Vendor Questions and Answers - B-46893 LIMS RFP FINAL.docx
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- Attached to
- Laboratory Information Management System RFP
- Solicitation number
- 25-448DOIT-ADMIN-B-46893
- Issued by
- St. Clair County, Illinois
About this file
This document is a Vendor Questions and Answers addendum for the Illinois Department of Innovation and Technology (DoIT) Laboratory Information Management System (LIMS) Request for Proposal (RFP), BidBuy # 25-448DOIT-ADMIN-B-46893. The RFP seeks a comprehensive LIMS solution to replace the current STARLIMS and paper-based systems, with proposals due on April 24, 2025. The project requires a cloud-hosted system supporting multiple testing domains including Arbovirus, Blood Lead, Enteric, Whole Genome Sequencing, and Influenza, with capabilities for specimen intake, sample tracking, test result processing, and comprehensive reporting. The implementation timeline is set at 12 months, with 150 concurrent users expected to access the system, and the current database size is 376GB.
The procurement includes a 10% Business Enterprise Program (BEP) goal, targeting minority, women, and disabled-owned businesses, with an estimated contract value of $2,000,000. Vendors must provide detailed pricing across project phases, including project management, implementation, data migration, training, SaaS provisioning, maintenance, and ongoing support. The system must meet extensive security requirements, including compliance with HIPAA, NIST, and other federal and state regulations. Evaluation will be based on technical capabilities, system functionality, and alignment with a detailed traceability matrix, with a total possible scoring of 1,944 points across technical, diversity, and price categories. Gartner Consulting was engaged to assist with RFP development, and the Department of Innovation & Technology (DoIT) will manage the implementation.
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JB PRITZKER
Governor
SANJAY GUPTA
Acting Secretary
STATE OF ILLINOIS
Department of innovation and technology
DoIT.illinois.gov
Vendor Question & Answers Laboratory Information Management System RFP BidBuy # 25-448DOIT-ADMIN-B-46893
DoIT is publishing an addendum to BidBuy 25-448DOIT-ADMIN-B-46893 entitled “Vendor Questions & Answers 4/11/2025” based on questions received from potential offerors and answers provided by the agency.
The Bid Opening Date for this solicitation is Thursday, April, 24, 2025 at 2:00 p.m.
| Q# |
| Vendor Question |
| Agency Response |
| 1 |
| Vendor would like to NBS-only bid. Can you please advise: |
1. Have you seen anything preventing this approach?
2. Have you seen anything on “Add/Alternates” called out?
3. Have you seen anything preventing us from submitting two proposals?
An NBS-only bid will not be accepted as it does not meet the program's needs. The lab is looking for a LIMS that can accommodate all clinical and environmental testing. Inclusion of NBS testing is preferred but not required. An NBS-only bid does not meet the needs of the program.
| 2 |
| In Section F.1 Mandatory Requirements Without Evidence, #18, we maintain encryption keys for multiple clients that meet or exceed FIPS 140 requirements. It is not a standard practice to grant access to the KMS systems for clients. |
Please clarify specifically what information system access you require to meet this criteria.
Is this access to the encryption keys for auditing purposes or to manipulate/manage? Which users or groups will need to be granted this access? Upon request, we can provide screenshots of encryption status and settings without granting access.
Mandatory Requirement without Evidence #18 is to ensure that the encryption of State of Illinois data at rest and in motion complies with encryption security controls defined in the most current version of FIPS 140. This would be for auditing purposes, and advanced maintenance needs. This will not be for regular maintenance and data manipulation. LIMS administrators will require key to view data at rest.
