UnityWeb 2.

0
TM

Reference Guide for Easy QC Data Management

June 04, 2008

Version 1.0
Contents

Chapter 1: Getting Started 1

Welcome . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Contact Bio-Rad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Organization of this Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Typographical Styles and Conventions. . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Software Items . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Keyboard Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Notes, Tips, and Important Notes. . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Note . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Tip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Important . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Essential Startup Tasks for New Users . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
First Time Log In . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
QC Configuration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Program Hints . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Tabs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Menu Items . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Links . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Check Boxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Lists. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Scroll Bars and Scroll Arrows. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Unavailable Items. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

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Chapter 2: Introduction to Quality Control Statistics 13

What is Quality Control? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

How Are QC Results Used? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Normal and Abnormal Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Example Scenario. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
CLIA Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Basic QC Statistics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Useful Statistics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Mean . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Standard Deviation (SD) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Calculate a Control Mean and Range . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Standard Deviation Index (SDI). . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Interpreting the SDI. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Bias . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Coefficient of Variation (CV) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Example Scenario. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Determining an Acceptable CV . . . . . . . . . . . . . . . . . . . . . . . . 25
Coefficient of Variation Ratio (CVR). . . . . . . . . . . . . . . . . . . . . . . . . 25
Total Error (TE) and Total Allowable Error (TEa) . . . . . . . . . . . . . . . . 26
z-score . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
SPC Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
12s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
12.5s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
13s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
13.5s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
14s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
15s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
22s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Across run violation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Within run violation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
2 of 32s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
R4s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
31s and 41s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
31s Within a Control Level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
41s Across Control Levels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

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7T . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Nx Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
8x Within a Control Level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
9x Across Control Levels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Chapter 3: Choose and Troubleshoot a QC Procedure 41

Recommended Steps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Determine Quality Requirements for the Test . . . . . . . . . . . . . . . . . . . . . . . . . 43
Identify Appropriate QC Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Evaluate Test Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Six Sigma . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Use of Six Sigma . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Qualitative Evaluation of a Test's Bias and Imprecision . . . . . . . . . . . . . . 49
Identify Possible QC Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Predict the Performance of the QC Procedures. . . . . . . . . . . . . . . . . . . . . . . 51
Choose Goals Based on Required Quality. . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Select a QC Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Troubleshoot QC Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Repeat the Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Try a New Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Recalibrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Good Laboratory Habits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Determine the Type of Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Relate the Error to Possible Causes . . . . . . . . . . . . . . . . . . . . . . . . 56
Consider Common Factors on Multi Test Systems . . . . . . . . . . . . . 57
Relate the Problem to Recent Changes . . . . . . . . . . . . . . . . . . . . . 58
Systematic Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Random Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Verify and Document . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Keys to a Productive Review of the Laboratory Quality System . . . . . . . . . . . 60
Issues to Consider . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

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Chapter 4: Program and Database Basics 63

First Time Log In . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

Regular Log On and Log Off Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Log On to the Software. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Log Off the Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Current Lab, Panel, Lot, and Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Example Lists . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Understand the Navigation Tree . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Example of the Navigation Tree . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
UnityWeb™ Tabs and Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Functions and Where to Find Them . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Download Adobe® Reader® . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
System Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Update the License . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Update the License via the Internet . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Update the License via an XML File. . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Upgrade to UnityWeb™ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Configure UnityWeb™ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Configure UnityWeb™ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Data Entry Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Actions and Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
View Database Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Notifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Transmission. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Configure Unity™ Interlaboratory Report Frequency. . . . . . . . . . . . . . . . . . . . 86
Database Basics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Export Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Condense Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Reconcile Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Delete a Range of Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91

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Chapter 5: User Profiles and Security 93

Define, Modify, and Delete Users. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

Add a User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
Modify a User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Delete a User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
Passwords . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
Password Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
Group Login ID and Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
Password Expiration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
Set a Password Expiration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
Change a Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
User Permissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
Administration/Setup Permissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
Manage users. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
Edit action log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
Edit setup options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
Operator setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
Data Review Permissions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
Database Permissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
Condense data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
Reconcile data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
Rules and Settings Permissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
Labs, Lots, Tests, and Panels Permissions . . . . . . . . . . . . . . . . . . . . . 102
Manage labs/lots/tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
Manage panels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
Data Handling Permissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Communicate with Unity™ Interlab. . . . . . . . . . . . . . . . . . . . . . . . . 103
Export data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Data Permissions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Edit all data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Edit last line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Enter new data only . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
View data only . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Set Up User Permissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104

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Chapter 6: Labs and Lots 105

Labs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
Types of Lab Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
Primary Lab Number. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
Additional Lab Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
Affiliated Lab Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
Add and Update Lab Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Add a Lab Number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Update Lab Number Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Duplicate a Lab Number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Open and Close Lab Numbers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Close a Lab Number. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Open a Lab Number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Delete Lab Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
Lots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Add a Bio-Rad Lot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
Add Non-Bio-Rad Lots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
Duplicate Lots. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
Items Automatically Duplicated . . . . . . . . . . . . . . . . . . . . . . . . . . 114
Optional Items When Duplicating . . . . . . . . . . . . . . . . . . . . . . . . . 114
Duplicate a Bio-Rad Lot Number . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
Duplicate a Non-Bio-Rad Lot Number. . . . . . . . . . . . . . . . . . . . . . . . . 116
Edit Lot Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
Edit a Bio-Rad Lot Number. . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
Edit a Non-Bio-Rad Lot Number and Expiration Date . . . . . . . . 117
Close and Open Lots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
Close a Lot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
Open a Closed Lot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
Arrange and Sort Lots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
Delete Lot Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
Lot Expiration Notifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120

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Chapter 7: Tests 121

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
Add Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124
Direct Methods of Adding Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124
Indirect Methods of Adding Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124
Add Tests Manually . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
Add Tests With Instrument Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
Limitations of Instrument Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
Add Tests Using Instrument Setup . . . . . . . . . . . . . . . . . . . . . . . . 127
Add Tests with a Code of “Other” . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
Test Rules and Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
Select SPC Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
Select Test Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
Use a Fixed Mean and SD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130
Specify a Fixed Mean and SD. . . . . . . . . . . . . . . . . . . . . . . . . . . . 130
Duplicate Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132
Update Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132
Update a Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132
Close and Open Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
Close a Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
Open a Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
Sort Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
Sort Tests for a Lab Number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
Sort Tests in a Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
Delete Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136
Delete a Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136
VITROS® Slide Generation Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138
Change the VITROS® Slide Generation Number. . . . . . . . . . . . . . . . . . 138
Update the VITROS® Slide Generation Number . . . . . . . . . . . . . . . . . . 140

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Chapter 8: Panels and Data Groups 141

Panels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141
Create a Panel and Add Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142
Sort Tests in a Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142
Remove Tests from a Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
Rename a Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
Sort Panel Names. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
Delete a Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144
Data Groups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
Overview of Groups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
Change the Current Data Option. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146
Define or Edit a Group. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146

Chapter 9: Apply QC Rules 147

Overview of Rule Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147

Notes About Rule Evaluation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148
Rule Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148
SPC Rules Precedence When Showing Rule Violations. . . . . . . . . . . . 149
Set SPC Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
Set SPC Rules at the Test Level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
Set SPC Rules at the Lot Level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151
Use a Fixed Mean and Fixed SD with SPC Rules . . . . . . . . . . . . . . . . . . . . 154
Useful Facts about Fixed Mean and Fixed SD . . . . . . . . . . . . . . . . . . . 154
Set a Fixed Mean and/or Fixed SD . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
Set Floating Statistics as a Fixed Mean and/or Fixed SD . . . . . . . . . . . 155
SPC Rules: Tabular Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157

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Chapter 10: Enter Data 161

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161
Overview of the Single Test Data Entry Dialog Boxes. . . . . . . . . . . . . . . . . . 163
Lab, Panel, Lot, and Test Information . . . . . . . . . . . . . . . . . . . . . . . . . 163
Command Buttons and Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164
Data Entry Grid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166
Paging Arrows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166
Summary Statistics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167
Example of Summary Statistics . . . . . . . . . . . . . . . . . . . . . . . . . . 167
Group Statistics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167
Example of Group Statistics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167
Fixed Mean and SD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168
Data Entry Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169
Use the Set Date Feature. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169
Change the Date and Time for a Row of Data . . . . . . . . . . . . . . . . . . . 170
View a Levey-Jennings Chart. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 170
View Rules and Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 170
Navigate the Single Test Data Entry Dialog Boxes . . . . . . . . . . . . . . . . 171
Single Test Point Data Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172
Single Test Point Data Entry Grid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172
Fixed Statistics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174
Important Facts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174
Floating Mean/Floating SD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174
Floating Mean/Fixed SD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175
Fixed Mean/Fixed SD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175
Fixed Mean/Floating SD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175
Enter Single Test Point Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176
Single Test Summary Data Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177
Summary Data Entry Grid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178
Enter Single Test Summary Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179
Qualitative Data Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 180
Enter Qualitative Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181
Send Qualitative Data to the Unity™ Interlaboratory Program . . . . . . . . 182
Multi Test Data Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183
Multi Test Data Entry Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183
Multi Test Data Entry Grid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185
Enter Multi Test Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 186

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Chapter 11: Manage Data 187

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187
Change Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187
Data Entry Permissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188
Edit Data, Date, and Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189
Edit Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190
Edit the Date and Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191
Change a Data Point's Accepted/Rejected Status . . . . . . . . . . . . . . . . . . . 192
Change the Accepted/Rejected Status . . . . . . . . . . . . . . . . . . . . . . . 193
Insert Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 194
Insert a Data Row . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 194
Delete Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 196
Delete a Row of Data from the Data Entry dialog box . . . . . . . . . . . . . 196
Delete a Range of Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197
Operator Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 198
Operator Setup Shifts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199

Chapter 12: Review and Annotate Data 201

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201
Bench Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202
Perform Bench Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203
Select a Data Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 204
Review Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205
Manage Columns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205
Document the Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206
All Data Option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206
Save and Transmit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207
InstantQC™ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 208
Actions and Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 209
Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 209
View Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 209
Configure Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 210
Add a Custom Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 210
Edit an Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 211
Delete an Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 211

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Add, Edit, and Delete Actions in the Data Entry Dialog Boxes . . . . 212
Add an Existing Action to a Row of Data . . . . . . . . . . . . . . . . 212
Add a New Action to a Row of Data . . . . . . . . . . . . . . . . . . . 212
Edit the Action List from the Data Entry Dialog Box . . . . . . . . 213
Delete an Action from the Action List from the Data Entry
Dialog Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 214
Automatic Action Logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 215
Set Up Automatic Action Logs . . . . . . . . . . . . . . . . . . . . . . . 215
Turn Off Automatic Action Logs . . . . . . . . . . . . . . . . . . . . . . 215
Comments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 216
View Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 216
Add a Comment to a Row of Data . . . . . . . . . . . . . . . . . . . . . . . . 217
Actions and Comments by Instrument . . . . . . . . . . . . . . . . . . . . . . . . . 218
Add an Action by Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . 219
Add a Comment by Instrument. . . . . . . . . . . . . . . . . . . . . . . . . . . 220
Add an Action and Comment by Instrument . . . . . . . . . . . . . . . . . 221
Require Audit Trail Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 222
Require Audit Trail Comments . . . . . . . . . . . . . . . . . . . . . . . . 222
Turn Off the Require Audit Trail Comments Feature . . . . . . . . 222

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Chapter 13: UnityWeb™ Charts 223

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 223
General Chart Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 224
Fill background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 224
Select Fill Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 224
Grid Lines and Color . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 225
Edit Grid Lines and Color . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 225
Chart Header Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 226
Example of a Chart Header . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 226
Select Chart Header Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . 227
Save and Print Charts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 228
Levey-Jennings Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 230
How to Use the Levey-Jennings Chart . . . . . . . . . . . . . . . . . . . . . . . . 230
Select Levey-Jennings Chart Options . . . . . . . . . . . . . . . . . . . . . . . . 231
Levey-Jennings Chart Legend . . . . . . . . . . . . . . . . . . . . . . . . . . 233
Other Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 234
Create a Levey-Jennings Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 234
Multi-LJ Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 235
Select Multi-LJ Chart Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 235
Create a Multi-LJ Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 235
Bar Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 236
Select Bar Chart Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 236
Other Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 237
Create a Bar Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 237
Youden Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 238
How to Use the Youden Chart. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 238
Select Youden Chart Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 238
Other Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 239
Create a Youden Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 240

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Chapter 14: UnityWeb™ Reports 241

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 241
Save and Print Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 242
Save Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 242
Print Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 243
Document Report Reviews . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 244
Data Review Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 245
Create a Data Review Report. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 245
Point Data Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 246
Point Data Report Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 246
Create a Point Data Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 246
Summary Data Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 247
Summary Data Report Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 247
Create a Summary Data Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 247
Statistical Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 248
Statistical Report Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 248
Create a Statistical Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 248
Supervisor's Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 249
Supervisor's Report Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 249
Create a Supervisor’s Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 249
Operator Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 251
Operator Report Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 251
Create an Operator Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 251
Audit Trail Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 253
Audit Trail Events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 253
Create an Audit Trail Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 253
Listings Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 255
Listings Report Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 256
Create a Listings Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 256

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Chapter 15: Send Data to the Unity™ Interlaboratory Program 257

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 257
Submit Data Monthly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 258
Submit Data Manually . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 258
Activate Automatic Monthly Transmission . . . . . . . . . . . . . . . . . . . . . . 259
Submit Data from the Bench Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 260
Activate Transmission for InstantQC™ . . . . . . . . . . . . . . . . . . . . . . . . . 260

Chapter 16: Unity™ Interlaboratory Reports 261

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 261
Monthly Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 262
Comprehensive Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 263
Optional Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 263
InstantQC™ Reports and Charts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 263
Consensus Groups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 264
View and Print Interlaboratory Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . 265
Monthly Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 266
Monthly Evaluation Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 266
How to Use This Report. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 266
Example Monthly Evaluation Report . . . . . . . . . . . . . . . . . . . . . . 267
Data Rejection Report. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 268
How to Use This Report. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 268
Limits for the Mean . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 268
Limits for the CV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 268
Example Data Rejection Report . . . . . . . . . . . . . . . . . . . . . . . . . 269
Laboratory Performance Overview Report . . . . . . . . . . . . . . . . . . . . . 270
How to Use This Report. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 270
Example Laboratory Performance Overview Report . . . . . . . . . . 271
Laboratory Comparison Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 272
How to Use This Report. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 272
Example Laboratory Comparison Report . . . . . . . . . . . . . . . . . . 273
Laboratory Histogram Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 274
How to Use This Report. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 274
Example Laboratory Histogram Report . . . . . . . . . . . . . . . . . . . . 275

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Bias and Imprecision Histogram Report . . . . . . . . . . . . . . . . . . . . . . . . 276

How to Use This Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 276
Example Bias and Imprecision Histogram Report . . . . . . . . . . . . 277
Comprehensive Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 278
Worldwide Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 278
How to Use This Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 278
Example Worldwide Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 279
Manufacturer Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 280
How to Use This Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 280
Example Manufacturer Report . . . . . . . . . . . . . . . . . . . . . . . . . . . 280
Optional Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 281
Statistical Profile Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 281
How to Use This Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 281
Laboratory 2SD and 3SD Ranges. . . . . . . . . . . . . . . . . . . . . . . . . 281
Example Laboratory 2SD and 3SD Ranges . . . . . . . . . . . . . . 282
Summary Statistics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 282
Example Summary Statistics . . . . . . . . . . . . . . . . . . . . . . . . . 282
Frequency Histograms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 283
Example Frequency Histogram . . . . . . . . . . . . . . . . . . . . . . . 283
Percentile Distribution Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 284
How to Use This Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 284
Example Percentile Distribution Table . . . . . . . . . . . . . . . . . . 284
Affiliated Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 285
Affiliated Laboratory Comparison Report . . . . . . . . . . . . . . . . . . . . . . . 285
How to Use This Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 286
Example Affiliated Laboratory Comparison Report . . . . . . . . . . . . 286
Affiliated Laboratory Comparison Report: Abbreviated Summary . . . . . 287
How to Use This Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 287
Example Affiliated Laboratory Comparison Report:
Abbreviated Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 288
Affiliated Data Exception Report. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 288
How to Use This Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 288
Example Affiliated Data Exception Report . . . . . . . . . . . . . . . . . . 289
Urinalysis Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 290
Chemistry Section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 290
Microscopy Section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 292

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InstantQC™ Reports and Charts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 293

InstantQC™ Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 293
How to Use This Report. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 294
View InstantQC™ Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 294
InstantQC™ Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 295
How to Use This Report. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 295

Chapter 17: Regulatory Requirements and Reports 297

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 297
CLIA Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 298
CAP Accreditation Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 306
ISO 15189 Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 320

Chapter 18: Westgard Advisor™ online 323

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 323
View Existing QC Rules. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 324
View Lab Data and Group Statistics . . . . . . . . . . . . . . . . . . . . . . . . . . 325
Configure Westgard Advisor™ online . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 326
Total Allowable Error (TEa) Options . . . . . . . . . . . . . . . . . . . . . . . . . . . 326
View TEa Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 327
Configure the TEa for an Analyte . . . . . . . . . . . . . . . . . . . . . . . . . 327
Configure the TEa for All Analytes . . . . . . . . . . . . . . . . . . . . . . . . 328
Return TEa Selections to the Default . . . . . . . . . . . . . . . . . . . . . . 329
Data Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 330
Specify Data Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 330
Grid Display Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 331
Select Grid Display Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 331
Generate Rules with Westgard Advisor™ online. . . . . . . . . . . . . . . . . . . . . . 332
Consensus Groups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 333
Use the Westgard Advisor™ online Wizard . . . . . . . . . . . . . . . . . . . . . . 334
Use the Advanced Option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 336
Use the Westgard Advisor™ online Defaults . . . . . . . . . . . . . . . . . . . . 338
Apply Rules with Westgard Advisor™ online . . . . . . . . . . . . . . . . . . . . . . . . 339
Apply Rules. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 339
Westgard Advisor™ online Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 341
Print the Westgard Advisor™ online Report . . . . . . . . . . . . . . . . . . . . . 341

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Delete Historical Suggestions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 343

OPSpecs Chart. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 344
OPSpecs Chart Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 345
How to Interpret an OPSpecs Chart. . . . . . . . . . . . . . . . . . . . . . . . . . . 347
When Westgard Advisor™ online Recommends a Maximum
QC Procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 348

Chapter 19: Supplemental Information 349

Action Log Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 349

Audit Trail Events. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 351
Rejection Log Messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 353

Chapter 20: References 355

QC References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 355
Articles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 355
Books . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 356
Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 356

Glossary 357

License Agreement, Warranty Information, and Trademark Notices 377

License Agreement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 377

Warranty Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 378
Trademark Notices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 379

Index 381

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 CHAPTER
1
Getting Started

In This Chapter
Welcome . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Essential Startup Tasks for New Users . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Program Hints. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Welcome
Welcome to UnityWeb™, Bio-Rad's expert quality control (QC) data
management software. New users will find this powerful and user-friendly
software provides access to advanced tools and functions designed to meet or
exceed clinical laboratory quality requirements. UnityWeb™ provides data
access, analysis, review, management, storage, and reporting.

