ITB2025807 OraSure HIV Test Kits & Associated Quality Controls- Amendment 1.pdf

STATE OF IDAHO

DEPARTMENT OF HEALTH AND WELFARE

Invitation to Bid (ITB) ITB2025807

OraSure Rapid HIV Test Kits and Associated Quality Controls

Amendment 1

Date of Issuance: 2/26/2025

TABLE OF CONTENTS

ITB ADMINISTRATIVE INFORMATION

1 PURPOSE

2 GENERAL INFORMATION, SOLICITATION INSTRUCTIONS AND STANDARD TERMS AND

CONDITIONS

3 INQUIRIES

4 BACKGROUND

5 SPECIFICATIONS

6 COST

7 BILLING PROCEDURE

8 SUBMISSION REQUIREMENTS

9 AWARD

10 ACCEPTANCE

11 CONTRACT MONITORING

12 DELIVERY

13 SUBCONTRACTORS ............................................................................................. ERROR! BOOKMARK NOT DEFINED.

14 WEBSITE/ORDERING REQUIREMENTS

15 ADDITIONS TO CONTRACT

16 TRAINING AND DOCUMENTATION

17 PRICE ADJUSTMENT CLAUSE

18 INSURANCE REQUIREMENTS

19 RECORDS MAINTENANCE

20 AUDIT RIGHTS

21 OWNERSHIP OF INFORMATION

ATTACHMENT 1 - SPECIFICATIONS

ATTACHMENT 2 - MODIFICATION AND EXCEPTION FORM

ATTACHMENT 3 - BIDDER QUESTIONS

ATTACHMENT 4 - COVER FORM

ITB2025807 OraSure Rapid HIV Test Kits & Associated Quality Controls Page 1

ITB ADMINISTRATIVE INFORMATION

ITB Title: OraSure Rapid HIV Test Kits and Associated

Quality Controls ITB Project Description: OraSure Rapid HIV Test Kits and Associated

Quality Controls for the Division of Public Health ITB Lead:

J.P. Brady Senior Buyer JP.Brady@dhw.idaho.gov

Deadline To Receive Questions: Wednesday, March 12th 11:59:59 p.m. Mountain Time

ITB Closing Date: Wednesday, April 2nd, 5:00 p.m. Mountain Time

ITB Opening Date: Thursday, April 3rd, 8:00 a.m. Mountain Time By Conference Call Only

The Department is conducting Virtual Electronic Bid Openings instead of in-person Public Bid Openings.

Initial Term of Contract and Renewals: The initial term is anticipated to be two (2) years. Upon mutual, written agreement, the Contract may be renewed, extended or amended. The total Contract term, including all extensions, is not anticipated to exceed five (5) years.

mailto:JP.Brady@dhw.idaho.gov

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1 PURPOSE

The Idaho Department of Health and Welfare (Department) is requesting Bids from qualified Vendors for the purchase of OraSure Rapid Human Immunodeficiency Virus (HIV) test kits and associated quality controls in accordance with the specifications provided below. The Contractor must provide rapid Point-of-care HIV, Hepatitis C Virus (HCV), and Syphilis tests and controls to local public health districts, Federally Qualified Health Centers (FQHCs), free clinics, and community-based organizations (CBOs) the Department partners with. Services must include rapid test kits that detect antibodies to HIV-1/HIV-2, HCV, and syphilis and are approved for oral fluid, plasma, fingerstick or venipuncture whole blood specimens. Additionally, the Contractor must include self-testing educational materials and instructions (one for each self-testing kit) in each package shipped.

2 GENERAL INFORMATION, SOLICITATION INSTRUCTIONS AND STANDARD TERMS AND

CONDITIONS

The ITB Lead is the only contact for this Solicitation. All correspondence regarding this ITB must be in writing. In the event that it becomes necessary to revise any part of this ITB, amendments will be posted in IPRO. It is the responsibility of the Bidder to monitor IPRO for any updates or amendments. Any oral interpretations or clarifications of this ITB must not be relied upon. All changes to this ITB must be in writing and posted in IPRO to be valid. Alternate or multiple Bids are not allowed.

