30-24348-DPH-Newborn Genetic Screening Blood Collection Devices- IFB.pdf

STATE OF NORTH CAROLINA

Department of Health and Human Services

Division of Public Health

Invitation for Bid #: 30-24348-DPH

Newborn Genetic Screening Blood Collection Devices

Date Issued: May 14, 2024

Bid Opening Date: June 04, 2024

At 2:00 PM ET

Direct all inquiries concerning this IFB to:

Amanda Kerstetter

Procurement Specialist II

Email: Amanda.Kerstetter@dhhs.nc.gov

Ver. 11/2023

Invitation for Bids #

30-24348-DPH

For internal State agency processing, including tabulation of bids, provide your company’s eVP (Electronic Vendor

Portal) Number. Pursuant to G.S. 132-1.10(b) this identification number shall not be released to the public. This page will be removed and shredded, or otherwise kept confidential, before the procurement file is made available for public inspection.

This page shall be filled out and returned with your bid.

Failure to do so may subject your bid to rejection.

Vendor Name

Vendor eVP#

Note: For a contract to be awarded to you, your company (you) must be a North Carolina registered vendor in good standing. You must enter the vendor number assigned through eVP (Electronic Vendor

Portal). If you do not have a vendor number, register at https://vendor.ncgov.com/vendor/login https://vendor.ncgov.com/vendor/login

Ver: 11/2023 1

EXECUTION

In compliance with this Invitation for Bids (IFB), and subject to all the conditions herein, the undersigned Vendor offers and agrees to furnish and deliver any or all items upon which prices are bid, at the prices set opposite each item within the time specified herein.

By executing this bid, the undersigned Vendor understands that false certification is a Class I felony and certifies that:

▪ this bid is submitted competitively and without collusion (G.S. 143-54),

▪ that none of its officers, directors, or owners of an unincorporated business entity has been convicted of any violations of Chapter 78A of the General Statutes, the Securities Act of 1933, or the Securities Exchange Act of 1934 (G.S. 143-59.2), and

▪ it is not an ineligible Vendor as set forth in G.S. 143-59.1.

Furthermore, by executing this bid, the undersigned certifies to the best of Vendor’s knowledge and belief, that:

▪ it and its principals are not presently debarred, suspended, proposed for debarment, declared ineligible or voluntarily excluded from covered transactions by any Federal or State department or agency.

As required by G.S. 143-48.5, the undersigned Vendor certifies that it, and each of its sub-Contractors for any Contract awarded as a result of this

IFB, complies with the requirements of Article 2 of Chapter 64 of the NC General Statutes, including the requirement for each employer with more than 25 employees in North Carolina to verify the work authorization of its employees through the federal E-Verify system.

As required by Executive Order 24 (2017), the undersigned vendor certifies will comply with all Federal and State requirements concerning fair employment and that it does not and will not discriminate, harass, or retaliate against any employee in connection with performance of any

Contract arising from this solicitation.

G.S. 133-32 and Executive Order 24 (2009) prohibit the offer to, or acceptance by, any State Employee associated with the preparing plans, specifications, estimates for public Contract; or awarding or administering public Contracts; or inspecting or supervising delivery of the public

Contract of any gift from anyone with a Contract with the State, or from any person seeking to do business with the State. By execution of this bid response to the IFB, the undersigned certifies, for Vendor’s entire organization and its employees or agents, that Vendor are not aware that any such gift has been offered, accepted, or promised by any employees or agents of Vendor’s organization.

By executing this bid, Vendor certifies that it has read and agreed to the INSTRUCTION TO VENDORS and the NORTH CAROLINA GENERAL TERMS

AND CONDITIONS incorporated below. These documents can be accessed from the Ariba Sourcing Tool.

Failure to execute/sign bid prior to submittal may render bid invalid and it MAY BE REJECTED. Late bids cannot be accepted.

COMPLETE/FORMAL NAME OF VENDOR:

STREET ADDRESS: P.O. BOX: ZIP:

CITY & STATE & ZIP: TELEPHONE NUMBER: TOLL FREE TEL. NO:

PRINCIPAL PLACE OF BUSINESS ADDRESS IF DIFFERENT FROM ABOVE (SEE INSTRUCTIONS TO VENDORS ITEM #21):

PRINT NAME & TITLE OF PERSON SIGNING ON BEHALF OF VENDOR: FAX NUMBER:

VENDOR’S AUTHORIZED SIGNATURE: DATE: E-MAIL:

Department of Health and Human Services

Refer ALL Inquiries regarding this IFB to:

Amanda Kerstetter (Procurement Lead) through the Message Board in the Sourcing Tool. See section 2.5 for details.

Invitation for Bids # 30-24348-DPH

Bids will be publicly opened: June 04, 2024, @ 2:00 PM ET

Using Agency: Division of Public Health Commodity No. and Description: 411158 Clinical and diagnostic analyzers and accessories and supplies Requisition No.: RQ55418

Bid Number: 30-24348-DPH Vendor: ____________________________________

Ver: 11/2023 2

FOR STATE USE ONLY: Offer accepted and Contract awarded this ____ day of _______________, 20____, as indicated on the attached certification, by ______________________________________________________

VALIDITY PERIOD

Offer shall be valid for at least ninety (90) days from date of bid opening, unless otherwise stated here: ______ days, or if extended by mutual agreement in writing of the parties. Any withdrawal of this offer shall be made in writing, effective upon receipt by the agency issuing this IFB.

BID ACCEPTANCE

If your bid is accepted, all provisions of this IFB, along with the written results of any negotiations, shall constitute the written agreement between the parties (“Contract”). The NORTH CAROLINA GENERAL TERMS AND CONDITIONS are incorporated herein and shall apply. Depending upon the

Goods or Services being offered, other terms and conditions may apply, as mutually agreed.

