47QSWC22Q0157 - Q_A Document_Amendment 1.pdf

Question No. Offeror Question Government Response

1 Can the infusion smart pumps be refurbished? Please reference VAAR Clauses 852.212-71, Gray Market Items (APR 2020) and 852.212-72, Gray Market and Counterfeit Items (MAR 2020)(Deviation), listed in the RFP, pg. 12.

2 We would like to request a submission deadline extension to Thursday September 22nd, and a question deadline extension to Friday September 16th.

In order to meet VA VISN 12 mission requirements, we are unable to extend the RFP close date beyond 12 Noon CST on Friday, September 9th, 2022 or offer a question deadline extension at this time.

For your consideration please note, On page 35 of your solicitation, Factor #1 Compliance with Solicitation Minimum Requirements:

#3 Proof of Federal Information Processing Standard (FIPS) 140-2 or 140-3 Certification for proposed product solution. If not FIPS 140-3 certified, provide plans for FIPS 140-3 certification.

We respectfully request that this verbiage be removed from the solicitation requirement on the grounds that our manufacturing partner is unable to comply because this older encryption standard is not compatible with our equipment structure and cyber-security technology platforms.

The Department of Veterans Affairs is mandated to adhere to the Federal Information Security Modernization Act of 2014, Federal Information Processing Standards and VA Directive 6550 requiring wireless devices that generate, process or store PHI data to use cryptographic modules that have valid FIPS 140-2 certificates (or have a FIPS 140-3 submission request to update the FIPS 140-2 certificate). VISN 12 has conducted extensive research and examined multiple options with regard to infusion systems. Based on this research, VISN 12 has determined wireless connectivity enhances system management, enabling better interoperability and ultimately dramatically improving patient care, safety and outcomes. This improves nursing and pharmacy productivity while simultaneously reducing variation and waste. Therefore, wireless capability and FIPS 140-2 certification is a minimum requirement for both the Large Volume Pump (LVP) and the Patient Controlled Analgesia (PCA) pump medical devices.

4 Is it a requirement that an offeror’s proposed infusion system equipment and software be 510(k) cleared? Yes - FDA 510(k) clearance to market the infusion system is required.

Can you confirm VISN 12 has a "Centralize" design with only one server and single common Drug Library for the Infusion Pumps wireless capabilities and drug library?

VISN 12 currently has a single server that supports individual facility drug libraries and houses quality data from current systems. Each facility currently has a their own drug library files and facility Pharmacy groups manage this content locally.

Has VISN 12 decided on keeping the current "Centralized" configuration? Or does VISN 12 desire alternate "Decentralized" design proposals for comparison for the Infusion Pump Wireless Infrastructure and Drug Library?

In an effort to stimulate as much competition as possible, VISN 12 is willing to consider and evaluate both centralized and decentralized design proposals in an effort to identify the best configuration. With Cerner there is national effort underway to have a single drug library to facilitate smart pump programming capability with Cerner (which is centralized). There is also nothing that prevents offerors from submitting more than one proposal/approach for evaluation. If submitting different approaches, please be sure to submit each as a separate independent proposal.

47QSWC22Q0157 - VA VISN 12 INFUSION PUMPS SYSTEMS

AMENDMENT 1

RFP QUESTIONS AND ANSWERS

For section Phase Two invited Offerors - it states within the Oral Q&A Session and Format:

The offeror shall not present any information to the Government other than answering the clarification questions posed.

Proposal revisions are not expected and will not be allowed.

In the event VISN 12 evaluation personnel identify design changes, how will the offeror revisions be managed to incorporate the customer changes?

The Government understands there may be multiple configurations or equipment options. In those instances, as advised in Attachment 1: Pricing Worksheet - offerors are allowed to propose required components, highly suggested components and optional components in their proposal that will enable VA VISN 12 staff to fully utilize the proposed product solution for its intended purposes. For different approaches to meeting the RFP requirements, see also the Government's response to Question 6 above.

The RFP solicitation refers to Form SF 1449 requirements in Section F of this RFP multiple times, but no Form SF1449 has been provided by the government for this submission.

Will the government be providing an amendment to include Form SF 1449 with all terms, conditions, and provisions for Phase I? Or is the government's intent to provide Form SF1449 for Phase II final proposals?

In accordance with FAR 12.603(b), when using the combined synopsis/solicitation procedure, the SF 1449 is not used for issuing the solicitation. This was solicited as a combined synopsis/solicitation - therefore, Form SF 1449 is not being used. In Section F, provision 52.212-1 Instructions to Offerors - Commercial Products and Commercial Services (Nov 2021) , paragraph b states "offers may be submitted on the SF 1449, letterhead stationery, or as otherwise specified in the solicitation." The provision then lists minimum information that should be included in offers. One of the minimum requirements, paragraph (11) states "If the offer is not submitted on the SF 1449, include a statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation. Offers that fail to furnish required representations or information, or reject the terms and conditions of the solicitation may be excluded from consideration."

The requirement for paragraph 11 is addressed in Section B, page 6 of the RFP which is required to be submitted with offeror's proposal.

•In section “Requirements for All Infusion Systems” item 1.2 requires products to be “FDA approved”. As previously noted, the BD Alaris systems, those from ICU Medical and those from other manufacturers are all classified by the FDA as “Class II Medical Devices”. As such, they are governed by the FDA 510(k) process and receive “FDA clearance” to market rather than “FDA approval”.

No known manufacturer of devices related to the general specifications you provided would be FDA approved. Refer to 21 CFR Part 807 Subpart E for further information related to medical device classification. Should this requirement be “FDA cleared”?

The RFP document has been amended so all areas of the RFP are consistent and contain the same verbiage and require completion of 510(k) process and FDA clearance.

•Under “Training and Support” the notation is made that offeror “must comply with current FDA regulations pertaining to Recalls and Medical Device correction notices.” Does this mean that currently recalled products cannot be offered?

Only FDA cleared devices may be offered. Please also reference FDA Mandatory Reporting Requirements located at: Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities | FDA

•Note that the link (https://www.fda.gov/medical-devices/device- advice-comprehensive-regulatory-assistance/overview-device-regulation) does not work. Is there an alternate link?

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation

12 •How will the socioeconomic status of the offerors influence or dictate award under this RFQ?

Socio-economic status or subcontracting goals are being evaluated on a pass/fail basis under Factor 1:

Compliance with Solicitation Minimum Requirements. Other than small business offerors submitting a proposal must submit a Small Business Subcontracting Plan and the Subcontracting Plan Goals/Targets must meet or exceed the provided minimum goal/target percentages provided for all socio-economic categories, consistent with Small Business Administration FY 2022 published goals for the Department of Veterans Affairs. Any small businesses submitting a proposal will have been determined to have met this requirement and therefore, are not required to submit a subcontracting plan. Failure by any independent offeror to comply with this requirement or any of the other 11 listed minimum requirements under Factor #1, Compliance with Solicitation Minimum Requirements, would eliminate an offeror from any further consideration and make them ineligible for award.

Will the government extend the solicitation for one month to allow for the VISN to submit a Certificate of Medical Necessity (CMN) request through this process?

Please reference Government's response to Question #2 above.