The Department of Veterans Affairs, VISN 9 Healthcare System, intends to award, on a sole-source basis, a fixed price purchase order to Censis, 830 Crescent Centre Dr. Ste. 610, Franklin, TN, in accordance with FAR 8.405-6. Censis shall utilize the Censitrac software which serves as the VHA s nationwide surgical/medical and dental instrument inventory and workflow system. The contractor will mark, fully commission all required data fields, and build instrument set count sheets as designated for assigned dental, medical-surgical instruments, and RME within each facility. Count Sheet creation will take place at the time of tray disassembly for marking/commissioning by the Contractor. Estimations of need are derived from site complexity levels for the provision of marks, commissioning, and type of stencils (i.e., standard or small). As part of this effort, the Contractor shall conduct requisite site assessments, mark and commission instruments, perform quality assurance testing, perform data validation, and load data standard-compliant data into the new system for all facilities within VISN 9. Contract is to be effective for a full year, beginning from the date of obligation, with four additional option years to continue service. (Please see draft performance work statement contained herein for a complete description of required services.) This notice of intent is not a request for competitive proposals. No solicitation document is available and telephone requests will not be accepted. However, any responsible source who believes it is capable of meeting the requirement may submit a capability statement which shall be considered by the agency, only if received by the closing date and time of this notice. A determination not to compete the proposed requirement based upon the responses to this notice is solely within the discretion of the government. Responses to this notice are due by Monday, July 9, 2018 at 12:00 PM CST by email to [email protected]. Statement of Work VISN 9 Instrument Tracking Acquisition Project Scope Tracking enhances the ability of VA to ensure patient and staff safety by providing reasonable assurance that instruments have been processed in accordance with regulatory guidelines and individual instrument manufacturer s Instructions for Use (IFU) for reusable medical equipment (RME) and dental/medical-surgical instrumentation. The Sterile Processing Inventory and Workflow Management Solution shall establish a solid foundation of enterprise-wide compliance with generally accepted recommendations from the World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), Association of periOperative Registered Nurses (AORN), The Joint Commission (TJC), International Organization for Standardization (ISO), International Association of Healthcare Central Service Materiel Management (IAHCSMM), Association for the Advancement of Medical Instrumentation (AAMI), and applicable VA Directives and Handbooks. The Sterile Processing Inventory and Workflow Management Solution workflows shall be based on the CDC Spaulding Classification, which has been used to categorize RME, surgical instruments, and patient care equipment (items) for over 40 years (See Section 3.3.4 for specific items.) This classification is based on the degree of risk for infection involved in the use of these items, which are categorized as Critical, Semi-Critical, and Non-Critical devices. Items will be used when referencing surgical / medical / and dental instruments throughout this document. Critical items are those that come into contact with sterile tissue and must be sterilized prior to use. This category includes surgical instruments, dental instruments, emergency procedure trays, loaner instruments, and implant sets. The category may include endoscopes that enter a sterile body cavity or items used on a sterile field. Semi-Critical items contact mucous membranes or non-intact skin. Examples of Semi-Critical items include, but are not limited to, flexible endoscopes and ultrasound transducers that enter an intact body cavity. Non-Critical items are those that come in contact with intact skin only. The Sterile Processing Inventory and Workflow Management Solution shall record the location, time stamp, and the status of a device/instrument/surgical container (set), etc. as it goes through the Sterile Processing System (SPS) reprocessing workflow. Locations to be scanned include, but may not be limited to Decontamination, Assembly and Preparation, Sterilization, Quality Assurance (QA), and Storage areas. Within these locations, there will be at least one scan point where work instructions are needed, a work step needs to be recorded, and/or a location update is required. Facility processes, number of stations, physical layout, and the complexity of the workflow in a facility may increase