PWS DRAFT - VA-26-00020962 - Simplifi Brand Name or Equivalent.docx

CSP Compliance Software 2025

VA-26-00020962

PERFORMANCE WORK STATEMENT (PWS)

DEPARTMENT OF VETERANS AFFAIRS

Veterans Health Administration (VHA) Veterans Integrated Service Network (VISN) 2

Compounded Sterile Products (CSP) Compliance Software 2025

Date: 1/12/2025

VA-26-00020962

PWS Version Number: 1.3

Contents

BACKGROUND

The Department of Veterans Affairs (VA), Veterans Health Administration (VHA) Veterans Integrated Service Network (VISN) 2, 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.

VISN 2 Medical Centers Pharmacies have a requirement for Compliance Software for their Compounded Sterile Products (CSP) area. This system shall replace the current burdensome paperwork system.

This PWS will specifically detail Pharmacies that will be purchasing a Brand Name or equivalent CSP Compliance Software system

APPLICABLE DOCUMENTS

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

1. “Federal Information Security Modernization Act of 2014”

2. Federal Information Processing Standards (FIPS) Publication 140-3, “Security Requirements for Cryptographic Modules”, March 22, 2019

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

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

5. FIPS Pub 201-3, “Personal Identity Verification of Federal Employees and Contractors,” January 2022

6. 10 U.S.C. § 2224, "Defense Information Assurance Program", as amended

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

8. Public Law 109-461 (P.L. 109-461), Veterans Benefits, Health Care, and Information Technology Act of 2006, as amended, Title IX, Information Security Matters

9. 42 U.S.C. § 2000d “Title VI of the Civil Rights Act of 1964”, as amended

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

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

12. VA Directive 6102, “Internet/Intranet Services,” August 5, 2019

13. 36 C.F.R. Part 1194 “Information and Communication Technology Standards and Guidelines,” as amended

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

15. 32 C.F.R. Part 199, “Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)”, as amended

16. NIST SP 800-66 Rev. 2, “Implementing the Health Insurance Portability and Accountability Act (HIPAA) Security Rule: A Cybersecurity Resource Guide,” February 2024

17. 45 C.F.R Parts 160 and 164, Subparts A and E, the Standards for Privacy of Individually Identifiable Health Information (“Privacy Rule”); and 45 C.F.R. Parts 160 and 164, Subparts A and C, the Security Standard (“Security Rule”); as amended

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

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

20. VA Directive 6500, “VA Cybersecurity Program,” February 24, 2021 (see VA NOTICE 24-18, dated September 27, 2024, “Update to VA Directive 6500 Cybersecurity Program”, and VA Notice 25-07, dated 3/18/25, “Amending VA Directive 6500 to incorporate M-24-15”)

21. VA Handbook 6500, “Risk Management Framework for VA Information Systems VA Information Security Program,” February 24, 2021 (see VA Notice 25-01, dated October 15, 2024, “Update to VA Handbook 6500 Risk Management Framework for VA Information Systems VA Information Security Program”, and VA Notice 25-06, dated 3/18/25, “Amending VA Directive 6500 to incorporate M-24-15”)

22. VA Handbook 6500.2, “Management of Breaches Involving Sensitive Personal Information (SPI),” June 30, 2023

23. VA Handbook 6500.6, “Contract Security,” March 12, 2010 (see VA Notice 24-12, dated April 22, 2024, “Update to VA Handbook 6500.6, Contract Security, Appendix C VA Information and Information System Security/Privacy Language For Inclusion Into Contracts, As Appropriate”)

24. VA Handbook 6500.8, “Information System Contingency Planning,” March 25, 2025

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

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

27. OIT Process Asset Library (PAL), OIT Process Asset Library.

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

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

30. VA Directive 6510, “VA Identity, Credential and Access Management,” September 3, 2024

31. VA Handbook 6510, “VA Identity, Credential and Access Management,” September 27, 2024

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

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

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

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

36. 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)

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

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

39. 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

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

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

42. Federal Identity, Credential, and Access Management (FICAM) Architecture, June 30, 2023 (FICAM Architecture (idmanagement.gov))

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

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

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

46. 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)

47. 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)

