EXP2682 PUR7778_Final.pdf

PUR 7778 (Revised 07/2022) Page 1 of 2

Incorporated by Reference: Rule 60A-1.045, F.A.C.

NOTICE OF INTENDED DECISION

TO ENTER INTO A SINGLE SOURCE CONTRACT

(PUR 7778)

Commodity or Contractual Service Required (commodity or United National Standard Products and Services Code (NSPSC), manufacturer, model, and description, as appropriate):

12161500 Indicators and Reagents

41116000 Clinical and diagnostic analyzer reagents

41116100 Manual test kits and quality controls and calibrators and standards

Requestor (division, bureau, office, individual, as appropriate):

Bureau of Public Health Laboratories (BPHL)

Performance and/or Design Requirements (e.g. intended use, function or application, compatibility, requirements; reference to policy, rule, statute or other act of the Legislature, etc., as appropriate): The FDOH BPHL has a need to purchase a FDA approved confirmatory assay system to perform HIV-1/HIV-2 Supplemental differentiation assay testing to confirm HIV infection in patients testing positive on an initial screen. The assay must be able to test whole blood, serum, plasma, and in-house validated oral fluid to conform to the CDC 2014 HIV

Diagnostic Algorithm guidelines. In accordance with Chapter 60A-1.045, Florida Administrative

Code, the Florida Department of Health, BPHL, requests authorization to purchase, as a single source, the Bio-Rad Laboratories Geenius™ System assays and controls.

AGENCY: Florida Department of Health (Department)

TITLE: Bio-Rad Laboratories Geenius™ System and Sickle Cell kits

Short description of the commodity or service desired: Assays and controls necessary to perform HIV-

1/HIV-2 Supplemental differentiation testing and Newborn Screening Sickle Cell tests.

CONTACT

Name: Benjamin Roberts

Address: 4052 Bald Cypress Way

Telephone: 850-245-4502

Email: Benjamin.Roberts@FlHealth.gov

Internal tracking number, if any: EXP2682

DMS Single Source number, if applicable: SS-16263

Date posted: July 9, 2026 Time posted: 2:30 pm mailto:Benjamin.Roberts@FlHealth.gov

PUR 7778 (Revised 07/2022) Page 2 of 2

Incorporated by Reference: Rule 60A-1.045, F.A.C.

Intended Single Source:

Bio-Rad Laboratories, Inc.

Estimated Dollar Amount: $460,000.00

Justification for Single Source Purchase (what is necessary and unique about the product, services or source; steps taken to confirm unavailability of competition, as appropriate):

• The Geenius™ System is the only FDA approved HIV-1/HIV-2 differential assay currently on the U.S. market and has been validated in-house for the confirmation of

HIV-1 Oral Fluid meeting the guidelines required.

• Bio-Rad Laboratories (manufacturer) is the sole distributor of the Geenius™ System.

Approved By (names & titles, as appropriate, e.g., requestor, requestor management, information systems, budget, purchasing):

Sonja German-Jones, Purchasing Director

Failure to file a protest within the time prescribed in Section 120.57(3), Florida Statutes, or failure to file a bond or other security within the time allowed for filing a bond, shall constitute a waiver of proceedings under Chapter 120, Florida Statutes. Protests may be filed with the agency by:

Mail:

Agency Clerk

Florida Department of Health

4052 Bald Cypress Way, Bin A-02

Tallahassee, FL 32399-1703

Telephone No. (850) 245-4005

Physical Address for hand deliveries:

Agency Clerk

Florida Department of Health

2585 Merchants Row Blvd.

Tallahassee, FL 32399

Email: This office DOES NOT accept electronically filed documents.

Fax: 850-413-8743