Abbott RALS POC Middleware, Chalmers P. Wylie VA Ambulatory Care Center, Columbus, Ohio 43219

Page 1 of 1 36C25027Q0023 SPECIAL NOTICE NOTICE OF INTENT TO SOLE SOURCE Abbott RALS POC Middleware - Columbus, OH The Department of Veterans Affairs, The Chalmers P. Wylie VA Ambulatory Care Center, Columbus OH, 420 N. James Road, Columbus, Ohio 43219 intends to solicit and negotiate with only one source under the authority of FAR 6.302-1(a), Only one responsible source and no other supplies or services will satisfy agency requirements. The VA intends to solicit and negotiate with Abbott Rapid Diagnostics Informatics, Inc., RALS, 915 East High Street, Suite 500, Charlottesville, VA 22902. This purchase is with Abbott Rapid Diagnostics Informatics, Inc., RALS; Abbott does not use third parties to distribute their products to the government. Abbott has a program for connecting Abbott i-STAT, Abbott ID NOW and Accu-Chek point of care instruments to RALS Software so that Veteran test results automatically upload to the Electronic Health Medical Records. RALS is already in use at Columbus VA ACC and outlying CBOCs. RALS is the only Middleware capable of restricting user access for manual POC test entry into the EHRM and compatible with Cerner. The Government believes that only Abbott Rapid Diagnostics Informatics, Inc., RALS can satisfy the agency requirement. We intend to negotiate with only one source under the authority of FAR 6.302-1(a)(2), Only one responsible source and no other supplies or services will satisfy agency requirements. Other people may identify their interest and capability to respond to this requirement by October 13, 2026, by 5PM EST. Such capabilities information will be used solely for the purpose of determining whether or not to conduct this procurement on a competitive basis. All information shall be furnished at no cost or obligation to the Government. A determination by the Government not to open the requirement to competition based upon responses to this notice is solely within the discretion of the Government. No solicitation is available at this time.  All inquiries must be submitted by email to Gina P. Crank at [email protected] Enter RFQ 36C25027Q0023 Abbott RALS POC Middleware - Columbus, OH in the email subject line. DEPARTMENT OF VETERANS AFFAIRS Justification for Single Source Awards IAW FAR 13.106-1 For Over Micro-Purchase Threshold but Not Exceeding the SAT Acquisition Plan Action ID: 36C250-27-AP-0832 Contracting Activity: Department of Veterans Affairs, Network/Program Contracting Office 10, in support of VISN 3 VA Health Care System located at 420 N James Rd, Columbus, Ohio 43219 using 2237# 757-27-1-775-0010 Brief Description of Supplies/ Services required and the intended use/Estimated Amount: Abbott Rapid Diagnostics Informatics RALS Middleware to support ID Now point of care patient testing instrumentation. This middleware allows the transmission of point of care instrumentation data to the facilities Laboratory Information System (LIS) which is subsequently viewable to the clinicians via Cerner Electronic Health Record Modernization (EHRM). The interface connections will transmit results from the provided POC testing for COVID 19, Influenza A/B, RSV, Strep A, Creatinine and Glucose at the main facility and all Community Based Outpatient Clinic (CBOC) locations. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: This middleware is proprietary for the use of these point of care testing devices and the subsequent transmission of data into the facilities LIS system. Description of market research conducted and results or statement why it was not conducted: Per the End user, not applicable, as this is proprietary middleware for use with this specific point of care testing devices. The CO conducted market research to locate adequate small business concerns on ADDS-UP, GSA Advantage/eBuy, eLibrary, FPDS, SAM, SBL, and the Internet. The SBA nor the VA s Rule of Two can be met. An Intent to Sole Source will be posted on Contract Opportunities. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. ______________ Gina P. Crank 10/06/2026 Contracting Officer STATEMENT OF WORK (SOW) PROGRAM REQUESTOR/MANAGER. Name: Marie Brown Section: Pathology & Laboratory Medicine Service (PLM) Address: 420 N James Rd, Columbus, OH, 43219 Fax Number: 614-257-5629 E-Mail Address: [email protected] 2. Contract Title. Point-of-Care Middleware, Remote Automated Laboratory System (RALS) 3. Background. Columbus VA Central Ohio Healthcare System has a requirement to maintain the Remote Automated Laboratory Systems (RALS) software technology currently connecting multiple devices to one data manager. The RALS software enables review and release of patient results to the Laboratory Information System (LIS) directly from each device. RALS allows the ability to manage, update, review and troubleshoot quality control results, operator and device issues remotely. 4. Scope. The contractor shall provide RALS software licensing and interface for Point-of-Care testing connectivity software that is used to post patient test results to the electronic patient record (Cerner). This software allows the end user to monitor tests completed at the point-of-care and to meet numerous accreditation requirements for laboratory tests performed throughout the VA Columbus Ambulatory Care Center located at 420 North James Rd, Columbus, OH 43219 and surrounding Community Based Outpatient Clinics (CBOCs) located in Grove City, Newark, Zanesville, Marion and Delaware Ohio. Software must be compatible with Roche Accu-Chek® Inform II Module (38 devices), Abbott i-STAT® Module (8 devices), and Abbott ID-Now (9 devices) and the VHA s current Electronic Health Record (Cerner). The software must have the capability to add more instruments when the need arises. The Technology Licensure shall include service, support, updates and hardware maintenance. 