METHOD FOR DETECTING THE IMPENDING ANALYTICAL FAILURE OF NETWORKED DIAGNOSTIC CLINICAL ANALYZERS

• US 20160132375A1
• Filed: 01/13/2016
• Published: 05/12/2016
• Est. Priority Date: 09/12/2011
• 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: Jacobs, Merrit N., Doody, Christopher Thomas, Bashaw, Edwin Craig, Indovina, Joseph Michael, Altland, Owen, Gould, Nicholas John
• Application Number:
  US14/994,791
• Publication Number:
  US 20160132375A1
• Time in Patent Office: Days
• US Class Current: 1/1
• 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

Abstract

A method of detecting impending analytical failure in a networked diagnostic clinical analyzer is based upon detecting whether the operation of a particular analyzer is statistically distinguishable based on one or more thresholds. A failure occurs when one or more components or modules of the analyzer fails. A method to detect such an impending failure is disclosed. Baseline data on a pre-selected set of analyzer variables for a population of diagnostic clinical analyzers is used to generate an impending failure threshold. Subsequently, operational data comprising the same pre-selected set of analyzer variables allows generation of a time series of operational statistics. If the operational statistic exceeds the impeding failure threshold in a prescribed manner, an impending analytical failure is predicted. Such detection of impending analytical failures facilitates intelligent scheduling of service for the analyzer in question to maintain high assay throughput and accuracy.

Claims

1. A method for detecting an impending failure in a networked diagnostic clinical analyzer comprising the steps of

monitoring a plurality of variables in a plurality of diagnostic clinical analyzers;

screening out outliers from values of the plurality of variables;

deriving a threshold for a first variable from the plurality of variables based on the screened values of the first variable;

normalizing the values of variables including the first variable selected from the plurality of variables for computing a composite threshold;

generating the composite threshold using normalized variable values;

collecting operational data from the networked diagnostic clinical analyzer; and

generating an alert if the composite threshold is exceeded by the diagnostic clinical analyzer.

2. The method of claim 1 wherein a threshold for a first variable is also used to normalize the first variable.

3. The method of claim 1 wherein a threshold for a first variable is also used to identify the first variable representing a first troubleshooting effort.

4. The method of claim 1 wherein the operational data is used to calculate an alert value for comparison to the composite threshold.

5. A method of detecting an impending analytical failure of a networked diagnostic clinical analyzer comprising the steps of:

collecting baseline data from a plurality of networked diagnostic clinical analyzers during commercial operation over a first specified time period,

transforming the baseline data into a first statistic,

collecting a sequence of operational data from a particular networked diagnostic clinical analyzer during commercial operation over a second specified time period,

transforming the sequence of operational data into a sequence of second statistics, and

notifying the Remote Monitoring Center of an impending diagnostic clinical analyzer analytical failure in said particular diagnostic clinical analyzer when the second statistic exceeds the first statistic by a pre-specified amount in a specified manner.

6. The method of claim 5 where the networked diagnostic clinical analyzers are performing commercial assays using thin-film slides, cuvettes, bead and tube formats, or micro-wells.

7. The method of claim 5 where the networked diagnostic clinical analyzers are connected using a network selected from the group consisting of the Internet, an intranet, a wireless local area network, a wireless metropolitan network, a wide area computer network, and the Global System for Mobile communications network.

8. The method of claim 5 where the first time period is 24 hours and the second time period is 24 hours.

9. The method of claim 5 where the pre-specified amount is 10 percent of the first statistic and the specified manner is two out of three successive time periods.

10. A method for servicing a networked diagnostic clinical analyzer in response to detecting an impending analytical failure comprising the steps of:

identifying monitored variables used to detect the impending failure,

investigating a set of variables from the monitored variables that exceed their respective thresholds during a time period transforming the baseline data into a first statistic, and

providing servicing recommendations to better control one or more members of the set of variables.

11. The method of claim 10 further comprising investigating subsystems corresponding to the one or more members of the set for serviceable faults.

12. The method of claim 10 further comprising confirming that the one or more members of the set do not exceed their respective thresholds following servicing.