36C25020Q0880_1.docx

Combined Synopsis-Solicitation for Commercial Items

Contract Opportunity Combined Synopsis/Solicitation Notice

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* = Required Field Contract Opportunity Combined Synopsis/Solicitation Notice Snap Plus Annual Subscription Fee 44131 36C25020Q0880 07-22-2020 23:59

EASTERN TIME, NEW YORK, USA

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SBA

334613 Department of Veterans Affairs Network Contracting Office (NCO) 10 6150 Oak Tree Blvd., Suite 300 Independence OH 44131 Contracting Officer Christopher A. Callihan christopher.callihan@va.gov 216-447-8300 216-447-8310 Department of Veterans Affairs Louis Stokes Cleveland VA Medical Center 10701 East Boulevard Cleveland OH 44106-1702

USA

https://www.va.gov Department of Veterans Affairs christopher.callihan@va.gov Contractnig Officer

Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Items,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued.

This solicitation is issued as an RFQ. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2020-06.

This solicitation is set-aside for Small Business

The associated North American Industrial Classification System (NAICS) code for this procurement is 334613, with a small business size standard of1000 Employees.

The FSC/PSC is 6515.

The Department of Veterans Affairs, Network Contracting Office (NCO) 10, 6150 Oak Tree Boulevard, Independence, OH 44131 is seeking to Drug Supply Chain Security Act (DSCSA) Software.

All interested companies shall provide quotations for the following:

Supplies/Services

SNAP PLUS ONE TIME IMPLEMENTATION FEE

09/01/2020-08/31/2021

SNAP + YEAR 1 ANNUAL SUBSCRIPTION FEE

09/01/2021-08/31/2022

SNAP + YEAR 2 ANNUAL SUBSCRIPTION FEE

09/01/2022-08/31/2023

SNAP+ YEAR 3 ANNUAL SUBSCRIPTION FEE

09/01/2023-08/31/2024

SNAP+ YEAR 4 ANNUAL SUBSCRIPTION FEE

09/01/2024-08/31/2025

SNAP+ YEAR 5 ANNUAL SUBSCRIPTION FEE

09/01/2025-08/31/2026

STATEMENT OF WORK (SOW)

1. Contracting Officer’s Representative (COR).

Cleveland, OH 44106

2. Contract Title.

Drug Supply Chain Security Act (DSCSA) Compliance Software

3. Background.

In 2013 the Drug Quality and Security Act was sign into law and this included the Drug Supply Chain Security Act. DSCSA requires Dispensers (the VA) to meet certain requirements of tracking prescription medications through the supply chain with increasing responsibilities over a 10-year period. We do not meet the current requirements of tracking T3 data (transaction history, information and statement) and of validating our authorized trading partners’ licensure and authorization on an ongoing basis. By November 2020 we will be required to meet additional requirements including serialization and tracing of products to the individual unit level. There is currently no functionality within our system to accomplish these goals for all of our trading partners. We are also required to report any suspect products to the FDA. This software will allow users to do that automatically through current scanning functions. In addition to these requirements certain companies have the ability to track medications throughout the entire supply chain. This would provide significant cost savings in redirecting soon-to-expire products to sites that will use them faster, as well as enabling patient recalls to be tracked down to the specific patient level in the inpatient wards and clinics, which is not currently possible with existing systems. This feature would also allow for more precise distribution channels ensuring we are getting the correct products to the correct areas to best meet our Veterans’ needs.

4. Scope.

The VA Northeast Ohio Healthcare System Pharmacy Service is requesting Drug Supply Chain Security Act (DSCSA) compliance software.

5. Specific Tasks.

5.1 Task 1 – Drug Supply Chain Security Act (DSCSA) Compliance Software The contractor shall provide software that enables the VANEOHS to achieve and maintain DSCSA compliance. This software will have the following capabilities:

· Shall provide tracking of transaction history, information, and statement (T3) data

· Shall store T3 documents for the required minimum of six (6) years and process documents in compliance with the FDCA Sec. 581 (27) (A-G).

· Software shall be able to receive, update, and provide required transaction documents for all shipments/receipt of drug, returns, drop shipments, and exceptions, including product exchange to institutions outside of Customer and Customer’s definition.