(Authorized Representative of DHHS)

Ver: 11/2023 3

1.0 PURPOSE AND BACKGROUND

1.1 CONTRACT TERM

2.0 GENERAL INFORMATION

2.1 INVITATION FOR BID DOCUMENT

2.2 E-PROCUREMENT FEE

2.3 NOTICE TO VENDORS REGARDING IFB TERMS AND CONDITIONS

2.4 IFB SCHEDULE

2.5 BID QUESTIONS

2.6 BID SUBMITTAL

2.7 BID CONTENTS

2.8 ALTERNATE BIDS

2.9 DEFINITIONS, ACRONYMS, AND ABBREVIATIONS

3.0 METHOD OF AWARD AND BID EVALUATION PROCESS

3.1 METHOD OF AWARD

3.2 CONFIDENTIALITY AND PROHIBITED COMMUNICATIONS DURING EVALUATION

3.3 BID EVALUATION PROCESS

3.4 PERFORMANCE OUTSIDE THE UNITED STATES

3.5 INTERPRETATION OF TERMS AND PHRASES

4.0 REQUIREMENTS

4.1 PRICING

4.2 ESTIMATED QUANTITIES

4.3 PRODUCT IDENTIFICATION

4.4 TRANSPORTATION AND IDENTIFICATION

4.5 DELIVERY

4.6 WARRANTY

4.7 SAMPLES

4.8 DESCRIPTIVE LITERATURE/CERTIFICATION

4.9 HUB PARTICIPATION

4.10 REFERENCES

4.11 VENDOR’S REPRESENTATIONS

4.12 FINANCIAL STABILITY

4.13 AGENCY INSURANCE REQUIREMENTS MODIFICATION

5.0 PRODUCT SPECIFICATIONS

SPECIFICATIONS

5.2 CERTIFICATION AND SAFETY LABELS

5.3 DEVIATIONS

6.0 CONTRACT ADMINISTRATION

6.1 CONTRACT MANAGER AND CUSTOMER SERVICE

6.2 POST AWARD PROJECT REVIEW MEETINGS

6.3 CONTINUOUS IMPROVEMENT

6.4 ACCEPTANCE OF WORK

6.5 INVOICES

6.6 DISPUTE RESOLUTION

6.7 PRODUCT RECALL

6.8 PRICE ADJUSTMENTS

6.9 CONTRACT CHANGES

6.10 ATTACHMENTS

ATTACHMENT A: PRICING FORM

ATTACHMENT B: INSTRUCTIONS TO VENDOR

ATTACHMENT C: NORTH CAROLINA TERMS AND CONDITIONS

ATTACHMENT D: HUB SUPPLEMENTAL SUPPLIER INFORMATION

ATTACHMENT E: CUSTOMER REFERENCE FORM

ATTACHMENT F: LOCATION OF WORKERS UTILIZED BY VENDOR

ATTACHMENT G: CERTIFICATION OF FINANCIAL CONDITION

ATTACHMENT H: VENDOR REQUEST FOR EO50 PRICE-MATCHING

Ver: 11/2023 4

1.0 PURPOSE AND BACKGROUND

PURPOSE: The State of North Carolina, Department of Health and Human Services, (hereinafter referred to as the DEPARTMENT) has issued this Invitation for Bid (IFB) seeking to obtain fair, reasonable and acceptable pricing provide for the North Carolina

Department of Health and Human Services (DHHS), Division of Public Health, State Laboratory of Public Health (SLPH) for Newborn

Screening (NBS) Genetic Screening Blood Collection Devices.

BACKGROUND: The Division of Public Health, State Laboratory of Public Health (SLPH) requires these devices for the testing of inborn errors of metabolism in newborns. The Newborn Screening Laboratory has three Genetic Screening Processors (GSPs) to run six assays. All assays included are to test newborns for these metabolic disorders. The SLPH Newborn Screening (NBS) program performs newborn screening as mandated by North Carolina Law, G.S. 130A-125, which requires that every newborn receive a screen for conditions listed on the State’s Newborn Screening panel. Specimens are collected on filter paper cards that meet the characteristics defined by the Clinical and Laboratory Standards Institute for absorption, homogeneity, diameter of the circle for the dried blood aliquot, and absorption time. Forms are received and analyses performed at SLPH located at 4312 District Dr, Raleigh, NC, 27607.

The intent of this solicitation is to award an Agency Specific Contract.

1.1 CONTRACT TERM

The Contract shall have an initial term of three (3) years, beginning on the date of final Contract execution (the “Effective Date”).

In addition, the State reserves the right to extend a contract term after the last active term. Bids shall be submitted in accordance with the terms and conditions of this IFB and any addenda issued hereto.

Bids shall be submitted in accordance with the terms and conditions of this IFB and any addenda issued hereto.

2.0 GENERAL INFORMATION

2.1 INVITATION FOR BID DOCUMENT

The IFB is comprised of the base IFB document, any attachments, and any addenda released before Contract award, which are incorporated herein by reference.

2.2 E-PROCUREMENT FEE

ATTENTION: This is an NC eProcurement solicitation facilitated by the Ariba Network. The E-Procurement fee may apply to this solicitation. See paragraph entitled ELECTRONIC PROCUREMENT of the North Carolina General Terms and Conditions.

General information on the E-Procurement Services can be found at: http://eprocurement.nc.gov/.

What is the Ariba Network?

The Ariba Network is a web-based platform that serves as a connection point for buyers and vendors. Vendors can log in to the

Ariba Network to view purchase orders, respond to electronic requests for quotes, participate in Sourcing Events, and collaborate with buyers on contract documents.

For training on how to use the Sourcing Tool to view solicitations, submit questions, develop responses, upload documents, and submit offers to the State, Vendors should go to the following site:

http://eprocurement.nc.gov/training/vendor-training.

