6515--NuVasive Excavation Posterior Disc. Prep/Graft Delivery System

This Sources Sought Notice is for informational and planning purposes only and shall not be construed as a solicitation or as an obligation or commitment by the Government. This notice is intended strictly for Market Research. This is a Request for Information only. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The Department of Veterans Affairs Dallas VA Medical Center Nursing/SPS Service in Dallas, Texas intends to award a brand name or equal contract award for the purchase of NuVasive Excavation Posterior Disc. Prep/Graft Delivery System. The Government is conducting a market survey to help determine the availability and technical capability of qualified service-disabled veteran-owned small businesses, veteran-owned small businesses, small businesses, HUBZone small businesses and/or other large businesses capable of serving the needs identified below. This notice of intent is for open market as well as Federal Supply Schedule items. The purpose of this notice is to gain knowledge of potential qualified sources and their size classification/socioeconomic status (service-disabled veteran owned small business, veteran owned small business, women owned small business, HUB Zone, 8(a), small business or large business, relative to NAICS 339113 with a size standard of 750 employees. Responses to this notice will be used by the Government to make appropriate acquisition decisions. A solicitation is not currently available. If a solicitation is issued, it will be announced on Federal Business opportunities website http://www.fbo.gov or GSA E-Buy at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this announcement. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0001 3.00 EA GRAFT DELIVERY SYSTEM MANUFACTURER PART NUMBER (MPN): GRFTDLVRY LOCAL STOCK NUMBER: GRFTDLVRY 0002 3.00 EA EXCAVATION,POSTERIOR DISC,PREP,STRAIGHT MANUFACTURER PART NUMBER (MPN): EXDISCPREPSTRT LOCAL STOCK NUMBER: EXDISCPREPSTRT VA North Texas Health Care System STATEMENT OF WORK Equipment Package (Surgical Instrument Sets) Neurosurgical Excavation Posterior Disc Prep Straight/Graft Delivery System Introduction The VA North Texas Health Care System (VANTHCS) has a requirement to purchase Neurosurgical Excavation Posterior Disc Prep Straight/Graft Delivery System with an authorized vendor to supply and deliver the item(s) identified in Table 1 below. See attachments for salient characteristics. This requirement is in support of the activation of the VANTHCS. Item(s) are to be delivered to the location specified in section 2.4.1. Table 1 Package Items Summary Item Number Item Description Quantity EXDISCPREPSTRT Excavation Posterior Disc Prep Straight 3 GRFTDLVRY Graft Delivery System 3 General Conditions Site Address The address of the VA North Texas Health Care is listed below. Additional information on delivery is located in section 2.4. VA North Texas Health Care System 4500 S Lancaster Rd Dallas, TX 75216 Site Visit Information for Vendors Full Address (Please include Bldg./Rm): VANTHCS, 4500 S Lancaster Rd, Dallas, TX 75216; Sterile Processing Service, Basement, Building: 2J/ Room: BA-232 POC Number (If multiple people are attending then please provide their names and telephone contact information): TBD Date: TBD Time: n/a Delivery Schedule Items shall be delivered no earlier than the estimated delivery start date and no later than the delivery end date listed in Table 2 below. Table 2 Anticipated Building Outfitting Schedule Building Name Building # & Letter Acronym Est. Delivery Start Date Est. Delivery End Date VA North Texas Health Care System 2J VANTHCS 2023-07-10 2023-07-10 Schedule and Order Management The above delivery schedule is based upon the current construction schedule, which is subject to change. The vendor shall not increase prices for a change in delivery date for up to 30+ days due to construction delays. The awardees actual delivery dates will be confirmed by VA upon award. Post-award the vendor will coordinate delivery prior to beginning any work (see section 2.4). Once the dates have been confirmed, modifications to the schedule are subject to written approval by the VA POC and the vendor. Schedule changes that are beyond the dates specified in the contract will require approval by the Contracting Officer and a contract modification. Delivery and Receiving Delivery and receipt of the proposed items is anticipated to be directed to the location identified below. Confirmation of delivery location will be provided by the VA POC post-award. Delivery must be coordinated with VA Logistics Warehouse (primary), ______________ prior to any attempts at delivery. Any item that has not been coordinated will be turned away and any additional charges will be the responsibility of the sender/transportation company. VA North Texas Health Care System (Direct Delivery to address detailed in paragraph 2.1.1) Delivery shall be freight on board (FOB) Destination. The vendor is required to define the need for a staging area to accommodate item delivery, if