Vendor Solution Demonstration Use Cases LIMS VF.docx

Vendor Solution Demonstration: LIMS Use Cases

Vendor Solution Demonstration Use Cases

Top vendors that are invited to Stage 3 of the Procurement will have the opportunity to conduct oral presentations and solution demonstrations. This document contains the use cases that vendors must use to plan for their solution demonstrations.

Table of Contents

Solution Demonstrations Overview Solution Demonstrations provide vendors the opportunity to conduct live demonstrations of their solution functionality. The demonstrations should be structured based on a shortlist of scenarios and use cases as defined by IDPH in this document.

IDPH requests that all demonstrations include highlighting how the demonstrated solution complies with the Usability requirements included in “Desirable Business Functionality Tab” of Attachment G.

Vendors will be provided limited time to demonstrate the functionalities described in each use case and should manage their demonstration timelines accordingly.

Use Cases Overview The vendor must read all eleven (11) use cases outlined in this document in preparation for the solution demonstrations with the IDPH team. The use cases are intended to provide sufficient information and relevant supporting details to enable the vendors in preparing for their scheduled solution demonstrations.

Use Case Summary Full List of Use Cases and Objectives Covered in this Document:

Use Case 1: Specimen Receipt and Accessioning Overview The ability for the future state Laboratory Information Management System (LIMS) to support laboratory staff in performing their job duties is critical to IDPH. The solution should enable the specimen analysis process to be seamless and provide ease for staff.

Use Case Details Objective: Demonstrate the LIMS's capability to handle specimen receipt and accessioning, including customizable test profiles, panels, and workflows Actor(s): Intake Worker, Laboratory Technician, LIMS Administrator, Laboratory Supervisor Supporting Details:

A Laboratory Technician obtains a bacterial sample from a patient The Laboratory Technician logs into the LIMS and selects appropriate test profiles and panels LIMS Administrator ensures workflows are customized to accommodate various testing needs Specimens are accessioned, and the system generates an accession log and workflow configuration report

· Pre-Condition(s):

· The LIMS is configured to support customizable workflows. Personnel have necessary permissions

· Post-Condition(s):

· Specimens are accurately accessioned with customizable workflows applied Alignment with LIMS Requirements Table 1 includes a sample of mandatory requirements related to Use Case 1: Specimen Receipt and Accessioning, as described in the Requirements Traceability Matrix (RTM).

Example Requirements Related to Use Case 1: Specimen Receipt and Accessioning

a. test profiles

b. test panels

c. test workflows

Use Case 2: Barcode Generation

The ability for the future state LIMS to support efficient inventory management is critical to IDPH. The solution should enable seamless integration of barcode technology to ensure accurate tracking of specimens and laboratory supplies, thereby enhancing operational efficiency and reducing errors.

Use Case Details Objective: Demonstrate the LIMS's capability to integrate barcode technology for specimen receipt, ensuring accurate inventory tracking Actor(s): Laboratory Technician, Inventory Manager Supporting Details:

Upon receiving specimens, the Laboratory Technician generates and prints barcode labels, which are affixed to each specimen The Inventory Manager then uses the LIMS to track these specimens, ensuring they are properly logged and monitored throughout the testing process The inventory manager checks for levels of associated supplies and is able to see an accurate inventory level view and reagent expiration dates

· Pre-Condition(s):

· The LIMS is configured with barcode technology. Personnel have necessary permissions

· Post-Condition(s):

· Specimens and supplies are accurately tracked using barcodes Alignment with LIMS Requirements Table 2 includes a sample of mandatory requirements related to Use Case 2: Barcode Generation, as described in the Requirements Traceability Matrix (RTM).

Example Requirements Related to Use Case 2: Barcode Generation

Use Case 3: Demographic Collection

The ability for the future state LIMS to effectively manage patient demographic information is critical to IDPH. The solution should enable seamless collection and management of comprehensive patient data during specimen intake, ensuring accuracy and completeness. This capability is essential for maintaining patient records and facilitating efficient laboratory operations, while also supporting compatibility with Electronic Test Order and Result (ETOR) entry systems.

