Addendum 1 Questions and Responses.pdf

Addendum 1

COLORADO DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT

SOLICITATION QUESTIONS AND ANSWERS

Solicitation #: RFI 2027*011 Solicitation Name: Laboratory Information Management System

Vendor Question #1: Is the State able to provide the name of the current LIMS vendor or any information on the existing contract supporting the Newborn Screening Program?

CDPHE Answer #1: Revvity, Specimen Gate with Screening Center.

Vendor Question #2: Is the State able to provide an anticipated budget or estimated cost range for the replacement LIMS, including implementation and ongoing maintenance?

CDPHE Answer #2: The primary purpose of this RFI is to get an expected cost range for this project.

This will allow the program to work towards meeting the programs financial needs. The vendors response should not be based on our budget but what they will charge to meet our requirements.

Once funds are identified for the project, a budget will be established in the RFP for the program and State requirements.

Vendor Question #3: If the State moves forward with a formal solicitation, does it have an anticipated timeframe for issuing the procurement?

CDPHE Answer #3:

Q1 (July-August) or Q2 (September-October) of 2027

Vendor Question #4: Exhibit A, General section, asks the LIMS vendor to support data migration from the legacy LIMS (including dual-entry testing) and to provide the Master Test Plan covering UAT, system integration testing and performance testing.

Question: Will the State accept a response that addresses only independent verification of the data migration and pre-go-live validation testing, separate from the LIMS vendor? Or does the State expect those services to come only from the LIMS vendor?

CDPHE Answer #4:

Yes, this could be completed by a 3rd party The State will accept independent data migration processes as long as the work is included in the estimated budget.

Vendor Question #5: Please provide your test compendium or, if the complete compendium is not available, the number and types of testing the laboratory performs?

CDPHE Answer #5: Included as Addendum 1a 2026 CONBS Testing Menu With Assays

Vendor Question #6: What is the size of the current database?

CDPHE Answer #6: This system consists of 9 databases totalling approximately 1.5 Tb in size. Note this does not include the archived reports which total approximately 8 Tb.

Vendor Question #7: Please describe your reporting and data-delivery requirements, including operational reports, analytical reports, and regulatory or compliance reports, certificates/results reports, as applicable. Please provide representative examples of current report formats, templates, or required output files, and identify any reports or deliverables that must conform to a prescribed client, regulatory agency, or third-party format.

CDPHE Answer #7: The reporting format currently is through a web based portal with downloadable PDFs. In addition HL7 messaging is sent out to Colorado’s Health Information Exchange (HIE) and select hospitals.

Vendor Question #8: Is there a desired contract award and go-live date?

CDPHE Answer #8: We desire this contract to be awarded Q2 2027 and expect implementation to take approximately 2 years.

Vendor Question #9: How many laboratory facilities are covered by this RFP? If more than one, how many of those locations perform lab work? If there are multiple Labs, will the database be shared or is a separate instance for each lab required?

CDPHE Answer #9: This will cover one (1) location.

Vendor Question #10: What is the client's preferred deployment strategy (Big Bang, phased deployment by location or department, etc.)?

CDPHE Answer #10: The program would prefer phased deployment (instrument integration, result review, sample receiving, reporting..). This will aid with staffing for UAT for program.

Vendor Question #11: How many users will access the LIMS? Of those, how many are anticipated to be using at the same time (concurrent users)?

CDPHE Answer #11:

25 concurrent users, not including web clients. The system will have heavy usage in the morning for data entry, result review and sample preparation.

Vendor Question #12: What is the current LIMS being used today?

CDPHE Answer #12: Revvity, Specimen Gate with Screening Center.

Vendor Question #13: Are there any desired 3rd party integrations?

CDPHE Answer #13: Yes, integrations with birth centers.

Vendor Question #14: General: How many of each instrument type are in the lab?

CDPHE Answer #14: QSight 210 -2, QSight 225-2, Revvity GSP -3, LaCAR Seeker - 2/4 unit systems, BioRad VNBS HPLC -3, QuantStudio 12k flex - 4, Panthera Punchers-4

Vendor Question #15: General: Can the State confirm the number of concurrent users and their role?

CDPHE Answer #15: 25 concurrent users, not including web clients

Vendor Question #16: Exhibit A LIMS Requirement: Pre-Analytical - Barcode Validation: Instrument load lists must be validated against physical barcodes during the loading process to ensure sample integrity.

Could the State please clarify the expected loading process?

Does the State expect the instrument to validate the barcodes on the plate against the plate number contained in the load list file generated by OMNI-Lab? Or is a different validation process expected during plate loading?

