ITB538 Antituberculosis Medication.pdf

STATE OF IDAHO

DEPARTMENT OF HEALTH AND WELFARE

Invitation to Bid (ITB) ITB538

Antituberculosis Medications

Date of Issuance: 06/13/2024

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 REPORTING REQUIREMENTS

13 DELIVERY

14 SUBCONTRACTORS

THE CONTRACTOR MAY SUBCONTRACT AS NEEDED. THE CONTRACTOR MUST BE RESPONSIBLE FOR ANY WORK OR PRODUCT THAT IS PRODUCED AND DELIVERED TO THE DEPARTMENT UNDER THIS CONTRACT WHETHER PRODUCED SOLELY OR IN PART BY THE CONTRACTOR OR SUBCONTRACTOR

15 WEBSITE/ORDERING REQUIREMENTS

16 ADDITIONS TO CONTRACT

17 COMPLIANCE WITH

18 PRICE ADJUSTMENT CLAUSE

19 INSURANCE REQUIREMENTS

20 RECORDS MAINTENANCE

21 AUDIT RIGHTS

22 OWNERSHIP OF INFORMATION

23 END OF CONTRACT OBLIGATIONS

ATTACHMENT 1 – SPECIFICATIONS

ATTACHMENT 2 - MODIFICATION AND EXCEPTION FORM

ATTACHMENT 4 - LOCATIONS

ITB538 Antituberculosis Medications Page 1

ITB ADMINISTRATIVE INFORMATION

ITB Title: Antituberculosis Medications

ITB Project Description: Antituberculosis Medications

ITB Lead:

Quinn Shea Senior Buyer Quinn.Shea@dhw.idaho.gov

Deadline To Receive Questions: 06/21/2024 by 11:59:59 pm MT

ITB Closing Date: 07/08/2024 at 5:00:00 pm MT

ITB Opening Date: 07/09/2024 at 10:00:00 am MT

Initial Term of Contract and Renewals The initial term is anticipated to be one (1) year. 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:Quinn.Shea@dhw.idaho.gov

ITB538 Antituberculosis Medications Page 2

1 PURPOSE

The Idaho Department of Health and Welfare (Department) is requesting Bids from qualified Vendors for the purchase of antituberculosis medications in accordance with the specifications provided below.

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 shall be in writing. In the event that it becomes necessary to revise any part of this ITB, amendments will be posted in IPRO, powered by Luma (IPRO). It is the responsibility of the Bidder to monitor IPRO for any updates or amendments. Any oral interpretations or clarifications of this ITB shall not be relied upon. All changes to this ITB must be in writing and posted in IPRO to be valid. Alternate bids are not allowed.

3 INQUIRIES

Questions must be submitted using the Q & A tab 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 to the Q & A tab in IPRO.

Any requests for modifications regarding the State of Idaho Standard Contract Terms and Conditions found at Standard-Terms-and-Conditions_May-2021.pdf (idaho.gov) must be submitted in writing, using Attachment 2, Modification and Exception, and uploaded in IPRO to the Q & A tab 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 shall 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/Standard-Terms-and-Conditions_May-2021.pdf

ITB538 Antituberculosis Medications Page 3

Except as otherwise provided in the solicitation document, including the State of Idaho Standard Contract Terms and Conditions (updated May 2021), the State will not consider modifications or exceptions to the requirements, terms, or conditions which are proposed after the Closing Date.

4 BACKGROUND

The Idaho Epidemiology Section, within the Bureau of Communicable Disease Prevention, Division of Public Health, is seeking to purchase antituberculosis medications necessary for the treatment of drug-susceptible or drug-resistant tuberculosis (TB) disease or infection. The TB medications will be ordered and purchased by the Epidemiology Section directly from the Contractor once ordered by an Idaho prescriber and will be drop-shipped to either the TB clinic, public health district (PHD), or healthcare provider’s office where the TB patient is receiving their care.

5 SPECIFICATIONS

See SPECIFICATIONS (Attachment 1)

6 COST

Provide your fully burdened Total Cost on the Lines tab in IPRO.

7 BILLING PROCEDURE

The Contractor must provide an invoice within ten (10) business days after medication is processed. The invoice must include, but not be limited to:

a. All medications delivered during the billing period, identified by each item as reflected in the cost matrix and the total for each.

b. Total amount billed for the billing period.

c. Contract number

d. Billing period

e. Contractor name, address, phone number, and/or e-mail address

f. Invoice numbers, IPRO contract number, Department purchase order number

Submit invoices to:

Epidemiology Section Bureau of Communicable Disease Prevention 450 W. State St, 4th Floor PO Box 83720 Boise, Idaho 83720-0036

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

ITB538 Antituberculosis Medications Page 4

Enter your Total Cost on the Lines tab 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 Attachments tab.

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 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 Cost meeting all of the requirements of the ITB. Bidders that do not bid on all items 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 from shipment delivery to confirm acceptance of product.

