EXP2621 PUR7776 - Qiagen Final.pdf

PUR 7776 (Revised 07/2022) Page 1 of 2 Incorporated by Reference: Rule 60A-1.045, F.A.C.

DESCRIPTION OF INTENDED

SINGLE SOURCE PURCHASE

(PUR 7776)

This description of commodities or contractual services intended for purchase from a single source is posted in accordance with Sections 120.57(3) and 287.057(3), Florida Statutes (F.S.), and will remain posted for a period of at least 15 business days.

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

Quantity or Term (as appropriate):

3 years

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

Florida Department of Health, Palm Beach County Laboratory

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 Florida Department of Health (FDOH), Palm Beach County Laboratory has a need to purchase reagents and supplies to perform Mycobacterium tuberculosis specific antigen testing using the QuantiFERON-TB Gold Plus, an Interferon Gamma Release Assay (IGRA). FDOH, Palm Beach County Laboratory requires specialized reagents and collection devices for the automated quantitative measurement of Interferon gamma (IFN-g) for Cell mediated immune response to infection with Mycobacterium tuberculosis performed on instrumentation currently owned by the FDOH, Palm Beach County Laboratory. This testing is critical to the clients served in Palm Beach to identify those that have been infected with Mycobacterium tuberculosis and is also used for testing outreaches conducted by the County Health Department’s Tuberculosis Program to identify possible clusters of tuberculosis outbreaks within the county.

AGENCY: Florida Department of Health

TITLE: QuantiFERON-TB Gold Plus (IGRA) Short description of the commodity or services desired: Testing Mycobacterium tuberculosis infection using the QuantiFERON-TB Gold Plus, an Interferon Gamma Release Assay (IGRA).

CONTACT

Name: Bill Zimmerman Address: 4052 Bald Cypress Way, Tallahassee, FL, 32399 Telephone: (850) 617-5894 Email: Bill.Zimmerman@flhealth.gov

Internal tracking number, if any: EXP2621

Date posted: 3/12/2025 Last day for receipt of information: 4/2/2025

PUR 7776 (Revised 07/2022) Page 2 of 2 Incorporated by Reference: Rule 60A-1.045, F.A.C.

In accordance with Chapter 60A-1.045 Florida Administrative Code, the FDOH in Palm Beach County requests authorization to purchase, as a single source, test kits and collection devices from Qiagen, LLC.

Intended Single Source:

Qiagen, LLC

Estimated Dollar Amount:

$360,000.00

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

Qiagen, LLC is the sole manufacturer and distributor of FDA approved reagents and collection devices for the QuantiFERON-TB Gold Plus In-Tube (IGRA) system and testing products.

It is in the best interest of the state to maintain continuity by using these specialized reagents and collection devices needed for the testing instrumentation currently owned by the FDOH, Palm Beach County Laboratory.

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

Allegra Small, Purchasing Director

Prospective vendors are requested to provide information regarding their ability to supply the commodities or contractual services described. If it is determined in writing by the agency, after reviewing any information received from prospective vendors, that the commodities or contractual services are available only from a single source, the agency shall provide notice of its intended decision to enter a single-source purchase contract in the manner specified in Rule 60A-1.045, Florida Administrative Code, and section 120.57(3), F.S.