DOH21-029 - CT GC Testing - FINAL 0719.pdf

Version 3/2022

TITLE PAGE

FLORIDA DEPARTMENT OF HEALTH

DOH21-029

INVITATION TO BID (ITB)

FOR

Chlamydia trachomatis and Neisseria gonorrhea (CT and GC) Nucleic Acid Amplification Test System

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 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 Chlamydia trachomatis and Neisseria gonorrhea (CT and GC) Nucleic Acid Amplification Test System 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

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: HIPAA Business Associate Agreement………….…………………….

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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, through its Bureau of Public Health Laboratories (Department), to obtain competitive prices for a laboratory-based nucleic acid amplification test (NAAT) system for diagnostic detection of the presence or absence of Chlamydia trachomatis and Neisseria gonorrhea (CT and GC).

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 (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.

Pursuant to Rule 60A-1.002, Florida Administrative Code, the terms of this solicitation, which includes the Department’s Order Terms and Conditions, control in the event of a conflict between either the PUR1000 or the PUR1001, unless such conflicting term is required by Florida law.

1.5 Definitions

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

Bid: The complete written response of Provider to this I TB, 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.

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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.

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 (Attachment A), the definition in this solicitation will prevail when the term is used in this solicitation. The definition in the Specifications (Attachment A), will prevail when the term is used in the Specifications (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: Katrina Ferguson 4052 Bald Cypress Way, Bin B07 Tallahassee, FL 32399-1749 Email: Katrina.Ferguson@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 three-year period from July 1, 2022, 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.

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2.5 Timeline

EVENT DUE DATE LOCATION

ITB Advertised / Released July 19, 2022 Posted to the Vendor Information Portal https://vendor.myfloridamarketplace.com

Questions Submitted in

Writing

Must be received

PRIOR TO:

July 26, 2022 by 5:00 pm

Submit to: Florida Department of Health Central Purchasing Office

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

Answers to Questions

(Anticipated Date) August 9, 2022 Posted to Vendor Information Portal at:

https://vendor.myfloridamarketplace.com

Sealed Bids Due and Opened

Must be received PRIOR to:

August 17, 2022

@ 3:00 pm

Submit to: Florida Department of Health Central Purchasing Office

Attention: Katrina Ferguson Suite 310 4052 Bald Cypress Way, Bin B07 Tallahassee, FL 32399-1749

Anticipated Posting of Intent to Award August 29, 2022

Posted to the Vendor Information Portal at:

https://vendor.myfloridamarketplace.com https://vendor.myfloridamarketplace.com/

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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 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.

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.

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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 (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 at a minimum, contact information for three entities for which the Respondent has provided services of a similar contract value and testing volume as 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 Subcontractor List

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

3.8 Licenses/Certifications

Respondent must submit documentation of U.S. Food and Drug Administration (FDA) approval for the assay and testing platform with the Bid.

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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. Documentation of FDA approval for the assay and testing platform, as specified in Section 3.8.

3.10.7. 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.

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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.

The terms of this solicitation control over any conflicting terms of the PUR 1000.

Paragraph 31 of PUR 1000 does NOT apply to this ITB or any resulting contract.

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.

Refer to Statement of Non-Collusion Form, Attachment D.

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

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4.5 Provider Registration

Each Provider 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 Provider 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 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.

4.8 Performance Measures

Pursuant to section 287.058, Florida Statutes, the resulting Contract must contain performance measures which specify the required minimum level of acceptable service to be performed. The performance measures are detailed in the Specifications (Attachment A).

4.9 Financial Consequences

Pursuant to section 287.058, Florida Statutes, the resulting Contract must contain financial consequences that will apply if successful Respondent fails to perform in accordance with the Contract terms. The financial consequences are detailed in the Specifications (Attachment A).

https://vendor.myfloridamarketplace.com/

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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:

http://www.floridahealth.gov/about/administrative-functions/purchasing/DOHTermsandConditions1272021.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 http://www.floridahealth.gov/about/administrative-functions/purchasing/DOHTermsandConditions1272021.pdf http://www.floridahealth.gov/about/administrative-functions/purchasing/DOHTermsandConditions1272021.pdf

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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, or by facsimile during business hours will be accepted. Documents received after business hours will be filed the following business day.