CDPHE Answer #16: The State’s expectation is that the system can read and digest the barcode providing a chain of custody for the plate along with the sample on the plate.

Vendor Question #17: Exhibit A LIMS Requirement: Instrumentation - Native Instrument Drivers: System must include intefaces for data ingestion from GSP, MS/MS, and NexGen Sequencing (NGS) platforms.

Could the State please clarify whether it currently has an established NGS pipeline?

Additionally, for the NGS data ingestion requirement, is the expectation to import data from a structured file format such as CSV, or from outputs generated by the bioinformatics pipeline, such as

JSON files? Understanding the expected data source and format will help us better assess the integration requirements.

CDPHE Answer #17: The current NGS pipeline is a laboratory developed test that is run on Illumina systems and processed through Qiagen CLC Genomics software for analysis. Data is manually entered into the current LIMS. It would be preferred if the proposed application would accept QC data and results from the Qiagen software.

Vendor Question #18: Exhibit A LIMS Requirement: Reagent and Consumable Tracking - Barcode-Driven Inventory Ingestion: Support for scanning manufacturer barcodes (GS1 or 2D) to instantly add new shipments into the LIMS inventory.

Is the requirement simply to capture the kit lot number and expiration date in the LIMS by scanning the barcode on the kit packaging, or are there additional data elements that should also be imported and tracked through the barcode scan process?

CDPHE Answer #18: The focus is on traceability of reagents and consumables including compiled reagents. Example primers and probes with individual lots are combined to make a working qPCR lot.

The system would be able to track the individual lots and expiration dates used to create the working lot and expiration date. System would flag and prevent use of the reagent prior to acceptance of reagent QC testing and reagent expiration.

Vendor Question #19: Exhibit A LIMS Requirement: Reagent and Consumable Tracking - Vendor Catalog Integration: Ability to import or sync supply l.ists from major NBS vendors (e.g., Revvity, Waters) for simplified ordering.

Could state clarify "for simplified ordering"? Does the intention to be able to track what is low in the laboratory so they can be ordered?

CDPHE Answer #19: This is to manage the inventory process from placing the order through receipt at the lab and generating individual LIMS lots for traceability. Some functionality to reconcile inventory is desired.

Vendor Question #20: Reporting: Requirement: Branded PDF Generation: System must generate high-fidelity, laboratory-branded PDF reports that are stored permanently and are tamper-proof.

Please clarify the intended meaning of “tamper-proof” as it relates to laboratory-branded PDF reports.

Specifically, what are the expectations for protection against modification after report generation?

CDPHE Answer #20: The LIMS should securely store a copy of all generated reports for verification against any modification made after delivery.

Vendor Question #21: Exhibit A LIMS Requirements, Row 23 Requirement: “Implementation Support:

Vendor must support the full transition from legacy LIMS, including data migration strategies and dual-entry testing.”:

Can more information be provided related to the scope of data migration?

Can we please receive clarification as to how many years of data is required to be migrated.

Is it acceptable that migrated data is searchable/viewable only, or is there a requirement to be able to take action/modify migrated data?

CDPHE Answer #21: We require migrated reports to be searchable and viewable from within the application

Vendor Question 22: Exhibit A LIMS Requirements, Row 100 Requirement: “System must track, manage, and report on test requests/specimens forwarded to external reference laboratories.”:

Is this related to sending a specimen for second tier testing at an external lab and needing to be able to track that the specimen was sent, receive a result, and report that result?

CDPHE Answer #22: Yes. The system should be able to accept scanned reports from outside testing facilities to link to the newborns record.

Vendor Question #23: Scope: Is the State seeking replacement of only the Newborn Screening LIMS, or a broader LIMS platform that could support additional laboratory programs in the future?

CDPHE Answer #23: This solicitation specifically focuses on newborn screening testing

Vendor Question #24: Scope: Will the new NBS solution be expected to integrate with other Laboratory Services Division systems? If so, which ones?

CDPHE Answer #24: It is preferred that the system allows for CDPHE vital records link, REDCap, and epidemiologist systems.

Vendor Question #25: Scope: The CDPHE laboratory performs newborn screening for Wyoming. Should the solution support multi-jurisdiction requirements, such as state-specific panels, fees, consent rules, reporting, and billing? Are any other jurisdictions or partner states anticipated?

CDPHE Answer #25: It is preferred there is a billing component. Currently we do not have state-specific panels, consent rules and reporting. It would be preferred to have panel flexibility in the system.

Vendor Question #26: Scope: Are there planned panel additions, or plans to expand molecular, genomic, or NGS workflows, within the next five years that should be considered?