| 3 |
| In Attachment G-Traceability-Matrix, Tab 4. Desirable Business Fn., B18, please clarify what is meant by “perform test planning.” |
| Test planning refers to the ability of the LIMS to perform calculations related to workflows and, based on test performed, be able to integrate with analytical instruments to calculate quantitative measurements (concentrations) or qualitative measurements (presence/absence) based on predetermined established values. |
| 4 |
| In Attachment G-Traceability-Matrix, Tab 4. Desirable Business Fn., B53, please clarify what type of documentation is referred to in “consolidate product sample data and documentation.” |
| The LIMS system should be able to capture test reagent information (i.e. product description, lot numbers, expiration dates) and provide an inventory breakdown of what has been entered, used, expired, and is available for use (not expired). |
| 5 |
| In Attachment G-Traceability-Matrix, Tab 5. Desirable Technical Fn., Line 68 and 69 in General System Behavior, please clarify what is meant by “consent audit trails”, and “consent audit events”, respectively. |
| Audit trails are required to track any/all changes conducted during pre-analytic, analytic, and post-analytic changes processes. |
Line 68 refers to the LIMS system tracking those changes and the inability to turn-off audit tracking by any user other than an administrator of the system.
Line 69 refers to the ability of the LIMS administrator to archive/remove test data from the system based on current regulations set forth by CLIA (42 CFR 493) and State retention requirements.
| 6 |
| Can the State share the reason that this RFP was re-released? Was there an issue with the earlier RFP? |
| No issues with, or changes to, the RFP solicitation. |
Pursuant to JCAR Title 44 1.2040 (b) (e) – “Cancellation of Solicitation; Rejection of All Bids or Proposals” - The solicitation did not provide for consideration of all factors of significance to the State.
Therefore, the State canceled this solicitation according to JCAR Title 44 1.2040 (b) (e).
| 7 |
| In Tab 5. Desirable Technical Fn., System Technology, Scalability and Extensibility, regarding support for Advanced Molecular Detection (AMD), we would like to submit the following questions: |
· Please define what is meant by “Advanced Molecular Detection” in the context of this RFP. Are there specific technologies, assays, or methodologies being referenced (e.g., PCR, next-generation sequencing, metagenomics, etc.)?
· What specific AMD workflows are expected to be supported by the LIS? For example, are you seeking support for instrument integration, data management, results interpretation, reporting, or a combination of these?
· Are you expecting the LIS to support only FDA-approved assays, or should it also be capable of supporting laboratory-developed tests (LDTs)?
· Will the LIS be required to interface with specific molecular instrumentation (e.g., ThermoFisher QuantStudio, Illumina, Roche, etc.)? If so, please specify which platforms.
· Is there a requirement for public health or epidemiological reporting capabilities in connection with AMD workflows?
· Are there expectations around scalability in testing volume related to AMD, and if so, can you provide estimates for future capacity or throughput?
Advanced Molecular Detection testing includes Nucleic Acid Amplification Assays, Next-generation/Whole genome sequencing, and. The lab desires a system that can handle all aspects of testing including instrument interface, data management, results interpretation, and reporting. This LIS should be able to support LDTs and FDA-approved assays. Specimen sample volumes vary based upon outbreaks. The LIMS should be able to process/handle large volumes of molecular testing for each analyte tested / infectious disease pathogen.
Ideally, all instruments need to be interfaced with the LIMS system. We have a current list of instrumentation but we are also acquiring new instrumentation as well. The LIMS should have the ability to directly integrate with laboratory equipment, regardless of type.
There is a need for epidemiological reporting.
| 8 |
| Please confirm if it is acceptable for the State to use the Attachment E - Reference Questionnaires that were completed by our references for the prior RFP, rather than require them to complete and submit all new forms again. |
| New forms will need to be completed for Attachment E. The “Attachment E – Reference” for this RFP will have a different BidBuy reference number on the top of the document. The prior “Attachment E – Reference” cannot be used, as it references the prior BidBuy reference number. |
| 9 |
| What was the specific rationale that led to the SPO determining that terminating the original Solicitation under 1.2040 b) 1), and subsequently reissuing the Solicitation under a different number? |
Please see response to Question #6.
