RFP 36C10B23R0021.pdf

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

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

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

36C10B23R0021 08-16-2023

William Waterhouse 848.377.5097 08-23-2023

1000 EDT

36C10B Department of Veterans Affairs Technology Acquisition Center

23 Christopher Way Eatontown NJ 07724

X 100

X

513210

$47 Million

N/A

X

See Delivery Schedule

36C10B

Department of Veterans Affairs Technology Acquisition Center

TBD

36C10A

Technology Acquisition Center Financial Services Center PO Box 149971 Austin TX 78714-8971

TITLE: Drug Supply Chain Security Act Solution Provider

See Section B

Contracting Officer: Kendra Casebolt, Kendra.Casebolt@va.gov

Type of Contract: Firm-Fixed-Price

X X

Kendra M. Casebolt Contracting Officer

36C10B23R0021

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 GOVERNING LAW

B.2 SOFTWARE LICENSE, MAINTENANCE AND TECHNICAL SUPPORT

B.3 CONTRACT ADMINISTRATION DATA

B.4 PRICE SCHEDULE

B.5 PERFORMANCE WORK STATEMENT

ADDENDUM A – ADDITIONAL VA REQUIREMENTS, CONSOLIDATED

ADDENDUM B – VA INFORMATION AND INFORMATION SYSTEM

SECURITY/PRIVACY LANGUAGE

SECTION C - CONTRACT CLAUSES

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

C.2 52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR

INFORMATION SYSTEMS (NOV 2021)

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

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (JUN 2023)

C.4 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ..75

C.5 MANDATORY WRITTEN DISCLOSURES

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

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

1998)

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN

TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT

(NOV 2021)

E.3 52.204-26 COVERED TELECOMMUNICATIONS EQUIPMENT OR SERVICES -

REPRESENTATION (OCT 2020)

E.4 52.209-5 CERTIFICATION REGARDING RESPONSIBILITY MATTERS

(AUG 2020)

E.5 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS

(OCT 2018)

E.6 52.209-11 REPRESENTATION BY CORPORATIONS REGARDING

DELINQUENT TAX LIABILITY OR A FELONY CONVICTION UNDER ANY FEDERAL

LAW (FEB 2016)

E.7 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)

E.8 52.216-1 TYPE OF CONTRACT (APR 1984)

E.9 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.10 BASIS FOR AWARD

E.11 EVALUATION APPROACH

E.12 PROPOSAL SUBMISSION

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 GOVERNING LAW

Federal law and regulations, including the Federal Acquisition Regulations (FAR), shall govern this Contract/Order. Commercial license agreements may be made a part of this Contract/Order but only if both parties expressly make them an addendum hereto, as permitted by FAR 12.212. If the commercial license agreement is not made an addendum, it shall not apply, govern, be a part of or have any effect whatsoever on the Contract/Order; this includes, but is not limited to, any agreement embedded in the computer software (clickwrap), any agreement that is otherwise delivered with or provided to the Government with the commercial computer software or documentation (shrinkwrap), or any other license agreement otherwise referred to in any document. If a commercial license agreement is made an addendum, only those provisions addressing data rights regarding the Government’s use, duplication and disclosure of data (e.g., restricted computer software) are included and made a part of this Contract/Order, and only to the extent that those provisions are not duplicative or inconsistent with Federal law, Federal regulation, the incorporated FAR clauses and the provisions of this Contract/Order; those provisions in the commercial license agreement that do not address data rights regarding the Government’s use, duplication and disclosure of data shall not be included or made a part of the Contract/Order. Federal law and regulation including, without limitation, the Contract Disputes Act (41 U.S.C. § 7101 et seq.), the Anti-Deficiency Act (31 U.S.C. § 1341 et seq.), the Competition in Contracting Act (41 U.S.C. § 3301 et seq.), the Prompt Payment Act (31 U.S.C. § 3901 et seq.), Contracts for Data Processing or Maintenance (38 USC § 5725), and FAR clauses 52.212-4, 52.227-14, 52.227-19 shall supersede, control, and render ineffective any inconsistent, conflicting, or duplicative provision in any commercial license agreement. In the event of conflict between this clause and any provision in the Contract/Order or the commercial license agreement or elsewhere, the terms of this clause shall prevail. The Contractor shall deliver to the Government all data first produced under this Contract/Order with unlimited rights as defined by FAR 52.227-14. Claims of patent or copyright infringement brought against the Government as a party shall be defended by the U.S.

