36C10B23Q0021_DRAFT_PWS_ DSCSA Solution Provider.pdf

DRAFT

PERFORMANCE WORK STATEMENT (PWS)

DEPARTMENT OF VETERANS AFFAIRS

Veterans Health Administration Pharmacy Benefits Management

Clinical Informatics

Drug Supply Chain Security Act (DSCSA) Solution Provider

Date: June 15, 2023

VA-23-00061369

PWS Version Number: 2.0

Request for Information/Sources Sought Solicitation # 36C10B23R0021

Contents

1.0 BACKGROUND

2.0 APPLICABLE DOCUMENTS

3.0 SCOPE OF WORK

4.0 PERFORMANCE DETAILS

4.1 PERFORMANCE OBJECTIVE

4.2 PERFORMANCE PERIOD

4.3 PLACE OF PERFORMANCE

4.4 TRAVEL

5.0 SPECIFIC TASKS AND DELIVERABLES

5.1 PROJECT MANAGEMENT

5.1.1 CONTRACT KICKOFF MEETING

5.1.2 CONTRACTOR PROJECT MANAGEMENT PLAN

5.1.3 REPORTING REQUIREMENTS

5.2 IMPLEMENTATION

5.2.1 SUBSCRIPTION SERVICES- COMPLIANCE WITH DSCSA

REQUIREMENTS:

5.3 DATA MANAGEMENT and Vendor Mapping

5.4 DATA TRACING/RETRIEVAL

5.5 SUBSCRIPTION SERVICES - MAINTENANCE AND SUPPORT

5.6 SOFTWARE AS A SERVICE

5.6.1 ASSESSMENT, AUTHORIZATION, AND CONTINUOUS MONITORING ... 15

5.7 ADD-ON SERVICES

5.8 FUTURE ENHANCEMENTS

6.0 GENERAL REQUIREMENTS

6.1 ENTERPRISE AND IT FRAMEWORK

6.1.1 VA TECHNICAL REFERENCE MODEL

6.1.2 FEDERAL IDENTITY, CREDENTIAL, AND ACCESS MANAGEMENT

(FICAM)

6.1.3 INTERNET PROTOCOL VERSION 6 (IPV6)

6.1.4 TRUSTED INTERNET CONNECTION (TIC)

6.1.5 STANDARD COMPUTER CONFIGURATION

6.1.6 VETERAN FOCUSED INTEGRATION PROCESS (VIP) AND PRODUCT

LINE MANAGEMENT (PLM)

6.1.7 PROCESS ASSET LIBRARY (PAL)

6.1.8 AUTHORITATIVE DATA SOURCES

6.1.9 SOCIAL SECURITY NUMBER (SSN) REDUCTION

6.1.10 SOFTWARE AND LICENSING REQUIREMENTS

6.2 SECURITY AND PRIVACY REQUIREMENTS

6.2.1 POSITION/TASK RISK DESIGNATION LEVEL(S)

6.2.2 CONTRACTOR PERSONNEL SECURITY REQUIREMENTS

6.3 METHOD AND DISTRIBUTION OF DELIVERABLES

6.4 PERFORMANCE METRICS

6.5 FACILITY/RESOURCE PROVISIONS

6.6 GOVERNMENT FURNISHED PROPERTY

6.7 SHIPMENT OF HARDWARE OR EQUIPMENT - Not Applicable

7.0 POINTS OF CONTACT

ADDENDUM A – ADDITIONAL VA REQUIREMENTS, CONSOLIDATED

ADDENDUM B – VA INFORMATION AND INFORMATION SYSTEM

SECURITY/PRIVACY LANGUAGE

1.0 BACKGROUND

The Department of Veterans Affairs (VA), Veterans Health Administration (VHA) Pharmacy Benefits Management, Clinical Informatics (PBM-CI) strives to provide high quality, effective, and efficient 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 PBM-CI systems to meet mission goals.

This acquisition is for the implementation of subscription service to ensure compliance with the Drug Supply Chain Security Act which requires that drugs be tracked through the supply chain and that their provenance can be established via the ability to trace ownership from the manufacturer to the dispenser on an interoperable data exchange.