One of the most powerful utilities of UnityWeb™ is the ability to connect a

laboratory to the worldwide clinical laboratory community. Bio-Rad's Unity™
Interlaboratory Program collects data from thousands of laboratories worldwide
and combines the data to create consensus groups for data comparison.

Existing users of other Bio-Rad software will find UnityWeb™ provides familiar
functionality plus several new features. New features include:

• Westgard Advisor™ online (page 323)

This optional feature recommends statistical process control (SPC) rules
based on a total allowable error plus historical data and Bio-Rad
consensus group information.

• New charts and chart options (page 223)

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 Getting Started

• Bench Review (page 202)

Provides documentation of QC data review and helps improve laboratory
QC workflow.

• Qualitative Data Entry (page 180)

Enter qualitative and semi-quantitative data and send to Bio-Rad's
Unity™ Interlaboratory Program for comparison.

• Automatic monthly transmission (page 259)

Ensures data always arrives at Bio-Rad on time.

• Audit Trails (page 253)

Comprehensively tracks events which could affect decisions determined
from QC data.

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 Getting Started

Contact Bio-Rad
Every attempt has been made to ensure this guide is accurate and complete.
However, if you need to contact Bio-Rad for assistance, you can:

• Search the Bio-Rad knowledge base at: [Link]

• Send an e-mail to: unity_support@[Link].
• In the United States, phone a Bio-Rad Software Support Representative at
1-800-854-6737. Software Support Representatives are available Monday
through Friday, 5 am to 5 pm (Pacific Standard Time).

Important: If phoning Bio-Rad outside of normal working hours, leave a

message and a Software Support Representative will return the call,
typically within 24 hours.

• Outside the United States, contact your local Bio-Rad QC Program

Representative.

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 Getting Started

Organization of this Guide

This guide is organized with more frequently used information at the beginning
of the guide and the less frequently used information at the end of the guide.

The major function of UnityWeb™ is to oversee QC data. Therefore, QC

information appears first in this guide, the specifics of using the software
appear next, and set up instructions appear last.

Typographical Styles and Conventions

This guide uses consistent styles and conventions to assist with readability. The
following information describes the styles and conventions.

Software Items
Items on the screen such as tabs, menu items, dialog boxes, buttons, options,
and check boxes appear in bold.

Software Item Example

Tab Click the Reports tab.

Menu item Click Security.

Dialog box Comments that are added in the Data

Entry dialog box do not appear on the
Audit Trail Report.

Button Click Save.

Option Select the Lab or Panel option.

Check box Select the Overlay check box.

Keyboard Keys
Names of keys on the keyboard appear in all capital letters. For example, press
the TAB key on the keyboard.

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 Getting Started

Notes, Tips, and Important Notes

This guide uses notes, tips, and important notes to call attention to additional
information or information of special importance.

Note
A note indicates information supplementing the main text. A note supplies
information that may only apply in special cases and is separated from the
surrounding text by a box. For example:

Note: A comment is automatically added when inserting a row of data.

Tip
A tip provides useful extra information and suggestions for implementation. A
tip is not essential to the basic understanding of the text and is separated from
the surrounding text by a box. For example:

Tip: For convenience, rearrange the order of tests in the Open tests list to
match your instrument or LIS printout.

Important
An important note provides information essential to the completion of a task.
Do not disregard information in an important note. An important note is
separated from the surrounding text by a shaded box. For example:

Important: Make sure to select Dedicated reagent or kit as the Reagent

Type if using a VITROS® instrument.

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 Getting Started

Essential Startup Tasks for New Users

Important: Make sure to disable any pop-up blockers or allow pop-ups for
the UnityWeb™ site.

Bio-Rad provides your laboratory with an administrator ID and password for

UnityWeb™. This default administrator login allows new users first time access
to the software. For ultimate security of UnityWeb™, delete the default
administrator login after another administrator login has been setup.

First Time Log In

1 Start an Internet browser window and navigate to [Link].
2 Point to Unity™ Interlab and then click UnityWeb™ 2.0.
The Server Login dialog box appears.
3 Type the server name provided by Bio-Rad in the Server field or click
(ellipsis button) located to the right of the Server field and select the
server from the list.
4 Select the SQL Server authentication option.
5 Type the server user name in the User field. This is the server user name
provided by Bio-Rad.
6 Type the server password in the Password field. This is the server
password provided by Bio-Rad.
7 Type the database name provided by Bio-Rad in the Database field or
click (ellipsis button) located to the right of the Database field and
select the database from the list.
8 Click OK.
The Login dialog box appears.
9 Type the group login ID provided by Bio-Rad in the User field.
10 Type the password in the Password field.
11 Click Login.

Note: See Chapter 5, “User Profiles and Security” for more information
about adding additional users and security basics.

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 Getting Started

QC Configuration
Perform the following tasks before manually entering data:

• Add a lab number–see Chapter 6, “Labs and Lots”

• Add a lot number–see Chapter 6, “Labs and Lots”
• Add tests–see Chapter 7, “Tests”

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 Getting Started

Program Hints
UnityWeb™ contains common software elements you have probably used with
other Internet-based software. Each element provides a specific function for
performing different actions.

Tabs
Software functions in UnityWeb™ are organized by different tabs. Click each tab
to access different functionality of the software.
Tab

Menu Items
First level
sub-menu item

Second level
sub-menu item

Links
Click a link to go to or open another window in the software. Links are
underlined in blue.

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 Getting Started

Buttons
Click a button to initiate an action.

Check Boxes
A square box selected or cleared to turn on or off an option. More than one
check box can be selected.

Options
A round button used to select one of a group of options. Unlike check boxes,
only one option can be selected.

Lists
A list has a down-pointing arrow next to it. Click the arrow to open the list and
make a selection.

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 Getting Started

Scroll Bars and Scroll Arrows

Depending on the size of your monitor, it may be necessary to use the scroll
bars and scroll arrows to view the entire contents on the screen.

Click the Maximize button to enlarge the screen to its largest size and to
minimize scrolling.

Maximize button

Scroll arrow

Scroll bar

Scroll bar Scroll arrow

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 Getting Started

Unavailable Items
Items in the software appear dimmed if not available. Items that may appear
dimmed include buttons, options, check boxes, and icons. Items may be
dimmed if a user does not have the required permission to perform a task or if
another action is required before the item is available.

A button appears dimmed if it is unavailable.

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 CHAPTER
2
Introduction to Quality Control
Statistics

In This Chapter
What is Quality Control? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Basic QC Statistics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
SPC Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

What is Quality Control?

Quality control in the medical laboratory is a statistical process used to monitor
and evaluate the analytical process producing patient results. The statistical
process requires:

• Regular testing of quality control products along with patient

samples.
Good laboratory practice requires testing normal and abnormal controls at
least once a day when patient testing is performed. If the test is stable for
less than 24 hours or some change has occurred that could potentially
affect the test stability, controls should be tested more frequently. All
laboratories in the United States must comply with CLIA Requirements
(see “CLIA Requirements” on page 16 for more information).

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 Introduction to Quality Control Statistics

• Generation of QC results for evaluation.

When performing a diagnostic test in the medical laboratory, the outcome
of the test is a result. The result may be a patient result or a quality control
(QC) result. The result may be quantitative (a number), qualitative (positive
or negative), or semi-quantitative (limited to a few different values).

Note: UnityWeb™ currently provides QC rule evaluation only for quantitative

tests. You may enter data from qualitative and semi-quantitative tests;
however, the data is not evaluated against any rules.

How Are QC Results Used?

Use QC results to validate patient results. After the validation of QC results, use
patient results for diagnosis, prognosis, or treatment planning. For example,
when testing a patient’s serum for potassium, the test result shows how much
potassium (what concentration) is present in the blood. The physician uses this
result to determine whether the patient has a low, normal, or high potassium
level.

For example, if the measured value of potassium in a patient's serum is 2.8

mmol/L (a unit of measure, millimoles per liter), this result is abnormally low and
indicates an inappropriate loss of potassium.

What indicates this test is truly reliable? Perhaps the instrument is out of
calibration and the patient's true potassium value is 4.2 mmol/L, which is a
normal result.

Resolve the question of reliability for most testing by regular testing of quality
control materials and the application of statistical process control values.

Test QC materials and develop a database of values to calculate a mean and

range (for example, the mean ±3SD). Compare the QC results to the range
using statistical process control (SPC) rules and make decisions to accept or
reject patient results based on the outcome of the rule evaluation.

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 Introduction to Quality Control Statistics

Normal and Abnormal Controls

A normal control product contains normal levels for the analyte. An abnormal
control product contains the analyte at a concentration above or below the
normal range for the analyte. For example, the normal range for a potassium
level is approximately 3.5–5.0 mmol/L. A normal control contains potassium at
a level within this range. An abnormal control contains potassium at a level
below 3.5 mmol/L or above 5.0 mmol/L.

Example Scenario
The following example QC log shows normal and abnormal control results
as well as patient results for a seven-day period.
Analyte: Potassium
Instrument: Instrument Number 1
Unit of measure: mmol/L

Level 1 Level 2
(Normal Control) (Abnormal Control) Patient Results
Range: 3.7 – 4.3 mmol/L 6.7 – 7.3 mmol/L

Date: Dec-01 4.0 7.0 4.2, 4.0, 3.8, 5.0, 5.8, 4.2

Dec-02 4.1 7.0 3.8, 4.4, 4.6, 3.9, 4.6, 4.4, 3.9

Dec-03 4.0 6.9 4.4, 3.9, 3.7, 4.7

Dec-04 4.2 7.1 4.7, 5.6, 4.2, 3.7, 4.3

Dec-05 4.1 7.0 4.3, 4.3, 4.1, 4.3

Dec-06 4.1 7.0 4.6, 4.4, 5.5, 3.8, 3.2

Dec-07 4.2 8.0 2.8, 4.6, 4.2, 3.2, 3.9, 4.1, 6.0, 4.3

The acceptable range for Level 1 (normal control) is 3.7–4.3 mmol/L. The
acceptable range for Level 2 (abnormal control) is 6.7–7.3 mmol/L. When
comparing the daily QC result obtained for the normal control to the range
calculated for the normal control, each result is within the expected range.
This indicates the analytical process is “in control” at the normal level on the
day of testing.

When comparing the daily QC result for Level 2 (abnormal control) to the
defined range for the abnormal control, the analytical process is “in control”
for each day of testing except for the last day (Dec-07 in the example
above). On December 1 through December 6, both levels were “in control,”
and the laboratory could report patient values reliably.

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 Introduction to Quality Control Statistics

Example Scenario
However, the laboratory was “out of control” for abnormal high potassium on
December 7 because the value obtained for the QC material (8.0 mmol/L)
was outside the acceptable range (6.7–7.3 mmol/L). This result indicates
some type of error occurred which may have produced unreliable patient
results which are abnormally high. In this scenario, the laboratory should not
report any patient samples with an abnormally high potassium until resolving
the error and re-testing the abnormally high sample.

From this example, it is apparent the range defined for each level of control
is fundamental to the quality control system. The section “Basic QC
Statistics” on page 17 describes the calculations required to develop an
acceptable control range.

CLIA Requirements
In the United States, the Clinical Laboratory Improvement Amendments (CLIA)
of 1988, as modified by the final CLIA Rule, requires the testing of two levels of
control (one normal and one abnormal) each day the test is performed. This
requirement applies to all non-waived tests, unless the Centers for Medicare
and Medicaid Services (CMS) approves an equivalent quality testing procedure
as specified in Appendix C of the State Operations Manual.

In other words, if testing patient samples for potassium on Wednesday, the

laboratory must test at least one normal and one abnormal potassium control
product on Wednesday, unless CMS has approved an equivalent QC
procedure. Blood gas testing is slightly different.

For instruments verifying calibration internally, a laboratory in the United States

must run one control every eight hours and use a combination of materials
including low and high values on each day of testing.

If the instrument does not verify calibration internally, a laboratory must test
these same controls with each patient sample.

Note: As with any government regulation, these requirements can change.

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 Introduction to Quality Control Statistics

Basic QC Statistics
A total QC system must control both trueness and precision. The goal is for a
test to have both low bias and low imprecision. Problems with imprecision are
less likely to cause analytical failure in the modern laboratory due to
computerization and mechanization of the analytical process. Therefore, bias is
brought to the forefront.

The following illustration represents low bias and low imprecision as a target,
where the center of the target represents the target value.

The illustrations below show two other possibilities.

• The illustration on the left represents a situation where the standard

deviation (SD) for a test is small (good precision) but is shifted away from
the target value (high bias).
• The illustration on the right represents poor precision but surprisingly, low
bias because the average of the results is close to the target. Of course,
individually none of the points are close, and their individual z-scores
would reflect this.

Note: Bias and imprecision are most important at the clinical decision levels.
For example, ß-hCG clinical decision levels are at low concentrations
(corresponding to early pregnancy in the female and early testicular cancer
in the male) or at moderate concentrations (to diagnose the progression of
pregnancy).

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 Introduction to Quality Control Statistics

Useful Statistics
Evaluation of a test's bias and imprecision uses several calculations. Although
UnityWeb™ performs these calculations, it is useful to understand the
calculations, which include:

• Mean (page 18).

• Standard Deviation (page 19).
• Standard Deviation Index (page 21).
• Bias (page 22).
• Coefficient of Variation (page 23).
• Coefficient of Variation Ratio (page 25).

Mean
The mean for a group of data points is simply the calculated average. The
mean provides a laboratory's best estimate of the analyte's “true” value for a
specific level of control. The mean ± a predetermined number of standard
deviations represents the error expected in a test when the analytical system is
stable. Use the following formula to calculate the mean:

Xn
Mean = ∑n
where: ∑ = sum
Xn = each value in the data set
n = the number of values in the data set

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 Introduction to Quality Control Statistics

Standard Deviation (SD)

Note: Standard deviation is often abbreviated as SD or s.

The standard deviation measures a test's precision; that is, how close
individual measurements are to each other. (The standard deviation does not
measure bias, which requires the comparison of your results to a target value
such as your peer group.) The standard deviation provides an estimate of how
repeatable a test is at specific concentrations. Test repeatability can be
consistent (low standard deviation, low imprecision) or inconsistent (high
standard deviation, high imprecision).

It is optimum to have repeated measurements of the same specimen in order

to have results as close to each other as possible. Good precision is especially
important for tests repeated regularly on the same patient in order to track
treatment or disease progress. For example, a diabetic patient in a critical care
situation may have glucose levels run every two to four hours. In this case, test
precision is important since the lack of precision can cause loss of test
reliability. If there is a lot of variability in the test performance (high imprecision,
high standard deviation), the glucose result at different times may not be true.

Use the following formula to calculate the standard deviation:

∑ ⎛⎜⎝ Xn
− X ⎞⎟
⎠
SD =
n −1

where: x = mean (average) of the QC values

∑(xn- x )2 = the sum of the squares of differences between
individual QC values and the mean
n
= the number of values in the data set

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 Introduction to Quality Control Statistics

A high standard deviation can be attributed to:

• Inherent variability in the test which represents expected error.