3 INQUIRIES

Questions must be submitted using the Q & A Board in IPRO. QUESTIONS MUST BE RECEIVED BY 11:59:59 P.M. Mountain Time ON THE DATE LISTED IN THE ITB ADMINISTRATIVE INFORMATION section. Official answers to all questions will be posted on the Q & A Board in IPRO.

Any requests for modifications regarding the State of Idaho Standard Contract Terms and Conditions found at (Contract Terms and Conditions) must be submitted in writing, using Attachment 2, Modification and Exception, and uploaded in IPRO on the Supplier Attachment page by the deadline identified in the ITB Administrative Information section. The State will not consider proposed modifications to these requirements after the date and time set for receiving questions. Proposed modifications and exceptions to requirements, terms or conditions must contain the following:

1. The rationale for the specific requirement being unacceptable to the party submitting the question (define the deficiency).

2. Recommended verbiage for the State’s consideration that is consistent in content, context, and form with the State’s requirement that is being questioned.

3. Explanation of how the State’s acceptance of the recommended verbiage is fair and equitable to both the State and to the party submitting the question.

The State has sole discretion to determine if the modifications or exceptions submitted by a Bidder would result in a material change or otherwise threaten the integrity of the procurement process. Pursuant to IDAPA 38.05.01.084, the State may only negotiate non-material modifications or exceptions. Modifications or exceptions which the State determines to be material, or which otherwise threaten the integrity of the procurement process, will not be accepted or negotiated. In the event that the Bidder has conditioned its Bid on the State’s acceptance or negotiation of its proposed modifications or exceptions, and the modifications or exceptions are deemed material, the Bidder will be given the opportunity to retract the proposed modifications or exceptions from its Bid. Failure to do so will result in the Bidder’s Bid being found non-responsive, after which it will receive no further consideration.

Non-material modifications or exceptions may be negotiated with the apparent successful Bidder, at the discretion of the State; however, the State must have the right to reject any and all such modifications and or exceptions, and to instruct the Bidder to amend its Bid and remove the modifications and or exceptions. Failure to do so may result in the State finding the Bid non-responsive.

https://purchasing.idaho.gov/wp-content/uploads/State-of-Idaho-Contract-Terms-and-Conditions_2024.pdf

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Except as otherwise provided in the solicitation document, including the State of Idaho Standard Contract Terms and Conditions (updated July 2024), the State will not consider modifications or exceptions to the requirements, terms, or conditions which are proposed after the Closing Date.

4 BACKGROUND

The OraSure Technologies OraQuick Advance Rapid HIV Antibody Test (Test) will be used by clinical and non-clinical partners of the Department’s HIV, Sexually Transmitted Diseases (STD), and Hepatitis Programs, to conduct HIV testing throughout Idaho. The Test detects antibodies to HIV-1 and HIV-2 in twenty (20) minutes.

Approved for oral fluid, fingerstick whole blood, and venipuncture whole blood and plasma specimens, the test is ideal for both clinical and non-clinical settings. It is Clinical Laboratory Improvement Amendments (CLIA)-waived for oral fluid, fingerstick and venipuncture whole blood and has greater than ninety-nine percent (99%) agreement with confirmatory Western blot testing.

5 SPECIFICATIONS

See SPECIFICATIONS (Attachment 1)

6 COST

Provide your fully burdened Total Cost on the Lines page at IPRO.

7 BILLING PROCEDURE

The Contractor must submit invoices to the Department, via email, within five (5) business days of placement of the order. The cost of shipping/ delivery must be included in the price of the test kits. The Department requests that the Contractor provide a dedicated representative to work with staff in all aspects of the Contract.