| 10 |
| What has changed under the new solicitation compared to the original solicitation, to prevent the issues that couldn't be cured? |
| Please see response to Question #6. |
| 11 |
| If not all vendors were deemed not responsive, why weren't individual proposals rejected pursuant to 1.2040 c)? |
| Pursuant to Section “C.8 AWARD” of the solicitation: The State is not obligated to award a contract pursuant to this solicitation. |
| 12 |
| In that it is not cost effective for the State, nor practical for the ongoing relationship (in terms of scope), will IL consider reducing the BEP goal to 5% and limit the requirement only to the implementation period of the anticipated contract? |
| The BEP goal was carefully considered in formulating this RFP. Given the nature of the contract, which includes Software and Services, there are viable areas for BEP participation, such as Project Management, Training, Technical Design, Development, Configuration, and Testing. The estimated contract value is $2,000,000, and the Department of Innovation & Technology (DoIT) believes that a 10% goal; equating to $200,000 over the life of the contract is reasonable. |
If a vendor believes that meeting the BEP goal is not feasible, they must demonstrate a good faith effort by submitting a Utilization Plan and Participation Agreement(s), along with a full or partial waiver request (Part III of the U-Plan) This must outline the steps taken to include BEP vendors and explain why full participation was not achievable. Therefore, rather than reducing the BEP goal to 5% or limiting it to only the implementation phase, vendors are encouraged to engage BEP vendors where possible and follow the established waiver process if necessary.
| 13 |
| What consulting firm(s) has IL engaged to assist with the RFP development and selection process? |
| Gartner Consulting |
| 14 |
| What consulting firm(s) has IL engaged to assist with the implementation of the new LIMS? |
| State of Illinois Department of Information Technology (DoIT) will function as the project manager for the LIMS implementation. |
| 15 |
| Can the State clarify the math in the following: |
D.5 PRICE
The State opens Price proposals after evaluating all Technical and Commitment to Diversity proposals.
If the State does not consider the price to be fair and reasonable and negotiations fail to meet an acceptable price, the State reserves the right to cancel the award and take appropriate action to meet the needs of the State. The State determines whether the price is fair and reasonable by considering the offer, including the offeror's qualifications, the offeror's reputation, all price proposals submitted, other known prices, the project budget, and other relevant factors.
D.5.1 The total number of points for Price is three hundred sixty (324).
D.5.2 The State will determine Price points using the following formula:
Maximum Price Points X (Lowest Price/Offeror’s Price) = Total Price Points
D.6 MAXIMUM AVAILABLE POINTS
The maximum number of points is 1,350 (Technical) + 270 (Commitment to Diversity) + 324 (Price) = 2,160 maximum available points.
1) D.5.1. needs to be updated to “three hundred twenty-four”.
2) The maximum available points should be updated to 1,944.
MAXIMUM AVAILABLE POINTS
The maximum number of points is calculated as follows:
· Technical: X
· Commitment to Diversity: Y=20%×X
· Price: C=20% × (X+Y) The total maximum available points P is:
P=20% ×(X+Y+C) For example, if the points are:
Technical: 1,350 Commitment to Diversity: 270 (which is 20% of 1,350) Price: 324 (which is 20% of (1,350 + 270))
Then, the total maximum available points would be:
1,350+270+324=1,944
| 16 |
| Concerning the requirement to submit a signed BAA with the proposal package (RFP Sections C.1 and G): |
In that the Business Associate Agreement terms are somewhat overreaching and dependent upon there being an underlying agreement, which is not fully contemplated at the point at which responses to the RFP are being made, will the state consider modifying the requirement to return a signed Business Associate Agreement with the proposal package and instead align the BAA requirements with such same requirements for the Information and Technology Standard Terms and Conditions, in BidBuy as follows:
: Select “Yes,” “No,” or “Yes with Exceptions” Note: If taking any exceptions to Information and Technology Standard Terms and Conditions, and/or the Business Associate Agreement, an offeror must submit a redline version of the Information and Technology Standard Terms and Conditions, and or the Business Associate Agreement, with their proposal.
