Multi-rule quality control method and apparatus

• US 6,269,276 B1
• Filed: 03/31/1998
• Issued: 07/31/2001
• Est. Priority Date: 03/31/1998
• Status: Expired due to Fees

• Current Assignee: Roche Diagnostics Corporation (Roche Holding AG)
• Original Assignee: Roche Diagnostics Corporation (Roche Holding AG)
• Inventors: Scarr, Gary K., Simmons, Mark J., Wedel, Dale L., Akhavan, Kamran, Rusu, Laurian I.
• Primary Examiner(s): Gordon, Paul P.
• Assistant Examiner(s): Bahta, Kidest
• Application Number:
  US09/052,613
• Time in Patent Office: 1,218 Days
• Field of Search: 700/26, 700/6, 700/97, 700/90, 700/11, 700/17, 700/18, 700/19, 700/8, 700/3, 700/96, 702/19, 702/25, 702/121, 702/81
• US Class Current: 700/97
• CPC Class Codes: G01N 33/487 of liquid biological material
• 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
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

A method and apparatus for analyzing the results of determinations of the concentrations of medically significant components of control solutions comprise providing a programmable machine, executing on the machine a program which tests the results against a set of statistical quality control rules, and producing indications to an operator of the results of the tests. Illustratively, (a) laboratory analytical instrument(s) run(s) the control solutions interspersed among patient samples, the concentrations of medically significant components of which are determined by the laboratory instrument(s). The quality of the laboratory instrument'"'"'s(s'"'"') process(es) for determining the concentrations of the medically significant components of the patient samples are monitored by testing the outcomes of the concentration determinations of the control solutions against the set of QC rules. The QC testing process is conducted as the concentrations of the medically significant components of the control solutions are determined, so that delays between the determination of the concentrations of the medically significant components of the patient samples and the determination of the state of control of the process(es) by which those concentrations are determined are minimized.

Claims

1. A system for analyzing results of determinations of concentrations of medically significant components of control solutions, the system consisting essentially of a programmable machine, a program executable on the machine for testing the results against a set of multiple rules selected by a system operator, and for producing indications to the operator of the results of the tests, an instrument for sequentially determining the concentrations of medically significant components of multiple samples of control solutions, and an interface for relaying the results of the determinations of the concentrations of the medically significant components of the control solutions to the programmable machine to be tested by the program.

2. A system for analyzing results of determinations of concentrations of medically significant components of control solutions, the system including a programmable machine, a program executable on the machine for testing the results against selected rules from among a set of multiple, operator-selectable rules, and for producing indications to the operator of the results of the tests, an instrument for sequentially determining the concentrations of medically significant components of multiple samples of control solutions, and an interface for relaying the results of the determinations of the concentrations of the medically significant components of the control solutions to the programmable machine to be tested by the program, the program for testing the results against selected rules including a program for testing a result of a first determination of the concentration of a first medically significant component of a first sample of a first control solution against a first subset of the set of multiple rules, and subsequently testing a result of at least one of:

a second determination of the concentration of the first medically significant component of the first sample of the first control solution;

the concentration of a second medically significant component of the first sample of the first control solution;

the concentration of the first medically significant component of a second sample of the first control solution; and

, the concentration of a first medically significant component of a first sample of a second control solution, against at least one of the first subset and a second subset of the set of multiple rules.

3. The system of claim 2 wherein the instrument includes an instrument for sequentially determining the concentrations of medically significant components of multiple samples of body fluids.

4. A system for analyzing results of determinations of concentrations of medically significant components of control solutions, the system including a programmable machine, a program executable on the machine for testing the results against selected rules from among a set of multiple, operator-selectable rules, and for producing indications to the operator of the results of the tests, an instrument for sequentially determining the concentrations of medically significant components of multiple samples of control solutions, and an interface for relaying the results of the determinations of the concentrations of the medically significant components of the control solutions to the programmable machine to be tested by the program, the instrument for sequentially determining the concentrations of medically significant components of multiple samples of control solutions including an instrument for sequentially determining the concentrations of different medically significant components of samples of different control solutions in response to instructions to determine the concentrations of different medically significant components of samples of different control solutions, and the program including a program for instructing the instrument to determine the concentrations of different medically significant components of samples of different control solutions.

5. The system of claim 4 wherein the instrument includes an instrument for sequentially determining the concentrations of medically significant components of multiple samples of body fluids.

6. A system for analyzing results of determinations of concentrations of medically significant components of control solutions, the system including a programmable machine, a program executable on the machine for testing the results against selected rules from among a set of multiple, operator-selectable rules, and for producing indications to the operator of the results of the tests, a first instrument for sequentially determining the concentrations of medically significant components of multiple samples of control solutions, a first interface for relaying the results of the determinations of the concentrations of the medically significant components of the control solutions from the first instrument to the programmable machine to be tested by the program, a second instrument for sequentially determining the concentrations of medically significant components of multiple samples of control solutions, and a second interface for relaying the results of determinations by the second instrument to the programmable machine to be tested by the program.

7. The system of claim 6 wherein the program for testing the results against selected rules from among a set of multiple rules includes a program for testing a result of a first determination of the concentration of a first medically significant component of a first sample of a first control solution against a first subset of the set of multiple rules, and subsequently testing a result of at least one of:

a second determination of the concentration of the first medically significant component of the first sample of the first control solution;

the concentration of a second medically significant component of the first sample of the first control solution;

the concentration of the first medically significant component of a second sample of the first control solution; and

, the concentration of a first medically significant component of a first sample of a second control solution, against at least one of the first subset and a second subset of the set of multiple rules.

