DOH25-008 - ITB Final.pdf

TITLE PAGE

FLORIDA DEPARTMENT OF HEALTH

DOH25-008

INVITATION TO BID (ITB)

FOR

Mycobacterium Tuberculosis Complex (MTBC) Nucleic Acid Amplification Test (NAAT) and Testing Instrument

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 Mycobacterium Tuberculosis Complex (MTBC) Nucleic Acid Amplification Test (NAAT) and Testing Instrument 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 Certifications (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 Mycobacterium Tuberculosis Complex (MTBC) Nucleic Acid Amplification Test (NAAT) and Testing Instrument.

1.2. Legal Authority

Chapter 287, 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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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.

Respondent: The business entity that submits a Bid.

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

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.

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: Yasemin Sulker 4052 Bald Cypress Way, Bin B07 Tallahassee, FL 32399-1749 Email: Yasemin.Sulker@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 three years, from an anticipated Contract start date of August 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 7/16/2025 Posted to the Vendor Information Portal https://vendor.myfloridamarketplace.com mailto:Yasemin.Sulker@flhealth.gov https://vendor.myfloridamarketplace.com/

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Questions Submitted in

Writing

Must be received

PRIOR TO:

8/1/2025

4:30 PM

Submit to: Florida Department of Health Central Purchasing Office

Attention: Yasemin Sulker Suite 310 4052 Bald Cypress Way, Bin B07 Tallahassee, FL 32399-1749 E-mail: Yasemin.Sulker@flhealth.gov

Answers to Questions

(Anticipated Date) 8/8/2025 Posted to Vendor Information Portal at:

https://vendor.myfloridamarketplace.com

Sealed Bids Due and Opened

Must be received

PRIOR to:

8/20/2025

2.30 PM

PUBLIC OPENING

Submit to: Florida Department of Health

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

Anticipated Posting of Intent to Award 8/25/2025 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 delivery, mailto:Yasemin.Sulker@flhealth.gov

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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 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.

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

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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.

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 Prior Experience Form (Attachment C) 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

Mycobacterium Tuberculosis Complex (MTBC) Nucleic Acid Amplification Test (NAAT) and Testing Instrument Page | 10 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%.

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 the 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.

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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.

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 3.7.

3.10.11. Bids must document the Respondent’s ability to meet the requirements specified in the Specifications (Attachment A).

3.10.12. Technical documentation is required to be provided with Bid submissions to demonstrate compliance of the product Bid with applicable technical requirements of this ITB (Attachment A).

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.

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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(19)(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 http://dms.myflorida.com/content/download/2933/11777

Mycobacterium Tuberculosis Complex (MTBC) Nucleic Acid Amplification Test (NAAT) and Testing Instrument Page | 13 appropriate registration may result in withdrawal of the Contract award and forfeiture of its Bid Bond, if applicable.

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 the Forced Labor Certifications (PUR 2024) (Attachment H) 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 https://vendor.myfloridamarketplace.com/

Mycobacterium Tuberculosis Complex (MTBC) Nucleic Acid Amplification Test (NAAT) and Testing Instrument Page | 14 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 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, https://www.floridahealth.gov/about/administrative-functions/purchasing/DOHTermsandConditions09022022.pdf https://www.floridahealth.gov/about/administrative-functions/purchasing/DOHTermsandConditions09022022.pdf

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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.

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:

Mycobacterium Tuberculosis Complex (MTBC) Nucleic Acid Amplification Test (NAAT) and Testing Instrument Page | 16 https://agency_clerk-fdh.mycusthelp.com/WEBAPP/_rs/supporthome.aspx?&lp=3 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fagency_clerk-fdh.mycusthelp.com%2FWEBAPP%2F_rs%2Fsupporthome.aspx%3F%26lp%3D3&data=05%7C01%7CAllegra.Small%40flhealth.gov%7Ced6ef13ace184fb11b7908dae457e3ab%7C28cd8f803c444b2781a0cd2b03a31b8d%7C0%7C0%7C638073363391464622%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=kR3RdMTBEMnpD1bRPC31L4z7S59FQPDy6B1wdSUApXY%3D&reserved=0

ATTACHMENT A

SPECIFICATIONS

DOH25-008

Invitation to Bid Mycobacterium Tuberculosis Complex (MTBC) Nucleic Acid Amplification Test (NAAT) and Testing Instrument Page | 17

The following information details the specification requirements of the Department’s Mycobacterium Tuberculosis Complex (MTBC) Nucleic Acid Amplification Test (NAAT), and Testing Instrument. Respondent must have prior written approval from the Department’s Contract Manager for any modifications or alterations to the specifications of Mycobacterium Tuberculosis Complex (MTBC) Nucleic Acid Amplification Test (NAAT) and Testing Instrument.

