DOH24-019 ITB Final.pdf

TITLE PAGE

FLORIDA DEPARTMENT OF HEALTH

DOH24-019

INVITATION TO BID (ITB)

FOR

Viral Hepatitis and Treponemal Antibody Diagnostic Test Kits

Respondent Name:

Respondent Mailing Address:

City, State, Zip:

Phone: Fax Number:

E-Mail Address:

Federal Employer Identification Number (FEID):

BY AFFIXING MY SIGNATURE ON THIS BID TITLE PAGE, I HEREBY STATE THAT I HAVE

READ THE ENTIRE ITB TERMS, CONDITIONS, PROVISIONS, AND SPECIFICATIONS AND

ALL ITS ATTACHMENTS, INCLUDING THE REFERENCED PUR 1000 AND PUR 1001.

I hereby certify that my company, its employees, and its principals agree to abide to all of the terms, conditions, provisions and specifications during the competitive solicitation and any resulting Contract including those contained in the Department’s Purchase Order Terms and Conditions.

Signature of Authorized Representative:

Printed (Typed) Name and Title:

*An authorized representative is an officer of the Respondent’s organization who has legal authority to bind the organization to the provisions of this Bid. Documentation establishing delegated authority must be included with the Bid if signed by someone other than the authorized representative.

Invitation to Bid Viral Hepatitis and Treponemal Antibody Diagnostic Test Kits Page | 2

TABLE OF CONTENTS

SECTION 1.0: Introductory Materials

SECTION 2.0: Procurement Process, Schedule, & Constraints

SECTION 3.0: Instructions for Bid Submittal

SECTION 4.0: Special Conditions

ATTACHMENT A: Specifications Page

ATTACHMENT B: Price Page

ATTACHMENT C: Prior Experience Form

ATTACHMENT D: Statement of Non-Collusion Form

ATTACHMENT E: Respondent Certification Regarding Scrutinized Companies List

ATTACHMENT F: Identical Tie Certification Form

ATTACHMENT G: Vendor Certification (PUR 7801)

ATTACHMENT H: Forced Labor Certification (PUR 2024)

ATTACHMENT I: Foreign Countries of Concern Attestation (PUR 1355)

ATTACHMENT J: Foreign State Preference Opinion Form…………………………….….

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SECTION 1.0 INTRODUCTORY MATERIALS

1.1. Statement of Purpose

The purpose of this Invitation to Bid (ITB) is for the State of Florida, Department of Health (Department) to obtain competitive prices for FDA approved laboratory-based immunoassays for chronic hepatitis and syphilis Treponemal antibody tests.

1.2. Legal Authority

Chapter 287, Florida Statutes and section 381.0202, Florida Statutes.

1.3. Scope of Services

A detailed specifications page for this solicitation is provided as Specifications Page (Attachment A), in this ITB.

1.4. Incorporation by Reference

The PUR 1001, General Instructions to Respondents (PUR 1001), and PUR 1000, General Contract Requirements (PUR 1000), are hereby incorporated by reference to the terms of this solicitation. Refer to Sections 3.1 and 4.1 of this ITB for further detail.

1.5. Definitions

In addition to the definitions in the PUR 1000 and PUR 1001, and the Specifications Page (Attachment A), the following definitions also apply to this ITB:

Bid: The complete written response of Provider to this ITB, including properly completed forms, supporting documents, and attachments.

Business Days: Monday through Friday, excluding state holidays.

Business Hours: 8:00 a.m. to 5:00 p.m., Eastern Time on all business days.

Calendar Days: All days, including weekends and holidays.

Certified Minority Business Enterprise: A business certified by any local governmental jurisdiction or organization accepted by the Department of Management Services, Office of Supplier Diversity (DMS), as a certified minority business enterprise for purposes of doing business with state government when DMS determines that the state’s minority business enterprise certification criteria are applied in the local certification process in accordance with section 287.0943, Florida Statutes.

Contract: The formal agreement or Order that will be awarded to the successful Provider under this ITB, unless indicated otherwise.

Department: The Department of Health; may be used interchangeably with DOH.

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Diagnostic Test Kit: A product containing reagents and other items necessary to conduct a test to detect the presence of or to measure a given biomarker in a given patient sample.

Food and Drug Administration (FDA): The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation.

Intended Use Statement: An FDA required statement for all approved diagnostic tests, detailing what the test is used for and acceptable clinical specimen types for testing.

Minor Irregularity: As used in the context of this solicitation, indicates a variation from the ITB terms and conditions which does not affect the price of the Bid, or give the Respondent an advantage or benefit not enjoyed by other Respondents, or does not adversely impact the interests of the Department.

Order: As used in the context of this solicitation, refers to a Purchase Order.

Package Insert: A document included in a diagnostic test kit that includes information about intended use, summary and explanation of the test, reagents, specimen collection and preparation, assay procedure, calculations and interpretations of results, and other performance characteristics.

Provider: The successful Respondent awarded a contract by the Department in accordance with the terms of this ITB.

Reagent: A substance or compound added to a system to cause a chemical reaction or added to test if a reaction occurs.