Department of Justice (DOJ) in accordance with 28 U.S.C. § 516; at the discretion of DOJ, the Contractor may be allowed reasonable participation in the defense of the litigation. Any additional changes to the Contract/Order must be made by modification (Standard Form 30) and shall only be made by a warranted Contracting Officer. Nothing in this Contract/Order or any commercial license agreement shall be construed as a waiver of sovereign immunity.

B.2 SOFTWARE LICENSE, MAINTENANCE AND TECHNICAL SUPPORT

(1). Definitions

a) Licensee. The term “licensee” shall mean the U.S. Department of Veterans Affairs (“VA”) and is synonymous with “Government.”

b) Licensor. The term “licensor” shall mean the Contractor having the necessary license or ownership rights to deliver license, software maintenance and support of the computer software being acquired. The term “Contractor” is the party identified in Block 17a on the SF1449. If the Contractor is a reseller and not the Licensor, the Contractor remains responsible for performance under this Contract/Order.

c) Software. The term “software” shall mean the licensed computer software product(s) cited in the Schedule of Supplies/Services.

d) Maintenance. The term “maintenance” is the process of enhancing and optimizing software, as well as remedying defects. It shall include all new fixes, patches, releases, updates, versions and upgrades, as further defined below.

e) Technical Support. The term “technical support” refers to the range of services providing assistance for the software via the telephone, email, a website or otherwise.

f) Release or Update. The term “release” or “update” are terms that refer to a revision of software that contains defect corrections, minor enhancements, or improvements of the software’s functionality. This is usually designated by a change in the number to the right of the decimal point (e.g., from Version 5.3 to 5.4). An example of an update is the addition of new hardware.

g) Version or Upgrade. The term “version” or “upgrade” are terms that refer to a revision of software that contains new or improved functionality. This is usually designated by a change in the number to the left of the decimal point (e.g., from Version 5.4 to 6).

(2). Software License

a) Unless otherwise stated in the Schedule of Supplies/Services, the Performance Work Statement or Product Description, the software license provided to the Government is a perpetual, nonexclusive license to use the software.

b) The Government may use the software in a networked environment.

c) Any dispute regarding the license grant or usage limitations shall be resolved in accordance with the Disputes Clause incorporated in FAR 52.212-4(d).

d) All limitations of software usage are expressly stated in the Schedule of Supplies/Services and the Performance Work Statement/Product Description.

(3). Software Maintenance and Technical Support

a) If the Government desires to continue software maintenance and support beyond the period of performance identified in this Contract/Order, the

Government will issue a separate contract or order for maintenance and support. Conversely, if a contract or order for continuing software maintenance and technical support is not received, the Contractor is neither authorized nor permitted to renew any of the previously furnished services.

b) The Contractor shall provide software support services, which includes periodic updates, enhancements and corrections to the software, and reasonable technical support, all of which are customarily provided by the Contractor to its commercial customers so as to cause the software to perform according to its specifications, documentation or demonstrated claims.

c) Any telephone support provided by Contractor shall be at no additional cost.

d) The Contractor shall provide all maintenance services in a timely manner in accordance with the Contractor’s customary practice or as defined in the Performance Work Statement or Product Description. However, prolonged delay (exceeding 2 business days) in resolving software problems will be noted in the Government’s various past performance records on the Contractor (e.g., www.cpars.gov).

e) If the Government allows the maintenance and support to lapse and subsequently wishes to reinstate it, any reinstatement fee charged shall not exceed the amounts that would have been charged if the Government had not allowed the subscription to lapse.

(4). Disabling Software Code

The Government requires delivery of computer software that does not contain any code that will, upon the occurrence or the nonoccurrence of any event, disable the software. Such code includes but is not limited to a computer virus, restrictive key, node lock, time-out, or other function, whether implemented by electronic, mechanical, or other means, which limits or hinders the use or access to any computer software based on residency on a specific hardware configuration, frequency of duration of use, or other limiting criteria. If any such disabling code is present, the Contractor agrees to indemnify the Government for all damages suffered as a result of a disabling caused by such code, and the contractor agrees to remove such code upon the Government’s request at no extra cost to the Government.

Inability of the Contractor to remove the disabling software code will be considered an inexcusable delay and a material breach of contract, and the Government may exercise its right to terminate for cause. In addition, the Government is permitted to remove the code as it deems appropriate and charge the Contractor for consideration for the time and effort expended in removing the code.