A. Background information

The Department has a need for MTBC NAATs for its Bureau of Public Health Laboratories (BPHL) in Jacksonville to perform mycobacteriology testing as an essential part of the algorithm for mycobacteriology diagnostics and to provide crucial results for the rapid diagnosis of Tuberculosis (TB). NAAT’s are used by the Department to detect DNA of infectious disease organisms in clinical samples. There are several NAAT methods, but BPHL utilizes a real-time PCR (polymerase chain reaction) assay, a common molecular method for detection of DNA and identification of infectious disease organisms.

B. Product Specifications

1. MTBC NAAT Requirements:

a. The test protocol must take no longer than 6 hours to complete from sample receipt to test result.

b. The NAAT must follow three main steps: extraction, amplification, and detection of DNA. This test will be performed on automated instrumentation.

The Respondent must provide the reagents and kits to perform the steps in the process and the instrument that automates these steps.

c. DNA extraction kits must be able to extract MTBC DNA from multiple specimen types i.e. respiratory and non-respiratory sources.

d. All other instrument specific consumables required for the amplification and detection steps must be able to accommodate the Department’s in-house Laboratory Developed Test (LTD).

2. Testing Instrument and System Requirements:

Respondent must provide to the Department a laboratory system that can automate a laboratory developed test for real-time PCR detection of MTBC organisms in patient specimens. The system must fit within a total available floorspace of 2.5 feet by 8.5 feet. The system must have the following capabilities:

a. Automate the sample extraction, amplification, and detection of a MTBC on a single platform.

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b. Be capable of yielding high quality nucleic acid extractions free of substances that inhibit real time PCR from a variety of specimen types, both respiratory and non-respiratory specimens, for the detection of MTBC. DNA extraction procedures should disrupt cellular structure to create a lysate, separate soluble nucleic acids from cellular debris and other insoluble material, bind nucleic acids to a purification matrix, wash way proteins and contaminants and elute purified nucleic acids.

c. Include all the necessary supporting computer equipment (e.g., monitor, keyboard, and barcode scanner) and must be capable of interfacing with the Departments laboratory information management system, LabWare.

d. Include an uninterruptible power supply (UPS), defined as an automated battery backup which activates when an input power source fails. This UPS should be capable of providing short-term power allowing instruments to complete its processes.

e. An open architecture that allows for ‘user-defined protocols’ with customizable cycling parameters (i.e. time and temperature) and customizable reagents (i.e. user-developed lyophilized or wet reagents as needed) to maximize ease of use and to minimize wase.

f. Perform qualitative, quantitative, and multiplexed detection of targets.

g. Perform independent extraction and amplification of samples to aid in assay development and optimization. Additionally, each PCR reaction must be individually ‘controlled’ and read.

h. Ability to use multiple real time PCR methodologies e.g. scorpion primer or probes, molecular beacons, and TaqMan probes.

i. Equipped with at least five optical channels for detection of multiple targets.

The system must support fluorescent detection of:

Color (Spec)

Typical Dye (Assay)

Wavelength Name

Excitation Range

Emission Range

Green FAM 470/510 470±12 510±6 Yellow TET, VIC 530/555 530±6 555±6 Orange Texas Red, ROX 585/610 585±6 610±6 Red Cy5 625/660 625±6 660±6 Crimson Cy5.5 680/715 680±6 > 710

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j. Ability to perform small sample volume PCR reactions to facilitate rapid thermos-cycling and rapid turnaround time and must seal the PCR reaction chamber to reduce risk of amplicon contamination and cross reactivity.

k. Walk-away automation with the ability to scan in a sample tube barcode ID, match to specific test protocols, flag any error in set-up prior to initiating run and perform all steps to complete sample processing, (i.e. nucleic acid extraction and PCR set-up and run) and provide data analysis.

l. Ability to perform up to 50 tests per day but also able to perform as few as one sample at a time with minimal waste.

m. Provision of the reagents and consumables required for instrument operation.

