DSCSA Questions _ Answers -.pdf

QUESTIONS and ANSWERS DA10--Solicitation# 36C10B23R0021

Drug Supply Chain Security Act Solution Provider

VA-23-00061369

Q1) How many designated VA users (from end user to national administrator) do you expect to see under this contract?

A1) 1000 - 2000

Q2) Can you provide more detail on anticipated “development of additional APIs needed”?

A2) Anticipated potential APIs needed include a possible future National Reverse Distributor, or automated pharmacy systems, such as Pyxis or Omnicell for the purpose of receiving shipments directly into their inventory management software.

Q3) Would the above include any tracking of inventory below the saleable unit level?

A3) The saleable unit is the level of tracking requested, except for situations where inference will be utilized

Q4) For the integration with the Oracle/Cerner EHR system, what are the primary objectives and desired outcomes of this integration project?

A4) The primary objectives will be the capability to scan received items directly into the Oracle/Cerner inventory management system to include serialized data

Q5) For the integration with the Oracle/Cerner EHR system, what specific Oracle products or versions are in use? Which specific Cerner modules or versions?

A5) There are currently 5 VA sites that have gone live with the shared DOD/VA Federal Cerner system (known in DOD as MHS Genesis and in the VA as simply the new EHR system/Cerner Millennium)

Q6) For the integration with the Oracle/Cerner EHR system, are there specific modules or components that require integration?

A6) The integration will include the inventory management component

Q7) For the integration with the Oracle/Cerner EHR system, how frequently will data synchronization occur?

A7) Data synchronization is yet to be determined.

Drug Supply Chain Security Act Solution Provider

VA-23-00061369

Q8) For the integration with the Oracle/Cerner EHR system, are there any known technical limitations or challenges with the current versions of Cerner and Oracle systems in place?

A8) No limitations or challenges that are known to specifically impact this project have been identified at this time.

Q9) For the integration with the Oracle/Cerner EHR system, what is the current hosting environment for these systems?

A9) The Federal EHRM is hosted by Oracle/Cerner.

Q10) For the integration with the Oracle/Cerner EHR system, are there plans for future upgrades to either system that could impact this integration?

A10) Future upgrades are yet to be determined.

Q11) Is the Oracle/Cerner EHR system where POs are held? If not, where are these hosted?

A11) For sites live with Cerner, POs are generated within the Cerner system.

Q12) Is the Oracle/Cerner EHR system where ASNs are received and held? If not, where are these hosted?

A12) For sites live with Cerner, ASNs are received and held inside the Cerner system.

Q13) What file types and standards do VA’s POs adhere to?

A13) VA is partnering with GS1 for EPCIS data standards

Q14) What file types and standards do VA’s ASNs adhere to?

A14) VA will require ASNs to utilize GS1 standards

Q15) How does VA currently handle linking returns with original invoice for correct price credit in case of price change?

A15) Currently, returns are linked to original invoices in the Pharmaceutical Prime Vendor system- and future requirements will mandate this practice for all PPV returns

Drug Supply Chain Security Act Solution Provider

VA-23-00061369

Q16) What is the nature of VA’s current EPCIS repository, if any (e.g. hosting, protocol, etc.)?

A16) VA has no current EPCIS repository

Q17) Does VA wish for GLNs to be managed on their behalf, or for GLNs to be provisioned and transferred?

A17) VA will manage their own GLNs through GS1 Data Hub

Q18) Does VA have a process in place for drug verification?

A18) The current process is manual, but with the initiation of a Solution Provider contract, this process is expected to be an electronic data exchange for scanning of an item to verify against the invoice for correct data, as well as verification of ATP status prior to receipt.

Q19) Will this process have any impact on the DSCSA solution outlined in the solicitation?

A19) The process is expected to be an extension of the outlined solution.

Q20) Does VA have a process in place for suspect & illegitimate product investigations?

A20) The current process is manual, but with the initiation of a Solution Provider contract, this process is expected to be electronic with alerts to halt the receiving process upon scanning of a suspect/illegitimate product, as well as follow up with the ATP and a quarantine process. Vendors are expected to explain in detail how their software will satisfy this need.

Q21) Will this process have any impact on the DSCSA solution outlined in the solicitation?

A21) This process should be an extension of the DSCSA solution outlined in the solicitation.

Q22) Does VA have a preference for the serial number decommissioning process (e.g. EPCIS

vs. another standard)?

A22) The vendors should explain in detail their current or proposed process for meeting this requirement. The VA will review and compare each proposal to determine a preference.

Drug Supply Chain Security Act Solution Provider

VA-23-00061369

Q23) We do not see any signature place for the Certifications and Representations. Is there an expectation for a signature for these that we should include in the proposal? If the answer is yes, where do we find this?

A23) The signature location is on the face page of the SF1449 beginning at Box 30a and ending at 30c.

Q24) Could you please let me know if this solicitation is for multiple sites?

A24) Multiple sites

Q25) Is it intended for a single VA location or for an entire VISN?

A25) The award will be for the enterprise system to include all VA facilities, CMOPs and EPS (a total of approximately 320 GLNs)

Q26) Will there be an RFP after this Solicitation, or does the Solicitation fill the same role as an RFP?

A26) Solicitation and RFP (Request for Proposal) are synonymous…solicitation is the entire announcement whereas the RFP is the type of solicitation.

Q27) Do you expect there to be discussions or negotiation as part of the proposal evaluation process?

A27) Under Section E.11 EVALUATION APPROACH paragraph C. EVALUATION APPROACH it states “The Government reserves the right to award without discussions based upon the initial evaluation of proposals.

Q28) Will there be a BAFO phase, or are Solicitation responses final?

A28) Under Section E.11 EVALUATION APPROACH paragraph C. EVALUATION APPROACH it states “The Government reserves the right to award without discussions based upon the initial evaluation of proposals.

Drug Supply Chain Security Act Solution Provider

VA-23-00061369

Q29) The RFP mentions “Future Enhancements” such as integration with VistA and Oracle/Cerner. Should {a vendor} include these integration costs in the first year costs or add to year 2?

A29) The VA DSCSA database integration project is in the beginning stages, and is ready to include the vendor as soon as the award is made. The DSCSA VA Integration (to include Vista) is a go for the base year. The Oracle/Cerner integration is being discussed, and is expected to be an option year item however, reference is made to PWS paragraph 5.8.1 in relation to the expected / possible Oracle/Cerner integration.