(5). Manuals and Publication

Upon Government request, the Contractor shall furnish the most current version of the user manual and publications for all products/services provided under this Contract/Order at no cost.

http://www.cpars.gov/

B.3 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR: TBD

b. GOVERNMENT: Contracting Officer 36C10B Kendra M. Casebolt

Technology Acquisition Center

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with (IAW):

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

Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] After Government acceptance of Deliverables in Section B.4 - Price Schedule and IAW Section B.5 - Product Description

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically IAW VA Acquisition Regulation (VAAR) Clause 852.232-72 Electronic Submission of Payment Requests.

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO DATE

B.4 PRICE SCHEDULE

NOTE: Offerors are instructed to complete Section B.4 and submit with their quote.

Offerors are cautioned that alterations to the line items as specified below may render quotes unacceptable.

All questions shall be directed to William Waterhouse, Contract Specialist, at william.waterhouse@va.gov and Kendra M. Casebolt, Contracting Officer, at Kendra.Casebolt@va.gov prior to the closing date and time specified in Block 8 on page 1 of the SF 1449.

Inspection and Acceptance: Destination

BASE PERIOD

Period of Performance shall be 12 months from date of award

Line No Description QTY Unit Unit Price Extended Price

0001 Set up and implementation to include all VA dispensing sites, CMOPS and EPS in accordance with (IAW) the Performance Work Statement (PWS) located at Section B.5.

1 YEAR $ $

0002 Subscription Services- Compliance with November 2023 FDA DSCSA requirements, mapping of vendors, maintenance and support, any add-on services IAW the PWS located at Section B.5.

1 YEAR $ $

0003 Future Enhancements to include software support to the Electronic Health Record and VA DSCSA Data Integration Development Project IAW the PWS located at Section B.5.

1 YEAR $ $

0004 Contract Management: Contract Kick-Off Meeting IAW PWS paragraph 5.1.1 and the Deliverables Schedule of the PWS located at Section B.5.

1 LOT NSP NSP

0005 Contract Management: Contractor Project Management Plan IAW PWS paragraph

5.1.2 and the Deliverables Schedule of the PWS located at Section B.5.

1 LOT NSP NSP

0006 Contract Management: Contract Staff Roster IAW PWS paragraph 5.1.2 and the Deliverables Schedule of the PWS located at Section B.5.

mailto:william.waterhouse@va.gov mailto:Kendra.Archbald@va.gov

0007 Contract Management: Number of active existing dispenser clients and years of experience IAW PWS paragraph 5.1.2 and the Deliverables Schedule of the PWS located at Section B.5.

0008 Contract Management: Process to implement and maintain GLNs IAW PWS paragraph 5.1.2 and the Deliverables Schedule of the PWS located at Section B.5.

1009 Reporting Requirements: Monthly Progress Report IAW PWS paragraph

5.1.3 and the Deliverables Schedule of

0010 Implementation: List of VA locations viewable and actionable in software IAW PWS paragraph 5.2 and the Deliverables

0011 Implementation: Visibility of VA data in software by users IAW PWS paragraph

5.2 and the Deliverables Schedule of the

0012 Implementation: List of multi-level user profiles and assigned users’ access IAW PWS paragraph 5.2 and the Deliverables

0013 Implementation: Verification of NABP data exchange IAW PWS paragraph 5.2 and the Deliverables Schedule of the PWS

0014 Implementation: VA Wholesaler mapping IAW PWS paragraph 5.2 and the Deliverables Schedule of the PWS

0015 Implementation: VA Single Sign-on authentication IAW PWS paragraph 5.2

0016 Implementation: GS1 EPCIS 1.2 or higher IAW PWS paragraph 5.2 and the Deliverables Schedule of the PWS located at Section B.5.

