Exhibit A LIMS Requirements.xlsx
XLSX spreadsheet 64 KB Posted
- Solicitation number
- RFI FAAA 2027000011 1
- Issued by
- Denver County, Denver City, Colorado
About this file
This document is an Exhibit A requirements specification for a Laboratory Information Management System (LIMS) to support Colorado's Newborn Screening (NBS) program, managed by the Office of Information Technology (OIT). The LIMS must provide comprehensive case management functionality for abnormal screens, including automated case creation, outcome tracking, specialist referral integration, and detailed patient/family contact history with timestamped logs. The system must support complex chain of custody tracking through hierarchical storage mapping and electronic chain of custody (eCoC) with immutable logging of possession changes and automated aliquot genealogy tracking. Additionally, the LIMS must include customer management capabilities with submitter profiles for hospitals and birthing centers, automated ICD-10 and CPT code mapping, and EDI/financial integration compatible with state enterprise resource planning systems.
The system must feature advanced data analysis capabilities including a complex formula engine for user-defined calculations such as analyte ratios in mass spectrometry/mass spectrometry (MS/MS), multi-tiered cutoff logic based on gestational age and birth weight, automated result interpretation using decision-tree logic, and Ct value analysis for molecular screening. The LIMS must incorporate Levey-Jennings and Westgard rules for quality control monitoring with real-time application to invalidate failed runs, population trend monitoring to detect instrument drift, and second-tier trigger logic for automated flagging of samples. The vendor must be a US-based entity with at least five years of SOC II Type II certification experience, provide a cloud-based application with 99.9% uptime guarantee, maintain a documented disaster recovery plan with annual reviews, and supply dedicated project management, implementation support including legacy system data migration, and comprehensive testing and validation services covering UAT, system integration testing, and performance testing.
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Other files
| File | Type | Posted |
|---|---|---|
| Attachment 1 Vendor Information-Confirmation of Offer Form.docx | DOCX document | |
| RFI 2027000011 NBS Laboratory Information Management System.pdf | ||
| Exhibit B Budget Template.xlsx | XLSX spreadsheet |
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Requirements
| Category | Requirement | Req / Des |
| Case Follow Up | Integrated Case Management Workflow: Automated creation of a "Case" for every abnormal screen, allowing for the tracking of phone calls, letters, and specialist referrals in one place. | Required |
| Case Follow Up | Outcome Tracking & Closing: Ability to record final diagnostic outcomes (e.g., True Positive, False Positive, Carrier) and associate them with the initial screen. | Required |
| Case Follow Up | Specialist Referral Integration: Support for secure sharing of case data (PDFs, analyte levels) with state-designated specialists or clinics via the portal. | Required |
| Case Follow Up | Patient/Family Contact History: A time-stamped log of all outreach attempts, including the ability to upload recordings or notes from phone calls with parents. | Required |
| Chain of Custody | Hierarchical Storage Mapping: System must support a multi-level location hierarchy (Building → Room → Freezer/Fridge → Shelf → Rack → Box → Position/Well). | Required |
| Chain of Custody | Electronic Chain of Custody (eCoC): Automated, immutable logging of every "possession change," including the User ID, timestamp, and action (e.g., "Moved from Intake to Bench 1"). | Required |
| Chain of Custody | Aliquot & Derivative Genealogy: System must automatically maintain a "Parent-Child" relationship for all aliquots, DNA extracts, or plates derived from the original card. | Required |
| Customer Management | Comprehensive Submitter Profiles: Centralized management of all hospitals, birthing centers, and midwives, including NPI validation and primary/billing contact details. | Required |
| Customer Management | Automated ICD-10 & CPT Mapping: Rules-based engine that automatically assigns appropriate billing codes to a case based on the screening performed and the patient’s age. | Required |
| Customer Management | EDI/Financial Integration: Support for industry-standard financial messaging (e.g., X12 837 for claims, HL7 DFT for financial transactions) to sync with state ERPs. | Required |
