part I and part II DPH B-38605 CPO Signed.pdf

Sole Source Justification Form

Version 7.01 Page 1 of 6

Bulletin Reference Number 24-482DPH-OFCDI-B-38605

Requesting Agency/University IDPH

Sole Source Justification Form - Part I Section I - General Information

Department/Bureau/Section: Public Health, Division of Laboratories

Need Identified Date: Aug 1, 2023 Supply/Service Need By Date: 12/1/2023

Project Title: Clear Lab Reagent Contract

Vendor: Clear Labs, Inc

Provide a description of the supplies or services required:

This request is for a sole source contract to purchase reagents from Clear Labs for the Clear DX all in one instrument for PulseNet bacterial isolate sequencing. The Clear Lab Clear DX instruments were purchased in June of 2023 under a sole source contract 38500025K BidBuy PO# P-52605. This sequencing platform is the only system on the market that can perform automated bacterial isolate sample extraction, whole genome sequencing and post sequence analysis within 18 hours of loading a raw sample on the instrument. Clear Labs Inc. is the only company that offers the reagents that can be used on the Clear DX instrument platform.

Value: Estimated Value of Initial Term, this Change Order or Amendment: 1,004,000

Will this Sole Source amend a Professional or Artistic Services contract? Yes No

*Sole Source may not be used for amendments for Professional or Artistic Services if the amendment would increase the value by more than 5% of the initial award or extend the term by more than 60 days.

Type: New Sole Source

Section II - Proposed Term

One-Time Purchase Term Contract

Estimated Contract Begin Date: 12/1/2023

Estimated Contract End Date: 11/30/2024

Number of Potential Renewals: 0

Length of Each Renewal in Months: 0

Total Value of All Renewals: 0

If a Term Contract, does the term, including renewals, exceed 12 months? Yes No

Section III - Funding Source Select the type of funding to be used (Check all that apply): State Appropriate Funds Federal Funds Other (Explain):

Section IV - Sole Source Justification

This purchase is economically only available from a single source primarily because it is: (If "Other" explain in one sentence)

Items are Copyrighted or Patented and the Items are Only Available from the Holder

Are there secondary justification(s) for this sole source? Yes No

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Bulletin Reference Number 24-482DPH-OFCDI-B-38605

Requesting Agency/University IDPH

Section V - Purchase History

Has the Agency or University Purchased these supplies or services in the past? Yes No

Term Term From Term To Value Description Contract Number Type

1 Jun 13, 2023 Jun 12, 2024 962,476 Equipment, Service and Reagents 38500028K Sole Source

If more than 10, or if other comments, explain:

Section VI - Business Rationale

1. Provide a detailed explanation of the need for the supplies or services:

IDPH Division of Labs purchased two Clear DX sequencing instruments from Clear Labs, Inc in June of 2023. The Clear Lab ClearDX system is the only system on the market that can perform automated bacterial isolate sample extraction, whole genome sequencing, and post-sequence analysis within 18 hours of loading raw samples on the Clear DX instrument. The Clear DX instruments have been purchased for the sequencing of PulseNet Enteric and Foodborne pathogens. The Clear DX single workflow instrument allows for IDPH sequencing department technologists to focus other sequencing initiatives for Newborn screening and respiratory pathogens using sequencing methodologies which require greater involvement. The Clear DX instruments play a crucial role in the sequencing of the 4,000 microbial pathogens for diagnostic and epidemiological reporting.

At the time of contract execution, only $200,000 was included for reagents. The Division of Labs estimates it will need enough reagents for up to 4000 microbial surveillance samples in one year and will expend the currently contracted amount by 12/1/23. The lab is requesting an additional $1,004,000 in reagents from Clear Labs, Inc to use through 11/30/2024.

The State of Illinois will have to continue to purchase reagents/consumables and service coverage for use with the Clear DX instruments. Currently IDPH is processing approximately 1500 specimens annually in each lab that owns this instrumentation. The expected 20-30% increase in test volume dictates the need for this contract. With the current disease environment, genomic sequencing needs are increasing.