0017 Implementation: VA data use for other purposes IAW PWS paragraph 5.2 and

0018 Implementation: End user training material and training IAW PWS paragraph 5.2 and the Deliverables

0019 Subscription Services-Compliance with DSCSA Requirements: Provide Login information, usernames and passwords IAW PWS paragraph 5.2.1 and the

0020 Subscription Services-Compliance with DSCSA Requirements: Process for ATP verification IAW PWS paragraph 5.2.1 and

0021 Subscription Services-Compliance with DSCSA Requirements: Alert mechanism for API failures IAW PWS paragraph 5.2.1

0022 Subscription Services-Compliance with DSCSA Requirements: Audit trail for all transactions IAW PWS paragraph 5.2.1

0023 Subscription Services-Compliance with DSCSA Requirements: PO Processing Capabilities IAW PWS paragraph 5.2.1

0024 Subscription Services-Compliance with DSCSA Requirements: Process for NDC formats and translation IAW PWS paragraph 5.2.1 and the Deliverables

0025 Subscription Services-Compliance with DSCSA Requirements: Data Exchange Processes IAW PWS paragraph 5.2.1 and

0026 Subscription Services-Compliance with DSCSA Requirements: Functionality and Serialization Processes IAW PWS paragraph 5.2.1 and the Deliverables

0027 Data Management and Vendor Mapping:

VA transaction data storage processes IAW PWS paragraph 5.3 and the

0028 Data Tracing/Retrieval: Process for data retrieval IAW PWS paragraph 5.4 and the

0029 Subscription Services-Maintenance and Support: Process for communication regarding system unavailability IAW PWS paragraph 5.5 and the Deliverables

0030 Subscription Services-Maintenance and Support: Customer support phone numbers IAW PWS paragraph 5.5 and the

0031 Subscription Services-Maintenance and Support: End user customer support plan IAW PWS paragraph 5.5 and the

0032 Subscription Services-Maintenance and Support: On-call availability and end user customer support back up plan IAW PWS paragraph 5.5 and the Deliverables

0033 Subscription Services-Maintenance and Support: Process for communicating to ATPs IAW PWS paragraph 5.5 and the

0034 Subscription Services-Maintenance and Support: Process for new vendor mapping IAW PWS paragraph 5.5 and the

0035 Subscription Services-Maintenance and Support: Plan for creating auditing and custom reports IAW PWS paragraph 5.5

0036 Subscription Services-Maintenance and Support: Plan to handle peak usage IAW PWS paragraph 5.5 and the Deliverables

0037 Subscription Services-Maintenance and Support: Standard Operating Procedures IAW PWS paragraph 5.5 and the

0038 Subscription Services-Maintenance and Support: Disaster Recovery Plan IAW PWS paragraph 5.5 and the Deliverables

0039 Subscription Services-Maintenance and Support: Plan and notification process for hacker protection and security controls IAW PWS paragraph 5.5 and the

0040 Subscription Services-Maintenance and Support: Process for providing release/upgrade information and process for working with VA on release development and testing IAW PWS paragraph 5.5 and the Deliverables

0041 Subscription Services-Maintenance and Support: Process for working with VA on release development and testing IAW PWS paragraph 5.5 and the Deliverables

0042 Software Information Security- Assessment, Authorization and Continuous Monitoring: Provide documentation of meeting characteristics for SaaS by collaborating with DTC IAW PWS paragraph 5.6.1 and the

0043 Software Information Security- Assessment, Authorization and Continuous Monitoring: FedRAMP System Security Plan (SSP) and supporting documentation IAW PWS paragraph 5.6.1

0044 Software Information Security- Assessment, Authorization and Continuous Monitoring: VA Implementation Diagram IAW PWS paragraph 5.6.1 and the Deliverables

0045 Software Information Security- Assessment, Authorization and Continuous Monitoring: 3PAO Security Assessment Plan (SAP) IAW PWS paragraph 5.6.1 and the Deliverables

0046 Software Information Security- Assessment, Authorization and Continuous Monitoring: 3PAO Security Assessment Report (SAR) IAW PWS paragraph 5.6.1 and the Deliverables

0047 Add-On Services: Pharmaceutical returns process IAW PWS paragraph 5.7 and the

0048 Add-On Services: PO scanning/linking process IAW PWS paragraph 5.7 and the

0049 Add-On Services: Serial Number Decommissioning process IAW PWS paragraph 5.7 and the Deliverables

0050 Add-On Services: Item Borrowing process IAW PWS paragraph 5.7 and the

0051 Add-On Services: Quarantined Item Removal Tracking Process IAW PWS paragraph 5.7 and the Deliverables

0052 Add-On Services: Additional APIs developed IAW PWS paragraph 5.7 and

0053 Future Enhancements: VA DSCSA data base integration development meeting attendance, recommendations and updates IAW PWS paragraph 5.8.1 and