ITB538 Antituberculosis Medications Page 5

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 REPORTING REQUIREMENTS

The Contractor must provide required reports to the Billing Contact as indicated below:

Product Purchasing Report – the report must contain the name of the medication, size, strengths, National Drug Code (NDC), and number of units purchased. The report must be submitted ten (10) business days after the end of the quarter.

Annual Purchasing Report – the report must contain the name of the medication, size, strengths, NDC, number of units purchased, Department cost per thirty (30) day supply, total number of orders filled, and total cost to the Department. The report must be submitted within ten (10) calendar days after the end of the state fiscal year, June 30.

13 DELIVERY

Medications must be shipped within forty-eight (48) hours of receipt of order. Medications must be shipped to pre-established sites as determined by the Department as well as additional sites to be determined later. All delivery/shipping costs must be included in the price of the medications. Tracking for all shipments must be provided.

14 SUBCONTRACTORS

The Contractor may subcontract as needed. The Contractor must be responsible for any work or product that is produced and delivered to the Department under this contract whether produced solely or in part by the Contractor or Subcontractor.

Subcontractor relationships, performance, and compliance with the terms of the contract are solely the responsibility of the Contractor. The Bidder must provide an overview of any Subcontractor relationships that will be reflected in the total proposed solution. The above information shall be included for any planned subcontractors if any exist. Additionally, the bidder must provide:

A description of the nature of the subcontractor agreement(s) (if any).

It’s reliance on the subcontractor with respect to fulfilling any of the ITB requirements.

The bidder must disclose the information requested above for the parent company if the Bidder is a subsidiary of a parent company that owns more than five percent (5%) of the Bidders’ company.

The bidder must disclose the detailed information requested above for any subsidiary in which the Vendor is more than a five percent (5%) owner.

The Contractor must be the sole point of contact regarding any and all contractual matters. The Department will only pay the Contractor and will not pay Subcontractors directly.

ITB538 Antituberculosis Medications Page 6

15 WEBSITE/ORDERING REQUIREMENTS

The Contractor must have a working website able to accept all orders twenty-four hours a day, seven days a week (24/7), three-hundred-sixty-five (365) days per year, hosted and maintained by the Contractor. The Contractor must provide one (1) Primary Account Representative who must be the main point of contact between the Department’s Contract Monitor and the Contractor and one (1) Secondary Account Representative who must provide back-up support to the Primary Account Representative between the Department’s Contract Monitor and the Contractor. The Primary and Secondary Account Representatives must be able to support the Department with order-related inquiries or website order troubleshooting within a twenty-four (24) hour timeframe or the next business day following a weekend or State observed holiday, (https://sos.idaho.gov/state-holidays/). All pharmaceutical product orders submitted by the Department and received by the Contractor no later than 4:00 p.m. Mountain Time (MT) must be processed by the Contractor the same day it is received. The Contractor must provide electronic shipment tracking capability, including a tracking number for each shipment. Electronic tracking must be available on the Contractor’s website.

16 ADDITIONS TO CONTRACT

The Department reserves the right to order related medications and product 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.

17 COMPLIANCE WITH

The Contractor must comply with all State and Federal law regarding the requirements surrounding the distribution and delivery of pharmaceuticals.

18 PRICE ADJUSTMENT CLAUSE

Costs shall remain firm throughout the first year of the Contract, unless otherwise agreed to by the Department and modifications will only be considered under extenuating circumstances.

The parties may consider rate changes upon renewal based on verifiable cost increases submitted by the Contractor. The Contractor must request potential rate changes at least forty-five (45) 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.

19 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.

https://sos.idaho.gov/state-holidays/

ITB538 Antituberculosis Medications Page 7

• Bidder or Offeror may request a waiver from providing Commercial Automobile and Commercial Umbrella

Liability Insurance in its Bid or Proposal if the Bidder or Offeror will not use any owned, hired or non-owned vehicles to conduct business under the Contract, if it is awarded the Contract, and the State of Idaho will consider the request. If the Bidder or Offeror submits a request to waive the provision of Commercial Automobile and Commercial Umbrella Liability Insurance after the due date and time for receipt of Bids or Proposals, the State of Idaho may not consider the request.

• 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

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

20 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.

mailto:DHWInsurance@dhw.idaho.gov

ITB538 Antituberculosis Medications Page 8

21 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.

22 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.

23 END OF CONTRACT OBLIGATIONS

The Contractor remains obligated to fulfill orders placed before the expiration of the contract. For up to sixty

(60) days after the contract has expired, the Contractor must ship medications ordered by the Department.

ITB538 Antituberculosis Medications Page 9

ATTACHMENT 1 – SPECIFICATIONS

ITB538 Antituberculosis Medications

GENERAL REQUIREMENTS

The medications, once ordered by the Department’s Epidemiology Section, must be drop-shipped by the Contractor directly to the ship-to site, as determined by the Epidemiology Section. The receiving agency or healthcare provider of the shipment will be responsible for the appropriate storage and dispensing of the medications. The anti-tuberculosis medications must be made available by the Contractor as expeditiously as possible. The medications will be used to treat TB disease or infection.

