Shared Protocol Statements in Molecular Diagnostics
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Solution Overview
Problem
In molecular diagnostic laboratories, the steps between specimen receipt and test result generation are not adequately electronically documented, leading to manual recording and lack of searchable data, which hinders trend analysis, error identification, and accuracy in test results.
Innovation Solution
Implementing computerized methods and systems for creating and documenting protocol orders, allowing values to be entered for protocol statements, associating protocol orders into batches, and sharing values among batch members, with proactive notification for changes affecting other orders or results.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of information
If manual recording methods are used for protocol data, then data can be captured without electronic systems, but data cannot be searched for trend analysis and error identification
Solution Approach 1:
The patent replaces manual mechanical recording systems (paper-based laboratory notebooks) with an electronic computerized system. The LIMS captures protocol data electronically, enabling searchable databases that maintain all workflow information while eliminating the limitations of manual recording. This substitution transforms uncsearchable paper records into queryable electronic data without requiring complete workflow redesign.
2Productivity
If each protocol order requires independent data entry, then data accuracy can be maintained, but time consumption increases significantly
Solution Approach 1:
The patent merges data entry operations by implementing batch processing functionality where multiple protocol orders are grouped together. A single data entry operation can populate information across multiple batched orders simultaneously, reducing repetitive typing while maintaining data integrity through the system's validation rules and accuracy checks.
Solution Approach 2:
The system implements automated copying of protocol data across batched orders. When a protocol statement value is entered for one order in a batch, the system automatically copies this value to corresponding fields in other batched orders, eliminating manual repetition while preserving accuracy through centralized data management.
3Device complexity
If protocol data is not electronically captured, then system complexity is reduced, but trend evaluation and error identification become impossible
Solution Approach 1:
The patent implements feedback mechanisms where the electronic LIMS continuously captures protocol data and makes it available for real-time analysis. The searchable database enables automated feedback loops that can identify trends, flag potential errors, and provide quality control metrics without adding significant operational complexity to the core protocol execution process.
Data Source
AI summary
Computerized methods and systems for creating and documenting protocol orders in a molecular diagnostic laboratory environment are provided. Utilizing the methods and systems described herein, protocol statements may require values to be entered in association therewith prior to permitting access to subsequent protocol orders. Accordingly, more accurate test runs and, consequently, more accurate test results, may be achieved. Additionally, as values associated with protocol statements are electronically captured, in accordance with embodiments hereof, such values may be searched to evaluate trends or identify protocol orders and/or results that may be affected by a later discovered error or the like.