0054 Future Enhancements: VA DSCSA data base Integration Project charter IAW PWS paragraph 5.8.1 and the Deliverables

0055 Future Enhancements: VA DSCSA data base Integration project management plan IAW PWS paragraph 5.8.1 and the

0056 Future Enhancements: Testing and troubleshooting mechanism IAW PWS paragraph 5.8.1 and the Deliverables

0057 Future Enhancements: Item level traceability interface with EHR and required documentation IAW PWS paragraph 5.8.1 and the Deliverables

Base Period Total $

OPTION PERIOD 1

Period of Performance shall be 12 months

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

Line No Description QTY Unit Unit Price Extended Price

1001 Set up and implementation to include all VA dispensing sites, CMOPS and EPS in accordance with (IAW) the Performance Work Statement (PWS) located at Section B.5.

1 YEAR $ $

1002 Subscription Services- Compliance with November 2023 FDA DSCSA requirements, mapping of vendors, maintenance and support, any add-on services IAW the PWS located at Section

1 YEAR $ $

1003 Future Enhancements to include software support to the Electronic Health Record and VistA integration Development Project IAW the PWS located at Section B.5.

1 YEAR $ $

1004 Reporting Requirements: Monthly Progress Report IAW PWS paragraph

1005 Subscription Services-Compliance with DSCSA Requirements, Option Years:

Subscription service support for compliance with DSCSA requirements IAW PWS paragraph 5.2.2 and the

1006 Subscription Services-Maintenance and Support, Option Years: Process for continued system support IAW PWS paragraph 5.5.1 and the Deliverables

1007 Software Information Security- Assessment, Authorization and Continuous Monitoring, Option Years:

Plan for continued meeting of requirements for both SaaS and FEDRAMP authorization IAW PWS paragraph 5.6.2 and the Deliverables

1008 Add-On Services, Option Years:

Additional API development IAW PWS paragraph 5.7.1 and the Deliverables

1009 Future Enhancements: VA DSCSA data base integration support IAW PWS paragraph 5.8.2 and the Deliverables

1010 Future Enhancements: VA Oracle/Cerner data base integration support IAW PWS paragraph 5.8.2 and the Deliverables

Option Period 1 Total $

OPTION PERIOD 2

This 12-month Option Period may be exercised in accordance with FAR 52.217-9 Option to formal modification is issued by the Contracting Officer. If exercised, this Option Period shall commence immediately after expiration of Option Period 1.

2001 Set up and implementation to include all

VA dispensing sites, CMOPS and EPS in accordance with (IAW) the Performance Work Statement (PWS) located at Section B.5.

1 YEAR $ $

2002 Subscription Services- Compliance with November 2023 FDA DSCSA requirements, mapping of vendors, maintenance and support, any add-on services IAW the PWS located at Section B.5.

1 YEAR $ $

2003 Future Enhancements to include software support to the Electronic Health Record and VistA integration Development Project IAW the PWS located at Section B.5.

1 YEAR $ $

2004 Reporting Requirements: Monthly Progress Report IAW PWS paragraph

2005 Subscription Services-Compliance with DSCSA Requirements, Option Years:

Subscription service support for compliance with DSCSA requirements IAW PWS paragraph 5.2.2 and the

2006 Subscription Services-Maintenance and Support, Option Years: Process for continued system support IAW PWS paragraph 5.5.1 and the Deliverables

2007 Software Information Security- Assessment, Authorization and Continuous Monitoring, Option Years:

Plan for continued meeting of requirements for both SaaS and FEDRAMP authorization IAW PWS paragraph 5.6.2 and the Deliverables

2008 Add-On Services, Option Years:

Additional API development IAW PWS paragraph 5.7.1 and the Deliverables

2009 Future Enhancements: VA DSCSA data base integration support IAW PWS paragraph 5.8.2 and the Deliverables

2010 Future Enhancements: VA Oracle/Cerner data base integration support IAW PWS paragraph 5.8.2 and the Deliverables

Option Period 2 Total $

OPTION PERIOD 3

commence immediately after expiration of Option Period 2.

3001 Set up and implementation to include all

VA dispensing sites, CMOPS and EPS in accordance with (IAW) the Performance Work Statement (PWS) located at Section B.5.

1 YEAR $ $

3002 Subscription Services- Compliance with November 2023 FDA DSCSA requirements, mapping of vendors, maintenance and support, any add-on services IAW the PWS located at Section

1 YEAR $ $

3003 Future Enhancements to include software support to the Electronic Health Record and VistA integration Development Project IAW the PWS located at Section B.5.