Use Case Details

· Objective: Demonstrate the LIMS's capability to collect and manage comprehensive patient demographic information during specimen intake both manually and compatibility with ETOR entry

· Actor(s): Laboratory Technician, Patient Intake Specialist

· Supporting Details:

The Patient Intake Specialist manually enters patient demographic information into the LIMS. This includes details such as the patient's name, date of birth, contact information, and insurance details The specialist also records the test requested and specimen type The system verifies the completeness of the information, and a demographic report is generated for review If ETOR is available through LIMs, please demonstrate compatibility with above steps

· Pre-Condition(s):

· The LIMS is configured to capture and store patient demographic data. Personnel have necessary permissions

· Post-Condition(s):

· Patient records are updated with complete demographic information

Alignment with LIMS Requirements Table 3 includes a sample of mandatory requirements related to Use Case 3: Demographic Collection, as described in the Requirements Traceability Matrix (RTM).

Example Requirements Related to Use Case 3: Demographic Collection

a. patient demographics

b. name

c. date of birth (DOB)

d. contact information

e. other relevant demographics as determined by DoIT Optional -

a. sex at birth

b. ethnicity

c. race

Use Case 4: Bacteriology Culture and Results Entry

The ability for the future state LIMS to support comprehensive bacteriology culture workflows is critical to IDPH. The solution should enable the accurate entry and management of culture results, including morphological observations and growth characteristics over specified time intervals. This functionality is essential for ensuring precise documentation of laboratory findings and supports customizable test profiles, panels, and workflows to meet diverse testing needs.

Use Case Details Objective: Demonstrate the LIMS's capability to manage bacteriology culture workflows, including entry of culture results from bacterial media Actor(s): Laboratory Technician, System Administrator Supporting Details:

The Laboratory Technician enters culture results into the LIMS, documenting morphology observations and growth characteristics at specified intervals (24, 48, 72, and 96 hours) Gram staining results are recorded The System Administrator ensures that test profiles and workflows are appropriately configured to capture all necessary data. The system generates a detailed culture result report and morphology observation log

· Pre-Condition(s):

· The LIMS is configured to capture culture results and morphological observations. Personnel have necessary permissions

· Post-Condition(s):

· Culture results, including morphology and growth characteristics over time (24 hrs, 48 hrs, 72 hrs, 96 hrs, are accurately recorded

· Based on the results of initial testing, reflexes to create additional tests (reflex testing) Alignment with LIMS Requirements Table 4 includes a sample of mandatory requirements related to Use Case 4: Bacteriology Culture and Result Entry, as described in the Requirements Traceability Matrix (RTM).

Example Requirements Related to Use Case 4: Bacteriology Culture and Result Entry

a. test profiles

b. test panels

c. test workflows

Use Case 5: Equipment Interface for Test Result Import

The ability for the future state LIMS to seamlessly integrate with laboratory equipment is critical to IDPH. The solution should facilitate the import of test results from various automated testing devices, ensuring efficient data transfer and accuracy. This capability is vital for supporting diverse testing methods, including culture identification, molecular testing, and whole genome sequencing (WGS), thereby enhancing laboratory operations and data integrity.

Use Case Description Objective: Demonstrate the LIMS's capability to interface with laboratory equipment for importing test results, ensuring seamless integration across various testing methods. If it's not possible to demonstrate with actual equipment, you can instead use a virtual display that illustrates the solution's ability to directly consume data from file-based sources into the LIMS Actor(s): Laboratory Technician, IT Specialist Supporting Details:

The Laboratory Technician initiates the interface between the LIMS and various testing equipment Culture ID results from devices like Bruker MALDI-TOF and BD Phoenix M50 are imported into the system. Molecular testing results from ABI 7500 FAST and QuantStudio devices, as well as WGS results from Illumina sequencers, are seamlessly integrated into the LIMS The IT Specialist ensures all connections are secure and data is accurately captured. An interface log and test result import summary are generated Translate results from instrument into the system specified analyte names

