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-11995598-B2
Publication Date
2024-05-28
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 invention relates to a compliance monitor system for point-of-care biological sample testing. A data tracking system generates a plurality of attributes configured to assess a competency level of an operator to operate at least one sample testing instrument, and the plurality of attributes are selected from practical tests that include obtaining biological sample test results, quality control testing, and data entry and data handling with the at least one sample testing instrument.
The data tracking system 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, and the system determines a compliance status of the operator for the plurality of attributes based on the obtained operator derived data.
The competency level of the operator is determined by comparing the compliance status to the set compliance threshold, and the data tracking system communicates the competency level to the at least one sample testing instrument. The instrument is configured to receive the competency level and lock the operator from further operating the at least one sample testing instrument when the competency level is non-compliant.
The data tracking system further comprises a testing result store configured to communicate in a mono-directional or bi-directional manner with the at least one sample instrument internal to the system such that the data tracking system obtains the operator derived data.
Claims Coverage
The independent claim includes five inventive features centered on generating attributes for operator competency assessment, using a compliance threshold to determine compliance status and competency level, enforcing competency by locking non-compliant operators at the instrument, and obtaining operator-derived data through testing result store communication. The dependent claim further links the operator-derived data to an operator identifier.
Attribute-based competency assessment
A compliance monitor system generating a plurality of attributes configured to assess a competency level of an operator to operate at least one sample testing instrument, wherein generating the plurality of attributes comprises selecting at least two attributes from practical tests on obtaining biological sample test results, quality control testing, and data entry and data handling.
Compliance threshold determination of competency level
The data tracking system sets a compliance threshold for the at least one sample testing instrument, obtains operator derived data comprising at least two attribute test results obtained by the operator, determines a compliance status of the operator for the plurality of attributes based on the obtained operator derived data, and determines the competency level based on comparison of the compliance status to the set compliance threshold.
Instrument enforcement using competency level lockout
Communicating the competency level of the operator to the at least one sample testing instrument, wherein the at least one sample testing instrument is configured to receive the competency level and lock the operator from further operating the at least one sample testing instrument when the competency level is non-compliant.
Mono-directional or bi-directional testing result store communication
The data tracking system comprises a testing result store configured to communicate in a mono-directional or bi-directional manner with the at least one sample instrument internal to the system such that the data tracking system obtains the operator derived data.
Operator identifier linkage to attribute test results
The compliance monitor system wherein the operator derived data comprises at least two attribute test results obtained by the operator and the obtaining of the operator derived data comprises receiving the at least two test attribute results and an operator identifier configured to identify the operator.
Overall, the claim coverage is focused on an attribute-driven operator competency framework that uses a compliance threshold to determine a competency level from operator-derived attribute test results, communicates that competency level to the instrument, and enforces compliance by locking non-compliant operators. Operator-derived data is obtained via a mono-directional or bi-directional testing result store communication, and the dependent claim further links attribute test results to an operator identifier.
Stated Advantages
Documented Applications
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