DPH SSJF Roche .pdf

Sole Source Justification Form

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Bulletin Reference Number 25-482DPH-OFCDI-B-47257

Requesting Agency/University Illinois Department of Public Health

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

Department/Bureau/Section: Illinois Department of Public Health / Office of Disease Control / Division of Laboratories

Need Identified Date: 10/23/2025 Supply/Service Need By Date: 05/01/2025

Project Title: Sole Source Roche Instrument Warranty Maintenance

Vendor: Roche Diagnostics Corporation

Provide a description of the supplies or services required:

Roche Diagnostics Corporation (Roche) will provide a 36-month service agreement for the Illinois Department of Public Health Department of Laboratories (IDPH-DOL) 's ePlex—2 Tower instrument and MagNA Pure extraction systems. This agreement includes routine maintenance, emergency repairs, and manufacturer-certified technical support to ensure compliance with Clinical Laboratory Improvement Amendments (CLIA) regulations and uninterrupted laboratory operations. As the sole authorized service provider, Roche will perform all necessary servicing to maintain instrument accuracy, reliability, and regulatory compliance.

The contract covers multiple laboratory locations, including Chicago, Springfield, and Carbondale, and applies to the following instruments: ePlex - 2 Tower, MagNA Pure 96, and MagNA Pure 24 systems. These instruments are essential for high-throughput molecular diagnostics, supporting disease surveillance, outbreak response, and public health initiatives. This agreement ensures that IDPH-DOL laboratories remain fully operational and capable of delivering timely and accurate diagnostic testing to protect public health.

Value: Actual Value of Initial Term, this Change Order or Amendment: 223,916.4

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

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Bulletin Reference Number 25-482DPH-OFCDI-B-47257

Requesting Agency/University Illinois Department of Public Health

Section II - Proposed Term

One-Time Purchase Term Contract

Estimated Contract Begin Date: Jul 1, 2025

Estimated Contract End Date: Jun 30, 2028

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

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

A multi-year agreement addresses the critical need for uninterrupted operation of essential high-throughput molecular diagnostic testing instruments. These instruments enhance the Illinois Department of Public Health Division of Laboratories’ (IDPH-DOL) ability to conduct timely disease surveillance, respond effectively to emergency outbreaks, and provide rapid diagnostic results crucial for clinical decision-making and public health monitoring. Any disruption in service jeopardizes these core functions, potentially delaying critical interventions and hindering containment efforts.

A multi-year contract mitigates the following risks:

• Avoidance of escalating service and maintenance costs: Locking in a fixed cost for three-years shields IDPH-DOL from potential price hikes in labor, parts, and service fees. This ensures predictable resource allocation and prevents unexpected financial strain on the budget.

• Prevention of increased costs associated with emergency repairs: Consistent, proactive maintenance minimizes the likelihood of critical instrument failures. Emergency repairs are typically significantly more expensive than scheduled maintenance and can lead to prolonged downtime. A multi-year agreement incentivizes preventative care, reducing the risk of these costly and disruptive events.

• Ensured regulatory compliance: Maintaining these sophisticated instruments according to manufacturer specifications is paramount for compliance with Clinical Laboratory Improvement Amendments (CLIA) regulations. A dedicated service contract guarantees that the instruments are regularly inspected, calibrated, and serviced by qualified technicians, safeguarding IDPH-DOL’s accreditation and the reliability of test results.

• Streamlined operational efficiency across multiple locations: Covering seven MagNA Pure extraction systems and six ePlex - 2 Tower instruments across multiple IDPH-DOL Laboratory sites under a single contract simplifies service coordination, ensures consistent service quality, and reduces administrative burden.

• Long-term reliability and minimized downtime: Consistent maintenance extends the lifespan and reliability of these essential instruments. Predictable service schedules minimize potential downtime, ensuring continuous high-throughput testing capacity, which is vital for ongoing disease surveillance and rapid response capabilities.

Economic Benefit: A multi-year contract provides IDPH-DOL with a 10% discount, further enhancing the cost-effectiveness and value of this essential service agreement.

