FA7000-17-R-0042 Notice of Intent to Sole Source - STERIS Surgical Sterilization Maintenance

NOTICE OF INTENT TO SOLE SOURCE The 10th Contracting Squadron (10 CONS/PKB), United States Air Force Academy (USAFA) intends to award on Sole Source basis to the vendor, STERIS, Corp. for preventative maintenance and repair services on STERIS manufactured equipment. This notice document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2005-89, effective 15 August 2016. 10th Medical Group currently has surgical/dental sterilization equipment that requires quarterly preventative maintenance and unscheduled repair services. Surgical/Dental Equipment includes two (2) STERIS V-PRO 1 Single Door Chemical Sterilizers, two (2) STERIS Reliance Synergy Washers, one (1) STERIS Vision Electric Washer and one (1) STERIS System 1E Scope Washer. STERIS, Corp., a large business is the only authorized service provider and parts supplier for the STERIS manufactured equipment. This procurement is for the acquisition of a sole source commercial item using simplified procedures in accordance with FAR Parts 12 & 13. The North American Industry Classification System Code (NAICS) is 811219 and the business size standard is $20.5M. 1. Only one responsible source, and no other, will satisfy current USAFA requirements. 2. Comprehensive preventative maintenance on the surgical/dental equipment is required. Services must be in accordance with (IAW) manufacturer's preventive maintenance procedures. Repairs must be performed IAW manufacturer requirements on all unscheduled repair service calls. All parts used during maintenance and repair services should be original equipment manufacturer parts. All personnel, software updates, parts, tools, materials, supervision, technical literature, manufacturer repair requirements/manuals, transportation and services necessary to meet the Surgical Sterilization Equipment Maintenance and Repair Services requirement shall be provided. All services shall be conducted using manufacturer trained and authorized personnel. Maintenance of surgical/dental equipment, to include repairs shall be performed IAW manufacturer specifications. The following summarizes the justification and approval of single source from STERIS, Corp. by detailing more specifically the proprietary nature of the requirement, as well as requirements that other vendors do not meet. a. STERIS Corporation is the manufacturer of our existing surgical/dental sterilization equipment. b. In order to meet the rigid infection control standards, preventative maintenance and repairs services for STERIS equipment can only be performed by STERIS trained and authorized/certified personnel. All equipment must be serviced in accordance with manufacturer specifications, any deviation from these service procedures could put medical patients at risk of infection. In addition to having an authorized STERIS service technician, suitable replacement equipment parts can only be provided by the manufacturer. c. These equipment items are specialized, sterilization units used to clean surgical instruments. Each piece of equipment must adhere to rigid infection control standards. Those control standards are set by the Centers for Disease Control Guidelines for Disinfection and Sterilization in Healthcare Facilities and Accreditation Association for Ambulatory Health Care. All equipment must pass a Daily Air Removal Test and three biological indicator tests prior to each use. Surgical/dental instruments must pass each sterilization indicator test or the instrument cannot be used in surgery. Along with the tests, the equipment has to maintain sterilization temperatures of 275F. d. STERIS is the only authorized service provider and parts supplier for STERIS manufactured equipment. Service providers for STERIS equipment must be STERIS trained/certified technicians using STERIS manufactured parts. STERIS does not train, certify, or support independent third party providers to service their equipment or supply their parts. STERIS trained/certified technicians and manufactured parts are required to ensure the equipment is maintained within manufacturer specifications. e. The use of an unauthorized STERIS technician or non-manufactured STERIS part could lead to improper sterilization and eventual patient infection, possible death, lawsuits against the hospital and potential loss of hospital accreditation. This utilization of such untrained and uncertified sources would present a significant liability and risk to the Government. Additionally, if the surgery department could not properly sterilize the surgical/dental instruments they would not be permitted to perform surgery as scheduled, which would lead to a cancellation. Canceled surgeries result in a Government loss of $15,000.00 per cancellation. This synopsis is for notification purposes only and does not constitute a solicitation for bids or proposals. DO NOT submit a bid/quote at this time. Any offerors believing they can provide the preventative maintenance and repair services on STERIS manufactured equipment that meets the requirements described above may provide evidence for consideration. Evidence must support the offeror's claim that they can provide these services. All qualified sources may submit a response, which if received timely, will be considered by this agency. Information received will be considered solely for the purpose of determining whether a competitive procurement can be conducted. A determination not to compete this proposed procurement based on responses to this notice is solely within the discretion of the Government. Responses must be received NLT 04:00 p.m. MDT on 9 June 2017. Responses received after this date, will not be be considered. The Government does not intend to pay for any information provided under this announcement. Contractors must have a current registration with the System for Award Management (SAM) at http://sam.gov/. The Government intends to award a firm fixed price purchase order processed in accordance with FAR 12 and 13. Questions should be addressed to the Primary POC: Pamela Reimers, Contract Specialist, (719) 333-4493 or send via e-mail to pamela.reimers@us.af.mil. Alternate POC is Chad Miller, Contracting Officer, (719)-333-3829, chad.miller.24@us.af.mil. 5352.201-9101 OMBUDSMAN (JUN 2016) (a) An ombudsman has been appointed to hear and facilitate the resolution of concerns from offerors, potential offerors, and others for this acquisition. When requested, the ombudsman will maintain strict confidentiality as to the source of the concern. The existence of the ombudsman does not affect the authority of the program manager, contracting officer, or source selection official. Further, the ombudsman does not participate in the evaluation of proposals, the source selection process, or the adjudication of protests or formal contract disputes. The ombudsman may refer the interested party to another official who can resolve the concern. (b) Before consulting with an ombudsman, interested parties must first address their concerns, issues, disagreements, and/or recommendations to the contracting officer for resolution. Consulting an ombudsman does not alter or postpone the timelines for any other processes (e.g., agency level bid protests, GAO bid protests, requests for debriefings, employee-employer actions, contests of OMB Circular A-76 competition performance decisions). (c) If resolution cannot be made by the contracting officer, the interested party may contact the ombudsman, James Anderson 8110 Industrial Drive, Ste 103 USAFA, CO 80840 Telephone number 719-333-2704 FAX 719-333-9103 Email: james.anderson.72@us.af.mil Concerns, issues, disagreements, and recommendations that cannot be resolved at the Center/MAJCOM/DRU/SMC ombudsman level, may be brought by the interested party for further consideration to the Air Force ombudsman, Associate Deputy Assistant Secretary (ADAS) (Contracting), SAF/AQC, 1060 Air Force Pentagon, Washington DC 20330-1060, phone number (571) 256-2395, facsimile number (571) 256-2431. (d) The ombudsman has no authority to render a decision that binds the agency. (e) Do not contact the ombudsman to request copies of the solicitation, verify offer due date, or clarify technical requirements. Such inquiries shall be directed to the Contracting Officer. (End of clause)