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

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

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

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

52. Sections 524 and 525 of the Energy Independence and Security Act of 2007, (P.L. 110–140), December 19, 2007

53. Section 104 of the Energy Policy Act of 2005, (P.L. 109–58), August 8, 2005

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

55. VA Directive 0057, “VA Environmental Management Program,” October 25, 2022

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

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

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

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

60. “Product Line Management Transformation Playbook” version 3.1, August 2023, https://www.voa.va.gov/DocumentView.aspx?DocumentID=4946

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

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

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

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

65. C.F.R Title 15 Part 7, “Securing the Information and Communications Technology and Services (ICTS) Supply Chain”, as amended

66. Executive Order 14028, “Executive Order on Improving the Nation's Cybersecurity,” May 12, 2021, https://bidenwhitehouse.archives.gov/briefing-room/presidential-actions/2025/01/16/executive-order-on-strengthening-and-promoting-innovation-in-the-nations-cybersecurity/

67. OMB Memorandum M-22-09, “Moving the U.S. Government Toward Zero Trust Cybersecurity Principles”, January 26, 2022, https://www.whitehouse.gov/wp-content/uploads/2022/01/M-22-09.pdf.

68. NIST SP 800-52 Revision 2, “Guidelines for the Selection, Configuration, and Use of Transport Layer Security (TLS) Implementations

69. OMB M-22-18, “Enhancing the Security of the Software Supply Chain through Secure Software Development Practices,” September 14, 2022

70. OMB M-23-16, “Update to Memorandum M-22-18,” June 9, 2023

71. OMB M-21-31, “Improving the Federal Government’s Investigative and Remediation Capabilities Related to Cybersecurity Incidents,” August 27, 2021

72. NIST SP 800-88 Revision 1 “Guidelines for Media Sanitization,” December 2014

73. CISA Binding Operational Directive (BOD) 19-02: “Vulnerability Remediation Requirements of Internet-Accessible Systems,” April 29, 2019, BOD 19-02: Vulnerability Remediation Requirements for Internet-Accessible Systems | CISA

74. CISA BOD 22-01: “Reducing the Significant Risk of Known Exploited Vulnerabilities,” November 3, 2021, BOD 22-01: Reducing the Significant Risk of Known Exploited Vulnerabilities | CISA

75. CISA BOD 23-01: Improving Asset Visibility and Vulnerability Detection on Federal Networks.” Cybersecurity & Infrastructure Security Agency (CISA), BOD 23-01: Improving Asset Visibility and Vulnerability Detection on Federal Networks | CISA

76. VA Directive 6550, Pre-Procurement Assessment and Implementation of Medical Devices/Systems, June 03, 2019

77. VA Memorandum, “VA Security Controls,” January 17, 2025, https://www.voa.va.gov/DocumentView.aspx?DocumentID=5010

SCOPE OF WORK

The Contractor shall provide all equipment, tools, materials, remote supervision, remote installation, remote implementation of and other items and services necessary to deliver the following Brand Name or equivalent CSP software solution:

· A fully functional Simplifi 797 Software system to include:

· Simplifi 797 with SoleSource Academy

· USP 795

· USP 800

· Compounding Module

· Simplifi+MedTrays

· Clinical Training for all VISN 2 VA Medical Center staff (Webex and Online)

· Technical Training for VISN 2 VA Medical Center staff (Webex and Online)

PREIMPLIMENTATION TEAM

The Contractor’s Implementation team shall perform the following activities:

· Initiating the Kickoff Call

· A complete workflow evaluation

· Initial site build, including sample tasks

· Perform training - Administrator

· Perform training - Super User

· Coach the Client on drug recipe cards creation

· Coach the Client on creation of batch recipes with compounding instructions

· Complete testing of label printing

PREIMPLIMENTATION ACCEPTANCE CRITERA

The Contractor’s Implementation Acceptance Criteria includes the following:

· Starter-site build created by P1S

· All necessary competencies are activated

· All training has been completed

· All validation has been completed by the Client

· The Client demonstrates the ability to use the application as agreed upon during implementation

A. Upon receipt of a signed contract, The Contractor shall:

1. Assign an Application Specialist

2. Obtain the following information from the government:

a. Diagrams of all compounding areas, indicating workflow and equipment (preparation areas, etc.)

b. A Completed Simplifi 797 questionnaire

c. A Completed configuration document

d. A Completed label configuration worksheet

3. Provide all labor, materials, tools, equipment/software and etc. to prepare for and complete the installation of the equipment/software in the space determined by the Government.