The Contractor must provide the following information with each invoice:

1 IPRO Contract number and Agency PO number 2 Identification of billing period 3 Total amount billed for the billing period 4 Detailed description of services/products provided and associated # of hours/$ amounts, as appropriate 5 Name of authorized individual and contact information for Contractor

8 SUBMISSION REQUIREMENTS

8.1 Bid Submission Method

Bids must be submitted electronically through IPRO. The Department will not accept hardcopy (manual) submissions. Supporting documents can be uploaded in IPRO on the Supplier Attachment page.

All Bidders participating in Solicitation issued through IPRO must establish an account in the IPRO system as it is necessary in order to process and award the resulting Contract(s). It is free to establish an account and only takes a few minutes.

Enter your Total Cost on the Lines page in IPRO. It must be entered prior to the deadline established in the ITB ADMINISTRATIVE INFORMATION section above.

8.2 Signature Page

Bids must be accompanied by a signed State of Idaho Signature Page. This page is attached in the IPRO Supplier Attachment’s page as Exhibit A.

8.3 Trade Secrets

If your Bid contains trade secret information which you have identified, you must also submit a redacted copy of the Bid (in electronic format, with the word “redacted” in the file name) with all trade secret information removed or blacked out; as well as a separate document containing a complete list (per the instructions in the three (3) paragraphs directly below) of all trade secret information which was removed

ITB2025807 OraSure Rapid HIV Test Kits & Associated Quality Controls Page 4 or blacked out in the redacted copy. Redacted file must be submitted in IPRO on the Supplier Attachment page.

Paragraph 28 of the Solicitation Instructions to Vendors describes trade secrets to “include a formula, pattern, compilation, program, computer program, device, method, technique or process that derives economic value, actual or potential, from not being generally known to, and not being readily ascertainable by proper means by other persons and is subject to the efforts that are reasonable under the circumstances to maintain its secrecy.” In addition to marking each page of the document with a trade secret notation (as applicable; and as provided in Paragraph 28 of the Solicitation Instructions to Vendors), Bidders must also:

Identify with particularity the precise text, illustration, or other information contained within each page marked “trade secret” (it is not sufficient to simply mark the entire page). The specific information you deem “trade secret” within each noted page must be highlighted, italicized, identified by asterisks, contained within a text border, or otherwise clearly delineated from other text/information and specifically identified as a “trade secret.”

Provide a separate document entitled “List of Redacted Trade Secret Information” which provides a succinct list of all trade secret information noted in your Bid; listed in the order it appears in your submittal documents, identified by Page #, Section #/Paragraph #, Title of Section/Paragraph, specific portions of text/illustrations; or in a manner otherwise sufficient to allow the State’s procurement personnel to determine the precise text/material subject to the notation. Additionally, this list must identify with each notation the specific basis for your position that the material be treated as exempt from disclosure.

9 AWARD

Award will be “All or None” to the responsive, responsible bidder with the lowest Total two (2) year Cost meeting all of the requirements of the ITB. Bidders that do not bid on all items for both years will not be considered for award. Multiple or alternate bids will not be accepted. Bidders that include multiple or alternate bids may be found non-responsive.

10 ACCEPTANCE

Department personnel, or their affiliates, will consider goods accepted once the product is received and total shipment quantity verified. The Department must have forty-eight (48) hours or two (2) business days from shipment delivery to confirm acceptance of product.

11 CONTRACT MONITORING

If the Contractor fails to perform as required, the Contractor will be given written notice to remedy any performance issues. If the Contractor fails to perform as required, the Contract may be cancelled, and the Contractor may be disqualified from participating in the solicitation or the subsequent Contract that supersedes the failed Contract.

12 DELIVERY

The Contractor must ship the test kits to the Department and various health districts, FOB Destination, Prepaid and Allowed. The Department has provided the known addresses for shipping in Exhibit B (attached) and reserves the right to add additional locations throughout the state as needed.

