Analytical Test Manager for Automated Multi-Test Sequencing
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Solution Overview
Problem
Current medical testing systems, especially in small hospital laboratories, face challenges in managing complex combinations of tests due to staffing shortages, lack of training, and increased regulatory and quality demands, leading to potential mistakes and delays in time-critical treatment decisions.
Innovation Solution
A system and method for managing analytical tests through an analyzer and a test manager module that processes both simple and complex test orders, generating secondary test requests as needed, to ensure reliable and controllable testing outcomes, while maintaining vendor control over testing sequences and reagent management.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If complex combinations of tests are managed manually in small hospital laboratories, then flexibility in test selection is maintained, but error rate increases and reliability decreases
Solution Approach 1:
A test manager module is introduced as an intermediary between the order interface and analyzer. This module automatically manages complex test combinations, sample routing, and result integration, eliminating manual coordination errors while maintaining system flexibility through programmable test protocols
Solution Approach 2:
The testing system is segmented into distinct functional modules: order management interface, test manager module, analyzer, and result reporting system. Each module handles specific tasks independently, improving reliability through modular error isolation while reducing overall system complexity through standardized interfaces
2Reliability
If samples are transferred to certified laboratories for complex testing, then regulatory compliance is improved, but time delay increases and productivity decreases
Solution Approach 1:
The system performs preliminary quality control checks, sample validation, and test protocol verification at the hospital laboratory before analysis. This preliminary preparation ensures samples meet regulatory requirements, allowing complex tests to be performed in-house without time-consuming transfers to external laboratories
Solution Approach 2:
The hospital laboratory is equipped with analyzers capable of performing complex test combinations autonomously under automated management. The test manager module handles sample tracking, test execution coordination, and result validation, enabling the laboratory to self-service complex testing needs without external dependency
3Adaptability or versatility
If multiple tests are ordered individually and results are combined manually, then test flexibility is maintained, but mistake probability increases and reliability decreases
Solution Approach 1:
The test manager module provides universal management capabilities for multiple test types and combinations through a single automated system. It can handle simple single-analyte tests, complex multi-analyte panels, and conditional test sequences, maintaining flexibility through programmable protocols while ensuring accurate result integration through automated data processing
4Productivity
If certified laboratories increase throughput and reduce personnel costs, then productivity improves, but device complexity and automation requirements increase
Solution Approach 1:
The test management system employs dynamic protocols that can be configured for different test scenarios, patient conditions, and laboratory capabilities. Test sequences, sample routing, and result interpretation rules are dynamically adjusted based on real-time conditions, enabling high throughput while maintaining clinical decision-making flexibility through adaptable automation
Data Source
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AI summary
Disclosed is an analytical test management system and method that can in certain embodiments reduce the likelihood that errors are made during the performance of combinations of analytical tests that together are used to provide an analytical result that can be the basis of a diagnosis or a treatment decision. In one embodiment, test orders submitted through a test order interface are received at a test manager module that decides whether the test order is for a simple test or whether the test order is for a combination of tests. If the test order is for a simple test, the test order is forwarded to an analyzer for processing. If the test order is for a combination of tests that together lead to a final result, the test order manager module assumes control over the test order and directs the analyzer according to secondary test requests, the results of which are used by the test order manager module to, for example, decide whether additional secondary test requests should be sent to the analyzer or make calculations used to provide the final result.