36C10G25Q0081 0001.docx

Amendment to a Previous Combined Solicitation

Amendment to a Previous Combined Solicitation

GENERAL INFORMATION

OPAL | Strategic Acquisition Center

10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697

POINT OF CONTACT*

Contracting Officer Kimberly LeMieux Kimberly.LeMieux@va.gov

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Amendment to Combined Synopsis-Solicitation 36C10G25Q0081 0001 The purpose of this amendment is providing questions and answers to the RFQ.

a. FDA Recalls and Safety History Consideration

- In alignment with the VHA National Center for Patient Safety (NCPS) goals to promote patient safety, will the VA conduct or require an analysis of FDA recall data, safety alerts, MAUDE database adverse events, and historical safety performance for all proposed infusion pump models and manufacturers during the evaluation process?

Answer to question a: SC#1 Must be FDA approved.

b. Pre-Award Recall Screening Procedures

· Regarding the Combined Synopsis/Solicitation notice (page 11), how does the VA currently incorporate active recalls, pending investigations, or historical manufacturer safety issues (e.g., high recall frequency) into the technical evaluation or source selection process?

Answer to question b: Active recall or pending investigation items should not be submitted for competition.

c. Weight of Safety Record in Source Selection Criteria

· Will the infusion pump’s historical safety performance and regulatory track record (including FDA Warning Letters or safety alerts) be a weighted factor in the award decision? If so, can the VA clarify the evaluation methodology or point assignment for this area?

Answer to question c: FDA Warning can be evaluated for past performance.

d. Request for Onsite Demonstration or Virtual Demonstration

· To better understand how “brand name or equal” products meet or exceed the Salient Characteristics (SCs), would the VA consider an onsite or virtual demonstration, usability test, or comparative evaluation by clinical and biomedical stakeholders?

Answer to question d: No on site or virtual demonstration for this RFQ.

e. Opportunity to Submit Supplementary Product Information

· Can offerors provide supplementary documentation beyond descriptive literature (e.g., white papers, safety risk assessments, product training videos) to illustrate unique safety features, error-reduction technology, or clinical usability enhancements?

Answer to question e: yes, it is encouraged.

f. Fielding and Training Proposal

a. Should offerors provide a proposal for fielding the pumps and training users?

If so, please provide estimates for how many facilities will be fielded per year Answer to question f.a.: yes fielding & training must be coordinated with the ordering facility as appropriate.

b. Please clarify if the quantity per year for each CLIN in the Price+Cost+ Schedule is for each facility or the entire VA?

Answer to question f.b.: entire VA.

c. Can the VA also clarify how a proposed fielding and training plan will be evaluated?

Answer to question f.c.: will not be evaluated. However, fielding & training must be coordinated with the ordering facility as appropriate.

g. Instructions to Quoters

a. D.6 ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO QUOTERS — COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES ITEMS (SEP 2023), A.1. 2nd paragraph states “The quote shall consist of the five (5) volumes listed below.”

The Volumes listed are:

i. Volume I: Technical

ii. Volume II: Past Performance

iii. Volume III: Price

iv. Volume IV: Offer, Amendments, and Certifications & Representations

- Please confirm there are in fact only four (4) volumes required to submitted.

Answer to question g.a.: Quotes submitted in response to this solicitation shall contain four (4) separate volumes listed in the Table below with the titles as shown.

b. Page 10, VOLUME II – PAST PERFORMANCE:

· The opening paragraph states: The Offeror shall complete Attachment G: Past Performance Reference in its entirety, listing a total of three contracts/orders for work performed in the past three years or currently being performed, for nationwide delivery of Washer Decontamination Units.

· Please confirm that Past Performance References should be for nationwide delivery of Infusion Pumps Multitherapy Ambulatory.

Answer to question g.b.: Past Performance References should be for nationwide delivery of Infusion Pumps Multitherapy Ambulatory. Corrected Attachment D Section D.6 VOLUME II- Past Performance, see below image.

h. Attachment A – Price Cost Schedule

· In Attachment A Line 2-6 for CADD Solis and VIP pumps, are the quantities listed per facility or total nationwide?

Answer to question h.: total nationwide/entire VA.

i. Delivery and Training Timeline

· What are the expectations/timeframe for pump delivery, rollout, and training?

Answer to question i.: this is as needed per ordering facility.

j. Can we get a list of tubing cassettes utilized by part number for planning purposes?

Answer to question j: Vendors are encouraged to provide any product solution or configuration so long as they meet the SCs.

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