6515--CUSTOM SURGICAL PACKS-VAGLA_VALB

Page 5 of 5 Page 1 of 2 SOURCES SOUGHT SYNOPSIS ONLY This request for information (RFI) and sources sought is issued solely for information and planning purposes only and does not constitute a solicitation. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. The submission of pricing, capabilities for planning purposes, and other market information is highly encouraged and allowed under this RFI in accordance with FAR 15.201(e). The purpose of this sources sought/RFI is to gain knowledge of potential qualified sources, their socioeconomic status, and their size classification relative to NAICS 339113 Surgical Appliance and Supplies Manufacturing size standard of 800 employees. Responses to this sources sought will be used by the Government to make appropriate acquisition decisions. This synopsis is neither a request for competitive proposals nor a solicitation of offers. This synopsis is to assist the VA in determining sources only and a solicitation is not currently available. If a solicitation is issued it shall be announced at a later date, and all interested parties must respond to that solicitation announcement separately from responses to this RFI and sources sought. The Department of Veterans Affairs Veterans Integrated Service Network (VISN) 22 is seeking potential sources capable of supplying custom packs for scheduled procedures in the Operating Room, Interventional Radiology, and Cardiac Catheterization Lab that at a minimum meet the brand name and/or can possibly provide an equal product. The proposed action is for a firm-fixed price, IDIQ Base Plus Four Year Contract. The Government contemplates issuing one (1) solicitation for these supplies to be provided to the following facilities: VA Greater Los Angeles Healthcare System VA Long Beach Healthcare System 11301 Wilshire Blvd 5901 E. 7th Street Los Angeles, CA 90073 Long Beach, CA 90822 Contractor shall provide the following information: Vendor: Address: Telephone Number: Business Size: Socioeconomic Category (i.e. SDVOSB, 8a, VOSB, etc.): UEI Number: FSS/ GSA Contract Holder Yes No FSS/ GSA Contract Number Effective Date / Expiration Date Country of Origin ( COO ) Responses to this sources sought are not request to be added to a prospective bidders list or to receive a copy of the solicitation. Information received as a result of this notice will normally be considered solely for the purpose of determining whether conduct a competitive procurement. This notice does not represent a commitment by the Government to pay for cost incurred in the preparation and submission of information or any other cost incurred as a response to this announcement. Inquiries will only be accepted in writing via email to Jonathan.Ford1@va.gov telephone responses shall not be accepted. Please respond by March 29th, 10AM PT. *PLEASE REFER TO PAGE 5 FOR THE PWS ( PERFORMANCE WORK STATEMENT ). Note* The Non-Manufacturer Rule (NMR) in accordance with 13 CFR § 121.406, September 4, 2019 applies to this acquisition. Additionally, as prescribed on 25.1101(a)(1). FAR 52.225-1 Buy American Supplies and FAR 52.225-2 Buy American Certificate applies to this acquisition. a) For small business set-asides other than construction or service contracts the prime contractor that s supplying products to the government is required to cover at least 50 percent of the cost of manufacturing those products. The non-manufacturer rule is an exception to that requirement. The rule allows a small business to supply products it did not manufacture as long as those products come from another small business. b) A manufacturer is defined as a business that, with its own facilities, performs primary activities in transforming inorganic or organic substances, including the assembly of parts and components, into the end product being acquired. In other words, a manufacturer makes or produces products. Businesses may qualify as a non-manufacturer if it meets the following criteria: Does not exceed 500 employees Is primarily engaged in the retail or wholesale trade and normally sells the type of products being supplied Will supply the end products of a small business manufacturer or processor made in the United States, or obtains a waiver of such requirement See Title 13 Part 121.406 of the Code of Federal Regulations (CFR) for detailed information about the non-manufacturer rule. FAR 52.225-1 Buy American-Supplies (Oct 2022) (a) Definitions. As used in this clause Commercially available off-the-shelf (COTS) item (1) Means any item of supply (including construction material) that is (i) A commercial product (as defined in paragraph (1) of the definition of commercial product at Federal Acquisition Regulation (FAR) 2.101); (ii) Sold in substantial quantities in the commercial