4. Schedule the Implementation kickoff meeting and establish an Implementation timeline that will ensure that Simplifi 797 is integrated into the clinical workflow no later than six weeks from the date of kickoff. Installation and implementation dates are to be coordinated in advance with the COR.

B. The project will transition from “implementation” status to “support” status following facility rollout of Simplifi 797.

C. The Contractor shall address and resolve all issues raised by the government.

D. The Contractor shall provide all their services remotely. The Contractors will not be coming on site to any of the VA facilities.

E. All of the Contractor’s personnel shall know how to properly install the equipment/software. Resumes and certifications shall be submitted for review upon request by the Government.

F. All Government installation personnel shall be trained by the contractor on requirements relevant to the work outlined in this Scope of Work.

G. The Contractor shall communicate to the Government the estimated downtime required to complete full installation and testing of Simplifi 797 software system and Simplifi+MedTrays. If the Contractor is unable to install the equipment/software to its normal operational state within 24 hours the Contractor shall compensate the Government for the downtime by extending the warranty service in a period equivalent to the downtime of the equipment.

TASK FREQUENCY AND INSTRUCTIONS

A. The work set forth in thIS Scope of Work shall be completed in a single visit, be it a single day or multiple days as required for appropriate completion. All work shall be scheduled in advance with the COR.

B. Equipment delivery shall not precede installation by more than 20 days. Installation and implementation must be immediately followed by clinical user training including “go live” support. Implementation and integration with VistA CPRS shall not exceed 90 days from date of award.

Definitions:

I. COR – Contracting Officer Representative II. EMR – Electronic Medical Record III. Compounded Sterile Products (CSP)- compounding sterile preparations for patient administration includes the process of safe storage, handling, manipulation and transportation while ensuring a safe, clean environment exists for their preparation.

PERFORMANCE DETAILS

PERFORMANCE PERIOD

The period of performance (PoP) shall be 12 months from date of award, with four 12-month option periods. The overall PoP shall not exceed 60 months.

PLACE OF PERFORMANCE

Tasks under this PWS shall be performed at Contractor facilities. The Contractor shall identify the Contractor’s place of performance in their proposal submission.

All quoted items shall be delivered to the following nine addresses for initial inspection and acceptance:

VISN2 Upgrade

Albany VA (Samuel S. Stratton) 113 Holland Avenue Attn: Pharmacy Service Albany, NY 12208 Terri Wank Terri.Wank@va.gov 518-626-5718

Buffalo VA

3495 Bailey Ave, Attn: Pharmacy Service Buffalo, NY 14215 Jeremy Zimmer Jeremy.Zimmer@va.gov 716-834-9200 ext. 24812

Attn: Pharmacy Service Syracuse, NY 13210 Kyle Hacker Kyle.Hacker2@va.gov 315-425-4400 x52072

Hudson Valley VA (Franklin D. Roosevelt) Va Hudson Valley Health Care System Castle Point Campus 41 Castle Point Rd Attn: Pharmacy Service Wappingers Falls, NY 12590 Barbara Romeo Barbara.Romeo2@va.gov 914-737-4400 x3195 x4744

NY Harbor VA (Manhattan) (Brooklyn) 423 East 23 Street Attn: Pharmacy Service New York, NY 10010 Evelyn Diaz Evelyn.Diaz@va.gov 212-686-7500 x17654

Bronx VA (James J. Peters) 130 W Kingsbridge Rd, Attn: Pharmacy Services Bronx, NY 10468 Davit Kitt David.Kitt@va.gov

718.584.9000 x:5884

New Jersey VA (East Orange) (Lyons) 385 Tremont Ave Attn: Pharmacy Service East Orange, NJ 07018

Adel Gaballah Adel.Gaballah@va.gov 973-676-1000 x2244

Attn: Pharmacy Service Northport, NY 11768 Alberto Ambizas Alberto.Ambizas@va.gov 631-261-4400 Ext: 2373

TRAVEL

The Government anticipates no travel under this effort.

SPECIFIC TASKS AND DELIVERABLES

The Contractor shall perform the following:

PROJECT MANAGEMENT

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

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. The Contractor shall monitor performance against the CPMP and report any deviations. It is expected that the Contractor will keep in communication with VA accordingly so that issues that arise are transparent to both parties to prevent escalation of outstanding issues.

