B-27583 SSJF Bruker Scientific MALDI TOF.pdf

Sole Source Justification Form

Version 7.01 Page 1 of 5

Bulletin Reference Number 22-482DPH-HLTHP-B-27583

Requesting Agency/University Public Health

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

Department/Bureau/Section: Division of Labs

Need Identified Date: 11/15/2021 Supply/Service Need By Date: 5/1/2022

Project Title: Bruker MALDI TOF

Vendor: Bruker Scientific LLC

Provide a description of the supplies or services required: To obtain 3 Bruker MALDI TOF instruments, subtyping modules and special organism libraries.

Value: Actual Value of Initial Term, this Change Order or Amendment: 730,874

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

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

Another justification that this purchase is only available from a sole source is because it is:

Other: The Bruker BioTypers are the only system compatible with the MicrobeNet bacterial identification system used by CDC.

Another justification that this purchase is only available from a sole source is because it is:

Federal/State Grant Requires Contract with Vendor

Section V - Purchase History

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

Section VI - Business Rationale

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

The Illinois Department of Public Health (IDPH) Division of Labs wishes to establish a 1 year sole source contract to acquire instrumentation and additional identification tools, including special organism libraries and subtyping modules. The Bruker BioTyper systems utilize Time of Flight Mass Spectrometry (TOF) for identification compared to biochemical testing to rapidly identify bacterial microorganisms. The Bruker MALDI TOF would significantly improve IDPH's capacity as it is faster and has a much larger identificaon library of organisms compared to the existing testing platform. IDPH Division of Labs has received funding from ELC Enhancing Detection and ELC Enhancing Detection Expansion grants to procure Bruker MALDI TOF instrumentation.

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Bulletin Reference Number 22-482DPH-HLTHP-B-27583

Requesting Agency/University Public Health

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

ITEM DESCRIPTION QUANTITY COST PER UNIT TOTAL

MALDI BIOTYPER SIRIUS CA SYSTEM 3 EA $230,000.00 $690,000.00

MBT MYCOBACTERIA LIBRARY 1 EA $8,755.00 $8,755.00

SECURITY LIBRARY 2 EA $6,774.50 $13,549.00

MBT SUBTYPING MODULE 3 EA $3,430.00 $10,290.00

FREIGHT 3 EA $2,760.00 $8,280.00

GRAND TOTAL $730,874.00

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?

The items listed are proprietary to Bruker Scientific LLC and not distributed by a 3rd party. The Bruker MALDI TOF system must utilize their libraries and modules for compatibility purposes. The ELC Enhancing Detection grant provided this funding to allow IDPH to expand capacity for the organisms that are tested in-house as well as the number of samples that can be tested per day. This testing platform was encouraged by the CDC's Laboratory Response Network as it is only method available to test for Clostridium botulinum.

This system was also encouraged by the CDC as it allows IDPH to connect with MicrobeNet which allows the State of Illinois to submit characteristics of pathogens that can assist with identification and/or outbreak investigations in a remote fashion.

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:

Compatibility of CDC MicrobeNet, ability to test for Clostridium botulinum using CDC's Laboratory Response Network Protocol. The CDC MicrobeNet is an online database that contains information about more than 2,400 rare disease-causing microbes, like bacteria and fungi. MicrobeNet was designed specifically by CDC for public health laboratories to allow anywhere in the world to match results from their diagnostic tests against CDC's unique collection of pathogens. The Bruker MALDI TOF is the only system that links to the CDC MicrobeNet.

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

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

BioMerieux

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:

Not compatible with CDC MicrobeNet, inability to test for Clostridium botulinum

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).

MicrobeNet brochure reviewed, BioMerieux library review, Laboratory Response Network Standard Operating Procedure review

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?

Direct purchase from Bruker Scientific LLC. Significant discount given to public health labs as well as discount for multiple systems being purchased.

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 22-482DPH-HLTHP-B-27583

Requesting Agency/University Public Health

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?

Upon bringing these platforms into the lab, the lab could eliminate other sole source contracts associated with platforms that utilize biochemicals for identification, including BioMerieux and the use of their Vitek 2 system. The failure to approve this request will result in potential loss of grant money due to expiration. The grant request was specific to the acquisition of Bruker MALDI TOF Systems. The Bruker MALDI TOF system utilizes time of flight mass spectrometry (TOF MS) compared biochemicals, which is the current identification method. TOF MS is a much quicker technique that requires a smaller amount of sample. The IDPH Labs will be unable to enroll in CDC's MicrobeNet to remotely identify unique pathogens. Additionally, the IDPH Labs will not be able to implement Botulism testing, which has been requested by IDPH Communicable Disease. The implementation of this methodology will allow the laboratory to perform more testing in-house, which will allow IDPH Communicable Disease to respond to outbreaks rapidly.

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

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Bulletin Reference Number 22-482DPH-HLTHP-B-27583

Requesting Agency/University Public Health

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 1/31/2022

Printed Name Kristin Goldesberry E-mail Address kristin.goldesberry@illinois.gov

Phone Number 217-524-6228

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 sarina.omalley@illinois.gov

Phone Number 217-782-4044 Date Mar 1, 2022

Printed Name Sarina O'Malley

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 217622-4035 Date Mar 1, 2022

Printed Name Dwayne Curry E-mail Address dwayne.curry@illinois.gov

Version 7.01 Page 5 of 5

Bulletin Reference Number 22-482DPH-HLTHP-B-27583

Requesting Agency/University Public Health

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

Project Title Bruker MALDI TOF

Vendor Bruker Scientific LLC

Initial Date of Procurement Bulletin Posting

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

Printed Name Date

CPO E-mail

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

MALDI BIOTYPER SIRIUS CA SYSTEM 3 EA $230,000.00 $690,000.00

MBT MYCOBACTERIA LIBRARY 1 EA $8,755.00 $8,755.00

SECURITY LIBRARY 2 EA $6,774.50 $13,549.00

MBT SUBTYPING MODULE 3 EA $3,430.00 $10,290.00

FREIGHT 3 EA $2,760.00 $8,280.00

GRAND TOTAL $730,874.00