marketplace; and (iii) Offered to the Government, under a contract or subcontract at any tier, without modification, in the same form in which it is sold in the commercial marketplace; and (2) Does not include bulk cargo, as defined in 46 U.S.C. 40102(4), such as agricultural products and petroleum products. Component means an article, material, or supply incorporated directly into an end product. Cost of components means (1) For components purchased by the Contractor, the acquisition cost, including transportation costs to the place of incorporation into the end product (whether or not such costs are paid to a domestic firm), and any applicable duty (whether or not a duty-free entry certificate is issued); or (2) For components manufactured by the Contractor, all costs associated with the manufacture of the component, including transportation costs as described in paragraph (1) of this definition, plus allocable overhead costs, but excluding profit. Cost of components does not include any costs associated with the manufacture of the end product. Critical component means a component that is mined, produced, or manufactured in the United States and deemed critical to the U.S. supply chain. The list of critical components is at FAR 25.105 . Domestic end product means (1) For an end product that does not consist wholly or predominantly of iron or steel or a combination of both- (i) An unmanufactured end product mined or produced in the United States; (ii) An end product manufactured in the United States, if- (A) The cost of its components mined, produced, or manufactured in the United States exceeds 60 percent of the cost of all its components, except that the percentage will be 65 percent for items delivered in calendar years 2024 through 2028 and 75 percent for items delivered starting in calendar year 2029. Components of foreign origin of the same class or kind as those that the agency determines are not mined, produced, or manufactured in sufficient and reasonably available commercial quantities of a satisfactory quality are treated as domestic. Components of unknown origin are treated as foreign. Scrap generated, collected, and prepared for processing in the United States is considered domestic; or (B) The end product is a COTS item; or (2) For an end product that consists wholly or predominantly of iron or steel or a combination of both, an end product manufactured in the United States, if the cost of foreign iron and steel constitutes less than 5 percent of the cost of all the components used in the end product. The cost of foreign iron and steel includes but is not limited to the cost of foreign iron or steel mill products (such as bar, billet, slab, wire, plate, or sheet), castings, or forgings utilized in the manufacture of the end product and a good faith estimate of the cost of all foreign iron or steel components excluding COTS fasteners. Iron or steel components of unknown origin are treated as foreign. If the end product contains multiple components, the cost of all the materials used in such end product is calculated in accordance with the definition of "cost of components". End product means those articles, materials, and supplies to be acquired under the contract for public use. Fastener means a hardware device that mechanically joins or affixes two or more objects together. Examples of fasteners are nuts, bolts, pins, rivets, nails, clips, and screws. Foreign end product means an end product other than a domestic end product. Foreign iron and steel means iron or steel products not produced in the United States. Produced in the United States means that all manufacturing processes of the iron or steel must take place in the United States, from the initial melting stage through the application of coatings, except metallurgical processes involving refinement of steel additives. The origin of the elements of the iron or steel is not relevant to the determination of whether it is domestic or foreign. Predominantly of iron or steel or a combination of both means that the cost of the iron and steel content exceeds 50 percent of the total cost of all its components. The cost of iron and steel is the cost of the iron or steel mill products (such as bar, billet, slab, wire, plate, or sheet), castings, or forgings utilized in the manufacture of the product and a good faith estimate of the cost of iron or steel components excluding COTS fasteners. Steel means an alloy that includes at least 50 percent iron, between 0.02 and 2 percent carbon, and may include other elements. United States means the 50 States, the District of Columbia, and outlying areas. (b) 41 U.S.C. chapter 83, Buy American, provides a preference for domestic end products for supplies acquired for use in the United States. In accordance with 41 U.S.C. 