Reagent Rental Agreement: An agreement wherein proprietary testing equipment and dedicated consumables (include but are not limited to pipette tips, cuvettes, etc.) are provided at no additional cost with the purchase of diagnostic reagent kits. Due to the extremely high cost of laboratory equipment, a reagent rental agreement allows for the temporary use of laboratory equipment without requiring a commitment to purchase the equipment. The cost associated with the temporary use of the equipment is included in the cost per test (CPT), based on the estimated annual volume. The provider will furnish the necessary laboratory equipment compatible with the FDA approved viral hepatitis and Treponemal antibody diagnostic test kits for use during the term of the resulting contract from this solicitation.

Respondent: The business entity that submits a Bid.

State: State of Florida.

State Holidays: New Year’s Day, Martin Luther King, Jr. Day, Memorial Day, Independence Day, Labor Day, Veteran’s Day, Thanksgiving Day, Friday After Thanksgiving, Christmas Day.

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Vendor Information Portal (VIP): Refers to the State of Florida’s internet-based vendor information system, which is available at:

https://vendor.myfloridamarketplace.com.

Where there is a conflict between a definition in this solicitation, Section 1.5, above, and the definition in Specifications Page (Attachment A), the definition in this solicitation will prevail when the term is used in this solicitation. The definition in the Specifications Page (Attachment A), will prevail when the term is used in the Specifications Page (Attachment A).

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SECTION 2.0 PROCUREMENT PROCESS, SCHEDULE, & CONSTRAINTS

2.1. Procurement Officer

The Procurement Officer assigned to this solicitation is:

Florida Department of Health Attention: Summer Lindsley 4052 Bald Cypress Way, Bin B07 Tallahassee, FL 32399-1749 Email: summer.lindsley@flhealth.gov

******ALL EMAILS TO THE PROCUREMENT OFFICER MUST CONTAIN THE

SOLICITATION NUMBER IN THE SUBJECT LINE OF THE EMAIL*************

2.2. Restrictions on Communications

Pursuant to section 287.057(25), Florida Statutes, Respondents to this solicitation or persons acting on their behalf may not contact, between the release of the solicitation and the end of the 72-hour period following the agency posting the notice of intended award, excluding Saturdays, Sundays, and state holidays, any employee or officer of the executive or legislative branch concerning any aspect of this solicitation, except in writing to the Procurement Officer listed in Section 2.1., above. Violation of this provision may be grounds for rejecting a Bid.

2.3. Term

It is anticipated that the Contract resulting from this ITB will be for a one-year period from March 1, 2025 or the Contract execution date whichever is later, subject to renewal as identified in Section 2.4. The Contract resulting from this ITB is contingent upon availability of funds.

2.4. Renewal

The Contract resulting from this solicitation may be renewed. Renewals may be made for no more than three years beyond the initial Contract, or for the term of the original Contract, whichever is longer. Renewals must be in writing, subject to the same terms and conditions set forth in the initial Contract and any written amendments signed by the parties. Renewals are contingent upon satisfactory fiscal and programmatic performance evaluations as determined by the Department and are subject to the availability of funds.

2.5. Timeline

EVENT DUE DATE LOCATION

ITB Advertised / Released 04/30/2025 Posted to the Vendor Information Portal https://vendor.myfloridamarketplace.com https://vendor.myfloridamarketplace.com/

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Questions Submitted in Writing

Must be received

PRIOR TO:

05/06/2025

2:30PM

Submit to: Florida Department of Health Central Purchasing Office

Attention: Summer Lindsley Suite 310 4052 Bald Cypress Way, Bin B07 Tallahassee, FL 32399-1749 E-mail: summer.lindsley@flhealth.gov

Answers to Questions

(Anticipated Date) 05/12/2025 Posted to Vendor Information Portal at:

https://vendor.myfloridamarketplace.com

Sealed Bids Due and Opened

Must be received

PRIOR to:

05/19/2025

3:30PM

PUBLIC OPENING

Submit to: Florida Department of Health

Central Purchasing Office Attention: Summer Lindsley Suite 310 4052 Bald Cypress Way, Bin B07 Tallahassee, FL 32399-1749

Anticipated Posting of Intent to Award 05/26/2025 Posted to the Vendor Information Portal at:

https://vendor.myfloridamarketplace.com

2.6. Addenda

If the Department finds it necessary to supplement, modify, or interpret any portion of the solicitation during the procurement process, a written addendum will be posted on the VIP.

It is the responsibility of the Respondent to be aware of any addenda that might affect this ITB or their Bid.

2.7. Questions

This provision takes precedence over General Instruction #5 in PUR1001.

Questions related to this solicitation must be received in writing (either via United States Postal Service, courier, e-mail, or hand-delivery) by the Procurement Officer identified in Section 2.1, within the time indicated in Section 2.5. Verbal questions or those submitted after the period specified in Section 2.5 will not be addressed.

Answers to questions submitted in accordance with Section 2.5 will be posted on the

VIP.

2.8. Basis of Award

A single award will be made to the responsive, responsible Respondent offering the lowest grand total for the commodities and/or services requested in this ITB including inside mailto:summer.lindsley@flhealth.gov

Viral Hepatitis and Treponemal Antibody Diagnostic Test Kits Page | 8 delivery, FOB destination. The Department reserves the right to not make an award under this ITB, as determined to be in the best interest of the State.