Facilities must also be able to furnish data to a trading partner within 24 hours of a request for information and to exchange data on the GS1 Electronic Product Information Service (EPCIS). Medications will have a 2D barcode that contains a Global Trade Identification Number (GTIN). The National Drug Code (NDC) for the item is incorporated within the GTIN, as well as the lot number, the expiration date, and the serial number which will be included in the electronic data exchange for the receipt, verification, storage (for 6 years), tracking and retrieval of this data. This contract includes all current 155 VA locations including all areas with a pharmacy that receives or stores pharmaceuticals as well as Consolidated Mail Outpatient Pharmacies (CMOPS) (hereto forth “the VA”) as well as provides education on utilization of the system software. The Contractor will share implementation guidelines and instructions to the designated VA administrative users and be available to answer related questions as well as problem solve any issues with the implementation. Included in this contract will be coordination with the National Accreditation for Boards of Pharmacy (NABP), the set up and implementation of service to all VA sites, subscription service with all aspects for DSCSA law compliance, mapping of current wholesalers, maintenance, support and add-on services specific to the vendor award. Future enhancements that include integration to the Veterans Health Information Systems and Technology Architecture (VistA) and Oracle/Cerner to be included when these projects are ready for implementation.

The Drug Quality and Security Act (DQSA) was enacted by Congress on November 27, 2013. The second section of this law, Title II of DQSA, is the Drug Supply Chain Security Act (DSCSA). This Act concerns the integrity of the Pharmacy Supply Chain, the purpose of this procurement is to provide VA with tools and support in meeting the requirements of the DSCSA.

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”, NIST CSRC

4. FIPS Pub 140-3, “Security Requirements for Cryptographic Modules”, March 22,

5. FIPS Pub 199. “Standards for Security Categorization of Federal Information and

Information Systems,” February 1, 2004

6. FIPS Pub 200, “Minimum Security Requirements for Federal Information and

Information Systems,” March 1, 2006

7. FIPS Pub 201-2, “Personal Identity Verification of Federal Employees and

Contractors,” August 2013

8. FIPS Pub 201-3, “Personal Identity Verification of Federal Employees and

Contractors,” January 24, 2022

9. 10 U.S.C. § 2224, "Defense Information Assurance Program"

10. 5 U.S.C. § 552a, as amended, “The Privacy Act of 1974”

11. Public Law 109-461, Veterans Benefits, Health Care, and Information Technology

Act of 2006, Title IX, Information Security Matters

12. 42 U.S.C. § 2000d “Title VI of the Civil Rights Act of 1964”

13. VA Directive 0710, “Personnel Security and Suitability Program,” June 4, 2010, VA

Publications

14. VA Handbook 0710, “Personnel Security and Suitability Program,” May 2, 2016

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

16. 36 C.F.R. Part 1194 “Information and Communication Technology Standards and

Guidelines,” January 18, 2017

17. Office of Management and Budget (OMB) Circular A-130, “Managing Federal

Information as a Strategic Resource,” July 28, 2016

18. 32 C.F.R. Part 199, “Civilian Health and Medical Program of the Uniformed

Services (CHAMPUS)”

19. NIST SP 800-66 Rev. 1, “An Introductory Resource Guide for Implementing the

Health Insurance Portability and Accountability Act (HIPAA) Security Rule,” October 23, 2008

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

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

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

23. VA Handbook 6500, “Risk Management Framework for VA Information Systems

VA Information Security Program,” February 24, 2021

24. VA Handbook 6500.2, “Management of Breaches Involving Sensitive Personal

Information (SPI),” March 12, 2019

25. VA Handbook 6500.5, “Incorporating Security and Privacy into the System

Development Lifecycle,” March 22, 2010 https://csrc.nist.gov/publications/search?sortBy-lg=Number+DESC&viewMode-lg=brief&ipp-lg=all&status-lg=Final%2CDraft&topicsMatch-lg=ANY&controlsMatch-lg=ANY https://www.va.gov/vapubs/index.cfm https://www.va.gov/vapubs/index.cfm http://www.va.gov/vapubs http://www.va.gov/vapubs

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

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

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

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

30. OIT Process Asset Library (PAL), PAL Library. Reference Process Maps at

Process Maps Directory and Artifact templates at PAL Artifacts

31. One-VA Technical Reference Model (TRM) TRM Home Page

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

Impact Assessment,” October 15, 2014

33. VA Handbook 6508.1, “Procedures for Privacy Threshold Analysis and Privacy

Impact Assessment,” July 30, 2015

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

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

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

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

38. NIST SP 800-37 Rev 2, “Risk Management Framework for Information Systems and Organizations: A System Life Cycle Approach for Security and Privacy,” December 20, 2018,

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

40. NIST SP 800-53A Rev, 5, “Assessing Security and Privacy Controls in Information Systems and Organizations,” January 25, 2022

41. NIST SP 800-53B, “Control Baselines for Information Systems and Organizations,” September 23, 2020 (includes updates as of December 10, 2020)