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)

Compatibility of Equipment, Accessories, Replacement Parts or Service

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

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Bulletin Reference Number 25-482DPH-OFCDI-B-47257

Requesting Agency/University Illinois Department of Public Health

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 05/07/2024 May 6, 2026 101,896.72 Roche Equipment Service & PM Contract 48500036L Sole Source

2 11/01/2021 11/01/2023 248,159.71 Roche Equipment Service & PM Contract 25500012J Exemption

3 Exemption

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:

The Illinois Department of Public Health Division of Labs (IDPH-DOL) requires a 36-month service contract with Roche Diagnostics Corporation (Roche) to maintain and support both ePlex - 2 Tower instrument and MagNA Pure extraction systems. These instruments are essential for high-throughput molecular diagnostic testing, enabling the detection of a wide range of pathogens, including those responsible for respiratory infections, bloodstream infections, and gastrointestinal illnesses.

Ensuring these instruments are properly maintained is critical for:

• Uninterrupted public health laboratory operations to support ongoing disease surveillance and emergency outbreak response.

• Timely disease diagnosis to allow for rapid medical interventions and containment strategies.

• Reduced test result turnaround times are essential for clinical decision-making and public health monitoring.

• Compliance with Clinical Laboratory Improvement Amendments (CLIA) regulations, ensuring all instruments operate within manufacturer specifications.

• Operational efficiency across multiple IDPH-DOL laboratory locations, including Chicago, Springfield, and Carbondale.

The contract includes comprehensive service coverage for seven (7) MagNA Pure extraction systems and one (1) ePlex—2 Tower instruments across multiple IDPH-DOL sites. The MagNA Pure 96 and 24 systems are used for nucleic acid extraction, a critical step in molecular testing workflows, while the ePlex - 2 Tower instrument provides fully automated sample-to-answer diagnostic testing.

Without these services, IDPH-DOL laboratories would experience instrument downtime, increased costs due to emergency repairs, and potential regulatory compliance risks, which would ultimately affect public health response capabilities and patient care.

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Bulletin Reference Number 25-482DPH-OFCDI-B-47257

Requesting Agency/University Illinois Department of Public Health

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

The procurement includes the following items, specifically designed for use with IDPH-DOL's existing Roche ePlex - 2 Tower instrument and Roche MagNA Pure extraction systems at Department’s laboratory facilities.

• Quantity One (1) Roche ePlex - 2 Tower Instrument: The procurement includes "Classic Plan" service agreements for one (1) specific ePlex - 2 Tower instrument, with three (3) individual parts identified by serial numbers 2042200984 (Base), 2042200994 (Tower), and 2128100843 (Tower), all located at the Carbondale laboratory. This automated system is vital for high-throughput, sample-to-answer diagnostic testing, directly supporting the detection of a wide array of pathogens critical for disease surveillance and outbreak response.

• Roche MagNA Pure Extraction Systems: The request also specifies "Classic Plan" service agreements for seven MagNA Pure extraction systems, crucial for the nucleic acid extraction step in the molecular testing workflow. These extraction systems are fundamental to preparing samples for downstream molecular analysis on the ePlex instruments.

Roche MagNA Pure Extraction Systems include:

o Two (2) MagNA Pure 96 systems with serial numbers 4912 and 5098, located at the Chicago laboratory.

o Two (2) MagNA Pure 24 systems with serial numbers 1327, 1328, located at the Chicago Laboratory.

o One (1) MagNA Pure 24 system with serial number 2288 located at the Carbondale Laboratory.

o Two (2) MagNA Pure 24 system with serial numbers 2312 and 2328, located at the Springfield Laboratory.

The "Classic Plan" ensures these complex instruments receive both routine preventative maintenance to minimize disruptions and responsive emergency repair services to address any malfunctions swiftly and ensures their consistent and reliable operation through scheduled maintenance and timely repairs.

The "Classic Plan" specification for both instrument types provides:

• Comprehensive Coverage: Including both routine and emergency maintenance, minimizing potential downtime of these mission-critical instruments.

• Guaranteed Repairs and Parts Replacement: Ensuring that any necessary repairs are conducted promptly using manufacturer-certified parts, maintaining the instruments' accuracy and reliability.

• Manufacturer-Trained Technicians: Access to Roche-certified technicians guarantees that all service and maintenance are performed by personnel with the specific expertise required for these sophisticated instruments, crucial for adhering to CLIA regulations and maintaining optimal performance.

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 ePlex system and MagNA Pure extraction instruments are proprietary to Roche, and only Roche-trained service engineers can perform manufacturer-approved maintenance and repair procedures. Roche is the sole manufacturer, distributor, and service provider for MagNA Pure 24, MagNA Pure 96, and ePlex instruments in the United States.

