Methods for assuring quality compliance of point-of-care instruments used with single-use testing devices
Inventors
Glavina, Paul • Tirinato, Jody Ann
Assignees
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Publication Number
US-11994526-B2
Publication Date
2024-05-28
Expiration Date
Abstract
The present invention relates to systems and methods of determining quality compliance for one or more biological sample testing instruments used with one or more type of single-use blood testing cartridge, at the point-of-care in a hospital, or other location that deliver medical care. In particular, the systems and methods ensure that only instruments that pass a quality assurance protocol are used for point-of-care testing.
Core Innovation
The invention describes a computer implemented method for centrally coordinating risk-management based quality compliance for point-of-care biological sample testing. A data manager transmits requests for instrument calibration verification to two or more instruments based on a predetermined schedule, and the instruments perform instrument calibration verification in response to the requests. The calibration verification uses either predetermined numbers and types of calibration fluids and predetermined numbers of sample testing cartridges, or an electronic simulator, to generate calibration verification data.
The data manager receives the calibration verification data from the two or more instruments and determines a compliance status for each instrument by determining whether the calibration verification data is within range of predetermined calibration target values. The method stores the compliance status for each instrument in a data table that includes identification information associated with the instruments and the compliance status. The data manager transmits the data table to the two or more instruments.
The method controls whether analytical testing proceeds based on the stored compliance status. The method enables use of a first instrument for performing one or more analytical tests on a first biological sample when the compliance status indicates the first instrument is in compliance, and it at least partially disables use of a second instrument when the compliance status indicates the second instrument is not in compliance.
Claims Coverage
One independent claim covers scheduling and transmitting calibration verification requests, generating calibration verification data using calibration fluids and cartridges or an electronic simulator, determining per-instrument compliance against predetermined target value ranges, storing compliance status in a data table, and selectively enabling or at least partially disabling analytical testing based on compliance status.
Scheduled calibration verification request transmission to instruments
Transmitting a request for instrument calibration verification from a data manager to two or more instruments based on a predetermined schedule.
Calibration verification data generation using calibration fluids and cartridges or electronic simulator
Performing instrument calibration verification in response to the request and using a predetermined number and type of calibration fluids and a predetermined number of sample testing cartridges, or an electronic simulator, to generate calibration verification data.
Compliance status determination against calibration target values
Determining at the data manager a compliance status for each of the two or more instruments as compliant or non-compliant based on whether the calibration verification data is within range of predetermined calibration target values.
Compliance status data table storage and distribution
Storing the compliance status for each of the two or more instruments in a data table comprising identification information associated with the instruments and the compliance status, and transmitting the data table to the two or more instruments.
Selective enabling or disabling of analytical tests based on compliance status
Enabling use of a first instrument for performing one or more analytical tests on a first biological sample when the compliance status indicates the first instrument is in compliance, and at least partially disabling use of a second instrument when the compliance status indicates the second instrument is not in compliance.
The independent claim implements a centrally managed calibration verification and compliance workflow in which calibration verification data is generated by instruments, compliance is determined against predetermined calibration target value ranges, compliance status is stored and distributed via a data table, and analytical testing is selectively enabled or at least partially disabled according to whether each instrument is marked compliant or non-compliant.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Risk-management based quality compliance for point-of-care (POC) biological sample testing using centrally coordinated calibration verification for two or more instruments.
Selective enabling and at least partially disabling of instruments for performing analytical tests on biological samples based on compliance status determined from instrument calibration verification.
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