Page 1 of 9 DEPARTMENT OF VETERANS AFFAIRS Sole Source Justification Under Simplified Procedures For Certain Commerical Items In Accordance With FAR 13.5 Acquisition Plan Action ID: 36C252-21-AP-2251 Contracting Activity: Department of Veterans Affairs Great Lakes Acquisition Center, NCO-12 115 South 84th Street, Suite 101 Milwaukee, WI 53214-1476 Department of Veterans Affairs William S. Middleton VA Medical Center 2500 Overlook Terrace Madison, WI 53705-2254 Identify purchase request number: 607-21-3-969-0164 Nature and/or Description of the Action Being Processed: This procurement is for Quantum Perfusion (Heart-Lung Machine) in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. Furthermore, justification and approval are for sole source to Spectrum Medical Inc. and will be awarded as a firm-fixed-priced purchase order. Description of Supplies/Services Required to Meet the Agency s Needs: William S. Middleton VA Medical Center located in Madison, Wisconsin is requesting an additional Quantum Perfusion (Heart-Lung Machine) for their operating room (OR) in order to perform surgeries that require heart-lung bypass. Estimated Amount: $X.XX Statutory Authority Permitting Other than Full and Open Competition: FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below: - - - - (X) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements - - - - ( ) Unusual and Compelling Urgency - - - - ( ) - Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services - - - - ( ) International Agreement - - - - ( ) Authorized or Required by Statute - - - - ( ) National Security - - - - ( ) Public Interest Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Accordingly, Spectrum Medical Inc. is the only firm capable of providing the supplies and services described in Section III above without the Veteran s Health Administration experiencing substantial duplication of cost that could not be expected to be recovered through competition and unacceptable delays in fulfilling its requirements. Heart-Lung bypass units are FDA regulated Class 3 devices and are considered High-Risk Medical Equipment as defined by the VA Healthcare Technology Management program office per memo SB2016-009. The current (EE# 31436) is past end of life and will not be supported by the end of 2021. Facility recently procured a Heart-Lung Machine, PO# 607A10010, 36C25221P0274, and would prefer to have two of the same models in the fleet. Consistency in operation of and familiarity with these machines is a major component of perfusion practice. Since the new machine will be used interchangeably with the current machine and among the providers, it is necessary to provide the identical machine in order to avoid dangerous or unsafe conditions. Furthermore, staff are familiar with the Quantum Perfusion Console. Standardization also assists with service and repair costs. Having an identical system allows the new unit to be rolled into the existing support agreement for Quantum Perfusion (Heart-Lung) Machines upon conclusion of the warranty period, thereby eliminating the need to create and manage a separate support agreement with a different vendor. Spectrum Medical Inc. does not authorize any 3rd party vendors to support devices due to their sensitive nature, the highly specialized knowledge, and training required to support these devices. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Posted Intent to Sole Source 36C25221Q0568 to beta.SAM from 04/08/2021 to 04/12/2021 to negotiate a limited source contract with Spectrum Medical Inc. for quantum perfusion technologies. Information received in response to this special notice would be considered solely for the purpose of determining whether to conduct a competitive procurement. No other Contractor is interested in the quantum perfusion technology procurement besides Spectrum Medical Inc. Reason for Intent to Sole Source was based on previous procurement results. Pre-solicitation 36C25221Q0152 was posted to beta.SAM from 11/19/2020 to 12/04/2020 to conduct a small business set-aside as brand name or equal. Open Market RFQ was posted to beta.SAM from 12/04/2020 to 12/16/2020 that only rendered one offer. Procurement was awarded to Spectrum Medical Inc on 12/30/2020 Purchase Order 36C25221P0274 PO: 607A10010. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The steps to be taken to find that the price will be determined fair and reasonable will be based on historical data from similar Heart-Lung Machines from Federal Procurement Data System - Next Generation (FPDS-NG). Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: In accordance with FAR Part 10, VAAR 810 and VAAM M810, market research has been conducted for this acquisition. Used VA s VIP database to identify verified capable SD/VOSBs. VIP query on November 12, 2020 keyword Perfusion with FSC 6515 revealed one VOSB. VOSB is not a manufacturer but coordinates medical staffing. Therefore, the VA Rule of Two cannot be met. Original Equipment Manufacturer (OEM) for this requirement is Spectrum Medical Inc. who is considered a Small Business (SB) per System for Award Management (SAM) Reps & Certs. Electronic Business Controller Dana Hopkins at Spectrum Medical Inc. states that they do not have authorized distributors. CS conducted a search in GSA Advantage by entering Perfusion and Heart that revealed books and a couple of replacement parts, but not Perfusion Machine. Contract Specialist (CS) entered Spectrum Medical into the Interagency Contract Directory Portal and received zero results. CS conducted a search in NASA SEWP by entering Perfusion that displayed zero results. Any Other Facts Supporting the Use of Other than Full and Open Competition: It is necessary to provide the identical Heart-Lung Machines in order to avoid dangerous or unsafe conditions within the operating room (OR) in order to perform surgeries that require heart-lung bypass. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Spectrum Medical Inc. Small Businesses (SB) A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: Spectrum Medical Inc. was the only Contractor who provided a quote on previous open market solicitation over SAT. Furthermore, no other Contractor showed any interest to current Intent to Sole Source. Spectrum Medical Inc. does not authorize any 3rd party vendors to support devices due to their sensitive nature, the highly specialized knowledge, and training required to support these devices. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief. ES_______________________________________________________ Carl R. Weber Contract Specialist Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: Contracting Officer or Designee s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. ES_______________________________________________________ Thomas H. Chesak Contracting Officer One Level Above the Contracting Officer (Required over SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition. ES_______________________________________________________ Parris S. Weidenbach Equipment Branch Chief Contracting Officer