Key Reasons Why Only Roche Can Satisfy IDPH-DOL’s Service Needs

• Proprietary Technology: The ePlex and MagNA Pure systems utilize Roche-exclusive molecular diagnostic technology, requiring specialized service procedures and proprietary replacement parts that are not available from third-party providers.

• Regulatory Compliance: Under CLIA regulations (42 CFR § 493.1254), instruments must be serviced according to manufacturer specifications to maintain accuracy and reliability. Third-party servicing would violate regulatory requirements and compromise testing accuracy, leading to potential laboratory certification risks. (CLIA Regulations)

• No Authorized Distributors or Service Providers: Roche does not sell or authorize third-party service providers to maintain or repair ePlex or MagNA Pure systems. Using an unauthorized provider would void the manufacturer’s warranty and risk instrument failure, inaccurate test results, and laboratory downtime.

• Critical Public Health Role: These instruments are essential for IDPH-DOL’s high-throughput testing operations, supporting disease surveillance, outbreak response, and critical diagnostics. Any service disruption would delay test results, hinder disease containment efforts, and increase overall costs.

• Service Contract Coverage: The service agreements cover both ePlex - 2 Tower instruments and MagNA Pure extraction systems, ensuring continuous operation across multiple IDPH-DOL locations, including Chicago, Springfield, and Carbondale.

Without Roche’s manufacturer-certified servicing, IDPH-DOL would face regulatory non-compliance, increased downtime, and compromised diagnostic accuracy, ultimately impacting public health outcomes and emergency response capabilities. Roche remains the only vendor capable of meeting IDPH-DOL’s service and maintenance needs for these instruments.

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Bulletin Reference Number 25-482DPH-OFCDI-B-47257

Requesting Agency/University Illinois Department of Public Health

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 maintenance and service procedures required for the ePlex - 2 Tower instrument and MagNA Pure extraction systems are proprietary to Roche. The operator’s manual restricts critical maintenance and repair activities to Roche-certified engineers, ensuring compliance with Clinical Laboratory Improvement Amendments (CLIA) regulations.

According to 42 CFR § 493.1254, laboratories must perform maintenance and function checks as defined by the manufacturer and at the frequency specified. These function checks must be within the manufacturer’s established limits before conducting patient testing (CLIA Regulations).

Key factors that make Roche the only vendor capable of providing these services include:

• Exclusive Manufacturer Authorization: Roche does not authorize third-party service providers for ePlex and MagNA Pure instruments.

• Regulatory Compliance: Using unauthorized service providers would violate CLIA regulations, compromise instrument accuracy, and risk regulatory penalties.

• Specialized Diagnostic Capabilities: The MagNA Pure 96 and MagNA Pure 24 are essential for nucleic acid extraction in high-throughput infectious disease testing. The ePlex system provides multiplex PCR-based syndromic panel testing, which is critical for outbreak response.

• Instrument-Specific Components & Software: Only Roche-certified service technicians can access proprietary software updates, calibration tools, and replacement parts.

This service contract includes comprehensive coverage for seven MagNA Pure extraction systems and six ePlex - 2 Tower instrument across multiple IDPH-DOL laboratory locations, including Chicago, Springfield, and Carbondale.

Using an alternative vendor would void manufacturer warranties, increase downtime due to incompatible service procedures, and jeopardize public health testing operations. Roche remains the only vendor to meet IDPH-DOL’s service and maintenance requirements for these critical diagnostic instruments.

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?

No alternatives were considered because Roche is the sole manufacturer, distributor, and service provider for the ePlex - 2 Tower instrument and MagNA Pure extraction systems. These instruments are proprietary, and only Roche-certified service engineers are authorized to perform maintenance and repairs in compliance with Clinical Laboratory Improvement Amendments (CLIA) regulations.

According to 42 CFR § 493.1254, laboratories must perform maintenance and function checks as defined by the manufacturer and at the frequency specified by the manufacturer (CLIA Regulations). Using an alternative service provider would void manufacturer warranties, violate regulatory requirements, and compromise instrument performance, leading to inaccurate diagnostic results and potential laboratory certification risks.

Additionally, Roche does not authorize third-party service providers or resellers for its instruments, making competitive bidding infeasible. Attempting to replace these instruments with alternative systems would require the following:

• A complete overhaul of IDPH-DOL’s laboratory infrastructure, disrupting ongoing diagnostic testing.