No filings may be made by email or any other electronic means. All filings must be made with the Agency Clerk ONLY and are only 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.

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.

The Agency Clerk’s mailing address:

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

The Agency Clerk’s physical address for hand deliveries:

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

Tallahassee, Florida 32399 Fax No. (850) 413-8743

ATTACHMENT A

SPECIFICATIONS

Version 3/2022

The Department’s Bureau of Public Health Laboratories (Department) is seeking a laboratory-based Nucleic Acid Amplification Test (NAAT) system for CT and GC testing and onsite testing instrument trainings for laboratory staff at its three locations in Jacksonville, Miami, and Tampa, Florida.

A. Background Information

The Department performs approximately 175,000 tests annually for the detection of CT and GC.

The patient population includes individuals from various settings, including county health department clinics, correctional facilities, family planning clinics, and refugee health centers.

Testing is performed at each of the Department’s three laboratories: Jacksonville, Miami, and Tampa, Florida.

B. Product Specifications

1. Diagnostic reagent kit requirements:

a. Assay must provide documentation of approval by the FDA molecular method for the in vitro diagnostic detection of CT and GC from a single specimen collected from male and female urine specimens, clinician collected male urethral and female endocervical swabs, clinician and patient-collected vaginal swabs, clinician collected throat and rectal swabs.

b. Show proof (with either FDA approval or internal study) that the assay results are not affected by interfering substances that naturally appear in patient samples such as blood, mucous, or bilirubin, or man-made components such as vitamins or gynecological products.

c. Show proof (with either FDA approval or internal study) that the assay results are not affected by interfering substances that naturally appear in patient samples such as blood, mucous, or bilirubin, or man-made components such as vitamins or gynecological products.

d. Show proof (with either FDA approval or internal study) that the assay does not cross-react with organisms other than Chlamydia trachomatis and Neisseria gonorrhea, nor cross react with other non-gonococcal Neisseria species.

e. All reagent kits used in testing must have a minimum shelf-life of 90 days from the date of receipt at each BPHL site.

f. Will include all reagents and components as specified in the package insert.

g. Dedicated consumables and non-reagent consumables as specified in the package insert will be provided at no additional cost upon request.

2. Collection kit requirements:

a. Vendor must supply specimen collection kits for onsite test collection of urine and swab specimens, and these must include transport vials that can stabilize or preserve specimen for a minimum of 14 days at room temperature.

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b. Specimen collection kits must include instructions for use.

c. Specimen collection kits must have a minimum shelf-life of 12 months from the date of receipt at each BPHL site.

d. Specimen collection vials must be able to be loaded directly onto the instrument upon receipt from the specimen submitter without additional manipulation by the laboratorian, other than placing into a instrument loading rack.

3. Instrument requirements:

a. Come with a heavy-duty printer and onboard computer, as well as data cable(s) necessary for connection to printer and networking to a bi-directional LIMS.

b. Instrumentation must be capable of processing the number of specimens specified below within a six-hour time period. Each specimen will have a total of two results, which equals the daily total indicated in the table.

Location Specimen samples per day Daily result totals (per six-hour time period) Jacksonville 450 900 Miami 325 650 Tampa 325 650

c. If multiple instruments will be needed at each Department location to accommodate the projected sample throughput requirement in 3.b. above, the total square feet of floor space (including clearances) should not exceed 80 square feet and 125 lbs/square feet at each Department laboratory.

d. The test system should have the operational capabilities as follows:

i. No more than 15 minutes per day needed for daily maintenance.

ii. True random-access capability with test requests performed in a random manner and allowing multiple batches and samples to be loaded randomly in a sample rack and continuously as they arrive in the laboratory.

iii. True random-access capability to load a patient sample with different test orders randomly in a sample rack and load continuously as they arrive in the laboratory.

iv. The test system has the ability for all different specimen types to be processed identically and simultaneously and does not require any specimen type segregation or analyst manipulation (e.g., manual cap removal, swab expression, swab removal or centrifugation) prior to sample loading.

v. After specimens are accessioned and loaded onto sample holders, the test system must not require any additional manual steps or processing of specimens by analyst.