· Shall provide for continual validation of authorized trading partners’ licensure and authorization

· Shall provide serialization and tracing of products to the individual unit level

· Shall provide workload neutral (must be incorporated into current scanning and maintain or reduce workload for end users)

· Shall provide reporting of suspect product to FDA

· Shall provide be cloud based with single tenant environment with updates controlled by the Customer

· Shall provide customizable and adaptable to meet our specific needs

· Shall provide ability to communicate with several different commercial off the shelf solutions on independent VLANs

· Shall provide ability to use existing scanners, which vary by location

· Shall provide interface with VistA, CPRS, and Pharmacy management systems

· Software Shall be the single source for storing & retrieving DSCSA documents. Software will enable Customer to meet the DSCSA requirement for information within the 2-day timeframe, in response to an FDA request.

· Shall provide monitor and audit T3 documents for missing or unknown NDCs, addresses, or description fields as required

· Shall provide timely system updates in response to changes in DSCSA regulations

5.2 Task 2 – Maintenance and Support

The contractor shall provide the necessary maintenance and support for the software detailed above.

6. Place of Performance The DSCSA compliance software will function within Pharmacy Service at the following locations:

Louis Stokes Cleveland VAMC 10701 East Boulevard Cleveland, OH 44106

Akron VA Clinic 55 West Waterloo Road Akron, OH 44319 Canton VA Clinic 733 Market Avenue South Canton, OH 44702 Parma VA Clinic 8787 Brookpark Road Parma, OH 44129 Youngstown VA Clinic 2031 Belmont Avenue Youngstown, OH 44505

7. Period of Performance.

12-month contract + 4 option years

8. Delivery Schedule This software needs to be installed and operational within 90 days from solicitation award.

The purchase order period of performance is 09/01/2020-08/31/2026 Place of Performance/Place of Delivery

Louis Stokes Cleveland VA Medical Center 10701 East Boulevard Cleveland, OH

The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html.

The following solicitation provisions apply to this acquisition:

1. FAR 52.212-1, “Instructions to Offerors–Commercial Items” OCT 2018

2. FAR 52.212-3, “Offerors Representations and Certifications–Commercial Items” JUN 2020

Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, “Offerors Representations and Certifications–Commercial Items.” If paragraph (j) of the provision is applicable, a written submission is required.

The following contract clauses apply to this acquisition:

FAR 52.212-4, “Contract Terms and Conditions–Commercial Items” OCT 2018 ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

852.215–70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors.

852.215–71, Evaluation Factor Commitments.

852.232–72, Electronic Submission of Payment Requests.

GRAY MARKET LANGUAGE (MAY 2016)

· FAR 52.212-5, “Contract Terms and Conditions Required to Implement Statutes or Executive Orders” JUN 2020 The following subparagraphs of FAR 52.212-5 are applicable:

52.203-6, 52.204-10, 52.209-6, , 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.222-40, 52.222-50, 52.223-18, 52.225-1, 52.225-13, and 52.232-33.] All quoters shall submit the following: one electronic copy via email to Christopher A. Callihan @ Christopher.callihan@va.gov.

Award will be based upon a comparative evaluation of quotes in accordance with the Simplified Acquisition Procedures of FAR 13. Comparative evaluation is the side by side pairwise comparison of quotes based on factors resulting in a Contracting Officer decision for the quote most favorable to the Government.

Options will be evaluated at time of award.

The following are the decision factors:

Lowest Priced Technically Acceptable The award will be made to the response most advantageous to the Government.

Responses should contain your best terms, conditions.

To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows:

"The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."

OR

"The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:"

Quoters shall list exception(s) and rationale for the exception(s), if any.

Submission shall be received not later than 2359 EDT 23 July 2020 to Network Contracting Office (NCO) 10 (Ohio, Indiana, & Michigan) 6150 Oaktree Boulevard Suite 300, Independence, OH 44131.

Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f).

Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Point of Contact listed below.

Point of Contact Point of Contact Christopher A. Callihan Contract Specialist Network Contract Office (NCO) 10 Office: 216-447-8300 x49579 Email: christopher.callihan@va.gov

VHAPM Part 813.106 SAP: Soliciting Competition & Evaluation of Quotations SOP Page 9 of 9 Original Date: 10/12/17 Revision 04 Date: 06/10/20