2.3 NOTICE TO VENDORS REGARDING IFB TERMS AND CONDITIONS

It shall be the Vendor’s responsibility to read the Instructions to Vendors, the North Carolina General Terms and Conditions, all relevant exhibits and attachments, and any other components made a part of this IFB and comply with all requirements and specifications herein. Vendors also are responsible for obtaining and complying with all Addenda and other changes that may be issued in connection with this IFB.

http://eprocurement.nc.gov/ http://eprocurement.nc.gov/training/vendor-training

Ver: 11/2023 5

If Vendors have questions, or issues regarding any component within this IFB, those must be submitted as questions in accordance with the instructions in the BID QUESTIONS Section. If the State determines that any changes will be made as a result of the questions asked, then such decisions will be communicated in the form of an IFB addendum. The State may also elect to leave open the possibility for later negotiation and amendment of specific provisions of the Contract that have been addressed during the question-and-answer period.

Other than through the process of negotiations under 01 NCAC 05B.0503, the State rejects and will not be required to evaluate or consider any additional or modified terms and conditions submitted with Vendor’s bid. This applies to any language appearing in or attached to the document as part of the Vendor’s bid that purports to vary any terms and conditions or Vendors’ instructions herein or to render the bid non-binding or subject to further negotiation. Vendor’s bid shall constitute a firm offer that shall be held open for the period required herein (“Validity Period” above).

The State may exercise its discretion to consider Vendor proposed modifications. By execution and delivery of this IFB Response, the Vendor agrees that any additional or modified terms and conditions, whether submitted purposely or inadvertently, shall have no force or effect, and will be disregarded unless expressly agreed to during negotiations and incorporated by way of a

Best and Final Ofer (BAFO). Noncompliance with, or any attempt to alter or delete, this paragraph shall constitute sufficient grounds to reject Vendor’s bid as nonresponsive.

2.4 IFB SCHEDULE

The table below shows the intended schedule for this IFB. The State will make every effort to adhere to this schedule.

Event Responsibility Date and Time

Issue IFB State May 14, 2024

Submit Written Questions Vendor May 20, 2024, @ 2:00 PM ET

Provide Responses to Questions State May 22, 2024

Submit Bids Vendor June 04, 2024, @ 2:00 PM ET

Microsoft Teams Need help?

Join the meeting now

Meeting ID: 260 220 898 604

Passcode: SuRkgH

Dial in by phone

+1 984-204-1487,,1665598# United

States, Raleigh

Find a local number

Phone conference ID: 166 559 8#

Join on a video conferencing device

Tenant key: ncgov@m.webex.com

Video ID: 114 019 285 0

More info

Contract Award State TBD https://aka.ms/JoinTeamsMeeting?omkt=en-US https://teams.microsoft.com/l/meetup-join/19%3ameeting_NWRlZDQyZmEtODA3YS00ZWNhLTkyZWUtMDAzOWMzY2Q2YmZj%40thread.v2/0?context=%7b%22Tid%22%3a%227a7681dc-b9d0-449a-85c3-ecc26cd7ed19%22%2c%22Oid%22%3a%223881eaa9-63a6-4b3b-a2b8-e42290f15e88%22%7d tel:+19842041487,,1665598 https://dialin.teams.microsoft.com/c102d528-0544-4660-b869-294e85047e28?id=1665598 https://www.webex.com/msteams?confid=1140192850&tenantkey=ncgov&domain=m.webex.com

Ver: 11/2023 6

2.5 BID QUESTIONS

Upon review of the IFB documents, Vendors may have questions to clarify or interpret the IFB in order to submit the best bid possible. To accommodate the Bid Questions process, Vendors shall submit any such questions by the “Submit Written Questions” date and time provided in the IFB SCHEDULE Section above, unless modified by Addendum.

Questions related to the content of the solicitation, or the procurement process should be directed to the person on the title page of this document via the Sourcing Tool's message board by the date and time specified in the IFB SCHEDULE Section of this IFB.

Vendors will enter “IFB # 30-24348-DPH – Questions” as the subject of the message. Question submittals should include a reference to the applicable IFB section. This is the only manner in which questions will be received.

Questions or issues related to using the Sourcing Tool itself can be directed to the North Carolina eProcurement Help Desk at 888-

211-7440, Option 2. Help Desk representatives are available Monday through Friday from 7:30 AM ET to 5:00 PM ET.

Questions received prior to the submission deadline date, the State’s response, and any additional terms deemed necessary by the State will be posted in the Sourcing Tool in the form of an addendum and shall become an Addendum to this IFB. No information, instruction or advice provided orally or informally by any State personnel, whether made in response to a question or otherwise in connection with this IFB, shall be considered authoritative or binding. Vendors shall rely only on written material contained in an Addendum to this IFB.

2.6 BID SUBMITTAL

IMPORTANT NOTE: This is an absolute requirement. Late bids, regardless of cause, will not be opened or considered, and will be automatically disqualified from further consideration. Vendor shall bear the sole risk of late submission due to unintended or unanticipated delay. It is the Vendor’s sole responsibility to ensure its bid has been received as described in this IFB by the specified time and date of opening. Failure to submit a bid in strict accordance with instructions provided shall constitute sufficient cause to reject a Vendor’s bid(s). Solicitation responses are subject to Sealed Bidding requirements.

Vendor’s bids for this procurement must be submitted through the Sourcing Tool. For training on how to use the Sourcing Tool to view solicitations, submit questions, develop responses, upload documents, and submit offers to the State, Vendors should go to the following site: https://eprocurement.nc.gov/training/vendor-training

Questions or issues related to using the Sourcing Tool itself can be directed to the North Carolina eProcurement Help Desk at 888-

211-7440, Option 2. Help Desk representatives are available Monday through Friday from 7:30 AM EST to 5:00 PM EST.