· Pre-Condition(s):

· The LIMS is configured to interface with equipment for culture ID testing (e.g., Bruker MALDI-TOF, BD Phoenix M50), molecular testing (e.g., ABI 7500 FAST, QuantStudio 5, QuantStudio DX), and WGS testing (e.g., Illumina NextSeq 2000, Illumina iSeq / ClearDX, Illumina MiSeq)

· Post-Condition(s):

· Test results from culture ID, molecular, and WGS testing are successfully imported into the LIMS Alignment with LIMS Requirements Table 5 includes a sample of mandatory requirements related to Use Case 5: Equipment Interface for Test Result Import, as described in the Requirements Traceability Matrix (RTM).

Example Requirements Related to Use Case 5: Equipment Interface for Test Result Import

Use Case 6: Secondary Review and Approval of Results

The ability for the future state LIMS to enforce a robust secondary review and approval process is critical to IDPH. The solution should support workflow customization to ensure compliance with laboratory standards, preventing the same individual from both entering and approving test results. This functionality is essential for maintaining data accuracy and accountability, ensuring that all results undergo a thorough review before release.

Use Case Details Objective: Demonstrate the LIMS's capability to enforce secondary review and approval of test results, ensuring compliance with workflow requirements Actor(s): Laboratory Technician, Laboratory Supervisor Supporting Details:

After test results are entered, the Laboratory Technician performing testing submits them for review The LIMS ensures that the same individual cannot approve their own entries, requiring an approval from a separate individual following secondary review The secondary reviewer assesses the results for accuracy and compliance, then approves them for release. The system logs all actions in an approval log and maintains an audit history report for future reference

· Pre-Condition(s):

· The LIMS is configured to prevent the same person from entering and approving their own results

· Postcondition(s):

· Results are reviewed and approved by a secondary reviewer before release Alignment with LIMS Requirements Table 6 includes a sample of mandatory requirements related to Use Case 6: Secondary Review and Approval of Results, as described in the Requirements Traceability Matrix (RTM).

Example Requirements Related to Use Case 6: Secondary Review and Approval of Results

Use Case 7: Test Report Generation

The ability for the future state LIMS to generate comprehensive test reports is critical to IDPH. The solution should provide robust reporting capabilities, including the generation of preliminary, final, amended, and corrected reports. This functionality is crucial for delivering accurate and timely information to stakeholders, supporting laboratory operations, and providing insights into laboratory performance.

Use Case Details Objective: Demonstrate the LIMS's capability to generate various types of reports, including preliminary, final, amended, and corrected reports

· Preliminary Report: Includes initial culture and identification results prior to additional testing (e.g., Molecular and WGS)

· Final Report: Comprehensive report after all testing is completed

· Amended Report: Incorporates demographic corrections after testing and release of results

· Corrected Report: Reflects changes in test results (e.g., from Negative to Positive) after re-testing Actor(s): Laboratory Technician, LIMS Administrator, Laboratory Technical Supervisor, Quality Assurance Staff, System Administrator Supporting Details:

The Laboratory Technician uses the LIMS to generate a preliminary report, capturing initial culture and identification results before additional testing like Molecular and WGS Once all testing is completed, a comprehensive final report is created. If demographic corrections are needed after results are released, an amended report is issued. In cases where test results change (e.g., from Negative to Positive) after re-testing, a corrected report is generated The LIMS Administrator ensures all reporting functionalities are operational

· Pre-Condition(s):

· The LIMS is configured to generate and manage different report types. Personnel have necessary permissions

· Postcondition(s):

· Reports are generated accurately, reflecting the current status of test results

· QA Staff are automatically notified of any corrected reports Alignment with LIMS Requirements Table 7 includes a sample of mandatory requirements related to Use Case 7: Test Report Generation, as described in the Requirements Traceability Matrix (RTM).