2.9. Identical Outcomes

In the event the Department’s evaluation results in identical scoring outcomes between two or more Respondents, the Department will provide the Identical Tie Certification, Attachment F, form for the affected Respondents to complete. If one or more Respondents are entitled to the certified veteran business enterprise preference specified in section 295.187, Florida Statutes, and one or more business entitled to this preference or another preference provided by law submit bids, proposals, or replies for procurement of commodities or contractual services which are equal with respect to all relevant considerations, including price, quality, and service, the Department will award the procurement or contract to the business having the smallest net worth. If one or more Respondents has the certified veteran preference, it and any other vendor entitled to another preference provided by law will be requested by the Department to submit Respondents net worth.

In the event the Department is unable to select a Respondent using the Tie Breaker Criteria specified in Attachment F, and the net worth criteria above, or if the net worth criteria above does not apply, then, the affected Respondent(s) name will be placed in a container for the Department’s Procurement Officer to randomly select the awardee of this solicitation. The date, time, and location will be posted on VIP.

2.10. Modifications and Withdrawal

A Respondent may modify or withdraw its Bid at any time prior to the submittal deadline, as specified in Section 2.5, by submitting a request to the Procurement Officer. Requests for modification or withdrawal of a submitted Bid must be in writing and signed by an authorized signatory of the Respondent. Upon receipt and acceptance of such a request, the entire Bid will be returned to the Respondent and will not be considered unless resubmitted by the Bid due date and time.

2.11. Clarification Process

The Department may request clarification from the Respondent to resolve ambiguities or to question minor irregularities presented in its Bid. Clarifications may be requested throughout this procurement process. The Respondent’s answers to requested clarifications must be in writing and address only the information requested. The Respondent’s answers to requested clarifications must be submitted to the Department within the time specified by the Department.

2.12. Federal Excluded Parties List

In order to comply with Federal grant requirements, and determining Provider responsibility in accordance with sections 287.057(1), (2) and (3), Florida Statutes, and Florida Administrative Code, Rule 60A-1.006(1), a Respondent or its subcontractor(s) that, at the time of submitting a Bid for a new Contract or renewal of an existing Contract is on the Federal Excluded Parties List, is ineligible for, may not submit a Bid for, enter into, or renew a Contract with an agency for goods or services, if any federal funds are being utilized.

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2.13. Contract Formation

The Department will enter into a Contract with the Provider pursuant to Section 2.8, Basis of Award. The Contract will incorporate the terms of the Specifications Page (Attachment A), the Department’s Order Terms and Conditions, and the awarded Provider’s Price Page (Attachment B).

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SECTION 3.0 INSTRUCTIONS FOR BID SUBMITTAL

3.1. General Instructions to Respondents (PUR 1001)

The General Instructions to Respondents (PUR 1001) is incorporated by reference in this solicitation. This document should not be returned with the Bid. The PUR 1001 is located at http://dms.myflorida.com/content/download/2934/11780.

The terms of this solicitation control over any conflicting terms of the PUR1001.

3.2. Instructions for Submittal

3.2.1 Respondents must complete, sign, and return the “Title Page” with their Bid submittal.

3.2.2 Respondents must complete and return the Price Page (Attachment B) with their Bid submittal.

3.2.3 Respondents must submit all technical and pricing data in the formats specified in the ITB.

3.2.4 Respondents must submit one original paper copy of their Bid and one original copy on a single USB storage device, or CD viewable in Adobe Acrobat Reader (PDF). The electronic copy submitted must contain the entire Bid as the submitted original copy, including all supporting and signed documents. Refer to Section

3.4 for information on redacting confidential information, if applicable.

3.2.5 Bids must be sent by United States Postal Service, courier, or hand delivered to the location indicated in Section 2.5, Timeline.

3.2.6 Bids submitted via electronic mail (email) or facsimile will not be considered.

3.2.7 Bids must be submitted in a sealed envelope or sealed package with the solicitation number, date, and time of the Bid opening clearly marked on the outside.

3.2.8 The Department is not responsible for improperly marked Bids.

3.2.9 It is the Respondent’s responsibility to ensure its Bid is submitted at the proper place and time indicated in Section 2.5, Timeline.

3.2.10 Bids must be received by the date and time specified in Section 2.5, Timeline.

3.2.11 The Department’s clocks will provide the official time for Bid receipt.

3.2.12 Materials submitted will become the property of the State and accordingly, the State reserves the right to use any concepts or ideas contained in the Bid.

3.3. Cost of Preparation

Neither the Department nor the State is liable for any costs incurred by a Respondent in responding to this solicitation.

http://dms.myflorida.com/content/download/2934/11780

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3.4. Public Records and Trade Secrets

Notwithstanding any provisions to the contrary, public records must be made available pursuant to the provisions of the Public Records Act. If Respondent considers any portion of their Bid to this solicitation to be confidential, exempt, trade secret, or otherwise not subject to disclosure pursuant to Chapter 119, Florida Statutes, the Florida Constitution, or any other authority, Respondent must segregate and clearly mark the document(s) as

“CONFIDENTIAL”.

Simultaneously, Respondent will provide the Department with a separate redacted paper and electronic copy of their Bid and briefly describe in writing the grounds for claiming exemption from the public records law, including the specific statutory citation for such exemption. This redacted copy must contain the solicitation name, number, and the name of Respondent on the cover, and must be clearly titled “REDACTED COPY”.

