Redundant Error Detection in a Clinical Diagnostic Analyzer

• US 20100005342A1
• Filed: 06/29/2009
• Published: 01/07/2010
• Est. Priority Date: 07/01/2008
• Status: Abandoned Application

• Current Assignee: Ortho-Clinical Diagnostics Incorporated (The Carlyle Group LP (Corporate Private Equity))
• Original Assignee: Ortho-Clinical Diagnostics Incorporated (The Carlyle Group LP (Corporate Private Equity))
• Inventors: Dambra, Joseph J., Hurpeau, Jean-Christophe, Reed, Mark D.
• Application Number:
  US12/493,689
• Publication Number:
  US 20100005342A1
• Time in Patent Office: Days
• US Class Current: 714/38
• CPC Class Codes: G06F 11/3668 Software testing software testing in telephone exchanges H04M3/242, testing of hardware G06F11/22
• 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 70/00 ICT specially adapted for the handling or processing of medical references
• CPC Class Codes: G16H 70/60 relating to pathologies
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

Disclosed is a clinical diagnostic analyzer employing a redundant error detection capability to further examine the internal message traffic for possible errors or questionable results by comparing the actual parameters against a fingerprint generated for each assay using an assay database and a configuration file. This testing does not rely on inputs from the software module being tested, and hence is an independent test. Further, a testing mechanism is provided to test the Redundant Error Detection (“RED”) capability itself.

Claims

1. A module executable on a processor in a clinical diagnostic analyzer for detecting questionable laboratory results in the clinical diagnostic analyzer, the module comprising:

a mechanism for receiving messages comprising Subsystem Commands, Command Responses, and Asynchronous messages;

a fingerprint of expected events to be tested for a replicate, wherein the fingerprint is generated from at least a configuration information and protocol information, wherein the protocol information contains details for an assay required by the replicate;

instructions for completing a comparison between the received messages with the fingerprint; and

instructions for reporting a result of the comparison.

2. The module of claim 1 further comprising instructions for generating the fingerprint in response to receiving a Preview command for the replicate.

3. The module of claim 1 further comprising instructions for completing, in response to a Check command, a comparison of the fingerprint with received messages.

4. The module of claim 1 comprising instructions for releasing all resources, which were sequestered in response to receiving the Preview command for the replicate, in response to receiving a Complete command.

5. The module of claim 1 comprising instructions for dynamically reconfiguring the instructions for releasing a result of the comparison.

6. The module of claim 1 comprising instructions for logging conditions in response to determining the result is suspect.

7. The module of claim 1 comprising instructions for logging conditions in response to flagging the results of the assay with a warning.

8. The module of claim 1 further comprising instructions for generating events corresponding to a subsystem in response to receiving a Preview command for the replicate, wherein the generation is based on the configuration information.

9. A quality control method for testing a software module in a clinical diagnostic analyzer comprising the steps of:

generating subsystem commands, command responses, and asynchronous messages suitable for delivery to a redundant error detector;

reviewing the generated subsystem commands, command responses, and asynchronous messages using the redundant error detector for inconsistencies; and

debug the software module in response to detecting inconsistencies.

10. The method of claim 9, wherein the subsystem commands, command responses, and asynchronous messages are generated in a simulation of a performance of the clinical diagnostic analyzer using at least one script file which contains at least one command in addition to a record of messages in an example operation of the clinical diagnostic analyzer.

11. The method of claim 10, wherein the software module is used in the example operation of the clinical diagnostic analyzer to generate the record of messages.

12. The method of claim 9, wherein the redundant error detector uses a configuration file and an assay database to generate a fingerprint for at least one replicate in the at least one script file.

13. The method of claim 9, wherein the software module is a test redundant error detector.

14. The method of claim 9, wherein the software module is not a test redundant error detector.

15. The method of claim 9, wherein a system is tested by testing several software modules.

16. A method for preventing release of a questionable result by a clinical diagnostic analyzer, the method comprising facilitating the steps of:

receiving a preview replicate command for a replicate;

allocating resources for redundant error checking for the replicate;

generating a fingerprint of required events for the replicate using at least a configuration information and an protocol information, wherein the fingerprint has fewer events than the events performed in accordance with the protocol information for the replicate;

comparing messages corresponding to carrying out the replicate with the fingerprint;

sending a result of the comparison; and

logging conditions corresponding to the replicate.

17. The method of claim 16, wherein the configuration information is coded in eXtensible Markup Language.

18. The method of claim 16, wherein logging conditions includes writing to a log file in a specified format data relating to specified events.

19. The method of claim 16, wherein the result corresponding to the replicate being fail causes the clinical diagnostic analyzer to not release the result.