• Extensive staff retraining, which would delay operations and increase costs.

• Loss of compatibility with existing testing protocols, potentially leading to disease surveillance and outbreak response gaps.

This service agreement includes comprehensive coverage for seven (7) MagNA Pure extraction systems and one (1) ePlex—2 Tower instruments, ensuring continued operation across multiple IDPH-DOL laboratory locations, including Chicago, Springfield, and Carbondale. Given these factors, no alternatives were considered because none meet IDPH-DOL’s regulatory, technical, and public health requirements.

6. Are there resellers or distributors?

Yes No N/A

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Bulletin Reference Number 25-482DPH-OFCDI-B-47257

Requesting Agency/University Illinois Department of Public Health

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?

Pricing is fixed and consistent with past Roche contracts, ensuring cost predictability for IDPH-DOL. Roche, as the sole provider, offers standardized pricing for service agreements, ensuring cost consistency.

Purchase is for the following items:

• Roche Service Plan: Classic Plan for ePlex - 2 Tower Instrument with three (3) individual parts identified by Serial Numbers: 2042200984 (Base), 2042200994 (Tower), 2128100843 (Tower) located at 1155 S Oakland Ave, Carbondale, IL 62901.

• Roche Service Plan: MagNA Pure 96 Extraction Systems Classic Service Plan for Serial Number: 4912 located at 2121 W Taylor St., Chicago, IL 60612.

• Roche Service Plan: MagNA Pure 96 Extraction Systems Classic Service Plan for Serial Number: 5098 located at 2121 W Taylor St., Chicago, IL 60612.

• Roche Service Plan: MagNA Pure 24 Classic Service Plan for Serial Number: 1327 located at 2121 W Taylor St., Chicago, IL 60612.

• Roche Service Plan: MagNA Pure 24 Classic Service Plan for Serial Number: 1328 located at 2121 W Taylor St., Chicago, IL 60612.

• Roche Service Plan: MagNA Pure 24 Classic Service Plan for Serial Number: 2288 located at 1155 S. Oakland Ave., Carbondale, IL 62901.

• Roche Service Plan: MagNA Pure 24 Classic Service Plan for Serial Number: 2312 located at 825 N. Rutledge St., Springfield, IL 62702.

• Roche Service Plan: MagNA Pure 24 Classic Service Plan for Serial Number: 2328 located at 825 N. Rutledge St., Springfield, IL 62702.

Overall Contract Details

• Term: 36 months (7/1/2025 – 6/30/2028)

• Total Combined Service Contract Cost: $223,916.40

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

Yes No

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?

IDPH-DOL would face significant financial and operational risks if this sole source procurement is not approved. Without a service agreement with Roche, the ePlex - 2 Tower instrument and MagNA Pure extraction systems would be left without proper maintenance, increasing the likelihood of equipment failures and operational downtime. This could severely disrupt laboratory testing, delaying critical diagnostic results for infectious diseases, including respiratory, bloodstream, and gastrointestinal infections. Such delays could hinder IDPH-DOL’s ability to respond effectively to outbreaks and public health emergencies, leading to increased disease spread and public health risks.

Additionally, failure to maintain the instruments according to manufacturer specifications would put IDPH-DOL in violation of Clinical Laboratory Improvement Amendments (CLIA) regulations, jeopardizing laboratory certification and compliance. Noncompliance could lead to regulatory penalties, the inability to conduct essential testing, and the potential loss of federal funding for public health initiatives.

Financially, if a competitive bid were required, IDPH-DOL could not secure equivalent maintenance services, as Roche is the sole provider authorized to service its proprietary instruments. Any attempt to use third-party service providers would void manufacturer warranties, leading to significantly higher long-term repair costs. Emergency service requests or the need to replace malfunctioning equipment could result in unplanned expenditures far exceeding the price of this sole source agreement.

Beyond financial implications, the inability to properly maintain these instruments could compromise public health and safety. Delays in detecting and responding to disease outbreaks could increase infection rates, strain healthcare systems, and undermine public confidence in the state’s ability to manage public health crises. Approving this sole source contract ensures that IDPH-DOL can continue providing timely, reliable testing while maintaining regulatory compliance and cost-effective operations.