1907, the domestic content test of the Buy American statute is waived for an end product that is a COTS item (see 12.505(a)(1)), except that for an end product that consists wholly or predominantly of iron or steel or a combination of both, the domestic content test is applied only to the iron and steel content of the end product, excluding COTS fasteners. (c) Offerors may obtain from the Contracting Officer a list of foreign articles that the Contracting Officer will treat as domestic for this contract. (d) The Contractor shall deliver only domestic end products except to the extent that it specified delivery of foreign end products in the provision of the solicitation entitled "Buy American Certificate." (End of clause) FAR 52.225-2 Buy American Certificate (Oct 2022) (a)(1) The Offeror certifies that each end product, except those listed in paragraph (b) of this provision, is a domestic end product and that each domestic end product listed in paragraph (c) of this provision contains a critical component. (2) The Offeror shall list as foreign end products those end products manufactured in the United States that do not qualify as domestic end products. For those foreign end products that do not consist wholly or predominantly of iron or steel or a combination of both, the Offeror shall also indicate whether these foreign end products exceed 55 percent domestic content, except for those that are COTS items. If the percentage of the domestic content is unknown, select no . (3) The Offeror shall separately list the line item numbers of domestic end products that contain a critical component (see FAR 25.105). (4) The terms commercially available off-the-shelf (COTS) item, critical component, "domestic end product," "end product," and "foreign end product" are defined in the clause of this solicitation entitled "Buy American-Supplies." Line Item No. Country of Origin Exceeds 55% domestic content (yes/no) ______________ _________________ _________________ ______________ _________________ _________________ ______________ _________________ _________________ (b)Foreign End Products: (b)[List as necessary] (c) Domestic end products containing a critical component: Line Item No. ___ [List as necessary] (d) The Government will evaluate offers in accordance with the policies and procedures of part 25 of the Federal Acquisition Regulation. (End of provision) PERFORMANCE WORK STATEMENT Surgical Custom Packs Scope: Custom surgical packs are tailored to specific needs of Clinical and Logistical staff to improve patient care, improve utilization, and reduce waste. VALBHS and VAGLAHS need a constant supply of surgical packs with no interruption of source for scheduled procedures in the Operating Room, Interventional Radiology, and Cardiac Catheterization Lab. The Custom Sterile Procedure Pack Program will include pack assembly/manufacture, sterilization, quality assurance, and packaging, contractor electronic communication ordering reporting, and delivery. Due to the complexity and customization of this product, custom surgical packs shall take no more than 24 weeks to produce, sterilize, and deliver for the initial order after the commencement of the forthcoming contract. The Contractor shall provide all labor, materials, transportation, equipment, and supervision, in compliance with federal, state, and local regulations, to provide a Custom Sterile Procedure Pack program for the following VA Medical Facilities: VA Long Beach Healthcare System VA Greater Los Angeles Healthcare System 5901 E. 7th Street 11301 Wilshire Blvd Long Beach, CA 90822 Los Angeles, CA 90073 Period of Performance: Unless otherwise specified, this contract will be for the period of one (1) one-year base period plus four (4) one-year option periods. Products to be Provided: The forthcoming contract will be a firm fixed price requirements contract as identified in FAR 16.503(b), to the awardee shall deliver Custom Surgical Packs as requested by VALBHS and VAGLAHS in a manner described in section VII of this document. The custom surgical packs will be ordered by the COR or designee in accordance with Section III of this document. The contractor shall make delivery of requested contract items and quantities within the timeframes outlined in Section VII. The vendor is required to provide the exact components listed for each custom pack for all requests made under the forthcoming contract. See attachment for required items in each kit. VALBHS Packs (Bill of Materials Attachment) Product Description Estimated Quantities ANGIOGRAM 211 EA NEURO 62 EA CATARACT 1044 EA CYSTO 468 EA ENT 468 EA EXTREMITY 902 EA LAPARATOMY 2200 EA LUMPS& BUMPS 395 EA TOTAL JOINT 158 EA BASIC HEART 949 EA VAGLAHS Packs : (Bill of Materials Attachment) Product Description Estimated Quantities Intubation