The redacted copy must be provided to the Department at the same time Respondent submits its Bid and must only exclude or obliterate those exact portions which are claimed confidential, proprietary, or trade secret. Respondent will be responsible for defending its determination that the redacted portions of their Bid are confidential, trade secret, or otherwise not subject to disclosure. Further, Respondent must protect, defend, and indemnify the Department for all claims arising from or relating to the determination that the redacted portions of their Bid are confidential, proprietary, trade secret, or otherwise not subject to disclosure. If Respondent fails to submit a redacted copy with their Bid, the Department is authorized to produce the entire documents, data, or records submitted by Respondent in answer to a public records request for these records.

3.5. Price Page

Respondent must fill out the Price Page (Attachment B), as indicated, and return it with their Bid.

3.6. Prior Experience Form

Respondents must provide contact information for three entities the Respondent has provided services of a similar size and nature of those requested in this solicitation.

Respondents must use Attachment C, Prior Experience Form of this ITB to provide the required information. The Department reserves the right to contact any and all entities in the course of this solicitation in order to verify experience.

3.7. Florida Preference

As required by section 287.084, Florida Statutes, if this is a Contract for personal property (i.e., commodities) and the lowest bid price, as determined in accordance with Section 3.5 above, is from “a vendor whose principal place of business is in a state or political subdivision thereof which grants a preference (hereafter, “Foreign State Preference”) for the purchase of such personal property to a person whose principal place of business is in such state,” then the Department shall award the Foreign State Preference to the lowest responsible and responsive vendor having a principal place of business within Florida.

If the lowest bid is submitted by a vendor whose principal place of business is located outside of Florida and that state does not grant a preference to vendors having a principal place of business in such state, the preference to the lowest responsible and responsive vendor having a principal place of business in Florida will be 5%.

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This shall be calculated by the following formula for each Foreign State Vendor whose Lowest Total Price is lower than the lowest Florida-based vendor: Lowest Total Price of the Foreign State Vendor x 0.05 = Adjusted Lowest Total Price

Consistent with section 287.084(2), Florida Statute, if the Respondent’s principal place of business is outside the State of Florida, the Respondent must have an attorney who is licensed to practice law in the state of their principal place of business complete Attachment J, Foreign State Preference Opinion, and submit it with their Bid if applicable.

3.8. Subcontractor List

The Department will not authorize the use of subcontractors in the Contract resulting from this solicitation.

3.9. Special Accommodations

Persons with disability requiring special accommodations should call the Department’s Purchasing office at least five business days, prior to any pre-Bid conference, Bid opening, or meeting at (850) 245-4199. If hearing or speech impaired, please contact the Department’s Purchasing office through the Florida Relay Service, at 1-800-955-8771

(TTY).

3.10. Responsive and Responsible (Mandatory Requirements)

Respondents must complete and submit the following mandatory information or documentation as part of their Bid by the time specified in Section 2.5. Any Bid which does not contain the information below will be deemed non-responsive to this ITB.

3.10.1 Title Page must be completed, signed, and submitted with the Bid.

3.10.2 Price Page (Attachment B), as specified in Section 3.5.

3.10.3 Prior Experience Form (Attachment C), as specified in Section 3.6.

3.10.4 Statement of Non-Collusion (Attachment D) as specified in Section 4.3.

3.10.5 Respondent Certification Regarding Scrutinized Companies Lists

(Attachment E) as specified in Section 4.2.

3.10.6 Identical Tie Certification (Attachment F), as specified in Section 2.9.

3.10.7 Vendor Certification (PUR 7801) (Attachment G) must be completed and submit with the Bid.

3.10.8 Forced Labor Certifications (PUR 2024) (Attachment H), as specified in Section 4.7.

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3.10.9 Foreign Countries of Concern Attestation (PUR1355) (Attachment I), as specified in Section 4.8.

3.10.10 Foreign State Preference Opinion (Attachment J), as specified in Section 3.8.

3.10.11 Technical documentation, the FDA approved immunoassay package insert, to demonstrate compliance of the product with applicable technical requirements of this ITB.

3.10.12 Respondent’s Reagent Rental Agreement terms and conditions with their response and Titled Exhibit A. The Department’s Order Terms and Conditions will control in the event of a conflict with the Respondent’s Reagent Rental Agreement Terms and Conditions.

3.10.13 Proposed Equivalent and Supporting Documentation as specified in

Section 3.12.

3.10.14 Bids must document the Respondent’s ability to meet the requirements specified in Attachment A, Specifications.

3.11. Late Bids

The Procurement Officer must receive Bids pursuant to this ITB no later than the date and time specified in Section 2.5. Bids that are not received by the date and time specified will not be considered.

3.12 Proposed Equivalent and Supporting Documentation

Respondent may submit an equivalent specification that meets or exceeds the specifications referenced in Attachment A for the following tests. All Bids proposing an “equivalent” must be clearly marked and include detailed specifications so the Department can make an accurate comparison. The Department or its designee, at their sole discretion, will determine if the submitted specifications meet or exceed the requirements specified in this solicitation.

3.12.1. Hepatitis A total antibody is an approved equivalent test for Hepatitis A IgG antibody test by the BPHL.

3.12.2. Hepatitis B core IgG antibody is an approved equivalent test for Hepatitis B core total antibody test by the BPHL.