13 WEBSITE/ORDERING REQUIREMENTS

The Contractor must accept orders placed via email. The Contractor should also accept orders placed on their website and over the telephone. The Contractor must send order acknowledgements within three (3) business days to the Department after each accepted order.

14 ADDITIONS TO CONTRACT

The Department reserves the right to order related tests and products of a similar nature and within the scope of the Contract as those listed in this ITB, but not anticipated to be included in the first year’s purchase. The Department and Contractor will negotiate prices for any proposed additions to the subsequent Contract.

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15 TRAINING AND DOCUMENTATION

The Contractor must provide HIV, HCV, and Syphilis educational information and updates regarding the test technology to our partners, as well as provide as-needed reports of tests purchased to the various health districts.

16 PRICE ADJUSTMENT CLAUSE

The Department may consider rate changes annually. The Department or Contractor must request potential rate changes (either increases or decreases) at least sixty (60) calendar days prior to the Contract renewal date and provide written justification for the request for a rate change. No rate change will be effective until accepted in writing by the Department.

17 INSURANCE REQUIREMENTS

For the term of the Contract and until all services specified in the Contract are completed, the Contractor must maintain in force, at its own expense, the following insurance.

• Commercial General Liability Insurance and, if necessary, Commercial Umbrella Liability Insurance with a limit of not less than one million dollars ($1,000,000) each occurrence and two million dollars ($2,000,000) in general aggregate. Insurance required by this section must name the State of Idaho, Department of Health and Welfare as an additional insured.

• Commercial Automobile Liability Insurance and, if necessary, Commercial Umbrella Liability Insurance with a limit of not less than one million dollars ($1,000,000) each accident. Such insurance must cover liability arising out of any auto incident (including owned, hired, and non-owned autos). Insurance required by this section must name the State of Idaho, Department of Health and Welfare as an additional insured.

(Required when product is delivered using owned, leased, hired, non-owned and employee-owned vehicles. Not required when shipped via FedEx/UPS vs using their own vehicle for delivery.)

• Workers Compensation Insurance and Employer's Liability. The Contractor must maintain Workers Compensation and Employer's Liability. The Employer's Liability must have limits not less than one million dollars ($1,000,000) each accident for bodily insurance by accident, one million dollars ($1,000,000) disease policy limit, and one million dollars ($1,000,000) disease, each employee.

The Contractor must provide either a certificate of workers compensation insurance issued by a surety licensed to write Workers Compensation Insurance in the State of Idaho, as evidence that the Contractor has in effect a current Idaho workers compensation insurance policy, or an extraterritorial certificate approved by the Idaho Industrial Commission from a state that has a current reciprocity agreement with the Idaho Industrial Commission.

If coverage is not available on an occurrence basis, coverage must be provided on a claims-made basis. For claims made policies the retroactive date must be shown and must be before the date of the Contract or the beginning of Contract work; insurance must be maintained and evidence of insurance must be provided for at least five (5) years after completion of the Contract of work; if coverage is canceled or non-renewed, and not replaced with another claims-made policy form with a retroactive date prior to the Contract effective date, the Contractor must purchase “extended reporting” coverage for a minimum of five (5) years after completion of Contract work.

Prior to performing any services, the Contractor must provide certificates of insurance to the Department. The Contractor is also required to maintain current certificates on file with the Department and to provide updated certificates upon request. Failure to provide the required certificates of insurance shall constitute a default under this Contract and upon such failure the Department may, at its option, terminate the Contract.

Insurance required by this section must be policies or Contracts of insurance issued by insurers approved by the Department. Should any of above-described policies be cancelled before the expiration date thereof, notice must be delivered in accordance with the policy provision.

Email updated certificates to: DHWInsurance@dhw.idaho.gov mailto:DHWInsurance@dhw.idaho.gov

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Additional Insured name and address:

State of Idaho, Department of Health and Welfare Contracting & Procurement Services Unit -- 9th Floor 450 West State Street Boise, ID 83702

18 RECORDS MAINTENANCE

The Contractor must maintain or supervise the maintenance of all records necessary to properly account for all payments made to the Contractor pursuant to the Contract. These records must be retained by the Contractor for at least three (3) years after the Contract terminates, or until all audits initiated within the three (3) years have been completed, whichever is later.

