic and meaningful simulations for systems testing, workflow optimization, or training. The SimLEARN National SimVET Center currently is running aged Pyxis devices at its Orlando, Florida location.

This version of the cabinets are outdated and nearing end of life. All of the SimLEARN National SimVET Center’s networked Pyxis automated medication dispensing cabinets need to be replaced.

This procurement will address both the viability of this system to run on VA information technology (IT) systems as well as the impacts on clinical workflow with the full utilization of this new technology. The SimVET Center is the ideal location for testing and validating this technology. This will affect all networked BD Pyxis MedStation ES-323 and PAS AMDCs at the SimLEARN National SimVET Center located in Orlando, Florida.

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. 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

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 in 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 https://www.energystar.gov/products https://vaww.portal2.va.gov/sites/infosecurity/ca/Policy%20Home%20Documents/Contract%20Security%20Documents/Flow%20Chart%20and%20Guide%206500.6%20Appendix%20A.doc

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. National Institute Standards and Technology (NIST) Special Publications

31. VA Directive 6508, “Implementation of Privacy Threshold Analysis and VA

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,

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

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

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

38. 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)

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

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

41. 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

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

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

44. 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)

45. NIST SP 800-116 Rev 1, “Guidelines for the Use of Personal Identity Verification (PIV) Credentials in Facility Access,” June 2018 https://www.va.gov/process/ https://dvagov.sharepoint.com/sites/OITECSO/Shared%20Documents/Cloud%20101/Cloud%20Policies/VAEC%20First%20Policy%20Memo%2007-Jan-2019.pdf https://dvagov.sharepoint.com/sites/OITECSO https://www.cisa.gov/publication/tic-30-core-guidance-documents https://dvagov.sharepoint.com/sites/OITECSO/SitePages/VAEC-Acquisition.aspx#what-is-the-ficam-architecture https://dvagov.sharepoint.com/sites/OITECSO/SitePages/VAEC-Acquisition.aspx#what-is-the-ficam-architecture

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

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

48. NIST SP 800-164, “Guidelines on Hardware-Rooted Security in Mobile Devices

(Draft),” October 2012

49. Draft National Institute of Standards and Technology Interagency Report (NISTIR)

7981, ”Mobile, PIV, and Authentication,” March 2014

50. 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

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

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

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

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

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

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

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

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

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

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

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

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

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

64. “Veteran Focused Integration Process (VIP) Guide 4.0,” January 2021, https://www.voa.va.gov/DocumentView.aspx?DocumentID=4371 https://www.voa.va.gov/documentlistpublic.aspx?NodeID=514 https://www.va.gov/process/maps.asp?NodeID=514 https://www.va.gov/process/artifacts.asp?DocumentID=4896 https://www.acquisition.gov/sites/default/files/current/far/html/Subpart%2023_2.html https://www.voa.va.gov/DocumentListPublic.aspx?NodeId=28 https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule?DocumentID=4371

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

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

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

68. OMB Memorandum M-21-07, “Completing the Transition to Internet Protocol

Version 6 (IPv6),“ November 19, 2020

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

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

3.0 PERFORMANCE DETAILS

3.1 PERFORMANCE PERIOD

Delivery, installation and deployment of the hardware/software shall be completed within 30 days of the contract award. The maintenance period of performance (PoP) shall be a 12-month base period from date of deployment, with four 12-month option periods. The overall PoP shall not exceed 5 years.

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:

New Year's Day January 1 Independence Day July 4 Veterans Day November 11 Christmas Day December 25 Juneteenth National Independence Day June 19

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:

Martin Luther King's Birthday Third Monday in January Washington's Birthday Third Monday in February Memorial Day Last Monday in May Labor Day First Monday in September Columbus Day Second Monday in October Thanksgiving Fourth Thursday in November https://www.voa.va.gov/DocumentListPublic.aspx?NodeId=28 https://www.voa.va.gov/DocumentView.aspx?DocumentID=4946

3.2 PLACE OF PERFORMANCE

Tasks under this PWS shall be performed in VA facilities located in SimLEARN National SimVET Center, 13800 Veterans Way, Building 13, Orlando, FL 32827. Work may be performed at remote locations with prior concurrence from the Contracting Officer’s Representative (COR).

