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Hypothectical Case Study ELN Outcomes:
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Abbottlink Study GroupCase Studies and Demos10/10/2012
1
Company Confidential© 2012 Abbott
Intermediate JMP TrainingHypothectical Case Study
Hypothectical Case Study Background:
Two evaluate the impact of the depressed RLU values a study was done by a technical scientist with a normal calibration curve and an impacted calibration curve. •The purpose of this study was to evaluate the impact to the controls and 3 medically significant decision points off of the calibration curves. •From this study, a magnitude of shift caused by the depressed RLU was determined and ranges where calculated around the 3 decision points for those patient samples which could potentially be impacted.
Medical Decision Point Lower Range Shift Upper Range Shift
0.0300 0.015-0.03 0.0658-0.03 0.1000 0.0447-0.1 0.1-0.2239 0.3000 0.1349-0.3 0.3-0.6499
Hypothectical Case Study ELN Outcomes:
Hypothectical Case Study Methods:The following items where removed from the queries from the ASSET database:•Remove all rows missing a value for column Result_Value
• Why? Because we are only interested in potentially impacted Test results.
•Remove all testing for Reagent Master Lot Apple
• Why? This is the impacted lot and there is no way to know what the configuration of every Module
SN was and determine the impacted shift.•Remove all Calibrator and Control Sample Type data
• Why? We are only interested in the potential impact on Patient Data.
•Remove all testing for Module SN's with less than 1 full days worth of information in the data set
• Why? Module SN’s with less than one day of testing are not reliable at giving us a true “frequency” of
normal performance.
Let’s see how we Clean up the Data!
Open the Sample Data Table:• Hypothectical Case Study
Data Clean:Remove all rows missing a value for column Result_Value
• Select Matching
• Rows>>Delete Rows
JMP Skill:•Select Matching•Delete Rows
9642 Rows
Remove all testing for Reagent Master Lot Apple
Rows>>Rows Selection>>Select Where• Adjust column name window if need be
• REAGENT_MASTER_LOT equals Apple• Press>>Add Condition
• Press>>OK
• Rows>>Delete Rows
JMP Skill:•Select Where
8601 Rows
Remove all Calibrator and Control Sample Type data• Select Matching• Invert Selection• Rows>>Delete Rows
JMP Skill:•Invert Selection
7318 Rows
Remove all testing for Module SN's >1 full DAYs worth of information in the data set
JMP Skill:•Tabulate•Make Into Datatable
926 Rows
Remove all testing for Module SN's with less than 1 full days worth of information in the data set
Add a column to calculate how many days are in the data set for each Module SN.
JMP Skill:•Column Formula
Remove all testing for Module SN's with less than 1 full days worth of information in the data set
Add a column to calculate how many days are in the data set for each Module SN.
JMP Skill:•Column Formula•Hidden Functions
Don’t forget to Give your column a name!
Data Clean:
JMP Skill:•Jion
7318 Rows
Remove all testing for Module SN's with less than 1 full days worth of information in the data set
JMP Skill:•Sort
7112 Rows
Clean Table!
Presentation TitleDate
14Company Confidential© 200X Abbott
Take Note of theNumber of Samples in this New Data set
As we will need this number later
JMP Skill:•Planning
7106 Rows
Find SMPs in Ranges
JMP Skill:•Column Formula
Medical Decision Point Lower Range Shift Upper Range Shift 0.0300 0.015-0.03 0.03-0.0658 0.1000 0.0447-0.1 0.1-0.2239 0.3000 0.1349-0.3 0.3-0.6499
Find SMPs in Ranges
JMP Skill:•Column Formula
Medical Decision Point Lower Range Shift Upper Range Shift 0.0300 0.015-0.03 0.03-0.0658 0.1000 0.0447-0.1 0.1-0.2239 0.3000 0.1349-0.3 0.3-0.6499
Find SMPs in Ranges
JMP Skill:•Column Formula
Medical Decision Point Lower Range Shift Upper Range Shift 0.0300 0.015-0.03 0.03-0.0658 0.1000 0.0447-0.1 0.1-0.2239 0.3000 0.1349-0.3 0.3-0.6499
Find SMPs in Ranges
JMP Skill:•Column Formula
Medical Decision Point Lower Range Shift Upper Range Shift 0.0300 0.015-0.03 0.03-0.0658 0.1000 0.0447-0.1 0.1-0.2239 0.3000 0.1349-0.3 0.3-0.6499
Find SMPs in Ranges
JMP Skill:•Column Formula
Medical Decision Point Lower Range Shift Upper Range Shift 0.0300 0.015-0.03 0.03-0.0658 0.1000 0.0447-0.1 0.1-0.2239 0.3000 0.1349-0.3 0.3-0.6499
Find SMPs in Ranges
JMP Skill:•Column Formula
Medical Decision Point Lower Range Shift Upper Range Shift 0.0300 0.015-0.03 0.03-0.0658 0.1000 0.0447-0.1 0.1-0.2239 0.3000 0.1349-0.3 0.3-0.6499
Find SMPs in Ranges
JMP Skill:•Column Formula
Medical Decision Point Lower Range Shift Upper Range Shift 0.0300 0.015-0.03 0.03-0.0658 0.1000 0.0447-0.1 0.1-0.2239 0.3000 0.1349-0.3 0.3-0.6499
Find SMPs in Ranges
JMP Skill:•Column Formula
Medical Decision Point Lower Range Shift Upper Range Shift 0.0300 0.015-0.03 0.03-0.0658 0.1000 0.0447-0.1 0.1-0.2239 0.3000 0.1349-0.3 0.3-0.6499
Find SMPs in Ranges
JMP Skill:•Column Formula
Medical Decision Point Lower Range Shift Upper Range Shift 0.0300 0.015-0.03 0.03-0.0658 0.1000 0.0447-0.1 0.1-0.2239 0.3000 0.1349-0.3 0.3-0.6499
Find SMPs in Ranges
JMP Skill:•Column Formula
Medical Decision Point Lower Range Shift Upper Range Shift 0.0300 0.015-0.03 0.03-0.0658 0.1000 0.0447-0.1 0.1-0.2239 0.3000 0.1349-0.3 0.3-0.6499
Add some Additional Columns for Good
Measure!
JMP Skill:•Column Formula
Stack Columns:
JMP Skill:•Stack
Stack Columns:
Presentation TitleDate
28Company Confidential© 200X Abbott
JMP Skill:•Stack
Get Rows where Frequency is Empty
JMP Skill:•Get Rows Where•Delete Rows
Set a Value Ordering Property:
JMP Skill:Value Ordering
Tabulate the Frequency:
JMP Skill:Tabulate
Tabulate the Frequency:
JMP Skill:Tabulate
Frequency:
These frequencies where than used as part of the Risk evaluation process to help determine occurrence and properly assess the risk to our customer.
< 0.0150.015-0.030.03-0.0658> 0.0658< 0.04470.0447-0.1> 0.2239< 0.13490.1349-0.30.3-0.6499> 0.6499
SMP Range3113
980856
21635268
69621635268
428293
2163
N44%14%12%30%74%10%30%74%
6%4%
30%
% TotalFrequency
Questions?