3.12.3. Hepatitis C IgG antibody is an approved equivalent test for Hepatitis C total antibody test by the BPHL.

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SECTION 4.0 SPECIAL CONDITIONS

4.1. PUR 1000, General Contract Conditions

The PUR 1000 is incorporated by reference in this ITB and contains general Contract terms and conditions that will apply to any Contract resulting from this ITB, to the extent they are not otherwise modified. This document should not be returned with the Bid. The PUR 1000 is located at http://dms.myflorida.com/content/download/2933/11777.

4.2. Scrutinized Companies

All Respondents seeking to do business with the Department must be in compliance with section 287.135, Florida Statutes. The Department may, at its option, terminate a Contract if Respondent is found to have submitted a false certification as provided under section 287.135(5), Florida Statutes, been placed on the Scrutinized Companies with Activities in Sudan List, the Scrutinized Companies with Activities in the Iran Petroleum Energy Sector List, the Scrutinized Companies that Boycott Israel List, or is engaged in a boycott of Israel, or have been engaged in business operations in Cuba or Syria.

Refer to Respondent Certification Regarding Scrutinized Companies Lists Form, Attachment E.

4.3. Conflict of Interest and Statement of Non-Collusion

Section 287.057(17)(c), Florida Statutes, provides “A person who receives a contract that has not been procured pursuant to subsections (1)-(3) to perform a feasibility study of the potential implementation of a subsequent contract, who participates in the drafting of a solicitation or who develops a program for future implementation, is not eligible to contract with the agency for any other contracts dealing with that specific subject matter, and any firm in which such person has any interest is not eligible to receive such contract. However, this prohibition does not prevent a vendor who responds to a request for information from being eligible to contract with an agency.”

The Department considers participation through decision, approval, disapproval, recommendation, preparation of any part of a purchase request, influencing the content of any specification or procurement standard, rendering of advice, investigation, or auditing or any other advisory capacity to constitute participation in drafting of the solicitation.

All Respondents must complete and submit the Statement of Non-Collusion Form, Attachment D with its Bid.

4.4. Certificate of Authority

All limited liability companies, corporations, corporations not for profit, and partnerships seeking to do business with the State must be registered with the Florida Department of State in accordance with the provisions of Chapters 605, 607, 617, and 620, Florida Statutes, respectively, prior to Contract execution. The Department retains the right to ask for verification of compliance before Contract execution. Failure of the Provider to have appropriate registration may result in withdrawal of the Contract award and forfeiture of its Bid Bond, if applicable.

http://dms.myflorida.com/content/download/2933/11777

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4.5. Vendor Registration

Each Vendor doing business with the State for the sale of commodities or contractual services as defined in section 287.012, Florida Statutes, must register in the MyFloridaMarketPlace system, unless exempted under Rule 60A-1.033, Florida Administrative Code. State agencies must not enter into an agreement for the sale of commodities or contractual services as defined in section 287.012, Florida Statutes, with any Respondent not registered in the MyFloridaMarketPlace system, unless exempted by rule. The Provider must be registered in the MyFloridaMarketPlace system within five days after posting of the Intent to Award.

Registration may be completed at: https://vendor.myfloridamarketplace.com

A Vendor lacking internet access may request assistance from MyFloridaMarketPlace Customer Service at 866-352-3776 or from State Purchasing, 4050 Esplanade Drive, Suite 300, Tallahassee, FL 32399.

4.6. Minority, Women, and Florida Veteran Business Participation

The Department encourages certified minority, women, and Florida veteran business participation in all its solicitations.

4.7. Forced Labor Certifications (PUR 2024)

In accordance with section 787.06(13), Florida Statutes and section 287.1346(4)(b), Florida Statutes, Respondents must complete and submit ATTACHMENT H, Forced Labor Certifications (PUR 2024), with its Bid.

4.8. Foreign Countries of Concern (PUR 1355)

In accordance with section 287.138, Florida Statutes, the Department may not accept a bid, proposal, or reply for a contract which would grant Respondent access to Personal Identifying Information unless the Respondent provides the Department with an attestation signed by an officer or representative of the Respondent on Form PUR 1355, “Foreign Country of Concern Attestation” Form.

All Respondents must complete and submit the ATTACHMENT I, Foreign Countries of Concern Attestation form (PUR 1355), with its Bid.

4.9. Indemnification

Provider must save and hold harmless and indemnify the Department against any and all liability, claims, judgments, or costs of whatsoever kind or nature for injury to, or death of any person or persons and for loss or damage to any property resulting from the use, service operation, or performance of work under the terms of the Contract, resulting in whole or in part from the negligent acts or omissions by Respondent, their subcontractor, or any of the employees, agents, or representatives of Respondent or subcontractor.

4.10. Order Terms and Conditions

Respondent must become familiar with the Department’s Order Terms and Conditions which contains administrative, financial, and non-programmatic terms and conditions https://vendor.myfloridamarketplace.com/

Viral Hepatitis and Treponemal Antibody Diagnostic Test Kits Page | 16 mandated by federal laws, state statutes, administrative code rules, and directive of the Department of Financial Service’s Chief Financial Officer.

Use of the Department’s Order Terms and Conditions are mandatory for Department Orders issued in MyFloridaMarketplace as they contain the basic clauses required by law. The terms and conditions contained in the Department’s Terms and Conditions are non-negotiable. The Department’s Terms and Conditions are located at:

https://www.floridahealth.gov/about/administrative-functions/purchasing/DOHTermsandConditions09022022.pdf

4.11. Conflict of Law and Controlling Provisions

Any Contract resulting from this ITB, and any conflict of law issue, will be governed by the laws of Florida. Venue must be in Leon County, Florida, to the exclusion of all other jurisdictions.