needed. Post-award, this information will be confirmed with the vendor. The delivery of items identified in this document shall take place during normal business hours which are defined as: 0800 to 1600 (i.e.: 8:00am to 4:00pm Central Time), Monday through Friday, and excluding Federal Holidays. Delivery trucks will not be permitted to remain at the loading dock. Trucks shall be unloaded, moved from the dock, and then brought back to the dock if required to haul out any waste, tools, or excess materials. Labeling of delivered items shall include the awarded contract number and VA purchase order number for identification and reference upon receipt of product. Use of Warehouse If the vendor requires the use of the Government s activation contractor s warehouse to meet the requirements of this contract the vendor must provide a certificate of insurance prior to the delivery and offloading of the item(s). This insurance certificate must be completed and presented to the activation contractor prior to delivery. The vendor shall communicate through the VA POC any required coordination requirements. Clean Up and Disposal There are no dumpsters available for vendor use. The removal of waste and/or excess material shall be conducted through the loading dock area. Delivery trucks and/or other vendor vehicles will not be permitted to remain at the loading dock. Vehicles will need to be brought back to the dock if required to remove any waste, tools, or excess materials. Deliverables The vendor shall provide CAD drawings (including shop drawings) and specifications for site prep for their product as required. The vendor shall provide a completed VA Form 6550 with submittal documents for any and all item(s) that may connect to the VA network and medical devices that store sensitive patient information. Assembly and Installation [ is is not required] The vendor is required to manage and coordinate installation at the VANTHCS with the VA POC. On-site assembly and installation of items, and performance of services identified in this document shall take place during normal business hours which are defined as: 0800 to 1600 (i.e.: 8:00am to 4:00pm Central Time), Monday through Friday, and excluding Federal Holidays. The vendor is required to define the need for a staging area to accommodate item assembly and installation, if needed. Post-award, this information will be confirmed with the vendor. The vendor is required to provide tools, labor and materials to complete assembly and installation of the items detailed in this document. The vendor shall protect all finished spaces and surfaces as required from delivery and installation damage. The vendor shall use covering and protection to the extent necessary to prevent damage to finished spaces. Any damage occurred during delivery and installation is the responsibility of the vendor. The vendor will be responsible for paying for and repairing any damage or noted deficiencies to finished spaces and surfaces that occur as a result of the vendor s (or associated sub-contractors) installation. During the entire duration of assembly and installation, the vendor will have a competent representative on-site as the vendor s contact, and to serve as the interface between the vendor and VANTHCS. On-site representative can be the installer. All instructions provided from COR to the representative will be binding as if given to the vendor s main contact. The COR may provide specific instructions, however, only the Contracting Officer may change the terms or conditions of the contract. Training [ X is is not required] The vendor shall coordinate through the VA POC to provide a hands-on training session to staff selected by the VA. Training shall be completed within 45 days after final installation of equipment. The vendor will record the training and provide an electronic copy of the training to the VA POC for VA to use to train additional personal at a future date. In addition, the vendor shall provide additional training documents to the VA POC for training additional persons at a future date. Standard Warranty The products shall be covered by vendor s standard warranty terms and provisions, provided, however that the warranty coverage shall be no less than the following: The Vendor shall provide a warranty certificate/form stating the warranty period, terms, and information required to initiate the warranty. The warranty period set forth therein shall run for one year following the first day of use at VANTHCS; The vendor shall extend such warranty directly to the customer as if such customer had purchased the Products directly from the vendor. The vendor shall warrant the products against defects in material and workmanship under normal use and service, repair or replace at vendor s cost any defective Product (or issue a credit or refund based on the purchase price paid therefor); and The vendor shall pay (or refund the amount of) all freight and shipping charges for any defective Products returned under this paragraph. Use of Premises If during the performance of this contract, work will be carried out on