the number of scan points in each area. The Sterile Processing Inventory and Workflow Management Solution shall capture the movement of VAMC s Critical and Semi-Critical RME, and Non-Critical RME that have or shall receive an electrochemical or similar supplemental mark. It is assumed that any Non-Critical RME reprocessed by a VAMC Sterile Processing Services (SPS) will have or shall generally receive a linear barcode or 2-dimensional electrochemical mark that can be scanned into the solution. Some individual items, as well as instrument baskets and packages, cannot be marked electrochemically. These items shall be affixed with a linear barcode label which allows a handheld scanner to read and identify these items as they are inventoried, assembled, disinfected/sterilized, and prepared for distribution or storage. Under this requirement the Contractor shall provide the solution to serve as a VISN-wide Sterile Processing Inventory Tracking and Workflow Management Solution (ITS). The Contractor shall ensure the system is deployed to meet the needs of each unique VA facility based on their current business processes that will be impacted by the new technology. The Contractor shall provide hardware and software components as described in section 2 Hardware/software. As part of this effort, the Contractor shall conduct site assessments, update facility drawings, develop implementation plans, document system configuration unique to each site, install, configure and test hardware and software, provide pre-testing training to VA staff, provide roles-based training, warranty overview, and facility transition support. Hardware/Software Part Number 596 Lexington VA Medical Center Quantity 1 CSGOV Censitrac GOV Cloud Server 1 2 CT0142 Hardware 23 All in One touch screen PC 4 3 CT0157 Hardware Camera and Stand Bundle 2 4 CT0003 Hardware Censitrac Buffer Server Rack Mount 1 5 CT0154 Hardware Cognex DM 8600 Bundle 7 6 CT0098 Hardware Document Scanner 2 7 CT0088 Hardware Electromechanical Marking Kit 1 8 CT0128 Hardware FIPS Compliant Wireless Scanner 8 9 CT0024 Hardware Label Printer with Network Card 8 10 ICONS Implementation Consumables Package (tray/location labels, printer ribbons) 1 11 IMT301 Implementation Tier 3 InstrumenTrac Implementation Fee 1 12 IMS101 Marking Services Single Instrument estimated 25,000 instruments 1 13 CT0087a Stencils Electrochemical Marking Stencils standard 20 14 CT0087b Stencils Electrochemical Marking Stencils small 5 15 SUT301 Subscription Tier 3 Instrumen Trac 1 16 Lexington Instrument Tracking System Service Option Year 1 September 1, 2019 August 31, 2020 1 17 Lexington Instrument Tracking System Service Option Year 2 September 1, 2020 August 31, 2021 1 18 Lexington Instrument Tracking System Service Option Year 3 September 1, 2021 August 31, 2022 1 19 Lexington Instrument Tracking System Service Option Year 4 September 1, 2022 August 31, 2023 1 Part Number 603 Louisville VA Medical Center Quantity 20 CSGOV Censitrac GOV Cloud Server 1 21 CT0141 Hardware 22 All in One Medical grade touch screen PC 3 22 CT0142 Hardware 23 All in One touch screen PC 3 23 CT0157 Hardware Camera and Stand Bundle 2 24 CT0003 Hardware Censitrac Buffer Server Rack Mount 1 25 CT0154 Hardware Cognex DM 8600 Bundle 9 26 CT0098 Hardware Document Scanner 3 27 CT0088 Hardware Electromechanical Marking Kit 1 28 CT0128 Hardware FIPS Compliant Wireless Scanner 18 29 CT0024 Hardware Label Printer with Network Card 6 30 CT0071 Hardware Laser Jet Printer 4 31 CT0104 Hardware Waterproof Keyboard with Integrated Touchpad 3 32 ICONS Implementation Consumables Package (tray/location labels, printer ribbons) 1 33 IMT301 Implementation Tier 3 InstrumenTrac Implementation Fee 1 34 IMS101 Marking Services Single Instrument estimated 20,000 instruments 1 35 CT0087a Stencils Electrochemical Marking Stencils standard 5 36 CT0087a Stencils Electrochemical Marking Stencils standard 15 37 SUT301 Subscription Tier 3 Instrumen Trac 1 38 Louisville Instrument Tracking System Service Option Year 1 September 1, 2019 August 31, 2020 1 39 Louisville Instrument Tracking System Service Option Year 2 September 1, 2020 August 31, 2021 1 40 Louisville Instrument Tracking System Service Option Year 3 September 1, 2021 August 31, 2022 1 41 Louisville Instrument Tracking System Service Option Year 4 September 1, 2022 August 31, 2023 1 Part Number 614 Memphis VA Medical Center Quantity 42 CSGOV Censitrac GOV Cloud Server 1 43 CT0141 Hardware 22 All in One Medical grade touch screen PC 5 44 CT0142 Hardware 23 All in One touch screen PC 17 45 CT0157 Hardware Camera and Stand Bundle 1 46 CT0003 Hardware Censitrac Buffer Server Rack Mount 1 47 CT0154 Hardware Cognex DM 8600 Bundle 9 48 CT0098 Hardware Document Scanner 2 49 CT0088 Hardware Electromechanical Marking Kit 1 50 CT0128 Hardware FIPS Compliant