CLINICAL DIAGNOSTIC ANALYZER PERFORMANCE ESTIMATOR

• US 20080312893A1
• Filed: 06/16/2008
• Published: 12/18/2008
• Est. Priority Date: 06/15/2007
• 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: Denton, Gary
• Application Number:
  US12/139,811
• Publication Number:
  US 20080312893A1
• Time in Patent Office: Days
• US Class Current: 703/11
• CPC Class Codes: G01N 35/00613 Quality control
• CPC Class Codes: G01N 35/0092 Scheduling
• CPC Class Codes: G16B 5/00 ICT specially adapted for modelling or simulations in systems biology, e.g. gene-regulatory networks, protein interaction networks or metabolic networks
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

The disclosed methods and devices relate to tools for on-site and customizable evaluation of the performance of clinical diagnostic analyzers or automation systems by executing a portable simulation program utilizing actual data from a site of interest. The portable simulation program consists of an Intelligent LIS pre-processor, implementation of a simulation model, and analytical and graphical means to determine and present the performance metrics. This permits a realistic evaluation of the clinical diagnostic analyzers before installing the equipment, thus aiding in making decisions including a decision to buy or appropriately configure clinical diagnostic analyzer. The analysis also allows customers to modify the laboratory setup, improve delivery schedules, with better sample scheduling and storage, and in adding equipment.

Claims

1. A method for estimating performance of at least an analyzer for processing test samples at a site comprising the steps of:

preprocessing customer selected input data;

specifying a clinical diagnostic analyzer to be simulated;

selecting at least one parameter from the group consisting of a test mix, a retest rate, and resealing of data, wherein the resealing reflects the number of analyzers being deployed;

simulating performance of the clinical diagnostic analyzer by executing a simulation software; and

providing a measure of the performance of the clinical diagnostic analyzer, for pseudo-samples marked Routine or STAT, at least one member of the group consisting of a Maximum Turn Around Time, an Average Turn Around Time, a 95% Turn Around Time, a Maximum Throughput, Consumable Usage, a Walk-Away Time, and a Downtime, wherein the performance measure may further include an Arrival and Exit Rate Graph and a Cumulative Turn Around Time Graph.

2. The method of claim 1, wherein the preprocessing step converts the customer selected data into a standard format.

3. The method of claim 1, wherein failure to manually specify the clinical diagnostic analyzer to be simulated invokes a default clinical diagnostic analyzer specification.

4. The method of claim 1, wherein the at least one clinical diagnostic analyzer is part of a configuration of clinical diagnostic analyzers.

5. The method of claim 4, wherein the configuration of clinical diagnostic analyzers includes a plurality of diagnostic clinical analyzers of different types, wherein at least one of the plurality of diagnostic clinical analyzers does not support immunoassays.

6. The method of claim 4, wherein the configuration of clinical diagnostic analyzers includes a plurality of diagnostic clinical analyzers of different types, wherein at least one of the plurality of diagnostic clinical analyzers does not support chemistry assays

7. A portable software instruction bearing memory device for providing software instructions to at least one computing device, the computing device comprising a processor and buffer memory;

the software instructions including commands for executing a simulation software package to evaluate the performance of a candidate clinical diagnostic analyzer based on user approved data and user selected configuration of the candidate clinical diagnostic analyzer whereby the simulation software package causes generation of a report on the performance of the candidate clinical diagnostic analyzer for pseudo-samples marked Routine and STAT.

8. The software instruction bearing memory device of claim 7, wherein the software instruction bearing memory device is implemented using optical media, magnetic media, and portable memory media devices.

9. The software instruction bearing memory device of claim 7, wherein the software instruction bearing memory device is suitable for copying the instructions to a computer instruction bearing medium whereby causing execution of commands simulating the software package to evaluate the performance of the clinical diagnostic analyzer based on the user approved data and the user selected configuration of the clinical diagnostic analyzer whereby the simulation software package causes generation of the report on the performance of the candidate clinical diagnostic analyzer for samples marked standard and urgent.