8. The system of claim 6 wherein the first instrument and the second instrument respectively include:

an instrument for sequentially determining the concentrations of different medically significant components of samples of different body fluids and control solutions in response to instructions to determine the concentrations of different medically significant components of samples of different body fluids and control solutions; and

, a second instrument for sequentially determining the concentrations of different medically significant components of samples of different body fluids and control solutions in response to instructions to determine the concentrations of different medically significant components of samples of different body fluids and control solutions, and the program comprises a program for selectively instructing one of the first instrument and the second instrument to determine the concentrations of different medically significant components of samples of different control solutions, the system further including a third interface for relaying instructions from the programmable machine to the one of the first instrument and the second instrument.

9. The system of claim 8 wherein the program for testing the results against the set of multiple rules includes a program for testing a result of a first determination of the concentration of a first medically significant component of a first sample of a first control solution against a first subset of the set of multiple rules and subsequently testing a result of at least one of:

a second determination of the concentration of the first medically significant component of the first sample of the first control solution;

the concentration of a second medically significant component of the first sample of the first control solution;

the concentration of the first medically significant component of a second sample of the first control solution; and

, the concentration of a first medically significant component of a first sample of a second control solution, against at least one of the first subset and a second subset of the set of multiple rules.

10. The system of claim 6 wherein the instrument includes an instrument for sequentially determining the concentrations of medically significant components of multiple samples of body fluids.

11. The system of claim 7 wherein the instrument includes an instrument for sequentially determining the concentrations of medically significant components of multiple samples of body fluids.

12. The system of claim 8 wherein the instrument includes an instrument for sequentially determining the concentrations of medically significant components of multiple samples of body fluids.

13. The system of claim 9 wherein the instrument includes an instrument for sequentially determining the concentrations of medically significant components of multiple samples of body fluids.

14. A method for analyzing results of determinations of concentrations of medically significant components of control solutions, the method consisting essentially of providing a programmable machine, having an operator select a set of multiple rules against which the results are to be tested, having the programmable machine test the results against the set of multiple rules by sequentially determining the concentrations of medically significant components of multiple samples of body fluids and control solutions and relaying the results of the determinations of the concentrations of the medically significant components of the control solutions to the programmable machine to be tested by the program and having the programmable machine produce indications to the operator of the results of the tests.

15. A method for analyzing results of determinations of concentrations of medically significant components of control solutions, the method including providing a programmable machine, programming the programmable machine with a set of multiple, operator-selectable rules against selected ones of which the results may be tested, selecting from among the set of multiple rules a subset of all or fewer than all of the rules against which the operator desires to test the results, sequentially determining the concentrations of medically significant components of multiple samples of control solutions, relaying the results of the determinations of the concentrations of the medically significant components of the control solutions to the programmable machine to be tested, testing the results on the machine against the subset of rules, and producing indications to the operator of the results of the tests, testing the results against multiple rules including testing a result of a first determination of the concentration of a first medically significant component of a first sample of a first control solution against a first subset of the set of multiple rules and subsequently testing a result of at least one of:

a second determination;

the concentration of a second medically significant component;

a second sample; and

, a second control solution against at least one of the first subset and a second subset of the set of multiple rules.

16. The method of claim 15 further including sequentially determining the concentrations of medically significant components of multiple samples of body fluids, and relaying the results of the determinations of the concentrations of the medically significant components of the body fluids to the programmable machine.

17. A method for analyzing results of determinations of concentrations of medically significant components of control solutions, the method including providing a programmable machine, programming the programmable machine with a set of multiple, operator-selectable rules against selected ones of which the results may be tested, selecting from among the set of multiple rules a subset of all or fewer than all of the rules against which an operator desires to test the results, sequentially determining the concentrations of medically significant components of multiple samples of control solutions, relaying the results of the determinations of the concentrations of the medically significant components of the control solutions to the programmable machine to be tested against the subset of rules, testing the results on the machine against the subset of rules, and producing indications to the operator of the results of the tests, sequentially determining the concentrations of medically significant components of multiple samples of control solutions including sequentially determining the concentrations of different medically significant components of samples of different control solutions in response to instructions to determine the concentrations of different medically significant components of samples of different control solutions, and instructing the determination of the concentrations of different medically significant components of samples of different control solutions.

18. The method of claim 17 wherein testing the results against the set of multiple rules comprises testing a result of a first determination of the concentration of a first medically significant component of a first sample of a first control solution against a first subset of the set of multiple rules and subsequently testing a result of at least one of:

a second determination of the concentration of the first medically significant component of the first sample of the first control solution;

the concentration of a second medically significant component of the first sample of the first control solution;

the concentration of the first medically significant component of a second sample of the first control solution; and

, the concentration of a first medically significant component of a first sample of a second control solution, against at least one of the first subset and a second subset of the set of multiple rules.

19. The method of claim 17 further including sequentially determining the concentrations of medically significant components of multiple samples of body fluids, and relaying the results of the determinations of the concentrations of the medically significant components of the body fluids to the programmable machine.

20. The method of claim 18 further including sequentially determining the concentrations of medically significant components of multiple samples of body fluids, and relaying the results of the determinations of the concentrations of the medically significant components of the body fluids to the programmable machine.