• Analytical system malfunction which represents unexpected error the
laboratory must investigate and correct.

Tip: Levey-Jennings Charts allow you to visually review data points plotted
against a ±3SD range. See “Levey-Jennings Chart” on page 230 for more
information.

Calculate a Control Mean and Range

1 Collect a minimum of twenty data points for each level of control.
• Obtain data points from twenty separate analytical runs reflecting
variables such as calibration frequency, change of reagent or reagent
lot, operator technique, temperature and humidity of testing location,
daily and weekly maintenance, and so on.
*Based on the Clinical and Laboratory Standard Institute (CLSI)
recommendation for the minimum number of data points necessary
to calculate a range.
• Compare new control products to previously validated controls
(parallel testing).
2 Calculate the mean and standard deviation from the data points collected.
• Use a statistical test for outliers before eliminating any questionable
data points.
• Calculate the statistical control limit from the mean ±2SD and the
mean ±3SD.

Important: Use product insert ranges as guidelines only. Ranges are based
on reagent lots and materials available at the time of value assignment.
During the life of the control lot, manufacturers may reformulate tests or
begin using a new source of raw materials for kit/reagent production.
Published ranges cannot account for variables such as instrumentation
software updates or performance differences over time.

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Standard Deviation Index (SDI)

The standard deviation index is a measurement of bias (how close your value is
to the target value). The Bio-Rad Unity™ Interlaboratory Program uses the
consensus group value as the target value. Use the following formula to
calculate the SDI:

Laboratory Mean – Consensus Group Mean

SDI =
Consensus Group Standard Deviation

Interpreting the SDI

The target SDI is 0.0, which indicates there is not any difference between the
laboratory mean and the consensus group mean. A SDI ±1 indicates a
possible problem with the test.

The SDI expresses bias as increments of the standard deviation. A SDI of -1.8
indicates a negative bias of 1.8 standard deviations from the consensus group
mean. This is not favorable.

Bias increases or decreases the percentage of patients outside the defined

reference limit. For example, a positive bias decreases the percentage of
patients normally outside the lower limit and increases the percentage of
patients normally outside the upper reference limit. This creates an increase in
false positive test results. Negative bias has an opposite effect and decreases
true positives and creates false negatives.

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 Introduction to Quality Control Statistics

Use the following guidelines to interpret the SDI:

SDI value Interpretation

0.0 Perfect comparison with consensus group

≤ 1.25 Acceptable

1.25 - 1.49 Acceptable to marginal performance. Some

investigation of the test system may be required.

1.5 - 1.99 Marginal performance. Investigation of the test

system is recommended.
≥ 2.0 Unacceptable performance. Remedial action
usually required.

Bias
Bias measures how far your observed value is from a target value. Determine
bias by a reference value or estimate from outside sources such as proficiency
testing results or the Bio-Rad Unity™ Interlaboratory Program. Express bias as a
percentage. Use the following formula to calculate bias:

Laboratory Mean – Consensus Group Mean

Laboratory Bias % = × 100
Consensus Group Mean

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 Introduction to Quality Control Statistics

Coefficient of Variation (CV)

The coefficient of variation is the ratio of the standard deviation to the mean.
Express CV as a percentage. Use the following formula to calculate the CV:

Standard Deviation
CV % = × 100
Mean

Using the CV makes it easier to compare the overall precision of two analytical
systems. The CV is a more accurate comparison than the standard deviation
as the standard deviation typically increases as the concentration of the analyte
increases. Comparing precision for two different methods using only the
standard deviation can be misleading.

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 Introduction to Quality Control Statistics

Example Scenario
Compare a hexokinase method and glucose oxidase method for
measuring glucose. The standard deviation for the hexokinase method is
4.8. The standard deviation for the glucose oxidase method is 4.0. Based
on the standard deviation, you might conclude the glucose oxidase
method is more precise than the hexokinase method.

However, in this example, a comparison of the CV shows the methods are

equally precise. Assuming the mean for the hexokinase method is 120 and
the mean for the glucose oxidase method is 100, the CV for both methods
is 4%.

Example of Coefficient of Variation (CV) versus Standard Deviation (SD)

Analyte: Glucose Analyte: Glucose

Method: Hexokinase Method: Glucose oxidase
Standard deviation = 4.8 Standard deviation = 4.0
Mean = 120 Mean = 100

Which method is more precise ?

Calculate the CV to see:
Standard Deviation
CV (%) = × 100
Mean

4.8 (SD) 4.0 (SD)

× 100 = 0.04% (CV) × 100 = 0.04% (CV)
120 (Mean) 100 (Mean)

In this example, the CV proves both methods are equally precise .

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 Introduction to Quality Control Statistics

Determining an Acceptable CV
When determining an acceptable CV, several sources provide expected levels
of precision, including:

• Precision information provided in the product insert or instrument manual.

• Interlaboratory comparison programs.
• Proficiency surveys.
• Evaluations of instruments and methods published in professional journals.

These sources are useful for evaluating the CV for a test or when comparing
two test systems.

Coefficient of Variation Ratio (CVR)

The coefficient of variation ratio compares your laboratory precision for a
specific test to the CV of other laboratories performing the same test. Use the
following formula to calculate the CVR:

Laboratory CV
CVR =
Consensus Group CV

In UnityWeb™, the CVR appears on the following Unity™ Interlaboratory Reports:

• Laboratory Comparison Reports

• Monthly Evaluation Reports
• Affiliated Laboratory Comparison Report: Abbreviated Summary
This report includes the CVR based on your affiliated group as well as the
CVR for the Peer and Method consensus groups.

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 Introduction to Quality Control Statistics

Total Error (TE) and Total Allowable Error (TEa)

Total error and total allowable error are useful when choosing the SPC rule(s) to
apply to a test. For example, SPC rules can identify a test exceeding a quality
specification (TEa). Total error for a test includes both bias and imprecision. Use
the following formula to calculate the TE:

Laboratory TE = [Laboratory Bias (%)] + z-score × (Laboratory Imprecision %)

TEa specifications are available from several sources as described in

“Determine Quality Requirements for the Test” on page 43. After choosing a
TEa, calculate the TE budget. Use the following formula to calculate the TE
budget:

⎛ Laboratory TE ⎞
TE Budget % = ⎜ ⎟ × 100
⎝ TEa ⎠

With the optional Westgard Advisor™ online, choose a TEa and the program
suggests SPC rules based on test data and Unity™ Interlaboratory Program
information.

z-score
The z-score is the number of standard deviations a control result is from the
expected mean. Use the following formula to calculate the z-score:

Observed Result – Expected Mean

z-score =
Expected Standard Deviation

A z-score of 2.3 indicates the observed value is 2.3SD away from the expected
mean. A data point with this z-score would violate the 12s rule, but not the 13s
rule. The z-score appears on the Single Test Point Data Entry dialog box.

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SPC Rules
In 1981 Dr. James Westgard of the University of Wisconsin published an article
on laboratory quality control setting the basis for evaluating analytical run
quality for medical laboratories. The Westgard system is based on the
principles of statistical process control used in manufacturing nationwide since
the 1950s. There are six basic rules in the Westgard scheme: 13s, 22s, R4s,
12s, 41s, and 10x. Use these rules individually or in combination (multi-rule) to
evaluate the quality of analytical runs.

The rationale for applying these rules is:

• Reduce false rejections made when applying just the 12s rule for run
rejection.
• Increase error detection more than provided when applying just the 13s
rule for run rejection.
• Include rules to detect and distinguish random and systematic error
(13s and R4s to detect random error and 22s, 41s, and 10x to detect
systematic error).

Westgard devised a shorthand notation for expressing quality control rules.

Most quality control rules can be expressed as NL, where N represents the
number of control observations to be evaluated and L represents the statistical
limit for evaluating the control observations. Therefore, 13s represents a control
rule violation when one control observation exceeds the ±3SD control limit.

12s
The 12s rule is usually a warning rule violated when a single control observation
is outside the ±2SD limit.

Some laboratories consider any quality control value outside its ±2SD limit to
be out of control, and therefore incorrectly decide the patient specimens and
QC values are invalid.

An analytical run usually should not be rejected if a single quality control value
is outside the ±2SD QC limit but within the ±3SD QC limit. Approximately 4.5%
of all valid QC values will fall somewhere between ±2SD and ±3SD limit.

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 Introduction to Quality Control Statistics

Laboratories universally rejecting values outside the ±2SD limit end up rejecting
good runs too frequently.

The 12s rule was originally designed as a warning rule for manual application of
the Westgard rules. If one control measurement within a run exceeds the mean
±2SD in a manual application of Westgard rules, evaluate other controls in the
run (within the run) and in previous runs (across runs) before accepting the run
and reporting the results. With computer-based applications of Westgard rules,
the 12s rule is usually not necessary.

Using the 12s rule alone in performing quality control tests causes frequent
rejection of valid runs. According to Dr. Westgard, failure to allow for valid
points between 2SD and 3SD may result in falsely rejecting:

• 5% of all analytical runs when using one level of control.

• 10% of all analytical runs when using two levels of control.
• 14% of all analytical runs when using three levels of control.

These false rejections result in the unnecessary repeat of patient samples, the
waste of labor and materials, and the unnecessary delay of patient results.

The following figure shows a Levey-Jennings Chart with a data point between
+2SD and +3SD.

+3s Level 1
+2s
12s
+1s

Mean

-1s

-2s

-3s
1 2 3 4 5 6 7 8 9 10 11 12

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 Introduction to Quality Control Statistics

12.5s
The 12.5s rule indicates random error and may also point to systematic error.
This rule is applied within the run only. The following figure shows a
Levey-Jennings Chart with a data point outside the ±2.5SD limit.

+3s Level 1
+2s

+1s

Mean

-1s
1 2.5s
-2s

-3s
1 2 3 4 5 6 7 8 9 10 11 12

13s
The 13s rule identifies unacceptable random error or possibly the beginning of
a large systematic error. Any QC result outside ±3SD violates this rule. Since
only 0.3% or 3 out of 1000 points will fall outside the ±3SD limit, any value
outside of ±3SD is usually considered to be associated with a significant error
condition.

While a value outside ±3SD may be statistically significant, it may not be

biologically or medically relevant due to the fact that modern laboratory
instruments are often more precise than what is needed medically.

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 Introduction to Quality Control Statistics

The following figure shows a Levey-Jennings Chart with a data point outside
the ±3SD limit.

+3s Level 1
+2s 1 3s

+1s

Mean

-1s

-2s

-3s
1 2 3 4 5 6 7 8 9 10 11 12

13.5s
The 13.5s rule indicates random error and may also indicate systematic error.
The run is considered out of control when one control value exceeds the mean
±3.5SD. This rule is applied within the run only. The following figure shows a
Levey-Jennings Chart with a data point outside the ±3.5SD limit.

+4s Level 1
+3s
1 3.5s
+2s

+1s

Mean

-1s

-2s
1 2 3 4 5 6 7 8 9 10 11 12

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 Introduction to Quality Control Statistics

14s
Violation of the 14s rule indicates random error and may also point to
systematic error. The run is considered out of control when one control value
exceeds the mean ±4SD. This rule is applied within the run only. The following
figure shows a Levey-Jennings Chart with a data point outside the ±4SD limit.

+6s Level 1
+4s

+2s 1 4s
Mean

-2s

-4s

-6s
1 2 3 4 5 6 7 8 9 10 11 12

15s
Violation of this rule indicates random error and may also point to systematic
error. The run is considered out of control when one control value exceeds the

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 Introduction to Quality Control Statistics

mean ±5SD. This rule is applied within the run only. The following figure shows
a Levey-Jennings Chart with a data point outside the ±5SD limit.

+6s Level 1
+4s

+2s

Mean

-2s

-4s
1 5s

-6s
1 2 3 4 5 6 7 8 9 10 11 12

22s
The 22s rule detects systematic error only. The 22s rule is violated when two
consecutive QC results are:

• Greater than 2SD.

• On the same side of the mean.

The rule is applied both within a run and across runs:

• Within run violation

Two control values in the same run are >2SD on the same side of the
mean. Violation of the within run application indicates systematic error is
present and potentially affecting the entire analytical curve.

• Across run violation

In one run a single level of control is >2SD from the mean. In the next run,
the same level of control is >2SD on the same side of the mean. Violation
of the across run application indicates systematic error is present but
affects only a single portion of the analytical curve.

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 Introduction to Quality Control Statistics

The following figures show a Levey-Jennings Chart with a data point violating
the 22s rule within and across a run.

Across run violation

+3s Level 1
+2s
22s
+1s

Mean

-1s

-2s

-3s
1 2 3 4 5 6 7 8 9 10 11 12

Within run violation

+3s Level 1
+2s Level 2

+1s

Mean

-1s 22s
-2s

-3s
1 2 3 4 5 6 7 8 9 10 11 12

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 Introduction to Quality Control Statistics

2 of 32s
This is a variation of the 22s rule and detects systematic errors. It is triggered
when any two of all three levels of control in a run exceed 2SD on the same
side of the mean. The following figure shows a Levey-Jennings Chart with two
points violating the 2 of 32s rule.

+3s Level 1
+2s Level 2
Level 3
+1s

Mean

-1s 2 of 32s

-2s

-3s
1 2 3 4 5

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 Introduction to Quality Control Statistics

R4s
The R4s rule identifies random error. It is applied only within the current run.
This rule is violated when there is at least a 4SD difference between control
values within a single run.

For example, assume both Level 1 and Level 2 have been tested within the
current run. Level 1 is +2.8SD above the mean and Level 2 is -1.3SD below
the mean. The total difference between the two control levels is greater than
4SD (+2.8SD - (-1.3SD) = 4.1SD).

The following figure shows a Levey-Jennings Chart with two points violating the
R4s rule.

+3s Level 1
+2s Level 2

+1s

Mean R 4s
-1s

-2s

-3s
1 2 3 4 5 6 7 8 9 10 11 12

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 Introduction to Quality Control Statistics

31s and 4 1s
These rules are violated when three or four consecutive results are:

• Greater than 1SD.

• On the same side of the mean.

The 31s and 41s rules have two applications:

• Within a control level (for example, all Level 1 control results).

Violations within a control level indicate systematic bias in a single area of
the method curve.

• Across control levels (for example, Level 1, 2, and 3 control results in

combination).
Violations across control levels indicate systematic error over a broader
range of concentrations.

The following figures show a Levey-Jennings Chart with a data point violating
the 31s rule within a run and a 41s rule across a run.

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 Introduction to Quality Control Statistics

31s Within a Control Level

+3s Level 1
+2s

+1s

Mean 31s
-1s

-2s

-3s
1 2 3 4 5 6 7 8 9 10 11 12

41s Across Control Levels

+3s Level 1
+2s Level 2

+1s
4 1s
Mean

-1s

-2s

-3s
1 2 3 4 5 6 7 8 9 10 11 12

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 Introduction to Quality Control Statistics

7T
The 7T rule is violated when a group of seven consecutive data points for a
single level of control show either a “strict” increasing or decreasing pattern. A
“strict” increasing pattern is defined as a series of points increasing
incrementally from the previous point (each point greater than the last) without
a break in the pattern. A “strict” decreasing pattern is the same pattern in the
opposite direction.

The following figure shows a Levey-Jennings Chart with points violating the 7T
rule.

+3s Level 1
+2s
7T
+1s

Mean

-1s

-2s

-3s
1 2 3 4 5 6 7 8 9 10 11 12

Nx Rules
Nx rules are violated when there are 7, 8, 9, 10, or 12 control results on the
same side of the mean.

Each of these rules has two applications:

• Within a control level (for example, all Level 1 control results).

Violations within a control level indicate systematic bias in a single area of
the method curve.

• Across control levels (for example, Level 1, 2, and 3 control results in

combination).

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 Introduction to Quality Control Statistics

Violations across control levels indicate systematic error over a broader

range of concentrations.

The 7x control rule is far more sensitive to analytical bias than the 12x rule. The
chance of finding seven consecutive control observations on one side of the
mean is much higher than finding twelve.

The following figures show a Levey-Jennings Chart with data points violating
the 8x rule within a run and the 9x rule across a run.

8x Within a Control Level

+3s Level 1
+2s

+1s

Mean

-1s
8x-

-2s

-3s
1 2 3 4 5 6 7 8 9 10 11 12

9x Across Control Levels

+3s Level 1
+2s Level 2
Level 3
+1s
9x-
Mean

-1s

-2s

-3s
1 2 3 4 5

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 CHAPTER
3
Choose and Troubleshoot
a QC Procedure

In This Chapter
Recommended Steps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Determine Quality Requirements for the Test . . . . . . . . . . . . . . . . . . . . . . . . . 43
Identify Appropriate QC Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Evaluate Test Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Identify Possible QC Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Predict the Performance of the QC Procedures. . . . . . . . . . . . . . . . . . . . . . . 51
Choose Goals Based on Required Quality. . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Select a QC Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Troubleshoot QC Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Keys to a Productive Review of the Laboratory Quality System . . . . . . . . . . . 60

Recommended Steps
When setting up a QC system, it is important to make sure you choose
statistical process control (SPC) rules to maximize error detection while
minimizing false rejections.

