Analytical Instrument User Certification via Examination Module

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Solution Overview

Problem

Current quality assurance methods for bedside or point of care diagnostic testing are inadequate, relying heavily on self-training and supervision, which can lead to unreliable test results due to the lack of standardized certification for users.

Innovation Solution

A system that includes an analytical instrument with an input section for user authentication and a testing section that runs a routine only accessible to certified users. This system features an examination module that administers a certification exam to users, ensuring they have sufficient knowledge about the instrument and testing procedures before allowing access to the testing routine.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If self-training and supervisor training are used for user certification, then ease of operation is improved, but reliability of test results deteriorates

Engineering Contradiction:
Improveease of user certificationVSAvoidreliability of test results
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent introduces an examination module as an intermediary between users and the analytical instrument. This module administers standardized exams with predefined questions and answers, objectively assessing user knowledge without relying on subjective supervisor judgment or self-assessment, thereby improving reliability while maintaining ease of certification

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The system enables users to independently complete standardized exams and obtain certification without requiring continuous supervisor involvement. The automated examination module handles question delivery, answer evaluation, and certificate generation, making the certification process self-service while ensuring consistent quality standards

Inventive Principle:
Principle #25Self-service

2Reliability

If individual training by supervisor is provided for each user, then reliability of test results is improved, but loss of time increases

Engineering Contradiction:
Improvereliability of test resultsVSAvoidtime for user certification
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent creates a standardized examination template that can be replicated and administered to multiple users simultaneously. Instead of customizing training for each user, the same validated exam questions and criteria are copied and applied across all users, ensuring consistent reliability while dramatically reducing the time and effort required for certification

Inventive Principle:
Principle #26Copying

Solution Approach 2:

The examination module is pre-configured with standardized questions, correct answers, and passing criteria before users arrive. This preliminary preparation eliminates the need for supervisors to create and deliver individualized training content during user certification, reducing time loss while maintaining reliable assessment standards

Inventive Principle:
Principle #10Preliminary action

3Reliability

If access control based on supervisor decision is implemented, then reliability of test results is improved, but device complexity increases

Engineering Contradiction:
Improvereliability of test resultsVSAvoidcomplexity of access control system
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent replaces the mechanical/manual system of supervisor-based access decisions with an automated electronic examination module. The system uses computer-based question delivery, automatic answer evaluation, and electronic certificate management, substituting complex human judgment processes with simpler automated digital operations that maintain reliability while reducing system complexity

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Data Source

PatentEP3822952B1System and method for quality assured analytical testing
Publication Date: 2025.06.04 F HOFFMANN LA ROCHE & CO AG
  • EP3822952B1 patent drawingFigure 1
  • EP3822952B1 patent drawingFigure 2~3
  • EP3822952B1 patent drawingFigure 4a~4g

AI summary

Disclosed is a system for quality assured testing in the field of extra corporal analytical testing that comprises: an analytical instrument (40) for conducting analytical testing, the analytical instrument (40) having an input section for inputting a user identification, and the analytical instrument (40) being adapted to run a testing routine. An examination module is programmed to conduct an exam during which it: prompts questions to the user which relate to the analytical instrument (40) and/or a diagnostic test to be conducted therewith, receives answers from the user to the questions and evaluates the answers, determines if the user has passed the exam, and the examination module in case that the user passed the exam transmits a user certificate to the analytical instrument. The analytical instrument (40) is programmed to check if a user is a certified user based on an inputted user identification. The analytical instrument (40) is programmed to grant access to the testing routine only if the user is a certified user.