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vi. The instrument must have either an onboard automated de-capper to remove the caps from the specimens (if needed prior to testing) or a method to puncture the specimen tube caps that does not require manual intervention.

e. Testing processes and any subsequent decontamination of waste with bleach must not generate any hazardous substances.

f. Testing instrumentation must have the capability to access and change universal fluids or dispose solid waste during assay processing.

g. Testing instrumentation must have the capability to communicate across multiple instruments, at a minimum, information regarding reagents, maintenance, results, quality control data and be able to share reagent kits.

h. Provide, at no additional cost, all required components to verify the assay system performance, including but not limited to specimen or verification panels, specimen collection kits, test kits, as stipulated in the current Clinical Laboratory Improvement Amendments (CLIA-88) requirements for verification. Anticipated volume for method verification is a minimum of 100 tests.

i. Supply all equipment and supplies, including consumables, necessary in the preparation and testing of specimens.

j. The test system must have bi-directional interface capability with the current BHPL Laboratory Information Management System (LIMS) Labware 7 to receive test orders and download results. Programming code (#14) will provide additional information about connecting.

k. Provide the programming code needed to interface the instrument to the LIMS including, if necessary, the purchase fees for a Data Innovations driver, at no additional cost to BPHL.

l. Testing instrumentation must have true positive sample ID capable of reading barcode font 128 with an automated onboard scanner. Specimens must be placed in the rack prior to scanning and will not require any manual procedures until the results are produced.

m. Specify process-specific consumables that must be supplied by BPHL (if applicable).

n. Provide required preventative maintenance and repairs for the initial term and any subsequent renewals at no additional cost to BPHL.

o. Provider will retain ownership of the testing instrument and must provide service or replacement of the instrument within 24 hours of a reported problem to avoid interruptions in testing.

p. Have technical support with personnel available, at a minimum during BPHL business hours of 8:00 AM to 6:00 PM Eastern Time, to answer calls, and if needed, dispatch a field engineer on site within 24 hours after testing instrument problem is reported.

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q. Test system must have the capability of performing other FDA-approved diagnostic assays that the current test system can provide, specifically HCV NAAT (Viral load), HIV Viral load, Trichomonas vaginalis, Mycoplasma genitalium, Bacterial vaginosis, SARS CoV-2 and Flu/SARS CoV-2.

r. Instrument must be able to use the original Lab ID barcode for repeat testing.

s. Upgrades to be provided, at no charge, by the manufacturer when workflow warrants or per directives from the FDA or the manufacturer.

C. Training

Onsite training for the testing instrument and process will be conducted at the three laboratories listed in Section F of this ITB to ensure staff are properly trained on use of the testing instrument.

At a minimum the training will include one BPHL technician or technologist at each laboratory location.

Training shall be provided no later than 30 days after first instrument installation at each location.

D. Literature

Technical documentation, including the FDA approved package insert, is required to be provided with Provider’s Bid 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.

E. Manuals

Provider must furnish the testing instrument’s operation manuals upon delivery at no additional cost to the Department.

F. Delivery

All testing instrumentation requested in this ITB must be delivered and installed, FOB destination to the addresses listed below no later than 45 calendar days after executed PO.

