Management system for point of care testing
Inventors
Glavina, Paul • Tirinato, Jody Ann • Emeric, Pierre • Molloy, Dan • Weber, Maureen • Fetters, Christopher
Assignees
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Publication Number
US-11488088-B2
Publication Date
2022-11-01
Expiration Date
Abstract
The present invention relates to a method and system for quality compliance, system and operator verification, and process management for point of care biological sample testing systems used in hospitals and other medical delivery environments. Specifically, the present invention may be directed to a computing device configured to generate a plurality of attributes configured to assess a competency level of an operator to operate at least one sample testing instrument, obtain operator derived data pertaining to the operator's ability to operate the at least one sample testing instrument, and determine a competency level of the operator for the at least one sample testing instrument based the plurality of attributes and the operator derived data.
Core Innovation
The disclosed invention provides a method and system for assessing a competency level of an operator to operate at least one sample testing instrument. The at least one sample testing instrument includes a disposable device operating in conjunction with an analyzer to perform an analytical test on a sample. The approach generates a plurality of attributes for the operator competency assessment, including at least two attributes selected from knowledge tests and practical tests for operating the instrument, acquiring and disposing of the sample, sample testing regulations, obtaining analytical test results, quality control testing, and data entry and data handling.
The method sets a compliance threshold for the at least one sample testing instrument and obtains operator derived data pertaining to the operator’s ability to operate the at least one sample testing instrument. The operator derived data comprises at least two attribute test results obtained by the operator. The invention determines a compliance status for each of the at least two attributes by comparing each obtained attribute test result to a set compliance status threshold for that attribute, and then determines an overall compliance status based on the determined compliance status for each attribute.
The invention determines the competency level of the operator for the at least one sample testing instrument by comparing the overall compliance status to the set compliance threshold. The competency level is communicated to the at least one sample testing instrument such that, when the competency level is indicative of non-compliance, the competency level causes the at least one sample testing instrument to lock out the operator from operating the at least one sample testing instrument. In dependent refinements and system refinements, the invention can further link operator identifiers to attribute test results, use electronic signature elements and electronic log event elements, and generate an event profile for an operator linked to the operator identifier.
Claims Coverage
The independent claims are directed to a method, a system, and a computer-program product for operator competency assessment using multiple attribute-based tests. Across these independent claims, four inventive features are present: generating a plurality of attributes, evaluating per-attribute and overall compliance using compliance thresholds, determining a competency level from the overall compliance, and communicating the competency level to the sample testing instrument to lock out non-compliant operators.
Generate a plurality of attributes for operator competency assessment
Generating a plurality of attributes configured to assess a competency level of an operator to operate at least one sample testing instrument, the at least one sample testing instrument comprising a disposable device operating in conjunction with an analyzer to perform an analytical test on a sample, wherein the plurality of attributes comprises at least two attributes selected from the group consisting of a knowledge test for operation of the at least one sample testing instrument, a knowledge test for acquisition and disposition of the sample with the at least one sample testing instrument, a knowledge test on sample testing regulations, a practical test on obtaining results of the analytical test with the at least one sample testing instrument, a practical test on quality control testing with the at least one sample testing instrument, and a practical test on data entry and data handling with the at least one sample testing instrument.
Set compliance threshold and obtain operator derived attribute test results
Setting a compliance threshold for the at least one sample testing instrument; obtaining operator derived data pertaining to an ability of the operator to operate the at least one sample testing instrument, wherein the operator derived data comprises at least two attribute test results obtained by the operator.
Determine per-attribute compliance status and overall compliance status
Determining a compliance status of the operator for each of at least two attributes of the plurality of attributes based on a comparison of each of the obtained at least two attribute test results to a set compliance status threshold for each of at least two attributes, respectively; determining an overall compliance status of the operator based on the determined compliance status of the operator for each of the at least two attributes.
Determine competency level and communicate to lock out non-compliant operators
Determining the competency level of the operator for the at least one sample testing instrument based on a comparison of the overall compliance status of the operator to the set compliance threshold; communicating the competency level of the operator to the at least one sample testing instrument, wherein when the competency level of the operator is indicative of non-compliance, the competency level causes the at least one sample testing instrument to lock out the operator from operating the at least one sample testing instrument.
Across the independent method, system, and computer-program product claims, operator competency is established by generating multiple attribute-based tests for disposable-device sampling with an analyzer, comparing per-attribute results against set compliance status thresholds, deriving an overall compliance status, mapping that to a competency level using a set compliance threshold, and communicating the competency level to the instrument so that non-compliance results in lockout.
Stated Advantages
Automatically locks out non-compliant operators from operating the sample testing instrument when the competency level is indicative of non-compliance.
Documented Applications
No documented applications found
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