Accuracy Management for Clinical Analyzers

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Solution Overview

Problem

Existing accuracy management systems for clinical inspection automatic analyzers lack the ability to assess measurement result fluctuations based on specific operation events, rely heavily on human expertise for estimating cause, and often require extensive time to identify abnormal patterns before they exceed control ranges.

Innovation Solution

An accuracy management system that extracts and stores fluctuation patterns from past measurement results, displays them in a time-series format, and identifies operation events like calibration, reagent changes, and maintenance, allowing for the superposition of latest patterns with daily patterns to warn of deviations and facilitate cause analysis.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If manual assessment of measurement result fluctuations is performed by clinical laboratory technologists, then expert judgment can be applied, but time consumption and labor intensity increase significantly

Engineering Contradiction:

Improveaccuracy of cause identificationVSAvoidtime for cause analysis

Core Design Contradiction:

Measurement precisionVSLoss of time

Solution Approach 1:

The system performs self-assessment by automatically extracting fluctuation patterns, comparing them with stored daily patterns, and identifying causes without requiring manual intervention from laboratory technologists. The automatic analyzer system itself conducts the accuracy management assessment that previously required human expertise.

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

Manual mechanical assessment by technologists is replaced with automated computer-based analysis. The system uses algorithms to extract fluctuation patterns, compare them with historical data, and identify causes, substituting human cognitive processes with automated computational methods.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Reliability

If comprehensive monitoring of accuracy management results is implemented, then measurement quality is improved, but system complexity increases

Engineering Contradiction:

Improvemeasurement qualityVSAvoidsystem complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The system extracts only the essential fluctuation patterns from measurement results, separating the critical information needed for quality assessment from the complete dataset. By focusing on extracted patterns rather than analyzing all raw data, the system maintains high reliability while reducing processing complexity.

Inventive Principle:

Principle #2Taking out (Extraction)

3Loss of information

If detailed fluctuation pattern analysis is performed to identify causes, then accuracy of problem diagnosis is improved, but processing time increases

Engineering Contradiction:

Improvecompleteness of cause identificationVSAvoidspeed of accuracy management

Core Design Contradiction:

Loss of informationVSProductivity

Solution Approach 1:

The system pre-extracts and stores daily fluctuation patterns in advance, so that when analysis is needed, the comparison can be performed immediately against pre-processed reference data. This preliminary preparation of pattern data enables rapid cause identification without sacrificing diagnostic completeness.

Inventive Principle:

Principle #10Preliminary action

Data Source

PatentUS9229015B2Accuracy management method

Publication Date: 2016.01.05 HITACHI HIGH TECH CORP

AI summary

There is provided a comprehensive accuracy management method attained by including the steps of: displaying operation event information in time series in an accuracy management result chart or a calibration result chart on the same screen; accumulating a characteristic daily measurement value fluctuation pattern on the basis of a kind of an operation event; displaying the latest fluctuation pattern of measurement results and the daily measurement value fluctuation pattern in superposition with each other to warn of fluctuations which differ from the daily measurement value fluctuation pattern; and estimating and reporting the cause of the fluctuations.