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

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

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

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

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

47. Federal Identity, Credential, and Access Management (FICAM) Roadmap and Implementation Guidance, December 2, 2011, (NOTE: Part A of the FICAM Roadmap and Implementation Guidance, v2.0, was replaced in 2015 with an updated Architecture Federal ICAM Architecture Introduction

48. NIST SP 800-116 Rev 1, “Guidelines for the Use of Personal Identity Verification (PIV) Credentials in Facility Access, “June 29, 2018

49. NIST SP 800-63-3, “Digital Identity Guidelines,” updated March 02, 2020 https://www.va.gov/process/ https://www.va.gov/process/maps.asp https://www.va.gov/process/artifacts.asp https://www.oit.va.gov/services/trm/ https://playbooks.idmanagement.gov/arch/#what-is-the-ficam-architecture

50. NIST SP 800-63A, “Digital Identity Guidelines: Enrollment and Identity Proofing”, December 16, 2022

51. NIST SP 800-63B, “Digital Identity Guidelines: Authentication and Lifecycle Management”, March 2, 2020

52. NIST SP 800-63C, “Digital Identity Guidelines: Federation and Assertions,” March 02, 2020

53. NIST SP 800-63-4, “Digital Identity Guidelines,” December 16, 2022

54. NIST SP 800-63C-4, “Digital Identity Guidelines: Federation and Assertions,”

December 16, 2022

55. NIST SP 800-63B-4, “Digital Identity Guidelines: Authentication and Lifecycle

Management,” December 16, 2022

56. NIST SP 800-63A-4, “Digital Identity Guidelines: Enrollment and Identity Proofing,”

December 16, 2022

57. NIST SP 800-157, “Guidelines for Derived PIV Credentials,” December 19, 2014

58. VA Memorandum, VAIQ #7100147, “Continued Implementation of Homeland

Security Presidential Directive 12 (HSPD-12),” April 29, 2011

59. IAM Identity Management Business Requirements Guidance document, May 2013, (reference Enterprise Architecture Section, PIV/IAM (reference Identity Management Business Requirements Guidance v2_6.pdf

60. VA Memorandum “Personal Identity Verification (PIV) Logical Access Policy Clarification,” July 17, 2019, PIV Logical Access Policy Clarification.pdf

61. Trusted Internet Connections (TIC) 3.0 Core Guidance Documents, Trusted Internet Connections (TIC) 3.0 Core Guidance Documents | CISA

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

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

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

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

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

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

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

69. Office of Information Security (OIS) VAIQ #7424808 Memorandum, “Remote

Access,” January 15, 2014, OIS Memo VAIQ # 7424808 January 15 2014.pdf

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

71. “Veteran Focused Integration Process (VIP) Guide 4.0,” January 2021, VIP Guide

4.0.pdf (va.gov)

72. VA Memorandum “Proper Use of Email and Other Messaging Services,” January

2, 2018, Proper Use of Email.pdf (va.gov)

73. “DevSecOps Product Line Management Playbook” version 2.0, May 2021, DevSecOps PLM L2 Playbook.pdf (va.gov)

74. NIST SP 500-267B Revision 1, “USGv6 Profile,” November 2020 file://r04.med.va.gov/V03/EAS/Users/VHAEASWaterW/Documents/Identity%20Management%20Business%20Requirements%20Guidance%20v2_6.pdf file://r04.med.va.gov/V03/EAS/Users/VHAEASWaterW/Documents/Identity%20Management%20Business%20Requirements%20Guidance%20v2_6.pdf file://r04.med.va.gov/V03/EAS/Users/VHAEASWaterW/Documents/PIV%20Logical%20Access%20Policy%20Clarification.pdf https://www.cisa.gov/resources-tools/resources/trusted-internet-connections-tic-30-core-guidance-documents https://www.cisa.gov/resources-tools/resources/trusted-internet-connections-tic-30-core-guidance-documents file://r04.med.va.gov/V03/EAS/Users/VHAEASWaterW/Documents/OIS%20Memo%20VAIQ%20#%207424808%20January%2015%202014.pdf file://r04.med.va.gov/V03/EAS/Users/VHAEASWaterW/Documents/VIP%20Guide%204.0.pdf file://r04.med.va.gov/V03/EAS/Users/VHAEASWaterW/Documents/VIP%20Guide%204.0.pdf file://r04.med.va.gov/V03/EAS/Users/VHAEASWaterW/Documents/Proper%20Use%20of%20Email.pdf file://r04.med.va.gov/V03/EAS/Users/VHAEASWaterW/Documents/DevSecOps%20PLM%20L2%20Playbook.pdf

