6515--FY23-066 M3185A Electrosurgical, Monopolar (VA-23-00027665)

Department of Veterans Affairs Program Contracting Activity Central NAO VA Pacific Islands Health Care System Radiofrequency Lesion Generator December 7, 2022 **IMPORTANT: Please read this notice in full BEFORE responding!** The Veterans Health Administration (VHA), Program Contracting Activity Central (PCAC) is in the process of planning a requirement in which a contractor will be required purchase a Radiofrequency Lesion Generator - Brand Name or Equal, for use in the new VA Pacific Islands Health Care System. (Statement of work (SOW) attached). The VA is conducting market research and is seeking written responses with information to assist with identifying potential sources that are interested in, and capable of, providing the products described (in whole or in part). Please review the information contained herein and identify whether your company has the capability and interest to provide the brand name items listed or equivalent items that possess the salient characteristics as described. Please see ATTACHED Vendor Market Research Response Form for completion. Below is the information included in that form for your company s response. GOVERNMENT QUESTIONS The VA is requesting vendors answer the following questions in response to this notice. What is the place of manufacture? Are there any specifications for individual items that you believe may be too restrictive when taking into consideration industry standards (see draft Statement of Work)? What specifications and why? Are there any accessories for any equipment item that are normally separately priced? What accessories? Are there any items that you would recommend be purchased separately? What items and why? Is there any reason you would not be interested in responding to a solicitation? What are the reason(s) and why? What is the lead time on this equipment? Does your company manufacture the items in accordance with the Limitations on Subcontracting (see FAR 52.219-14, 52.219-27, and 13 C.F.R. § 125.6) or supply the product of a small business manufactured in the United States? Do you have any questions or comments that may otherwise assist us? SET-ASIDE Complete responses to this notice will assist the VA in determining any potential set-aside for the requirement. Not providing all information requested in response to this notice may result in the VA being unable to determine a vendor potentially capable of satisfying the requirement and, subsequently, if the rule of two criteria is not met, a specific set-aside category may not be decided by the Contracting Officer. AUTHORIZED DEALER/DISTRIBUTOR VERIFICATION Gray market items are Original Equipment Manufacturers (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts) for VA Medical Centers. No remanufactures or gray market items will be acceptable. Vendor shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts), verified by an authorization letter or other documents from the OEM, such that the OEM s warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the medical supplies, medical equipment and/or services contracts for maintenance of medical equipment shall be in accordance with the OEM terms and conditions. The delivery of gray market items to the VA in the fulfillment of an order/award constitutes a breach of contract. Accordingly, the VA reserves the right enforce any of its contractual remedies. This includes termination of the contract or, solely at the VA s election, allowing the Vendor to replace, at no cost to the Government, any remanufactured or gray market item(s) delivered to a VA medical facility upon discovery of such items. This requirement is for new equipment ONLY; remanufactured or gray market items will not be accepted. Gray market, also known as parallel market is the trade of a commodity through distribution channels which, while legal, are unofficial, unauthorized, or unintended by the original manufacturer. Any vendor interested in this requirement shall be an Original Equipment Manufacturer (OEM) authorized dealer or distributor for the proposed equipment/system such that OEM warranty and services are provided and maintained by the OEM or that the OEM gives authorization to the vendor to fulfill all warranty, service, and/or preventative maintenance obligations for the equipment on their behalf. All software licensing, warranties, and service associated with the equipment/system shall be in accordance with the OEM terms and conditions. To assist the VA in determining any potential set-aside, we are requiring vendors provide the authorized dealer/distributor letter in response to this Request for Information (RFI). Any future solicitation will include the requirement for vendors to provide authorized dealer verification for all items of equipment. To satisfy this requirement, the vendor shall provide the original documentation from the manufacturer stating they are an authorized dealer/distributor for the items being procured. This letter shall be on the manufacturers official letter head or from an official manufacturer email and guarantees the products are safe, are not counterfeit or adulterated devices, have maintained adequate storage conditions, and that: 1. All product warranties and service and/or preventative maintenance agreements transfer to the VA and will be honored by the OEM or 2. Guarantees that the OEM gives authorization to the vendor to fulfill all warranty, service, and/or preventative maintenance obligations for the equipment. LIMITATIONS ON SUBCONTRACTING AND THE NON-MANUFACTURER RULE (NMR) The requirement that a non-manufacturer supply the product of a small business concern is referred as the Non-Manufacturer Rule (NMR) [13 C.F.R. § 121.406]. In order to qualify as a small business concern for a small business set-aside, an offeror must either manufacture the item in accordance with the Limitations on Subcontracting (see FAR section 52.219-14, 52.219-27 and 13 C.F.R. § 125.6) or supply the product of a small business made in the United States. SALIENT CHARACTERISTICS/DELIVERY SPECIFICATIONS/WARRANTY SPECIFICATIONS See attached DRAFT Statement of Work (ATTACHMENT 1). SUBMITTAL OF RFI RESPONSE If you believe you are capable of meeting this requirement (in whole or in part), please provide a complete response no later than Monday December 19, 2022 at 1:00 pm (Eastern). A complete response satisfies the information requested below. The Government requests responders provide the information requested in ATTACHMENT 2 Vendor Market Research Response Form by completing and returning a completed Attachment 2 Cut sheets for proposed products Authorized Distributor Letter Further, if you believe a different NAICS code or Product Service Code (PSC) is a better fit for the subject requirement, please provide that information to us as well. NAICS: 334510 Electromedical and Electrotherapeutic Apparatus Manufacturing PSC: 6515 - Medical and Surgical Instruments, Equipment, and Supplies NOTE: This email is being sent solely for information and planning purposes and does not constitute a solicitation or obligation on the part of the Government. Per FAR 15.201(e), responses to this notice are not considered offers, shall not be used as a proposal, and cannot be accepted by the Government to form a binding contract. Neither unsolicited proposals nor any other kinds of offers will be considered in response to this notice. No evaluation letters and/or results will be issued to the respondents; however, the Government does reserve the right to contact any respondent and/or respondent reference to obtain additional information. At this time, no solicitation exists; therefore, please do not request a copy of the solicitation. Any resulting procurement action will be the subject of a separate, future announcement. The information is provided for discussion purposes and any potential strategy for this acquisition may change prior to any solicitation release. The acquisition strategy, evaluation methodology, contract type, and any other acquisition decisions are to be determined.