Epinephrine Auto-Injectors 2022

New York State Office of Children and Family Services

Division of Child Care

INVITATION FOR BIDS (IFB)

Epinephrine Auto-Injectors 2022

IFB Release Date: March 09, 2022

BID DUE DATE: March 31, 2022 at 2:00 p.m.

Table of Contents

1. Introduction.. 4

1.1 Overview.. 4

1.2 Designated Contacts. 5

1.3 Calendar of Events. 5

1.4 IFB Questions and Clarifications. 5

1. Bid Submission.. 6

2.1 Instructions for Bid Submission.. 6

2.2 Packaging of IFB Response. 7

1. Specifications. 8

3.1 Eligible Bidders. 8

3.2 Product/Service Specifications. 8

3.3 Delivery. 10

3.4 Security Procedures. 10

3.5 Warranty (if commodity purchase) 10

1. Administrative Information.. 10

4.1 Method of Award.. 10

4.2 Price. 11

4.3 Term of Purchase Authorization.. 11

4.4 Method of Payment 12

1. Introduction

• Overview

In conjunction with the implementation of Elijah's Law, OCFS implemented an auto injector initiative. This phase provided non-patient specific epinephrine auto injectors to eligible licensed/registered child care programs for the infant weight range only. The goal is to provide non patient specific epinephrine auto injectors to licensed/registered child care programs for each available weight range. OCFS is prepared to expand the initiative with the addition of the two higher doses as soon as possible for a period of five years from the date of the signed agreement, is issuing this Invitation for Bids (IFB).

In November 2017, three-year-old Elijah Silvera, a child with a diagnosed severe dairy allergy, was given a grilled cheese sandwich while attending child care. Elijah experienced anaphylaxis and died as a result. In September 2019, NYS signed Elijah's Law which required OCFS is to develop a policy with DOH regarding preventing and responding to anaphylactic emergencies in child care. OCFS would like to ease as many barriers toward programs obtaining a non-patient specific epinephrine auto injector as possible. As such, OCFS created a no cost allergy awareness training for child care programs. The cost to purchase epinephrine auto injectors is prohibitive to child care programs, so this initiative would provide this life saving tool to eligible programs.

Child care programs care for children from ages 6 weeks -12 years. OCFS is looking to expand this life-saving initiative to include all children. Food allergies are the most common cause of anaphylaxis outside the hospital setting. The most common food allergies in infants and children are eggs, milk, peanuts, tree nuts, soy, wheat, fish and shellfish. Other causes of anaphylaxis include allergies to insect bites, dogs, cats, medications, and latex. Nearly 8 percent of United States children (1 in 13 children) have at least one food allergy, and approximately one in five children with a food allergy reported one or more allergy-related emergency room visits in the previous year. Anaphylaxis must be treated right away to provide the best chance for improvement and prevent serious, potentially life-threatening complications. Epinephrine is the FIRST LINE drug of choice for the emergency treatment of severe allergic reactions to foods, insect stings or bites, drugs, or other allergens. Epinephrine is a safe medication. There is no medical reason for trained, designated staff to withhold administration of an epinephrine auto-injector in an emergency if anaphylaxis is suspected. A delay in the administration of epinephrine could result in death. Furthermore, improved outcomes have been reported with early administration of epinephrine (including decreased likelihood of needing additional medications in the Emergency Department and less likely to require overnight hospitalization). For that reason, in addition to keeping on hand patient-specific epinephrine auto-injectors for a child with a known allergy, child care programs are permitted to keep stock epinephrine auto-injectors on site and use them for children not previously identified as having allergies who have their first reaction while at child care (nonpatient specific epinephrine auto-injectors)

• Designated Contacts

In compliance with the Procurement Lobbying Law, from the issuance of this IFB until contractors are selected, all contacts with OCFS personnel concerning this IFB, except as otherwise specified herein, must be made via email or hard copy mailed to:

New York State Office of Children and Family Services

Attn: Bureau of Contract Management - Purchasing Unit - Kathleen Belmonte

Epinephrine Auto-Injectors 2022

52 Washington Street, Room 202 South

Rensselaer, NY 12144

Email: kathleen.belmonte@ocfs.ny.gov. In both cases, you MUST reference IFB

"Epinephrine Auto-Injectors 2022"

• Calendar of Events

The table below outlines the schedule for important action dates.

