Biometric quality control process

• US 7,203,619 B2
• Filed: 06/06/2005
• Issued: 04/10/2007
• Est. Priority Date: 08/24/2001
• Status: Expired due to Term

• Current Assignee: Bio-Rad Laboratories Incorporated
• Original Assignee: Bio-Rad Laboratories Incorporated
• Inventors: Parvin, Curtis, Cooper, William G., Cembrowski, George
• Primary Examiner(s): Tsai; Carol S. W.
• Assistant Examiner(s): O MALLEY, MARY CATHERINE
• Application Number:
  US11/039,179
• Publication Number:
  US 20050125186A1
• Time in Patent Office: 673 Days
• Field of Search: 702 81- 84, 702/179, 702181-182, 714703-705, 700107-108
• US Class Current: 702/179
• CPC Class Codes: G01N 35/00594 Quality control, including calibration or testing of components of the analyser
• CPC Class Codes: G06Q 10/10 Office automation; Time management
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 40/20 for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
• CPC Class Codes: Y10T 436/10 Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing

Abstract

Systems and methods configured to guide and manage laboratory analytical process control operations. A Biometric quality control (QC) process application is configured to monitor bias and imprecision for each test, characterize patient population data distributions and compare, contrast, and correlate changes in patient data distributions to any change in QC data populations. The Biometric QC process monitors the analytical process using data collected from repetitive testing of quality control materials and patient data (test results). The QC process identifies the optimal combination of, for example, frequency of QC testing, number of QCs tested, and QC rules applied in order to minimize the expected number of unacceptable patient results produced due to any out-of-control error condition that might occur.

Claims

1. A computer-implemented method of determining an optimal quality control rule for confirming that an analytical process is in control after an event has occurred, the method comprising:

identifying a maximum false rejection rate, pfr;

identifying a maximum acceptable risk of producing patient test results that contain analytical errors that exceed a specified total allowable error value, TEa;

determining a minimum number of quality control samples to test that would satisfy the false rejection rate and acceptable risk requirements;

determining optimal quality control rule rejection limits that satisfy the false rejection rate and acceptable risk requirements with the minimum number of quality control samples; and

testing the analytical process using the minimum number of quality control samples.