6515--NX EQ Laparoscopic Insufflators (VA-26-00024810)

Form / Attachment / Pricing Sheet

This document is a mandatory certification form for bidders responding to Solicitation Number 36C10X26R0009 for NX EQ Laparoscopic Insufflators. It requires companies to certify that the medical equipment they propose does not have any outstanding recalls or known safety issues, and complies with all relevant regulations and standards.

• Company Unique Entity Identifier (UEI): To be filled in by the bidder.
• Certification Statement: A declaration that the proposed medical equipment has no outstanding recalls, no known safety issues, and complies with all relevant regulations and standards.
• Authorized Representative Information: Fields for Name, Title, Signature, and Date of the individual signing on behalf of the company.

Bidders must complete and sign this form accurately. Failure to provide truthful information may lead to disqualification from the solicitation process. This certification is a required part of the offer submission.

Form / Attachment / Pricing Sheet

This document is a template for bidders to submit questions to the Contracting Officer (CO) regarding the solicitation. It also contains responses to previously submitted industry questions.

• Questions for CO Sheet: Provides a template with columns for Item, RFQ Section, Document, RFQ Page, Paragraph/Section, Questions, and Government Response.
• Industry Questions & Answers: Contains specific questions raised by industry and the Government's official responses.

This document is crucial for bidders to understand:

• Clarifications on Solicitation Details: Provides answers to specific questions about the solicitation, including:
  • Award type (single award requirements contract).
  • Product specifications (proposing newer technology is permitted if it meets salient characteristics).
  • Recall and safety issue disclosures (Attachment J is required, and non-compliance leads to disqualification).
  • System communication capabilities and intensity levels (refer to Evaluation Subfactors, Section E.6).
• Set-Aside Information: Confirms the requirement is a Service-Disabled Veteran-Owned Small Business (SDVOSB) set-aside, meaning all offerors must be certified SDVOSBs, and no additional SDVOSB evaluation preference factors are applied.
• Proposal Preparation: Helps bidders refine their proposals by addressing ambiguities and ensuring compliance with stated requirements, particularly regarding product certifications and recall disclosures.

Solicitation / RFP / RFQ

This solicitation is for the nationwide procurement of NX EQ Laparoscopic Insufflators, including accessories, consumables, and warranties, for the Department of Veterans Affairs (VA) Equipment Life Cycle Management (ELCM) Program. The government is seeking a single award requirements contract with Firm-Fixed Price (FFP) orders.

• Procurement of NX EQ Laparoscopic Insufflators.

• Includes accessories, consumables, and warranties.

• Products must meet Salient Characteristics detailed in Attachment B.

• Only original equipment manufacturer (OEM) parts and new equipment are acceptable; no remanufactured, used/refurbished, or "gray market" items.

• Products in development are not considered.

• All items must be covered by the manufacturer's warranty.

• Offerors must submit Attachment H - Certification of Recall or Safety Issues.

• Type: Requirements contract with Firm-Fixed Price (FFP) orders.

• Period of Performance: One 12-month base period with four 12-month option periods.

• Estimated Value: Not explicitly stated, but it is a nationwide contract.

• Questions due: April 29, 2026, 10:00 AM Eastern, via email using Attachment G.

• Proposals due: By the date and time indicated on SAM.gov Contract Opportunities.

• Submission Format: Proposals must be submitted in four volumes: Technical, Past Performance, Price, and Offer, Amendments, Certifications & Representations.

• Evaluation Factors: Technical (most important), Past Performance, and Price. Technical must achieve an "Acceptable" rating. Non-price factors combined are more important than price.

• Award Basis: Best value to the Government.

• NAICS Code: 339113

• Size Standard: 800 Employees

• An individual SBA Nonmanufacturer Rule Waiver has been granted.

• Specific clauses related to small business concerns, HUBZone, SDVOSB, and WOSB are included.

• The contract will deliver to VA medical centers and facilities throughout CONUS and OCONUS.

• Offerors are encouraged to propose volume discounts.

• All questions, proposal submissions, and Past Performance Questionnaires must be submitted via email to Anthony.Zibolski@va.gov and Carey.Kauzlarich@va.gov with the solicitation number in the subject line.

Amendment / Modification

This amendment (A0001) to Solicitation 36C10X26R0009 makes the following changes:

• Industry Question Responses: Provides answers to industry questions and updates the solicitation accordingly. These responses are incorporated as Attachment G_A0001.

• New FAR Clause: Incorporates FAR Clause 52.222-90, "Addressing DEI Discrimination by Federal (APR 2026)," by reference.

