Inactive

The Naval Medical Logistics Command (NMLC) intends to negotiate on a sole source basis in accordance with 10 U.S.C. 2304(c)(1) and FAR 6.302-1 sole source (including brand name) acquisitions OR FAR 13... The Naval Medical Logistics Command (NMLC) intends to negotiate on a sole source basis in accordance with 10 U.S.C. 2304(c)(1) and FAR 6.302-1 sole source (including brand name) acquisitions OR FAR 13.106-1(b)(1) soliciting from a single source. The proposed source is Johnson & Johnson Health Care Systems Inc. of 425 Hoes Ln Piscataway, NJ 08854-4103. The Naval Hospital Pensacola (NHP) has a requirement for one (1) Sterilizing Unit, Germicidal Gas, Gaseous Plasma [18-146]. The Naval Hospital Beaufort (NHB) has a requirement for two (2) Sterilizing Units, Germicidal Gas, Gaseous Plasma [18-146]. The sterilizers shall be capable of sterilization through the use of low temperature gas plasma generated in an enclosed vacuum chamber using radio frequency or microwaved energy. The units shall be capable of inactivating microorganisms by the combined use of hydrogen peroxide (H2O2) gas sterilant coupled with the generation of free radicals during the plasma phase of the sterilization cycle. The units shall be validated for low-temperature gas plasma sterilization at temperatures less than 60 ? C. The units shall utilize a H2O2 concentration as the sterilant. The sterilant concentration levels shall be monitored by ultraviolet (UV) sensors within the chamber. The stand-alone units shall be capable of high-level disinfection of flexible endoscopes, light cords, cameras and accessories utilized in arthroscopic and laparoscopic procedures. The units shall automatically detect and remove moisture within the vacuum chamber prior to sterilization. The units shall be capable of standard cycle sterilization and processing endoscopes with and without lumens to meet each scope's manufacturer's instructions for use (IFU). The sterilizers shall be compatible with the installed base of flexible endoscopes at NH Pensacola and NH Beaufort, including, but not limited to, equipment listed in table 1 and table 2 below. The units shall be compatible with Aesculap sterilization trays. The units shall have one single door for ingress and egress of flexible endoscopes, light cords, cameras and accessories. The electrical power requirements are 208 VAC, 60 Hz. Table 1: NH Pensacola Inventory Scope Nomenclature Manufacture Urology Scopes (flexible, rigid, micro) Olympus Urology Flexible Scopes Stryker Cameras Olympus Light Cords Olympus Cameras Stryker Light Cords Stryker Cystoscopy Scopes Stryker Arthroscopy Scopes Stryker ENT Scopes Stryker Laparoscopy Scopes Stryker Hysteroscopy Scopes Stryker Drill & Saw Batteries Stryker Table 2: NH Beaufort Inventory Scope Nomenclature Manufacture Arthroscopes Arthrex Inc. Arthroscopes Stryker Cameras Stryker Light Cords Olympus Light Cords Stryker Laparoscopy Scopes Stryker Drill & Saw Batteries Stryker Drill Hand piece Smith and Nephew The units shall meet the validation standards set forth by Association for the Advancement of Medical Instrumentation (AAMI), International Organization for Standards (ISO) and American National Standards Institute (ANSI). Sterilization cycles shall meet the International Organization for Standards ISU14937 - Sterilization of Healthcare Products and AAMI ST58 - Sterilization and High Level Disinfection in Healthcare Facilities. The system, including claims made for the product, 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. The system shall be installed in compliance with OSHA requirements. Contractor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the equipment/system shall be in accordance with the OEM terms and conditions. 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 in this process. If interim storage is required, the vendor shall make arrangements for the storage. The vendor is also responsible for the initial instrument operational and performance validations. There are not set-aside restrictions for this requirement. The intended procurement will be classified under North America Industry Classification System (NAICS) 339113. This notice of intent is not a request for competitive proposals and no solicitation document exists for this requirement. However, parties interested in responding to this notice will need to submit technical data sufficient to determine capability in providing the same product. All capability statements received by the closing date of this synopsis will be considered by the Government. 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. If a vendor challenges the basis of this requirement, please email product capability statements (formats for submission: PDF, MS Word, or MS Excel) to Benjamin Marcus at Benjamin.t.marcus2.civ@mail.mil. Closing date for challenges is no later than 2:00 PM ET on 12 February 2019. No phone calls will be accepted.