Deliverable:

A. Monthly Progress Report

BRAND NAME OR EQUIVALENT CSP SOFTWARE SOLUTION

A. The Contractor shall deliver a fully functional Brand Name or equivalent CSP Software solution to each VA facility identified in this PWS. All equipment/software delivered by the Contractor shall be in new condition and fully operational in accordance with manufacturer’s literature specifications.

B. The Contractor’s Brand Name or equivalent CSP Software solution shall deliver system that has the following characteristics:

1. Pharmacy OneSource Application Security

2. Web-based applications deployed via a Software-as-a-Service (SaaS) model

3. Secure SSL connections

4. External firewalls are configured for SSL utilizing the 2048 bit standard

5. Servers located within an SSAE16 and SysTrust certified data center

6. The software shall facilitate:

a. Generation of summary reports

b. Provide established algorithms to run reports, including counts and lists

c. Allow to create and save new algorithms to run reports

d. Run quality reports

i. By personnel

ii. By procedure

iii. By date

iv. By standard

A. Fully functional Brand Name or equivalent CSP Software Solution

STAFF AND PATIENT SAFETY

The Contractors’ solution shall ensure staff and patient safety. The Contractor’s solution shall have 24/7 monitoring and alerts to QA plan deviations, overdue task and other key notifications. The Contractor’s solution shall enable expert consultations on facility-specific QA plans, policies and procedures, and continued best practice offerings.

OPERATIONAL EFFICENCY

The Contractors’ solution shall maximize operational efficiency. The Contractor’s plan shall simplify, streamline and automate cleanroom operations, enhance and automate compliance tracking documentation, and ensure trouble-free regulatory inspections.

BEST PRACTICES

The Contractor shall deliver best practices that can easily be streamlined and standardized across multiple locations, while system-level risk, trends and deviations are more rapidly identified and communicated with on-demand reporting capabilities.

The Contractor shall provide all tools and equipment necessary to properly and safely perform the services set forth within this statement of work. This shall include, but is not limited, to all Personal Protective Equipment (PPE) which may be required for the work to be completed in a safe manner. The Contractor shall provide any equipment necessary for proper infection control measures during installation.

SaaS FedRAMP REQUIREMENTS

If the solution is FedRAMP Authorized and VA Authorized:

1. The information system solution selected by the Contractor shall comply with the Federal Information Security Management Act (FISMA) and have a current VA authorization.

2. The Contractor shall comply with FedRAMP requirements as mandated by Federal laws and policies, including making available any documentation, physical access, and logical access needed to support this requirement.

3. The FedRAMP Authorization level and existing VA ATO should be no less than the level required for this use case which has been defined as <<Insert Impact Level from the Data Security Categorization. This should be done by DTC.>>

4. The Contractor shall, where applicable, assist with the VA ATO Sustainment Process to help maintain health and quality of agency authorization of the cloud service or migrated application.

5. The Contractor shall exclusively provide licenses and/or accounts to FedRAMP authorized and VA authorized environments.

6. The Contractor shall afford VA access to the Contractor’s and Cloud Service Provider’s (CSP) facilities, installations, technical capabilities, operations, documentation, records, and databases.

7. If new or unanticipated vulnerabilities are discovered by either VA or the Contractor, or if existing safeguards have ceased to function, the discoverer shall immediately bring the situation to the attention of the other party in accordance with Addendum B, VA Information and Information System Security/Privacy Language. VA Privacy and Security deliverables as directed by the VA System owner.

8. The Contractor shall comply with data management requirements.

9. Successful issuance of a VA ATO will be required before live VA data can be used in the system.

10. The Contractor shall participate in FedRAMP Continuous Monitoring activities as outlined by FedRAMP’s Continuous Monitoring Strategy Guide found on the FedRAMP Website.

11. The Contractor shall participate in monthly Agency and FedRAMP Sustainment meetings following the granting of a VA ATO.

12. The Contractor shall provide a monthly inventory report of VA sites currently utilizing the cloud product post ATO award. The inventory report will include the number of licenses being utilized and the specific VA site.

Deliverable:

A. 3PAO Security Assessment Report (SAR) B. Continuous Monitoring Monthly Scans C. Plan of Action and Milestones Monthly Reports.

D. Monthly Inventory Rep

TRAINING

The Contractor shall deliver web-based compounding training. This training shall streamline staff competency validation and offer easy access to ACPE accredited continuing education credit for pharmacists and technicians. Training shall enable the creation of a comprehensive list of observational staff competencies that helps validate proficiency and sterile cleanroom operations.