• New Attachment H: Adds "Attachment H – Certification of Recall or Safety Issues." Offerors are required to complete, sign, and submit this attachment with their proposals. Failure to do so will result in the proposal being deemed Unacceptable.

• Revisions to Instructions to Offerors (Section E.5.B – Volume I Technical): Clarifies that Attachment H must be submitted, signed by an authorized representative, affirming that all proposed items have no outstanding recalls, known safety issues, and comply with applicable regulations.

• Revisions to Technical Evaluation Approach (Section E.6.B – Volume I Evaluation): States that Attachment H will be evaluated. Proposals missing, incomplete, or containing items with recalls/safety issues (as determined by the Government) will be evaluated as Unacceptable. The sentence regarding evaluation of salient characteristics has been revised to include the condition of "no known recall or safety issues."

• Section D (New Attachment H)

• Section E.5.B – Volume I Technical (Attachment H requirement)

• Section E.6.B – Volume I Evaluation (Attachment H evaluation)

• 52.252-2 CLAUSES INCORPORATED BY REFERENCE (Addition of FAR 52.222-90)

• Offerors must now submit the newly added Attachment H.

• Failure to submit Attachment H correctly will result in an Unacceptable proposal rating.

• The evaluation criteria have been updated to include the assessment of Attachment H for recalls and safety issues.

• Attachment A_RFP 36C10X26R0009 A0001_NX EQ Laparoscopic Insufflators

• Attachment G_Template for Industry Questions_A0001

• Attachment H_CERTIFICATION OF RECALL OR SAFETY ISSUES

Solicitation / RFP / RFQ

This is a solicitation for a nationwide Department of Veterans Affairs (VA) Requirements Contract for the procurement of NX EQ Laparoscopic Insufflators. The contract will include accessories, consumables, and warranties. The VA intends to award a single Firm-Fixed Price (FFP) contract.

• The primary deliverable is Laparoscopic Insufflators.

• The contract is intended to include all ancillary items necessary for the equipment to function as designed by the Original Equipment Manufacturer (OEM) and as clinically required.

• The Government may, through bilateral modification, add or remove items within the scope of the solicited product line, or replace discontinued items with OEM-identified replacement parts that serve the same clinical purpose.

• New technology may be evaluated for inclusion.

• Only original equipment manufacturer (OEM) parts and new equipment are acceptable; no remanufactured, used/refurbished, or "gray market" items. Products in development are not considered.

• All items must be covered by the manufacturer's warranty.

• Contract Type: Requirements Contract with Firm-Fixed Price (FFP) orders.

• Period of Performance: Anticipated one 12-month base period with four 12-month option periods.

• Estimated Value: Not explicitly stated, but it is a requirements contract.

• Proposal Submission Deadline: May 7, 2026, 10:00 AM Eastern Time.

• Questions Deadline: April 29, 2026, 10:00 AM Eastern Time, using Attachment G - Template for Industry Questions.

• Submission Method: Via email to the Contract Specialist (Anthony.Zibolski@va.gov) and Contracting Officer (Carey.Kauzlarich@va.gov), with "36C10X26R0009" in the subject line.

• Proposals must be submitted in four volumes: Technical, Past Performance, Price, and Offer, Amendments, Certifications & Representations.

• Evaluation Factors: Technical (most important), Past Performance, and Price.

• Technical Factor: Must achieve a rating of "Acceptable" or higher. Evaluation will be based on Salient Characteristics listed in Attachment B.

• Past Performance: Will be evaluated based on recent (last three years) and relevant contracts/orders.

• Price: Will be evaluated for fairness and reasonableness. Volume III (Price Factor) will include Attachment D, Price Cost Schedule.

• This acquisition is set aside for Small Business.

• NAICS Code: 339113

• Size Standard: 800 Employees

• An individual SBA Nonmanufacturer Rule Waiver has been granted for this requirement.

• Offerors must include the Service Level Agreement (SLA) fee (currently 3.0%) in their prices.

• Monthly and quarterly sales reports are required.

• Electronic invoice submission is mandatory.

• Offerors must acknowledge all amendments to the solicitation.

• The Government reserves the right to award without exchanges or negotiations.

Form / Attachment / Pricing Sheet

This document is a template provided for industry partners to submit questions to the Contracting Officer (CO) regarding the solicitation. It is designed to standardize the format of questions, ensuring clarity and facilitating efficient responses.