Clinical and Laboratory Standards Institute (CLSI–C24-A3, section 6)

recommends using the following steps when setting up a QC system:

1 Determine the quality requirements for the test.

2 Identify appropriate control materials to use.
3 Evaluate test performance.
4 Identify possible QC procedures.
5 Predict the performance of the identified QC procedures.

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 Choose and Troubleshoot a QC Procedure

6 Choose goals based on the required quality.

7 Select a QC procedure.

Obviously, this is not a simple process which may explain why many
laboratories fall back on the 12s rule. Although the 12s rule produces too many
false alarms, it feels safe.

Tip: The optional Westgard Advisor™ online makes the complex task of
choosing the appropriate SPC rules easier. See Chapter 18, “Westgard
Advisor™ online” for more information.

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 Choose and Troubleshoot a QC Procedure

Determine Quality Requirements for the

Test
How good does a test need to be? Answering this question will help determine
the total allowable error (TEa); the amount of error a test has and is still
considered “in control.” The laboratory can use several models to determine
quality requirements:

1 Medical usefulness requirements based on the effect of analytical

performance on clinical decisions such as:
• Biological variation information.
• Clinicians' opinions.
2 Published professional recommendations from:
• National and international expert bodies and agencies.
• Expert local groups or individuals.
3 Performance goals set by:
• Regulatory bodies and agencies.
• Organizers of External Quality Assessment (EQA) schemes.
4 Goals based on the current state of the art, which include:
• Interlaboratory comparison programs such as the Unity™
Interlaboratory Program.
• EQA or proficiency testing schemes.
• Current published information on methodology.

The preceding hierarchy is based on the consensus agreement published in

the Scandinavian Journal of Clinical and Laboratory Investigation 1999; 59:
585.

Note: When available and appropriate, models higher in the list are preferred
to those lower in the list.

Based on requirements needed to maintain accreditation, proficiency testing

requirements define the minimum standards for performance. While proficiency
testing may be appropriate for some tests, medical usefulness requirements
are usually more stringent and may be preferred.

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 Choose and Troubleshoot a QC Procedure

Identify Appropriate QC Materials

CLSI (C24-A3, Section 6.2) suggests the following considerations when
selecting control materials:

• The control material should share common characteristics with the

intended patient sample types.
• To minimize the amount of testing required when a lot change occurs the
laboratory should purchase a large enough volume of control materials. If
practical, at least a one year supply is recommended.
• Upon opening, the control material should demonstrate stability over the
claimed shelf life.
• The vial to vial variance should be much less than the expected variance
of the procedure being tested.
• To verify proper performance over the measuring range, the control
material should consist of a sufficient number of levels and concentrations.

Note: Local government regulations might specify a minimum number of

control levels for particular testing protocols.

• The control material should contain the analyte to be tested in

concentrations at the clinically relevant levels that might be seen in patient
samples.

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 Choose and Troubleshoot a QC Procedure

Evaluate Test Performance

After the quality requirement for a test is determined, evaluate the bias and
imprecision for the test in order to quantify its total error (TE). UnityWeb™ uses
the following formula to calculate the laboratory total error (TE) at a 99% (p <
0.01) confidence interval:

Laboratory TE = | Laboratory Bias (%) | + 2.33 Laboratory CV

This formula shows a test can have a higher bias as long as the CV
(imprecision) is low, and vice versa. The objective is to limit the total error in
patient test results.

You can evaluate the bias and imprecision of a test using the standard
deviation index (SDI) and coefficient of variation ratio (CVR). Several Unity™
Interlaboratory Reports contain both.

As scientists, laboratorians should concern themselves with which component

(bias or imprecision) is contributing to error, in what amount, and how the
component's performance can be improved. However, as long as patient test
results do not have more than the total allowable error (TEa), laboratorians
should not be concerned about the reliability of those results. When analytical
error exists, the question becomes whether it is critical error; this depends on
the quality requirements chosen for the test.

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 Choose and Troubleshoot a QC Procedure

Six Sigma
Six sigma provides a convenient way to monitor the performance capability of
a testing system. During the 1980s, Motorola set out to improve their
manufacturing process so virtually no defective product would be produced.
Motorola defined this as having six sigmas (standard deviations) of process
variation fit within the product tolerances.

Assuming a normal (Gaussian) distribution, the following table shows the effect
of product specifications (expressed as standard deviations) on the defect rate
and defects per million.

SD range Defect rate (%) Defects per million

±2SD 4.5 45,400

±3SD < 0.27 ~2,700

±4SD 0.0063 63

±5SD 0.0057 0.57

±6SD 0.000002 0.002

Note: The advantage of controlling a process to six sigma is that the

process can tolerate small shifts without significantly increasing the defect
rate. In an ideal world, all processes would be six sigma and could be
monitored with very simple QC.

Unfortunately, not all processes are six sigma and as process capability
decreases, the choice of QC procedures becomes increasingly important in
detecting significant errors. In fact, some processes may have such low
process capacity (that is, a high total error), that they cannot be controlled to a
defined level of quality. This condition would trigger a maximum QC condition in
the optional Westgard Advisor™ online.

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 Choose and Troubleshoot a QC Procedure

For clinical laboratory tests, the total error (TE) for a test provides an indication
of the process capability of the test because the TE combines bias and
imprecision. The following formula is used to calculate sigma:

Total Allowable Error - Bias

Sigma =
Coefficient of Variation

Note: The optional Westgard Advisor™ online calculates and displays sigma
based on the data for a test, the selected TEa, and the consensus group.

It is possible to correlate sigma with the TEa as shown in the following table.
(The table assumes bias is zero.)

Process classification Process capability criterion

4-sigma process TEa > bias + 4SD

3-sigma process TEa > bias + 3SD

2-sigma process TEa > bias + 2SD

Note: When the bias is not zero, the sigma classification of a process
decreases as its bias increases.

The information in this chapter was abstracted from the Six Sigma Quality
Management and Desirable Laboratory Precision lesson available on
[Link] Dr. Westgard provides an interesting correlation
between CLIA performance requirements and the performance requirements
for a five or six sigma process. As Dr. Westgard concludes, “Six sigma quality
management sets demanding standards of performance for laboratory testing
processes.”

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 Choose and Troubleshoot a QC Procedure

Use of Six Sigma

The sigma value for a test is a good indication of its process capability because
it considers both bias and imprecision. Unfortunately, most clinical laboratory
tests are below six sigma processes.

So how is six sigma achieved? The obvious answer is to choose a test method
with a six sigma process. Laboratories can take steps to control precision
through proper training, instrument maintenance, and so on; however, to a
large extent, method precision is a function of instrument methodology.

While method precision may not be controllable, a QC procedure can be

chosen that detects small changes in the testing system so that reject runs
having defects are identified and corrective action taken.

Note: The optional Westgard Advisor™ online calculates sigma values and
displays them on the Grid and Chart options on the Design QC Rules
dialog box. The sigma value also appears on the Westgard Advisor™ online
Report.

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 Choose and Troubleshoot a QC Procedure

Qualitative Evaluation of a Test's Bias and

Imprecision
Laboratories can access information about imprecision using interlaboratory
comparison reports supplied by the vendor of their control materials. While
these reports can also be used to evaluate bias, some laboratories prefer
proficiency report data for this purpose.

Participants in the Bio-Rad Unity™ Interlaboratory Program can use the

Laboratory Comparison Report, the Laboratory Performance Overview Report,
or the Statistical Profile Report. These reports contain two relevant statistics for
qualitative assessment of laboratory bias and imprecision:

• CVR (coefficient of variation ratio)

CVR is a peer-based evaluation of imprecision. The ratio is calculated as
the laboratory coefficient of variation (CV) for the test divided by the
average CV reported for the consensus group.

• SDI (standard deviation index)

SDI is a relative peer-based estimate of bias.

SDI describes or quantifies bias (the difference between the laboratory's

observed mean and the consensus group mean) in terms of standard
deviation.

OPSpecs Charts and sigma values are available in the optional Westgard
Advisor™ online and provide information about a test's maximum allowable bias
(inaccuracy) and imprecision. See Chapter 18, “Westgard Advisor™ online” for
more information.

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 Choose and Troubleshoot a QC Procedure

Identify Possible QC Procedures

Consider and include the following components in any QC procedure design:

• The QC materials to use (see “Identify Appropriate QC Materials” on

page 44).
• The number of control samples to analyze with each run.
• The distribution of the control samples within the run (for example, at the
beginning, in the middle, at the end, or distributed throughout the run).
• The statistical process control (SPC) rules to apply to optimize the QC
process while reducing false errors.

Consider the following when making decisions about how to apply these
components to the QC procedure:

• The quality required for the testing procedure.

• The anticipated instability of the testing procedure (for example, the type,
size and frequency of the errors).
• The practicality of the QC procedure working for the laboratory.

The optional Westgard Advisor™ online module is an excellent tool for assisting
in the design of QC procedures. While considering the selected quality
specifications, Westgard Advisor™ online makes recommendations as to the
SPC rules to apply and the number of control samples to run. See Chapter 18,
“Westgard Advisor™ online” for more information.

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Predict the Performance of the QC

Procedures
You can predict the performance of a QC procedure using probability
calculations or computer simulation studies. It is important to know before
selecting a QC procedure what the probability is that the procedure will detect
a critical systemic error and the probability that the procedure will produce false
rejections.

The optional Westgard Advisor™ online calculates the probability of error

detection (Ped) and the probability of false rejections (Pfr) for each
recommended SPC rule and number of control samples combination. Each of
these values is shown on the Westgard Advisor™ online Report with the Ped
corresponding to the detection level expressed as AQA (SE).

Note: AQA (SE) is the percent of analytical quality assurance (AQA) for
systematic error (SE) and indicates the chance of detecting medically
important systematic errors. Percent AQA (SE) is synonymous with
probability of error detection (Ped).

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 Choose and Troubleshoot a QC Procedure

Choose Goals Based on Required

Quality
The objective of any QC procedure is to optimize the chance of detecting
out-of-control conditions while minimizing the amount of false error flags. Each
laboratory must choose the desirable goals to use for achieving quality
requirements, the acceptable level of Ped (probability of error detection), and
Pfr (probability of false rejections).

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 Choose and Troubleshoot a QC Procedure

Select a QC Procedure
When selecting a QC procedure for implementation, select the procedure that
best fits the following parameters:

• Optimizes error detection

• Minimizes false rejections
• Lowest cost (for example, the least number of control samples per run)
• Easiest to implement (for example, the simplest control rules)

Regardless of the procedure selected, it must meet or exceed the laboratory’s

established quality requirements.

Note: The optional Westgard Advisor™ online automatically recommends

the best QC procedure.

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 Choose and Troubleshoot a QC Procedure

Troubleshoot QC Results
Inevitably, a QC system will indicate an out-of-control situation. What does a
laboratory do then? In a lesson titled “QC–The Out-of-Control Problem,” Elsa F.
Quam BS, MT (ASCP) describes two common bad habits and provides five
good habits to use when troubleshooting QC results.

Repeat the Control

Laboratories often apply the 12s rule, which yields a false rejection rate of 5%
for N=1, 9% for N=2, and 14% for N=3 (where N is the number of control
materials tested in the run).

When using the 12s rule, some laboratories think it is reasonable to simply
repeat the test for the control. However, with carefully chosen SPC rules, this
approach is unnecessary. As an example, consider that the false rejection rate
for a 13s rule is only 0.3%. It is also important to remember that even if the
repeat value is within control limits and the run is accepted, it is possible that a
problem is being ignored until a future run.

Try a New Control

Another bad habit is to test a different vial of control and repeat the testing until
it falls within an acceptable range. Although a bad vial of control material is
unlikely, it can occur. For example, controls are not properly reconstituted, are
stored improperly, are used beyond their expiration date, and so on. Training
can address these issues. Cost is another issue. A new vial of control material
is usually much less expensive than repeating a patient run.

As Ms. Quam concludes, “Automatically repeating controls or blaming the

control itself are often attempts to resolve the problem without the hassle and
time delay necessary in finding and eliminating the true cause of the QC failure.
These practices have become habit because they are easy and we often do
not have or do not teach the skills necessary to resolve the problem using a
more systematic approach.”

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 Choose and Troubleshoot a QC Procedure

Recalibrate
Although not mentioned in Ms. Quam’s lesson, another bad habit is frequent
recalibration. It is important to be concerned about the number of times a test
is recalibrated as each calibration or recalibration potentially introduces new or
additional systematic errors. Frequent recalibration can indicate a defective
SPC protocol (rules applied, mean, and range in use), instrument malfunction,
sub-optimal reagent quality, or failure to follow the manufacturer's instructions
and schedule for maintenance.

Good Laboratory Habits

If bad habits are eliminated, what are they replaced with? Ms. Quam lists five
good habits in her lesson:

1 Inspect the control charts or rules violated to determine type of error.

2 Relate the type of error to possible causes.
3 Consider factors in common on multi test systems.
4 Relate the problem to recent changes.
5 Verify the solution and document the remedy.

Although not mentioned by Ms. Quam, a sixth good habit is to perform a

regular review of the quality system to assess its effectiveness. See “Keys to a
Productive Review of the Laboratory Quality System” on page 60 for more
information.

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 Choose and Troubleshoot a QC Procedure

Determine the Type of Error

Determining the type of error, random or systematic, is a good first step when
investigating QC results. Different rules are sensitive to different types of errors.
For example:

• The 13s and the R4s rules usually indicate increased random error
because they test the tails or width of a distribution.
• The 22s, 41s, and 10x rules usually indicate systematic error because they
examine consecutive QC results that exceed the same limit.

Levey-Jennings Charts also indicate the type of error.

Tip: When possible, always identify the type of error before trying to identify
the cause of the problem. Further classification of systematic error as a shift
or trend is also useful.

Relate the Error to Possible Causes

Random errors (imprecision) and systematic errors (bias) have different causes.
Systematic errors are more common and usually easier to investigate.

• Systematic error is evidenced by a change in the mean of the control

values. The change in the mean may be gradual and demonstrated as a
trend or it may be abrupt and demonstrated as a shift. Causes of
systematic error include change in reagent lot, change in calibrator lot,
wrong calibrator values, improperly prepared reagents, deterioration of
reagents, deterioration of calibrator, inadequate storage of reagents or
calibrators, change in sample or reagent volumes due to pipettor
misadjustments or misalignment, change in temperature of incubators and
reaction blocks, deterioration of a photometric light source, and change in
procedure from one operator to another.
• Random error is any deviation away from an expected result. For QC
results, any positive or negative deviation away from the calculated mean
is defined as random error. Random error can be acceptable (or expected)
as defined by the laboratories acceptable range or unacceptable
(unexpected), which is any data point outside the expected population of

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 Choose and Troubleshoot a QC Procedure

data (for example, a data point outside the ±3SD limit). Random errors can
be caused by bubbles in reagents and reagent lines, inadequately mixed
reagents, unstable temperature and incubation, unstable electrical supply,
and individual operator variation in pipetting, timing, and so on.
Erratic performance due to occasional air bubbles in sample cups or
syringes or defective unit-test devices are a different kind of random error,
often called “flyers.” Flyers are not actually caused by a change in the
imprecision of the method, but rather represent an occasional disaster. It is
very difficult to catch flyers using quality control. Patient replicate
determinations are a better way of detecting these types of events.

Consider Common Factors on Multi Test Systems

If a multi test system is in use, there may be a problem with a single test or with
several tests.

• One test involved

Apply the first two steps (for example, determine the type of error and
relate it to possible causes).
• Several tests involved
Consider what, if anything, the tests have in common. Ask the following
questions:
• Do all the tests have small or large sample sizes?
• Do all the tests use the same filter?
• Do all the tests with the problem use the same lamp and tests without
the problem use a different lamp?
• Do all the tests use the same mode of detection (for example,
endpoint versus rate, MEIA versus FPIA)?
• Do all the tests have certain mechanical components in common or
certain optical components in common?

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 Choose and Troubleshoot a QC Procedure

Relate the Problem to Recent Changes

“What changed?” is a good question to ask when QC problems arise. The
error has already been classified as random or systematic which gives clues
about what to investigate first.

Tip: When performing troubleshooting, use a systematic and logical

approach in isolating the cause. Make only one change at a time and
document each action taken.

Systematic Error
If a sudden shift is observed, inspect the reagent, calibration, and maintenance
records, and note any recent actions. For example, if the shift occurred
immediately following a reagent replacement, verify the lot number is correct,
that it has been checked out or calibrated, that the reagent has been properly
prepared, and the reagent is indeed the correct reagent.

