SS2220 PUR7776 Orasure Reagents.pdf

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Orasure Reagents
Solicitation number
SS-00640
Issued by
Leon County, Florida

About this file

This document is a Description of Intended Single Source Purchase (PUR 7776) issued by the Florida Department of Law Enforcement (FDLE) for the procurement of Enzyme-Linked Immunosorbent Assay Reagents and Other Related Supplies. FDLE operates crime laboratories in Tallahassee and Orlando that screen blood and urine samples as part of criminal investigations. The required reagents are validated for use with the ELISA Immunoassay Drug Screening DSX procedure, and FDLE must maintain the current processes and product material used to ensure consistent testing. FDLE intends to award a single-source contract to OraSure Technologies, Inc. for a 5-year term from July 1, 2022, to June 30, 2027, with an estimated annual value of $75,000, for a total of $375,000.

The justification for the single-source procurement is that OraSure Technologies is the only vendor whose reagents are validated for use in FDLE's established testing protocols. Utilizing any other vendor would require costly and time-consuming revalidation of the testing processes, which would be detrimental to the laboratory's efficiency. FDLE has determined that the required commodities are available only from OraSure Technologies, and this notice is being provided as required by Florida Statutes prior to entering into the single-source contract.

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PUR 7776 (Eff. 01/2016) Page 1 of 2 60A-1.045, F.A.C.

DESCRIPTION OF INTENDED

SINGLE SOURCE PURCHASE

(PUR 7776)

AGENCY: Florida Department of Law Enforcement (FDLE)

TITLE: Orasure Reagents

Short description of the commodity or service desired: Enzyme-Linked Immunosorbent Assay Reagents and Other Related Supplies

CONTACT:

Name: Kimberly Bowling Address: 2331 Phillips Road, Tallahassee, Florida 32308 Telephone: 850-410-7300 Email: centralpurchasing@fdle.state.fl.us

Internal tracking number, if any: FDLE-SS-2220 Date posted: April 22, 2022 Last day for receipt of information: May 13, 2022

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 7 business days.

Commodity or Contractual Service Required (commodity or United National Standard Products and Services Code (UNSPSC), manufacturer, model, and description, as appropriate):

12161500 - Indicators & Reagents

Quantity or Term (as appropriate):

7/1/2022 - 6/30/2027

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

FDLE/Investigations and Forensic Science/Office of Forensic Services

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):

Pursuant to Chapter 943, FS, and Chapter 11, FAC, the Florida Department of Law Enforcement (FDLE), mission is to promote public safety and strengthen domestic security by providing services in partnership with local, state, and federal criminal justice agencies to prevent, investigate, and solve crimes while protecting Florida’s citizens by enforcing and supporting prevention of drug activity, responding to emergency situations, and preventing any act of criminal violence in the State of Florida.

Florida Department of Law Enforcement (FDLE) operates crime laboratories at the Tallahassee Regional Operations Center (TROC) and the Orlando Regional Operations Center (OROC). These crime laboratories play an integral part in providing immediate support services to our law enforcement officers and agents in an effort to support, intervene and suppress criminal activities for the entire State of Florida. One of the primary missions of these laboratories is to screen blood and urine samples for use in criminal investigations. This screening process must meet exacting measures for reliability and standardization, and the reagents utilized in this process are validated to ensure their dependability. Currently, FDLE standard operating procedures for screening of blood and urine samples are derived

PUR 7776 (Eff. 01/2016) Page 2 of 2 60A-1.045, F.A.C.

from validations utilizing OraSure reagents, and approved for use with Enzyme-Linked Immunosorbent Assay (ELISA) Immunoassay Drug Screening DSX procedure. FDLE must maintain the current processes and product material used to ensure that samples are constantly tested to detect the presence of a substance.

Intended Single Source:

OraSure Technologies, Inc.

220 East First Street Bethlehem, PA 18015

Estimated Dollar Amount:

$75,000/year X 5 years = $375,000

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):

FDLE's Toxicology Discipline provides timely, expert and professional examination and detection of various chemical and toxic materials to aid in the investigation, prosecution and/or exclusion of criminal offenses by utilizing sophisticated scientific equipment and proven techniques in the analysis of crime-related evidence.

As required by the FDLE Toxicology Section detailed protocol Standard Operating Procedure manual, the validation of any instrumentation utilized is required prior to use in testing. OraSure Technologies kits are the only assays available for use during the FDLE screening process for the following drug classes: Amphetamines, Methamphetamines, Barbiturates, Benzodiazepines, Cocaine, Opiates, Methadone, Oxycodone and Cannabinoids.

The test kits that FDLE uses from OraSure encompasses most test kits used in both TROC and OROC crime labs with the exception of Carisoprodal. The use of any vendor other than OraSure would require a revalidation of each of the listed test kits on FDLE specific instruments which would result in inconsistent validation. Additionally, the time and expense of changing the kits that FDLE currently utilizes would be substantial financially and counterproductive to laboratory efficiency.

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

Sonya Avant, Chief of General Services Jason Bundy, Director, Investigations and Forensic Science (IFS), Office of Forensic 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), F.S.

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