| Data Analysis | Complex Formula Engine: Support for user-defined calculations (e.g., analyte ratios in MS/MS) that update automatically upon data ingestion. | Required |
| Data Analysis | Multi-Tiered Cutoff Logic: Ability to apply distinct cutoffs based on Gestational Age (GA), Birth Weight (BW), and Age at Collection (in hours). | Required |
| Data Analysis | Automated Interpretation: System must automatically assign a "Screen Result" (e.g., Normal, Abnormal, Urgent) based on configured decision trees. | Required |
| Data Analysis | Advanced Calculation Engine: System must support user-definable complex formulas for MS/MS ratios (e.g., C3/C2, Phe/Tyr) and enzymatic activity calculations. | Required |
| Data Analysis | Multi-Tiered Cutoff Logic: System must automatically apply different cutoff values based on birth weight, gestational age (GA), and age at collection (AAC). | Required |
| Data Analysis | Automated Result Interpretation: System must assign a clinical interpretation (e.g., "Normal," "Abnormal," "Urgent") based on decision-tree logic and multiple analyte results. | Required |
| Data Analysis | Ct Value Analysis (Molecular): For QuantStudio/PCR, the system must capture raw Ct values and apply "Call" logic (e.g., Normal vs. Refer) for SMA/SCID screening. | Required |
| Data Analysis | Second-Tier Trigger Logic: System must automatically flag samples for second-tier testing (e.g., MS/MS follow-up) based on initial screen results. | Required |
| Data Analysis | Population Trend Monitoring: Integrated tools to monitor daily/weekly median values for all analytes to detect "drift" in instrument performance. | Required |
| Data Analysis | Levey-Jennings & Westgard Rules: Automated plotting of QC data with real-time application of Westgard rules to invalidate runs with failing controls. | Required |
| General | Project Management: Vendor must provide a dedicated Project Manager and a formal Project Plan, including Risk Mitigation and Change Management. | Required |
| General | Implementation Support: Vendor must support the full transition from legacy LIMS, including data migration strategies and dual-entry testing. | Required |
| General | Testing & Validation: Vendor must provide a Master Test Plan covering UAT, System Integration Testing (SIT), and Performance Testing. | Required |
| General | US-Based Operations: Vendor must be a US-based entity or have a significant US-based support/engineering presence. | Required |
| General | Vendor must provide a documented disaster recovery plan and schedule an annual review of the plan with OIT and/or CDPHE | Required |
| General | Application must be Cloud based on a system that is hosted and managed by the vendor. | Required |
| General | Vendor Experience: Vendor must have at least 5 years of experience managing SOC II Type II certification for the proposed system. | Required |
| Infrastructure | High Availability (Uptime): The system must guarantee at least 99.9% uptime, excluding scheduled maintenance windows. | Required |
| Infrastructure | Disaster Recovery (RTO/RPO): System must have a Recovery Time Objective (RTO) of <4 hours and a Recovery Point Objective (RPO) of <1 hour. | Required |
| Infrastructure | Security Compliance: System must meet SOC2 Type II, HIPAA, and State-specific technical OIT security standards. | Required |
| Infrastructure | Omnichannel Support: Support must be available via Web Portal, Email, and/or Phone, with a 24/7 "Critical" severity response. | Required |
| Infrastructure | Vendor must provide a documented disaster recovery plan and schedule an annual review of the plan with OIT and/or CDPHE. | Required |
| Infrastructure | Environment Separation: Vendor must provide separate Production, Test, and Development environments. Lower environments must be able to use synthetic data. | Required |
| Infrastructure | System must support mltip-factor atuhenictacton with state active directory | Required |
| Instrumentation | Real-time Ingestion: Results must be ingested into the LIMS as soon as the instrument run is finalized, with automated status updates on the dashboard. | Required |
| Instrumentation | GSP Bi-directional Flow: System must transmit batch worklists to the GSP and automatically ingest raw fluorescence data upon run completion. | Required |
| Instrumentation | QSight MS/MS Data Pipeline: Automated ingestion of TXT/XML result files from QSight, with integrated calculation of NBS-specific analyte ratios. | Required |