Kit 12 Hygiene Kit 84 Central Line Insertion Kit 72 EP Pack 36 WellnessPac 24 Cysto Pack 100 Cataract Pack 400 Open Heart PPS Pack 50 Major General PPS Pack 400 Plastic ENT PPS Pack 240 Ortho PPS Pack 220 Minor GYN PPS Pack 450 Podiatry PPS Pack 200 General Anesthesia Kit 180 Joint Accessory Pack 150 Neuro Spine Pack 120 Cysto Urological Module Pack 230 Vascular Extremity PPS Pack 70 Angio IR Drape Pack 192 Vascular PPS Pack 30 Angio Pack 204 Arthroscopy Pack 50 Intravitreal Injection Pack 92 Oral Surgery Pack 36 Perio Surgery Pack 36 MAC Anesthesia Kit 16 IV Starter Kit 900 Blood Culture Kit 250 Ordering Procedures: The COR or designee shall place orders by email. In case of emergencies, orders may be placed by telephone by the COR or designee. Requests for delivery shall contain at a minimum the following information: Date of order Description and quantity Place of Delivery Purchase Order Number The contractor shall confirm receipt of the order and contact the requestor to coordinate delivery within 24 hours. Contractor shall not accept any instructions or perform outside of the parameters of the forthcoming contract unless issued by the Contracting Officer via contract modification. Production and Supply: The Government shall provide the contractor with estimated monthly usage report by the 5th of every month. The government requires the Contractor to produce the initial quantities of the product and make them available for delivery within forty-five (45) days of contract award, to reasonably assure the Government of an uninterrupted supply of the product. The Government requires the contractor to maintain a 3-month supply on hand and maintain a 95% acceptance rate. Changes Requested by the Government: VAGLAHS and VALBHS may change individual component parts of the tray/pack twice a year, using Attachment C - Pack Change Worksheet (PCW). A completed PCW will be provided to the Contractor by the COR or designee. Individual components of the custom pack may only be changed via a bi-lateral modification of the contract provided by the Network Contracting Office (NCO) 22 Contracting Officer. Any component changes, the Contractor shall be required provide a price estimate for each item to be changed within five (5) business days to the COR or designee. If the change of individual components will result in a change of line-item pricing, the CO will make a price reasonableness determination and may require a price adjustment before modifying the contract. Upon award of the modification, production of the modified packs/kits shall begin within fourteen (14) days. Modified packs shall be delivered no later than forty-five 45 days after the award of the modification. Substitutions / Run-Withouts (RWO) Temporary substitutions of custom pack components may be made without a change in pricing, only when given prior authorization in writing by the COR or designee. The COR or designee, at their discretion may request a sample of any proposed substitution. If for any reason the Contractor is unable to deliver the agreed upon packs, the Contractor will provide 30-day notice, in writing, to the COR. The communication must include the Kit Item Number, specify the item(s) that are unavailable, and the number of kits that will be affected. The contractor shall provide the COR with a list of any available, equal substitutions, for review and approval. Substitution of items will not impact the delivery timeframes previously specified in paragraph VII. Each pack list must clearly identify and highlight the missing/substituted item(s) to be easily identified on each pack by clinical staff. Delivery Requirements: All components for Custom Packs shall be delivered to the following locations: VA Greater Los Angeles, Warehouse Building 249, Los Angeles, CA 90073 VA Long Beach Healthcare System, Warehouse Building 46, Long Beach, CA 90822 Pack deliveries shall be made one business day after receipt of the order if placed before 1:00 pm PST. Orders placed after 1:00pm shall be delivered within two (2) calendar days. The contractor shall furnish quarterly inventory reports by the fifth (5th) business day of October, January, April, and July to the COR for the duration of the forthcoming contract. Packaging: Items must be packaged in a manner adequate to prevent deterioration and damage during shipping, handling, and storage. Each pack shall have an outward facing label specifying the pack name, the manufactured date, the sterilization date of the pack, the expiration date of any dated products, and if the pack includes any items containing latex. A label, located inside each pack, shall also contain an itemized list of all components, as well as any missing items that were approved to be left out by the COR. The pack contents list must contain item a…