Consumables will include all the necessary pipette tips, processing and reaction tubes for the nucleic acid extraction, PCR set-up and amplification.

Reagents will include generic extraction reagents optimized for the MTBC

NAAT.

n. Ability to partner with other systems to provide quality-assure test master mix with an internal control.

C. Training

Onsite training on the complete test system must be conducted at the delivery site, specified in Section G, during business hours, 8 am to 5 pm, Monday through Friday.

D. Literature

Technical documentation is required to be provided with Bid submissions to demonstrate compliance of the product Bid with applicable technical requirements of this ITB. All Bids must meet or exceed all conditions and specifications of this ITB. This must include at least one peer reviewed publication concerning the performance of the system compared to other similar systems on the market.

The Department, in its sole discretion and in the best interest of the State, may determine the acceptability of the Bid through technical documentation made available to the Department as of the date and time of Bid opening. Such authority of the Department will in no way relieve the Respondent from the ultimate responsibility of submitting the required technical documentation, nor will the Respondent assume that such documentation is otherwise available to the Department. The Department will not be responsible for the accuracy of the technical documentation in its possession.

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E. Manuals

The respondent must furnish instrument manuals upon delivery at no additional cost to the Department.

F. Maintenance Agreement and Technical Support

The Department requires a maintenance agreement for the duration of the contract term for each instrument provided in this ITB. This maintenance agreement becomes effective upon installation and acceptance at the Department site listed in Section G.

Maintenance must include the following:

a. Technical support to be provided Monday through Friday 8am to 5pm EST.

b. Unlimited technical support and troubleshooting to be available via telephone or internet support.

c. Preventative maintenance visits (as required by manufacturer and regulatory agencies, at least two visits annually).

d. On-site service to be provided when required with 24 hours response time (when on-site service is required).

e. All parts and labor materials (excluding operating supplies and consumables), with no additional costs.

f. All labor (including travel), with no additional costs.

G. Delivery

Adherence to the delivery schedule stated in this ITB is critical to the success of this project. All items required to implement testing requested in this ITB must be delivered and installed, FOB destination to the address listed below no later than two weeks from the order date. Additional test kits will be ordered as necessary by the Department to meet test volume.

BPHL Jacksonville 1217 N Pearl Street Jacksonville, FL 32202

H. Pricing

1. The Department estimates an annual test volume of 7,000 units. However, the

Department does not guarantee this volume and will only pay for actual tests performed.

Cost per unit must include:

a. Testing Instrument shipping, delivery and installation

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b. Reagents and consumables required to complete the test (excluding probes and primers)

c. LIS interface

d. Service for testing Instrument, including repair and maintenance

e. Training and technical support

f. Literature and manuals

2. Any system provided with the MTBC NAATs must include new instruments. If the department already has instruments for the MTBC NAAT in place, Respondent must replace the instruments with new models.

3. Any system provided for the MTBC NAAT will require validation and verification. All reagents and kits required for either process must be provided at no cost to the Department.

ATTACHMENT B

PRICE PAGE

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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 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.

Unit price will control in the case of mathematical error(s).

The below prices submitted by the Respondent are all inclusive. There must be no additional costs charged to the Department for work performed under this Bid.

No changes should be made to the format of this price page. Any changes made to the price page may deem the Respondent’s Bid non-responsive and could be rejected. Respondent must round to 2 decimal points.