• Company Name: Field to insert the bidder's company name.
• Item: A row number for tracking questions.
• RFQ Section: Specifies which section of the Request for Quotation (RFQ) the question pertains to (e.g., A, B, C, D, E).
• Document: Identifies the specific document related to the question (e.g., PWS, RFQ Attachment A, Quote Submission Instructions).
• RFQ Page: The page number within the relevant RFQ document.
• Paragraph/Section: The specific paragraph or section number.
• Question for Contracting Officer: The area where the bidder should clearly articulate their question.

Bidders should use this template to formulate and submit any questions they have about the solicitation documents. Proper use of this template will help ensure that questions are understood and addressed by the Contracting Officer, aiding in the preparation of a compliant and accurate proposal.

Form / Attachment / Pricing Sheet

This document is a Past Performance Questionnaire for Solicitation No. 36C10X26R0009, "Laparoscopic Insufflators," issued by the Department of Veterans Affairs (VA) Strategic Acquisition Center (SAC). Its purpose is to gather feedback from references provided by offerors regarding their past performance on previous contracts.

• Offeror Information: Space for the offeror to insert their name and contract number.
• Reference Information: Fields for the reference to complete, including name, title, organization, phone, email, contract period of performance, total contract value, and whether options were exercised.
• Service Description: A section for the reference to briefly describe the services/commodity provided by the offeror.
• Contract Issues: Questions regarding Show Cause Orders, Stop Work Orders, and Terminations for Convenience, Cause, or Default.
• Performance Evaluation: A detailed rating scale (Exceptional to Unsatisfactory) for assessing performance in Quality, Schedule, Cost Control, Management, Utilization of Small Business, and Regulatory Compliance. Each area allows for comments.
• Contract Details: Specific questions about the contract period of performance, dollar value, and a brief description of services provided.
• Overall Recommendation: A final statement asking the reference if they would award to the offeror today.

Offerors must identify up to three references from the past three years and ensure these references receive and complete this questionnaire. The completed questionnaire will be emailed to Carey.Kauzlarich@va.gov and Anthony.Zibolski@va.gov, with the subject line including "36C10X26R0009". This feedback is critical for the VA's evaluation of the offeror's past performance.

Form / Attachment / Pricing Sheet

This document is a template for providing past performance references. Bidders are required to complete this form for each relevant past performance reference they wish to submit as part of their proposal.

• Offeror Name: The name of the bidding company.
• Company who performed this work: The name of the company that executed the referenced contract or task order.
• Relationship to offeror: Indicates if the company was the prime contractor or a subcontractor.
• Role on the Contract: Specifies the offeror's role (Prime or Subcontractor).
• Contracting Organization: The entity that awarded the contract.
• Contract / Task Order Number: Identification numbers for the contract and subcontract (if applicable).
• Contract Type: The type of contract awarded (e.g., FFP, Cost-Plus).
• Total Awarded Price/Cost: The initial or final awarded value.
• Final or Projected Final Total Price/Cost: The final or estimated final value.
• Delivery date/Period of performance: The duration of the contract.
• Contracting Officer's and Program Manager's Information: Contact details for key personnel.
• NAICS Code: The North American Industry Classification System code.
• CPARS Completed: Indicates if a Contractor Performance Assessment Reporting System report exists.
• Description of the Requirement: A summary of the work performed, emphasizing relevance to the current solicitation.
• Performance: Details on any performance issues, corrective actions, and outcomes.

This form is critical for bidders to document their relevant past performance. Completing it accurately and thoroughly will allow the government to assess the bidder's capability and experience based on previous contract performance. The information provided here will be a key factor in the evaluation of proposals.

Form / Attachment / Pricing Sheet

This document is a pricing and cost schedule for "NX EQ Laparoscopic Insufflators." Bidders are required to complete the highlighted sections to provide their proposed pricing for the listed items.

• CLIN: Contract Line Item Number for each item.

• Manufacturer Name, Part Number, Item Description: Details of the original equipment manufacturer (OEM) items.

• Unit of Measure (UOM) & Estimated Quantity: Specifies the unit for each item and the estimated quantities required for the base year and four option years.

• Commercial Price: The established commercial price for the item.

• Proposed Unit Price (Base & Option Years): Bidders must enter their proposed unit price for each year.

• SLA (3%): A 3% Service Level Agreement adjustment is factored into the total price.

• Total Price (Unit Price plus SLA): The calculated total price including the SLA.

• Total Evaluated Price: The final evaluated price for each year, incorporating SLA and estimated quantities.

• ARO: Delivery Days After Receipt of Order.