| Instrumentation | Automated Worklist Provisioning: System must automatically generate and export QuantStudio-compatible worklists to a secure network location or via API. | Required |
| Instrumentation | PCR Result Parsing: Native parsing of QuantStudio export files to capture Ct values and automated "Call" logic (e.g., for SMA/SCID). | Required |
| Instrumentation | Universal Device Networking: System must support secure networking for all benchtop instruments, eliminating the use of portable storage (USB). | Required |
| Instrumentation | SEEKER Automated Ingestion: Direct ingestion of Baebies SEEKER output files to trigger automated result categorization. | Required |
| Instrumentation | Provide ability to receive values from instruments and calculate calibration curves, control values, and patient values based on curve calculations. | Required |
| InterOperability | HL7 Resulting (LRI): System must generate HL7 v2.5.1 (or higher) Lab Results Interface (LRI) messages following the ONC/CDC implementation guides. | Required |
| InterOperability | Standardized Coding: Native support for LOINC (for analytes) and SNOMED-CT (for qualitative results) mapped at the test/analyte level. | Required |
| InterOperability | Electronic Test Orders (LOI): Ability to consume HL7 Lab Orders Interface (LOI) messages to automate sample registration (Electronic Accessioning). | Required |
| InterOperability | Bi-directional Instrument Integration: Native driver-level integration for data exchange with instruments (e.g., Revvity, Waters, AB Sciex) without manual file manipulation. | Required |
| InterOperability | Parallel Reporting: Ability to trigger electronic HL7 messages and paper/PDF reports simultaneously upon result verification. | Required |
| InterOperability | API Connectivity: Provide a secure RESTful API (JSON/FHIR) for real-time data queries by authorized 3rd party state systems (e.g., Billing, HIE). | Required |
| Pre-Analytical | Decoupled Workflow: System must allow samples to be punched and analytical runs started before demographic data entry is complete. | Required |
| Pre-Analytical | Automated Patient Linking: System must utilize a weighted algorithm (e.g., Name, DOB, Mother's Name) to automatically link initial and repeat screens. | Required |
| Pre-Analytical | Electronic Order Matching: System must automatically match physical barcodes on cards to electronic test orders (HL7) received from hospitals. | Required |
| Pre-Analytical | Unique Persistent Identifier: System must maintain a persistent Patient ID across multiple pregnancies/screens, distinct from sample-specific accession numbers. | Required |
| Pre-Analytical | Unsatisfactory Sample Logic: System must provide a one-click "Reject" workflow that triggers an automated notification to the submitter and requests a repeat. | Required |
| Pre-Analytical | Puncher Integration: Bi-directional communication with automated punchers (e.g., Panthera) to receive the sample ID and well location and generate plate maps for testing instruments. System must acknowledge reciept of the punch data and update the plate map in real time. | Required |
| Pre-Analytical | Bulk Action Tools: Ability to cancel, re-order, or change test status in bulk based on filtered criteria (e.g., batch rejection of a contaminated plate). | Required |
| Pre-Analytical | Dynamic Worklist Creation: Ability to generate instrument-specific worklists (load lists) based on pending tests, priorities, and repeat requirements. | Required |
| Pre-Analytical | Barcode Validation: Instrument load lists must be validated against physical barcodes during the loading process to ensure sample integrity. | Required |
| Reagent and Consumable Tracking | Integrated Reagent Traceability: System must automatically link reagent lot numbers and expiration dates to analytical runs and patient results. | Required |
| Reagent and Consumable Tracking | Reagent Validation Workflow: A dedicated workflow to track "New Lot vs. Old Lot" validation studies, including the storage of validation data and director approval. | Required |
| Reporting | Omni-Channel Distribution: System must simultaneously support result delivery via HL7, Secure Fax (efax), Email (encrypted), and a Web Portal. | Required |
| Reporting | Secure Provider Portal: Self-service portal for clinicians to search, view, and download official PDF reports for their specific patients. | Required |
| Reporting | Dynamic Report Content: Ability for lab managers to update report "mailer text," disclaimers, and follow-up recommendations without vendor coding. | Required |
