CUSUM Rule for Selective Specimen Retesting in Clinical Diagnostics
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Solution Overview
Problem
Current clinical diagnostic processes face inefficiencies in detecting and addressing large out-of-control conditions, leading to unnecessary retesting of specimens, as existing quality control methods often fail to accurately identify the onset and scope of errors, resulting in duplicative testing and resource burdens.
Innovation Solution
A system and method that automatically identifies large out-of-control conditions, estimates the number of incorrect results, and applies a CUSUM rule to re-evaluate specimens, thereby pinpointing the origin of the error and retesting only affected specimens, reducing unnecessary retesting.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If all patient specimens are retested after an out-of-control condition is detected, then reliability of results is improved, but productivity deteriorates due to unnecessary duplicative testing
Solution Approach 1:
The patent segments the retesting process by dividing specimens into two groups: those tested during an out-of-control condition (which require retesting) and those tested during in-control conditions (which do not require retesting). This segmentation allows the system to selectively retest only the necessary specimens rather than all specimens, thereby maintaining reliability while improving productivity.
Solution Approach 2:
The patent applies partial action by retesting only the portion of specimens that were actually affected by the out-of-control condition, rather than performing excessive retesting on all specimens. The system uses quality control data to determine the exact timeframe of the out-of-control condition and retests only specimens processed during that specific period, eliminating unnecessary duplicative testing.
2Measurement precision
If the testing process is halted to identify unreliable results, then measurement precision is improved, but loss of time increases
Solution Approach 1:
The patent performs preliminary identification of unreliable results by using quality control data to automatically determine the timeframe of out-of-control conditions before reporting results. The system pre-identifies which specimens are affected by tracking the timing of quality control failures relative to specimen processing times, allowing rapid identification without halting the entire testing process.
Solution Approach 2:
The patent implements feedback mechanisms where quality control results are continuously monitored and used to automatically adjust the status of patient specimens. When quality control failures occur, the system provides feedback to identify affected specimens and triggers automatic retesting only for those specific specimens, enabling continuous operation while maintaining precision.
3Reliability
If quality control rules are made more stringent to detect out-of-control conditions, then reliability improves, but device complexity increases
Solution Approach 1:
The patent applies universality by using a single quality control system that performs multiple functions: it monitors quality control materials, automatically determines out-of-control timeframes, identifies affected patient specimens, and triggers selective retesting. This multi-functional approach consolidates what would otherwise require separate complex systems into one unified solution, maintaining high reliability while managing complexity.
Data Source
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AI summary
Disclosed are a system and method to recover from a large out-of-control condition in a clinical diagnostic process. Upon detection of a large out-of-control condition, a CUSUM rule is designed to predict if specimen test data was produced during the occurrence of that condition. Specimen test data is re-evaluated and the CUSUM rule is applied to determine whether to accept or reject the test results. Upon completion of the re-evaluation, old test results identified as being invalid are replaced with the the new, re-evaluated results and the new results are published if publication did not occur previously.