System and method for integrating the internal and external quality control programs of a laboratory

• US 7,467,054 B2
• Filed: 05/02/2003
• Issued: 12/16/2008
• Est. Priority Date: 05/02/2003
• Status: Active Grant

• Current Assignee: Bio-Rad Laboratories Incorporated
• Original Assignee: Bio-Rad Laboratories Incorporated
• Inventors: Yundt-Pacheco, John
• Primary Examiner(s): Cosimano; Edward R
• Assistant Examiner(s): Washburn; Douglas N
• Application Number:
  US10/428,584
• Publication Number:
  US 20040220761A1
• Time in Patent Office: 2,055 Days
• Field of Search: 700/110, 702/81, 702/84, 702/182, 702/83, 702/179, 702/181, 702/183, 702/184, 702/185
• US Class Current: 702/84
• CPC Class Codes: G01D 18/00 Testing or calibrating apparatus or arrangements provided for in groups G01D1/00 - G01D15/00
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis

Abstract

A system and method that enables a laboratory to integrate its internal and external quality control programs to thereby control the quality of its laboratory testing services. The system comprises a storage device and a processor operable to maintain in the storage device a database identifying a plurality of laboratory tests and the corresponding internal laboratory statistical data, group statistical summary data and control rules. The processor is also operable to calculate a control range for a specified laboratory test by applying the group statistical summary data (and, in some cases, the internal laboratory statistical data) to the control rule corresponding to the specified laboratory test. Preferably, the processor is also operable to receive a test result from a laboratory instrument, and determine whether the test result falls within the calculated control range for the specified laboratory test. Various exemplary embodiments of the system and associated method are provided.

Claims

1. A system for integrating the internal and external quality control programs of a laboratory utilizing control rules for specified laboratory tests, comprising:

at least one storage device;

at least one processor operable to;

maintain in the storage device at least one database identifying a plurality of laboratory tests and corresponding group statistical summary data, the database also identifying the plurality of laboratory tests data and corresponding control rules expressed as a function of the group statistical summary data;

calculate a control range for a specified one of the laboratory tests by applying the group statistical summary data for the specified laboratory test to the control rule for the specified laboratory test whereby the calculated control range defines an acceptable range of test result values for the specified laboratory test;

receive updated group statistical summary data from a central agency in response to a synchronization command; and

transfer the updated group statistical summary data to the database whereby the updated group statistical summary data becomes the group statistical summary data.

2. A computerized method for integrating the internal and external quality control programs of a laboratory utilizing control rules for specified laboratory tests, comprising:

maintaining at least one database identifying a plurality of laboratory tests and corresponding group statistical summary data, the database also identifying the plurality of laboratory tests and corresponding control rules expressed as a function of the group statistical summary data;

calculating a control range for a specified one of the laboratory tests by applying the group statistical summary data for the specified laboratory test to the control rule for the specified laboratory test whereby the calculated control range defines an acceptable range of test result values for the specified laboratory test;

receiving updated group statistical summary data from a central agency in response to a synchronization command; and

transferring the updated group statistical summary data to the database whereby the updated group statistical summary data becomes the group statistical summary data.

3. A computer-readable medium having computer-executable instructions for performing a method of integrating the internal and external Quality control programs of a laboratory utilizing control rules for specified laboratory tests, the method comprising:

maintaining at least one database identifying a plurality of laboratory tests and corresponding group statistical summary data, said database further identifying the plurality of laboratory tests and corresponding control rules expressed as a function of the group statistical summary data;

calculating a control range for a specified one of the laboratory tests by applying the group statistical summary data for the specified laboratory test to the corresponding control rule whereby the calculated control range defines an acceptable range of test result values for the specified laboratory test; and

receiving updated group statistical summary data from a central agency in response to a synchronization command; and

transferring the updated group statistical summary data to the database whereby the updated group statistical summary data becomes the group statistical summary data.

4. A computer-readable medium having computer-executable instructions for performing a method of integrating the internal and external quality control programs of a laboratory utilizing control rules for specified laboratory tests, the method comprising:

maintaining at least one database identifying a plurality of laboratory tests and the corresponding group statistical summary data and the database also identifying the corresponding control rules;

receiving updated group statistical summary data from a central agency in response to a synchronization command;

transferring the updated group statistical summary data to the database whereby the updated group statistical summary data becomes the group statistical summary data;

receiving a test result from a laboratory instrument for a specified one of the laboratory tests;

calculating a control range for the specified laboratory test by applying the corresponding group statistical summary data to the corresponding control rule; and

determining whether the test result falls within the calculated control range.