EXP2553 Roche_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):

41113000 Chemical evaluation instruments and supplies 81111805 Proprietary or licensed systems maintenance or support

Quantity or Term (as appropriate):

One Year

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

DOH 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 DOH BPHL has a need to purchase a FDA-approved analyzer compatible with multiple HIV and STI molecular assays to use as a comprehensive refugee testing pathway.

The Roche Cobas 5800 meets this need and allows for HIV-1/HIV-2 Differentiating RNA testing and CT/NG/TV/MG quad testing from a single patient sample at the Jacksonville PHL.

In accordance with Chapter 60A-1.045, Florida Administrative Code, the DOH BPHL requests authorization to purchase, as a single source, the Roche Cobas 5800 from Roche Molecular.

AGENCY: Florida Department of Health (DOH)

TITLE: Roche Short description of the commodity or services desired: Analyzer

CONTACT

Name: Chris Lowery Address: 4052 Bald Cypress Way, Bin B07, Tallahassee, FL 32399 Telephone:850-245-4530 Email: christina.lowery@flhealth.gov

Internal tracking number, if any:EXP2553

Date posted: Click or tap to enter a date. Last day for receipt of information: Click or tap to enter a date.

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

Intended Single Source:

Roche Molecular

Estimated Dollar Amount:

$200,000.00

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):

• Roche Molecular is the exclusive manufacturer and distributor of the Cobas 5800 instrument.

• The Cobas 5800 is the sole FDA-approved analyzer system for use with multiple sole source HIV and STI molecular assays at the BPHL Jacksonville lab.

• The Cobas 5800 has the unique ability to assess and differentiate multiple HIV and STI analytes with a single patient sample, reducing patient clinical visits and excessive blood draws.

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.