Tips for Using the Sourcing Tool

1. Vendors should review available training and confirm that they are able to access the Sourcing Event, enter responses, and upload files well in advance of the date and time response are due to allow sufficient time to seek assistance from the North Carolina eProcurement Help Desk.

2. Vendors may submit their responses early to make sure there are no issues, and then submit a revised response any time prior to the response due date and time. The State will only review the most recent response.

3. Vendors should respond to all relevant sections of the Sourcing Event. Certain questions or items are required in order to submit a response and are denoted with an asterisk. The Sourcing Tool will not allow a response to be submitted unless all required items are completed. The Sourcing Tool will provide error messages to help identify any required information that is missing when response is submitted.

4. Simply saving your response in the Sourcing Tool is not the same as submitting your response to the State. Vendors should make sure they complete the submission process and receive a message that their response was successfully submitted.

5. Only Bids submitted through the Content Section of the Ariba Sourcing Event will be considered. Bids submitted through the Message Board will not be accepted or considered for award.

2.7 BID CONTENTS

Vendors shall provide responses to all questions and complete all attachments for this IFB that require the Vendor to provide information and upload them to the Sourcing Event in the Sourcing Tool. Vendor may not be able to submit its response in the https://eprocurement.nc.gov/training/vendor-training

Ver: 11/2023 7

Sourcing Tool unless all required items are addressed. Vendors shall provide authorized signatures where requested. Failure to provide all required items, or Vendor’s submission of incomplete items, may result in the State rejecting Vendor’s bid, in the State’s sole discretion.

Vendors shall upload the following items and attachments in the Sourcing Tool:

a) Completed and signed version of EXECUTION PAGES, along with the body of the IFB.

b) Signed receipt pages of any addenda released in conjunction with this IFB, if required to be returned.

c) Vendor Response to include Sections: 4.5, 4.6, 4.7, 4.8, 6.1.

d) Completed version of ATTACHMENT A: PRICING

e) Completed and signed version of ATTACHMENT D: HUB SUPPLEMENTAL VENDOR INFORMATION

f) Completed and signed version of ATTACHMENT E: CUSTOMER REFERENCE FORM

g) Completed and signed version of ATTACHMENT F: LOCATION OF WORKERS UTILIZED BY VENDOR

h) Completed and signed version of ATTACHMENT G: CERTIFICATION OF FINANCIAL CONDITION

i) Completed and signed version of ATTACHMENT H: VENDOR REQUEST FOR EO50 PRICE-MATCHING

2.8 ALTERNATE BIDS

Unless provided otherwise in this IFB, Vendor may submit alternate bids for comparable Goods, various methods or levels of

Service(s), or that propose different options. Alternate bids must specifically identify the IFB requirements and advantage(s) addressed by the alternate bid. Each bid must be for a specific set of Goods and Services and must include specific pricing. Each bid must be complete and independent of other bids offered. If a Vendor chooses to respond with various offerings, Vendor shall follow the specific instructions for uploading Alternate Bids in the Sourcing Tool

2.9 DEFINITIONS, ACRONYMS, AND ABBREVIATIONS

Relevant definitions for this IFB are provided in 01 NCAC 05A .0112 and in the Instructions to Vendors found Sourcing Tool, which are incorporated herein by this reference.

3.0 METHOD OF AWARD AND BID EVALUATION PROCESS

3.1 METHOD OF AWARD

North Carolina G.S. 143-52 provides a general list of criteria the State shall use to award contracts, as supplemented by the additional criteria herein. The Goods or Services being procured shall dictate the application and order of criteria; however, all award decisions shall be in the State’s best interest.

All responsive bids will be reviewed, and award or awards will be based on the responsive bid(s) offering the lowest price that meets the specifications provided herein, to include any required verifications set out herein such as but not limited to past performance, references, and financial documents.

While the intent of this IFB is to award a Contract(s) to a single Vendor for all line items, the State reserves the right to make separate awards to different Vendors for one or more line items, to not award one or more line items or to cancel this IFB in its entirety without awarding a Contract, if it is considered to be most advantageous to the State to do so.

If a Vendor selected for award is determined by the State to be a non-resident of North Carolina, all responsive bids will be reviewed to determine if any of them were submitted by a North Carolina resident Vendor who requested an opportunity to match the price of the winning bid, pursuant to Executive Order #50 and G.S. 143-59 (for more information, please refer to ATTACHMENT H:

VENDOR REQUEST FOR EXECUTIVE ORDER #50 PRICE MATCHING. If such bid(s) are identified, the State will then determine whether any such bid falls within the price-match range, and, if so, make a Contract award in accordance with the process that implements G.S. 143-59 and Executive Order #50.

Ver: 11/2023 8

The State reserves the right to waive any minor informality or technicality in bids received.

3.2 CONFIDENTIALITY AND PROHIBITED COMMUNICATIONS DURING EVALUATION

While this IFB is under evaluation, the responding Vendor, including any subcontractors and suppliers, is prohibited from engaging in conversations intended to influence the outcome of the evaluation. See the Paragraph of the Instructions To Vendors entitled

COMMUNICATIONS BY VENDORS.

Each Vendor submitting a bid to this IFB, including its employees, agents, subcontractors, suppliers, subsidiaries and affiliates, is prohibited from having any communications with any person inside or outside the using agency; issuing agency; other government agency office or body (including the purchaser named above, any department secretary, agency head, members of the General

Assembly and Governor’s office); or private entity, if the communication refers to the content of Vendor’s proposal or qualifications, the content of another Vendor’s proposal, another Vendor’s qualifications or ability to perform a resulting contract, and/or the transmittal of any other communication of information that could be reasonably considered to have the effect of directly or indirectly influencing the evaluation of proposals, the award of a contract, or both.