4.0 SCOPE

The contractor will furnish all labor, transportation, parts, test equipment, tools, and expertise necessary to provide the required software service, installation and configuration of the BD Pyxis MedStation ES-323 AMDC, Q-6 Drawer, Pyxis ES 5 cubic feet Refrigerator, Medical Label Module, and PAS to implement the Windows 10 upgrade, BD CCE virtual interface servers with the SimLEARN National SimVET Center’s instantiation of Oracle/Cerner Millennium to the PAS, and BD Pyxis ES-323 AMDC, Q-6 Drawer, Pyxis ES 5 cubic ft Refrigerator, and Med Label Module to the HL7 Logical Link for the equipment to interface Veterans Health Information Systems and Technology Architecture (VistA). Please see section 5.0 Specific Tasks and Deliverables for specific technical details and requirements.

5.0 SPECIFIC TASKS AND DELIVERABLES

The Contractor shall perform the following:

5.1 PROJECT MANAGEMENT

5.1.1 TECHNICAL KICK-OFF MEETING

The Contractor shall hold a technical kickoff meeting within five days after Contract award. The Contractor shall present, for review and approval by the Government, the details of the intended delivery approach and project schedule. The Contractor shall specify dates, locations (can be virtual), agenda (shall be provided to all attendees at least one calendar day prior to the meeting), and meeting minutes (shall be provided to all attendees within three calendar days after the meeting). The Contractor shall invite the Contracting Officer (CO), Contract Specialist (CS), COR, VHA Program Manager (PM), and other key stakeholders identified by the Government. The Contractor shall prepare a kickoff overview slide deck which includes and is not limited to the below items. The Contractor shall prepare and provide the meeting minutes for review and approval by the VHA PM/COR.

• Introductions and purpose of meeting

• Project overview, background, project importance

• Review and confirm project goals

• Clarify Contractor/Government Teams roles/responsibilities

• Discuss project deliverables and acceptance procedures (Deliverable Acceptance

Form

• Establish project management standards (e.g., weekly meetings, reporting, tracking status, etc.)

• Identify stakeholders and their roles/responsibilities

• Identify and discuss potential risks

• Collect Action Items and due outs

• Question and answer sessions

• Meeting and action item recap

For any delayed tasks/activities the Contractor shall provide reasons for the situation, identify risks created due to the delays, handling plans for the risks, and actions to return to scheduled performance.

Deliverables:

A. Technical Kick-Off Meeting Agenda B. Technical Kick-Off Meeting Minutes

5.1.2 REPORTING REQUIREMENTS

The Contractor shall provide the COR with Monthly Progress Reports in electronic form in Microsoft Word and Project formats. 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 Month.

The Monthly 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. 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.

Deliverable:

A. Monthly Progress Report

5.2 NEW HARDWARE AND SOFTWARE UPGRADES

1. The Contractor shall provide BD PAS, BD Pyxis ES-323 AMDC, Q-6 Drawer, Pyxis ES 5 cubic feet Refrigerator, and Med Label Module Integration.

2. Windows 10 (Windows 11 preferred) Workstations with Uninterruptible Power Supplies that can support the BD Pyxis ES-323 AMDC, Q-6 Drawer, Pyxis ES 5 cubic ft Refrigerator, Med Label Module, and PAS and requisite software.

3. The BD Pyxis ES-323 AMDC, Q-6 Drawer, Pyxis ES 5 cubic ft Refrigerator, Med Label Module, and PAS hardware and software shall include hardware installation and software configuration. Any software provided shall be the latest (or near latest) software revision. The offering vendor is responsible for configuring the software and testing it for proper functionality on each applicable hardware unit.

4. The Contractor shall install all necessary cabling/network equipment required for this hardware replacement and software upgrade. This shall include cable pulls to a central switch. Installation will include central monitoring stations and UPS units as well as servers (all locations to be determined by Biomedical Engineering including virtual and physical servers). All network cables, network switch gear, routers, and computers for this installation are to be included as part of the quote.

5. All Central Monitoring Workstations provided shall include a PC/Monitor/Keyboard/Mouse and shall include the latest revision of BD Pyxis ES-323 AMDC, Q-6 Drawer, Pyxis ES 5 cubic ft Refrigerator, Med Label Module, and PAS software available on the market.

