DOH24-009_Q&A.pdf

Mission:

To protect, promote and improve the health of all people in Florida through integrated state, county and community efforts.

Ron DeSantis Governor

Joseph A. Ladapo, MD, PhD

State Surgeon General

Vision: To be the Healthiest State in the Nation

Florida Department of Health Division of Administration • Bureau of General Services 4052 Bald Cypress Way, Bin B-07 • Tallahassee, FL 32399

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Addendum 1 Questions and Answers

ITB DOH24-009

HIV-1/2 Ag/Ab Immunoassay Diagnostic Test Kits

DATE: 3/18/2025

TO: Prospective Vendors

FROM: Yasemin Sulker, Procurement Officer

Florida Department of Health Central Purchasing Office

SUBJECT: Addendum 1

The purpose of this addendum is to modify Section 2.7, Questions, and Attachment A, Specifications, and to answer questions received in accordance with Section 2.7, Questions, of the ITB. This addendum serves as notice of the following change(s):

Deletions are indicated by “strikethrough” or reference. Additions, updates or replacements are indicated by highlighting.

A. Modifications: The following modifications are made to the ITB:

1. Section 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.

Attendance at the mandatory site visit and signing of the attendance sheet is a prerequisite for the Respondent being deemed responsive under this ITB.

2. Attachment A, Specifications, F.4.:

Provide technical support, including remote telephone assistance, Monday through Friday, with personnel available, 8:00 a.m. to 5:00 p.m., Eastern Time., to answer calls and if needed, Provide an on-site field service technician within a 24-hour dispatch of a reported technical issue by the Department and unresolved by telephone technical service.field engineer on site within 24 hours after common analyzer problem(s) is reported.

Questions and Answers

B. Responses to Questions received pursuant to Section 2.7, Questions: Please see the

Department’s response to questions received by the due date outlined in Section 2.5. Timeline, of the ITB, below:

# Question Answer

On the initial bid Advertisement email, it states Close date:

4/10/2025 06:00 AM. On your Timeline, Page 6, Sealed Bids Due and Opened dated 4/01/2025 2:00pm Eastern.

Please advise what the correct Due date is for this bid.

The advertisement closing date is different than the Sealed Bids Due and Opened date. See the Timeline of the ITB and any addenda which may update the Timeline on the Vendor Information Portal (VIP).

Page 6 – 2.7 Questions.

Attendance at the mandatory site visit and signing of the attendance sheet is a prerequisite for the Respondent being deemed responsive under this ITB.

Please advise what date the mandatory site visit is and locations or each site, as it is not listed on your Timeline.

See Modification 1 to Section 2.7, Questions, of the ITB above.

Page 20 – 7. Common Analyzer Software: Each common analyzer must include analyzer software. The analyzer software must:

a. Be capable of bi-directional interface with the LIMS using data innovation software. Upon installation of the common analyzer, provide the programming “code” required to complete this interface to the LIMS. Any fees for a data innovation driver must be at no additional expense to the Department.

What is the cost of the connection to Data Innovations for 4 connections, (2x in Miami and 2x in Jacksonville)?

The Department will not charge the successful respondent to link the common analyzers to the laboratory information management system already in place.

Page 20 – Attachment A – Specification No. 9) Replace a common analyzer at no additional charge to the Department as needed or as directed by the FDA or manufacturer.

Could you please provide more information on the criteria for replacing an instrument.

Replacement of common analyzers will be at no charge to the Department if the recommendation to replace is initiated by the manufacturer (Respondent) or FDA.

Where and when is the site visit taking place?

2.7 - Site visit- “Attendance at the mandatory site visit and signing of the attendance sheet is a prerequisite for the Respondent being deemed responsive under this ITB.”

See the Answer to Question 2.

Are there other variables factoring into the evaluation?

2.8 – Basis of award – How will technical characteristics be weighted in evaluation? It appears cost and timely response are the two main criteria being evaluated. Section 2.9 mentions quality, and service.

The ITB will be awarded to the responsive, responsible Respondent offering the lowest grand total in accordance with Section 2.8, Basis of Award. Section 2.9, Identical Outcomes, is only relevant in the event of an identical tie bids between two or more Respondents.

Are paper copies and USB/CD expected/required to be sent? Can email or another form of communication be used to submit the response?

3.2- “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).”

No. Bids must be submitted as specified in Section 3.2, Instructions for Submittal.

Will all locations have a medical grade water source and necessary equipment supplied to their immunoassay instruments?

If not, we will need to sub-contract and include costs for water systems.

3.8- Subcontractors – “The Department will not authorize the use of subcontractors in the Contract resulting from this solicitation.”

Yes.

Request: Please adjust phrasing from “must” to contractor shall “strive for”. The FL DOH can always request better dating for reagents that aren’t able to accommodate their volumes.

Attachment A B.1.i – “HIV-1/2 Ag/Ab Immunoassay Diagnostic Test Kits must have a minimum shelf-life of 120 calendar days from the date of receipt at the respective BPHL locations.”

The Department is not willing to revise this language.

Please share the level of service entitlement/coverage that each location desires (response time and hours for service technicians)? We saw the hours of operation, but would like to confirm if sites need “same day” or “next day” service.

See Modification 2 to Attachment A, Specifications, F.4., above.

Is there a requirement for the vendor to conduct surveillance of circulating viral strains in the United States?

Surveillance is not required but proven antibody detection performance as specified in Attachment A, Specifications, B.1,f.

Is there a requirement for the vendor to conduct global surveillance of circulating viral strains?

No.

Is there a requirement for the vendor to possess a biorepository of viral samples?

No.

Is there a requirement for the vendor to conduct genetic sequencing to evaluate detection capabilities of on-market tests?

No.

Can bidder only provide customer’s company name and address in Attachment C- Prior Experience Form?

Due to the confidentiality clauses in the contracts, Bidder is not allowed to provide our customers' contact information and agreement information such as service dates and scope of service.

No. The Respondent must complete the Attachment C, Prior Experience Form in its entirety in order for the Department to verify experience.

After reviewing solicitation DOH24-009 HIV-1/2 Ag/Ab Immunoassay Diagnostic Test Kits, we have the following item(s) for clarification:

Attachment B - Please confirm that the Estimated Number of Tests (134000) is the combined total annual volume of both sites.

Yes, this is the estimated total for both sites.

Attachment A, B.6. a) and G. Delivery and Pick-up - What is the expected implementation timeline and go live date of the system?

Within 30 calendar days of issuance of the initial Purchase Order. See timeline in Attachment A, Specifications, B.6.a).

Attachment A, B.6. Common Analyzers - We understand that the "common analyzers" as defined in this section will eventually provide testing for a menu greater than HIV 1/2 Ag and Ab. Would you please provide a list of these tests and expected volume to the vendors?

This is not applicable to ITB DOH24-009.

Attachment A - Is it acceptable for the vendors export to Attachment A into Word without invalidating the submission instruction for the attachment, or would you provide an editable version of Attachment A?

Yes, this is acceptable. Respondents must also clearly identify any proposed equivalent specification(s) and indicate for which section from Attachment A, Specifictions, it is proposing the equivalent specification so the Department can make an accurate comparison.

See Section C, Approved Equivalent, of Attachment A, Specifications.

Any proposed equivalent must be at no additional charge to the Department.

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