Method for automated exception-based quality control compliance for point-of-care devices

• US 20030097238A1
• Filed: 12/17/2002
• Published: 05/22/2003
• Est. Priority Date: 12/30/2000
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Harmon, Kirk C.
• Granted Patent: US 6,856,928 B2
• Time in Patent Office: Days
• US Class Current: 702/183
• CPC Class Codes: A61B 2560/0271 using a remote monitoring unit
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: G16H 40/20 for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms

Abstract

A computer-implemented method to process POC information for potential QC compliance issues. A system and method for implementation of traditional laboratory analyzer based QC compliance in point-of-care (POC) environments is disclosed. A specific system and method to analyze data from POC testing to identify when the testing exceeds the variation expected under stable operation (i.e., the testing is “out of control”) is disclosed. This system and method is characterized by solving the QC compliance problem for POC devices by individuals not trained in traditional laboratory practices. This also provides the capability in real-time or near real-time to analyze POC testing information regarding the performance of each POC device, reagent kit (i.e., one kit per analyte tested) and/or lot, and operator so one can respond quickly to a particular device, reagent kit and/or lot, or operator that is not performing properly.

Claims

1. A method of providing automatic quality control (QC) compliance for point-of-care (POC) devices, comprising the steps of

storing test results received from each of a plurality of POC devices, including an association with the operator of the POC device and/or a reagent used in obtaining the test results, and

processing the results to detect any random and/or systemic exception from results that have previously been stored.

2. A method as claimed in claim 1 including the further step of holding for review POC-collected patient results associated with a QC compliance exception.

3. A method as claimed in claim 2 including the further step responsive to said detecting step of delaying the reporting or transfer to an information system of potentially inaccurate patient results.

4. A method as claimed in claim 2 further including reporting on an expedited basis that patient results may be the result of a QC compliance exception.

5. A method as claimed in claim 2 including the further step of logging and maintaining QC compliance exceptions to the rules.

6. A method as claimed in claim 5 including the further step of alerting a POC administrator to detection of a QC compliance exception.

7. A method as claimed in claim 6 including the further step of allowing the POC administrator to review, comment on, and accept or reject associated patent results.

8. A method as claimed in claim 7 including the further step of allowing the POC administrator to clear a QC compliance alert after review.

9. A method as claimed in claim 3 including the further step of automatically disabling a questionable POC device based on detection of a QC compliance exception.

10. A method as claimed in claim 2 including the further step of automatically invalidating a reagent lot that has established a QC exception by configuring a selected POC device.

11. A method as claimed in claim 2 including the further step of automatically invalidating an operator who has established a QC exception by configuring a selected POC device.

12. A method as claimed in claim 1 including the step of graphically presenting QC exceptions.

13. A method as claimed in claim 12 wherein the administrator can establish via an interface to a storage database the rules for defining the exceptions.

14. A method as claimed in claim 14 wherein the step of establishing rules includes a choice made on the interface between analyzing the data for random error or systemic error.