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Bulletin Reference Number 24-482DPH-OFCDI-B-38605

Requesting Agency/University IDPH

2. Provide a list and describe in detail the specifications required to satisfy the need:

The following items are required to process microbial surveillance samples on the IDPH owned Clear DX instruments.

Clear DX Microbial Surveillance Reagents /Consumables- testing reagents (liquid based) and consumables (plastics, tips, ancillary items) necessary for processing of whole genome sequencing.

Clear Dx™ Microbial Surveillance WGS Reagent v2.0 & Automation Bundle including:

1.) Microbial Surveillance v2.0 Reagents-This includes the DNA library index reagents, extraction and amplification reagents needed for all 3 phases of DNA Sequencing 12.) Microbial Surveillance v2.0 Technology Access Fee - Use of of Clear Labs software for sequencing data analysis

3. Provide detail explaining the justification selected in Section IV to explain why the requested supplies or services are the only ones available that can satisfy the agency or university requirements?

Clear Labs, Inc. is the only manufacturer that can supply the Clear Dx™ Microbial Surveillance WGS Reagent v 2.0 and Automation bundle needed for testing on the Clear DX instruments owned by IDPH.

Clear Labs is the only manufacturer and authorized supplier in the United States. See Sole Source memo.

4. What are the unique features of the supplies or services that are not available in any other product or by any other vendor? Provide specific quantifiable factors/qualifications:

The Clear Lab, Inc Clear Dx™ Microbial Surveillance WGS Reagent v 2.0 and Automation bundle are the only sequencing reagent with the Clear DX instruments owned by IDPH. This contract is needed in order to test the expected sample volume that will be received by

IDPH.

The Clear Lab DX genomic sequencing instruments are the only fully-automated extraction, sequencing, and post sequencing analysis all in one instrument with minimal hands on tech time. Results are available 18 hours from sample loading which decreases turn around time and tech time for sample completion.

5. Has the Agency or University considered alternative supplies or services to satisfy their need? Yes No

5a. If no, why weren't alternatives evaluated?

There are no other fully-automated instruments on the market that will perform all 3 phases of testing in one instrument. Extraction, genomic sequencing, and post sequencing analysis. Clear Labs, Inc is the only manufacturer and authorized supplier in the U.S. that offers the Clear DX instrument platform. The Clear DX system is needed to perform sample extraction, quantification, PCR, and sequencing which is necessary to ensure accurate sample analysis.

There are no other reagents that will work with the Clear DX instruments that are fully-automated and will perform all 3 phases of WGS testing in one instrument

6. Are there resellers or distributors?

Yes No N/A

7. What efforts were made to get the best possible price (i.e. did the agency/university negotiate) and how did you determine the price for this purchase is considered fair and reasonable?

The lab reached out to other states across the U.S. that use the Clear DX instrument platforms to confirm that reagent pricing was competitive. The price given was consistent with other public health lab pricing.

8. Will this purchase obligate the State to this vendor for future purchases such as maintenance, licensing or continuing need?

Yes No

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Bulletin Reference Number 24-482DPH-OFCDI-B-38605

Requesting Agency/University IDPH

9. What will be the financial or other impact to the State if this sole source is not approved and a competitive bid is required?

Increasing pressure is being put on expansion of genomic sequencing to include other infectious diseases and microbes involved in outbreaks in long term/congregate care facilities and for antibiotic resistance genes that are creating a strain on treatment mechanisms used in healthcare settings. The Clear DX instruments have been purchased by IDPH and this reagent contract is needed in order to purchase the supplies needed for testing volume. Without approval, the State of Illinois will be unable to use the Clear DX instruments purchased under contract 38500028K and meet all of the increasing needs for genomic sequencing. Using Clear DX instrumentation and reagents reduces costs associated with increased turn around time for results associated with food borne outbreaks.

10. Is there any additional information you would like to add to justify this sole source?

No

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Bulletin Reference Number 24-482DPH-OFCDI-B-38605

Requesting Agency/University IDPH

Section VII

Requesting Department Representative

Requesting Department Signature Required

I know and understand the contents of this Sole Source Justification and attest that all statements are true and correct and the fairness and reasonableness of the price was adequately confirmed.