Wireless Scanner 38 51 CT0024 Hardware Label Printer with Network Card 10 52 CT0104 Hardware Waterproof Keyboard with Integrated Touchpad 4 53 ICONS Implementation Consumables Package (tray/location labels, printer ribbons) 1 54 IMT301 Implementation Tier 3 InstrumenTrac Implementation Fee 1 55 IMS101 Marking Services Single Instrument estimated 20,000 instruments 1 56 CT0087a Stencils Electrochemical Marking Stencils standard 25 57 CT0087a Stencils Electrochemical Marking Stencils standard 5 58 SUT301 Subscription Tier 3 Instrumen Trac 1 59 Memphis Instrument Tracking System Service Option Year 1 September 1, 2019 August 31, 2020 1 60 Memphis Instrument Tracking System Service Option Year 2 September 1, 2020 August 31, 2021 1 61 Memphis Instrument Tracking System Service Option Year 3 September 1, 2021 August 31, 2022 1 62 Memphis Instrument Tracking System Service Option Year 4 September 1, 2022 August 31, 2023 1 Part Number 621 Mountain Home VA Medical Center Quantity 63 CSGOV Censitrac GOV Cloud Server 1 64 CT0142 Hardware 23 All in One touch screen PC 3 65 CT0157 Hardware Camera and Stand Bundle 2 66 CT0003 Hardware Censitrac Buffer Server Rack Mount 1 67 CT0154 Hardware Cognex DM 8600 Bundle 11 68 CT0098 Hardware Document Scanner 2 69 CT0088 Hardware Electromechanical Marking Kit 1 70 CT0128 Hardware FIPS Compliant Wireless Scanner 20 71 CT0024 Hardware Label Printer with Network Card 6 72 CT0071 Hardware Laser Jet Printer 2 73 CT0104 Hardware Waterproof Keyboard with Integrated Touchpad 3 74 ICONS Implementation Consumables Package (tray/location labels, printer ribbons) 1 75 IMT301 Implementation Tier 3 InstrumenTrac Implementation Fee 1 76 IMS101 Marking Services Single Instrument estimated 20,000 instruments 1 77 CT0087a Stencils Electrochemical Marking Stencils standard 15 78 CT0087a Stencils Electrochemical Marking Stencils standard 5 79 SUT301 Subscription Tier 3 Instrumen Trac 1 80 Mountain Home Instrument Tracking System Service Option Year 1 September 1, 2019 August 31, 2020 1 81 Mountain Home Instrument Tracking System Service Option Year 2 September 1, 2020 August 31, 2021 1 82 Mountain Home Instrument Tracking System Service Option Year 3 September 1, 2021 August 31, 2022 1 83 Mountain Home Instrument Tracking System Service Option Year 4 September 1, 2022 August 31, 2023 1 Part Number 626 Murfreesboro VA Medical Center Quantity 84 CSGOV Censitrac GOV Cloud Server 1 85 CT0142 Hardware 23 All in One touch screen PC 3 86 CT0157 Hardware Camera and Stand Bundle 1 87 CT0003 Hardware Censitrac Buffer Server Rack Mount 1 88 CT0154 Hardware Cognex DM 8600 Bundle 3 89 CT0098 Hardware Document Scanner 1 90 CT0088 Hardware Electromechanical Marking Kit 1 91 CT0128 Hardware FIPS Compliant Wireless Scanner 6 92 CT0024 Hardware Label Printer with Network Card 3 93 CT0071 Hardware Laser Jet Printer 1 94 CT0104 Hardware Waterproof Keyboard with Integrated Touchpad 1 95 ICONS Implementation Consumables Package (tray/location labels, printer ribbons) 1 96 IMT301 Implementation Tier 3 InstrumenTrac Implementation Fee 1 97 IMS101 Marking Services Single Instrument estimated 5,000 instruments 1 98 CT0087a Stencils Electrochemical Marking Stencils standard 3 99 CT0087a Stencils Electrochemical Marking Stencils standard 2 100 SUT301 Subscription Tier 3 Instrumen Trac 1 101 Murfreesboro Instrument Tracking System Service Option Year 1 September 1, 2019 August 31, 2020 1 102 Murfreesboro Instrument Tracking System Service Option Year 2 September 1, 2020 August 31, 2021 1 103 Murfreesboro Instrument Tracking System Service Option Year 3 September 1, 2021 August 31, 2022 1 104 Murfreesboro Instrument Tracking System Service Option Year 4 September 1, 2022 August 31, 2023 1 Part Number 626 Nashville VA Medical Center Quantity 105 CSGOV Censitrac GOV Cloud Server 1 106 CT0175 Cybernet Medical Grade Windows Tablet 1 107 CT0141 Hardware 22 All in One Medical Grade touch screen PC 8 108 CT0142 Hardware 23 All in One touch screen PC 11 109 CT0157 Hardware Camera and Stand Bundle 2 110 CT0003 Hardware Censitrac Buffer Server Rack mount 1 111 CT0154 Hardware Cognex DM 8600 Bundle 7 112 CT0098 Hardware Document Scanner 2 113 CT0088 Hardware Electrochemical Marking Kit 1 114 CT0128 Hardware FIPS Compliant Wireless Scanner 23 115 CT0024 Hardware Label Printer with Network Card 5 116 CT0071 Hardware Laser Jet Printer 2 117 CT0104 Hardware Waterproof Keyboard with Integrated Touchpad Mouse 8 118 ICONS Implementation Implementation Consumables Package (tray/location labels, printer ribbons) 1 119 IMT301 Implementation Tier 3 Instrumen Trac Implementation Fee 1 120 IMS101 Marking Services Single Instrument estimated 20,000 instruments 1 121 CT0087a Stencils Electrochemical Marking Stencils standard 15 122 CT0087b Stencils Electrochemical Marking Stencils small 5 123 SUT301 