The Contractor shall provide curriculums for their training modules when submitting their proposal.

A. Training and training curriculums

COMPREHENSIVE TRAINING

The Contractor shall provide a comprehensive training program to consist of Webex and other online trainings for the operating clinicians. This training program shall include at the minimum the following sessions:

1. Technical Training

2. Operational Training

3. Administrative Training

4. Hardware Troubleshooting

5. Software Troubleshooting

Training shall be accessible during normal business hours, 7:00am-5:30pm, Monday through Friday. Competency assessments shall be provided with the training.

TECHNICAL TRAINING

The Contractor shall provide general overview technical training for Clinical Engineering personnel as requested. This training program shall include at the minimum the following sessions:

1. Technical overview of the mechanics of the system

2. Technical overview of the electronics of the system

3. Technical overview of the General operations of the system

This training program shall include detailed instruction regarding the following sessions:

1. Preventative maintenance

2. Troubleshooting

3. General maintenance of the equipment

4. General maintenance of the software.

MANUALS

The Contractor shall provide a minimum of two (2) copies of all associated operational and/or service manuals for all equipment/software listed below as applicable. One of the 2 copies shall be in electronic PDF format.

· Simplifi 797 with Critical point (web-based application). Including the following modules:

· Simplifi 797 with SoleSource Academy

· USP 795

· USP 800

· Compounding Module

· Simplifi+MedTrays

A. Manuals

ACCEPTANCE PROCEDURES

A. Contractor shall provide dates of completion of punch list items and replacement parts and/or short ship items from the manufacturer(s) if applicable.

B. The COR shall ensure all work is completed satisfactorily prior to acceptance. Disputes shall be resolved by the Contracting Officer. Submission of the notice of readiness for inspection, and any other notice required in accordance with this PWS by electronic mail is acceptable, provided that the party giving such notice obtains and preserves electronic evidence of receipt at the email address or addresses of the party or parties who have a right to the notice of readiness for inspection.

Deliverable:

A. Dates of completion of punch list items and replacement parts

REQUIREMENTS FOR SITES

A. The Contractor shall coordinate with each facility COR and/or CSP Pharmacist to implement the software remotely.

B. The Contractor shall facilitate live meetings/webinar calls with the CORs/CSP Pharmacists for training and a smooth transition to the software.

C. The Contractor shall coordinate with each facility COR and/or CSP Pharmacist to ensure appropriate VA staff participates in training conducted.

D. The Contractor shall coordinate with each facility COR and/or CSP Pharmacist to ensure that adequate resources will be available at their site for the following commitments (based on typical project timeline and scope):

· Configuring site

· Attend training

· Train additional staff

*Typical commitment is 2-3 hours/week.

Commitment will vary based on overall scope of site build and complexity.

INSPECTION AND TESTING

The Contractor shall conduct a joint inspection with the COR upon delivery of equipment/software.

WARRANTY, SERVICE, AND SUPPORT

A. The contractor warrants that the software applications will substantially conform to the functionality described in the current brochure as demonstrated by the contractor to our facilities. The contractor shall be responsible for any corrections of any failures to perform.

B. If the contractor is unable to correct the failure within a commercially reasonable time such as 5 working days, or if the failure substantially interferes with the customer’s use of the Service, the contractor shall have the option to either

Extend the term of any applicable subscription for the length of the effected period at no additional cost or expense to Customer, or

Terminate the subscription for the affected Application and refund the fee relating to the affected period for that Application.

C. The subscription will include unlimited support from the contractor’s team of product specialists available from 8am-8pm EST, Monday through Friday and 24/7 on call support for critical issues. Support will be provided via phone or email.

D. Software updates from the contractor should be automatic with advanced notice.

E. Contractor shall alert VISN 2 facilities in advance of any changes in technical requirements. For example, if their web-based browser is no longer supported on certain platforms (Microsoft Edge vs Chrome)

OPTIONAL TASK – ADDITIONAL VISN sites

Throughout the PoP, there may be additional requirements to implement Brand Name or equivalent CSP Software Solution system into the locations detailed in PWS section 4.2. These locations shall require the software, and services detailed in PWS section 4 and may be required in the base and each option period. The price shall be negotiated on a FFP basis prior to each exercise of the optional task. The Government will utilize the proposed FFP labor rates and equipment price list which shall be incorporated into the order at time of award and as set forth in the Price Schedule. Prior to each option exercise the Government shall provide a summary of the problem and required services and equipment. The Contractor shall provide an Execution Plan (EP) detailed the proposed services and equipment required to resolve the problem. The EP shall include a description of the Contractor’s approach and the proposed labor hours and equipment required. The cost proposal in the EP shall establish the cost ceiling for each task. If the proposed approach, labor hours and equipment are approved by the VA PM, COR and Contracting Officer, they shall be executed via a unilateral modification in the amount specified.