1 YEAR $ $

3004 Reporting Requirements: Monthly Progress Report IAW PWS paragraph

3005 Subscription Services-Compliance with DSCSA Requirements, Option Periods:

Subscription service support for compliance with DSCSA requirements IAW PWS paragraph 5.2.2 and the

3006 Subscription Services-Maintenance and Support, Option Periods: Process for system support IAW PWS paragraph

5.5.1 and the Deliverables Schedule of

3007 Software Information Security- Assessment, Authorization and Continuous Monitoring, Option Periods:

Plan for continued meeting of requirements for both SaaS and FEDRAMP authorization IAW PWS paragraph 5.6.2 and the Deliverables

3008 Add-On Services, Option Periods:

Additional API development IAW PWS paragraph 5.7.1 and the Deliverables

3009 Future Enhancements (Option Periods):

VA DSCSA data base integration support IAW PWS paragraph 5.8.2 and the

3010 Future Enhancements (Option Periods):

VA Oracle/Cerner data base integration support IAW PWS paragraph 5.8.2 and

Option Period 3 Total $

OPTION PERIOD 4

commence immediately after expiration of Option Period 3.

4001 Set up and implementation to include all

VA dispensing sites, CMOPS and EPS in accordance with (IAW) the Performance Work Statement (PWS) located at Section B.5.

1 YEAR $ $

4002 Subscription Services- Compliance with November 2023 FDA DSCSA requirements, mapping of vendors, maintenance and support, any add-on services IAW the PWS located at Section B.5.

1 YEAR $ $

4003 Future Enhancements to include software support to the Electronic Health Record and VistA integration Development Project IAW the PWS located at Section B.5.

1 YEAR $ $

4004 Reporting Requirements: Monthly Progress Report IAW PWS paragraph

4005 Subscription Services-Compliance with DSCSA Requirements, Option Periods:

Subscription service support for compliance with DSCSA requirements IAW PWS paragraph 5.2.2 and the

4006 Subscription Services-Maintenance and Support, Option Periods: Process for system support IAW PWS paragraph

5.5.1 and the Deliverables Schedule of

4007 Software Information Security- Assessment, Authorization and Continuous Monitoring, Option Periods:

Plan for continued meeting of requirements for both SaaS and FEDRAMP authorization IAW PWS paragraph 5.6.2 and the Deliverables

4008 Add-On Services, Option Periods:

Additional API development IAW PWS paragraph 5.7.1 and the Deliverables

4009 Future Enhancements (Option Periods):

VA DSCSA data base integration support IAW PWS paragraph 5.8.2 and the

4010 Future Enhancements (Option Periods):

Oracle/Cerner data base integration support IAW PWS paragraph 5.8.2 and

Option Period 4 Total $

Grand Total:

(Base Period + Option Periods 1 - 4 Totals)

B.5 PERFORMANCE WORK STATEMENT

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: July 20, 2023

VA-23-00061369

PWS Version Number: 3.0

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 and 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 Code Information Service (EPCIS). Medications will have a 2D barcode that contains a Global Trade Identification Number (GTIN). The 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 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 “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 VA DSCSA data integration 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 contract is for PBM CI to find a contractor 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. “Drug Supply Chain Security Act (DSCSA), Title II of Drug Quality and Security Act DQSA”, November 27, 2013

2. 44 U.S.C. § 3541-3549, “Federal Information Security Management Act (FISMA) of 2002”

3. “Federal Information Security Modernization Act of 2014”

4. Federal Information Processing Standards (FIPS) Publication 140-2, “Security Requirements for Cryptographic Modules”, NIST CSRC

5. FIPS Pub 140-3, “Security Requirements for Cryptographic Modules”, March 22, 2019

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

Information Systems,” February 1, 2004

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

Systems,” March 1, 2006

8. FIPS Pub 201-2, “Personal Identity Verification of Federal Employees and Contractors,”

August 2013

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

January 24, 2022

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

11. 5 U.S.C. § 552a, as amended, “The Privacy Act of 1974”

12. Public Law 109-461, Veterans Benefits, Health Care, and Information Technology Act of

2006, Title IX, Information Security Matters

13. 42 U.S.C. § 2000d “Title VI of the Civil Rights Act of 1964”

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

Publications

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

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

17. 36 C.F.R. Part 1194 “Information and Communication Technology Standards and

Guidelines,” January 18, 2017

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

Information as a Strategic Resource,” July 28, 2016

19. 32 C.F.R. Part 199, “Civilian Health and Medical Program of the Uniformed Services

