6515--AP-4537 Werewolf Coblation System NOTICE OF INTENT TO SET-ASIDE TO Small Business

Page 6 of 9 Page 1 of Notice of Intent to Sole Source Werewolf coblation systems for the Operating Room - Togus VA Medical Center, 1 VA Center, Augusta, ME 04330-6795 This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number is 36C24123Q0889 and the solicitation is issued as a request for quotation (RFQ). A statement that the solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2023-02. This requirement is being issued as an open market, Small Business set-aside. The associated NAICS code is 334510 Electromedical and Electrotherapeutic Apparatus Manufacturing and small business size standard is 1250 Employees. The Government intends to award a firm-fixed price award for the acquisition of three Werewolf Coblation systems for the Operating Room at Togus.VAMC. Please see the attached Statement of Work for full requirement details (Attachment 1) and submit with the quote submission. Please note the speculated period of performance start date is: 27- September-2023, this date is subject to change depending on the award date. The Contractor shall provide all resources necessary to provide the requested three Werewolf coblation systems for the Operating Room at Togus per IAW the attached statement of work. Please see the attached SOW for full requirement details. The Place of Performance is: Togus VA Medical Center, 1 VA Center, Augusta, ME 04330-6795 Provision at 52.212-1, Instructions to Offerors Commercial Products and Commercial Services (MAR 2023), 52.252-1 Solicitation Provisions Incorporated by Reference (FEB 1998), 52.204-7 System for Award Management (OCT 2018), 52.204-16 Commercial and Government Entity Code Reporting (AUG 2020), 52.229-11 Tax on Certain Foreign Procurements Notice and Representation (JUN 2020), 852.215-70 Service-Disabled Veteran-Owned and Veteran- Owned Small Business Evaluation Factors (JAN 2023), 852.215-71 Evaluation Factor Commitments (OCT 2019), 852.252-70 Solicitation Provisions or Clauses Incorporated by Reference (JAN 2008). Provision at 52.212-2, Evaluation -- Commercial Items, applies to this requirement, 52.232-3 Offer Representations and Certifications-Commercial Products and Commercial Services (DEC 2022) Submission of Quotes: Quotes shall be received on or before the date and time specified in Section (xv) of this solicitation. Note: Offers received after the due date and time shall not be considered. Offerors shall submit their quotes electronically via email to contact@example.gov. Questions: Questions shall be submitted to the Contracting Officer in writing via e-mail. Oral questions are not acceptable due to the possibility of misunderstanding or misinterpretation. The cut-off date and time for receipt of questions is July 19, 2023, 4:00 PM EST. Questions received after this date and time may not be answered. Questions shall be answered in a formal amendment to the solicitation so all interested parties can see the answers. Quote Format: The submission should be clearly indexed and logically assembled in order of the evaluation criteria below. All pages of the quote shall be appropriately numbered and identified by the complete company name, date and solicitation number in the header and/or footer. Evaluation Process: Award shall be made to the best value, as determined to be the most beneficial to the Government. Please read each section below carefully for the submittals and information required as part of the evaluation. Failure to provide the requested information below shall be considered non-compliant and your quote could be removed from the evaluation process. Offeror quotes shall be evaluated under FAR Part 13.106-2(b) -- Evaluation of Quotations or Offers. Therefore, the Government is not obligated to determine a competitive range, conduct discussions with all contractors, solicit final revised quotes, and use other techniques associated with FAR Part 15. The contracting techniques associated with FAR Part 15 are not mandatory. The Government shall award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation shall be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: Price (Follow these instructions): Offeror shall complete the attached Price Schedule, with offerors proposed contract line item prices inserted in appropriate spaces. Offerors must also provide all applicable labor rates for the solicited services so they can be compared to the applicable wage determination for compliance with the Service Contract Labor Standards. Ensure your representations and certifications are complete in the System for Award Management (SAM)( https://www.sam.gov). Otherwise, you will need to fill out solicitation Clause 52.212-3 "Offeror Representation and Certifications - Commercial Items", and submit with the quote. Federal Acquisition Regulations require that federal contractors register in the SAM database at http://www.sam.gov and enter all mandatory information into the system. Award cannot be made until the contractor has registered. Offerors are encouraged to ensure that they are registered in SAM prior to submitting