DOH24-019 Addendum 1 FINAL.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

PHONE: 850-245-4199

FloridaHealth.gov

Accredited Health Department Public Health Accreditation Board

Addendum 1 Questions and Answers

ITB DOH24-019

Viral Hepatitis and Treponemal Antibody Diagnostic Test Kits

DATE: 05/12/2025

TO: Prospective Vendors

FROM: Summer Lindsley, Procurement Officer

Florida Department of Health Central Purchasing Office

SUBJECT: Addendum 1

The purpose of this addendum is to modify the ITB, 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. Attachment A, Section B.1.b is modified as follows:

b. Hepatitis B surface antigen (HBSAG) including HBSAG confirmatory. Each HBSAG diagnostic test kit must:

2. Attachment A, Section B.1.i is added as follows:

i. Hepatitis B surface antigen Confirmatory (HBSAG Confirmatory). Each HBSAG Confirmatory diagnostic test kit must:

(1) Include reagent tests and all diagnostic test kit components (including controls and calibrators) as specified in the Package Insert;

(2) Be FDA approved on the same common automated, random-access laboratory-based analyzer suggested for the HBSAG screening test;

(3) Perform together with the other diagnostic test kits and the common analyzer as a complete and compatible system;

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

Questions and Answers

(5) Include a Package Insert. Have FDA approved statements in the Package Insert concerning acceptable sensitivity, specificity, and expected percent of antibody neutralization performance; and

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

3. Attachment B, Price Page is deleted in its entirety and replaced with the Revised

Attachment B attached below.

REVISED ATTACHMENT B

PRICE PAGE

DOH24-019

Invitation to Bid Viral Hepatitis and Treponemal Antibody Diagnostic Test Kits

A single award solicitation will be made to the responsive, responsible Respondent offering the lowest grand total for the commodities and/or services requested in this ITB including inside delivery, FOB destination. All shipping, handling and inside delivery costs must be FOB destination at Jacksonville, Tampa, and Miami Laboratories and included in the unit cost.

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.

Changes must not 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.

**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 TERM (2025-2026)

Description Cost per Reagent

**Estimated annual number of Reagent tests Total Price

HepA Antibody HAVAB As specified in the

Specifications (Attachment A)

$________ x 29,300 = $____________________

HepB Surface Antigen

HBSAG

As specified in the Specifications (Attachment A)

$________ x 39,300 = $____________________

HepB Surface Antigen Confirmatory

HBSAG Confirmatory As specified in the

Specifications (Attachment A)

$________ x 500 = $____________________

HepB Surface Antibody

HBSAB

As specified in the Specifications (Attachment A)

$________ x 37,900 = $____________________

HepB Core Antibody

HBCAB

As specified in the Specifications (Attachment A)

$________ x 37,600 = $____________________

HepC Antibody HCVAB As specified in the

Specifications (Attachment A) $________ x 35,300 = $____________________

Treponemal Immunoassay TPIA

As specified in the Specifications (Attachment A)

$________ x 11,300 = $____________________

DOH24-019

Initial Term Total:

RENEWAL YEAR ONE TERM (2026-2027)

Description Cost per

HepA Antibody HAVAB As specified in the

Specifications (Attachment A) $________ x 29,300 = $____________________

HepB Surface Antigen

HBSAG

As specified in the Specifications (Attachment A)

$________ x 39,300 = $____________________

HepB Surface Antigen Confirmatory

HBSAG Confirmatory As specified in the

Specifications (Attachment A)

$________ x 500 = $____________________

HepB Surface Antibody

HBSAB

As specified in the Specifications (Attachment A)

$________ x 37,900 = $____________________

HepB Core Antibody

HBCAB

As specified in the Specifications (Attachment A)

$________ x 37,600 = $____________________

HepC Antibody HCVAB As specified in the

Specifications (Attachment A) $________ x 35,300 = $____________________

Treponemal Immunoassay TPIA

As specified in the Specifications (Attachment A)

Renewal Year One Total: $____________________

RENEWAL YEAR TWO TERM (2027-2028)