VANTHCS premises, the vendor shall perform all work in such a manner that will cause a minimum interference with VANTHCS operations and the operations of other contractors on the premises. The vendor shall communicate through the VA POC any required coordination requirements with the General Construction contractor prior to and during delivery and installation activities. The project may be an active construction site during delivery and installation. The vendor shall take all necessary precautions to protect the premises and all persons and property therein from damage or injury. The vendor shall assume responsibility for taking precautions for the vendor's (and associated subcontractors ) employees, agents, licensees, and permittees. The vendor shall abide by any safety requirements imposed by the GC (e.g. hard hats, safety vests). 2.13 VHA Supplemental Contract Requirements for Ensuring Adequate COVID-19 Safety Protocols for Federal Contractors Contractor employees who work in or travel to VHA locations must comply with the following: Documentation requirements: If fully vaccinated, shall show proof of vaccination. NOTE: Acceptable proof of vaccination includes a signed record of immunization from a health care provider or pharmacy, a copy of the COVID-19 Vaccination Record Card (CDC Form MLS-319813_r, published on September 3, 2020), or a copy of medical records documenting the vaccination. If unvaccinated and granted a medical or religious exception, shall show negative COVID-19 test results dated within three calendar days prior to desired entry date. Test must be approved by the Food and Drug Administration (FDA) for emergency use or full approval. This includes tests available by a doctor s order or an FDA approved over-the-counter test. Documentation cited in this section shall be digitally or physically maintained on each contractor employee while in a VA facility and is subject to inspection prior to entry to VA facilities and after entry for spot inspections by Contracting Officer Representatives (CORs) or other hospital personnel. Documentation will not be collected by the VA; contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information. Contractor employees are subject to daily screening for COVID-19 and may be denied entry to VA facilities if they fail to pass screening protocols. As part of the screening process contractors may be asked screening questions found on the COVID-19 Screening Tool. Check regularly for updates. Contractor employees who work away from VA locations, but who will have direct contact with VA patients shall self-screen utilizing the COVID-19 Screening Tool, in advance, each day that they will have direct patient contact and in accordance with their person or persons who coordinate COVID-19 workplace safety efforts at covered contractor workplaces. Contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information. Contractor must immediately notify their COR or Contracting Officer if contract performance is jeopardized due to contractor employees being denied entry into VA Facilities. VANTHCS Sterile Processing Service Excavation Posterior Disc Prep Straight EXDISCPREPSTRT 4500 S Lancaster Rd. Dallas, TX 75216 _ Project: VANTHCS Sterile Processing Service Neurosurgical Instrument Sets Issue Date: July 2023 3_ Total Quantity: 3 Finish Sample Required if Checked Manufacturer Certified Installation Required if Checked _ BMET Training Required if Checked End User Training Required if Checked _ Item Name: Excavation Posterior Disc Prep Straight Set Basis of Design Brand or Equal: NuVasive |Excavation Straight Disc Prep Instrument Set | EXDISCPREPSTRT Main Image: *Salient Characteristics: (* indicates required items) The curettes are serrated for more aggressive tissue and cartilage removal. The endplate scraper is cut to be a pull only device and has laser markings on the distal end to indicate depth. Large curettes have a cup that is 10mm long and 6.5mm in width. There is one each of straight, up, down, left, and right angles. Small curettes have cups of 6.5mm and 4mm wide with the same angles as the large. The rasp has a 4.9mm height and an angled option at 35 degrees. VANTHCS Sterile Processing Service - Graft Delivery System GRFTDLVRY 4500 S Lancaster Rd. Dallas, TX 75216 _ Project: VANTHCS Sterile Processing Service Neurosurgical Instrument Sets Issue Date: July 2023 _ Total Quantity: 28 Finish Sample Required if Checked Manufacturer Certified Installation Required if Checked _ BMET Training Required if Checked End User Training Required if Checked _ Item Name: Graft Delivery System Basis of Design Brand or Equal: NuVasive | Graft Delivery System | GRFTDLVRY Main Image: *Salient Characteristics: (* indicates required item) The graft delivery system delivers 2.5x times quicker than traditional funnel delivery systems Controlled via a threaded applicator Can attach to quarter inch power drill Two different style of graft delivery tubes: * Round which has an 8.4mm outer diameter and a 127mm length * Tapered tube which the distal end has a 4.4mm height and a 10.5mm width