Redundant Error Detection in a Clinical Diagnostic Analyzer

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.

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.