GENERAL REQUIREMENTS

ENTERPRISE AND IT FRAMEWORK

VA TECHNICAL REFERENCE MODEL

The Contractor shall comply with the VA OIT Technical Reference Model (VA TRM). Compliance with the VA TRM is achieved by using only technologies and standards that are listed as approved for use in the VA TRM. The Contractor shall provide all necessary information requested by VA to ensure TRM approval is obtained prior to use on VA’s network.

ZERO TRUST – VA CRITICAL SECURITY CONTROLS

VA has established minimum mandatory security requirements and requires that any network connected software system or service must meet the VA Critical Security Controls as outlined in the VA Memorandum, “VA Security Controls”, https://www.voa.va.gov/DocumentView.aspx?DocumentID=5010. VA Critical Security Controls identify the minimum mandatory requirements that must be implemented across all VA enterprise infrastructure, cloud computing environments, information systems, networks, and specialized devices (medical devices/systems, special-purpose systems, and research scientific computing devices) that process, store, and/or transmit VA data. Effective July 1, 2025, the Contractor shall implement these VA Critical Security Controls, within any network connected software system or service prior to being authorized for use in the VA. This functional requirement is not negotiable, and Plan of Action & Milestones (POAM) will not be accepted in the event these controls cannot be implemented for new systems. Critical Security Controls are intended to increase VA’s security posture and provide security and privacy risk visibility into the VA network and is not a new requirement. The Contractor’s failure to maintain these VA Critical Controls after implementation will result in VA discontinuing the use of the system.

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 Architecture (EA), and VA Identity and Access Management (IAM) approved Enterprise Technology Guidelines (ETG). 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 Executive Order 14028, VA Handbook 6510 VA Identity and Access Management, VA Handbook 0735 Homeland Security Presidential Directive 12 (HSPD-12) Program, CISA Binding Operational Directive 23-01, 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, and VA IAM enterprise requirements for direct, assertion based authentication, and/or trust based authentication, as determined by the ETGs. 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, M-22-09, and NIST Federal Information Processing Standard (FIPS) 201-3. Contractor delivered applications and systems shall be on the FIPS 201 Approved Product List (APL). If 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 Technology Guideline as outlined in VA ETG.

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. Compliance with VIEWS 00155984, PIV Logical Access Policy Clarification https://www.voa.va.gov/DocumentView.aspx?DocumentID=4896.

The required Assurance Levels for this specific effort are Identity Assurance Level 3, Authenticator Assurance Level 3, and Federation Assurance Level 3.

INTERNET PROTOCOL VERSION 6 (IPv6)

The Contractor solution shall support IPv6-Only based upon the memo issued by the Office of Management and Budget (OMB) on November 19, 2020 (https://www.whitehouse.gov/wp-content/uploads/2020/11/M-21-07.pdf). Which defines IPv6-only as the state of an operational system or service when IPv4 protocol functions (addressing, packet forwarding) are not in use. The NIST USGv6 profile defines technical requirements for a product to be capable of operating in IPv6-Only environments. IPv6-Only technology, in accordance with the USGv6 Program ((https://www.nist.gov/programs-projects/usgv6-program/usgv6-revision-1), NIST Special Publication (SP) 500-267B Revision 1 “USGv6 Profile” (https://doi.org/10.6028/NIST.SP.500-267Br1), and NIST SP 800-119 “Guidelines for the Secure Deployment of IPv6” (https://doi.org/10.6028/NIST.SP.800-119), compliance shall be included in all IT infrastructures, application designs, application development, operational systems and sub-systems, and their integration. In addition to the above requirements, all devices, applications, and systems shall support all applicable functionality on native IPv6-Only as well as dual stack (IPv6 / IPv4) connectivity without additional memory or other resources being provided by the Government, so that they can function in a mixed environment. All public/external facing servers and services (e.g., web, email, DNS, ISP services, etc.) shall support native IPv6-Only and dual stack (IPv6 / IPv4) users and all internal infrastructure and applications shall support using native IPv6-Only and dual stack (IPv6 / IPv4) for all functionality and operations.