If a systematic trend is observed, review the QC records, including

documentation of function checks prior to taking actions to resolve the cause.
Trends can be caused by a slowly deteriorating reagent, a calibration shift, a
change in instrument temperature, or a deteriorating filter or lamp.
Unfortunately, systematic trends can be more difficult to resolve than shifts
because they occur over a longer time period.

Random Error
The causes of increased random error are generally more difficult to determine
because of their random nature. Random errors are more likely due to bubbles
in the reagent, reagent lines, sampling or reagent syringes, an improperly mixed
or dissolved reagent, pipette tips not fitting properly, a clog in the pipettor,
imprecise pipettor, the power supply, and even power fluctuations.

Many of these problems can be detected by inspecting the machine during

operation. If a careful inspection provides no clues, consult the manufacturer’s
troubleshooting guides and recommendations.

If a run is repeated and the controls are acceptable but concern remains that a
problem still exists, perform a precision run using ten back-to-back
determinations on the same patient sample. This precision run may help

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 Choose and Troubleshoot a QC Procedure

identify further imprecision problems. Duplicate analysis of patient specimens is

also recommended when monitoring random error problems.

Verify and Document

After identifying and correcting a problem, verify the correction by retesting the
controls. Generally, the controls are run at the beginning of a run. If the new QC
values are in control, repeat patient samples from the out-of-control run as
necessary. Finally, document the out-of-control event along with the corrective
action.

Note: UnityWeb™ provides reports and charts that are useful for problem
solving, especially for unusual problems.

Problems may be correlated with UnityWeb™ intralaboratory reports and charts,

Unity™ Interlaboratory Reports, and InstantQC™ reports and charts.

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 Choose and Troubleshoot a QC Procedure

Keys to a Productive Review of the

Laboratory Quality System
A laboratory quality system should include regular reviews of the QC results.
CAP-accredited laboratories must review and document QC performance at
least once a week. These reviews, which are often done retrospectively, offer
an excellent opportunity to critically assess the SPC rules applied to a test.

Issues to Consider
• Statistical out-of-control events.
• Frequency of outliers (QC values outside the established total allowable
error limits) during the period or across periods.
• The amount of bias present, if any.

Assessing these issues is key to a productive review and can be facilitated by

asking the following questions:

• Are the statistical process control (SPC) rules in effect for the test too
restrictive when the capability of the methodology or technology and TEa
are considered jointly?
• Should another more stringent single rule or more complex multi-rule be
applied to improve error detection?
• Should the mean for the test be adjusted?
• How much imprecision is present and is it a significant contributor to total
error? Should the laboratory focus its efforts on improving precision?
• How much comparative bias is present and is it a significant contributor to
total error? Should efforts be focused on removing or reducing analytical
bias?
• Is the appropriate consensus group (Peer, Method, All Labs) being used to
estimate the laboratory's comparative bias for the test?
• Are the performance goals for test imprecision and bias (which also affect
TEa), set appropriately?

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 Choose and Troubleshoot a QC Procedure

• How frequently do SPC errors occur for the test during the review period?
Are the errors across review periods? Are frequent errors due to
inappropriate selection of SPC rules, larger than expected imprecision, or
the presence of bias? Does the mean and range need adjustment?
• How frequently is the test being recalibrated? Does calibration exceed the
frequency recommended by the manufacturer?

There is probably not enough time to ask all of these questions during each
review cycle. However, each of these questions represents an opportunity to
measure and appraise the effectiveness of the process control in effect for a
specific test.

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62 Bio-Rad Laboratories, Inc.

 CHAPTER
4
Program and Database
Basics

In This Chapter
First Time Log In . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Regular Log On and Log Off Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Current Lab, Panel, Lot, and Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Understand the Navigation Tree . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
UnityWeb™ Tabs and Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Functions and Where to Find Them. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Download Adobe® Reader® . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
System Requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Update the License. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Upgrade to UnityWeb™ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Configure UnityWeb™ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Database Basics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

First Time Log In

1 Start an Internet browser window and navigate to [Link].
2 Point to Unity™ Interlab and then click UnityWeb™ 2.0.
The Server Login dialog box appears.
3 Type the server name provided by Bio-Rad in the Server field or click
(ellipsis button) located to the right of the Server field and select the
server from the list.
4 Select the SQL Server authentication option.
5 Type the server user name in the User field. This is the server user name
provided by Bio-Rad.

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 Program and Database Basics

6 Type the server password in the Password field. This is the server
password provided by Bio-Rad.
7 Type the database name provided by Bio-Rad in the Database field or
click (ellipsis button) located to the right of the Database field and
select the database from the list.
8 Click OK.
The Login dialog box appears.
9 Type the group login ID provided by Bio-Rad in the User field.
10 Type the password in the Password field.
11 Click Login.

Note: See Chapter 5, “User Profiles and Security” for more information on
adding additional users and security basics.

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 Program and Database Basics

Regular Log On and Log Off Process

Log On to the Software

1 Start an Internet browser window and navigate to [Link].
2 Point to Unity™ Interlab and then click UnityWeb™ 2.0.
3 Type your user ID in the User field.
4 Type your user password in the Password field.
5 Click Login.

Note: See “User Permissions” on page 100 for more information about
users and security.

Log Off the Software

Important: Save all data before logging off the software.

Make sure to use the Log out link to exit the software. Otherwise, access
to the software can be temporarily restricted due to concurrent user
licensing.

When ready to log off the software, click located at

the top of the screen.

Note: “Admin” will be replaced with your user ID.

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 Program and Database Basics

Current Lab, Panel, Lot, and Test

Select lab numbers, panels, lot numbers, and tests from lists in UnityWeb™.
The current lab, lot, and test selections determine the active lab, lot, and test.
For example, selecting a test in a Data Entry dialog box and then clicking Go
to Chart displays the Levey-Jennings Chart for the selected test.

Select the appropriate lab number from the Lab list to access a lot for the lab
number.

Select the appropriate lot number from the Lot list to access a test for the lot
number.

Example Lists

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 Program and Database Basics

Understand the Navigation Tree

UnityWeb™ uses a navigation tree in some areas of the software. The
navigation tree represents the hierarchy of labs, lots, and tests.

• Selecting a lab number determines the current lab.

• Selecting a lot number determines the current lab and lot.
• Selecting a test determines the current lab, lot, and test.

Example of the Navigation Tree

Lab
Lot
Tests

• Click + (plus sign) to the left of the lab number to view the lots.
• Click + (plus sign) to the left of the lot number to view the tests.

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 Program and Database Basics

TM
UnityWeb Tabs and Functions
UnityWeb™ organizes software functions by different tabs. Click each tab to
access different functions of the software.

UnityWeb™ tabs

Tab Items

Configure • Lab
• Lot
• Test
• Panel
– Add
– Update/Sort Tests
– Delete/Rename/Sort Panel Name
• Rules/Settings
– Rules
– Fixed Mean and SD
– Settings

Data Entry • Single Test Point Data Entry

• Single Test Summary Data Entry
• Multi Test Point Data Entry
• Multi Test Summary Data Entry
• WebConnect™
– WebConnect™ Home
– WebConnect™ History
– WebConnect™ Transformer
– WebConnect™ Rejection Log
– WebConnect™ File Import Monitor

Review • Bench Review

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 Program and Database Basics

UnityWeb™ tabs (continued)

Tab Items

Charts • Levey-Jennings
• Multi-LJ
• Bar
• Youden
• Options
– General
– Header
– Levey-Jennings
– Bar
– Youden

Reports • Data Review

• General
– Point Data Report
– Summary Data Report
– Statistical Report
• Supervisor’s Report
– Supervisor’s Report
– Operator Report
• Audit Trail
• Listings
– Labs
– Lots
– Tests
– Panels
– Test Code Report

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 Program and Database Basics

UnityWeb™ tabs (continued)

Tab Items

Advisors • Westgard Advisor™

– Existing QC Rules
– Lab Data and Group Stats
– Configure TEa
– Design QC Rules
– Preferences

Tools • Security
– Administrator
– Update License
– Change Password
• Unity™ Interlab
– Send Data to Bio-Rad
• Utilities
– Export
– Condense
– Reconcile
– Delete Range of Data
– Operator Setup
– Configure Actions Logs
– Action/Comment by Instrument
– View Rejection Log
– Import Settings
• Setup
– Configure UnityWeb™
– Unity™ Interlab Reports

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 Program and Database Basics

Functions and Where to Find Them

Functions and where to find them
Action Logs
Location: Tools | Utilities | Configure Action Logs
See: “Actions” on page 209
Actions/Comments by Instrument
Location: Tools | Utilities | Action/Comment by Instrument
See: “Actions and Comments by Instrument” on page 218
Add Users
Location: Tools | Security | Administrator
See: “Add a User” on page 94
Audit Trail
Location: Reports | Audit Trail
See: “Audit Trail Report” on page 253
Automatic Action Logs
Location: Tools | Setup | Configure UnityWeb™ |
Automatic action logs
See: “Automatic Action Logs” on page 215
Automatic Transmission, Bench Review
Location: Tools | Setup | Configure UnityWeb™ |
Data review transmission (for InstantQC™)
See: “Activate Transmission for InstantQC™” on page 260
Automatic Transmission, Monthly
Location: Tools | Setup | Configure UnityWeb™ |
Automatic monthly transmission
See: “Activate Automatic Monthly Transmission” on page 259
Bench Review
Location: Review | Bench Review
See: “Bench Review” on page 202

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 Program and Database Basics

Functions and where to find them (continued)

Change Password
Location: Tools | Security | Change Password
See: “Change a Password” on page 99
Charts, Bar
Location: Charts | Bar
See: “Bar Chart” on page 236
Charts, Levey-Jennings
Location: Charts | Levey-Jennings
See: “Levey-Jennings Chart” on page 230
Charts, Options
Location: Charts | Options
See: “General Chart Options” on page 224
Charts, Youden
Location: Charts | Youden
See: “Youden Chart” on page 238
Condense Data
Location: Tools | Utilities | Condense
See: “Condense Data” on page 89
Configure, Lab
Location: Configure | Lab
See: “Add and Update Lab Numbers” on page 107
Configure, Lot
Location: Configure | Lot
See: “Lots” on page 111
Configure, Panel
Location: Configure | Panel
See: “Create a Panel and Add Tests” on page 142

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Functions and where to find them (continued)

Configure, Rules/Settings
Location: Configure | Rules/Settings
See: “Select SPC Rules” on page 129 and “Select Test
Settings” on page 129
Configure, Test
Location: Configure | Test
See: “Add Tests” on page 124
Data Entry, Multi Test, Point
Location: Data Entry | Multi Test Point Data Entry
See: “Multi Test Data Entry” on page 183
Data Entry, Multi Test, Summary
Location: Data Entry | Multi Test Summary Data Entry
See: “Multi Test Data Entry” on page 183
Data Entry, Single Test, Point
Location: Data Entry | Single Test Point Data Entry
See: “Single Test Point Data Entry” on page 172
Data Entry, Single Test, Summary
Location: Data Entry | Single Test Summary Data Entry
See: “Single Test Summary Data Entry” on page 177
Data Review Transmission
Location: Tools | Setup | Configure UnityWeb™ |
Data review transmission (for InstantQC™)
See: “Activate Transmission for InstantQC™” on page 260
Delete Range of Data
Location: Tools | Utilities | Delete range of data
See: “Delete a Range of Data” on page 91
Export
Location: Tools | Utilities | Export
See: “Export Data” on page 87

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Functions and where to find them (continued)

Operator Setup
Location: Tools | Utilities | Operator Setup
See: “Operator Setup” on page 198
Passwords, Change
Location: Tools | Security | Change Password
See: “Change a Password” on page 99
Password Expirations
Location: Tools | Security | Administrator
See: “Password Expiration” on page 98
Reconcile Data
Location: Tools | Utilities | Reconcile
See: “Reconcile Data” on page 90
Reports, Data Review
Location: Reports | Data Review
See: “Data Review Report” on page 245
Reports, Listings, Labs
Location: Reports | Listings | Labs
See: “Listings Reports” on page 255
Reports, Listings, Lots
Location: Reports | Listings | Lots
See: “Listings Reports” on page 255
Reports, Listings, Panels
Location: Reports | Listings | Panels
See: “Listings Reports” on page 255
Reports, Listings, Tests
Location: Reports | Listings | Tests
See: “Listings Reports” on page 255

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Functions and where to find them (continued)

Reports, Listings, Test Code Report
Location: Reports | Listings | Test Code Report
See: “Listings Reports” on page 255
Reports, Operator Report
Location: Reports | Supervisor’s Report | Operator Report
See: “Operator Report” on page 251
Reports, Point Data Report
Location: Reports | General | Point Data Report
See: “Point Data Report” on page 246

Reports, Statistical Report

Location: Reports | General | Statistical Report
See: “Statistical Report” on page 248

Reports, Summary Data Report

Location: Reports | General | Summary Data Report
See: “Summary Data Report” on page 247

Reports, Supervisor’s Report

Location: Reports | Supervisor’s Report | Supervisor’s Report
See: “Supervisor's Report” on page 249
Require Audit-Trail Comments
Location: Tools | Setup | Configure UnityWeb™ |
Require audit-trail comments
See: “Require Audit Trail Comments” on page 222
Send Data to Bio-Rad
Location: Tools | Unity™ Interlab | Send Data to Bio-Rad
See: “Submit Data Manually” on page 258
Transmission, Automatic Monthly
Location: Tools | Setup | Configure UnityWeb™ |
Automatic monthly transmission
See: “Activate Automatic Monthly Transmission” on page 259

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Functions and where to find them (continued)

Transmission, from Data Review
Location: Tools | Setup | Configure UnityWeb™ |
Data review transmission (for InstantQC™)
See: “Activate Transmission for InstantQC™” on page 260
Transmission, Manual
Location: Tools | Unity™ Interlab | Send Data to Bio-Rad
See: “Submit Data Manually” on page 258
Unity™ Interlab Report Frequency and Language
Location: Tools | Setup | Unity™ Interlab Reports
See: “Configure Unity™ Interlaboratory Report Frequency” on
page 86
Update License
Location: Tools | Security | Update License
See: “Update the License” on page 79
Westgard Advisor™ online
Location: Advisors | Westgard Advisor™
See: “Westgard Advisor™ online” on page 323

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 Program and Database Basics

® ®
Download Adobe Reader
UnityWeb™ requires installation of the free Adobe® Reader® 5.5 or later. Follow
these steps to install Adobe® Reader®..

1 Open an Internet browser window and navigate to

[Link]
2 Click Downloads.
3 Click Get Adobe® Reader®.
4 Follow the instructions on the screen to install Adobe® Reader®.

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System Requirements
• Internet browser (Microsoft® Internet Explorer 6.0 or higher, Mozilla Firefox
2.0 or later, or Internet Explorer: Mac 4.5 or later).
• Broadband internet access for best results.
• Adobe® Reader® 5.5 or higher. (For information about downloading Adobe®
Reader®, see “Download Adobe® Reader®” on page 77.)

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 Program and Database Basics

Update the License

There are two ways to update the license for UnityWeb™:

• Via the Internet

• XML license file from Bio-Rad

Update the License via the Internet

1 Click the Tools tab.
2 Click Security.
3 Click Update License.

4 Click Get License.

5 Follow the instructions on the screen to update the license.
The Welcome page appears after the license is updated.

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Update the License via an XML File

1 Click the Tools tab.
2 Click Security.
3 Click Update License.

4 Click Browse.
5 Navigate to the location of the XML file.
6 Click Open.
7 Click Upload.
The Welcome page appears after the license is updated.

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TM
Upgrade to UnityWeb
If your laboratory has been using a previous version of Bio-Rad QC software,
contact your Bio-Rad QC Program Representative to upgrade to Unity Real
Time™ online or UnityWeb™ 2.0.

Previous software Upgrade to Unity Upgrade to

Real Time online
™ UnityWeb™ 2.0

UnityWeb™ 1.0

QC OnCall™

Unity Real Time™

Unity Desktop™

Note: Upgrading from Unity-PC™ and Unity Plus/Pro™ is not recommended.

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TM
Configure UnityWeb
UnityWeb™ provides different configuration options allowing for customization of
the software. For details about the different configuration options, see the
following sections:

• Data entry configuration (page 83)

• Actions/comments (page 84)
• Notifications (page 85)
• Transmission (page 85)

TM
Configure UnityWeb
1 Click the Tools tab.
2 Click Setup.
3 Click the Configure UnityWeb™ tab.
4 Select the configuration options.
5 Click Save.

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Data Entry Configuration

• Current data
This option controls the Summary Statistics shown on the Single Test
Point Data Entry dialog box and the Single Test Summary Data Entry
dialog box.
• Month
The Summary Statistics show the laboratory current calendar
month and cumulative statistics. Month is the default selection.
• Group
The Summary Statistics show the current data group and
laboratory cumulative statistics.

Note: Select and clear the Group check box on the Single Test Point
Data Entry dialog box and the Single Test Summary Data Entry dialog
box to switch between month and group Summary Statistics.