10. The software instruction bearing memory device of claim 7, wherein the report includes at least one member of the group consisting of a Maximum Turn Around Time, an Average Turn Around Time, a 95% Turn Around Time, a Maximum Throughput, Consumable Usage, a Walk-Away Time, and a Downtime, wherein the report may further include an Arrival and Exit Rate Graph and a Cumulative Turn Around Time Graph.

11. The software instruction bearing memory device of claim 7, wherein the software instructions include rules for evaluating a configuration of clinical diagnostic analyzers.

12. The software instruction bearing memory device of claim 11, wherein the rules for evaluating the configuration of clinical diagnostic analyzers include configurations comprising diagnostic clinical analyzers of different types, wherein at least one diagnostic clinical analyzer does not support one member of the set consisting of immunoassays and chemistry assays.

13. A simulation apparatus for simulation performance of a clinical diagnostic analyzer comprising:

a preprocessor for formatting and organizing customer approved input data including data corresponding to Routine and STAT samples;

a simulator based on a selected clinical diagnostic analyzer definition; and

a user interface providing an output, for samples marked standard and urgent, comprising at least one member of the group consisting of a Maximum Turn Around Time, an Average Turn Around Time, a 95% Turn Around Time, a Maximum Throughput, Consumable Usage, a Walk-Away Time, and a Downtime, wherein the output may further include an Arrival and Exit Rate Graph and a Cumulative Turn Around Time Graph.

14. The simulation apparatus of claim 13, wherein the simulator uses more than one clinical diagnostic analyzer definition for simulating the performance of a configuration of diagnostic clinical analyzers.

15. The simulation apparatus of claim 14, wherein rules for evaluating the configuration of clinical diagnostic analyzers include configurations comprising diagnostic clinical analyzers of different types, wherein at least one diagnostic clinical analyzer does not support one member of the set consisting of immunoassays and chemistry assays.

16. The simulation apparatus of claim 14, wherein customer approved input data is divided for processing by clinical diagnostic analyzers in the configuration of clinical diagnostic analyzers taking into account the tests to be simulated on samples included in the customer approved input data and the analyzer capabilities.

17. A software package comprising:

means for preprocessing customer selected input data;

means for specifying a clinical diagnostic analyzer to be simulated with data collected for at least one member of the group consisting of a test mix, delay due to retesting, and downtime;

means for simulating performance of the clinical diagnostic analyzer; and

means for reporting data collected in the simulation for at least one of standard samples, urgent samples and combined standard and urgent samples, wherein the means for reporting data include at least one member of the group consisting of a Maximum Turn Around Time, an Average Turn Around Time, a 95% Turn Around Time, a Maximum Throughput, Consumable Usage, a Walk-Away Time, and a Downtime, wherein the means for reporting data may further include an Arrival and Exit Rate Graph and a Cumulative Turn Around Time Graph.

18. Apparatus for simulating a clinical diagnostic analyzer comprising:

means for providing standardized data from data stored in a data store, the means for providing including any necessary preprocessing of the stored data;

means for accessing at least one clinical diagnostic analyzer definition;

means for identifying assay protocols for processing pseudo-samples extracted from the standardized data;

means for scheduling processing of a plurality of pseudo-samples from the pseudo-samples extracted from the standardized data;

means for evaluating whether a test result on the plurality of pseudo-samples requires retesting;

means for collecting performance metrics on the plurality of pseudo-samples, wherein the performance metrics are selected from the group consisting of a Maximum Turn Around Time, an Average Turn Around Time, a 95% Turn Around Time, a Maximum Throughput, Consumable Usage, a Walk-Away Time, and a Downtime, wherein the means for collecting performance metrics may further include an Arrival and Exit Rate Graph and a Cumulative Turn Around Time Graph.