their quotation. Past Performance: The Government also reserves the right to obtain information for use in the evaluation of past performance from any and all sources. Technical: The offeror s quote shall be evaluated to determine if the organization has the experience and capabilities to provide the requested services IAW the Performance Work Statement in a timely efficient manner. Contractor shall provide Material Lead times within the solicitation response. Please include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Items, with your offer via the SAM.gov website or a written copy. Clause 52.212-4, Contract Terms and Conditions -- Commercial Products and Services (DEC 2022), 52.252-2 Clauses Incorporated by Reference (FEB 1998), 52.204-13 System for Award Management Maintenance (OCT 2018), 52.204-18 Commercial and Government Entity Code Maintenance (AUG 2020), 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (MAR 2023), 852.203-70 Commercial Advertising (MAY 2018), 852.211-70 Equipment Operation and Maintenance Manuals (NOV 2018), 852.215-70 Service Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors, 852.215-71 Evaluation Factor Commitments (OCT 2019), 852.232-72 Electronic Submission of Payment Requests (NOV 2018), 852.242-71 Administrative Contracting Officer (OCT 2020), 852.247-71 Delivery Location (OCT 2018), 852.247-73 Packing for Domestic Shipment (OCT 2018). Clause at 52.212-5, Contract Terms and Conditions Required To Implement Statutes Or Executive Orders -- Commercial Items, applies to this acquisition and in addition to the following FAR clauses cited, which are also applicable to the acquisition: 52.204-10, 52.209-6, 52.219-6, 25.219-28, 52.219-33, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-36, 52.222-50, 52.223-18, 52.225-3, 52.225-13, 52.232-33. All contract requirement(s) and/or terms and conditions are stated above. The Defense Priorities and Allocations System (DPAS) and assigned rating are not applicable to this requirement. RFQ responses are due July 19, 2023, at 4:00 PM EST. RFQ responses must be submitted via email to: contact@example.gov. Hand deliveries shall not be accepted. The POC of this solicitation is Phillip Crockett (contact@example.gov). Performance Work Statement (PWS) Design and Content Introduction The VA Maine HCS requires the three Werewolf coblation systems for the Operating Room at Togus. Background Our goal in the VA is to provide veterans the world-class benefits and services they have earned and to do so by adhering to the highest standards of compassion, commitment, excellence, professionalism, integrity, accountability, and stewardship. The Werewolf coblation System can be used on a range of joint tissue types to provide coblation technology across a range of different settings. Designed for surgeons who want to restore joints as close as possible to their natural anatomy. VA Maine is looking to introduce this new technology to provide the standard of care. Scope (Provide an overview of the PWS emphasizing the most important aspects of your requirement and defining the boundaries of the contractor s performance responsibilities). Coblation technology means controlled ablation. The coblation process involves the creation and application of an energy field called glow discharge plasma. This plasma ablates tissue through a chemical process as highly-energized particles in the plasma break down molecules in the tissue. Coblation technology provides two distinct advantages to the surgeon: Coblation technology operates at lower temperatures than other radio-frequency (RF)-based technologies. The 100 m 200 m plasma field allows for precise removal of soft tissue with minimal damage to untargeted tissue. FLOW~IQ technology changes the size and intensity of the plasma field based on desired tissue effects. Enables VAC mode to rinse the joint and clear debris with a simple push of a button. The WEREWOLF system enables surgeons to treat various pathologies while minimizing instrument exchanges A single wand features 5* distinct operating modes, including VAC mode which quickly clears debris and optimizes visibility Intuitive touch screen and customized surgeon profiles simplify user experience. Compatible with 18-pin QUANTUM 2 wands Applicable Directives (List all documents referenced in the next section 5.0, Performance Requirements, with which the contractor will have to comply in performance of the contract effort. If only portions of a given document apply, specifically identify the applicable portions). The system must meet the manufacturer s specifications and be designed and implemented within the vendors 510K system design as an FDA regulated medical device/system. Performance Requirements (Identify what the contractor is required to do (major tasks and subtasks). The vendor will provide the Fluent Fluid Management System as specified in the quote provided. No additional requirements for these units. Deliverables (List all data required to manage or monitor contractor performance). Proaim provide a Standard 1-Year Warranty and will provide training on the unit once it has arrived and inventoried.