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

NA

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Bulletin Reference Number 25-482DPH-OFCDI-B-47257

Requesting Agency/University Illinois Department of 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 May 29, 2025

Printed Name Leslie 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 Mike.Caceres@illinois.gov

Phone Number 217-559-7905 Date May 29, 2025

Printed Name Mike Caceres

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 217-299-5883 Date 05/29/2025

Printed Name Rebecca Gossett E-mail Address rebecca.gossett@illinois.gov

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Bulletin Reference Number 25-482DPH-OFCDI-B-47257

Requesting Agency/University Illinois Department of Public Health

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

Project Title

Vendor

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

The contract covers multiple laboratory locations, including Chicago, Springfield, and Carbondale, and applies to the following instruments: ePlex - 2 Tower, MagNA Pure 96, and MagNA Pure 24 systems. These instruments are essential for high-throughput molecular diagnostics, supporting disease surveillance, outbreak response, and public health initiatives. This agreement ensures that IDPH-DOL laboratories remain fully operational and capable of delivering timely and accurate diagnostic testing to protect public health.

A multi-year contract mitigates the following risks:

• Avoidance of escalating service and maintenance costs: Locking in a fixed cost for three-years shields IDPH-DOL from potential price hikes in labor, parts, and service fees. This ensures predictable resource allocation and prevents unexpected financial strain on the budget.

• Prevention of increased costs associated with emergency repairs: Consistent, proactive maintenance minimizes the likelihood of critical instrument failures. Emergency repairs are typically significantly more expensive than scheduled maintenance and can lead to prolonged downtime. A multi-year agreement incentivizes preventative care, reducing the risk of these costly and disruptive events.

• Ensured regulatory compliance: Maintaining these sophisticated instruments according to manufacturer specifications is paramount for compliance with Clinical Laboratory Improvement Amendments (CLIA) regulations. A dedicated service contract guarantees that the instruments are regularly inspected, calibrated, and serviced by qualified technicians, safeguarding IDPH-DOL’s accreditation and the reliability of test results.

• Streamlined operational efficiency across multiple locations: Covering seven MagNA Pure extraction systems and six ePlex - 2 Tower instruments across multiple IDPH-DOL Laboratory sites under a single contract simplifies service coordination, ensures consistent service quality, and reduces administrative burden.

• Long-term reliability and minimized downtime: Consistent maintenance extends the lifespan and reliability of these essential instruments. Predictable service schedules minimize potential downtime, ensuring continuous high-throughput testing capacity, which is vital for ongoing disease surveillance and rapid response capabilities.

Economic Benefit: A multi-year contract provides IDPH-DOL with a 10% discount, further enhancing the cost-effectiveness and value of this essential service agreement.

Ensuring these instruments are properly maintained is critical for:

• Uninterrupted public health laboratory operations to support ongoing disease surveillance and emergency outbreak response.

• Timely disease diagnosis to allow for rapid medical interventions and containment strategies.

• Reduced test result turnaround times are essential for clinical decision-making and public health monitoring.

• Compliance with Clinical Laboratory Improvement Amendments (CLIA) regulations, ensuring all instruments operate within manufacturer specifications.

• Operational efficiency across multiple IDPH-DOL laboratory locations, including Chicago, Springfield, and Carbondale.

The contract includes comprehensive service coverage for seven (7) MagNA Pure extraction systems and one (1) ePlex—2 Tower instruments across multiple IDPH-DOL sites. The MagNA Pure 96 and 24 systems are used for nucleic acid extraction, a critical step in molecular testing workflows, while the ePlex - 2 Tower instrument provides fully automated sample-to-answer diagnostic testing. Without these services, IDPH-DOL laboratories would experience instrument downtime, increased costs due to emergency repairs, and potential regulatory compliance risks, which would ultimately affect public health response capabilities and patient care.

Q2Answer: The procurement includes the following items, specifically designed for use with IDPH-DOL's existing Roche ePlex - 2 Tower instrument and Roche MagNA Pure extraction systems at Department’s laboratory facilities.

• Quantity One (1) Roche ePlex - 2 Tower Instrument: The procurement includes "Classic Plan" service agreements for one (1) specific ePlex - 2 Tower instrument, with three (3) individual parts identified by serial numbers 2042200984 (Base), 2042200994 (Tower), and 2128100843 (Tower), all located at the Carbondale laboratory. This automated system is vital for high-throughput, sample-to-answer diagnostic testing, directly supporting the detection of a wide array of pathogens critical for disease surveillance and outbreak response.