| Reporting | Preliminary vs. Final Logic: System must allow the release of preliminary results (e.g., when one test is abnormal) while the rest of the panel is pending. | Required |
| Reporting | Branded PDF Generation: System must generate high-fidelity, laboratory-branded PDF reports that are stored permanently and are tamper-proof. | Required |
| System Administration | Granular Role-Based Access Control (RBAC): System must allow admins to define specific permissions (view, edit, delete, verify) by user role and department. | Required |
| System Administration | Immutable Audit Logs: Non-modifiable logs of every action, including "before and after" values, time-stamps, and the workstation ID used. | Required |
| System Administration | Controlled Reprint Workflow: System must require a "Reason for Reprint" and create an audit log whenever an accession label is duplicated. | Required |
| Usability | Role-Based Actionable Dashboards: Real-time visual summaries tailored to the user's role (e.g., Accessioning see "Cards to Punch"; Follow-up see "Urgent Calls Pending"). | Required |
| Usability | Intelligent Alert Tiering: Ability to configure alerts by severity (e.g., "Critical Result" = Immediate Popup/SMS; "Low Supply" = Dashboard Icon). | Required |
| Usability | Global Search ("Google-style"): A single search bar that scans the entire database (Accession #, Patient Name, Mother's Name, MRN) simultaneously. | Required |
| Web portal | MFA & Secure Authentication: Support for Multi-Factor Authentication (MFA) and integration with state-wide Identity Providers (IdP). | Required |
| Web portal | Electronic Order Entry (EOE): A digital form for submitters to enter infant demographics before mailing the card, generating a barcode to be attached to the paper. | Required |
| Web portal | Audit Trail for External Access: A log available to Lab Admins showing exactly when an external user viewed or downloaded a specific patient report. | Required |
| Case Follow Up | Automated "Lost to Follow-Up" Alerts: System-generated flags for cases that have not had an outcome recorded or a repeat sample received within a defined timeframe. | Desirable |
| Case Follow Up | Long-Term Developmental Tracking: Ability to store follow-up data at intervals (e.g., 6 months, 1 year, 5 years) to monitor the long-term efficacy of screening. | Desirable |
| Case Follow Up | Configurable Follow-Up Protocols: User-editable templates for follow-up actions based on specific disorders (e.g., "If PKU abnormal, then call metabolic clinic"). | Desirable |
| Chain of Custody | Inbound Courier Integration: Ability to track incoming shipments via API integration with state couriers or major carriers (FedEx/UPS) before they arrive. | Desirable |
| Chain of Custody | Batch Move/Transfer: Support for barcode-driven "Bulk Moves" (e.g., scanning a box barcode to move all 100 samples within it to a new freezer location). | Desirable |
| Chain of Custody | Retention & Disposal Alerts: System must track the age of samples and provide automated alerts/reports when samples reach their legal "purge" date (e.g., 19 years). | Desirable |
| Chain of Custody | Certified Disposal Workflow: A documented digital process for sample destruction, requiring two-user "witness" verification and a final disposal certificate. | Desirable |
| Chain of Custody | Temp-Link Integration: Ability to link environmental monitoring data (freezer temperature logs) to the sample location history. | Desirable |
| Customer Management | Hybrid Billing Models: System must support multiple billing triggers: "Fee-per-Kit" (prepaid cards), "Fee-per-Test" (clinical billing), and "Grant-funded" (no-charge). | Desirable |
| Customer Management | Customer Billing Portal: Secure web access for facilities to view their statements, manage payment methods, and resolve billing discrepancies. | Desirable |
| Customer Management | Use aliasing for matching and merging duplicate Submitter agency records based on standardized addresses. | Desirable |
| Customer Management | Consumable/Kit Ordering: Integrated e-commerce-style interface for submitters to order new NBS collection kits, linked to their account balance. | Desirable |
| Customer Management | Taxonomy & Provider Registry Sync: Automated daily/weekly sync with national or state provider registries to keep NPI and taxonomy data current. | Desirable |
| Data Analysis | Machine Learning / Predictive Analytics: Support for advanced algorithms (e.g., CLIR tools) to improve the specificity of metabolic screening results. | Desirable |