Subscription Tier 3 Instrumen Trac 1 124 Nashville Instrument Tracking System Service Option Year 1 September 1, 2019 August 31, 2020 1 125 Nashville Instrument Tracking System Service Option Year 2 September 1, 2020 August 31, 2021 1 126 Nashville Instrument Tracking System Service Option Year 3 September 1, 2021 August 31, 2022 1 127 Nashville Instrument Tracking System Service Option Year 4 September 1, 2022 August 31, 2023 1 Marking and Commissioning Contractor shall provide marking and commissioning services to include labor, travel, data management, project management and expenses for the following instrument quantities and labor weeks: Lexington 25,000 instruments; 25 labor weeks Louisville 20,000 instruments; 20 labor weeks Memphis 30,000 instruments; 30 labor weeks Mountain Home 20,000 instruments; 20 labor weeks Nashville 20,000 instruments; 20 labor weeks Murfreesboro 5,000 instruments; 5 labor weeks Instruments will be marked and commissioned in compliance with EDA Standard 2.0 descriptions. VISN 9 is responsible for reprocessing all instruments within 24 hours following the recommended processes and procedures as outlined by the instrument manufacturer. Instruments will be reviewed for legible catalog number and will have NMN and the stencil number entered as the catalog number. Instruments without a vendor name will have NVN entered as the vendor name. the marking technician will enter a description of the instrument based on their knowledge and experience. Instruments that are of an odd size, shape or configuration that prevent them from being electrochemically marked, as determined by the contractor, shall be returned to the sterile processing unit as unable to mark. If the instrument material is not conducive to receiving an electrochemical mark as determined by the contractor, the instrument shall be returned to the sterile processing unit as unable to mark. QUALITY CONTROL The following Quality Control (QC) requirements have been developed to ensure that all site implementations are provided an appropriate level of monitoring. These activities should afford the VISN 9 team with a reasonable and achievable level of activity intended to assure and/or improve the quality of the marking and commissioning. This approach evaluates both the physical and data characteristics, identifies concerns or shortcomings in the delivery of services, provides the ability to overcome any identified deficiencies, and monitors the effectiveness of any required corrective actions. After 2D mark application, the contractor will immediately QC the item to ensure it scans easily into the instrument tracking system. Marks that do not read within 3-5 seconds will be assessed for re-application prior to commissioning. VISN 9 staff will perform QC on the contractor-performed work on a contractor provided workstation, which permits access to the instrument database. This access will allow VISN 9 staff to evaluate the quality of the mark and that the instrument scanned is the one displayed in the instrument tracking system. It s important that the product name corresponds to the instrument being scanned. The QC of the instruments by VISN 9 should be performed daily on at least 10% of the instruments which have been marked that day. Successful QC results will be considered as acceptance of the work. Should VISN 9 not perform the QC check it will be considered that the work is accepted Project Management, Implementation and Marking Services Implementation Provide a project plan and manage the implementation. Install and manage the on-site server software. Convert and load count sheet data into the application prior to on-site implementation. Provide on-site training for hospital staff in the effective use of the application. Provide on-site training for the instrument marking process. Provide on-going support for the application to include travel and expenses. Marking Services Overall execution of the marking process to include management of equipment/personnel and communication and reporting to each VA facility. Tasks include management of the marking operation, mobile marking system technical administration and marking and commissioning of instruments at each facility. Travel and expenses included. Place of Performance: VISN 9 Facilities 596 Lexington VA Medical Center 2250 Leestown Rd Lexington, KY 40511-1093 603 Robley Rex VA Medical Center 800 Zorn Avenue Louisville, KY 40206 614 Memphis VA Medical Center 1030 Jefferson Avenue Memphis, TN 38104 621 James H. Quillen VA Medical Center Corner of Lamont and Veterans Way Dogwood Avenue, Building 205 Mountain Home, TN 37684 626 Alvin C. York VA Medical Center 3400 Lebanon Pike Murfreesboro, TN 37129 626 Nashville VA Medical Center 1310 24th Avenue South Nashville, TN 37212

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