This is a Sources Sought (SS) Notice only, not a solicitation announcement and should not be considered as such. There is no solicitation available at this time. The Government will not pay for any information received in response to this SS, nor will the Government compensate any respondent for any cost incurred in developing the information provided to the Government. This SS does not constitute a commitment by the Government. Any information provided in response to this market survey will be used for informational purposes only and will not be released. Vendor participation is not a promise of future business with the Government. The purpose of this Sources Sought is to conduct Market Research to determine an acquisition strategy for the acquisition of Drug Supply Chain Security Act (DSCSA) Compliance Software. VAMC Cleveland, is requesting the procurement of Drug Supply Chain Security Act (DSCSA) Compliance Software. 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. Sailient Characteristics Shall allow 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). Through software, Customer 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 continual validation of authorized trading partners licensure and authorization Serialization and tracing of products to the individual unit level shall be provide. Workload neutral (Shall be incorporated into current scanning and maintain or reduce workload for end users) Shall report suspect product to FDA Shall be cloud based with single tenant environment with updates controlled by the Customer Shall be customizable and adaptable Shall provide the ability to communicate with several different commercial off the shelf solutions on independent VLANs Shall provide the ability to use existing scanners, which vary by location Shall 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 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 Packaging and Delivery This software needs to be installed and operational within 90 days from solicitation award. 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 The current proposed equipment includes; ITEM DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE 0001 1.00 EA SNAP PLUS ONE TIME IMPLEMENTATION FEE Funding/Req. Number: 1 0002 1.00 EA SNAP + YEAR 1 ANNUAL SUBSCRIPTION FEE Funding/Req. Number: 1 0003 1.00 EA SNAP + YEAR 2 ANNUAL SUBSCRIPTION FEE Funding/Req. Number: 1 0004 1.00 EA SNAP+ YEAR 3 ANNUAL SUBSCRIPTION FEE Funding/Req. Number: 1 0005 1.00 EA SNAP+ YEAR 4 ANNUAL SUBSCRIPTION FEE Funding/Req. Number: 1 0006 1.00 EA SNAP+ YEAR 5 ANNUAL SUBSCRIPTION FEE Funding/Req. Number: 1 The Department of Veterans Affairs, Network Contracting Office 10, is conducting market research to determine if there are a sufficient number of Small Businesses capable of performing the requirements to warrant a set-aside. The proposed solicitation will be to furnish all materials, labor, equipment and transportation required to deliver the Drug Supply Chain Security Act (DSCSA) compliance software and associated components as described above. Contractor shall also comply with any other federal, state, and local laws applicable to the industry. Potential sources shall demonstrate experience and knowledge of requirement and capability to provide such commodities. Potential sources should submit: business name and address; point of contact; business size, and any applicable business socio-economic category; capability statement; provide information for recent and relevant projects similar in nature; Recommended alternative product Manufacturer and Part Number; IFUs (Instructions for Use) for alternative recommended products; Literature detailing the specification of any ALTERNATIVE RECOMMENDED PRODUCT; DUNS number; contract number if applicable; brochure of equipment. The NAICS code for this procurement is 334613 and the small business size standard is 1000 Employees. Responses to this notice shall be e-mailed to Christopher A. Callihan at
[email protected]. Telephone responses will not be accepted. Responses must be received in writing no later than 11:59 p.m., Monday, July 6, 2020. This notice is to assist the VA in determining sources only. A solicitation is not currently available. THE VA IS NOT SEEKING PRICING OR OFFERS OF ANY KIND. There is no guarantee, expressed or implicit, that the market research for this acquisition will result in a particular set-aside or sole source award, or any other guarantee of award strategy. All information is to be provided on a voluntary basis at no charge to the Government.