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Actions and Comments

• Automatic action logs
Select this check box for the Action dialog box to automatically open
every time a user enters a point violating an active SPC rule set to reject.

• Require action logs

Select this check box for the Action dialog box to automatically open
every time a user enters a point violating an active SPC rule set to reject.
Users cannot close, cancel, or exit the Action dialog box until an action is
added.

• Require audit-trail comments

Select this check box for the Audit-Trail Comment dialog box to appear
whenever the software applies an Audit Trail Event. Users cannot close,
cancel, or exit the Audit-Trail Comment dialog box until a comment is
added.
See “Audit Trail Events” on page 351 for a list of events that generate an
audit trail.

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View Database Information

Information about the database appears on the first screen after logging in.

Note: Access this information at any time by clicking on the UnityWeb™ icon
in the upper left hand corner.

Notifications
Select the Notifications check box and a message appears each time you
open Data Entry dialog box for a test in a lot expiring in 30 or fewer days.
Within the Data Entry dialog box, select the Do not display this message
again check box to stop the message from appearing.

Transmission
• Data review transmission (for InstantQC™)
Select this check box and point data is sent to the Unity™ Interlaboratory
Program from the Bench Review for inclusion in InstantQC™.
• Automatic monthly transmission
Select this check box and monthly data is automatically sent to the Unity™
Interlaboratory Program on the selected day of the month.

Note: If using the Automatic monthly transmission feature, the

UnityWeb™ software must be running in order to submit data.

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TM
Configure Unity Interlaboratory Report
Frequency
Specify the report frequency (monthly, quarterly, or never) and language for the
following Unity™ Interlaboratory Reports:

• Laboratory Performance Overview Report

• Laboratory Comparison Report
• Laboratory Histogram Report

1 Click the Tools tab.

2 Click Setup.
3 Click the Unity™ Interlab Reports tab.
4 Select the report frequency for the Laboratory Performance Overview
from the list.
5 Select the report frequency for the Laboratory Comparison Report from
the list.
6 Select the report frequency for the Laboratory Histogram from the list.
7 Select the report Language from the list.
8 Click Save.

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Database Basics
UnityWeb™ provides the following database utilities:

• Export data (page 87)

• Condense data (page 89)
• Reconcile data (page 90)
• Delete a range of data (page 91)

Export Data
Data in UnityWeb™ can be exported to formats compatible with popular
business software such as Microsoft® Access, Microsoft® Excel, and Microsoft®
Word.

Data can be exported to the following formats:

• Crystal Reports® (RPT)

• Adobe® Acrobat® (PDF)
• Microsoft® Excel 97–2000 (XLS)
• Microsoft® Excel 97–2000 - Data Only (XLS)
• Microsoft® Word (RTF)
• Microsoft® Word - Editable (RTF)
• Rich Text Format (RTF)

1 Log in as a user with the Export data permission.

2 Click the Tools tab.
3 Click Utilities.
4 Click Export.
5 Select the lab number from the Lab number list for the data to export or
select All.
6 Select the lot number from the Lot number list for the data to export or
select All.
7 Select the test from the Test list for the data to export or select All.

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8 Select the option for the type of file to export:

• Text file
This option creates a file for use with word processing software.
UnityWeb™ uses American Standard Code for Information Interchange
(ASCII) characters for exporting text files.
• Delimited file
This option creates a file for use with database or spreadsheet
software.
• Import file
This option creates a UnityWeb™ standard import file.
9 Click the arrow located to the right of the From date and select a
beginning date for the data to export.

10 Click the arrow located to the right of the To date and select an ending
date for the data to export.
11 Select the type of data you want to export:
• Point Data
• Summarized Data
12 Click OK.
The Download dialog box appears.
13 Click Download.
A File Download dialog box appears.
14 Click Open to view the file. Click Save to save the file.

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Condense Data

Important: You cannot reverse the condense data process. Bio-Rad

recommends exporting the data prior to condensing. See “Export Data” on
page 87 for more information.

Condensing data converts individual point data for each calendar month into a
single summarized entry. Condensing data conserves disk space. Condensing
data removes data points from the Single Test Point Data Entry dialog box
and adds them to the Single Test Summary Data Entry dialog box.

Note: Condensing data does not change the monthly summarized data
values; therefore, it is not necessary to resubmit condensed data to
Bio-Rad.

1 Log in as a user with the Condense data permission.

2 Click the Tools tab.
3 Click Utilities.
4 Click Condense.
5 Click the arrow located to the right of the From date and select a
beginning date for the data.

6 Click the arrow located to the right of the To date and select an ending
date for the data.
7 Select the Lab or Panel option for the data.
8 Select the lab number or panel name from the Lab or Panel list.

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9 If using the Lab option, select the lot number from the Lot number list or
select All.
10 Select the test from the Test list or select All.
11 Click OK.
A message appears asking for confirmation to condense data.

12 Click OK.
A message appears indicating the condensing of data is complete.

13 Click OK.

Reconcile Data

Important: The Reconcile Data feature is for special use only. Do not
reconcile data unless given specific instructions from your Bio-Rad Software
Support Representative.

The Reconcile Data feature creates a file including all of the laboratory data in
the software. Use this feature to send quality control data to Bio-Rad in rare
circumstances.

When reconciling data, the file replaces any existing data in the
Unity™ Interlaboratory Program. Reconcile data for a lab number, lot number, or
all labs in the database.

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Delete a Range of Data

Important: Deleting a range of data permanently removes the data from the
software. Bio-Rad recommends exporting the data before deleting. See
“Export Data” on page 87 for more information.

1 Click the Tools tab.

2 Click Utilities.
3 Click Delete range of data.
4 Click the arrow located to the right of the From date and select a
beginning date for the range of data.

5 Click the arrow located to the right of the To date and select an ending
date for the data.
6 Select the lab number from the Lab number list or select All.
7 Select the lot number from the Lot number list or select All.
8 Select the test from the Test list or select All.
9 Click OK.
A message appears asking for confirmation of the data deletion.
10 Click OK.
A message appears indicating the data deletion is complete.

11 Click OK.

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 CHAPTER
5
User Profiles and
Security

In This Chapter
Define, Modify, and Delete Users. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
Passwords . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
User Permissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100

Define, Modify, and Delete Users

UnityWeb™ uses user profiles with passwords and permissions to control
individual user access to program features. Each user should have an assigned
user name and password. Menu items and buttons for which a user does not
have permission are either not displayed or appear dimmed.

Note: Only administrators and users with the Manage users permission
can create, modify, and delete users.

In the Administrator dialog box, you can:

• Define, modify, and delete user profiles for individual users including their
passwords and permissions.
• Select the Administrator check box to create users with all permissions.
• Define password expiration periods.

Note: A check mark in the Administrator check box automatically selects

all user permissions. See “User Permissions” on page 100 for a description
of user permissions.

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 User Profiles and Security

The User profile section of the Administrator dialog box consists of the
User ID, User name, Password, Initials, the Password expires on
feature, and Assign Lab Numbers.

• The User ID can contain any combination of letters and numbers up to 80

characters.
• The User name can contain any combination of letters and numbers up
to 80 characters.
• The Password can contain between 1 and 20 characters and can consist
of any combination of letters and numbers. See “Password Requirements”
on page 97 for more information.
• The Initials appear in the OP column of the data entry screen and identify
the user (operator) who manually entered the data. User initials are also
added to actions and comments.
• Set a specific expiration date for the user profile with the Password
expires on feature.
• Define the lab number access for the user profile with the Assign Lab
Numbers feature.

Add a User
1 Log in as a user with the Manage users permission.
2 Click the Tools tab.
3 Click Security.
4 Click Administrator.
5 Click New.
6 Type the User ID, User name, Password, and Initials of the user in the
User profile section.
7 Select the Set password expiration period to check box and select an
expiration period from the list to set a password expiration for the user.
See “Password Expiration” on page 98 for more information.
8 Select an option to apply the expiration period:
• Applied to this user only
• Applied to all users

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9 Select the individual permissions for the user.

• To select a permission, select the check box next to the permission.
• To remove a permission, clear the check box.

Note: Select the Administrator check box to give the new user access to
all available software functions. See “User Permissions” on page 100 for
more information about all permissions.

10 Click OK.
11 Click Assign Lab Numbers.
12 Select the user to assign the lab number(s) to from the Operator list.
13 Select the lab numbers to assign to the user.
14 Click OK.
15 Click New and repeat steps 5-14 to add another user.

Modify a User

Note: The User ID field cannot be modified.

1 Log in as a user with the Manage users permission.

2 Click the Tools tab.
3 Click Security.
4 Click Administrator.
5 Select the user to modify from the User ID list.
6 Change the user’s profile and permissions as needed.
• To select a permission, select the check box next to the permission.
• To remove a permission, clear the check box.

Note: Select the Administrator check box to give the user access to all
available software functions. See “User Permissions” on page 100 for more
information about all permissions.

7 Click OK.

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Delete a User

Note: Deleting a user removes the associated User ID and Password from
the Login and Administrator dialog boxes. The user's initials remain in the
OP column of the Data Entry dialog box for any data the user previously
entered and elsewhere in UnityWeb™ where they were recorded (actions,
comments, audit trail, etc.)

1 Log in as a user with the Manage users permission.

2 Click the Tools tab.
3 Click Security.
4 Click Administrator.
5 Select the user to delete from the User ID list.
6 Click Delete.
A message appears asking for confirmation of the user deletion.
7 Click OK.

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Passwords

Password Requirements
• Passwords can contain between 1 and 20 characters.
• Passwords can contain any combination of letters and numbers.
• By default, the password expiration period is set to 3 months. Passwords
can be set to expire in three, six, or nine months.

Group Login ID and Password

Bio-Rad provides an assigned Group Login ID and Password.

The Group Login ID is set up with Administrator permissions and allows new
users initial access to the software. After creating additional users, delete this
user or change the password.

Note: At least one user must have Administrator permissions. If only one
user has Administrator permissions, you cannot delete this user or clear
the Administrator check box until another user with Administrator
permissions is set up.

Additional users can be given Administrator permissions as needed.

However, giving all, or even most, users Administrator permissions eliminates
the security precautions gained by using passwords.

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Password Expiration
Users with the Manage users permission can set passwords to expire after a
set period of time.

Tip: Use of this feature is entirely optional. However, using this feature is
helpful for adding security or satisfying regulatory requirements.

Set the password expiration period when adding new users. Modify existing
users by adding or changing the expiration period. When applying a password
expiration period, apply it to the current user or to all users.

Tip: If every user has the same expiration period, it is easier to specify the
expiration one time and apply it to all users. In addition, specifying Never as
the expiration period and applying it to all users is a convenient way to
cancel the use of the password expiration feature.

Set a Password Expiration

1 Log in as a user with the Manage users permission.
2 Click the Tools tab.
3 Click Security.
4 Click Administrator.
5 Select the applicable user from the User ID list.
6 Select the Set password expiration period to check box and select a
time period from the list:
• Never
• 3 months
• 6 months
• 9 months
7 Select an option to apply the password expiration:
• Applied to this user only
• Applied to all users
8 Click OK.

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Change a Password

Note: All users, regardless of permissions, can change their own password.

1 Click the Tools tab.

2 Click Security.
3 Click Change Password.
4 Type the old password.
5 Type the new password.
6 Type the new password again to confirm.
7 Click OK.

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User Permissions
Set up specific user permissions to restrict a user’s access to specific software
features and functions.

Important: At least one user must be set up with Administrator permissions.

The Administrator permission provides access to all features and functions
of the software.

User permissions are divided into the following groups:

• Administration/Setup permissions (page 100)

• Data Review permissions (page 101)
• Database permissions (page 101)
• Rules and settings permissions (page 102)
• Labs, lots, tests, and panels permissions (page 102)
• Data handling permissions (page 103)
• Data permissions (page 103)

Administration/Setup Permissions

Manage users
Users with this permission can:

• Create new users and set password expiration periods.

• Modify existing user profiles.
• Modify an existing user’s permissions.
• Delete users.
• Access the Operator Report.

Edit action log

Users with this permission can add, update, or delete pre-defined action logs.

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Edit setup options

Users with this permission can make changes on the Setup dialog box. See
“Configure UnityWeb™” on page 82 for more information.

Operator setup
Users with this permission can define the operator initials to appear on the data
entry screen for imported data if the transformed file does not contain operator
initials.

Data Review Permissions

Users with this permission can approve data from the Bench Review. When
transmitting data from the Bench Review to the Unity™ Interlaboratory Program,
the data appears on [Link] (in an InstantQC™ Report or Chart) after
processing by the Unity™ Interlaboratory Program.

Database Permissions

Condense data
Users with this permission can condense data. See “Condense Data” on
page 89 for more information.

Important: The Condense data feature is for special use only. Bio-Rad
recommends limiting user access to this feature.

Reconcile data
Users with this permission can reconcile data. See “Reconcile Data” on
page 90 for more information.

Important: The Reconcile data feature is for special use only. Bio-Rad
recommends limiting user access to this feature.

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Rules and Settings Permissions

Users with this permission can:

• Make changes to test settings (including changing the number of levels in

use, decimal places, setting fixed means and SDs, and changing the
number of points before rule evaluation).
• Specify settings by lot number.
• Make changes to the SPC rule profile for tests.
• Specify SPC rule profiles by lot number.
• Access the Westgard Advisor™ online (optional feature).

Note: Users without this permission can access Westgard Advisor™ online
(optional feature) but cannot apply rules.

Labs, Lots, Tests, and Panels Permissions

Manage labs/lots/tests
Users with this permission can:

• Add, update, close, delete, and duplicate Bio-Rad lab numbers.

Note: You cannot delete the primary lab number.

• Add, edit, delete, open, and close lot numbers.

• Add, delete, update, open, and close tests.
• Use the Instrument Setup feature.

Manage panels
Users with this permission can add, update, sort, delete, and rename panels.

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Data Handling Permissions

Communicate with Unity™ Interlab

Users with this permission can send data to the Unity™ Interlaboratory
Program.

Export data
Users with this permission can manually export data.

Data Permissions

Edit all data

Users with this permission can enter new data and edit any line of data in the
Data Entry dialog box.

Edit last line

Users with this permission can enter new data and edit the last line of data in
the Data Entry dialog box.

Important: When a user edits any line but the last line of data, the data is not
evaluated against any SPC rule(s).

Enter new data only

Users with this permission can enter new data but cannot edit or delete any
data.

View data only

Users with this permission can view data on the Data Entry dialog box but
cannot enter, edit, or delete data.

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Set Up User Permissions

1 Log in as a user with the Manage users permission.
2 Click the Tools tab.
3 Click Security.
4 Click Administrator.
5 Select the check box or option for each applicable permission.
6 Click OK.

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 CHAPTER
6
Labs and Lots

In This Chapter
Labs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
Lots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111

Labs
UnityWeb™ uses a six-digit lab number provided by Bio-Rad to uniquely identify
your laboratory and associated data. In order to use UnityWeb™, you must have
a primary lab number.

Important: Two instruments of the same type must be set up in separate lab
numbers. A lab number can only be assigned by Bio-Rad. If you need
additional lab numbers, contact your Bio-Rad QC Program Representative.

Types of Lab Numbers

UnityWeb™ uses three types of lab numbers:

• Primary lab numbers (page 106)

• Additional lab numbers (page 106)
• Affiliated lab numbers (page 106)

Reference Guide for UnityWeb™ 2.0 105

 Labs and Lots

Primary Lab Number

The first lab number set up in UnityWeb™ is the primary lab number. The
primary lab number can be closed but not deleted. (See “Close a Lab Number”
on page 109 for more information.) The primary lab number appears
highlighted in green in the Open labs dialog box. If you need to change your
primary lab number, contact your Bio-Rad QC Program Representative.

Additional Lab Numbers

You can use additional lab numbers in UnityWeb™. For example, you can use a
different lab number for each instrument or different lab numbers to identify
different departments or shifts.

Important: Two instruments of the same type must be set up in separate lab
numbers. A lab number can only be assigned by Bio-Rad. If you need
additional lab numbers, contact your Bio-Rad QC Program Representative.

Affiliated Lab Numbers

If you belong to a group of laboratories and want your Unity™ Interlaboratory
Reports based on combined lab numbers, contact your Bio-Rad QC Program
Representative.

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 Labs and Lots

Add and Update Lab Numbers

Add a Lab Number

1 Log in as a user with the Manage labs/lots/tests permission.
2 Click the Configure tab.
3 Click Lab.
4 Click Clear to clear the existing fields.
5 Type the six-digit lab number provided by Bio-Rad in the Lab number
field.
6 Type the additional information for your laboratory.

Note: An asterisk (*) identifies required fields.

7 Click Add.
The lab number appears in the Open labs list.

Update Lab Number Information

Note: You can change and update any information except for the lab
number itself. You cannot update a closed lab number; you must first open
it. See “Open a Lab Number” on page 109 for more information.