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

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

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

78. VA Directive 6066, “Protected Health Information (PHI) and Business Associate

Agreements Management,” September 2, 2014

3.0 SCOPE OF WORK

The Contractor shall provide project management and development for the implementation and subscription service to all current 155 VA locations including all areas with a pharmacy that receives or stores pharmaceuticals as well as Consolidated Mail Outpatient Pharmacies (CMOPS) and Emergency Pharmacy Services (EPS), (hereto forth “VA”) and provide education on utilization of the system software in written handout format, to include training guides with virtual calls for each level of training. The Contractor will share implementation guidelines and instructions to the designated VA administrative users and be available to answer related questions as well as problem solve any issues with the implementation. Specifically, the Contractor shall support VHA in the following areas of need:

1. Implementation

2. Subscription Services - Compliance with DSCSA requirements

3. Subscription Services - Data Management and Mapping of current list of wholesalers

4. Subscription Services- Data Tracing and Retrieval

5. Subscription Services - Maintenance and Support

6. Software as a Service

7. Add-ons

8. Future Enhancements

4.0 PERFORMANCE DETAILS

4.1 PERFORMANCE OBJECTIVE

The acquisition of this subscription service to:

o VA as a legal entity o Each VA pharmacy site that procures and receives pharmaceuticals identified by

Drug Enforcement Administration license o Physical Locations Medical Centers Dispensing Community Based Outpatient Clinics CMOPs EPS and All Hazard Emergency Caches

4.2 PERFORMANCE PERIOD

The Period of Performance (PoP) shall be a twelve (12) month base period with four (4) twelve (12) month option periods, if exercised. The overall PoP shall not exceed 60 months. The project start date shall be within 30 days after contract award.

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

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

Under current definitions, five (5) are set by date:

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

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 (6) 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

4.3 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.

4.4 TRAVEL

There is no travel required for this effort.

5.0 SPECIFIC TASKS AND DELIVERABLES

Electronic Product Code Information Services (EPCIS) 2D data matrix tracing, storage and retrieval, to include suspect product process and report functionality are described in detail in section 5.0 of this agreement.

The Contractor shall perform the following:

5.1 PROJECT MANAGEMENT

5.1.1 CONTRACT KICKOFF MEETING

The Contractor shall participate in contract kick-off meeting with a core group of VA representatives. This meeting will be to discuss the CPMP, training and implementation plans and review the requirements of the contract. Subsequent meetings may be required with a larger group of users for follow up.

Deliverable:

A. Kick-off meeting

5.1.2 CONTRACTOR PROJECT MANAGEMENT PLAN

The Contractor shall deliver a Contractor Project Management Plan (CPMP) that lays out the Contractor’s high-level approach and timeline to be used in execution of the contract no later than 30 days after the execution of the option. The CPMP shall take the form of both a narrative and/or graphic format that displays the schedule, milestones, and resource support. The CPMP shall include the Contractor Staff Roster as described in Section 6. 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.

A. Contractor Project Management Plan B. Contractor Staff Roster

5.1.3 REPORTING REQUIREMENTS

The Contractor shall provide the Contracting Officer’s Representative (COR) with monthly Progress Reports in electronic form in Microsoft Word 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 “scorecard” information related to Application Programming Interfaces (APIs) successes and failures, such as in a dashboard, with follow up or updated statuses of each failure, by VA location.

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.

A. Monthly Progress Report

5.2 IMPLEMENTATION

The Contractor shall perform the following 60 days after award date (unless otherwise stated):

1. Security requirements:

a. Meet all security requirements for VA approved Software as a Service (SaaS)

b. Initiate process to meet security requirements for Federal Risk and

Authorization Management Program (FedRAMP) (https://www.fedramp.gov/) (180 days after award date)

2. Set up all current 155 VA locations in software for data exchange/storage/retrieval

3. Exchange and store DSCSA required data for every VA location that receives or stores pharmaceuticals

4. Create or assist with creation of user profiles with differing levels or access to include administrative high level to end user levels. Assist with creation of user profiles when needed.

5. Coordinate and establish data exchange with

a. National Accreditation of Boards of Pharmacy (NABP) via their established

APIs to obtain and utilize Authorized Trading Partner (ATP) data

b. GS1 EPCIS to and from wholesalers and distributors

c. Daily Electronic Data Interchange (EDI) 856 Advanced Shipping Notice (ASN) from wholesaler

6. Map current VA wholesalers, establishing GS1 EPCIS data exchange

7. Establish interoperability with, and proactively remain updated to, the latest standards for

a. VA Single Sign-On (SSOi) authentication to validate authorized users

8. GS1 Electronic Product Code Information Services (EPCIS) (e.g., 1.2 or higher) https://www.fedramp.gov/

A. Security requirements for VA approved SaaS B. Process to meet security requirements for FEDRAMP approval C. Software for data exchange/storage/retrieval setup for all current 155 VA locations D. Multi-level access user profiles E. NABP, GS1 EPCIS, and Daily Electronic Data Interchange (EDI) 856 Advanced

