Method and apparatus for providing quality control in an instrument for medical analysis

• US 6,748,337 B2
• Filed: 12/14/2001
• Issued: 06/08/2004
• Est. Priority Date: 03/14/2001
• Status: Expired due to Term

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Wardlaw Partners LP
• Inventors: Wardlaw, Stephen C., Levine, Robert A.
• Primary Examiner(s): Barlow, John
• Assistant Examiner(s): BHAT, ADITYA S
• Application Number:
  US10/021,959
• Publication Number:
  US 20020133255A1
• Time in Patent Office: 907 Days
• Field of Search: 702/81, 702/84, 435/6, 250/288
• US Class Current: 702/84
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades

Abstract

A method and apparatus for providing quality control in a medical analysis instrument is provided. The method includes the steps of: 1) sending one or more quality control specimens to an operator of the analytical instrument; 2) directly or indirectly communicating control data to the analytical instrument, wherein the control data relates acceptable standards to the analytical instrument; 3) analyzing the quality control specimen using the analytical instrument and thereby creating instrument analysis data; 4) evaluating the instrument analysis data using the control data to determine a functional status of the analytical instrument; 5) providing notice to the operator regarding the functional status of the analytical instrument; and 6) optionally preventing the reporting of patient data from the instrument if the functional status is unacceptable.

Claims

1. A method for providing quality control in an analytical instrument, said method comprising the steps of:

sending one or more quality control specimens to an operator of the analytical instrument;

directly or indirectly communicating control data to the analytical instrument, wherein the control data includes characteristic values for the one or more quality control specimens;

analyzing the quality control specimen using the analytical instrument and thereby creating instrument analysis data;

evaluating the instrument analysis data using the control data to determine a functional status of the analytical instrument; and

providing notice to an operator regarding the functional status of the analytical instrument;

wherein the control data is communicated to the analytical instrument by a machine-readable label attached to the quality control specimen.

2. A method for providing quality control in an analytical instrument, said method comprising the steps of:

sending one or more quality control specimens to an operator of the analytical instrument;

directly or indirectly communicating control data to the analytical instrument, wherein the control data includes characteristic values for the one or more quality control specimens;

analyzing the quality control specimen using the analytical instrument and thereby creating instrument analysis data;

evaluating the instrument analysis data using the control data to determine a functional status of the analytical instrument; and

providing notice to an operator regarding the functional status of the analytical instrument;

wherein the control data is communicated to the analytical instrument by a machine-readable medium supplied with the quality control specimen.

3. A method for providing quality control in an analytical instrument, said method comprising the steps of:

sending one or more quality control specimens to an operator of the analytical instrument;

directly or indirectly communicating control data to the analytical instrument, wherein the control data includes characteristic values for the one or more quality control specimens;

analyzing the quality control specimen using the analytical instrument and thereby creating instrument analysis data;

evaluating the instrument analysis data using the control data to determine a functional status of the analytical instrument;

providing notice to an operator regarding the functional status of the analytical instrument; and

communicating to the analytical instrument that the quality control specimen is for quality control purposes;

wherein the step of communicating to the analytical instrument that the quality control specimen is for quality control purposes is performed by the analytical instrument reading a machine-readable label.

4. A method for providing quality control in an analytical instrument, said method comprising the steps of:

sending one or more quality control specimens to a operator of the analytical instrument;

directly or indirectly communicating control data to the analytical instrument, wherein the control data includes characteristic values for the one or more quality control specimens;

analyzing the quality control specimen using the analytical instrument and thereby creating instrument analysis data;

evaluating the instrument analysis data using the control data to determine a functional status of the analytical instrument; and

providing notice to an operator regarding the functional status of the analytical instrument;

wherein notice is provided to the operator by preventing the release of a test result until the functional status of the analytical instrument is acceptable.

5. A method for providing quality control in an analytical instrument, said method comprising the steps of:

sending one or more quality control specimens to an operator of the analytical instrument;

directly or indirectly communicating control data to the analytical instrument, wherein the control data includes characteristic values for the one or more quality control specimens;

analyzing the quality control specimen using the analytical instrument and thereby creating instrument analysis data;

evaluating the instrument analysis data using the control data to determine a functional status of the analytical instrument;

providing notice to an operator regarding the functional status of the analytical instrument; and

providing a preprogrammed schedule for quality control procedures to analytical instrument.

6. The method of claim 5, further including the step of providing notice to the operator that a quality control procedure is scheduled.

7. The method of claim 5, further including the step of disabling the analytical instrument if the scheduled quality control procedure is not performed within a predetermined period of time.

8. The method of claim 5, further including the step of automatically providing notice to a service provider that a scheduled quality control procedure has not been performed within a predetermined period of time.

9. A quality control system for analytical instruments, said system comprising:

one or more quality control specimens, each having one or more predetermined characteristic values and an identifier that can identify the quality control specimen;

an analytical instrument, having an analyzer for analyzing the one or more quality control specimens, and thereby create instrument analysis data that includes one or more sensed characteristic values;

means for evaluating the sensed characteristic values of the instrument analysis data using the predetermined characteristic values to determine a functional status of the analytical instrument, wherein the means for evaluating the sensed characteristic values of the instrument analysis data using the predetermined characteristic values does not require input from an operator;

means for notifying an operator regarding the functional status of the analytical instrument; and

means for selectively preventing the reporting of test results in the event the functional status of the analytical instrument is determined to be unacceptable.