Any Vendor not in compliance with this provision shall be disqualified from evaluation and award. A Vendor’s proposal may be disqualified if its subcontractor and/or supplier engage in any of the foregoing communications during the time that the procurement is active (i.e., the issuance date of the procurement until the date of contract award or cancellation of the procurement). Only those discussions, communications or transmittals of information authorized or initiated by the issuing agency for this IFB or inquiries directed to the purchaser named in this IFB regarding requirements of the IFB (prior to proposal submission) or the status of the award (after submission) are excepted from this provision.

3.3 BID EVALUATION PROCESS

Only responsive submissions will be evaluated.

The State will conduct an evaluation of responsive Bids, as follows:

Bids will be received according to the method stated in the Bid Submittal section above.

All bids must be received by the issuing agency not later than the date and time specified in the IFB SCHEDULE Section above, unless modified by Addendum. Vendors are cautioned that this is a request for offers, not an offer or request to contract, and the State reserves the unqualified right to reject any and all offers at any time if such rejection is deemed to be in the best interest of the State.

At the date and time provided in the IFB SCHEDULE Section above, unless modified by Addendum, the bids from each responding Vendor will be opened publicly and all offers (except those that have been previously withdrawn, or voided bids) will be tabulated. The tabulation shall be made public at the time it is created. When negotiations after receipt of bids is authorized pursuant to G.S. 143-49 and 01 NCAC 05B.0503, only the names of offerors and the Goods and Services offered shall be tabulated at the time of opening. Cost and price shall become available for public inspection at the time of the award... Interested parties are cautioned that these costs and their components are subject to further evaluation for completeness and correctness and therefore may not be an exact indicator of a Vendor’s pricing position.

At their option, the evaluators may request oral presentations or discussions with any or all Vendors for clarification or to amplify the materials presented in any part of the bid. Vendors are cautioned, however, that the evaluators are not required to request presentations or other clarification—and often do not. Therefore, all bids should be complete and reflect the most favorable terms available from the Vendor. Prices bid cannot be altered or modified as part of a clarification.

Bids will generally be evaluated, based on completeness, content, cost, and responsibility of the Vendor to supply the requested Goods and Services. Specific evaluation criteria are listed in Section 3.1 METHOD OF AWARD.

Upon completion of the evaluation process, the State will make Award(s) based on the evaluation and post the award(s) to the electronic Vendor Portal (eVP), https://evp.nc.gov, under the IFB number for this solicitation. Award of a Contract to one Vendor does not mean that the other bids lacked merit, but that, all factors considered, the selected bid was deemed most advantageous and represented the best value to the State.

https://evp.nc.gov/

Ver: 11/2023 9

The State reserves the right to negotiate with one or more Vendors, or to reject all original offers and negotiate with one or more sources of supply that may be capable of satisfying the requirement, and in either case to require Vendor to submit a Best and Final Offer (BAFO) based on discussions and negotiations with the State.

3.4 PERFORMANCE OUTSIDE THE UNITED STATES

Vendor shall complete ATTACHMENT F: LOCATION OF WORKERS UTILIZED BY VENDOR. In addition to any other evaluation criteria identified in this IFB, the State may also consider, for purposes of evaluating proposed or actual contract performance outside of the United States, how that performance may affect the following factors to ensure that any award will be in the best interest of the State:

a) Total cost to the State

b) Level of quality provided by the Vendor

c) Process and performance capability across multiple jurisdictions

d) Protection of the State’s information and intellectual property

e) Availability of pertinent skills

f) Ability to understand the State’s business requirements and internal operational culture

g) Particular risk factors such as the security of the State’s information technology

h) Relations with citizens and employees

i) Contract enforcement jurisdictional issues

3.5 INTERPRETATION OF TERMS AND PHRASES

This IFB serves two functions: (1) to advise potential Vendors of the parameters of the solution being sought by the State; and (2) to provide (together with other specified documents) the terms of the Contract resulting from this procurement. The use of phrases such as “shall,” “must,” and “requirements” are intended to create enforceable contract conditions. In determining whether bids should be evaluated or rejected, the State will take into consideration the degree to which Vendors have proposed or failed to propose solutions that will satisfy the State’s needs as described in the IFB. Except as specifically stated in the IFB, no one requirement shall automatically disqualify a Vendor from consideration. However, failure to comply with any single requirement may result in the State exercising its discretion to reject a bid in its entirety.

4.0 REQUIREMENTS

This Section lists the requirements related to this IFB. By submitting a bid, the Vendor agrees to meet all stated requirements in this Section, as well as any other specifications, requirements, and terms and conditions stated in this IFB. If a Vendor is unclear about a requirement or specification or believes a change in a requirement would allow for the State to receive a better bid, the Vendor is encouraged to submit these items in the form of a question during the question and answer period in accordance with the Bid Questions Section above.

4.1 PRICING

Bid price shall constitute the total cost to the State for delivery fully assembled and ready for use, including all applicable charges for shipping, delivery, handling, administrative and other similar fees. Complete ATTACHMENT A: PRICING FORM and upload in the Sourcing Tool. The pricing provided in ATTACHMENT A, or resulting from any negotiations, is incorporated herein and shall become part of any resulting Contract.

4.2 ESTIMATED QUANTITIES

The quantities indicated herein are annual estimates only and are provided for informational purposes based on the anticipated usage based on historical data. No maximum or minimum quantities are guaranteed. It shall be understood and agreed that the State may purchase more or less than the estimated quantities during the contract period. The State reserves the right to increase or decrease the quantities as needed. The State shall not be obligated to purchase more than its normal requirements. The State will be responsible only for items requested and received.

4.3 PRODUCT IDENTIFICATION

SUITABILITY FOR INTENDED USE

Ver: 11/2023 10

Vendors are requested to offer only items directly complying with the specifications herein or comparable items which will provide the equivalent capabilities, features and diversity called for herein. The State reserves the right to evaluate all bids for suitability for the required use and to award the one best meeting requirements and considered to be in the State’s best interest.

