PUR7776 -Hologic HCV .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 41116000 Clinical and diagnostic analyzer reagents 41116100 Manual test kits and quality controls and calibrators and standards

Quantity or Term (as appropriate):

3 years

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

FDOH, Division of Disease Control and Health Protection (DCHP), 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 FDA-approved HCV Qualitative/Quantitative assay kits that are compatible with the Department’s existing instrumentation system (Panther®) used by the BPHL Serology Unit for the detection and quantitation of hepatitis C virus.

AGENCY: Florida Department of Health (FDOH)

TITLE: Hologic, Inc. Aptima HCV Quant Dx Assay Kits Short description of the commodity or services desired: FDA-approved HCV (Hepatitis C) assay kits

CONTACT:

Name: Katrina Ferguson Address: 4052 Bald Cypress Road Telephone: 850-617-5854 Email: Katrina.Ferguson@flhealth.gov

Internal tracking number, if any: EXP2487

Date posted: 11/04/22 @ 12:00 PM Last day for receipt of information: 11/30/22 @ 12:00 pm

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

Intended Single Source:

Hologic, Inc.

Estimated Dollar Amount:

$1,170,000

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):

• Hologic Aptima HCV Quant Dx Assay Kit is the only FDA-approved HCV assay product that is compatible with the Department’s existing instrumentation system (Panther®) currently in use at BPHL.

• Hologic Inc. is the sole distributor and manufacturer of the Aptima HCV Quant Dx Assay Kits.

• In accordance with 60A-1.045 Florida Administrative Code, the FDOH, BPHL requests authorization to purchase, as a single source, Hologic Aptima HCV Quant Dx Assay Kits.

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

Samantha Washington, Chief, Bureau of General Services

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.