Shipping Notice (ASN) Data Exchanges F. VA wholesaler mapping

5.2.1 SUBSCRIPTION SERVICES- COMPLIANCE WITH DSCSA REQUIREMENTS:

The Contractor shall perform the following 60 days after award date:

1. Real-time ATP verification, prior to receipt of product

2. Monitor and alert mechanism for API failures

3. Provide an audit trail for Purchase Order (PO) processing requirements

4. Provide PO processing capabilities to include:

a. Receiving only against open PO numbers

b. Ability to open closed POs for editing

c. Manual addition of items not included on ASN

d. Ability to adjust quantity received

e. Ability to adjust expiration date for items requiring monitoring and removal prior to expiration, or extension of expiration date (e.g., Shelf-life extension project (SLEP)

f. Scanning and receiving options at the pallet, case, tote or individual item level using applicable standard (e.g., Standard Shipping Container Code)

5. Be capable of scanning, receiving, and processing

a. 6-4-2 NDC format

b. Eleven (11) and twelve (12) digit NDC numbers

c. Translation of NDC to 14-digit Global Trade Item Number (GTIN), and vice versa

6. Provide data exchange processes to include:

a. EPCIS 1.2 or higher data exchange with all mapped vendors

b. Validation Errors Identification Process

c. Non-compatible Data Exchange Process

d. Data Exceptions Process

e. Full Chain of Custody Records

f. Advanced ship notices repository

g. Product Identification Procedures for grandfathered and exempt/excepted/waved products

A. Process for ATP verification B. Alert mechanism for API failures

C. Audit trail for all transactions D. PO Processes to include:

a. Receiving only against open PO numbers

b. Ability to open closed POs for editing

c. Manual addition of items not included on ASN

d. Ability to adjust quantity received

e. Ability to adjust expiration date for items requiring monitoring and removal prior to expiration, or extension of expiration date (e.g., Shelf-life extension project, SLEP)

f. Scanning and receiving options at the pallet, case, tote or individual item level using applicable standard (e.g., Standard Shipping Container Code)

E. Process for NDC formats and translation F. Data exchange processes to include:

a. EPCIS 1.2 or higher data exchange with all mapped vendors

b. ATP Validation Errors Identification Process

c. Non-compatible Data Exchange Process

d. Data Exceptions Process

e. Full Chain of Custody Records

f. Advanced ship notices repository

g. Product Identification Procedures for grandfathered and exempt/excepted/waived products

5.3 DATA MANAGEMENT AND VENDOR MAPPING

The Contractor shall perform the following 60 Days after award date:

1. Store all data within the United States

2. In accordance with Title II of the Drug Quality and Security Act, Drug Supply Chain

Security, the contractor must store all received transaction data for 6 years from transaction date

3. In accordance with Title II of the Drug Quality and Security Act, Drug Supply Chain Security, the contractor must store all transaction data for any investigated receipt for 6 years from time of investigation request

4. Data remains the property of and accessible, without additional charge, to the VA regardless of contract status (e.g., active, terminated, expired)

5. Data will not include any Protected Health Information (PHI) or Personally Identifiable Information (PII)

A. VA transaction data storage

5.4 DATA TRACING/RETRIEVAL

The Contractor shall perform the following 60 Days after award date:

1. Respond to request for information

a. Within 24 hours for authorized auditing body (e.g., Office of the Inspector

General, Federal Drug Administration)

b. Within 2 days for an ATP in the event of a recall or investigation into suspected illegitimate product

2. Allow for selecting of multiple POs for the same item search

3. Data remains available for retrieval in the case of Pharmaceutical Prime Vendor

(PPV) contract change, expiration, termination, etc.

4. Data is available to export, manipulate, and process at VA’s sole discretion

5. Data will be available to ATP for use in complying with the DSCSA requests

6. Shall provide Login information, usernames, and passwords

7. Shall create a Process for data retrieval to meet specified time request

A. Process for data retrieval B. VA and ATP Data Access, Login information, usernames and passwords

5.5 SUBSCRIPTION SERVICES - MAINTENANCE AND SUPPORT

The Contractor shall perform the following at time of implementation, no later than 30 days after award:

1. Provide for communication regarding and continuity of operations due to planned or unexpected system unavailability, regardless of cause