5. Specific Tasks. The contractor shall provide the RALS device modules to include: Software Components: RALS device software module for the Roche Accu-Check® Inform II glucometers. RALS device software module for the Abbott i-STAT® instruments. RALS device software module for the Abbott ID-Now instruments. RALS HL7 Interface ADT Interface; ADT in-Unit Patient Verification with positive patient identification. 5.1. 2 Other Components: a. RALS User Documentation will be provided in the current medium. b. Standard Training, instruction and consultation for the Customer required for the use of the RALS Software Technology System (STS). Hardware Components provided by the vendor: RALS Data ports, if applicable Information Management System All written deliverables shall be phrased in layperson language. Statistical and other technical terminology shall not be used without providing a glossary of terms. Conformance Standards: The contractor s performance must follow all applicable state, federal and local laws and regulations. Hours of Work: The Warranty is in effect for the entire duration of the contract. The contractor shall provide 24 hours, 7 days a week Technical Support. Preventative Maintenance: The Contractor shall provide upgrades at no cost to the government throughout the duration of this contract. The Contractor shall provide documentation of services performed. Emergency Repair Service: 24 hours, 7 days a week Technical Support. 6. Records Management All records (administrative and program specific) created during the period of the contract belong to Columbus VA Ambulatory Care Center and must be returned to Columbus VA Ambulatory Care Center at the end of this contract. 7. Quality Assurance Surveillance Plan (QASP) The QASP and its performance are as follows: Task Indicator Standard Acceptable Quality Level Method of Surveillance Incentive Safety Recall Notification Timely recall notification 100% Monthly Monitoring Exercise of Option Period & Past Performance Quality Assurance Phone support Within 24 hours 95% Monthly monitoring Exercise of Option Period & Past Performance 8. VA Information and Information System Security and Privacy Language 8.1 GENERAL: This entire section applies to all acquisitions requiring any Information Security and Privacy language. Contractors, contractor personnel, subcontractors and subcontractor personnel will be subject to the same federal laws, regulations, standards, VA directives and handbooks, as VA personnel regarding information and information system security and privacy. 8.2 VA INFORMATION CUSTODIAL LANGUAGE: This entire section applies to all acquisitions requiring any Information Security and Privacy language. a. The Government shall receive unlimited rights to data/intellectual property first produced and delivered in the performance of this contract or order (hereinafter contract ) unless expressly stated otherwise in this contract. This includes all rights to source code and all documentation created in support thereof. The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data General. The primary clause used to define computer software license (not data/intellectual property first produced under this contractor or order) is FAR 52.227-19, Commercial Computer Software License. b. Information made available to the contractor by VA for the performance or administration of this contract will be used only for the purposes specified in the service agreement, SOW, PWS, PD, and/or contract. The contractor shall not use VA information in any other manner without prior written approval from a VA Contracting Officer (CO). The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data General. c. VA information will not be co-mingled with any other data on the contractor s information systems or media storage systems. The contractor shall ensure compliance with Federal and VA requirements related to data protection, data encryption, physical data segregation, logical data segregation, classification requirements and media sanitization. d. VA reserves the right to conduct scheduled or unscheduled audits, assessments, or investigations of contractor Information Technology (IT) resources to ensure information security is compliant with Federal and VA requirements. The contractor shall provide all necessary access to records (including electronic and documentary materials related to the contracts and subcontracts) and support (including access to contractor and subcontractor staff associated with the contract) to VA, VA's Office Inspector General (OIG), and/or Government Accountability Office (GAO) staff during periodic control assessments, audits, or investigations. e. The contractor may only use VA information within the terms of the contract and applicable Federal law, regulations, and VA policies. If new Federal information security laws, regulations or VA policies become applicable after execution of the contract, the parties agree to negotiate contract modification and adjustment necessary to implement the new laws, regulations, and/or policies. f. The contractor shall not make copies of VA information except as specifically authorized and necessary to perform the terms of the contract. If copies are made for restoration purposes, after the restoration is complete, the copies shall be destroyed in accordance with VA Directive 6500, VA Cybersecurity Program and VA Information Security Knowledge Service. g. If a Veterans Health Administration (VHA) contract is terminated for default or cause with a business associate, the related local Business Associate Agreement (BAA) shall also be terminated and actions taken in accordance with VHA Directive 1605.05, Business Associate Agreements. If there is an executed national BAA associated with the contract, VA will determine what actions are appropriate a…