EXP2497 PUR7776 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 41116000: Clinical and diagnostic analyzer reagents

Quantity or Term (as appropriate):

3 Years

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

Division of Disease Control and Health Protection, Bureau of Public Health Laboratories

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, Bureau of Public Health Laboratories (BPHL) has a need to purchase FDA approved assay kits that are compatible with the Cepheid GeneXpert system. This is a semi-quantitative nested real-time PCR used for the detection of Mycobacterium Tuberculosis complex DNA in sputum samples and the detection of Rifampin resistance associated mutations of the rpoB gene in samples from patients at risk for rifampin resistance.

AGENCY: Florida Department of Health

TITLE: Cepheid MTB/RIF Assay

Short description of the commodity or services desired: FDA approved assay kits that are compatible with the Cepheid GeneXpert system

CONTACT

Name: Summer Lindsley Address: 4052 Bald Cypress Way, Bin B07, Tallahassee, FL 32399 Telephone: 850-841-8528 Email: summer.lindsley@flhealth.gov

Internal tracking number, if any: EXP2497

Date posted: 2/21/2023 at 9:30 AM Last day for receipt of information: 3/14/2023 at 9:30 AM

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

In accordance with 60A-1.045 Florida Administrative Code, the Florida Department of Health BPHL requests authorization to purchase, as a single source, Cepheid Xpert GMTB/RIF-US-10 Assay kits.

Intended Single Source:

Cepheid

Estimated Dollar Amount:

$214,200.00

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):

• The Cepheid Cat. No. GMTB/RIF-US-10 Xpert Assay kits are the only FDA approved kits compatible with the Cepheid GeneXpert system and test algorithm used by the BPHL Tuberculosis section.

• Cepheid is the sole manufacturer and supplier of GeneXpert Technology including systems and assays globally.

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

Allegra Small, Purchasing Director, 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.