19 AUDIT RIGHTS

The Contractor agrees to allow State and Federal auditors and State purchasing staff access to all the records relating to this Contract, for audit, inspection, and monitoring of services or performance. Such access will be during normal business hours or by appointment.

20 OWNERSHIP OF INFORMATION

The Department and the United States Department of Health and Human Services must have unlimited rights to own, possess, use, disclose, transfer, or duplicate all information and data, copyrighted or otherwise, developed, derived, documented, or furnished by the Contractor under the Contract.

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ITB2025807 OraSure Rapid HIV Test Kits and Associated Quality Controls

ATTACHMENT 1 - SPECIFICATIONS

1. GENERAL REQUIREMENTS

• The Contractor must provide the OraSure products listed below:

o 1001-0078 KIT, OQ Advance HIV, 100 Count o 1001-0079 KIT, OQ Advance HIV, 25 Count o 1001-0077 KIT, OQ Advance HIV Controls o 1001-0340 OraQuick, In-home HIV Test Kit o 1001-0180 KIT, OQ, HCV, 100 Count o 1001-0181 KIT, OQ, HCV, 25 Count o 1001-0182 KIT, OQ, HCV, Controls o 1001-0698 KIT, OQ, Syphilis, 20 Count o 1001-0699 KIT, OQ, Syphilis, Controls

• The Contractor must provide the following tests and controls that have been approved by the U.S. Food and Drug Administration (FDA) or laboratory industry standard systems:

o Human Immunodeficiency Virus (HIV) 4th generation test -3rd generation test acceptable o Hepatitis C antibody o Syphilis antibody

• Rapid HIV, HCV, and Syphilis must be approved to use specimens from: oral fluid, plasma, fingerstick or venipuncture whole blood.

• The test kits must contain instructions on how to conduct the test and additional information on how to self-administer the tests.

• Collection kits must include, but are not limited to, band aids, alcohol wipes, lancets, absorbent cotton (cotton wool), and a Disposable Bag. If the test kit includes these items already then, these items do not need to be included as additional. If test kits do not include these items, then Contractor must provide them in addition to the kit.

• The Contractor must provide proper shipping containers to keep the quality controls at the proper temperature until reaching the destination.

• The cost of shipping/ delivery must be included in the price of the test kits

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ATTACHMENT 2 - MODIFICATION AND EXCEPTION FORM

Instructions: Complete this form and include with your ITB submittal if you are proposing modifications or exceptions to any of the requirements, terms, or conditions included in the ITB, including any documents incorporated by reference (Standard Contract Terms and Conditions). See ITB Section 3 for a full explanation of the process surrounding Bidder-proposed modifications and exceptions.

Bidders must specifically address any and all proposed modifications and exceptions. Blanket requests to negotiate requirements, terms, or conditions will not be considered. Bidders must provide an explanation as to why the requirement, term, or condition should be considered non-material. Bidder must also provide a reason for the proposed modification or alternative language, specifically addressing the issues itemized in ITB Section 3.

The determination of materiality will be made at the State’s sole discretion. Non-material modifications or exceptions may be negotiated with the apparent successful Bidder, at the discretion of the State, and as otherwise provided in ITB Section 3.

ITB

Section

ITB Requirement, Term, or Condition

Reason Requirement, Term, or Condition Should b Considered Non-Material

Proposed Modification, Alternative, or Exception

Reason for Proposed Modification, Alternative, or Exception

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ITB2025807 ORASURE RAPID HIV TEST KITS AND ASSOCIATED QUALITY CONTROLS

ATTACHMENT 3 - BIDDER QUESTIONS

PLEASE DO NOT IDENTIFY YOUR NAME OR YOUR COMPANY’S NAME OR PRODUCT NAMES OF

INTELLECTUAL PROPERTY IN YOUR QUESTIONS. See Section 3 of this ITB for instructions, questions must be received by the Q & A deadline.