Respondents acknowledge that this solicitation (including but not limited to the resulting Contract, exhibits, attachments, or amendments) is not a rule nor subject to rulemaking under Chapter 120 (or its successor) of the Florida Statutes and is not subject to challenge as a rule or non-rule policy under any provision of Chapter 120, Florida Statutes.

4.12. Agency Inspectors General

It is the duty of every state officer, employee, agency, special district, board, commission, contractor, and subcontractor to cooperate with the inspector general in any investigation, audit, inspection, review, or hearing pursuant to section 20.055, Florida Statutes.

4.13. Records and Documentation

To the extent that information is used in the performance of the resulting Contract or generated as a result of it, and to the extent that information meets the definition of “public record” as defined in section 119.011(12), Florida Statutes, said information is hereby declared to be and is hereby recognized by the parties to be a public record and absent a provision of law or administrative rule or regulation requiring otherwise, Respondent must make the public records available for inspection or copying upon request of the Department’s custodian of public records in accordance with Chapter 119, Florida Statutes. Respondent’s refusal to comply with Chapter 119, Florida Statutes, will constitute an immediate breach of the Contract resulting from this ITB and entitles the Department to unilaterally terminate the Contract.

Unless a greater retention period is required by state or federal law, all documents pertaining to the program contemplated by this ITB must be retained by Respondent for a period of six years after the termination of the resulting Contract or longer as may be required by any renewal or extension of the Contract. During the records retention period, Respondent agrees to furnish, when requested to do so, all documents required to be retained. Submission of such documents must be in the Department’s standard word processing format. If this standard should change, it will be at no cost incurred to the Department. Data files will be provided in a format readable by the Department.

Respondent must maintain all records required to be maintained pursuant to the resulting Contract in such manner as to be accessible by the Department upon demand. Where permitted under applicable law, access by the public must be permitted without delay.

https://www.floridahealth.gov/about/administrative-functions/purchasing/DOHTermsandConditions09022022.pdf https://www.floridahealth.gov/about/administrative-functions/purchasing/DOHTermsandConditions09022022.pdf

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4.14. Attorney’s Fees

In the event of a dispute prior to or post award, each party responding to this solicitation is responsible for its own attorneys’ fees, except as otherwise provided by law.

4.15. Protests

Failure to file a protest within the time prescribed in section 120.57(3), Florida Statutes, or failure to post a bond or other security required by law within the time allowed for filing a bond will constitute a waiver of proceedings under Chapter 120, Florida Statutes.

Only documents delivered by the United States Postal Service, a private delivery service, in person, by E-Filing, or by facsimile during business hours will be accepted. Documents received after business hours will be filed the following business day.

Do not send Bids to the Agency Clerk’s Office. Send all Bids to the Procurement Officer and address listed in Section 2.5, Timeline.

No filings may be made by email. All filings must be made ONLY with the Agency Clerk and are considered "filed" when stamped by the official stamp of the Agency Clerk. It is the responsibility of the filing party to meet all filing deadlines.

The protest must be submitted by using one of the following delivery methods:

By Mail:

Agency Clerk, Florida Department of Health 4052 Bald Cypress Way, BIN A-02 Tallahassee, Florida 32399-1703 Telephone No. (850) 245-4005;

By hand delivery:

Agency Clerk, Florida Department of Health 2585 Merchants Row Blvd.

Tallahassee, Florida 32399;

By facsimile: 850-413-8743; or

By E-Filing:

https://agency_clerk-fdh.mycusthelp.com/WEBAPP/_rs/supporthome.aspx?&lp=3 https://gcc02.safelinks.protection.outlook.com/?url=https://agency_clerk-fdh.mycusthelp.com/WEBAPP/_rs/supporthome.aspx?&lp=3&data=05%2525257C01%2525257CAllegra.Small@flhealth.gov%2525257Ced6ef13ace184fb11b7908dae457e3ab%2525257C28cd8f803c444b2781a0cd2b03a31b8d%2525257C0%2525257C0%2525257C638073363391464622%2525257CUnknown%2525257CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0=%2525257C3000%2525257C%2525257C%2525257C&sdata=kR3RdMTBEMnpD1bRPC31L4z7S59FQPDy6B1wdSUApXY=&reserved=0

ATTACHMENT A

SPECIFICATIONS

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The following information details the specification requirements of the Department’s Laboratory- Based Treponemal Antibody and Hepatitis Panel Test Kits. Respondent must have prior written approval from the Department’s Contract Manager for any modifications or alterations to the specifications (See Section 3.12 of the ITB).

A. Background Information

The Department’s Bureau of Public Health Laboratories (BPHL) performs a chronic hepatitis panel and syphilis diagnostics on specimens submitted by county health departments (CHD). The chronic hepatitis panel includes the following tests; Hepatitis A IgG antibody (HAVAB, Hepatitis B surface antigen (HBSAG) including confirmatory, Hepatitis B surface antibody (HBSAB), Hepatitis B core total antibody (HBCAB) and Hepatitis C total antibody (HCVAB). In addition, BPHL may perform Hepatitis A antibody IgM (HAVAB IgM) and Hepatitis B core antibody IgM (HBCAB IgM) as needed, i.e.

outbreak investigations. Syphilis screening is currently performed by a rapid plasma reagin (RPR) test however the goal of this ITB is to replace RPR screening with an automated, random-access Treponemal antibody immunoassay (TPIA). Anticipated annual test volumes are below and shall be used to calculate estimated product quantities required to provide these tests on the price page (Attachment B).