2. Create an End User Training 2- to 4- hour curriculum and the Training Material for

<Level 1-End User>, <Level 2-Pharmacy Chief>, <Level 3-VPE> and <Level 4 - National Administrator>. The training material should be in written format, to include training guides and virtual calls for each level of training, which includes measurable competencies for:

a. System functionality and usage

b. Overview of available reports and their functionalities

c. Creation of Standard Operating Procedures for:

i. Processing/sequestering Illegitimate or Suspect Products

ii. System unavailability

iii. Identification of grandfathered products or exempt/excepted/waived products

iv. Data exchange for drop-shipped items

3. Provide an End User Training 2- to 4- hour curriculum and the Training Material for <Level 1-End User>, <Level 2-Pharmacy Chief>, <Level 3-VPE> and <Level 4 - National Administrator>.

4. Provide customer support during business hours (0800-1700 Mon-Fri) for VA in all time zones (includes continental US, Alaska, Hawaii, the Philippines Islands, Guam, America Samoa, Puerto Rico, and the Virgin Islands)

5. Begin communication process with ATPs in coordination with designated VA staff to resolve:

a. Reports of suspect or illegitimate product

b. Incorrectly formatted or incompatible data

c. Issues related to mis-picked/mis-packed or missing items

d. Data exceptions

e. Communications related to suspected illegitimate products

6. Mapping of new vendors provided by VA

7. Report functionality for auditing purposes and ability to create specialized reports

8. The contractor shall

a. Provide Customer support phone numbers

b. Develop a Process for communicating to ATPs in coordination with VA designated staff

c. Develop a Process to add newly acquired vendors to mapping

d. Create and submit Auditing reports

A. End user training material and virtual end user training B. Customer support phone numbers C. Process for communicating to ATPs D. Process for vendor mapping E. Auditing reports

5.6 SOFTWARE AS A SERVICE

5.6.1 ASSESSMENT, AUTHORIZATION, AND CONTINUOUS MONITORING

1. The information system solution selected by the Contractor shall comply with the

Federal Information Security Management Act (FISMA).

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. Following guidance from the Federal CIO, VA will utilize existing JAB ATO or agency ATO issued by another agency as a starting point for FedRAMP requirements. If neither of those exist, VA will sponsor FedRAMP ATO. VA will be using the FedRAMP baselines as a starting point, since they are specifically tailored for cloud services.

https://www.fedramp.gov/agency-authorization/

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

5. The Contractor shall complete a FedRAMP System Security Plan (SSP) and supporting documentation within 45 days after contract award. (If Data Security Categorization is High Impact, this will be due 85 days after contract award.)

6. The Contractor shall complete a Third-Party Assessment Organization (3PAO) Security Assessment Plan (SAP) within 90 days after contract award. (If Data Security Categorization is High Impact, this will be due after 130 days after contract award.)

7. The Contractor shall complete a 3PAO Security Assessment Report (SAR) within 140 days after contract award. (If Data Security Categorization is High Impact, this will be due 180 days after contract award.)

8. 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.

9. If new or unanticipated threats or hazards 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 the security addendum B.

10. The Contractor shall not release any data without the consent of VA in writing. All requests for release must be submitted in writing to the Contracting Officer’s Representative (COR)/Contracting Officer (CO).

11. In order for live VA data to be used in this system, a FedRAMP Authorization and Agency ATO will be required.

Deliverables:

A. FedRAMP System Security Plan (SSP) and supporting documentation 30 days after award date

B. VA Implementation Diagram: This is a VA specific architecture diagram demonstrating the proposed implementation of this system at VA (VAID) 30 days after award date

C. 3PAO Security Assessment Plan (SAP) 30 days after award date D. 3PAO Security Assessment Report (SAR) 30 days after award date

Proposed Invoicing Schedule

Vendor is required to register and submit all invoices via the Tungsten/OB10 electronic invoicing system.

Contractor shall invoice and be paid as follows:

• Completed FedRAMP System Security Plan (SSP), VAID, and all supporting documentation (10% of contract value billable upon receipt) 30 Days after award date.

• 3PAO Security Assessment Plan (SAP) (10% of contract value billable upon receipt) 30 Days after award date.

• 3PAO Security Assessment Report (SAR) (10% of contract value billable upon receipt) 30 Days after award date.