ADD ROWS BY HITTING THE TAB KEY WHILE WITHIN THE TABLE AND WITHIN THE FINAL ROW.

The following instructions must be followed when submitting questions using the question format on the following page.

1. DO NOT CHANGE THE FORMAT OR FONT. Do not bold your questions or change the color of the font.

2. Enter the ITB section number that the question is for in the “ITB Section” field (column 2). If the question is a general question not related to a specific ITB section, enter “General” in column 2. If the question is in regard to a State Term or Condition, state the clause number in column 2. If the question is in regard to an attachment, enter the attachment identifier (example “Attachment A”) in the “ITB Section” (column 2), and the attachment page number in the “ITB page” field (column 3).

3. Do not enter text in the “Response” field (column 5). This is for the State’s use only.

4. Once completed, this form is to be e-mailed per the instructions in the ITB. The e-mail subject line is to state the ITB number followed by “Questions.”

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OraSure Rapid HIV Test Kits and Associated Quality Controls

ITB

Section

ITB

Page

Question Response

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ATTACHMENT 4 - COVER FORM

Attachment 4, Cover Form must be completed, signed, and uploaded to the Attachment’s page in IPRO.

Failure to complete and submit this form may result in your Bid being deemed non-responsive.

Instructions: The Bid must include a signed copy of this cover form. Copy and paste this form onto your company letterhead, or include the following information: Bidder’s company name, mailing address, phone number, fax number, e-mail address, and name of Bidder’s authorized signer. The Cover Form must include the ITB Number and Title and must be signed by an individual authorized to commit the Bidder to the contents of the Bid.

Requirement Response Bidder’s corporate or other legal entity status ☐ Corporation

☐ Limited Liability Corporation (LLC) ☐ Limited Liability Partnership ☐Sole Proprietorship ☐ Other (specify)

Bidder’s Tax Identification Number

EIN:

Bidder’s DUNS Number

DUNS:

Is Bidder a legal entity with the legal right to Contract?

☐ Yes ☐ No

Other than modifications/exceptions identified on Attachment 2, in compliance with Section 3 of this ITB, does Bidder accept, and is Bidder willing to comply with, the requirements of this

ITB?

Is Bidder in compliance with applicable equal employment regulations?

Does Bidder affirm that it has not employed any company or person other than a bone fide employee working solely for the Bidder or a company regularly employed as its marketing agent, to solicit or secure the Contract, and that it has not paid or agreed to pay any company or person, other than a bone fide employee working solely for the Bidder or a company regularly employed by the Bidder as its marketing agent, any fee, commission, percentage, brokerage fee, gifts, or any other consideration contingent upon or resulting from the award of the Contract?

Does Bidder understand and agree that for breach or violation of the above term, the State has the right to annul the Contract without liability or, in its discretion, to deduct from the offered price the amount of any such fee, commission, percentage, brokerage fee, gifts, or contingencies?

Firm(s) and/or staff responsible for writing the Bid?

Names:

Does Bidder affirm that it is not currently suspended, debarred, or otherwise excluded from federal or state procurement and non-procurement programs?

Note: vendor information is available at https://sam.gov.

Does the Bidder affirm that the Bid will be firm and binding for ninety (90) calendar days from the Bid opening date?

https://sam.gov/

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Does Bidder warrant that it does not knowingly and willfully employ persons who cann legally work in this country; and that Bidder takes steps to verify that it does not hire perso who have entered our nation illegally or cannot legally work in the United States; and that a misrepresentation in this regard or any employment of persons who have entered our nat illegally or cannot legally work in the United States constitutes a material breach and will cause for the imposition of monetary penalties up to five percent (5%) of the Bid price, p violation, and/or termination of the Contract?

Signed By:

Printed Name:

Date: