6515--InVitaTissue and Implant Tracking System Software

This is a notice of intent to sole source a contract under the authority of FAR 13.106-1(b)(2), only one source being available to meet the Government s need. The contract will be to purchase InVita UDITracker Operating Room (OR) Premium with VistA Interface software to be used for aTissue and Implant Tracking System for five separate sites within the VA Northern California Healthcare System. The North American Industrial Classification System (NAICS) code for this procurement is 513210 Electromedical diagnostic equipment manufacturing, with a small business size standard of $41.5 million. The FSC/PSC is 6515 Medical and Surgical Instruments, Equipment, and Supplies. The Department of Veterans Affairs intends to solicit and award a sole source contract for the purchase of InVita UDITracker Operating Room (OR) Premium with VistA Interface software to Champion Medical Technologies, Inc. dba InVita Healthcare Technologies, 765 Ela Rd., Ste. 200, Lake Zurich, IL 60047-6305. There are no

other source of supply/service that will satisfy agency requirements. The InVita UDITracker Operating Room (OR) Premium with VistA Interface software is currently being used by and is to be used by: Mare Island VA Clinic 201 Walnut Avenue, Building 201 Mare Island, CA 94592-1107 Martinez VA Outpatient Clinic 150 Muir Road Martinez, CA 94553-4668 McClellan VA Outpatient Center 5342 Dudley Boulevard, Building 88 McClellan Park, CA 95652-1012 Redding VA Outpatient Clinic 3455 Knighton Road Redding, CA 96002-9498 Sacramento VA Medical Center 10535 Hospital Way Mather, CA 95655-4200 The VA Northern California Health Care System tracks human biological and non-biological implants using InVita (UDI Tracker) Healthcare Technologies hardware and software as an inter-communicating system. This system complies with tissue and implant tracking requirements set by the Joint Commission (JCAHO). Each specialty is responsible for their own recalls and tracking of required UDI implants with oversight from Patient Safety, Prosthetics, Logistics, and Nursing Services. Prior to the use of this system in 2019, recalls on implantable products took a fair amount of time to track and often the request for information was asked multiple times causing confusion and frustration. UDITracker is in the process of integrating with Vista to streamline work and avoid data entry errors into VistA. VistA interface is expected to roll out after January 2023 at VA NCHCS. The implant system effectively manages inventory of all types of implantable items/devices (biological and non-biological), as well as have the full capacity to extend to other tracked items e.g. hearing aids, dental implants, etc. Tracking system shall support oversight of all devices across the VA Northern California Health Care System, which include the Sacramento, Martinez, McClellan, Mare Island and the Redding VA s sites. Going forward, the only in scope IT item is to assist with the installation and testing of the VistA integration software which automatically writes certain information into appropriate VistA files and fields when implants are used on a Veteran. This VistA integration piece avoids double data entry and the potential for data entry errors in VistA. System supplies access to a web based system to track devices from initiated request/use through to implant/delivery to patient and back (bi-directional) extending to warranty and supplier licensing/certification tracking. All integrated features will have retrievable supporting documentation with established analytics tools that drill by various fields and are exportable in various formats including but not limited to Excel & PDF. Hardware (scanner & printer full service for 5 locations), maintenance, licensing, unlimited storage capacity & information retention for a minimum of 75 years from last date of entry, multi-level training is already in place. Software must be compatible with and integrate with the VA s VistA system. Software must include the following features: VA dedicated centralized remote server - Authorized by VA Central Office through national ISA/MOU Patient privacy & security - No patient names stored Tissue supplier certifications automatically updated, maintained & stored within program Tissue prep instructions automatically updated, maintained & stored within program Automated delivery of tissue implant record back to supplier Automatic recall matching for all tissue and non-tissue implants - Not reliant on 3rd-party recall notification provider (Notifications direct from the FDA) No on-site server at facility or VISN level Integration with VistA - including scanning of tissue/implants into patient record eliminating the need for nurses to manually enter data. THIS FEATURE IS CRITICAL AND WILL BE IMPLEMENTED IN FY 2023. GS1/UDI barcode scanning ready - Label generation not required Warranty Credit Tracking - Integration with the device manufacturers providing real-time updates One-click entry of tissue shipments from LifeNet, Allosource, CTS, RTI, MTF, MiMedx directly into available inventory Ability to scan and parse out all UDI-certified bar code formats Integrated RFID storage with 24/7 remote monitoring - approved by VA Central Office through national ISA/MOU Data/Analytics for quick reconciliation including real-time cost per procedure per surgeon One scan check & certification of rep delivered inventory prior to use ITEM INFORMATION ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT 0001 1.00 EA 0001 Mare Island VA Clinic 0002 1.00 EA 0002 Martinez Outpatient Clinic 0003 1.00 EA 0003 McClellan Outpatient Center 0004 1.00 EA 0004 Redding Outpatient Clinic 0005 1.00 EA 0005 Sacramento VA Medical Center 0006 1.00 EA 0006 Vista Interface - All Facilities The anticipated contract will include a base year period of performance of one year/12 months and four option years each of one year/12 months for identical line items. Any responsible source that feels it is capable in performing this requirement may submit a quote (monthly per scope) for the above listed items and describe and/or submit documentation to support your capabilities. The response will be considered by the agency. If you are not the Original Equipment Manufacturer (OEM), you must submit an authorized distributor letter signed by the OEM. If you are not the OEM and a small business, you must indicate in your response how you will comply with limitations on subcontracting and/or the non-manufacturer rule. Responses should be submitted to Brian K. Fritz at Brian.Fritz@va.gov no later than December 5, 2022 at 10:00 AM Pacific Time to be considered. If no responses are received, the Government will continue with its sole source procurement, and a sole source Request for Quote will be published to contract opportunities in accordance with FAR 5.102.