EXP2459_PUR7776 Bio-Rad.pdf

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

DESCRIPTION OF INTENDED

SINGLE SOURCE PURCHASE

(PUR 7776)

AGENCY: Department of Health

TITLE: Bio-Rad Laboratories VARIANT™ Newborn Screening Systems (VNBS) and test kits

Short description of the commodity or service desired: Reagent rental agreement for use of seven (7) VARIANT™ Newborn Screening Systems through the purchase of VNBS Sickle Cell test kits (reagents)

CONTACT

Name: Diana K. Trahan Address: 4052 Bald Cypress Way, Tallahassee, Florida 32399 Telephone: (850) 245-4198 Email: diana.trahan@flhealth.gov Internal tracking number, if any: EXP2459

Date posted: 4/6/2022 Last day for receipt of information: 4/26/2022

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 15 business days.

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

41116000 Clinical and diagnostic analyzer reagents 81101706 Laboratory equipment maintenance 85121811 Laboratory equipment rental service

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 Department of Health's Bureau of Public Health Laboratories, (BPHL) has a need to purchase FDA approved Sickle Cell test kits which includes the use of seven VARIANT™ Newborn Screening Systems through a reagent rental agreement. The system and reagent test kits will be used to screen newborns for hemoglobinopathies, such as sickle cell, which is a required test in Florida’s approved newborn screening panel, per Chapter 383.14, Florida Statutes.

In accordance with Chapter 60A1.045 Florida Administrative Code, the Florida Department of Health, BPHL, requests authorization to purchase, as a single source, test kits with instrument systems rental (includes service), from Bio-Rad Laboratories, Inc.

mailto:diana.trahan@flhealth.gov

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

Intended Single Source:

Bio-Rad Laboratories, Inc.

Estimated Dollar Amount:

$1,276,020.00

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 Bio-Rad Laboratories VARIANT™ Newborn Screening System (VBNS) is the only FDA approved system for screening newborns for hemoglobinopathies using dried blood spots.

- Bio-Rad Laboratories, Inc. is the sole distributor and manufacturer of this system and reagents.

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.