4.4 TRANSPORTATION AND IDENTIFICATION

The Vendor shall deliver Free-On-Board (FOB) Destination to any requested location within the State of North Carolina with all transportation costs and fees included in the total bid price.

When an order is placed using a purchase order, the purchase order number shall be shown on all packages and shipping manifests to ensure proper identification and payment of invoices. If an order is placed without using a purchase order, such as via phone, the Buyer’s name shall be show on all packages. A complete packing list shall accompany each shipment. Vendors shall not ship any products until they have received an order.

4.5 DELIVERY

The Vendor shall deliver Free-On-Board (FOB) Destination to the following location listed below. Vendor should complete delivery within thirty (30) consecutive calendar days after receipt of purchase order to:

State Laboratory of Public Health

4312 District Drive

Raleigh, NC 27607

ATTN: Mark Jackson (Central Receiving)

Phone: 919-807-8964

Email: Mark.Jackson@dhhs.nc.gov

NOTE: Twenty-four-hour prior delivery notice is to be made to Mark Jackson, at the email address above.

For completion by Vendor: Delivery will be made from __________________________________________ (city, state) within

_____ consecutive calendar days after receipt of purchase order. Promptness of delivery may be used as a factor in the award criteria.

4.6 WARRANTY

Manufacturer’s standard warranty shall apply. Vendors shall include a copy of the manufacturer’s standard warranty with the bid response.

4.7 SAMPLES

SAMPLE

Vendor must attach along with bid response a graphic designed layout of the 3 devices (Newborn Screening, Hemoglobinopathy, and Known PKU) to include perforations between spots (circles) and the number of spots (circles) listed. Examples should also show that the form meets dimensions and total number of pages as listed in the Specifications.

4.8 DESCRIPTIVE LITERATURE/CERTIFICATION

Each bid shall be accompanied by complete descriptive literature, specifications, certifications, and all other pertinent data necessary for thorough evaluation of the item(s) offered and sufficient to determine compliance of the item(s) with the specifications. Failure to include such information shall be a sufficient basis for rejection of the bid, at the discretion of the State.

4.9 HUB PARTICIPATION

Pursuant to North Carolina General Statute G.S. 143-48, it is State policy to encourage and promote the use of small, minority, physically handicapped, and women contractors in purchasing Goods and Services. As such, this IFB will serve to identify those

Vendors that are minority owned or have a strategic plan to support the State’s Historically Underutilized Business program by mailto:Mark.Jackson@dhhs.nc.gov

Ver: 11/2023 11 meeting or exceeding the goal of 10% utilization of diverse firms as 1st or 2nd tier subcontractors. Vendor shall complete

ATTACHMENT D: HUB SUPPLEMENTAL VENDOR INFORMATION.

4.10 REFERENCES

Vendors shall upload to the Sourcing Tool at least three (3) references, using ATTACHMENT E: CUSTOMER REFERENCE FORM, for which your company has supplied the exact model of equipment offered. The State may contact these users to determine the quality level of the offered equipment; as well as, but not limited to user satisfaction with Vendor performance. Information obtained may be considered in the evaluation of the bid.

4.11 VENDOR’S REPRESENTATIONS

If Vendor’s bid results in an award, Vendor agrees that it will not enter any agreement with a third party that may abridge any rights of the State under the Contract. If any Services, deliverables, functions, or responsibilities not specifically described in this solicitation are required for Vendor’s proper performance, provision and delivery of the Service and deliverables under a resulting

Contract, or are an inherent part of or necessary sub-task included within such service, they will be deemed to be implied by and included within the scope of the contract to the same extent and in the same manner as if specifically described in the Contract.

Unless otherwise expressly provided herein, Vendor will furnish all of its own necessary management, supervision, labor, facilities, furniture, computer and telecommunications equipment, software, supplies and materials necessary for the Vendor to provide and deliver the Services and/or other Deliverables.

4.12 FINANCIAL STABILITY

As a condition of contract award, the Vendor must certify that it has the financial capacity to perform and to continue to perform its obligations under the Contract; that Vendor has no constructive or actual knowledge of an actual or potential legal proceeding being brought against Vendor that could materially adversely affect performance of this Contract; and that entering into this

Contract is not prohibited by any contract, or order by any court of competent jurisdiction

Each Vendor shall certify it is financially stable by completing the ATTACHMENT G: CERTIFICATION OF FINANCIAL CONDITION. The

State is requiring this certification to minimize potential performance issues from Contracting with a Vendor that is financially unstable. This Certification shall be deemed continuing, and from the date of the Certification to the expiration of the Contract, the Vendor shall notify the State within thirty (30) days of any occurrence or condition that materially alters the truth of any statement made in this Certification.

4.13 AGENCY INSURANCE REQUIREMENTS MODIFICATION

A. Default Insurance Coverage from the General Terms and Conditions applicable to this Solicitation:

☐ Small Purchases

☒ Contract value in excess of the Small Purchase threshold, but up to $1,000,000.00

☐ Contract value in excess of $1,000,000.00

5.0 PRODUCT SPECIFICATIONS

SPECIFICATIONS

Vendor must attach along with bid response a graphic designed layout of the 3 devices (Newborn Screening, Hemoglobinopathy, and Known PKU) to include perforations between spots (circles) and the number of spots (circles) listed. Examples should also show that the form meets dimensions and total number of pages as listed in the Specifications.

This Section describes the Blood Collection Devices that are required to be provided to the State Laboratory of Public Health (SLPH).

The awarded Vendor must be able to provide all requested services and product(s) throughout the entire three (3) year contract term. The following design specifications refer to the first year of the contract. Quantity and design for all subsequent years is

Ver: 11/2023 12 estimated to be largely the same. However, the State reserves the right to make design changes for subsequent years of the contract. Basic design of the form, form size, and filter paper position of the Blood Collection Device may change.