The Contractor must:

• Obtain medications, as indicated in the Items page of IPRO, that are estimated to be utilized at less than ten (10) units per year within seven (7) business days of order placement by the Department. Upon receipt of the product, priority processing must be assigned to ship within one (1) business day.

• Maintain at least a one (1) month supply of medications, as indicated in the Cost Matrix of this solicitation, that exceed ten (10) estimated units of use per year.

• Ship medications that require refrigeration. Prescription medications which require storage conditions of thirty-six to forty-six degrees (36–46°) Fahrenheit must be shipped overnight to healthcare providers in cold storage packaging.

• Not invoice the Department for shipping costs (including refrigeration).

• Provide the Department with a return policy which must include, but is not limited to the following policies:

o Pharmaceutical products must be accepted for return within sixty (60) calendar days after shipment, provided such pharmaceutical products are unopened, in clean salable condition and have a minimum remaining shelf life of at least six (6) months.

o All returns must be authorized in advance by a Contractor Account Manager (not to be unreasonably withheld or delayed).

o Freight on returned pharmaceutical products may be charged to the Department, provided it is not the Contractor’s mistake.

o All returns are subject to inspection by the Contractor for proper prior authorization and for damage to the label, container, and tamper-evident seal.

o Must not issue a credit for any unauthorized returns.

o Pharmaceutical products that are damaged upon receipt may be returned by the Department at no additional charge. Claims for damaged medications will be made by the Department to the Contractor’s Account Management contact within ten (10) calendar days of receipt and will be subject to the Contractor’s verification of damage and a return authorization (not to be unreasonably withheld or delayed).

o Freight must be accepted and paid by the Contractor on pharmaceutical products shipped in error. Claims for returns will be made by the Department to the Contractor’s Account Management within ten (10) calendar days of receipt and shall be subject to the Contractor’s verification of error and a return authorization (not to be unreasonably withheld or delayed).

ITB538 Antituberculosis Medications Page 10

• The Contractor must ship orders within forty-eight (48) from receipt of order.

• The Contractor must include the price of delivery/freight in the cost of the medications.

• The Contractor must be able to ship orders to multiple sites, (Attachment 4), and have the ability to add sites as needed by the Department.

The Contractor must offer the following medications, at a minimum, at the packaging and dose sizes listed below:

Product Dosage Tabs/Caps per bottle Estimated Units/Ye Amikacin 250mg/ml 10 2ml vials 1 Amikacin 250mg/ml 10 4ml vials 1 Ethambutol 400 mg 60 TABS 18 Ethambutol 100 mg 60 TABS 1 Isoniazid 100 mg 100 TABS 3 Isoniazid 300 mg 30 TABS 152 Isoniazid Syrup 50 mg/5 ml 16oz Syrup 1 Levofloxacin 500 mg 10 x 10 TABS 9 Levofloxacin 250 mg 10 x 10 TABS 5

Linezolid 600 mg

20 TABS

OR

100 TABS

OR

10 x 10 TABS

Moxifloxacin 400 mg 30 TABS 6 Pyrazinamide 500 mg 100 TABS 29 Pyridoxine 25 mg 100 TABS 45 Rifampin 300 mg 60 CAPS 128 Rifapentine 150 mg 24 TABS 31

ITB538 Antituberculosis Medications Page 11

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 Considered Non-Material

Proposed Modification, Alternative, or Exception

Reason for Proposed Modification, Alternative, or Exception

ITB538 Antituberculosis Medications Page 12

ATTACHMENT 4 - LOCATIONS

Provider/PHD Shipping address Panhandle Health District (PHD1) 8500 N Atlas Road, Hayden ID 83835

Idaho North Central District (PHD2) 215 10th Street, Lewiston ID 83501 Southwest District Health (PHD3) 13307 Miami Lane, Caldwell ID 83607

Central District Health Department (PHD4) 707 N. Armstrong Pl., Boise ID 83704

South Central Public Health (PHD5) 1020 Washington St. N., Twin Falls ID 83301

Southeastern Idaho Public Health (PHD6) 1901 Alvin Ricken Dr., Pocatello ID 83201

Eastern Idaho Public Health (PHD7) 1250 Hollipark Dr., Idaho Falls ID 83401 Family Medicine Residency of Idaho 6565 W. Emerald Ave., Boise ID 83704

Dr. Solbrig (Idaho State University Health Services) 990 Cesar Chavez Ave., Pocatello ID 83209

Dr. Souvenir 415 6th St. 2A, Lewiston ID 83501 St. Luke’s Pediatrics/Dr. Lundgren 100 E Idaho Ste 200, Boise ID 83712

St Luke’s Family Medicine 1450 Aviation Dr Ste 100, Hailey, ID 83333