6550--North Texas VA Fungitell Testing

siness concerns that are capable of performing the work described for the requirement. 1.0 Purpose Request the procurement of the Lab Kinetics Incubating 8-well Tube Reader with BG Analytics software to perform Fungitell STAT testing. 2.0 Scope Vendor will provide Lab Kinetics Incubating 8-well Tube reader with designated options, initial on-site training event, technical support, and business hours service plan for all equipment, Fungitell® STAT reagents, and consumables during the base year. The test menu must include Fungitell® STAT testing. All option years will be initiated to procurement all required reagents and consumable necessary for testing. This analyzer will be in the Dallas Laboratory P&LMS at VANTHCS. 3.0 Location The reader will be located, and testing will be performed in the Client Services and Immunopathology (CSI) section of the Pathology & Laboratory Medicine Service at VANTHCS, 4500 S. Lancaster Rd, Dallas, TX 75216. 4.0 Performance Maintenance includes the following: 4.1.1 Inventory and recording of systems components. 4.1.2 Testing all components for proper test performance. Equipment shall reproduce results according to manufacturer s specifications. 4.2. Repairs and Support. 4.2.1 Technical Support: Support Personnel will be available by telephone 8am to 4:30pm M-F Central Time.� 4.2.2.1 On-site Repairs: With respect to any technical support issue that the vendor determines to require replacement, the vendor will send the replacement unit normally within 24 business hours after the complaint has been logged by Customer Support. This includes all components of the system. Replacement units are shipped overnight and at no cost to the government. VANTHCS will decontaminate and package the defective unit per vendor s instructions and return it to the vendor. Vendor will supply return postage at no cost to the government. 4.3. Vendor shall remove all parts, equipment or materials replaced or upgraded by the vendor due to and not limited to repairs, replacements, recall, and upgrades without any cost to the government. 4.4 Training: The vendor will provide one initial onsite training for the analyzer. VANTHCS P&LMS agrees to not report results until initial vendor- led training has occurred. 4.4.1 Validations: The vendor will provide initial installation and validation guidance of the new system and any replacement systems. 4.5 Safety 4.5.1 Vendor shall immediately notify the service of any changes in reagent composition, procedure modification, recall notification or any changes that will affect the performance of the test or procedure. 4.6 Test Performance 4.6.1 All tests, procedures, and equipment must perform at manufacturer specifications; deviations from the performance specifications shall be corrected by the vendor. 4.6.2. All test performance will be evaluated by and not limited for performance through peer comparison, quality control and proficiency testing. 5.0 Period of Performance Cost per Test Purchase Agreement for the Fungitell STAT system, reader, reagents, consumables, is anticipated to be in effect from December 27, 2026, through December 26, 2027, with four additional ordering periods. 6.0 Deliverables/Supplies This order is for the cost per test procurement of the Fungitell® STAT system. 6.1 The vendor shall provide one on-site customer training slot to meet the objectives identified in paragraph 4. In addition, the vendor shall provide handouts and training materials in sufficient quantity for each participant. These are off-the-shelf courses. The vendor shall provide lesson plan, course materials and media (DVD s, CD s, videos, etc. if required), and editable procedures at no additional cost. 6.2 The vendor shall deliver all equipment necessary for test performance. 6.2.1 The vendor shall deliver all and not limited to operational, maintenance, troubleshooting, small repairs, equipment specifications and test manuals. 6.3 The vendor shall install the equipment and perform test verification according to manufacturer specification and regulatory requirements. Vendor shall provide annual linearity/verification. 6.4 The vendor shall provide equipment: Fungitell® STAT assay. 6.4.1 In the event that requested supplies are on back-order, vendor is to provide information as to the estimated time of availability. 6.5 The vendor shall deliver all invoices for review according to the established contract at the end of each billing cycle. 6.5.1 All items not contracted shall be specifically detailed on the invoice including description, quantity acquired, and government cost. 6.6 Remedies: 6.6.1 Any changes in reagents or equipment modifications shall be immediately disclosed by the vendor electronically as well as by postal mail with supporting documentation of the change and detailed guidance against implementation within twenty-four hours of its application. 6.6.2 Additional charges incurred by the government to provide the continuity of contracted tests to patients and not limited to outsourcing, transportation and or any other additional cost shall be covered by the vendor at no additional charge to the government. Sole Source Justification 7.1 FDA clearance for diagnostic testing. 7.2 The Fungitell® STAT assay is a design modification to the Fungitell® assay format. The Fungitell® STAT assay was developed to answer the need for a single use test format and smaller kit size relative to the 96-well plate format of the Fungitell® assay. 7.3 The Fungitell assay detects circulating (1,3)-beta-D-glucan in serum. This antigen is released from many invasive fungal organisms (eg,� Candida� species,� Aspergillus� species,� Fusarium� species, and� Pneumocystis jirovecii). 8.0 Vendor Security Contract Requirements. The Lab Kinetics Incubating 8-well Tube reader does not have the capability for remote access for service-related issues, with no access to PHI, and the vendor must follow the terms of the agreement outlined in the VA National site-to-site agreement. There will be supervised access when the vendor is physically present for technical support, service calls, and scheduled preventative maintenance. The instrument hard drive will remain on site for external repairs or termination of the lease. NO VA DATA OF ANY TYPE SHALL BE TRANSFERRED FROM THE VA. 9. Records Management All records (administrative and program specific) created during the period of the contract belong to VA North Texas Health Care System (VANTHCS) and must be returned to VANTHCS at the end of the contract.