**The estimated number of Reagent tests in this ITB are only to be used in determining bid prices and not to be considered as definite. The number of Reagent tests may be less than or greater than those stated in this ITB, at no penalty to the Department. **

INITIAL ONE YEAR TERM (2025-2026)

Description Unit Price Estimated Annual Quantity**

Total Price

MTBC NAAT $____________ X 7,000 = $__________________

INITIAL TWO YEAR TERM (2026-2027)

Description Unit Price Estimated Annual Quantity**

INITIAL THREE YEAR TERM (2027-2028)

INITIAL THREE YEAR TERM TOTAL: $_______________________

Mycobacterium Tuberculosis Complex (MTBC) Nucleic Acid Amplification Test (NAAT) and

Page | 23

RENEWAL FIRST TERM (2028-2029)

MTBC NAAT $____________ X 7,000 = $_________________

RENEWAL SECOND TERM (2029-2030)

RENEWAL THIRD TERM (2030-2031)

RENEWAL THREE YEAR TERM TOTAL: $_______________________

GRAND TOTAL

OVERALL GRAND TOTAL

INITIAL THREE YEAR TERM TOTAL

(Initial Years 1, 2 & 3) $__________________________

RENEWAL THREE YEAR TERM TOTAL

(Renewal Years 1, 2, & 3)

GRAND TOTAL

(INTITIAL TERM + RENEWAL TERM = Grand Total )

Respondent Name:

Respondent Mailing Address:

City, State, Zip:

Phone: Fax Number:

E-Mail Address:

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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 Purchase Order 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.

ATTACHMENT C

PRIOR EXPERIENCE FORM

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Provider’s Name: _______________________________________________________

Providers 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 this experience form 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.

1.

Company/Agency Name:

Address:

City, State, Zip:

Contact Name:

Contact Phone:

Contact Email Address:

General Description of Work (related to the scope of this solicitation):

Service Dates: Services began:________ Services ended: _________

Approximate Contract Value: $

2.

Company/Agency Name:

Address:

City, State, Zip:

Contact Name:

Contact Phone:

Contact Email Address:

General Description of Work

ATTACHMENT C

PRIOR EXPERIENCE FORM

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3.

Company/Agency Name:

Address:

City, State, Zip:

Contact Name:

Contact Phone:

Contact Email Address:

General Description of Work

ATTACHMENT D

STATEMENT OF NON-COLLUSION

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I hereby certify that my company, its employees, and its principals, had no involvement in performing a feasibility study of the implementation of the subject Contract, in the drafting of this solicitation document, or in developing the subject program. Further, my company, its employees, and principals, engaged in no collusion in the development of the instant Bid, proposal or reply.

This Bid, proposal or reply is made in good faith and there has been no violation of the provisions of Chapter 287, Florida Statutes, the Florida Administrative Code Rules promulgated pursuant thereto, or any procurement policy of the Department. I certify I have full authority to legally bind Respondent to the provisions of this Bid, proposal or reply.

Signature of Authorized Representative* Date

*An authorized representative is an officer of the Respondent’s organization who has legal authority to bind the organization to the provisions of the Bids. This usually is the President, Chairman of the Board, or owner of the entity. A document establishing delegated authority must be included with the Bid if signed by someone other than the President, Chairman or owner.

ATTACHMENT E

RESPONDENT CERTIFICATION REGARDING SCRUTINIZED COMPANIES LIST

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Respondent Name: ______________________________________________________________

Respondent Mailing Address: _____________________________________________________

City-State-Zip: __________________________________________________________________

Telephone Number: _____________________________________________________________

Email Address: _________________________________________________________________

Federal Employer Identification Number (FEID): ______________________________________

Section 287.135, Florida Statutes prohibits a company from bidding on, submitting a proposal for, or entering into or renewing a contract for goods or services of any amount if, at the time of contracting or renewal, the company is on the Scrutinized Companies that Boycott Israel List, created pursuant to section 215.4725, Florida Statutes, or is engaged in a boycott of Israel. Section 287.135, Florida Statutes, also prohibits a company from bidding on, submitting a proposal for, or entering into or renewing a contract for goods or services of $1,000,000 or more, that are on either the Scrutinized Companies with Activities in Sudan List or the Scrutinized Companies with Activities in the Iran Petroleum Energy Sector Lists which were created pursuant to section 215.473, Florida Statutes.

As the person authorized to sign on behalf of the Respondent, I hereby certify that the company identified above in the section entitled “Respondent Name” is not listed on either the Scrutinized Companies with Activities in Sudan List, the Scrutinized Companies with…