Date Aug 17, 2023

Printed Name Leslie A Chapman E-mail Address leslie.chapman@illinois.gov

Phone Number 618-457-5131

State Agency Bureau/Division Head or University Purchasing Director Approval and Signature Required

I know and understand the contents of this Sole Source Justification and attest that all statements are true and correct and the fairness and reasonableness of the price was adequately confirmed. (All prior form fields will lock once this e-signature is completed)

E-mail Address nicole.hildebrand@illinois.gov

Phone Number 217-558-0264 Date Aug 17, 2023

Printed Name Nicole Hildebrand

Agency Bureau/Division Head or University Purchasing Director and Not a Designee

SPO Approval and Signature Required

I have reviewed and understand the contents of this Sole Source Justification and agree with the State Agency or University determination.

I have reviewed and understand the contents of this Sole Source Justification and do not agree with the State Agency or University determination. As a result, the State Agency or University must explore other sourcing methods to satisfy their need.

State Purchasing Officer Signature Phone Number 217-299-5563 Date

Printed Name Gina Jacaway E-mail Address gina.jacaway@illinois.gov

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Bulletin Reference Number 24-482DPH-OFCDI-B-38605

Requesting Agency/University IDPH

Sole Source Justification Form - Part II Section I - General Information

Project Title Clear Lab Reagent Contract

Vendor Clear Labs, Inc

Initial Date of Procurement Bulletin Posting 8/23/2023

Was a Sole Source hearing held per 30 ILCS 500/20-25?

Yes - Complete Section II and III below (Section II will only be visible when this option is selected)

No - Section II not required, go to Section III below Section III - CPO Approval and Signature Required

Based on my review, I authorize the Agency/University to proceed in accordance with the published Notice referenced above.

Based upon my review, I authorize the Agency/University to proceed with the following Changes.

Based on my review, the Agency/University is not authorized to proceed with this sole source as presented and my recommendation is that it be cancelled.

Other

CPO Signature CPO Phone 217-558-2231

Printed Name Ellen H. Daley Date

CPO E-mail Ellen.H.Daley@illinois.gov

Version 7.01 Page of Sole Source Justification Form - Part I Section I - General Information Will this Sole Source amend a Professional or Artistic Services contract?

If yes, what was the original contract value?

*Sole Source may not be used for amendments for Professional or Artistic Services if the amendment would increase the value by more than 5% of the initial award or extend the term by more than 60 days.

Section II - Proposed Term If a Term Contract, does the term, including renewals, exceed 12 months?

If yes, provide a detailed justification including any economic benefit received for agreeing to a multi-year term:

Section III - Funding Source Select the type of funding to be used (Check all that apply):

Section IV - Sole Source Justification Are there secondary justification(s) for this sole source?

Section V - Purchase History Has the Agency or University Purchased these supplies or services in the past?

Term Term From Term To Value Description Contract Number Type Section VI - Business Rationale

1. Provide a detailed explanation of the need for the supplies or services:

2. Provide a list and describe in detail the specifications required to satisfy the need:

3. Provide detail explaining the justification selected in Section IV to explain why the requested supplies or services are the only ones available that can satisfy the agency or university requirements?

4. What are the unique features of the supplies or services that are not available in any other product or by any other vendor? Provide specific quantifiable factors/qualifications:

5. Has the Agency or University considered alternative supplies or services to satisfy their need?

5a. If yes, name the alternative vendors whose supplies or services were evaluated:

5b. If yes, what were the alternatives for each vendor and why were they unacceptable? Be specific with regard to features, characteristics, requirements, capabilities and compatibility:

5c. Explain how the market evaluation was conducted?

*This evaluation is to determine available options within a market. If the evaluation is to determine quality or best suited option, this is not the appropriate source selection. Under no circumstances shall the evaluation consist of testing alternative options. These activities must be conducted in a competitive transparent environment (i.e. IFB or RFP).

5a. If no, why weren't alternatives evaluated?