6. All cables shall be terminated with appropriate wall jacks and shall look aesthetically pleasing.

7. The Contractor shall install IBE HL7 virtual servers with clustering functionality to allow for redundancy/failover. The contractor shall configure the IBE HL7 virtual servers to interface with Cerner (EHR), and HL7 Logical Link to the VistA. All configurations and testing are to be performed in accordance with the SimLEARN National SimVET Center Local Biomedical Engineering team as well as the dedicated VISN 8 Cerner team. IBE Installation will not be considered complete until the VA and Oracle/Cerner approves all testing that has been completed.

8. The Contractor shall provide labor/resources for all HL7 Cerner/IBE and HL7 Logical Link VistA testing events.

9. The Contractor shall provide after-hours go live support for the IBE/Cerner HL7 and HL7 Logical Link VistA testing events.

10. The Contractor shall provide a pre-production (test) to complete testing of the HL7 IBE/Cerner and HL7 Logical Link to VistA interfaces. These environments will be configured as part of the IBE installation.

A. BD PAS Integration, Lessons Learned, Future Recommendations, and Testing Summary for VA’s desired state (Oracle/Cerner Millennium) EHR

B. BD Pyxis ES-323 AMDC, Q-6 Drawer, Pyxis ES 5 cubic ft Refrigerator, Medical Label Module Integration, Lessons Learned, Future Recommendations and Testing Summary for VA’s current state (VistA/CPRS)

EHR.

5.3 BIOMEDICAL ENGINEERING REQUIREMENTS:

1. The Contractor shall provide details of the BD Pyxis ES-323 AMDC, Q-6 Drawer, Pyxis

ES 5 cubic ft Refrigerator, Med Label Module, and PAS clinical and technical alarms.

2. The Contractor shall ensure that switches and controls of the proposed BD Pyxis ES- 323 AMDC, Q-6 Drawer, Pyxis ES 5 cubic ft Refrigerator, Med Label Module, and PAS shall be protected against accidental setting changes (e.g., due to someone brushing against the panel / screen). Device design shall prevent misinterpretation of displays and control settings. The controls (i.e., switches, knobs, etc.) shall be visible and clearly identified, and their functions shall be self-evident.

3. The Contractor shall certify that the proposed BD Pyxis ES-323 AMDC, Q-6 Drawer, Pyxis ES 5 cubic ft Refrigerator, Med Label Module, PAS and workstations/virtual servers shall withstand normal hospital power interruptions, including generator testing, without manual intervention and that normal device operation will be restored automatically, without loss of data, once power is restored. The Contractor shall specify and provide power conditioning if required and generate a deliverable Power and Conditioning Report.

4. The Contractor shall confirm that the performance of the proposed BD Pyxis ES-323 AMDC, Q-6 Drawer, Pyxis ES 5 cubic ft Refrigerator, Med Label Module, PAS and virtual servers shall not be affected by Electromagnetic Interference radiated or conducted through the power lines from another device.

5. The Contractor shall provide a listing of all Recalls, Safety Alerts, and Field Engineering Change notices pertaining to the proposed BD Pyxis ES-323 AMDC, Q-6 Drawer, Pyxis ES 5 cubic ft Refrigerator, Med Label Module, and PAS over the past 24 months.

6. Cleaning and disinfecting protocols for the proposed workstations/equipment shall be provided and demonstrated to staff by the offering vendor. A list of acceptable cleaning and disinfecting chemistries shall be included with the purchase of the proposed BD Pyxis ES-323 AMDC, Q-6 Drawer, Pyxis ES 5 cubic ft Refrigerator, Med Label Module, and PAS in an acceptable cleaning and disinfecting chemistries report.

7. The Contractor shall provide two copies of all service literature, including any necessary service and maintenance software, keys, and/or passwords (in accordance with: 21-CFR 820.170(a), NFPA99 (2012 edition) Chapter 10.5.3, VAAR 852.211-70, and the VA NAC AS3000 clause) for BD Pyxis ES-323 AMDC, Q-6 Drawer, Pyxis ES 5 cubic ft Refrigerator, Med Label Module, and PAS.

8. The Contractor shall provide onsite clinical user education/training for users in each department. Clinical Education shall include all shifts/work hours for each department (this includes standard shifts and overtime shifts). Clinical Education shall be coordinated with SimLEARN Clinical Lead to provide one-day, in-person, training session for approximately 10 SimLEARN personnel on the safe use of operating the proposed BD Pyxis ES-323 AMDC, Q-6 Drawer, Pyxis ES 5 cubic ft Refrigerator, Med Label Module, and PAS after software installation, system configuration, and hardware installation are completed. Live training will also include a training manual and quick start guide.