Three (3) Blood Collection Devices will be designed and produced, including:

1. Device 1: Newborn Screening device. Estimated usage: 600,000

2. Device 2: Hemoglobin Screening device. Estimated usage: 60,000

3. Device 3: Known PKU device. Estimated usage: 60,000

Device Images with Parts provides a visual of the three (3) devices to be designed as provided herein.

I. Specifications for the Newborn Screening device (Device 1): Newborn screening relies on collection of dried blood taken from the baby via a heel stick. The device is a 6-part form with a tear-off tab.

The form then has an informational cover (Part 1) and 3 demographic pages. The first demographic page (Part 2) is retained by SLPH. The second demographic page (Part 3) is a replica of the first copy and is for the submitter to maintain in the infant’s medical record. The third demographic page (Part 4) contains 7 10-mm circles for the place of the infant’s blood. Parts 3 and 4 are carbon copies of Part 2. The device includes an instructional back page (Part 6) with flap. The card with a specifically manufactured filter paper (Part 5) becomes the “specimen”. A barcode number is printed on Parts 2, 3, 4, and 5.

1. Design: The Vendor must assist SLPH in redesigning the blood collection device, with input from SLPH program staff.

The design will include revisions that are detailed below. Additional changes may be proposed “upon request” by

SLPH and the Vendor must submit a unit price in the event the SLPH exercises their option to request additional changes. SLPH must approve all designs prior to production. All designs will be the property of SLPH.

2. Size of the blood collection device: Note: Parts 1-4 and Part 6 may need to be enlarged to no larger than 9” X 6” upon request of SLPH.

a. Part 1 - 7.5" x 5.5" (overall size) – Informational Cover.

b. Part 2 - 7.625” x 5.5” (overall size) – Demographics Top Copy Page 1.

c. Part 3 - 8.625" x 5.5” (overall size) – Demographics Carbon Copy Page 2 (“Keep for Your Records”).

d. Part 4 - 7.875” x 5.5" (overall size) – Demographics Carbon Copy Page 3 (attached to filter paper).

e. Part 5 - 1.5" strip of filter paper glued to the right edge of Part 4. Visible strip from right edge of Part 4 to right edge of filter paper 1.25”. Seven pre-printed circles with perforations between circles.

f. Part 6 - 12.5" x 5.5" (overall size) – Specimen Cover with Instructions.

Overall size is to allow placement of collection instrument into a standard legal-size envelope and is not to exceed above measurements.

3. Production: Filter paper specifications must meet requirements described in CLSI NBS01-A6; Blood Collection on

Filter Paper for Newborn Screening Programs; Approved Standard. Working with the new designs and WHATMAN

903 U.S. Food and Drug Administration (“FDA”) Approved Filter Paper, Blood Collection Device, the Vendor will produce an estimated 200,000 blood collection forms annually (an estimated 1,000,000 devices over the contract period).

4. Composition: Include all required regulatory copy and graphics:

a. Part 1, informational cover, about 30 lines of type.

b. Part 2, top copy, about 15 lines of type.

c. Part 3, carbon copy of Part 2 with “Keep for Your Records” printed at top.

d. Part 4, carbon copy of Part 2, attached to filter paper.

e. Part 5 is different, about 2 lines of type that includes Lot, Expiration, and Filter Paper Type and barcode.

f. Part 6, copy different, about 30 lines of type.

Ver: 11/2023 13

5. Layout: The layout is to be maintained as indicated and is not to be repositioned by the Vendor except as approved in writing by SLPH staff. Any questions regarding placement and possible repositioning must be directed to the

Newborn Screening Program prior to the contractor’s preparation of first proof.

6. Presswork and Ink: All parts - Black ink plus instructions in Red.

a. Parts 1, 2, 3 & 4 – Black.

b. Part 5 – Black.

c. Part 6 - Black and Red.

7. Fold: Part 6 - Folds 2-1/2" from right side to form a wraparound flap over form.

8. Perforations:

a. All sections should detach from Part 6 by vertical perforation. Perforation should not come apart under normal handling.

b. All 7 spots should contain perforations between them on Part 5

9. Barcode: All Forms should be consecutively pre-numbered with a barcode that is listed on Parts 2, 3, 4, 5 and must follow the following standards:

The 9-digit sequence number with check digit feature shall be increased by +1 on each successive form and shall be printed in human-readable form at the top of each part. The 9-digit sequence number with check digit feature in human-readable form shall be printed on Parts 2, 3, 4, and 5 of the Form, INCLUDING ON THE STRIP OF FILTER PAPER.

There shall be no duplication of the pre-printed 9-digit sequence number.

With each shipment, Vendor is to furnish SLPH with a shipping manifest indicating the number of cartons in shipment, listing each carton and the barcode form numbers contained therein, and specifically listing any missing numbers.

Vendor will submit the first and last 9-digit sequence number printed to the Agency in writing as soon as printing is completed.

Range of Barcodes shall be hand-written in upper corner of each box of 1500 devices and carton of boxes for identification of contents. SLPH will supply the Vendor with the beginning number once the contract has been awarded.

The barcode shall be 2-3/8" wide by 3/8" high with a concentration of not greater than 9 characters per inch. The barcode plus human-readable digits shall be about 16-point font, no greater than 2-3/16" wide x 9/16" high.

Printing ink is to be of the best quality and color shall be black only. Density of print is to be checked to assure density equivalent to other 100% black print densities.

The barcode shall consist of 3 fields as follows:

1) Start character (*).

2) User defined data field of 9 characters in length: 9-digit sequence number to be provided by Agency;

increment 1 (NOTE: The eighth position check digit MUST be replicated in bar code).

3) Stop character (*).