6. Are there resellers or distributors?

7. What efforts were made to get the best possible price (i.e. did the agency/university negotiate) and how did you determine the price for this purchase is considered fair and reasonable?

8. Will this purchase obligate the State to this vendor for future purchases such as maintenance, licensing or continuing need?

8a. If yes, please provide details regarding future obligations and/or needs:

9. What will be the financial or other impact to the State if this sole source is not approved and a competitive bid is required?

10. Is there any additional information you would like to add to justify this sole source?

Section VII Requesting Department Signature Required I know and understand the contents of this Sole Source Justification and attest that all statements are true and correct and the fairness and reasonableness of the price was adequately confirmed.

State Agency Bureau/Division Head or University Purchasing Director Approval and Signature Required I know and understand the contents of this Sole Source Justification and attest that all statements are true and correct and the fairness and reasonableness of the price was adequately confirmed. (All prior form fields will lock once this e-signature is completed) SPO Approval and Signature Required Sole Source Justification Form - Part II Section I - General Information Was a Sole Source hearing held per 30 ILCS 500/20-25?

Section II - Sole Source Hearing Details The State posted to the Illinois Procurement Bulletin a description of the State's need, the justification for the sole source decision, and information regarding the opportunity to submit comments and testify at a public hearing. Notice of the hearing was also posted outside of the hearing room 48 hours prior to the hearing.

The public hearing was conducted for the purpose of receiving testimony regarding the sole source determination. The Hearing Officer recommends the following:

The following relevant documents are attached:

Section III - CPO Approval and Signature Required 9.0.0.2.20101008.1.734229 Ellen.H.Daley@illinois.gov

The second is with the purchase of the system equipment, IDPH will also have ongoing ability to perform the food borne outbreak microbial sequencing which currently processes 1,500 specimens per year with anticipated need of increasing sequencing by 20-30% annually.

At the time of contract execution, only $200,000 was included for reagents. The Division of Labs estimates it will need enough reagents for up to 4000 microbial surveillance samples in one year and will expend the currently contracted amount by 12/1/23. The lab is requesting an additional $1,004,000 in reagents from Clear Labs, Inc to use through 11/30/2024.

The State of Illinois will have to continue to purchase reagents/consumables and service coverage for use with the Clear DX instruments. Currently IDPH is processing approximately 1500 specimens annually in each lab that owns this instrumentation. The expected 20-30% increase in test volume dictates the need for this contract. With the current disease environment, genomic sequencing needs are increasing.

Q2Answer: The following items are required to process microbial surveillance samples on the IDPH owned Clear DX instruments.

Clear DX Microbial Surveillance Reagents /Consumables- testing reagents (liquid based) and consumables (plastics, tips, ancillary items) necessary for processing of whole genome sequencing.

Clear Dx™ Microbial Surveillance WGS Reagent v2.0 & Automation Bundle including:

1.) Microbial Surveillance v2.0 Reagents-This includes the DNA library index reagents, extraction and amplification reagents needed for all 3 phases of DNA Sequencing 12.) Microbial Surveillance v2.0 Technology Access Fee - Use of of Clear Labs software for sequencing data analysis Q3Answer: Clear Labs, Inc. is the only manufacturer that can supply the Clear Dx™ Microbial Surveillance WGS Reagent v 2.0 and Automation bundle needed for testing on the Clear DX instruments owned by IDPH.

Clear Labs is the only manufacturer and authorized supplier in the United States. See Sole Source memo.

Q4Answer: The Clear Lab, Inc Clear Dx™ Microbial Surveillance WGS Reagent v 2.0 and Automation bundle are the only sequencing reagent with the Clear DX instruments owned by IDPH. This contract is needed in order to test the expected sample volume that will be received by IDPH.

The Clear Lab DX genomic sequencing instruments are the only fully-automated extraction, sequencing, and post sequencing analysis all in one instrument with minimal hands on tech time. Results are available 18 hours from sample loading which decreases turn around time and tech time for sample completion.

There are no other reagents that will work with the Clear DX instruments that are fully-automated and will perform all 3 phases of WGS testing in one instrument