Predictive quality control apparatus and methods in diagnostic testing systems

A quality control method, comprising:

• receiving, at a controller, a quality control test result from a diagnostic analyzer in response to executing a quality control test;
• receiving continually, at the controller, a plurality of data values related to the diagnostic analyzer before a next quality control test;
• analyzing, with a decision module executing in the controller, the quality control test result and the data values related to the diagnostic analyzer;
• and
• sending, from the controller to a user interface, a message indicating that the diagnostic analyzer is operating acceptably now but subsequently may not continue to do so based on the analyzing by the decision module indicating that the quality control test result is satisfactory and that at least one of the data values lies between an acceptable range and an unacceptable range;
• wherein the plurality of data values related to the diagnostic analyzer comprise one or more of:
• degree of water ionization;
• refrigerated storage temperature reading;
• reagent lot number;
• reagent lot expiration date;
• and
• onboard stability expiration date.

A quality control apparatus, comprising:

• a diagnostic analyzer configured to perform one or more tests on biological specimens;
• a controller in electronic communication with the diagnostic analyzer, the controller including:
• a communication interface configured to receive:
• a quality control test result from the diagnostic analyzer in response to the diagnostic analyzer executing a quality control test, and
• data values related to the diagnostic analyzer, each data value associated with a first set or range of one or more values indicating acceptable analyzer operation and a second set or range of one or more values indicating unacceptable analyzer operation;
• and
• a decision module configured and operable to analyze the quality control test result and the data values related to the diagnostic analyzer to determine whether the quality control test result corresponds with an expected quality control test result and whether each of the data values corresponds with its associated first set or range of one or more values or its associated second set or range of one or more values;
• and
• a user interface coupled to the controller to communicate a message indicating that the diagnostic analyzer is operating acceptably now and analyzer results received from the diagnostic analyzer are valid but the diagnostic analyzer subsequently may not continue to operate acceptably and subsequent analyzer results may not be valid in response to the decision module determining that the quality control test result corresponds with the expected quality control test result and at least one of the data values is between the first and second sets or ranges of one or more values associated with that at least one of the data values.