• Roche MagNA Pure Extraction Systems: The request also specifies "Classic Plan" service agreements for seven MagNA Pure extraction systems, crucial for the nucleic acid extraction step in the molecular testing workflow. These extraction systems are fundamental to preparing samples for downstream molecular analysis on the ePlex instruments.

Roche MagNA Pure Extraction Systems include:

o Two (2) MagNA Pure 96 systems with serial numbers 4912 and 5098, located at the Chicago laboratory.

o Two (2) MagNA Pure 24 systems with serial numbers 1327, 1328, located at the Chicago Laboratory.

o One (1) MagNA Pure 24 system with serial number 2288 located at the Carbondale Laboratory.

o Two (2) MagNA Pure 24 system with serial numbers 2312 and 2328, located at the Springfield Laboratory.

The "Classic Plan" ensures these complex instruments receive both routine preventative maintenance to minimize disruptions and responsive emergency repair services to address any malfunctions swiftly and ensures their consistent and reliable operation through scheduled maintenance and timely repairs.

The "Classic Plan" specification for both instrument types provides:

• Comprehensive Coverage: Including both routine and emergency maintenance, minimizing potential downtime of these mission-critical instruments.

• Guaranteed Repairs and Parts Replacement: Ensuring that any necessary repairs are conducted promptly using manufacturer-certified parts, maintaining the instruments' accuracy and reliability.

• Manufacturer-Trained Technicians: Access to Roche-certified technicians guarantees that all service and maintenance are performed by personnel with the specific expertise required for these sophisticated instruments, crucial for adhering to CLIA regulations and maintaining optimal performance.

Q3Answer: The ePlex system and MagNA Pure extraction instruments are proprietary to Roche, and only Roche-trained service engineers can perform manufacturer-approved maintenance and repair procedures. Roche is the sole manufacturer, distributor, and service provider for MagNA Pure 24, MagNA Pure 96, and ePlex instruments in the United States.

Key Reasons Why Only Roche Can Satisfy IDPH-DOL’s Service Needs

• Proprietary Technology: The ePlex and MagNA Pure systems utilize Roche-exclusive molecular diagnostic technology, requiring specialized service procedures and proprietary replacement parts that are not available from third-party providers.

• Regulatory Compliance: Under CLIA regulations (42 CFR § 493.1254), instruments must be serviced according to manufacturer specifications to maintain accuracy and reliability. Third-party servicing would violate regulatory requirements and compromise testing accuracy, leading to potential laboratory certification risks. (CLIA Regulations)

• No Authorized Distributors or Service Providers: Roche does not sell or authorize third-party service providers to maintain or repair ePlex or MagNA Pure systems. Using an unauthorized provider would void the manufacturer’s warranty and risk instrument failure, inaccurate test results, and laboratory downtime.

• Critical Public Health Role: These instruments are essential for IDPH-DOL’s high-throughput testing operations, supporting disease surveillance, outbreak response, and critical diagnostics. Any service disruption would delay test results, hinder disease containment efforts, and increase overall costs.

• Service Contract Coverage: The service agreements cover both ePlex - 2 Tower instruments and MagNA Pure extraction systems, ensuring continuous operation across multiple IDPH-DOL locations, including Chicago, Springfield, and Carbondale.

Without Roche’s manufacturer-certified servicing, IDPH-DOL would face regulatory non-compliance, increased downtime, and compromised diagnostic accuracy, ultimately impacting public health outcomes and emergency response capabilities. Roche remains the only vendor capable of meeting IDPH-DOL’s service and maintenance needs for these instruments.

Q4Answer: The maintenance and service procedures required for the ePlex - 2 Tower instrument and MagNA Pure extraction systems are proprietary to Roche. The operator’s manual restricts critical maintenance and repair activities to Roche-certified engineers, ensuring compliance with Clinical Laboratory Improvement Amendments (CLIA) regulations.

According to 42 CFR § 493.1254, laboratories must perform maintenance and function checks as defined by the manufacturer and at the frequency specified. These function checks must be within the manufacturer’s established limits before conducting patient testing (CLIA Regulations).

Key factors that make Roche the only vendor capable of providing these services include:

• Exclusive Manufacturer Authorization: Roche does not authorize third-party service providers for ePlex and MagNA Pure instruments.

• Regulatory Compliance: Using unauthorized service providers would violate CLIA regulations, compromise instrument accuracy, and risk regulatory penalties.