Example Requirements Related to Use Case 7: Test Report Generation

a. generating standard reports

b. generating ad hoc reports

c. tracking key performance indicators (KPIs)

d. providing insight into laboratory operations

e. providing insight into laboratory performance

Use Case 8: Release of Reports to Submitters, LHDs, IDPH Programmatic Staff

The ability for the future state LIMS to efficiently release reports to various stakeholders is critical to IDPH. The solution should support data export in multiple standard formats, including HL7, ensuring that reports are delivered accurately and in a timely manner. This capability is essential for maintaining effective communication with submitters, Local Health Departments (LHDs), and IDPH Programmatic Staff.

Use Case Details Objective: Demonstrate the LIMS's capability to release reports to various stakeholders, using multiple formats and messaging protocols Actor(s): Laboratory Technician, LIMS Administrator Supporting Details:

The Laboratory Technician prepares the final test report and exports it in PDF format Using the LIMS, they ensure the report is sent to submitters, Local Health Departments (LHDs), and IDPH Programmatic Staff The LIMS Administrator configures the system to send reports via HL7 messaging and other custom formats like Excel, CSV, and XML, ensuring all stakeholders receive the information in their preferred format

· Pre-Condition(s):

· The LIMS is configured to export reports in formats such as PDF, Excel, CSV, XML, and HL7 messaging

· Post-Condition(s):

· Reports are successfully delivered to intended recipients in the required formats (ETOR, SFTP, S3, File Export)

Alignment with LIMS Requirements Table 8 includes a sample of mandatory requirements related to Use Case 8: Release of Reports to Submitters, LHDs, IDPH Programmatic Staff, as described in the Requirements Traceability Matrix (RTM).

Example Requirements Related to Use Case 8: Release of Reports to Submitters, LHDs, IDPH Programmatic Staff

Use Case 9: Generating Lab Statistics

The ability for the future state LIMS to generate detailed lab statistics and key performance indicators (KPIs) is critical to IDPH. The solution should include workflow dashboards and statistical data reports, providing insights into laboratory operations across different locations. This functionality is essential for monitoring performance, optimizing processes, and supporting data-driven decision-making.

Use Case Details Objective: Demonstrate the LIMS's capability to generate comprehensive lab statistics and KPIs, broken down by laboratory location (Carbondale, Chicago, Springfield).

Actor(s): Laboratory Manager, LIMS Administrator, Laboratory Supervisor Supporting Details:

The Laboratory Supervisor uses the LIMS to compile statistics for each test, categorized by laboratory location The system generates reports detailing the total number of specimens received, rejected, tested, and their results (positive, negative, inconclusive). It also calculates percentages of positive and negative specimens and analyzes turn-around-times The LIMS Administrator ensures that the data is accurately captured and presented in a KPI dashboard, providing insights into laboratory performance across locations

· Pre-Condition(s):

· The LIMS is configured to collect and analyze data across different laboratory sites. Personnel have necessary permissions

· Post-Condition(s):

· Statistical reports are generated, detailing specimen counts, result breakdowns, and turn-around times. Examples Include: Total number of specimens received, rejected, tested; specimens with positive, negative, and inconclusive results; percentage of positive and negative specimens; turn-around-time from specimen receipt to final result Alignment with LIMS Requirements Table 9 includes a sample of mandatory requirements related to Use Case 9: Generating Lab Statistics, as described in the Requirements Traceability Matrix (RTM).

Example Requirements Related to Use Case 9: Generating Lab Statistics

Use Case 10: Inventory Management

The ability for the future state LIMS to efficiently manage laboratory inventory is critical to IDPH. The solution should support comprehensive inventory management, including tracking and reordering of reagents, consumables, and other laboratory supplies. It should also provide alert systems for reagent expiration, stock levels, and instrument service requirements. This functionality is essential for maintaining accurate inventory levels, ensuring timely replenishment, and upholding safety and quality standards in laboratory operations.