Event

Date

IFB issued

March 09, 2022

Deadline for submission of offeror questions

March 16, 2022

by 4:00 p.m. Eastern time

Responses to questions published (on or about)

March 22, 2022

Bid due date/Bid opening date

March 31, 2022

by 2:00 p.m. Eastern time

Anticipated Purchase Authorization date

June 1, 2022

• IFB Questions and Clarifications

All questions regarding this IFB, including questions regarding the minimum qualifications and specifications, should be emailed to the designated contact identified in Section 1.2 Designated Contacts by the date and time indicated in Section 1.3 Calendar of Events. Questions submitted after the deadline indicated may not be answered. An offeror is strongly encouraged to submit questions as soon as possible. Answers to all questions of a substantive nature will be provided to all prospective offerors in the form of a question and answer document that will be posted to the New York State Contract Reporter website (https://www.nyscr.ny.gov) and will not identify the offeror asking the question.

1. Bid Submission

• Instructions for Bid Submission

Only bids from offerors who furnish all required information and meet the mandatory requirements stated in Section 3 - Specifications will be considered. Bidders must operate in accordance with all applicable laws, rules, and regulations. Submit all required bid documents to OCFS at the following address:

New York State Office of Children and Family Services

Attn: Bureau of Contract Management- Purchasing Unit- Kathleen Belmonte

Epinephrine Auto-Injectors 2022

52 Washington Street, Room 202 South

Rensselaer, NY 12144

E-MAIL OR FAX BID SUBMISSIONS ARE NOT ACCEPTABLE AND WILL NOT BE CONSIDERED.

The State of New York will not be held liable for any cost incurred by the offeror for work performed to prepare and produce a bid. Contractors may not begin to provide services before the Purchase Authorization start date; OCFS has no obligation to pay for services before that time. Payments cannot be made before the formal execution of a Purchase Authorization. Bids must be received in the above office on or before the date/time set forth in Section 1.3 - Calendar of Events. Offerors assume all risks for timely, properly submitted deliveries.

LATE BIDS MAY BE REJECTED

Any bid received at the designated location after the established time will be considered a late bid. A late bid will be rejected and disqualified from award. However, a late bid may be accepted in the Commissioner's sole discretion when

• no timely bids meeting the requirements of the solicitation are received; or
• the offeror has demonstrated to the satisfaction of the Commissioner that the late bid was caused solely by factors outside the control of the offeror.

Note: The Commissioner is under no obligation to accept a late bid.

The basis for any determination to accept a late bid shall be documented in the procurement record.

FIRM OFFER

Bids must remain an effective offer, firm and irrevocable, for at least 180 calendar days from the due date, unless the time for awarding the Purchase Authorization is extended by mutual consent of OCFS and the offeror. A bid shall continue to remain an effective offer, firm and irrevocable, subsequent to the 180 calendar-day period until either tentative award of the Purchase Authorization(s), withdrawal of the procurement, or withdrawal of the bid in writing by the offeror.

OWNERSHIP OF IFB AND BIDS

This IFB remains the property of the State at all times, and all responses to this IFB, once delivered, become the property of the State.

• Packaging of IFB Response

Required Contents of Bid Proposal

All bid proposals must include the following:

• OCFS-0910, Request for Bid
• OCFS-4822, Procurement Lobbying Act - Offeror Certification Form
• Vendor Responsibility Questionnaire For-Profit Business Entity
• OCFS-2647, EO 177 Certification (See Section 4.12 for more information)

Attachments to this announcement are also available for download from The New York State Contract Reporter (Contract Reporter) website at https://www.nyscr.ny.gov.

General Proposal Appearance

Bids must be submitted inside a sealed envelope. Bid submissions for this procurement should only contain bid proposals for this specific funding opportunity. Multiple bids should be submitted individually in their own separate sealed envelopes that are clearly labeled on the outside.