TRUSTED INTERNET CONNECTION (TIC)

The Contractor solution shall meet the requirements outlined in Office of Management and Budget Memorandum M-19-26, “Update to the Trusted Internet Connections (TIC) Initiative“ (https://www.whitehouse.gov/wp-content/uploads/2019/09/M-19-26.pdf), VA Directive 6513 “Secure External Connections”, and shall comply with the TIC 3.0 Core Guidance Documents, including all Volumes and TIC Use Cases, found at the Cybersecurity & Infrastructure Security Agency (CISA) (https://www.cisa.gov/publication/tic-30-core-guidance-documents).

STANDARD COMPUTER CONFIGURATION

The Contractor IT end user solution that is developed for use on standard VA computers shall be compatible with and be supported on the standard VA operating system, Windows 10 (64bit) and Windows 11, Edge (Chromium based), and 365 Apps for enterprise. Applications delivered to VA and intended to be deployed to Windows 10 and or Windows 11 workstations shall be delivered as a signed .msi package with switches for silent and unattended installation and updates shall be delivered in signed .msp file formats for easy deployment using Microsoft Endpoint Configuration Manager (CM) VA’s current desktop application deployment tool. Signing of the software code shall be through a vendor provided certificate that is trusted by VA using a code signing authority such as Verizon/Cybertrust or Symantec/VeriSign. The Contractor shall also ensure and certify that their solution functions as expected when used from a standard VA computer, with non-admin, standard user rights that have been configured using the Defense Information Systems Agency (DISA) Secure Technical Implementation Guide (STIG) specific to the particular client operating system being used.

VETERAN FOCUSED INTEGRATION PROCESS (VIP) AND PRODUCT LINE MANAGEMENT (PLM)

The Contractor shall support VA efforts IAW the Veteran-Focused Integration Process (VIP) Guide and Product Line Management (PLM) Playbook. The major focus of VIP is on Enterprise Oversight, Governance, reporting, and establishing practices that focus on outcomes and continuously delivering sustainable IT capabilities to benefit the Veteran. PLM is a framework that focuses on delivering functional products that provide the highest priority work to customers while delivering simplified, reliable, and practical solutions to the business, medical staff, and our Veterans. The VIP Guide is a companion guide to the PLM Transformation Playbook and can be found at: https://www.voa.va.gov/DocumentView.aspx?DocumentID=4371 and the PLM Transformation Playbook can be found at https://www.voa.va.gov/DocumentView.aspx?DocumentID=4946. VIP and PLM are the authoritative processes that IT projects must follow to ensure development and delivery of IT products.

The VIP Guide provides guidance for transitioning from project-centric to product-centric delivery. The VIP guide applies to all OIT Office of Management and Budget (OMB) reportable products that are required to collect and report costs, schedules, risks, and other valuable information in VA PARS (whether products are procured or developed by VA) and any VA Information Technology project effort in Software Product Management (SPM) and Infrastructure Operations (IO), or their successors, that touch the VA network regardless of IT organizational alignment (whether it spends government funding from VA's Congressional IT Appropriation or any other appropriation).

The PLM Transformation Playbook details how OIT leadership expects Product Lines (PLs) to implement PLM, DevOps, and Lean-Agile principles, methods, practices, and techniques through levels of maturity. The PLM Transformation Playbook applies to all Information Technology (IT) products aligned to PLs in the Software Product Management, Infrastructure Operations and Product Engineering organizations within the OIT organization.

Others outside the referenced groups or organizations may use the VIP Guide and PLM Transformation Playbook for situational awareness as needed.

PROCESS ASSET LIBRARY (PAL)

The Contractor shall perform their duties consistent with the processes defined in the OIT Process Asset Library (PAL). The Process Asset Library (PAL) includes a spectrum of OIT functions and activities, such as project management, operations, service delivery, communications, acquisition, and resource management. PAL serves as an authoritative and informative repository of searchable processes, activities or tasks, roles, artifacts, tools and applicable standards and guides to assist the OIT workforce, Government and Contractor personnel. OIT utilizes PAL processes to ensure compliance with policies and regulations and to meet VA quality standards. The PAL includes the contractor onboarding process consistent with Section 6.2.2 and can be found at process_CONB_ext.docx (live.com). The main PAL can be accessed at www.va.gov/process.