Ver: 11/2023 14

II. Specifications for the Hemoglobin Screening device (Device 2):

The device is a 5-part form with a tear-off tab. The form then has 3 demographic pages. The first demographic page (Part

1) is retained by SLPH. The second demographic page (Part 2) is a replica of the first and is for the submitter to maintain.

The third demographic page (Part 3) is also a replica and contains 5 10-mm circles for the place of the infant’s blood. Parts

2 and 3 are a carbon copy of Part 1. The device includes an instructional back page (Part 5) with flap. The card with a specifically manufactured filter paper (Part 4) becomes the “specimen”. A barcode number is printed on Parts 1, 2, 3, and

4.

1. Design: The Vendor must assist SLPH in redesigning the blood collection device, with input from SLPH program staff. The design will include revisions that are detailed below. Additional changes may be proposed “upon request” by SLPH and the Vendor must submit a unit price in the event the SLPH exercises their option to request additional changes. SLPH must approve all designs prior to production. All designs will be the property of SLPH.

2. Size of the blood collection device: Note: Parts 1-2 must be no larger than 9” X 4” upon request of SLPH.

a. Part 1 - 9” x 4” (overall size) – Demographics Top Copy Page 1

b. Part 2 - 9" x 4” (overall size) – Demographics Carbon Copy Page 2 (“Keep for Your Records”)

c. Part 3 - 9" x 4” (overall size) – Demographics Carbon Copy Page 3 (attached to filter paper)

d. Part 4 - 1.5" strip of filter paper glued to the right edge of Part 3. Visible strip from right edge of Part 3 to right edge of filter paper 1.25”. Five pre-printed circles with perforations between circles.

e. Part 5 - 12.5" x 4" (overall size) – Specimen Cover with Instructions

Overall size is to allow placement of collection instrument into a standard legal-size envelope and is not to exceed above measurements.

3. Production: Filter paper specifications must meet requirements described in CLSI NBS01-A6; Blood Collection on

Filter Paper for Newborn Screening Programs; Approved Standard. Working with the new designs and

WHATMAN 903 U.S. Food and Drug Administration (“FDA”) Approved Filter Paper, Blood Collection Device, the contractor will produce an estimated 20,000 blood collection forms annually (an estimated 100,000 devices over the contract period).

a. Part 1, top copy, about 15 lines of type.

b. Part 2, carbon copy of Part 1, with “Keep for Your Records” printed at top.

c. Part 3, carbon copy of Part 1, attached to filter paper.

d. Part 4, is different, about 2 lines of type that includes Lot, Expiration, and Filter Paper Type and barcode.

e. Part 5, copy different, about 30 lines of type.

Ver: 11/2023 15

5. Layout: The layout is to be maintained as indicated and is not to be repositioned by the contractor except as approved in writing by SLPH staff. Any questions regarding placement and possible repositioning must be directed to the Newborn Screening Program prior to Vendor's preparation of first proof.

a. Parts 1, 2, 3, 4 & 5 – Black

7. Fold: Part 4 - Folds 2-1/2" from right side to form a wraparound flap over form.

a. All sections should detach from Part 4 by vertical perforation. Perforation should not come apart under normal handling.

b. All 5 spots should contain perforations between them on Part 4

9. Barcode: All Forms should be consecutively pre-numbered with a barcode that is listed on Parts 1, 2, 3, 4 and must follow the following standards:

The 9-digit sequence number with check digit feature shall be increased by +1 on each successive form and shall be printed in human-readable form at the top of each part. The 9-digit sequence number with check digit feature in human-readable form shall be printed on Parts 1, 2, 3, and 4 of the Form, INCLUDING ON THE STRIP OF FILTER

PAPER. There shall be no duplication of the pre-printed 9-digit sequence number.

With each shipment, Vendor is to furnish SLPH with a shipping manifest indicating the number of cartons in shipment, listing each carton and the barcode form numbers contained therein, and specifically listing any missing numbers. Vendor will submit the first and last 9-digit sequence number printed to the SLPH in writing as soon as printing is completed.

Range of Barcodes shall be hand-written in upper corner of each box of 1500 devices and carton of boxes for identification of contents.

SLPH will supply the Vendor with the beginning number once the contract has been awarded. The barcode shall be 2-3/8" wide by 3/8" high with a concentration of not greater than 9 characters per inch. The barcode plus human-readable digits shall be about 16-point font, no greater than 2-3/16" wide x 9/16" high.

Printing ink is to be of the best quality and color shall be black only. Density of print is to be checked to assure density equivalent to other 100% black print densities.

The barcode shall consist of 3 fields as follows:

1) Start character (*).

2) User defined data field of 9 characters in length: 9-digit sequence number to be provided by Agency;

Ver: 11/2023 16

III. Specifications for the Known PKU Screening device (Device 3):

The device is a 5-part form with a tear-off tab. The form then has 3 demographic pages. The first demographic page (Part

1) is retained by SLPH. The second demographic page (Part 2) is a replica of the first and is for the submitter to maintain.

The third demographic page (Part 3) is also a replica and contains 5 10-mm circles for the place of the infant’s blood. Parts

2 and 3 are a carbon copy of Part 1. The device includes an instructional back page (Part 5) with flap. The card with a specifically manufactured filter paper (Part 4) becomes the “specimen”. A barcode number is printed on Parts 1, 2, 3, and

4.

1. Design: The Vendor must assist SLPH in redesigning the blood collection device, with input from SLPH program staff.

The design will include revisions that are detailed below. Additional changes may be proposed “upon request” by

SLPH and the Vendor must submit a unit price in the event the SLPH exercises the option to request additional changes. SLPH must approve all designs prior to production. All designs will be the property of SLPH.

2. Size of the blood collection device: Note: Parts 1-2 must be no larger than 9” X 4” upon request of SLPH.

o Part 1 - 9” x 4” (overall size) – Demographics Top Copy Page 1…