• Offerors must complete all "yellow" highlighted spaces.

• For equivalent products, provide the Manufacturer Name, Description, and Part Number starting at Column K.

• If an item is not applicable, indicate "N/A," "None," or "Zero (0)."

• Proposed items must align with the technical volume.

• Offerors are responsible for ensuring all calculations are correct.

This sheet is critical for bidders to understand the specific items, quantities, and delivery timelines required. It provides the framework for submitting detailed pricing proposals, which will be a key component of the evaluation process. Bidders must accurately complete this schedule to be considered for this opportunity.

Form / Attachment / Pricing Sheet

This Excel file, titled 'ATTACHMENT C_SALES REPORTING TOOL_NX EQ Laparoscopic Insufflators.xlsx', contains a tool for sales reporting. It appears to be designed to capture sales data across various VA healthcare facilities and networks.

The document includes two main sheets:

• Sheet2: Contains numerical data that seems to represent quantities or codes, potentially linked to locations or items. It also lists facility names and their corresponding VISN (Veterans Integrated Service Network) numbers.
• Sales Report: This sheet is structured to record sales data for FY 2026. It includes fields for Contractor, Contract Number, Reporting Quarter, CLIN/SLIN, Description/Salient Characteristics, Contract/Part Number, and Price. It lists numerous VA facilities organized by VISN and provides columns for 'Quantity Sold of Item' for each of the 22 line items. It also includes fields for total quantities sold, total sales amounts, and SLA (Service Level Agreement) information.

This attachment is crucial for bidders to understand potential sales tracking and reporting requirements if they are awarded a contract related to Laparoscopic Insufflators. It outlines the structure for reporting sales quantities and values by facility and VISN, which may be a contractual obligation. Bidders should review this document to understand the level of detail and format required for sales reporting post-award.

Form / Attachment / Pricing Sheet

This document is a Product Description for non-expendable equipment: Laparoscopic Insufflators. It outlines the requirements for a potential "Brand Name or Equal" contract for these devices.

• Scope of Work: The objective is to provide Laparoscopic Insufflators to VA medical centers nationwide for a base period of 12 months with four 12-month option periods.
• Requirement: Offers must be for an "equal" product to the Olympus UHI-4 Intra-abdominal Insufflation Unit. Vendors must provide a description of their "equal" product, including salient characteristics, brand name, and model number.
• Contract Line Items (CLINs): A list of specific components and their part numbers is provided (CLINs 0001-0007), including the main insufflation unit, footswitch, gas adapter, tubing, and suction tubing set.
• Salient Characteristics (SCs): Key requirements for the insufflator include:
  • FDA approval for laparoscopic procedures.
  • Smoke evacuation mode.
  • Use of CO2 for medical gas.
  • Specific alarms (excessive pressure, tube obstruction, CO2 pressure).
  • Two cavity modes (Normal and Small).

This document is crucial for potential bidders to understand the specific product requirements and salient characteristics for Laparoscopic Insufflators. Vendors must identify how their proposed "equal" product meets these detailed specifications to be considered for the contract. The listed CLINs and SCs will form the basis for proposal preparation and evaluation.

Solicitation / RFP / RFQ

This is a combined synopsis/solicitation (RFP) for NX EQ Laparoscopic Insufflators. The Department of Veterans Affairs, Strategic Acquisition Center - Frederick, is seeking proposals for new Original Equipment Manufacturer (OEM) laparoscopic insufflators. Refurbished, remanufactured, or gray market items are not acceptable.

• Offerors must provide NX EQ Laparoscopic Insufflators meeting the salient characteristics detailed in ATTACHMENT B – PRODUCT DESCRIPTION.

• Only new OEM equipment is acceptable.

• Delivery is FOB Destination, with specific locations and dates to be determined by individual orders.

• The solicitation number is 36C10X26R0009.

• The Product Service Code is 6515.

• The NAICS Code is 339113.

• Offers are due by May 7, 2026, 10:00 AM Eastern Time, New York, USA.

• Line items, quantities, and units of measure are detailed in ATTACHMENT D – PRICE COST SCHEDULE.

• Past performance references are required (ATTACHMENT E) and a questionnaire is provided (ATTACHMENT F).

• This acquisition is set-aside exclusively for Service-Disabled Veteran-Owned Small Business (SDVOSB) concerns.

• This solicitation incorporates provisions and clauses by reference, accessible at www.acquisition.gov.

• Numerous attachments are provided for detailed information, including product descriptions, price schedules, and past performance requirements.