• The remaining 70% will be billable when all ATO work is complete

5.7 ADD-ON SERVICES

The Contractor shall perform the following 60 days after award date:

1. 2D capable bar code scanners capable of being connected via USB to VA desktop, which shall become the property of VA after award

2. Develop Process for pharmaceutical returns and linking the returns to the original invoice for correct price credit

3. Develop Process for decommissioning of serial numbers and reporting same to manufacturer

4. Provide mechanism for tracking item removal from quarantine for diversion prevention, either by hard-stop or audit process

5. Develop additional APIs if needed (ex. Reverse Distributor)

A. Pharmaceutical Returns Process B. Decommissioning Process C. Item Removal Tracking Mechanism D. Additional APIs Developed

5.8 FUTURE ENHANCEMENTS

The Contractor shall perform the following:

1. Participation in Integration and implementation of interfacing with Government

VistA EHR system planning meetings and provide recommendations and updates resulting from the meetings in writing (90 Days after award).

2. Develop Integration project charter (120 days after award)

3. Develop Integration project management plan (120 days after award)

4. Participation in integration and implementation with Government VistA EHR system testing. (180 Days after award)

5. Participation in Integration and implementation of interfacing with Government Oracle/Cerner EHR system planning meetings (180 Days after award)

6. Develop Item level traceability interface with EHR and required documentation.

Timeframe determined during planning meetings. (No later than 180 days after award date)

7. Participation in integration and implementation with Government Oracle/Cerner EHR system testing. (300 Days after award)

A. VistA development meeting recommendations and updates B. Integration Project Charter C. Integration Project Management Plan D. Item Level Traceability Interface with EHR and required documentation

6.0 GENERAL REQUIREMENTS

6.1 ENTERPRISE AND IT FRAMEWORK

6.1.1 VA TECHNICAL REFERENCE MODEL

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

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

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

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 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.

https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/memoranda/2005/m05-24.pdf https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/memoranda/2005/m05-24.pdf https://www.whitehouse.gov/wp-content/uploads/2019/05/M-19-17.pdf

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.

6.1.3 INTERNET PROTOCOL VERSION 6 (IPV6)

The Contractor solution shall support Internet Protocol Version 6 (IPv6) 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). IPv6 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 shall support native IPv6 and 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 and dual stack (IPv6 / IPv4) users and all internal infrastructure and applications shall communicate using native IPv6 and dual stack (IPv6 / IPv4) operations.

6.1.4 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). Any deviations must be approved by the VA TIC 3.0 Working Group at vaoisesatic30team@va.gov.

6.1.5 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, https://www.voa.va.gov/DocumentView.aspx?DocumentID=4896 https://www.whitehouse.gov/wp-content/uploads/2020/11/M-21-07.pdf file://R04.med.va.gov/V03/EAS/Users/vhaeasWymbsk/TEMPLATES--NEW%20TAC%20PROCESS/PWS%20TEMPLATE%20(DO%20NOT%20TOUCH)%20-%20In%20Process%20Revisions/DO%20NOT%20TOUCH%20(next%20version/IPv6/(https:/www.nist.gov/programs-projects/usgv6-program/usgv6-revision-1 file://R04.med.va.gov/V03/EAS/Users/vhaeasWymbsk/TEMPLATES--NEW%20TAC%20PROCESS/PWS%20TEMPLATE%20(DO%20NOT%20TOUCH)%20-%20In%20Process%20Revisions/DO%20NOT%20TOUCH%20(next%20version/IPv6/(https:/www.nist.gov/programs-projects/usgv6-program/usgv6-revision-1 https://doi.org/10.6028/NIST.SP.500-267Br1 https://doi.org/10.6028/NIST.SP.800-119 https://www.whitehouse.gov/wp-content/uploads/2019/09/M-19-26.pdf https://www.cisa.gov/publication/tic-30-core-guidance-documents mailto:vaoisesatic30team@va.gov currently Windows 10 (64bit), Edge (Chromium based), and 365 Apps for enterprise. Applications delivered to VA and intended to be deployed to Windows 10 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 United States Government Configuration Baseline (USGCB) and Defense Information Systems Agency (DISA) Secure Technical Implementation Guide (STIG) specific to the particular client operating system being used.

6.1.6 VETERAN FOCUSED INTEGRATION PROCESS (VIP) AND PRODUCT LINE

MANAGEMENT (PLM)

The Contractor shall support VA efforts IAW the updated Veteran Focused Integration Process (VIP) and Product Line Management (PLM). The major focus of the new VIP is on Governance and Reporting and is less prescriptive, with a focus on outcomes and continuous delivery of value. Product Line Management (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 Playbook and can be found at:

https://www.voa.va.gov/DocumentView.aspx?DocumentID=4371 and the PLM Playbook can be found at https://www.voa.va.gov/DocumentView.aspx?DocumentID=4946. The PLM Playbook pivots from project-centric to product-centric delivery and contains descriptive practices that focuses on outcomes. The PLM Playbook contains a set of “plays” that implement Development, Security, and Operations (DevSecOps) principles and processes such as automated development, continuous integration/continuous delivery, and release on demand. The PLM Playbook details how product lines implement Lean-Agile principles, methods, practices, and techniques through levels of maturity. VIP and PLM are the authoritative processes that IT projects must follow to ensure development and delivery of IT products.

