W065--South Texas VA Geenius HIV Lease and Reagents

Sources Sought Notice

This notice is for planning purposes only and shall not be considered an invitation for bid, request for quotation, request for proposal, or as an obligation of the government to acquire any products or services. Responses to this notice will be used for informational purposes only. No entitlement to payment of direct or indirect costs from the government will arise as a result from a response to this announcement. No contract will be awarded from this notice.

The information requested in this notice will be used to determine if there are sufficient socioeconomic small business concerns that are capable of performing the work described for the requirement.

The South Texas Veterans Health Care System (STVHCS) has a need for a Cost per Reagent Rental agreement for the Geenius Automated HIV ½ System with single-use immunochromatographic assay for the confirmation and differentiation of individual antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1 and HIV-2) in serum, or plasma samples, lithium heparin, sodium citrate, and CPD) from blood donor that will include preventative service, maintenance and to be housed in the Molecular Laboratory of Pathology & Laboratory Medicine Service at Audie L. Murphy VA Hospital.

The Geenius System and its associated HIV1/2 supplemental assay is the confirmatory test done on all patients whose initial screening test is positive for HIV. Currently this confirmation is done in-house. This test confirms HIV infection for positive screens and differentiates HIV1 from HIV2, since the two types have markedly different clinical courses and treatment implications. STVHCS serves a patient population with a high prevalence of HIV, and accurate, rapid diagnosis is key to ensuring proper care and limiting spread of the infection within the community. Sending this test to a reference lab would be at a higher cost, and delay results by several days. This would likely result in newly diagnosed patients being lost to follow-up or getting started on therapy later than would be optimal. Rapid result turnaround time is important to public safety and quality of patient care. The Bio-Rad Geenius HIV 1/2 Supplemental Assay Rapid test are the only tests in the USA to offer detection and differentiation of HIV-1 and HIV-2 antibodies and are proprietary to the system.

Required Technical Specifications:

Must be able to detect confirmation and differentiation of individual antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1 and HIV-2)

Volume:

Estimated volume: 400 tests per year

FDA approved and approved by CDC as 2nd Line testing for HIV Algorithm used in the USA.

Sample: Serum, or plasma samples, lithium heparin, sodium citrate, and CPD) from blood donor

Includes all recommended preventative maintenance, software updates, and upgrades to next generation instrumentation.

Includes all labor, travel, expenses and all parts.

Unlimited number of on-demand service visits and telephone support calls.

24/7 Technical Call Center Support.

On site repairs and required parts. 7am to 7pm, 7 days a week

Service by Certified Field Service Engineer.

Provides all calibrators, controls and reagents required for HIV ½ testing.

Location

This service, maintenance and reagents will be used in the Molecular laboratory located in the Pathology and Laboratory Medicine Service s San Antonio Laboratories of the STVHCS.

Estimated Period of Performance

December 1, 2026 November 30, 2031

Deliverables/Supplies

As needed service, maintenance and reagents for HIV ½ testing.

Government Inherent Functions:

Contractor shall not perform inherently governmental functions. This includes, but is not limited to, determination of agency policy, determination of Federal program priorities for budget requests, direction and control of government employees, selection or non-selection of individuals for Federal Government employment including the interviewing of individuals for employment, approval of position descriptions and performance standards for Federal employees, approving any contractual documents, approval of Federal licensing actions and inspections, and/or determination of budget policy, guidance, and strategy.

General Duties, Requirements, and Expectations:

Be professionally competent to handle required duties.

Work with staff to ensure safety measures are in place and documented.

Services provided under the terms of this contract are required to be in compliance with the American Association of Blood Banks (AABB) and College of American Pathologists (CAP) accreditation policies and all applicable Federal, State and Government laws required by the Veteran s Healthcare System and VHA Handbook 1106.1.