(CHAMPUS)”

20. 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

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

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

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

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

Information Security Program,” February 24, 2021

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

Information (SPI),” March 12, 2019

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

Lifecycle,” March 22, 2010

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

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

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

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

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

Maps Directory and Artifact templates at PAL Artifacts

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

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

Assessment,” October 15, 2014

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

Assessment,” July 30, 2015

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

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

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

38. VA Handbook, 6300.1, “Records Management Procedures, “March 24, 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 https://www.va.gov/process/ https://www.va.gov/process/maps.asp https://www.va.gov/process/maps.asp https://www.va.gov/process/artifacts.asp https://www.oit.va.gov/services/trm/

39. 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,

40. 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)

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

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

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

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

45. 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

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

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

48. 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

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

50. NIST SP 800-63-3, “Digital Identity Guidelines,” updated March 02, 2020

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

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

Management”, March 2, 2020

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

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

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

16, 2022

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

Management,” December 16, 2022

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

December 16, 2022

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

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

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

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

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

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

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

64. OMB Memorandum M-08-23, “Securing the Federal Government’s Domain Name System Infrastructure,” August 22, 2008 https://playbooks.idmanagement.gov/arch/#what-is-the-ficam-architecture 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

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

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

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

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

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

70. Office of Information Security (OIS) VAIQ #7424808 Memorandum, “Remote Access,”

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

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

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

4.0.pdf (va.gov)

73. VA Memorandum “Proper Use of Email and Other Messaging Services,” January 2, 2018, Proper Use of Email.pdf (va.gov)

74. “DevSecOps Product Line Management Playbook” version 2.0, May 2021, DevSecOps

PLM L2 Playbook.pdf (va.gov)

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

76. OMB Memorandum M-21-07, “Completing the Transition to Internet Protocol Version 6

(IPv6),” November 19, 2020

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

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

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 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 Storage

4. Subscription Services - Data Tracing and Retrieval

5. Subscription Services - Maintenance and Support

6. Software Information Security

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 DEA license o Physical Locations 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 file://r04.med.va.gov/V03/EAS/Users/VHAEASWaterW/Documents/DevSecOps%20PLM%20L2%20Playbook.pdf

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, including your licensing/billing approach, (i.e. - by volume of product, number of connections, number of instances, etc.), plan to assist VA with national Standard Operating Procedure (SOP) for using software to ensure DSCSA compliance, implementation and maintainability (sustainment) strategies, timelines and schedules 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, resource support and plan to implement and maintain single or multiple VA locations Global Location Number(s) centrally for all VA location shipments. 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. The vendor must have current active traceability accounts with at least 5 dispensers with documented experience in the Track and Trace field (including lot-level product tracing and serialization), and regulatory change management process.

Deliverables:

A. Contractor Project Management Plan B. Contractor Staff Roster C. Number of active existing dispenser clients and years of experience D. Process to implement and maintain VA GLNs

5.1.3 REPORTING REQUIREMENTS

The Contractor shall provide the 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 API 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.

Deliverable:

A. Monthly Progress Report

5.2 IMPLEMENTATION

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

1. Set up of all current 155 VA locations in software for data exchange, storage and retrieval

2. Visibility in vendor software of exchanged and stored DSCSA required data for every VA location that receives or stores pharmaceuticals

a. GS1 EPCIS to and from wholesalers, distributors and repackagers

b. Daily Electronic Data Interchange (EDI) 856 Advanced Shipping Notice (ASN) from wholesalers

3. Create or assist with creation of multi-user profiles and access to include administrative high level to end-user levels. to include VA and ATP Data Access, Login information, usernames and passwords (ex. <Level 1-End User>, <Level 2-Pharmacy Chief>, <Level 3-VPE> and <Level 4 -National Administrator>)

4. Coordination with National Boards of Pharmacy (NABP) for data exchange via their designated API

5. Mapping of existing VA vendors per list provided by VA

6. VA Single Sign-On (SSOi) authentication to validate authorized users as well as fallback authentication when PIV/SSO is unavailable and the system’s ability to add end-users over time.

7. Establish interoperability with and proactively remain updated to, the latest standards for GS1 Electronic Product Code Information Services (EPCIS) (e.g., 1.2 or higher)

8. Explain if VA's data will…