6.1.7 PROCESS ASSET LIBRARY (PAL)

The Contractor shall perform their duties consistent with the processes defined in the OIT Process Asset Library (PAL). The PAL scope includes the full spectrum of OIT functions and activities, such as VIP 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 https://www.voa.va.gov/DocumentView.aspx?DocumentID=4371 https://www.voa.va.gov/DocumentView.aspx?DocumentID=4946

Contractor personnel. The Contractor shall follow the 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 https://www.va.gov/PROCESS/artifacts/maps/process_CONB_ext.pdf. The main PAL can be accessed at www.va.gov/process.

6.1.8 AUTHORITATIVE DATA SOURCES

Not applicable

6.1.9 SOCIAL SECURITY NUMBER (SSN) REDUCTION

Not applicable

6.1.10 SOFTWARE AND LICENSING REQUIREMENTS

This acquisition is a software product and/or solution acquired as subscription service within a SaaS environment (not via licenses), therefore this section does not apply.

6.2 SECURITY AND PRIVACY REQUIREMENTS

It has been determined that protected health information will NOT be disclosed or accessed and a signed Business Associate Agreement (BAA) in NOT required.

6.2.1 POSITION/TASK RISK DESIGNATION LEVEL(S)

https://www.opm.gov/investigations/suitability-executive-agent/position-designation-tool/)

In accordance with VA Handbook 0710, Personnel Security and Suitability Program, the position sensitivity and the level of background investigation commensurate with the required level of access for the following tasks within the PWS are:

Position Sensitivity and Background Investigation Requirements by Task

Task Number Tier1 / Low Risk Tier 2 / Moderate Risk

Tier 4 / High Risk

All

The Tasks identified above and the resulting Position Sensitivity and Background Investigation requirements identify the Background Investigation requirements for Contractor individuals, based upon the tasks the particular Contractor individual will be working. The submitted Contractor Staff Roster must indicate the required Background https://www.va.gov/PROCESS/artifacts/maps/process_CONB_ext.pdf http://www.va.gov/process https://www.opm.gov/investigations/suitability-executive-agent/position-designation-tool/

Investigation Level for each Contractor individual based upon the tasks the Contractor individual will be working, in accordance with their submitted proposal.

6.2.2 CONTRACTOR PERSONNEL SECURITY REQUIREMENTS

Contractor Responsibilities:

a. The Contractor shall prescreen all personnel requiring access to the computer systems to ensure they maintain the appropriate Background Investigation, and are able to read, write, speak, and understand the English language.

b. Within 3 business days after award, the Contractor shall provide a roster of Contractor and Subcontractor employees to the COR to begin their background investigations in accordance with the PAL template artifact. The Contractor Staff Roster shall contain the Contractor’s Full Name, Date of Birth, Place of Birth, individual background investigation level requirement (based upon Section 6.2 Tasks), etc. The Contractor shall submit full Social Security Numbers either within the Contractor Staff Roster or under separate cover to the COR. The Contractor Staff Roster shall be updated and provided to VA within 1 day of any changes in employee status, training certification completion status, Background Investigation level status, additions/removal of employees, etc. throughout the Period of Performance. The Contractor Staff Roster shall remain a historical document indicating all past information and the Contractor shall indicate in the Comment field, employees no longer supporting this contract. The preferred method to send the Contractor Staff Roster or Social Security Number is by encrypted e-mail. If unable to send encrypted e-mail, other methods which comply with FIPS 140-2 are to encrypt the file, use a secure fax, or use a traceable mail service.

c. The Contractor should coordinate with the location of the nearest VA fingerprinting office through the COR. Only electronic fingerprints are authorized. The Contractor shall bring their completed Security and Investigations Center (SIC) Fingerprint request form with them (see paragraph d.4. below) when getting fingerprints taken.

d. The Contractor shall ensure the following required forms are submitted to the COR within 5 days after contract award:

1) Optional Form 306

2) Self-Certification of Continuous Service

3) VA Form 0710

4) Completed SIC Fingerprint Request Form

e. The Contractor personnel shall submit all required information related to their background investigations (completion of the investigation documents (SF85, SF85P, or SF 86) utilizing the Office of Personnel Management’s (OPM) Electronic Questionnaire for Investigations Processing (e-QIP) after receiving an email notification from the Security and Investigation Center (SIC).

f. The Contractor employee shall certify and release the e-QIP…