9. The Contractor shall provide patching instructions for all future Windows software updates for both Windows Virtual Server and Windows Desktop Devices. If patching is not acceptable, the vendor must provide in writing monthly approved Windows patches.

10. The Contractor shall provide a minimum 1-year warranty on all parts/labor received for this BD Pyxis ES-323 AMDC, Q-6 Drawer, Pyxis ES 5 cubic ft Refrigerator, Med Label Module, IBE HL7 and PAS HL7 Logical Link interface installation.

A. Power and Conditioning Report B. Acceptable Cleaning and Disinfecting Chemistries Report C. Two Copies of Service Literature D. Training Manual and Quick Start User Guides E. Monthly Patching Instructions F. 24 Month Summary of Omnicell XT AMDC Recalls, Safety Alerts, and

Field Engineering Change notices over the past 24 months G. Electromagnetic Interference Report

5.4 MONTHLY MAINTENANCE SUPPORT

The Contractor shall provide monthly software and hardware maintenance support for the Omnicell XT AMDC systems. The Period of Performance for the Monthly Maintenance Support shall be for 12 months from date of award, with 4 12-month option periods.

A. Monthly Maintenance Support

5.5 OPTION PERIOD 1:

If the Option Period is exercised by VA, the Contractor shall perform all tasks as described in PWS Section 5.4.

Description Qty

12 Month Total Support Services 1

5.6 OPTION PERIOD 2:

If the Option Period is exercised by VA, the Contractor shall perform all tasks as described in PWS Section 5.4.

5.7 OPTION PERIOD 3:

PWS Section 5.4.

5.8 OPTION PERIOD 4:

PWS Section 5.4.

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 One-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 the design and integration patterns. Direct authentication at a minimum must include Public Key Infrastructure (PKI) based authentication supportive of PIV card and/or Common Access Card (CAC), as determined by the business need.

The Contractor shall ensure all Contractor delivered applications and systems conform to the specific Identity and Access Management PIV requirements set forth in the Office of Management and Budget (OMB) Memoranda M-05-24, M-19-17, and NIST Federal Information Processing Standard (FIPS) 201-2. OMB Memoranda M-05-24 and M-19-17 can be found at:

https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/memoranda/2005/m05-24.pdf, and https://www.whitehouse.gov/wp-content/uploads/2019/05/M-19-17.pdf respectively. Contractor delivered applications and systems shall be on the FIPS 201-2 Approved Product List (APL). If https://www.ea.oit.va.gov/EAOIT/VA_EA/Enterprise_Technical_Architecture.asp https://www.voa.va.gov/DocumentListPublic.aspx https://www.voa.va.gov/DocumentView.aspx https://www.whitehouse.gov/wp-content/uploads/2019/05/M-19-17.pdf the Contractor delivered application and system is not on the APL, the Contractor shall be responsible for taking the application and system through the FIPS 201 Evaluation Program.

The Contractor shall ensure all Contractor delivered applications and systems support:

1. Automated provisioning and are able to use enterprise provisioning service.

2. Interfacing with VA’s Master Person Index (MPI) to provision identity attributes, if the solution relies on VA user identities. MPI is the authoritative source for VA user identity data.

3. The VA defined unique identity (Secure Identifier [SEC ID] / Integrated Control Number

[ICN]).

4. Multiple authenticators for a given identity and authenticators at every Authenticator Assurance Level (AAL) appropriate for the solution.

5. Identity proofing for each Identity Assurance Level (IAL) appropriate for the solution.

6. Federation for each Federation Assurance Level (FAL) appropriate for the solution, if applicable.

7. Two-factor authentication (2FA) through an applicable design pattern as outlined in VA Enterprise Design Patterns.

8. A Security Assertion Markup Language (SAML) implementation if the solution relies on assertion-based authentication. Additional assertion implementations, besides the required SAML assertion, may be provided as long as they are compliant with NIST SP 800-63-3 guidelines.

9. Authentication/account binding based on trusted Hypertext Transfer Protocol (HTTP) headers if the solution relies on Trust based authentication.

10. Role Based Access Control.

11. Auditing and reporting capabilities.

12.…