HepA Antibody HAVAB As specified in the

$________ x 29,300 = $____________________

DOH24-019

HepB Surface Antigen

HBSAG

As specified in the Specifications (Attachment A)

$________ x 39,300 = $____________________

HepB Surface Antigen Confirmatory

HBSAG Confirmatory As specified in the

Specifications (Attachment A)

$________ x 500 = $____________________

HepB Surface Antibody

HBSAB

As specified in the Specifications (Attachment A)

$________ x 37,900 = $____________________

HepB Core Antibody

HBCAB

As specified in the Specifications (Attachment A)

$________ x 37,600 = $____________________

HepC Antibody HCVAB As specified in the

Specifications (Attachment A) $________ x 35,300 = $____________________

Treponemal Immunoassay TPIA

As specified in the Specifications (Attachment A)

Renewal Year Two Total: $____________________

RENEWAL YEAR THREE TERM (2028-2029)

HepA Antibody HAVAB As specified in the

Specifications (Attachment A) $________ x 29,300 = $____________________

HepB Surface Antigen

HBSAG

As specified in the Specifications (Attachment A)

$________ x 39,300 = $____________________

HepB Surface Antigen Confirmatory

HBSAG Confirmatory As specified in the

$________ x 500 = $____________________

DOH24-019

HepB Surface Antibody

HBSAB

As specified in the Specifications (Attachment A)

$________ x 37,900 = $____________________

HepB Core Antibody

HBCAB

As specified in the Specifications (Attachment A)

$________ x 37,600 = $____________________

HepC Antibody HCVAB As specified in the

Specifications (Attachment A) $________ x 35,300 = $____________________

Treponemal Immunoassay TPIA

As specified in the Specifications (Attachment A)

Renewal Year Three Total: $____________________

GRAND TOTAL:

Initial Term Total:

Renewal Term Total:

(Renewal Years 1, 2, & 3) $____________________

GRAND TOTAL

Initial Term + Renewal Term Total = Grand Total $____________________

OPTIONAL:

Description Cost per test

HAVAB IgM only As specified in the Specifications (Attachment A) $_______________

HBCAB IgM only As specified in the Specifications (Attachment A) $_______________

Note: Do NOT add the cost of the Optional tests (HAVAB IgM only and HBCAB IgM only) to the Grand total. These prices will NOT be included in the scoring criteria.

DOH24-019

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 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.

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

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. Question: Are there other variables factoring into the evaluation?

Please see Section 2.8. Requested documentation in Section 3.10 is for confirming Responsibleness but will not be evaluated for the purposes of determining award.

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

Submissions will not be acepted via email. Please see Section 3.2, Instructions for Submittal.

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

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.

Yes, all locations will have medical grade water plumbed to each analyzer.

Attachment A B.1.h.7. – “Have a minimum shelf-life of 90 calendar days from the date of receipt at the respective BPHL locations.” 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.

Based on current workflow and CLIA QA requirements, we prefer to retain the "must" requirement for minimum shelf-life applied to each assay represented.

Question: 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 Attachment A, Section F.4. Response is required within 24 hours.

6 Request: Please share estimated annual volumes for the following tests :

HBSAG Confirmatory; HAVAB IgM only & HBCAB IgM only.

We estimate 400-500 per year of HBSAG Confirmatory. As for HAVAB IgM less than 100 per year, if any. As for HBCAB IgM less than 100 per year, if any.

Question: HBSAG Confirmatory test is a separate billable line item for our organization. Can this please be adjusted in the bid so industry can quote and invoice for the HBSAG Confirmatory test? The HBSAG Confirmatory test was separately quoted and provided in previous bids/contracts.

Yes, see Addendum 1.

# Question Answer

The FL DOH has an opportunity to use less instrumentation and still have common analyzer backup in certain locations. The FL DOH can save money by implementing (1) common analyzer at sites where a vendor's other common analyzer is already in place and can perform for the purposes of this bid. Is the DOH able to move forward with (1) instrument when advantageous to the government for cost savings and/or operational efficiencies?

No.

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.