• Specialized Diagnostic Capabilities: The MagNA Pure 96 and MagNA Pure 24 are essential for nucleic acid extraction in high-throughput infectious disease testing. The ePlex system provides multiplex PCR-based syndromic panel testing, which is critical for outbreak response.

• Instrument-Specific Components & Software: Only Roche-certified service technicians can access proprietary software updates, calibration tools, and replacement parts.

This service contract includes comprehensive coverage for seven MagNA Pure extraction systems and six ePlex - 2 Tower instrument across multiple IDPH-DOL laboratory locations, including Chicago, Springfield, and Carbondale.

Using an alternative vendor would void manufacturer warranties, increase downtime due to incompatible service procedures, and jeopardize public health testing operations. Roche remains the only vendor to meet IDPH-DOL’s service and maintenance requirements for these critical diagnostic instruments.

Additionally, Roche does not authorize third-party service providers or resellers for its instruments, making competitive bidding infeasible. Attempting to replace these instruments with alternative systems would require the following:

• A complete overhaul of IDPH-DOL’s laboratory infrastructure, disrupting ongoing diagnostic testing.

• Extensive staff retraining, which would delay operations and increase costs.

• Loss of compatibility with existing testing protocols, potentially leading to disease surveillance and outbreak response gaps.

This service agreement includes comprehensive coverage for seven (7) MagNA Pure extraction systems and one (1) ePlex—2 Tower instruments, ensuring continued operation across multiple IDPH-DOL laboratory locations, including Chicago, Springfield, and Carbondale. Given these factors, no alternatives were considered because none meet IDPH-DOL’s regulatory, technical, and public health requirements.

Purchase is for the following items:

• Roche Service Plan: Classic Plan for ePlex - 2 Tower Instrument with three (3) individual parts identified by Serial Numbers: 2042200984 (Base), 2042200994 (Tower), 2128100843 (Tower) located at 1155 S Oakland Ave, Carbondale, IL 62901.

• Roche Service Plan: MagNA Pure 96 Extraction Systems Classic Service Plan for Serial Number: 4912 located at 2121 W Taylor St., Chicago, IL 60612.

• Roche Service Plan: MagNA Pure 96 Extraction Systems Classic Service Plan for Serial Number: 5098 located at 2121 W Taylor St., Chicago, IL 60612.

• Roche Service Plan: MagNA Pure 24 Classic Service Plan for Serial Number: 1327 located at 2121 W Taylor St., Chicago, IL 60612.

• Roche Service Plan: MagNA Pure 24 Classic Service Plan for Serial Number: 1328 located at 2121 W Taylor St., Chicago, IL 60612.

• Roche Service Plan: MagNA Pure 24 Classic Service Plan for Serial Number: 2288 located at 1155 S. Oakland Ave., Carbondale, IL 62901.

• Roche Service Plan: MagNA Pure 24 Classic Service Plan for Serial Number: 2312 located at 825 N. Rutledge St., Springfield, IL 62702.

• Roche Service Plan: MagNA Pure 24 Classic Service Plan for Serial Number: 2328 located at 825 N. Rutledge St., Springfield, IL 62702.

Overall Contract Details

• Term: 36 months (7/1/2025 – 6/30/2028)

• Total Combined Service Contract Cost: $223,916.40

Additionally, failure to maintain the instruments according to manufacturer specifications would put IDPH-DOL in violation of Clinical Laboratory Improvement Amendments (CLIA) regulations, jeopardizing laboratory certification and compliance. Noncompliance could lead to regulatory penalties, the inability to conduct essential testing, and the potential loss of federal funding for public health initiatives.

Financially, if a competitive bid were required, IDPH-DOL could not secure equivalent maintenance services, as Roche is the sole provider authorized to service its proprietary instruments. Any attempt to use third-party service providers would void manufacturer warranties, leading to significantly higher long-term repair costs. Emergency service requests or the need to replace malfunctioning equipment could result in unplanned expenditures far exceeding the price of this sole source agreement.

Beyond financial implications, the inability to properly maintain these instruments could compromise public health and safety. Delays in detecting and responding to disease outbreaks could increase infection rates, strain healthcare systems, and undermine public confidence in the state’s ability to manage public health crises. Approving this sole source contract ensures that IDPH-DOL can continue providing timely, reliable testing while maintaining regulatory compliance and cost-effective operations.