| General | Vendor Experience: Vendor preferred to have at least 5 years of experience implementing LIMS specifically for Newborn Screening (NBS) programs. | Desirable |
| General | Vendor Experience: Vendor must have at least 5 years of experience managing and hosting a cloud based LIMS and instrument integration. | Desirable |
| Infrastructure | Vendor must have at least 3 years experience with Saas/PaaS software management | Desirable |
| Infrastructure | Vendor must have a clear product roadmap demonstrating improved system design and functionality with each release | Desirable |
| Instrumentation | Native Instrument Drivers: System must include intefaces for data ingestion from GSP, MS/MS, and NexGen Sequencing (NGS) platforms. | Desirable |
| Instrumentation | Raw Data Storage: System must be able to store or link to raw instrument data files for audit purposes and troubleshooting. | Desirable |
| Instrumentation | HPLC Pattern Recognition: Ability to ingest peak data and area percentages from the Bio-Rad VARIANT to aid in hemoglobinopathy interpretation. | Desirable |
| Pre-Analytical | Card Image Capture: Integration with high-speed scanners to attach a digital image of the NBS card to the patient record. | Desirable |
| Pre-Analytical | Allow user to manually enter test request if received on paper form and perform independent verification on selected data fields by re-entry of the data in a second pass. | Desirable |
| Pre-Analytical | System must support configurable demographic validation rules (e.g., automatically flagging if the specimen collection date is prior to the birth date). | Desirable |
| Pre-Analytical | Determine and flag hold times/stability limits for specimens that have expired in transit or internal queues. | Desirable |
| Pre-Analytical | System must track, manage, and report on test requests/specimens forwarded to external reference laboratories. | Desirable |
| Pre-Analytical | System must track and log patient/parent consent status regarding long-term blood spot storage and research usage. | Desirable |
| Pre-Analytical | Positive Sample Tracking: Full chain-of-custody tracking from receipt to storage location, including freezer/shelf/box coordinates. | Desirable |
| Reagent and Consumable Tracking | NBS Card Lot Tracking: Ability to track and validate filter paper card lot numbers during accessioning to monitor for absorption consistency. | Desirable |
| Reagent and Consumable Tracking | Automated Inventory Alerts: Real-time dashboards and automated email/SMS alerts when stock levels for critical consumables (e.g., MS/MS internal standards) hit "Par" levels. | Desirable |
| 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. | Desirable |
| Reagent and Consumable Tracking | Multi-Location Storage Mapping: Ability to track consumables across multiple physical locations (e.g., "Main Warehouse," "Bench 1 Fridge," "Freezer A"). | Desirable |
| Reagent and Consumable Tracking | Vendor Catalog Integration: Ability to import or sync supply lists from major NBS vendors (e.g., Revvity, Waters) for simplified ordering. | Desirable |
| Reagent and Consumable Tracking | Consumable Usage Analytics: System provides reports on "Burn Rates" to help the lab manager forecast budget and supply needs for the fiscal year. | Desirable |
| Reporting | Unsatisfactory Sample Notifications: Automated generation and delivery of "Specimen Inadequate" letters to the birthing facility for immediate recollection. | Desirable |
| Reporting | Urgent Result Alerts: Automated "Critical Value" notifications (SMS or Email) triggered instantly upon director verification of an abnormal screen. | Desirable |
| Reporting | NewSTEPs Integration: Automated export tools to provide monthly/quarterly data quality metrics to the national NewSTEPs database. | Desirable |
| Reporting | Ad-Hoc Business Intelligence: Built-in tool for creating custom reports (e.g., Average TAT by hospital, Positivity rates by county) without SQL knowledge. | Desirable |
| System Administration | Single Sign-On (SSO) Integration: Support for SAML 2.0 or Active Directory (AD) to allow staff to use existing state credentials to log in. | Desirable |
| System Administration | No-Code Test Configuration: Lab Admins must be able to add new analytes, define units, and set decimal precision without vendor assistance. | Desirable |
| System Administration | Dynamic Workflow Designer: Ability for admins to modify the "status flow" of a sample (e.g., adding an extra review step for a specific instrument). | Desirable |