2024 Estimated Testing volumes:

Test Jacksonville Test Count Miami Test Count Tampa Test Count

HAVAB* 14,500 8,600 6,200

HBSAG** 17,000 16,000 6,300

HBSAB 16,000 15,400 6,500

HBCAB*** 16,000 15,400 6,200

HCVAB 14,600 14,500 6,200

TPIA• 4,000 4,100 3,200

* Includes total and (if applicable) IgM only tests ** Includes HBSAG Confirmatory test *** Includes total and (if applicable) IgM only tests

• Initial estimated number of tests based on current syphilis testing using the Traditional Algorithm.

These figures are subject to change pending transition to a Selective Reverse Algorithm, within the awarded contract period.

B. Specifications

1. Laboratory-Based TPIA and Hepatitis Panel Diagnostic Test Kits requirements:

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a. Hepatitis A IgG antibody (HAVAB) or approved equivalency (See Section

3.12 of the ITB). Each HAVAB Diagnostic Test Kit must:

(1) Include Reagent tests and all Diagnostic Test Kit components (including controls and calibrators) as specified in the Package Insert;

(2) Be FDA approved on a common automated, random-access laboratory-based analyzer;

(3) Be independent from the other Diagnostic Test Kits;

(4) Perform together with the other Diagnostic Test Kits and the common analyzer as a complete and compatible system;

(5) Be FDA approved for serum specimens. The specimen stability must include at least 1 day at room temperature, 6 days at 2 to 8 degrees Celsius, and three freeze/thaw cycles;

(6) Include a Package Insert. Have FDA approved statements in the

Package Insert concerning acceptable sensitivity, specificity, or other measures of the Diagnostic Test Kits’ performance. Have clearly specify acceptable specimen types in the Package Insert’s Intended Use Statement; and

(7) Have a minimum shelf-life of 90 days from the date of receipt at the respective Department BPHL locations.

b. Hepatitis B surface antigen (HBSAG) including HBSAG confirmatory. Each HBSAG Diagnostic Test Kit must:

(1) Include Reagent tests and all Diagnostic Test Kit components (including controls and calibrators) as specified in the Package Insert;

(2) Be FDA approved on a common automated, random-access laboratory-measures of the Diagnostic Test Kits’ performance. Have clearly

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Use Statement. Demonstrate in the FDA approved Package Insert the ability of the immunoassay(s) to detect serum HBSAG in persons with mutations that may occur on both loops of the “a” determinate (amino acid 124-147) region; and

c. Hepatitis B surface antibody (HBSAB). Each HBSAB Diagnostic Test Kit must:

(2) Be FDA approved on a common automated, random-access laboratory-

(4) Must perform together with the other Diagnostic Test Kits and the common analyzer as a complete and compatible system;

measures of the Diagnostic Test Kits’ performance. Have clearly

Use Statement;

respective Department BPHL location; and

(8) Be FDA approved for quantitative results, values reported in milli-international units per milliliter (mIU/mL).

d. Hepatitis B core total antibody (HBCAB) or approved equivalency (See

Section 3.12 of the ITB). Each HBCAB Diagnostic Test Kit must:

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e. Hepatitis C total antibody (HCVAB) or approved equivalency (See Section

3.12 of the ITB). Each HCVAB Diagnostic Test Kit must:

(1) Include Reagent tests and all diagnostic test kit components (including

(2) Be FDA approved on a common automated, random-access laboratory-measures of the Diagnostic Test Kits’ performance. Have clearly

f. The Treponemal antibody immunoassay TPIA. Each TPIA Diagnostic Test Kit must:

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(6) Must demonstrate in the FDA approved Package Insert the ability to detect reactivity to immunodominant T. pallidum antigens with molecular weights corresponding to proteins TpN47,TpN17, and TpN15;

(7) Include a Package Insert. Have FDA approved statements in the measures of the diagnostic test kits’ performance. Have clearly specify acceptable specimen types in the Package Insert’s Intended Use Statement; and

(8) Have a minimum shelf-life of 90 days from the date of receipt at the

g. Hepatitis B core IgM antibody (HBCAB IgM). Each HBCAB IgM Diagnostic Test Kit must:

include at least 6 days at 2 to 8 degrees Celsius, and three freeze/thaw cycles;

measures of the Diagnostic Test Kits’ performance. Have clearly

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h. Hepatitis A IgM antibody (HAVAB IgM). Each HAVAB IgM Diagnostic Test Kit must:

(2) Be FDA approved on a common automated, random-access laboratory-include at least 6 days at 2 to 8 degrees Celsius, and three freeze/thaw cycles;

measures of the Diagnostic Test Kits’ performance. Have clearly

i. Replacement of Diagnostic Test Kits: Replace damaged, defective, or non-performance compliant Diagnostic Test Kits at no additional charge within 24 hours of notification by the Department. Unacceptable products will be returned to the Respondent, if needed, at the Respondent’s expense.

j. Ordering Requirements: Provider’s inventory of all Diagnostic Test Kits described in this ITB must be sufficient to support up to an initial order of 15,000 tests for each of the hepatitis and syphilis analytes.