Bid proposals should be bound and labeled in a manner that allows pages to be easily removed, scanned, and/or added to the bid proposal. Acceptable methods include, but are not limited to, three-ring binders and binder clips. Do not use staples or spiral wire binding. Do not attach index tabs to your bid submission documents.

The fonts and margins used in the bid proposal should be reasonable. Twelve-point text using Arial, Times New Roman, or Calibri fonts are considered acceptable. Standard one-inch margins are recommended. It is permissible to use headers, footers, and page numbers inside the margins.

The bid documents must be submitted by mail, hand delivery, overnight carrier, or certified mail in a sealed package or envelope that clearly displays the following information on the outside (Please see IFB Section 2.1 Instructions for Bid Submission and Section 1.3 Calendar of Events):

Offeror's complete name and address

Solicitation number

Bid due date and time

Documents Required After Bid Submission

During Purchase Authorization negotiations, awarded offerors will be required to complete the following additional forms:

• ST-220-TD, Contractor Certification (New York State Department of Tax and Finance form)
• ST-220-CA, Contractor Certification to Covered Agency (New York State Department of Tax and Finance form)
• Proof of workers' compensation and disability benefits coverage or Certificate of Attestation of Exemption from New York State Workers' Compensation Board and Disability Benefits Coverage

1. Specifications

• Eligible Bidders

A bidder must be the manufacturer of the products being requested, or an authorized representative (i.e. dealer/reseller) of the manufacturer's products being requested.

• Product/Service Specifications

• A twin-pack that includes 2 epinephrine auto injectors and a voice guided instructional training device that a child care provider would use in a life-threatening anaphylactic emergency.
  • Lot 1 - One twin pack at the 0.1mg dose (for children weighing between 16.5 - 33 pounds)
  • Lot 2 - One twin pack at the 0.15mg dose (for children weighing between 33 - 66 pounds);
  • Lot 3 - One twin pack at the 0.3mg dose (for children who weigh more than 66 pounds).

• Each eligible child care program would receive a maximum of one twin pack of each dose- totaling a maximum of three twin packs per eligible program. To ensure eligible programs have the needed doses, when the auto injector expires or is dispensed, the initiative would replace the auto injector. There are approximately 16,000 providers at 100% uptake.
• The auto injector must adhere to FDA rules and regulations. In the event of a product recall, vendor must agree to replace the recalled device at no cost to NYS or the child care program.
• The auto injector device must have a retractable needle.
• The vendor must have the technological infrastructure to align with the current systems. The vendor must utilize a compatible technology solution that will allow them to interface with the application programming interface (API) offered by OCFS Division of Child Care Services(DCCS) electronic system of record, the Child Care Facility System(CCFS). The API provides CCFS with the ability to request new devices and be updated when devices have been shipped in a fully automated process.
• By also interfacing with DCCS' training vendor, CCFS developed a solution that determines if and when a device request is valid based on the successful completion of the Professional Development Program (PDP) training course. That information prompts CCFS to share data with the vendor to indicate a new device needs to be sent to a facility. It provides information on the individual that is able to handle the device and where the device is to be shipped. Once a device leaves the vendor, they need to provide CCFS with the details so that the device's expiration date can be monitored. To participate in the auto injector initiative, the successful vendor must have the capacity to interface with CCFS and the training vendor as the system is currently designed.
• At vendor's cost, the vendor must be able to provide ongoing support to child care providers by implementing a tele-outreach program promoting the initiative which includes telephone and email correspondence to child care programs. The scripting for the tele-outreach must be pre-approved by OCFS.
• The vendor must have the ability to directly ship the auto injector twin packs directly to the eligible child care program. Shipping costs should be included in the price.

1. • Delivery

Shipping shall be at FOB DESTINATION to any point in New York State.

Items ordered from this Purchase Authorization must be delivered within 30 days of notification of the order by OCFS, unless otherwise agreed to, in writing, by OCFS.

1. • Security Procedures

Please note that the delivery location may have security policies that must be followed. The contractor will work with OCFS to obtain necessary clearances. The contractor may be required to provide information such as, but not limited to, the company name, the employee's name (as it appears on ID), valid driver license number, vehicle make, model and license plate, etc. to gain access to the delivery location.