CDPHE Answer #26: Yes the system should be able to be updated to meet the growing needs of the program related to NBS, new conditions, new instruments, and disorders. A budget line for ongoing additions should be included.

Vendor Question #27: Scope: What are the primary pain points or limitations driving replacement of the current system?

CDPHE Answer #27: State IT concerns about hosting failure on State servers (one State data center), State accessibility legislation, compatibility with Windows updates, compatibility with server updates, security (multifactor) and architecture of deployed system.

Vendor Question #28: Current Environment and Sizing: What is the current NBS LIMS platform and version, and what systems currently exchange data with it?

CDPHE Answer #28: Current environment is locally deployed on State servers and individual user computers. Revvity, Specimen Gate, with Screening Center. Data exchange with vital records, Contexture (HIE), and local birthing centers.

Vendor Question #29: Current Environment and Sizing: Which components of the current environment are expected to be replaced by the new solution versus retained? This includes the existing provider portal, Tableau dashboards, and any billing or follow-up tools.

CDPHE Answer #29: The request is for information on all LIMS functions being replaced. Current environment is locally hosted on State servers. Colorado and Wyoming test just over 70,000 individual newborns for multiple samples. Sample volume normally exceeds 130,000 unique specimens tested on over 10 methods. Across the deployed methods there are more than 50 analytes or determination points. Data retention for patient reports is 19 years from birth.

Vendor Question #30: Current Environment and Sizing: Section 1.D references more than ten testing platforms, while the Exhibit A Instrument List identifies seven. Can the State confirm the complete list of platforms requiring integration, along with the current interface method for each?

CDPHE Answer #30: There are currently over 10 methods deployed on the listed platforms. QSight 210 -2, QSight 225-2, Revvity GSP -3, LaCAR Seeker - 2/4 unit systems, BioRad VNBS HPLC -3, QuantStudio 12k flex - 4, Panthera Punchers-4

Vendor Question #31: Current Environment and Sizing: Is follow-up case management currently performed within the LIMS, or by contracted specialists in separate systems? Which party is expected to use the case management functionality in Exhibit A?

CDPHE Answer #31: Follow-up case management is split between the current LIMS and REDCap.

REDCap allows the medical specialists to enter case data for diagnostic testing, outcomes, visit notes, and timeliness tracking. Current LIMS is on State servers and outside vendor access is not practical.

Vendor Question #32: Current Environment and Sizing: Approximately how many abnormal cases are managed annually through the follow-up program?

CDPHE Answer #32: Hgb abnormal carriers are the largest upload with over 60 a month. In total annually across all conditions cases would be 750 -900.

Vendor Question #33: Current Environment and Sizing: Where is newborn screening billing processed today (within the LIMS, a separate billing system, or a State financial system)? Which system is the intended source of truth going forward?

CDPHE Answer 33: Billing data is pulled from the current LIMS and uploaded to the State financial system.

Vendor Question #34: Current Environment and Sizing: Will historical data be migrated, and if so, how many years? Yes. Reports 19 years. Lab data for CLIA review 2-3 years.

CDPHE Answer #34: Our data retention policy requires 19 years of reports to be migrated. Reports would need to be searchable and viewable from within the application.

Vendor Question #35: Timing and Procurement: Has the State established a target go-live date or implementation window?

CDPHE Answer #35: Please refer to question #8 above.

Vendor Question #36: Timing and Procurement: Does the State anticipate issuing a formal solicitation following this RFI, and if so, in what timeframe?

CDPHE Answer #36: Please refer to question #3 above.

Vendor Question #37: Timing and Procurement: Several requirements marked “Desirable” in Exhibit A use “must” language. Should respondents treat the Req/Des column as the controlling designation?

CDPHE Answer #37: For the purposes of this request for information the Req/Des column is the controlling designation.

Vendor Question #38: Timing and Procurement: Can the State confirm where Attachment 1 (Vendor Information Form) and Exhibit B (Budget Template) are posted?

CDPHE Answer #38: Both forms can be found with the solicitation documents on Colorado VSS and BidNet Direct.

Vendor Question #39: Is the overall effort limited to newborn screening services, or is it intended to support a laboratory-wide testing portfolio and CDPHE is just starring with Newborn screening?

CDPHE Answer #39: This effort focuses specifically on the newborn screening program

Vendor Question #40: Is CDPHE looking to capture the full scope of services required for a successful LIMS implementation, including supporting activities such as PMO, change management, training, process mapping, data migration, and integration strategy, or only the costs associated with the platform and system implementation itself?

CDPHE Answer #40: CDPHE has performed extensive current state process mapping. However we expect the vendor to provide project management, training, data migration and to replace any current integrations.