Redundant error detection in a clinical diagnostic analyzer

• US 10,002,678 B2
• Filed: 02/17/2016
• Issued: 06/19/2018
• Est. Priority Date: 07/01/2008
• Status: Active Grant

• 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.
• Primary Examiner(s): Maskulinski, Michael
• Application Number:
  US15/045,852
• Publication Number:
  US 20160162653A1
• Time in Patent Office: 853 Days
• 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 clinical diagnostic analyzer system with validation of a replicate measurement of a patient sample using post-measurement error detection, the clinical diagnostic analyzer system comprising:

a patient sample input device for receiving the patient sample; and

a processor for executing instructions to perform the steps of an analysis method using the clinical diagnostic analyzer system, the analysis method comprising;

performing the replicate measurement of the patient sample with instructions of a required assay;

receiving measurement messages as a result of performing the replicate measurement;

receiving device status messages indicating status of the clinical diagnostic analyzer system;

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

validating the replicate measurement of the patient sample by comparing the received measurement and device status messages with the fingerprint to facilitate error detection, the validating step comprising the step of matching the received measurement messages and the received device status messages with the fingerprint of the expected events to determine a success or a failure of the replicate measurement; and

releasing the replicate measurement upon the success of the replicate measurement and preventing release of the replicate measurement upon the failure of the replicate measurement.

2. The clinical diagnostic analyzer system of claim 1, wherein the receiving comprises receiving messages comprising Subsystem Commands, Command Responses, and Asynchronous messages.

3. The clinical diagnostic analyzer system of claim 1, wherein the analysis method further comprises generating the fingerprint in response to receiving a Preview command for the replicate measurement.

4. The clinical diagnostic analyzer system of claim 3, wherein the analysis method further comprises releasing all resources, which were sequestered in response to receiving the Preview command for the replicate measurement, in response to receiving a Complete command.

5. The clinical diagnostic analyzer system of claim 1, wherein the analysis method further comprises completing, in response to a Check command, a comparison of the fingerprint with received messages.

6. The clinical diagnostic analyzer system of claim 1, wherein the analysis method further comprises dynamically releasing a result of the comparison.

7. The clinical diagnostic analyzer system of claim 1, wherein the analysis method further comprises logging conditions in response to validating the replicate measurement.

8. The clinical diagnostic analyzer system of claim 1, wherein the analysis method further comprises logging conditions in response to flagging results of the assay with a warning.

9. The clinical diagnostic analyzer system of claim 1, wherein the analysis method further comprises generating events corresponding to a subsystem in response to receiving a Preview command for the replicate measurement, wherein the generation is based on the configuration information.

10. A method for validation by a clinical diagnostic analyzer system of a replicate measurement of a patient sample using post-measurement error detection, the method comprising:

receiving a preview replicate command for a replicate measurement;

allocating resources for redundant error checking for the replicate measurement;

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

comparing measurement messages corresponding to carrying out the replicate measurement, and device status messages indicating status of the clinical diagnostic analyzer system, with the fingerprint, the comparing step comprising the step of matching the measurement messages and the device status messages with the generated fingerprint to determine a success or a failure of the replicate measurement;

sending a result of the comparison to facilitate releasing the replicate measurement upon the success of the replicate measurement and preventing release of the replicate measurement upon the failure of the replicate measurement; and

logging conditions corresponding to the replicate measurement.

11. The method of claim 10, wherein the configuration information is coded in eXtensible Markup Language.

12. The method of claim 10, wherein logging conditions includes writing data relating to specified events to a log file in a specified format.

13. The method of claim 10, wherein the result corresponding to the replicate measurement being an error detection causes the clinical diagnostic analyzer to not release the result.