| System Administration | Report Template Editor: Integrated "Drag-and-Drop" editor for updating header logos, footer text, and clinical recommendations on PDF reports. | Desirable |
| System Administration | System Health Dashboard: A real-time view for IT/Admins showing the status of all HL7 interfaces, instrument connections, and server performance. | Desirable |
| System Administration | Bulk Data Archiving & Purge: Configurable rules for moving older records (e.g., >19 years) to "Cold Storage" while maintaining searchability. | Desirable |
| System Administration | Scheduled Maintenance Mode: Ability for admins to broadcast a "System Going Down" message to all logged-in users with a countdown timer. | Desirable |
| System Administration | Native Thermal Printer Support: System must include native drivers for industry-standard thermal printers (e.g., Zebra, Brady) using ZPL or similar languages. | Desirable |
| System Administration | 2D Barcode Capability: Ability to generate and scan 2D barcodes (DataMatrix or QR) containing multiple data points (Accession # + Patient Initials). | Desirable |
| System Administration | Describe the system's ability to natively store, index, and access controlled documents (such as SOPs) directly from within the application user interface. | Desirable |
| System Administration | On-Demand Accessioning Labels: Ability to trigger label printing automatically the moment a sample is "Received" or "Accessioned" in the system. | Desirable |
| System Administration | Plate & Aliquot Labeling: Automated generation of labels for secondary containers (aliquots) and plates, automatically inheriting the parent sample's metadata. | Desirable |
| System Administration | Submitter Label Printing (Pre-Accession): A secure portal tool for hospitals to print standardized labels to be attached to the NBS card before it is mailed. | Desirable |
| System Administration | Custom Label Designer: An integrated, "What-You-See-Is-What-You-Get" (WYSIWYG) editor for admins to modify label layouts, font sizes, and barcode types. | Desirable |
| System Administration | Label Stock Monitoring: Ability to track "labels remaining" in a roll and alert the user when it's time to change the media. | Desirable |
| Usability | Visual TAT Monitoring: A "Heat Map" or countdown timer on the dashboard showing samples approaching their Turnaround Time (TAT) limit. | Desirable |
| Usability | Interface Status Monitor: A visual "Stoplight" (Red/Green) dashboard showing the health of HL7 feeds and instrument connections. | Desirable |
| Usability | Mobile-Responsive Access: Secure, browser-based interface that remains fully functional on tablets for follow-up coordinators or directors on call. | Desirable |
| Usability | Contextual Help & Tooltips: Embedded "hover-over" help text for complex data fields or clinical codes to assist in training and reduce errors. | Desirable |
| Usability | User-Configurable Views: Ability for individual users to "pin" their most-used reports or drag-and-drop dashboard widgets to suit their workflow. | Desirable |
| Usability | Dark Mode / High Contrast Support: Built-in UI themes to reduce eye strain during long shifts or high-glare laboratory environments. | Desirable |
| Web portal | Real-Time Sample Status: A "Track My Package" style view showing the current stage of a sample (e.g., "Received," "In-Testing," "Verified," "Reported"). | Desirable |
| Web portal | Batch Report Download: Ability for a clinic to download all results for a specific date range or birthing unit in a single, multi-page PDF. | Desirable |
| Web portal | Follow-Up Response Portal: A secure module where providers can respond to "Screen Positive" alerts, upload specialist consult notes, and record final outcomes. | Desirable |
| Web portal | Mobile-First Design: The portal must be fully responsive and functional on tablets and smartphones for "on-the-go" clinicians. | Desirable |
| Web portal | Integrated Kit & Supply Ordering: A "storefront" within the portal for clinics to order new NBS collection kits and educational materials. | Desirable |
Instrument List
| Instrument List |
| PerkinElmer QSight 210 MS Insturments |
| Revvity QSight 225 MS Instruments |
| Thermo Fisher QuantStudio 12K Flex Instruments |
| Revvity GSP Instruments |
| BioRad VNBS HPLC Instruments |
| LaCAR Seeker digitial-microfluidics Instruments |
| Revvity Panthera Sample Punching Instruments |
File details come from the government source that posted it. Updated .