Laboratory System Validation Profiles for Multisite LIS

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Solution Overview

Problem

In multisite laboratory environments, existing Laboratory Information Systems (LIS) face challenges in managing and validating test results due to the need for multiple configurations and varying validation criteria across different locations, leading to complexity in centralized control and increased risks of user error.

Innovation Solution

A laboratory system that utilizes a remote computer to define and assign profiles of validation criteria, allowing each laboratory to customize its validation criteria and perform automatic validation of analytical test results based on predefined groups, thereby reducing user error and increasing throughput.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If multiple configurations are created for each laboratory location with customized validation criteria, then validation accuracy and adaptability are improved, but system complexity and configuration management difficulty increase

Engineering Contradiction:
Improvevalidation accuracyVSAvoidsystem configuration complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent segments the validation criteria into modular templates that can be independently configured and reused across multiple laboratories. Each template represents a discrete validation rule that can be combined through profiling, allowing complex validation logic to be broken down into manageable, reusable components that reduce overall system complexity while maintaining high validation accuracy

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent implements template copying where validated validation criteria configurations are replicated across multiple laboratories through profile assignment. Instead of manually configuring each laboratory individually, administrators can create a template once and copy it to multiple locations with automatic adaptation, reducing configuration complexity while ensuring consistent validation accuracy across the network

Inventive Principle:
Principle #26Copying

2Adaptability or versatility

If manual validation processes are used with multiple configurations, then flexibility in handling different validation criteria is improved, but user error risk and processing time increase

Engineering Contradiction:
Improvevalidation criteria flexibilityVSAvoiduser error risk
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The patent implements self-service automation where the system automatically selects and applies the appropriate validation template based on the laboratory profile and test type. The automated validation engine retrieves the correct template, applies the validation criteria, and processes results without manual intervention, eliminating user errors while maintaining the flexibility to handle diverse validation requirements through pre-configured templates

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The patent incorporates feedback mechanisms where the system automatically validates test results against the appropriate template criteria and provides real-time feedback on validation status. This automated feedback loop ensures consistent application of validation rules across all laboratories while reducing reliance on manual processes, thereby decreasing user error risk while preserving adaptability through configurable templates

Inventive Principle:
Principle #23Feedback

3Stability of the object's composition

If centralized control is implemented across multiple laboratories, then system-wide consistency is improved, but control complexity and management overhead increase

Engineering Contradiction:
Improvesystem-wide consistencyVSAvoidcentralized control complexity
Core Design Contradiction:
Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The patent creates universal validation templates that can be applied across multiple laboratories through profile assignment. A single template definition serves multiple functions by being reusable across different locations and test types, ensuring system-wide consistency without requiring separate configurations for each laboratory. This multi-functional approach simplifies centralized control while maintaining uniform validation standards across the entire network

Inventive Principle:
Principle #6Universality (Multi-functionality)

4Manufacturing precision

If validation criteria are customized for each laboratory, then local validation quality is improved, but configuration creation time and system setup complexity increase

Engineering Contradiction:
Improvevalidation qualityVSAvoidconfiguration creation time
Core Design Contradiction:
Manufacturing precisionVSLoss of time

Solution Approach 1:

The patent implements preliminary action by pre-configuring validation templates with commonly used validation criteria before deployment. Administrators can prepare and validate template configurations in advance, then rapidly deploy them to multiple laboratories through profile assignment. This preliminary preparation ensures high validation quality while dramatically reducing the time required for configuration creation and deployment across the network

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentEP3422014B1Laboratory system
Publication Date: 2024.07.24 F HOFFMANN LA ROCHE & CO AG
  • EP3422014B1 patent drawingFigure 1
  • EP3422014B1 patent drawingFigure 2~4
  • EP3422014B1 patent drawingFigure 5

AI summary

A laboratory system (100) is disclosed, wherein the laboratory system (100) comprises a plurality of laboratories (102) comprising one or more analytical instruments (104) for performing a plurality of analytical tests (T1-n) and providing analytical test results (TR1-n), and a remote computer (110) communicatively connected to the laboratories (102), wherein each of the laboratories (102) is configured to define test result validation criteria (C1-n) for validating at least one of the analytical test results (TR1-n) associated with the respective analytical tests (T1-n) of one of the plurality of laboratories (102), wherein the remote computer (110) is configured to define a plurality of profiles (P1-n) of validation criteria, to assign the profiles (P1-n) of test result validation criteria (C1-n) to one or more of the laboratories (102), and to perform an automatic validation of groups (G1-n) of the analytical test results (TR1-n) according to the profiles (P1-n) of test result validation criteria (C1-n).