1 Log in as a user with the Manage labs/lots/tests permission.

2 Click the Configure tab.
3 Click Lab.
4 Select the lab number you want to update in the Open labs list.
5 Type the necessary changes.
6 Click Update.

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Duplicate a Lab Number

Duplicating a lab number creates a copy of the lab information and all open lots
and tests. The SPC rule settings are duplicated for all open tests. You can
choose if you want to duplicate fixed means and/or fixed SDs.

Note: Duplicating a lab number does not duplicate QC data.

To set up several lab numbers with similar information, create the primary lab
number and duplicate the lab number. Edit information for the duplicated lab
number as needed.

Note: You cannot duplicate a closed lab number; you must first open it. See
“Open a Lab Number” on page 109 for more information.

1 Log in as a user with the Manage labs/lots/tests permission.

2 Click the Configure tab.
3 Click Lab.
4 Select the lab number to duplicate in the Open labs list.
5 Click Duplicate.
6 Type the new target lab number in the Target lab number field.
7 Select the Duplicate fixed mean check box to duplicate the fixed mean
for all open tests.
8 Select the Duplicate fixed SD check box to duplicate the fixed SD for all
open tests.
9 Click OK.
The new lab number appears in the Open labs list.
10 If needed, edit the duplicated lab information. See “Update Lab Number
Information” on page 107 for more information.

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Open and Close Lab Numbers

Lab numbers can be open or closed. Open lab numbers are available for data
entry and submission. Results for their lot numbers appear on your Unity™
Interlaboratory Reports. Closed lab numbers are not available for data entry nor
submission. However, the data for closed lab numbers remain in the
UnityWeb™ database. Reopen a closed lab number at any time.

Close a Lab Number

1 Log in as a user with the Manage labs/lots/tests permission.
2 Click the Configure tab.
3 Click Lab.
4 Select the lab number you want to close in the Open labs list.
5 Click Close.
The lab number moves to the Closed labs list.

Open a Lab Number

1 Log in as a user with the Manage labs/lots/tests permission.
2 Click the Configure tab.
3 Click Lab.
4 Select the lab number you want to open in the Closed labs list.
5 Click Open.
The lab number moves to the Open labs list.

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Delete Lab Numbers

Important: Deleting a lab number permanently deletes all data for all tests in
the lab number. Information in the deleted lab number cannot be retrieved.
Bio-Rad recommends closing the lab number to make it inactive rather than
deleting the lab number. See “Close a Lab Number” on page 109 for more
information. You can also export the lab data to another file before deleting
it. See “Export Data” on page 87 for more information.

Note: Only open lab numbers can be deleted. See “Open a Lab Number”
on page 109 for more information.

1 Log in as a user with the Manage labs/lots/tests permission.

2 Click the Configure tab.
3 Click Lab.
4 Select the lab number you want to delete in the Open labs list.
5 Click Delete.
A message appears asking for confirmation of the lab number deletion.
6 Click OK.

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Lots
UnityWeb™ uses Bio-Rad and non-Bio-Rad lots. However, Unity™
Interlaboratory Reports are available for Bio-Rad control products only.

Bio-Rad master lot numbers consist of five digits ending in zero. The lot
number for Bio-Rad control products is located on the outside of the control
product box, on the control product label, and in the package insert.

The final zero of the master lot number is changed to a number to identify each
individual control level (for example, 1, 2, or 3 designating level 1, level 2, or
level 3).

Bio-Rad Master Lot Number : 45550

Level 1 : 45551
Level 2 : 45552
Level 3 : 45553

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Add a Bio-Rad Lot

1 Log in as a user with the Manage labs/lots/tests permission.
2 Click the Configure tab.
3 Click Lot.
4 If you have more than one lab number, make sure the correct number
appears in the Lab number list.
5 Select the Bio-Rad control name from the Control name list.
6 Select the master lot number for the control from the Lot number list.

Tip: Only unexpired lot numbers in the same product group appear in the
Lot number list.

7 Click Add.
The new lot number appears at the bottom of the Open lots list.
8 To add additional lots, repeat steps 5–7.

Add Non-Bio-Rad Lots

UnityWeb™ can be used for intralaboratory performance tracking of
non-Bio-Rad control products. UnityWeb™ reports and charts are available, but
Unity™ Interlaboratory Reports are not available for non-Bio-Rad control
products.

Non-Bio-Rad lot numbers can contain up to 15 characters, which can be a

mixture of numbers, letters, and symbols. However, you cannot assign a
Bio-Rad lot number to a non-Bio-Rad control.

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1 Log in as a user with the Manage labs/lots/tests permission.

2 Click the Configure tab.
3 Click Lot.
4 If you have more than one lab number, make sure the correct number
appears in the Lab number list.
5 Select Other from the Control name list in the Lot information section.
6 Click Add.
7 Define the control name in the Control name field.
8 Type the lot number in the Master lot number field.
9 Type the manufacturer name in the Manufacturer field.
10 Select the matrix from the Matrix list.
11 Click the up or down arrow located to the right of the Levels field and
select the number of levels for the control.

Note: You can specify up to nine levels; however, the software limits the test
evaluation to four levels on non-Bio-Rad controls.

12 Click the arrow located to the right of the Expiration date and select an
expiration date from the calendar.

Note: The default expiration date is one year from the last day of the current
month.

13 Click OK.
The lot number appears at the bottom of the Open lots list.

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Duplicate Lots
Duplicating a lot is helpful when switching to a new control material lot number.
Both Bio-Rad and non-Bio-Rad open lot numbers can be duplicated. When
duplicating a lot, the new lot number is set up exactly the same as the old lot
number; however, the new lot number does not contain any QC data.

Items Automatically Duplicated

When duplicating a lot, UnityWeb™ duplicates the:

• Open tests within the lot (closed tests are not duplicated).
• Test settings (levels in use, decimal places, and so on).
• Rule selections for SPC rules.

Optional Items When Duplicating

If using the following optional items, you can choose if you want to duplicate
them:

• Fixed mean
• Fixed SD

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Duplicate a Bio-Rad Lot Number

1 Log in as a user with the Manage labs/lots/tests permission.
2 Click the Configure tab.
3 Click Lot.
4 If you have more than one lab number, make sure the correct number
appears in the Lab number list.
5 Select the lot number you want to duplicate in the Open lots list.
6 Click Duplicate.
7 Select the new lot number from the New lot number list.

Tip: Only unexpired lot numbers in the same product group appear in the
list.

8 Select the appropriate check box for each parameter to duplicate:

• Fixed means
• Fixed SDs
9 Click OK.
The new lot number appears at the bottom of the Open lots list.
10 Repeat steps 4–9 to duplicate the lot number in each lab number.

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Duplicate a Non-Bio-Rad Lot Number

1 Log in as a user with the Manage labs/lots/tests permission.
2 Click the Configure tab.
3 Click Lot.
4 If you have more than one lab number, make sure the correct number
appears in the Lab number list.
5 Select the lot number you want to duplicate in the Open lots list.
6 Click Duplicate.
7 Type the new lot number in the Master lot number field.
8 Click the arrow located to the right of the Expiration date and select an
expiration date from the calendar.
9 Select the appropriate check field for each parameter to duplicate:
• Fixed means
• Fixed SDs
10 Click OK.
The new lot number appears at the bottom of the Open lots list.
11 Repeat steps 4–10 to duplicate the lot number in each lab number.

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Edit Lot Numbers

You can edit both Bio-Rad and non-Bio-Rad lot numbers, even if the lot
contains data. Editing a lot copies all test information, including test data to a
new lot number you select. Only edit a lot if you realize that a lot number was
defined in error and the lot number needs to be corrected.

Edit a Bio-Rad Lot Number

1 Log in as a user with the Manage labs/lots/tests permission.
2 Click the Configure tab.
3 Click Lot.
4 If you have more than one lab number, make sure the correct number
appears in the Lab number list.
5 Select the lot number you want to edit in the Open lots list.
6 Click Edit.
7 Select the new lot number from the New Lot Number list.
8 Click OK.
The previous lot number is replaced with the new lot number. The new lot
number appears at the bottom of the Open lots list.

Edit a Non-Bio-Rad Lot Number and Expiration Date

1 Log in as a user with the Manage labs/lots/tests permission.
2 Click the Configure tab.
3 Click Lot.
4 If you have more than one lab number, make sure the correct number
appears in the Lab number list.
5 Select the lot number you want to edit in the Open lots list.
6 Click Edit.
7 Type the new lot number in the Master Lot Number box.
8 Edit the expiration date if needed.
9 Click OK.
The previous lot number is replaced with the new lot number. The new lot
number appears at the bottom of the Open lots list.

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Close and Open Lots

Unexpired and expired lot numbers can appear in the Open lots list or Closed
lots list and can be toggled between the two lists.

Open and unexpired lot numbers are available for data entry and submission.
Results appear on your Unity™ Interlaboratory Reports.

Closed lots are not available for data entry nor submission. However, the data
for closed lots remains in the UnityWeb™ database. Open a closed lot to view,
print, or change data.

Close a Lot

Tip: If you are no longer running tests on a lot, you can close the lot. A
closed lot is ignored by the software although the data remains in the
database.

1 Log in as a user with the Manage labs/lots/tests permission.

2 Click Configure.
3 Click Lot.
4 If you have more than one lab number, make sure the correct number
appears in the Lab number list.
5 Select the lot you want to close in the Open lots list.
6 Click Close Lot.
The lot moves to the bottom of the Closed lots list.

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Open a Closed Lot

1 Log in as a user with the Manage labs/lots/tests permission.
2 Click Configure.
3 Click Lot.
4 If you have more than one lab number, make sure the correct number
appears in the Lab number list.
5 Select the lot you want to open in the Closed lots list.
6 Click Open Lot.
The lot moves to the bottom of the Open lots list.

Arrange and Sort Lots

Tip: For convenience, rearrange the order of lots in the Open lots list and
Closed lots list.

1 Log in as a user with the Manage labs/lots/tests permission.

2 Click Configure.
3 Click Lot.
4 If you have more than one lab number, make sure the correct number
appears in the Lab number list.
5 Select the lot you want to arrange in the Open lots list or Closed lots list.
6 Click the up and down arrows to move the lot up or down in the list.
7 Repeat steps 5 and 6 to sort other lots.

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Delete Lot Numbers

Important: Deleting a lot number permanently removes all data for all tests
under the lot number. Information in the deleted lot number cannot be
retrieved. Bio-Rad recommends closing the lot number to make it inactive
rather than deleting the lot number. See “Close a Lot” on page 118 for more
information. You can also export the lot data to another file before deleting
it. See “Export Data” on page 87 for more information.

1 Log in as a user with the Manage labs/lots/tests permission.

2 Click Configure.
3 Click Lot.
4 If you have more than one lab number, make sure the correct number
appears in the Lab number list.
5 Select the lot you want to delete in the Open lots list or Closed lots list.
6 Click Delete.
A message appears asking for confirmation of the lot number deletion.
7 Click OK.

Lot Expiration Notifications

You can configure the software to notify you when opening the Data Entry
dialog box for a test in a lot expiring in 30 days or less. This is a convenient
way to make sure your lots and software stay current.

1 Click the Tools tab.

2 Click Setup.
3 Select the Expired lot notification check box in the Notifications
section.
4 Click Save.

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 CHAPTER
7
Tests

In This Chapter
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
Add Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124
Test Rules and Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
Duplicate Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132
Update Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132
Close and Open Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
Sort Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
Delete Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136
VITROS® Slide Generation Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138

Overview
UnityWeb™ defines tests using six parameters. In combination with the lab
number and lot numbers, these codes uniquely identify your data in the Unity™
Interlaboratory Program.

The six test parameters are:

• Analyte
The analyte is the constituent being measured (for example, albumin,
calcium, glucose, and so on).

• Instrument/Kit
The instrument or kit used to test the analyte.

Note: When using RIA kits, code for the kit rather than the gamma counter.

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• Reagent type
– Dedicated reagent or kit
Choose Dedicated reagent or kit when the reagent manufacturer is
the same as the instrument or kit manufacturer. For VITROS®
instruments using slide generation numbers, choose Dedicated
reagent or kit and type the slide generation number in the VITROS®
slide generation number field.

– Alternate formulation/standardization
Alternate formulation/standardization is the applicable reagent
selection when using a dedicated reagent and a manufacturer update
or revision of the product results in a shift of the quality control data.
Your Bio-Rad QC Program Representative may request using this
option to ensure your data is in the correct consensus group. For
example, this selection is applicable when a manufacturer has
introduced a new formulation reagent or standardization. This
designation will be used until all of the existing formulation is
consumed or removed from the market. Once this occurs, you will be
directed by your Bio-Rad QC Program Representative to move your
data to the Dedicated reagent or kit category.

– Factored
Factored is applicable when quality control data is mathematically
altered to simulate results obtained on another instrument or at
another temperature.

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– More reagents
More reagents is applicable when using a reagent that is not
supplied by the instrument or kit manufacturer. Select More reagents
and then select a reagent from the list. Select Other if the reagent
does not appear in the list.

Note: Unity™ Interlaboratory Reports are not available for reagents using a
reagent code of Other. Bio-Rad recommends using Other only on a
temporary basis until the appropriate reagent is added to the code list.
Contact your Bio-Rad QC Program Representative to have codes added to
the code list.

• Method
Only methods Bio-Rad considers “valid” for the selected analyte appear in
the list. If the method does not appear, contact your Bio-Rad QC Program
Representative.

• Unit of measure
Only units Bio-Rad considers “valid” for the selected analyte appear in the
list. If your unit does not appear, contact your Bio-Rad QC Program
Representative.

• Temperature
For enzymes, choose an available temperature. For all other analytes, the
temperature defaults to “no temperature” and cannot be changed.

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Add Tests
Add tests to UnityWeb™ both directly and indirectly. Direct methods include
manually adding tests and using the Instrument Setup feature. Indirect
methods include duplicating labs, duplicating lots, changing the VITROS® slide
generation number, and the import of test configuration information when using
a Bio-Rad connectivity solution such as WebConnect™ 2.0.

Direct Methods of Adding Tests

When manually adding tests or using the Instrument Setup method, the new
tests appear in the Open tests list of the Test dialog box.

When manually defining tests, select the test parameters from lists in the Test
dialog box. When using Instrument Setup, UnityWeb™ supplies the codes
based on information in the Unity™ Method Guide for Selected Instruments.

Indirect Methods of Adding Tests

The following functions create tests in the background:

• Duplicating labs or lots

When duplicating a lab, its associated open lots and their open tests are
duplicated. When duplicating a lot, its associated open tests are
duplicated. Closed lots and closed tests are not duplicated.

• Changing the VITROS® slide generation number

Changing VITROS® slide generation number creates a new test with the
new slide generation number.

• Connectivity software
Tests are automatically configured in UnityWeb™ 2.0 when data
transformed with Bio-Rad connectivity software is imported.

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Add Tests Manually

1 Log in as a user with the Manage labs/lots/tests permission.
2 Click the Configure tab.
3 Click Test.
4 If you have more than one lab number, make sure the correct number
appears in the Lab number list.
5 Select the lot for which to add a test from the Lot list.
6 Select the analyte from the Analyte list.
7 Select the instrument/kit from the Instrument/Kit list.
8 Select a Reagent type:
• Dedicated reagent or kit
Select this option if the reagent manufacturer and the instrument/kit
manufacturer are the same.
• Alternate formulation/standardization

Note: The Alternate formulation/standardization option is not commonly

used. Do not select this option unless instructed to do so by your Bio-Rad
QC Program Representative.

• Factored
Select this option when the QC data is mathematically altered to
simulate results obtained on another instrument or at another
temperature.
More reagents
Select this option when using a reagent that is not supplied by the
instrument manufacturer. Select More reagents and then select a
reagent from the list. Select Other if the reagent does not appear in
the list.

Note: Unity™ Interlaboratory Reports are not available for reagents using a
reagent code of Other. Bio-Rad recommends using Other only on a
temporary basis until the appropriate reagent is added to the code list.
Contact your Bio-Rad QC Program Representative to have codes added to
the code list.

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9 Select the method for the test from the Method list.
10 Select the unit of measure from the Unit of measure list.
11 Select the temperature from the Temperature list.

Note: Temperature applies to enzymes only. For other analytes, No

temperature is automatically selected and cannot be changed.

12 Click Add.
The new test appears at the bottom of the Open tests list.

Add Tests With Instrument Setup

Instrument Setup is a convenient way to add a group of tests performed on an
instrument. Instrument Setup creates tests and all test parameters based on
information in the Bio-Rad Unity™ Method Guide for Selected Instruments.

Note: Only instruments appearing in the Unity™ Method Guide for Selected
Instruments are available using Instrument Setup. If the instrument does not
appear, contact your Bio-Rad QC Program Representative and ask that it
be added. The Unity™ Method Guide for Selected Instruments is available
on [Link]. Log in to QCNet™, point to QC Documents, and
click Method Guide.

