EXP2468_PUR7776_FINAL.pdf

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Attached to
SURE CHECK® HIV 1/2 Assay
Solicitation number
SS-01424
Issued by
Leon County, Florida

About this file

This document is a Description of Intended Single Source Purchase (PUR 7776) from the Florida Department of Health (FDOH) for the Chembio SURE CHECK HIV 1/2 Assay, a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Type 1 and Type 2. The FDOH, Bureau of Communicable Disease, HIV/AIDS Section has a need to purchase FDA approved HIV test kits to be used for at-risk communities. These kits require the least amount of finger-stick whole blood, which encourages those who may have an aversion to needles or blood to get tested, allowing HIV testers to reach more people with less resistance and anxiety. The intended single source is Chembio Diagnostics Systems, Inc., the sole manufacturer and distributor of the Chembio SURE CHECK HIV 1/2 Assay. The estimated dollar amount for the three-year contract is $3,000,000.

The justification for the single source acquisition is that the Chembio SURE CHECK HIV 1/2 Assay is the only FDA approved testing kit which requires 2.5 microliters of finger stick whole blood, and Chembio Diagnostics Systems, Inc. is the sole manufacturer and distributor of this product. The contract will be awarded in accordance with Chapter 60A-1.045 of the Florida Administrative Code.

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PUR 7776 (Eff. 03/2016) Page 1 of 2 60A-1.045, F.A.C.

DESCRIPTION OF INTENDED

SINGLE SOURCE PURCHASE

(PUR 7776)

AGENCY: Florida Department of Health (FDOH)

TITLE: SURE CHECK® HIV 1/2 Assay Short description of the commodity or service desired: Chembio SURE CHECK® HIV 1/2 Assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Type 1 and Type 2.

CONTACT

Name: Niki Branch Address: 4052 Bald Cypress Way, Tallahassee, FL 32399 Telephone: (850) 558-9698 Email: niki.branch@flhealth.gov

Internal tracking number, if any: EXP2468

Date posted: 6/1/22 @ 3:00 p.m. Last day for receipt of information: 6/22/22 @ 3:00 p.m.

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 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 (UNSPSC), manufacturer, model, and description, as appropriate):

41113000 Chemical evaluation instruments and supplies 41120000 Laboratory supplies and fixtures

Quantity or Term (as appropriate):

Three Years

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

FDOH, 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, Bureau of Communicable Disease, HIV/AIDS Section has a need to purchase FDA approved HIV test kits to be used for at-risk communities. These kits increase the opportunity in the non-traditional rapid point of care diagnostic method by using the least amount of finger-stick whole blood, which encourages those who may have an aversion to needles or blood to get tested. This allows HIV testers to reach more people with less resistance and anxiety. In accordance with Chapter 60A-1.045, Florida Administrative Code, the FDOH, Bureau of Communicable Disease, HIV/AIDS Section requests authorization to purchase as a single source the Chembio SURE CHECK® HIV 1/2 Assay, a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Type 1 and Type 2.

Intended Single Source:

Chembio Diagnostics Systems, Inc.

Estimated Dollar Amount:

$3,000,000

PUR 7776 (Eff. 03/2016) Page 2 of 2 60A-1.045, F.A.C.

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

• The Chembio SURE CHECK® HIV 1/2 Assay is the only FDA approved testing kit which requires 2.5 microliters of finger stick whole blood, thus requiring the least amount of whole blood for testing and allowing HIV testers to reach more people with less resistance and anxiety.

• Chembio Diagnostics Systems, Inc. is the sole manufacturer and distributor of the Chembio SURE CHECK®

HIV 1/2 Assay.

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 s.120.57(3), FS.

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