Jacksonville Laboratory 1217 N. Pearl Street Jacksonville, FL 32202

Miami Laboratory 1325 N.W. 14th Ave Miami, FL 33125

Tampa Laboratory 3602 Spectrum Blvd Tampa, FL 33612

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ATTACHMENT B

SPECIFICATIONS

A single award will be made to the responsive, responsible Respondent offering the lowest grand total for the commodities/services requested in this ITB, including delivery, FOB destination. The prices per reagent kit and collection kit must include the cost of all instrumentation, vendor performed preventive maintenance, training, reagents, controls, and other process-required consumables needed to perform the testing. Provide part numbers for different collection kits and reagent kits (if necessary).

Unit price will control in the event 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.

Initial Term

Item Description

Part Number

Price Per Kit Number of Units in Each Kit

Unit Price

Estimated Annual

Quantity

Annual Price

Total Price

Reagent Kit

$______ x (Per Test)

175,000 x 3 years =

Collection Kit

(Per

Collection) x 3 years =

Initial Term Total Price

(Add total prices of test and collection kits.)

Renewal Term – Test Kits

Renewal Year

Item Description

Part Number

Price Per Kit Number of Units in Each

Kit

Unit Price Estimated Annual

Quantity

Annual

Renewal Term Test Kit Total Price

(Add annual prices of renewal years 1, 2 and 3.)

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Renewal Term – Collection Kits

Renewal Year

Item Description

Part Number

Price Per Kit Number of Units in Each

Kit

Unit Price Estimated Annual

Quantity

Annual

(Per Collection)

Renewal Term Collection Kit Total Price

(Add annual prices of renewal years 1, 2 and 3.)

Initial Term Total Price

Renewal Term Test Kit Total Price

Renewal Term Collection Kit Total Price

Grand Total

(Add 3 rows above.)

Respondent Name:

Respondent Mailing Address:

City, State, Zip:

Phone: Fax Number:

E-Mail Address:

Federal Employer Identification Number (FEID):

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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

DOH21-029

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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

DOH21-029

Invitation to Bid Chlamydia trachomatis and Neisseria gonorrhea (CT and GC) Nucleic Acid Amplification Test System Page | 24

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

DOH21-029

Invitation to Bid Chlamydia trachomatis and Neisseria gonorrhea (CT and GC) Nucleic Acid Amplification Test System Page | 25

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 $1,000,000.00 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 Activities in the Iran Petroleum Energy Sector List, or the Scrutinized Companies that Boycott Israel List. I further certify that the company is not engaged in a boycott of Israel. I understand that pursuant to section 287.135, Florida Statutes, the submission of a false certification may subject company to civil penalties, attorney’s fees, and/or costs.

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 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 F

IDENTICAL TIE CERTIFICATION FORM

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Respondent Name: ______________________________________________________________

Respondent Mailing Address: _____________________________________________________

City-State-Zip: __________________________________________________________________

Telephone Number: _____________________________________________________________

Email Address: _________________________________________________________________

Federal Employer Identification Number (FEID): ______________________________________

Chapter 287, Florida Statutes, provide Respondents the advantage of “tie breakers” whenever two or more bids, proposal, or replies received by an agency are equal with respect to price, quality, and service. For a Respondent to take advantage of the below “tie breakers,” it must meet the statutory qualifications for one or more of these provisions and certify that it qualifies for the cited preference.

If the Department discovers that any information on this form is false after the award to the Respondent is made, the Department reserves the right to terminate the Contract and hold the awarded Respondent liable for costs associated with re-procuring the services. The Respondent certifies that below preferences apply:

Yes No Applicable Certification

Certified Minority Business Enterprise: This Bid is from a certified minority-owned firm or company in accordance with sections 287.057(11) and 287.0943, Florida Statutes.

Certified Veteran Business Enterprise: This Bid is from a certified veteran business enterprise in accordance with section 295.187, Florida Statutes.

Drug Free Workplace: This Bid is from a Respondent that currently maintains a drug-free workplace environment in accordance with section 287.087, Florida Statutes.

Foreign Manufacturer (This preference only applies to State procurements of commodities): This Bid is from a foreign…