Q301--New - QuantiFERON Testing Base + 4

Statement of Work 1.0 Purpose Request the procurement of supplies and reagent to perform QuantiFERON®- TB Gold Plus testing on the DiaSorin LIAISON XL instrument 2.0 Scope Vendor will provide blood collection tubes, reagents, and controls to perform testing utilizing the DiaSorin LIAISON XL instrument. 3.0 Location The instrument will be located, and testing will be performed in the Client Services and Immunopathology (CSI) section of the Pathology & Laboratory Medicine Service at the VANTHCS, 4500 S. Lancaster Rd, Dallas, TX 75216. 4.0 Performance Test Performance: All tests, procedures, and equipment must perform at manufacturer s specifications. Deviations from the performance specifications shall be corrected by the Contractor. Test performance will be evaluated by and not limited for performance thru peer comparison, quality control and CAP peer evaluation. The vendor shall reimburse VANTHCS for any costs and/or supplies related to tests sent to a referral laboratory when testing is not available through no fault of the facility due to reagent problems, other product issues, instrumentation failure, or other factors. The assessed damages shall be applied to the invoice in the form of a credit or deduction. Safety: The Contractor shall immediately notify VANTHCS of any changes in reagent kit composition, procedure modification, recall notification, or any changes that will affect the performance of the test or procedure according to FDA regulations. 5.0 Period of Performance Cost per Test Purchase Agreement for supplies and reagents will be in effect from December 01, 2026 through November 30, 2027 with four additional option years. Base Period: December 01, 2026 through November 30, 2027 Option 1: December 01, 2027 through November 30, 2028 Option 2: December 01, 2028 through November 30, 2029 Option 3: December 01, 2029 through November 30, 2030 Option 4: December 01, 2030 through November 30, 2031 6.0 Deliverables/Supplies Reagents and supplies will be purchased under the terms of the reagent purchase agreement. The Contractor shall deliver all supplies necessary for test performance at no Government cost. The Contractor shall provide supplies: reagents and consumables for test menu. In the event that requested supplies are on back-order, Contractor is to provide information as to the estimated time of availability. The Contractor shall deliver all invoices for review according to the established contract at the end of each billing cycle. All items not contracted shall be specifically detailed on the invoice including description, quantity acquired, and government cost. Any changes in reagents or equipment modifications shall be immediately disclosed by the Contractor electronically as well as by postal mail with supporting documentation of the change, and detailed guidance for implementation within twenty-four hours of its application. Additional charges incurred by the government to provide the continuity of contracted tests to patients and not limited to out sourcing, transportation, and or any other additional cost shall be covered by the Contractor at no additional charge to the government. Sole Source Justification See form VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT. 8.0 Vendor Security Contract Requirements. This Contractor requires no access to VANTHCS or any VA information system. 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. Quality Assurance Surveillance Plan (QASP) and its performance are as follows: Standard Task Indicator Acceptable Quality Level Method of Surveillance Incentive Repeat runs are minimal due to reagent or instrument issues. Schedule Successful reporting of results No more than 2 instances of repeat runs due to a single reagent or instrument issue per quarter. Exceptional: 0 Very Good: 1 Satisfactory: 2 Marginal: 3 Unsatisfactory: >3 Troubleshooting records Service records Exercise of Option Period Minimal unsuccessful performance due to instrument or reagent issues. Successful peer group comparison 90% satisfactory performance to peer group. Exceptional: 100% Very Good: 95-99% Satisfactory: 90-94% Marginal: 85-89% Unsatisfactory: <85% CAP survey reports Exercise of Option Period Telephone Support is responsive. Trouble-shooting via phone 95% Issues resolved within 3 calls or elevated to service. Exceptional: 100% Very Good: 98-99% Satisfactory: 95-97% Marginal: 85-89% Unsatisfactory: <85% Troubleshooting records Problem records Service records Exercise of Option Period Invoices are submitted monthly. Cost Control Invoice Accountability 100% Invoices received through OLCS via Austin, Texas Invoice records Exercise of Option Period Invoices are itemized by service or product received. Invoice Verification 80% Invoices contain all necessary information for proper processing. Excellent: 95-100% Very Good: 90-94% Satisfactory: 85-89% Marginal: 80-84% Unsatisfactory: <80% Invoice records Exercise of Option Period Backordered reagents and supplies are minimal. Backorders <5% Backorders per year. Excellent: 0% Very Good: 1-2% Satisfactory: 3-4% Marginal: 5% Unsatisfactory: >5% Order records Invoice records Customer communications Exercise of Option Period Provides timely follow-up for backorders. Management Backorder Notification 90% timely follow up for backorders Exceptional: 100% Very Good: 95-99% Satisfactory: 90-94% Marginal: 85-89% Unsatisfactory: <85% Order records Invoice records Customer communications Exercise of Option Period Contractor will provide proactive notification of changes. Notification of changes in reagent and equipment modifications 100% Proactive notifications. Quality Bulletins Customer Letters Customer Contact Exercise of Option Period Timely recall notification of reagent and supplies. Regulatory Recall Notification 100% Recall notifications within 1 month of issuance. Quality Bulletins Customer Letters Customer Contact Exercise of Option Period Works with customer to resolve complaints. Customer service Substantiated complaints No unresolved substantiated customer complaints per year Order records Invoice records Customer communications Problem records Troubleshooting records Exercise of Option Period Timely follow-up on complaints. Complaint Handling 90% Complaint follow-up within 24 hours of initial complaint or within agreed upon timeframe. Exceptional: 100% Very Good: 95-99% Satisfactory: 90-94% Marginal: 85-89% Unsatisfactory: <85% Order records Invoice records Customer communications Problem records Troubleshooting records Exercise of Option Period