2. Dedicated (proprietary) Non-reagent Consumables

Provide dedicated (proprietary) non-reagent consumables (i.e., disposable pipette tips, customized cuvettes, etc.) as specified in the Package Insert or analyzer operation manual (See Section E below) to the Department upon request.

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3. Analyzer Requirements:

a. Provider must provide a total of six new (not refurbished) common analyzers as follows: two common analyzers to BPHL Jacksonville, two common analyzers to BPHL Tampa, and two common analyzer to BPHL Miami. Each common analyzer must be delivered FOB destination and installed at the Delivery Location specified in Section G below no later than 30 calendar days from the date the initial purchase order is issued by the respective BPHL.

Provider will remove each common analyzer from the respective Delivery Location within 30 calendar days after the end of the Purchase Order term.

Provider will maintain ownership of each common analyzer provided throughout the Reagent Rental Agreement.

b. Each common analyzer:

1) Must be fully automated immunoassay platforms capable of random-access specimen sampling.

2) Shall be compatible with processing multiple tube sizes ranging from

10x75mm to 16x100mm.

3) Shall be compatible with pipetting directly from primary collection tubes and accommodates both plain and gel vacutainers.

4) Must have a static barcode reader for positive identification of specimens and Reagent packs. The barcode reader must normally operate without technologist interactions but provides a manual intervention whenever the barcode is not legible.

5) Must produce a minimum of 100 hepatitis panel (500 analyte) results and 200 Treponemal antibody results in 6 hours per workday.

6) Must perform repeat testing, if required, using the original Lab ID barcode number and the analyzer’s internal priority (stat) testing procedure.

7) Must be capable of pipetting all Reagents needed to perform the tests for each analyte listed above, without technologist direct involvement.

8) Must have an on-board incubator and detection system as well as on-board Reagent refrigeration, as needed, to preserve Reagent integrity for at least overnight assay run completion.

9) Must not exceed a maximum total “footprint” (bench top or floor) allowance of 150 sq. ft.

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10) The technologist(s) hands-on time for each common analyzer must be <20% of the daily processing time.

11) Daily and weekly maintenance of each common analyzer must require only limited maintenance by Department staff, 30 minutes or less per business day and 60-90 minutes or less per weekly and monthly requirements. Manufacturer’s preventive maintenance (PM) shall be performed on-site as often as required by the manufacturer and/or FDA.

12) Provide medium to heavy duty printers (either on-board or external) for each common analyzer.

13) Must be able to meet the bid specifications based on the estimated testing volumes at each BPHL location (See Section A Background Information/Attachment B).

c. Provide and install the following upon delivery of each common analyzer:

1) A medium to heavy duty printer (either on-board or external) for each common analyzer.

2) A UPS battery back-up(s) for each common analyzer.

d. Provide and install all required automation, data management hardware and software within for each common analyzer, UPS battery back, and printer (as applicable) at each location (See Section E) upon installation of the common analyzer(s).

4. Analyzer Software:

a. Each common analyzer must include analyzer software. Install analyzer software for each common analyzer upon installation of each common analyzer. Ensure the analyzer software:

1) Is capable of bi-directional interface with the BPHL information system (Labware) using data innovation software.

2) That identifies and alerts the operator on specimens that require repeat testing per package insert directive (includes initial reactive or indeterminate results) or abnormal/invalid results. When the specimen is reinserted for repeat testing, any pending test order for the laboratory ID must be retained in the software and have priority processing assignment.

3) Performs all calculations and test-specific interpretations.

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4) Is capable of archiving data for a minimum of two years.

5) Allows a user to search recent and archived data using the BPHL specimen ID number.

6) Has codabar numeric barcode reading capability. An additional manual entry option is required for non-barcoded specimens such as proficiency samples, special studies, etc.

7) Includes password and level accessing. Quality Control (QC) data available by technologist ID or master lot ID.

8) Is capable of printing hard copy(ies) of results linked to lab barcode IDs to include:

a) matrix assignment,

b) optical densities/index values and signal cutoffs,

c) interpretations (w/special flagging or coding of reactives),

d) must be able to reprint results at a later time,

e) common result data such as control values, calibration values, technologist name, date, lot numbers, etc. are required for a defined batch of patients’ results only.

b. Provide software coding upon installation of the common analyzer(s) to complete this interface at no additional expense to the Department.

c. Provide software upgrades and updates as needed or upon request at no charge during the Purchase Order term.

d. Provide automation hardware upgrades, at no charge, when workflow warrants or per directives from the FDA or the manufacturer.

5. Training:

a. Ensure Provider’s technical specialists perform the common analyzer’s system installation, start-up, verification of performance and initial user introductory training at each Department BPHL location no later than 14 calendar days after delivery of the common analyzer(s).

b. Provider must provide on-site training at each Department BPHL location (see Section G) for up to three BPHL technical staff.

c. If needed, Provider must provide training at the Provider’s location for at least one BPHL technical staff from each BPHL location (see Section G), at Provider’s expense. If training is provided at Provider’s location, Provider will

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d. On-site training at the BPHL location must include processing and performing all tests covered in the contract. The training shall include basic system troubleshooting, and all maintenance and quality control requirements.

e. Provide additional technical staff on-site training (or off-site per Provider’s standard) upon request by the BPHL or Provider’s recommendation at no…