Notice of Intent to Sole Source Two (2) Sharp Washer/Sterilizing Units and Services for US Naval Hospital Yokosuka (USNHY), Japan

Notice of Intent to Sole Source HT941023N0032 THIS IS A NOTICE OF INTENT TO AWARD A SOLE SOURCE CONTRACT TO ALFRESA CORPORATION. The Defense Health Agency Contracting Activity (DHACA), Western Markets Contracting Division (WMCD), San Diego, intends to award a firm fixed price Sole Source non-personal services contract for two (2) Sharp washer /sterilizer units and on-site preventative maintenance and repair services Outside the Continental of the United States (OCONUS) in support of United States Naval Hospital Yokosuka (USNHY), Japan UNDER THE AUTHORITY OF Federal Acquisition Regulation (FAR) 13.501(a), Sole Source acquisitions and FAR 13.106-1(b)(1)(i), only one source being available to meet the Government's needs, to: ALFRESA CORPORATION 2-1-14, Sachiura, Kanazawa-Ku Yokohama, Kanagawa 236-0003, Japan The anticipated North American Industry Classification System (NAICS) code for this requirement is 339113, Surgical Appliance and Supplies Manufacturing; the business size standard is 750 Employees. The Product Service Code (PSC) is 6515, Medical Equipment and Accessories and Supplies. SUPPLIES and SERVICES: USNHY has a requirement for two (2) Sharp Washer/Sterilizing Units [14-413]. The washer/sterilizing units shall disinfect medical and dental instruments for the Main Operating Room (MOR); Ears, Nose, Throat (ENT) department, Ophthalmology department, Emergency Room (ER), Dental department, and Branch Health Clinics (BHC's) Mother Infant Unit, Family Practice, General Surgery, Urology, Obstetrics/Gynecology (OB/GYN) Gyn, Respiratory, Oral, and Maxillofacial. Each unit shall: Be a single chamber washer capable of disinfecting a minimum of ten (10) daily loads. Have pass-through capability and shall be capable of being recessed into a wall without construction or physical structure change to the facility. Include two (2) two-level racks and four (4) three-level racks. Include one (1) black and white printer with the ability print the results of the cycles. Include a starter kit with all of the required instrument detergents and lubricants. Include all required accessories for full functionality. The anticipated period of performance is for a one-year base period, four (4) one-year option periods, and the option to add additional quantity (delivered by 1 July 2023). The pass-through washers shall have an individual dimensional footprint no greater than 83 1/4 x 42 x 38 (HxWxD). The units shall be compatible with the currently installed Original Equipment Manufacturer (OEM) Sharp washer / sterilizer, hot water, pure water, steam, and drainage dissipation system at USNHY. The potential vendor shall de-install, remove, and discard the currently installed units, and install the new configured proposed washer / sterilizer to operate within the USNHY electrical requirements: 200-208 VAC, 3 Phase, 50 Hz, without the support of additional electrical support (i.e., transformers, converters). 200-208 VAC is a requirement for United States equipment and facilities operating in Command Fleet Activities, Yokosuka. The units shall comply with infection control standards as set forth by the Joint Commission. The units shall comply with the following: (1) Association for the Advancement of Medical Instrumentation (AAMI) standard, and (2) ST79: A comprehensive guide to steam sterilization and sterility assurance in health care facilities. The units shall be certified with the Underwriters Laboratories (UL) seal, as required by the USNHY Safety Department. The vendor shall provide in-person on-site operational training for a minimum of two (2) personnel, subsequent to the installation. The vendor shall provide biomedical engineer training for a minimum of two (2) personnel. The vendor shall provide a minimum of two (2) operator and two (2) service manuals, each in English. The system shall be compliant with Food and Drug Administration (FDA) regulations, with respect to marketing and delivering medical products for use in the United States of America and installed in compliance with the Occupational Safety and Health Administration (OSHA) requirements. The anticipated Contractor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system; such that, the OEM warranty and service are provided and maintained. All software licensing, warranty, and service associated with the equipment/system shall be in accordance with the OEM terms and conditions. The washer/sterilizing unit will require on-site annual inspection, preventive maintenance, and calibration services. Maintenance includes services, labor, parts, materials, and equipment necessary for the preventive maintenance, calibration, and repair for the units. The units shall be serviced and maintained within the OEM specifications, in accordance with the US and Local Japan laws, regulations, and meet the Joint Commission requirements. Upon delivery, the contractor shall be responsible for uncrating the unit/system, transporting it through the facility to the location of intended use for installation, and removing of all trash created during this process. The anticipated vendor shall be responsible for the de-installation and removal of existing equipment. If interim storage is required, the vendor shall make arrangements. The vendor is also responsible for the initial instrument operational and performance validations. Following the warranty period, the vendor shall be able to provide in-person on-site maintenance to the unit/system in Japan. Market research indicates, Alfresa Corporation is the only source that can meet the Government's minimum salient characteristic washer / sterilizer units, delivery, and in-person on-site maintenance and repair services equipment requirements. at USNHY in working order. Alfresa Corporation shall provide, not limited, but to include 2 washer / sterilizer units IAW facility installation and electrical specifications no later than the required delivery date of 1 July 2023, in-person on-site preventative service maintenance, inspecting, and adjustments as necessary, and replacement of broken or worn parts in compliance with OEM specifications. Alfresa Corporation is the only proven local contractor capable of providing the required supplies and services through a site visit due to having the required exact equipment specification without needing to re-configure or the Government incurring additional cost due to ease of installation, OCONUS in-person on-site maintenance capability and not re-doing the plumbing, drainage, and electrical structure due to USNHY older building structure. Considering Alfresa is located in Japan, significant shipping cost and delivery times will be saved by the Government. This Notice of Intent is not a request for Expressions of Interest (EOIs), proposals, or quotations. No solicitation document exists for this requirement and no telephone inquiries will be accepted. No contract award will be made on the basis of EOIs, proposals, or quotations received in response to this notice. Sources interested in responding to this notice are required to submit a capability statement, that includes management and technical data and cost information, in sufficient detail and with convincing evidence that clearly demonstrates the capability to provide the required supply and services at USNHY, Japan. The Government will consider all EOIs received prior to 15-days after the date of publication of this synopsis before 5:00 PM PST on that date. All capability statements received by the due date of this notice will be considered by the Government. A request for documentation or additional information or submissions that only ask questions will not be considered as an affirmative response. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole source contract. Submitters bear the burden of ensuring the EOI reaches the designated point of contact above on time and should allow a reasonable time for emails to be received. All information must be received before the deadline specified below and any information received after the deadline will not be considered. The submitter bears the risk of non-receipt of emails and should confirm by telephone that any email was received. This purchase will be under Simplified Acquisition Procedures and Other Than Full and Open Competition as authorized under FAR 13.5. The anticipated award date is 22 May 2023. If a vendor challenges the basis of this requirement, please email capability statements (formats for submission: MS Word, PDF, or MS Excel) to Ms. April L. Burbage at contact@example.gov. The closing date for challenges is no later than 10:00 AM Pacific Time, 21 April 2023.