AUTHORITATIVE DATA SOURCES

The VA Enterprise Architecture Repository (VEAR) is one component within the overall EA that establishes the common framework for data taxonomy for describing the data architecture used to develop, operate, and maintain enterprise applications. The Contractor shall comply with the department’s Authoritative Data Source (ADS) requirement that VA systems, services, and processes throughout the enterprise shall access VA data solely through official VA ADSs where applicable, see below. The Information Classes which compose each ADS are located in the VEAR, in the Data & Information domain. The Contractor shall ensure that all delivered applications and system solutions support:

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

2. Interfacing with Capital Asset Inventory (CAI) to conduct real property record management actions, if the solution relies on real property records data. CAI is the authoritative source for VA real property record management data.

3. Interfacing with electronic Contract Management System (eCMS) for access to contract, contract line item, purchase requisition, offering vendor, and solicitation information above the micro-purchase threshold, if the solution relies on procurement data. ECMS is the authoritative source for VA procurement actions data.

4. Interfacing with HRSmart Human Resources Information System to conduct personnel action processing, on-boarding, benefits management, and compensation management, if the solution relies on personnel data. HRSmart is the authoritative source for VA personnel information data.

5. Interfacing with VA Profile to access personal contact information, if the solution relies on VA Veteran personal contact information data. VA Profile is the authoritative source for VA Veteran Personal Contact Data.

6. Interfacing with VA/Department of Defense (DoD) Identity Repository (VADIR) for determining eligibility for VA benefits under Title 38, if the solution relies on qualifying active duty military service data. VADIR is the authoritative source for qualifying active duty military service in VA.

7. Interfacing with VA Systems Inventory (VASI) to access VA systems information, if the solution relies on VA system information. VASI is the authoritative source for VA Information Technology systems.

8. Interfacing with Enterprise Mission Assurance Support Service (eMASS) to access the Authority to Operate (ATO) status of all VA Information Systems. eMASS contains the official Authority to Operate (ATO) status of all VA Information Systems.

SOCIAL SECURITY NUMBER (SSN) REDUCTION

The Contractor solution shall support the Social Security Number (SSN) Fraud Prevention Act (FPA) of 2017 which prohibits the inclusion of SSNs on any document sent by mail. The Contractor support shall also be performed in accordance with Section 240 of the Consolidated Appropriations Act (CAA) 2018, enacted March 23, 2018, which mandates VA to discontinue using SSNs to identify individuals in all VA information systems as the Primary Identifier. The Contractor shall ensure that any new IT solution discontinues the use of SSN as the Primary Identifier to replace the SSN with the ICN in all VA information systems for all individuals. The Contractor shall ensure that all Contractor delivered applications and systems integrate with the VA MPI for identity traits to include the use of the ICN as the Primary Identifier. The Contractor solution may only use a Social Security Number to identify an individual in an information system if and only if the use of such number is required to obtain information VA requires from an information system that is not under the jurisdiction of VA.

SOFTWARE AND LICENSING REQUIREMENTS

The Contractor shall be responsible for the provision of all software licenses and any associated licensing maintenance required for any development, delivery, integration, operation, and/or maintenance associated with its proposed application(s), software products, software solution, and/or system including, but not limited to, any and all application(s), software and/or software products that comprise, are a part of, or integrate with the Contractor’s proposed application(s), software products, software solution, and/or system for the life of any resulting contract.

SECURITY AND PRIVACY REQUIREMENTS

(Business Associate Agreements (BAA) - Please see “Notes to the Contracting Officer” Section for instructions to determine if a Business Associate Agreement (BAA) is required for this effort. If it is determined that a BAA is required, please add the following language to this section of the PWS and change the text to black and convert to “No Spacing” style. In addition, please add “VA Directive 6066, “Protected Health Information (PHI) And Business Associate Agreements Management”, September 2, 2014” as the last item in Section 2.0 Applicable Documents of this PWS)

It has been determined that protected health information may be disclosed or accessed and a signed Business Associate Agreement (BAA) shall be required. The Contractor shall adhere to the requirements set forth within the BAA, referenced in Section D of the contract, and shall comply with VA Directive 6066.

POSITION/TASK RISK DESIGNATION LEVEL(S)

(The Requiring Activity/Program Manager is required to identify the…