Use Case Details Objective: To demonstrate the LIMS's capability to manage laboratory inventory, including tracking, reordering, and managing reagents, consumables, and other supplies, with alert systems for expiration and service requirements Actor(s): Inventory Manager, Laboratory Technician, LIMS Administrator Supporting Details:

The Inventory Manager logs into the LIMS to monitor supplies, leveraging barcode technology for real-time tracking of reagents, consumables, and other items The system alerts the manager to reagents nearing expiration, both on-screen and via email, ensuring compliance and safety. Par levels for consumables like gloves and test kits trigger automatic reordering, preventing supply shortages Laboratory Technicians use barcode scanners to update inventory during testing, minimizing errors and maintaining accurate counts. The System Administrator sets alerts for instrument maintenance, ensuring timely servicing At day's end, the Inventory Manager generates a report detailing inventory status, including receive dates, product names, and quantities. This report aids in procurement decisions and trend analysis The LIMS's inventory management capabilities streamline operations, reduce waste, and uphold quality and safety standards

· Pre-Condition(s):

· The LIMS is configured with inventory data and integrated with barcode technology. Relevant personnel have the necessary permissions to access and manage inventory data

· Post-Condition(s):

· Inventory is accurately tracked and managed, including reagents, consumables, and laboratory supplies. The system provides alerts for items scheduled to expire, par levels reached, and instruments requiring service. Inventory levels are maintained using barcode technology, and manual adjustments are possible Alignment with LIMS Requirements Table 10 includes a sample of mandatory requirements related to Use Case 10: Inventory Management, as described in the Requirements Traceability Matrix (RTM).

Example Requirements Related to Use Case 10: Inventory Management

a. tracking of reagents

b. consumables

c. other laboratory supplies

d. managing reagent expiration dates

e. stock levels

f. reordering

g. manual adjustments of inventory amounts

a. inventory levels

b. reordering

c. stock management

a. chemicals

b. reagent test kits

c. gloves

d. lab coats

a. receive date

b. product name

c. lot number

d. expiration date

e. quantity

f. location of storage

g. procurement vendor name

Use Case 11: QA/QC Module

The ability for the future state LIMS to effectively manage and document quality control (QC) processes is critical to IDPH. The solution should facilitate the capture and storage of QC data alongside run information, providing a comprehensive record for future troubleshooting and quality assurance (QA) improvements. This functionality is essential for maintaining high laboratory standards, ensuring data integrity, and supporting continuous quality improvement efforts.

Use Case Details Objective: To demonstrate the LIMS's capability to manage and document quality control (QC) processes, ensuring that QC data is saved with run information for future troubleshooting and QA improvements Actor(s): Quality Control Technician, Laboratory Supervisor, LMIS Administrator Supporting Details:

The Quality Control Technician begins by accessing the LIMS to review and manage quality control (QC) processes. The system is configured to capture and store QC data alongside run information, ensuring a comprehensive record for future troubleshooting and QA improvements During testing, the technician records QC data in the LIMS, which is automatically linked with the corresponding run information. This integration allows for easy retrieval and analysis of QC data, facilitating quick identification of any anomalies or trends that may require attention The Laboratory Supervisor periodically reviews QC reports generated by the LIMS. These reports provide insights into the effectiveness of current QC procedures and highlight areas for potential improvement. The manager collaborates with the System Administrator to adjust QC protocols as needed, ensuring continuous enhancement of laboratory processes At the end of each testing cycle, the LIMS generates a QA improvement summary, detailing any issues encountered and the steps taken to address them. This summary serves as a valuable tool for ongoing quality improvement initiatives By leveraging the LIMS's QA/QC module, the laboratory ensures that QC data is accurately captured and stored, supporting efficient management of quality control processes and contributing to the overall integrity and reliability of laboratory results

· Pre-Condition(s):

· The LIMS is configured with barcode technology. Personnel have necessary permissions

· Post-Condition(s):

· Specimens and supplies are accurately tracked using barcodes

· QC data is accurately captured and stored, enhancing the integrity and reliability of laboratory results Alignment with LIMS Requirements Table 11 includes a sample of mandatory requirements related to Use Case 11: QA/QC Module, as described in the Requirements Traceability Matrix (RTM).

Example Requirements Related to Use Case 11: QA/QC Module