• Warranty (if commodity purchase)

The contractor hereby warrants and represents that products, components, or parts specified and furnished by or through the contractor, whether specified and furnished individually or as a system, shall be free from defects in material and workmanship and will conform to all requirements of the Purchase Authorization for a minimum of one year from the date of acceptance. If manufacturer's warranty exceeds one year that time frame will apply.

During the product warranty period, defects in the materials or workmanship of products, components, or parts specified and furnished by or through the contractor, whether specified and furnished individually or as a system, shall be repaired or replaced by the contractor at no cost or expense to OCFS. If needed, the contractor shall extend the product warranty period for individual products or the system, by the cumulative periods of time, after notification, during which a product or the system requires repairs or replacement that results in down time or is in the possession of the contractor, its agents, officers, subcontractors, distributors, resellers or employees ("extended warranty").

All warranties included in this IFB shall survive the termination of any resulting Purchase Authorization.

1. Administrative Information

• Method of Award

One award will be made to the lowest price vendor in each lot. The bidder(s) submitting a bid in compliance with Section 2.0 Bid Submission, meeting the requirements stated in Section 3.0 Specifications, passing vendor responsibility review, and offering the lowest bid will be awarded the Purchase Authorization.

The bid will be firm for 5 years. There will be no adjustment to the rate during the contract period, except as noted in section 4.2.

If a tie bid results, manufacturers/ authorized representatives names will be placed into a hat and the manufacturer/authorized representative selected will be offered a Purchase Authorization.

• Price

Price includes all custom duties and charges and is net, F.O.B. destination to the address identified by OCFS.

Bidder shall hold prices for one year. On each anniversary date of the contract, the awarded bidder may request in writing an increase in the contracted payment rate, dependent upon fluctuations in the latest published copy of the Consumer Price Index for New York State and Northeastern New Jersey as published by the US Department of Labor, Bureau of Labor Statistics, Washington, DC 20212. The Bidder has the sole responsibility to request the adjusted rate on the anniversary date and must provide a copy of the Consumer Price Index to support the request for increase. This increase is limited to 5% per year.

Should the Bidder fail to submit the rate increase request within 45 days of the anniversary date of the contract, the Bidder shall be deemed to have waived its right to any increase in price.

OCFS reserves the right, on each anniversary date of the contract, to make downward adjustments in the contracted payment rate in the case of a decrease in the Consumer Price Index. Notice of any such adjustment will be provided by OCFS in writing 30 days prior to the date of the adjustment.

• Term of Purchase Authorization

It is the intention of the State to award a single Purchase Authorization (PA) for each lot made to the bidder with the lowest cost for each lot, who also passes a mandatory vendor responsibility review. The PA will commence on or about the date as stated in Section 1.3 and will continue for a period of 5 years and is subject to approval by the, Office of the State Comptroller (OSC). Contractors may not begin to provide products/services before the PA start date; OCFS has no obligation to pay for products/services rendered before that time. All orders resulting from this IFB will be made via purchase orders (PO) issued against the PA. A copy of the terms and conditions of the Purchase Authorization are attached to this IFB.

• Method of Payment

Upon delivery and acceptance of product(s) specified; invoices shall be submitted to the Business Services Center Accounts Payable Unit. Invoices will be processed in accordance with established procedures of the Office of General Services and OSC, and payments will be subject to the prompt payment provisions of Article XI-A of the New York State Finance Law.

Invoices must contain the PO number, and invoices shall be consistent with the PO issued; including but not limited to purchase order number, description of items, quantity, unit and price per unit (in agreement with the contra

Service-Disabled Veteran-Owned Set Aside: No

Minority Owned Sub-Contracting Goal: 15%

Women Owned Sub-Contracting Goal: 15%

Service-Disabled Veteran-Owned Business Contracting Goal: 6%

Due date:04/01/2022 2:00 PM

Contract term: 5 years

County(ies): All NYS counties

* These goods or services have been purchased from an out-of-state/foreign vendor within the past three years.

Business entities awarded an identical or substantially similar procurement contract within the past five years: Health First