EXP2496_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):

41113000 Chemical evaluation instruments and supplies

Quantity or Term (as appropriate):

3 Year Term

Requestor (division, bureau, office, individual, as appropriate) FDOH, BCD, HIV/AIDS Section

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’s, BCD, HIV/AIDS Section has a need to purchase FDA-approved, rapid HIV – ½, IgG/IgM, 3rd generation testing devices, which provide a result in 60 seconds, for at-risk communities and testing kit training.

AGENCY: Florida Department of Health (FDOH), Bureau of Communicable Disease (BCD)

TITLE: bioLytical INSTI HIV-1/HIV-2 Antibody Test Short description of the commodity or services desired: bioLytical INSTI HIV-1/HIV-2 Antibody Test is a 3rd Generation HIV rapid point of care test which provides a result in 60 seconds.

CONTACT:

Name: Bill Zimmerman Address: 4052 Bald Cypress Way, Tallahassee, FL 32399 Telephone: 850-245-4199 Email: Bill. Zimmerman@flhealth.gov

Internal tracking number, if any: EXP2496

Date posted: 02/20/2023 at 3:30 pm Last day for receipt of information: 03/13/2023 at 3:30 pm

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, BPHL requests authorization to purchase as a single source, a preventative maintenance and service agreement from Agilent Technologies.

Intended Single Source:

bioLytical

Estimated Dollar Amount:

$3,000,000

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):

• The biolytical INSTI HIV-1/HIV-2 Antibody, 3rd Generation HIV rapid point of care test is the only FDA-approved, Clinical Laboratory Improvement Amendment (CLIA) waived rapid device providing a test result in 60 seconds.

• bioLytical is the sole approved provider for HIV-1/HIV-2 Antibody, 3rd Generation HIV rapid point of care test devices providing a result of 60 seconds and training for Public Health, Governmental entities, and the ability to offer HIV testing to more individuals.

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.