Yes, the state is open to considering modifications to the requirement of returning a signed Business Associate Agreement (BAA) with the proposal package. We understand that the BAA terms are dependent on an underlying agreement that may not be fully contemplated during the RFP response stage. Therefore, aligning the BAA requirements with the Information and Technology Standard Terms and Conditions in BidBuy is acceptable. Offerors must submit a redlined version of the Information and Technology Standard Terms and Conditions, and/or the Business Associate Agreement with their proposal, which will allow for a more tailored approach to meet the specific needs and circumstances of each proposal.
| 17 |
| Would an 18-month implementation timeline, in lieu of the requested 12-month, preclude a vendor from consideration? |
| Yes, an 18-month implementation timeline would preclude the vendor from consideration. |
| 18 |
| What is your existing LIMS database size? |
| Current system is using 376GB. |
| 19 |
| How many employees are using the LIMS at the same time (concurrent users)? |
| 150 individual users (testing, administrative, and office staff) must be able to access the LIMS at the same time. |
With the recent grant funding cuts from CDC, is this project in jeopardy?
Speculation of this question is outside the scope of the current RFP.
| 21 |
| Please describe a ‘test profile’ from the Traceability Matrix, Desirable Business Functions, ID # B17. |
A LIMS test profile is where the analyst inputs and manages results for a specific test performed on a sample.
| 22 |
| Please describe ‘The solution should perform test planning’ from the Traceability Matrix, Desirable Business Functions, ID # B18 |
| See response in Question 3. |
| 23 |
| Please describe the type of data that will be migrated on this project. Is the data sample/patient/test result data? |
Sample, Test, Result, and QA related data.
| 24 |
| The Traceability Matrix, Desirable Business Functions, ID # B34 and B35 references ‘support electronic messaging/notifications’. Is this an email notification or an internal system notification for the lab user? Or is this an electronic notification to the submitter? |
The proposed solution should support electronic messaging and notifications to all users of the system identified and described in the RFP.
This would include Interface messaging in HL7 format, Exports and reports in a variety of formats, and internal and external notifications using Email or other messaging tools.
| 25 |
| Please further describe ‘The solution should use fully configurable reports to create the laboratory results to be sent to the submitters’. Are there segments of the reports that require configuration? |
Reports will need to be able to be customized to accommodate the needs of the tests, CLIA regulations, and IDPH Program needs to accommodate and report the most accurate and complete information.
| 26 |
| Please define the type of file in this requirement ‘The solution should be able to select tests for diversion to CDC or a referral laboratory and create a file of diverted tests. The system should have the capability to create packing lists and other documentation for diverted tests.’ |
System should be able to create Sendout Tests and create shipping and packing lists of related samples for sending to external laboratories, including to the CDC.
The types of files in this requirement include but are not limited to:
1. HL7 (Health Level 7) Files
2. CDA (Clinical Document Architecture) Files
3. Packing List Files (PDF, Excel, Word)
4. CSV (Comma-Separated Values) Files
5. PDF (Portable Document Format) Files” The System should be able to create Send out Tests and create shipping and packing lists of related samples for sending to external laboratories, including to the CDC.”
| 27 |
| Please further describe ‘The solution should allow health care providers to manage newborn screening results’. What do you mean by manage? Are you referring to health care providers internal to the department or an external provider? |
This would be to provide the ability for external providers to review results either through a direct messaging interface, or web-based client with proper authentication methods.
| 28 |
| Traceability Matrix, Desirable Business Functions, Integrate Devices, ID# 105: ‘The solution should offer data trending and tracking of specific metrics with statistical analysis of routine data collection and control charts.’ Is this specifically referencing QC coming from the instrument via an instrument interface? |
This would refer to QC results as well as internal metrics including Turnaround time, and productivity metrics.
| 29 |
| Traceability Matrix, Service Requirements, ID# TE-5: Is the vendor obligated to provide automated testing licenses to IL IT to run automated testing cases? |
Yes, the vendor should provide automated testing tools and procedures as stated in the Service Requirements, ID# TE-5 requirement.
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