Biometric quality control process

• US 7,286,957 B2
• Filed: 05/02/2005
• Issued: 10/23/2007
• 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): Wachoman; Hal
• Assistant Examiner(s): O MALLEY, MARY CATHERINE
• Application Number:
  US11/039,701
• Publication Number:
  US 20050192775A1
• Time in Patent Office: 904 Days
• Field of Search: 702/19, 702 21- 25, 702 30- 32, 702/81, 702/84, 702179-181, 702/183, 702/27, 436 8- 19, 340/3.3, 340/3.32, 340 342- 343
• 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 implementing a quality control testing strategy based on patient test data, comprising:

acquiring patient test data from one or more laboratory instruments for a specific analyte, said patient test data including a plurality of weeks worth of data;

calculating time-interval baseline statistics for each of a plurality of specific recurring time intervals in the patient test data;

normalizing the patient test data using the time-interval baseline statistics;

applying a EWMA rule to the normalized patient data; and

generating a system alert signal if the normalized patient data exceeds the error threshold of the EWMA rule.

2. The method of claim 1, wherein each specific recurring time interval is a day of the week.

3. The method of claim 1, wherein each specific recurring time interval is an hour of the week.

4. The method of claim 1, further including truncating the patient test data.

5. The method of claim 4, wherein truncating the patient test data is performed prior to calculating the baseline statistics.

6. The method of claim 4, wherein truncating includes determining a set of truncation limits that maximize a decrease in the standard deviation of the patient data within the truncation limits relative to the number of patient data values outside the truncation limits.

7. The method of claim 4, wherein truncating includes determining non-parametric truncation limits.

8. The method of claim 1, wherein calculating time-interval baseline statistics includes calculating the mean and standard deviation of the patient data for each of the plurality of specific recurring time intervals.