Limitations of Instrument Setup

• Instrument Setup configures all reagent types as dedicated reagent or
kit. Edit the test and change the reagent type if using a different reagent.
• Instrument Setup assigns 37° C as the temperature for all enzymes. All
non-enzyme tests are designated as No temperature.

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Add Tests Using Instrument Setup

Note: Tests previously defined for the instrument in the lab/lot combination
are omitted from the list.

1 Log in as a user with the Manage labs/lots/tests permission.

2 Click the Configure tab.
3 Click Test.
4 If you have more than one lab number, make sure the correct number
appears in the Lab number list.
5 Select the appropriate lot in the Lots list.
6 Click Inst. Setup.
7 Select the instrument in the Instrument list. Use the scroll arrows to move
up and down the list as necessary.
A list appears with all available tests for the instrument and lot combination
according to the Unity™ Method Guide for Selected Instruments.

Note: A message appears if no tests are available for the instrument and lot
combination.

By default, all tests have a check mark and are selected. It may be
necessary to scroll to the bottom of the window to see all information.
8 By default, Conventional unit is selected. Select the SI option for SI units.
9 Select and clear the check boxes so only the tests to add are selected.

Tip: The Select None button clears all the check boxes. The Select All
button selects all the check boxes.

10 For VITROS® instruments only, enter the slide generation number in

each of the SG fields.
11 Click OK.
The new tests appear in the Open tests list.

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Add Tests with a Code of “Other”

Note: Unity™ Interlaboratory Reports are not available for tests using a test
code of Other. Bio-Rad recommends using Other only on a temporary
basis until the appropriate analyte is added to the code list. Contact your
Bio-Rad QC Program Representative to have codes added to the code list.

1 Log in as a user with the Manage labs/lots/tests permission.

2 Click the Configure tab.
3 Click Test.
4 If you have more than one lab number, make sure the correct number
appears in the Lab number list.
5 Select the appropriate lot from the Lot list.
6 Select a test parameter from each of the respective lists in the Test
information section or select Other for any code that does not appear.
7 Click Add.
The Other dialog box appears.
8 Enter the test description in the corresponding fields.
9 Click OK.
The new test appears at the bottom of the Open tests list.

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Test Rules and Settings

Select settings to customize how tests are displayed and evaluated.

Select SPC Rules

Note: See Chapter 9, “Applying SPC Rules” and Chapter 18, “Westgard
AdvisorTM online” for extensive information on selecting SPC rules.

1 Log in as a user with the Manage labs/lots/tests permission.

2 Click the Configure tab.
3 Click Rules/Settings.
4 Click the Rules tab.

Select Test Settings

1 Log in as a user with the Manage labs/lots/tests permission.
2 Click the Configure tab.
3 Click Rules/Settings.
4 Click the Settings tab.
5 By default, all available Levels in use for the control are selected. If you
do not run a particular level, clear the appropriate Levels in use check
box.

Note: Any level not in use is omitted from the Data Entry dialog box. This
simplifies data entry.

6 The default decimal places for each level is 2. Type a number (0 to 4) for
each level.

Note: Each level can have a different number of decimal places.

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7 Type the number of data points that must be entered before rule
evaluation begins in the Points before rule evaluation field. The default
is 20.

Use a Fixed Mean and SD

Note: The fixed mean and SD are independent; specify a fixed mean, a fixed
SD, or both.

Although the software allows the setting of a specific number of points to

collect before rule evaluation begins, when using a fixed mean and fixed SD,
rule evaluation begins immediately. The software continues to use the specified
values until new values are specified or the value is cleared. When a fixed mean
or fixed SD field is blank, UnityWeb™ uses the floating mean and floating SD.

Specify a Fixed Mean and SD

1 Click the Configure tab.
2 Click the Rules/Settings tab.
3 Click the Fixed Mean and SD tab.
4 Type a fixed mean and/or a fixed SD for each level of control material.
5 Select the % check box to calculate the SD as a percentage.
6 Select the Use floating statistics check box to use the current floating
statistics to set the fixed mean and SD.
7 Select a time period for calculating the floating statistics.
• Last 30 days
• Last 6 months
• Cumulative
• Date range

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8 If selecting Date range, click the arrow located to the right of the From
date and select a beginning date for the floating statistics.
9 Click the arrow located to the right of the To date and select an ending
date for the floating statistics.
10 Select the Mean and SD check box for each level to apply to the fixed
mean and fixed SD.
11 Click Save.

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Duplicate Tests
Note: Individual tests cannot be duplicated. However, duplicating a lab or lot
number duplicates the tests.

Update Tests
Change any test parameter for an existing test, even if the test contains QC
data. This feature is useful if making a mistake when setting up a test or if your
Bio-Rad QC Program Representative asks you to make a change.

Note: A qualitative test cannot be updated to a quantitative test or vice

versa if data has been entered for the test.

See “Update the VITROS® Slide Generation Number” on page 140 for
information about updating tests using a VITROS® slide generation number.

Update a Test
1 Log in as a user with the Manage labs/lots/tests permission.
2 Click the Configure tab.
3 Click Test.
4 Select the lab from the Lab list.
5 Select the lot from the Lot list.
6 Select the test to update in the Open tests list.
7 Select the new parameters as needed (Analyte, Instrument/Kit,
Reagent type, Method, Unit of measure, and Temperature).
8 Click Update.

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Close and Open Tests

Closed tests and their data remain in the UnityWeb™ database, but they are not
available for data entry and do not appear on the Unity™ Interlaboratory
Reports. Re-open the tests at any time if needed.

Close a Test
1 Log in as a user with the Manage labs/lots/tests permission.
2 Click the Configure tab.
3 Click Test.
4 Select the lab from the Lab list.
5 Select the lot from the Lot list.
6 Select the test to close in the Open tests list.
7 Click Close.
The test moves to the Closed tests list.

Open a Test
1 Log in as a user with the Manage labs/lots/tests permission.
2 Click the Configure tab.
3 Click Test.
4 Select the lab from the Lab list.
5 Select the lot from the Lot list.
6 Select the test to open in the Closed tests list.
7 Click Open.
The test moves to the Open tests list.

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Sort Tests
The order of the tests determines the order the tests appear for data entry and
in intralaboratory reports and charts.

Tip: Rearrange the order of tests to match the printout used for data entry.
This helps to speed up the data entry and review processes.

Sort Tests for a Lab Number

1 Log in as a user with the Manage labs/lots/tests permission.
2 Click the Configure tab.
3 Click Test.
4 Select the lab from the Lab list.
5 Select the lot from the Lot list.
6 Select the test to sort in the Open tests or Closed tests list.
7 Click the up and down arrows to move the test up or down in the list.
8 Repeat steps 6 and 7 to sort other tests.

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Sort Tests in a Panel

1 Log in as a user with the Manage labs/lots/tests permission.
2 Click the Configure tab.
3 Click Panel.
4 Click Update/Sort Tests.
5 Select the panel to sort from the Panel list.
6 Select the test to sort in the Selected tests list.
• To select consecutive tests, click the first test, press the SHIFT key on
the keyboard and click the last test.
• To select non-consecutive tests, press the CTRL key on the keyboard
and click each test.
7 Click Up or Down to move the test up or down in the panel.
8 Repeat steps 6 and 7 to sort other tests.
9 Click Save.

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Delete Tests
Open and closed tests can be deleted. Tests can be deleted at several levels:

• Lab
Deleting a lab also deletes its associated lots, tests, and data. See “Delete
Lab Numbers” on page 110 for more information.

• Lot
Deleting a lot deletes its associated tests and data. See “Delete Lot
Numbers” on page 120 for more information.

• Test

Important: Deleting a test permanently deletes all associated data from the
UnityWeb™ database. Deleted data cannot be retrieved. Bio-Rad
recommends closing the test to make it inactive while retaining the test
data. A closed test remains in the database but is unavailable for data entry
and is omitted from Unity™ Interlaboratory Reports. See “Close a Test” on
page 133 for more information. You can also export the lab data to another
file before deleting it. See “Export Data” on page 87 for more information.

Delete a Test
1 Log in as a user with the Manage labs/lots/tests permission.
2 Click the Configure tab.
3 Click Test.
4 Select the lab from the Lab list.
5 Select the lot from the Lot list.
6 Select the test to delete in the Open tests or Closed tests list.

Important: There are two Delete buttons in the Test dialog box. One Delete
button is located to the right of the Open tests list and the other Delete
button is located to the right of the Closed tests list. The Delete button
you click determines the test that is deleted. Be careful to click the correct
button to avoid inadvertently deleting a test.

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 Tests

7 Click Delete.
A message appears asking for confirmation of the test deletion.
8 Click OK.

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VITROS® Slide Generation Numbers

Important: The Unity™ Interlaboratory Program uses the VITROS® slide
generation numbers to determine consensus groups. To ensure accurate
reports, make sure the VITROS® slide generation number is correct for each
test.

Change the VITROS® Slide Generation Number

When changing the VITROS® slide generation number for a test, UnityWeb™
creates a new test with the new slide generation number. When changing the
VITROS® slide generation number, choose what to do with the old (existing
test) and the range of tests for which to apply the new slide generation number.

Important: Do not use this procedure to update or correct a slide generation

number. To update or correct a slide generation number, use the procedures
described in “Update the VITROS® Slide Generation Number” on page 140.

1 Log in as a user with the Manage labs/lots/tests permission.

2 Click the Configure tab.
3 Click Test.
4 Select the lab from the Lab list.
5 Select the lot from the Lot list.
6 Select the test with the slide generation number change in the Open tests
list.
7 Click Change Gen.
8 Type the new slide generation in the VITROS® slide generation number
field.

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 Tests

9 Select an Action option for the old test:

• Retain
Select this option to leave the existing test open and available for data
entry. This is the default selection.
• Close
Select this option to close the existing test and make it unavailable for
data entry.
• Delete
Select this option to delete the existing test.

Important: The Delete option permanently deletes all data for the test. The
data cannot be retrieved. Bio-Rad recommends using the Close option to
make it inactive. You can also export the data to another file before deleting
it. See “Export Data” on page 87 for more information.

10 Select an Apply to option:

• Selected test
Select this option to apply the new slide generation number only to
the currently selected test. This is the default selection.
• Current lab
Select this option to apply the new slide generation number to all
identical tests in the current lab number.
• All labs
Select this option to apply the new slide generation number to all
identical tests in the current database.
11 Click OK.

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 Tests

Update the VITROS® Slide Generation Number

When updating the VITROS® slide generation number, UnityWeb™ only updates
the slide generation number for the selected test. New tests are not created
and the existing test remains available for data entry, reports, and so on.

When correcting a slide generation number, update the test rather than change
the slide generation number. If a slide generation number is not correct and you
have already entered data for the test, updating the test corrects the problem
in UnityWeb™. Also, the test is updated in the Unity™ Interlaboratory Program
the next time you transmit data.

Follow this procedure to correct a slide generation number.

1 Log in as a user with the Manage labs/lots/tests permission.

2 Click the Configure tab.
3 Click Test.
4 Select the lab from the Lab list.
5 Select the lot from the Lot list.
6 Select the test with the slide generation number to update in the Open
tests list.
7 Enter the new slide generation number in the VITROS® slide generation
number field.
8 Click Update.

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 CHAPTER
8
Panels and Data Groups

In This Chapter
Panels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141
Data Groups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145

Panels
A panel is a user-defined group of tests organized to simplify data entry and
data review across lab and lot numbers. Panels provide a useful way to
organize tests in a convenient manner such as grouping a number of different
tests performed on a single instrument or the same test performed on multiple
instruments.

Any number of panels can be created. Tests added to a panel can come from
any lab number and lot number in the system. A single test may be added to
any number of panels but can only appear once in any one panel.

When the Data Entry dialog box is opened for a Panel, the navigation buttons
for data entry apply to the tests in the panel. (See “Navigate the Single Test
Data Entry Dialog Boxes” on page 171 for more information.) The panel name
appears with the current status information.

Note: Delete a panel at any time. Panels are a way of organizing tests for
data entry and data review; therefore, neither tests nor data within a panel
are deleted if the panel is deleted.

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 Panels and Data Groups

Create a Panel and Add Tests

1 Log in as a user with the Manage panels permission.
2 Click the Configure tab.
3 Click Panel.
4 Click Add.
5 Type the name for the panel in the Panel field.
6 Select the lot or test to add to the panel from the Available tests
navigation tree.
• Click + (plus sign) to the left of the lab number to view the lots.
• Click + (plus sign) to the left of the lot number to view the tests.
7 Click Add to add the selected test or to add all tests within the selected
lot. The Add All button adds all tests within the navigation tree regardless
of what is selected.
The test(s) appear in the Selected tests list.
8 Click Save.

Sort Tests in a Panel

1 Log in as a user with the Manage panels permission.
2 Click the Configure tab.
3 Click Panel.
4 Click Update/Sort Tests.
5 Select the panel with tests to sort from the Panel list.
6 Select the test to sort in the Selected tests list
• To select consecutive tests, click the first test, press the SHIFT key on
the keyboard and then click the last test.
• To select non-consecutive tests, press the CTRL key on the keyboard
and then click each test.
7 Click Up or Down to move the test up or down in the list.
8 Click Save.

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Remove Tests from a Panel

1 Log in as a user with the Manage panels permission.
2 Click the Configure tab.
3 Click Panel.
4 Click Update/Sort Tests.
5 Select the panel with the test(s) to remove from the Panel list.
6 Select the test to remove from the Selected tests list.
7 Click Remove to remove an individual test or click Remove All to remove
all tests in the Selected tests list.
8 Click Save.

Rename a Panel
1 Log in as a user with the Manage panels permission.
2 Click the Configure tab.
3 Click Panel.
4 Click Delete/Rename/Sort Panel Name.
5 Click the edit icon .
6 Type the new name for the panel.
7 Click the save icon .
A message appears asking for confirmation of the update.
8 Click OK.

Sort Panel Names

1 Log in as a user with the Manage panels permission.
2 Click the Configure tab.
3 Click Panel.
4 Click Delete/Rename/Sort Panel Name.
5 Click the up or down arrow to move the panel up or down in the list.

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Delete a Panel
1 Log in as a user with the Manage panels permission.
2 Click the Configure tab.
3 Click Panel.
4 Click Delete/Rename/Sort Panel Name.
5 Click the delete icon located to the right of the panel to delete .
A message appears asking for confirmation of the panel deletion.
6 Click OK.

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Data Groups
Categorizing tests by group name is a useful way to designate tests having
something in common. For example, tests with the same lab and lot number
can be grouped according to the reagent type. In this example, group all tests
using a specific reagent (for example, Reagent 1) into Group 1 and all tests
using another reagent (for example, Reagent 2) into Group 2. Tests can also be
grouped by calibrators, the standardization matrix of a kit, and so on.

Overview of Groups
• The Month and Group options are available for point data entry and
summary data entry.
• The Current data selection (Month or Group) in the Data entry
configuration section of the Setup dialog box applies to all tests.
• On the Single Test Point Data Entry dialog box or the Single Test
Summary Data Entry dialog box, select or clear the Group check box to
switch between Month and Group. Selecting the Group check box
changes the Summary Statistics. UnityWeb™ does not arrange data entry
rows into groups.
• UnityWeb™ assigns all data points to group 0 (zero) until a data group is
defined.
• If no Group is defined for a test, the Group and Cumulative summary
statistics are the same.

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Change the Current Data Option

Note: Toggle between Month and Group on the Data Entry dialog box. It is
not necessary to change the Current Data option even if using groups.

1 Log in as a user with the Edit setup options permission.

2 Click the Tools tab.
3 Click Setup.
4 Click the Configure UnityWeb™ tab.
5 Within the Data entry configuration section, select the Group option
located under Current data.
6 Click Save.

Define or Edit a Group

1 Log in as a user with the Edit all data permission.
2 Click the Data Entry tab.
3 Click Single Test Point Data Entry or Single Test Summary Data
Entry.
4 If you have more than one lab number, make sure the correct number
appears in the Lab number list.
5 Select the appropriate lot in the Lot list.
6 Select the appropriate test in the Test list.
7 Select the Group check box.
The screen refreshes, and the Group column appears.
8 Add a group name in the Group column.
9 Click Save.

Note: UnityWeb™ assigns successive data entry rows to the same group
until another group name is assigned in the Group column.

Tip: Type a comment to describe the group. See “Add a Comment to a

Row of Data” on page 217 for more information.

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 CHAPTER
9
Apply QC Rules

In This Chapter
Overview of Rule Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
Set SPC Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
Use a Fixed Mean and Fixed SD with SPC Rules . . . . . . . . . . . . . . . . . . . . 154
SPC Rules: Tabular Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157

Overview of Rule Evaluation

UnityWeb™ provides statistical process control (SPC) rules to monitor test
performance. UnityWeb™ evaluates data points against the active SPC rules to
determine whether to accept or reject the data. The software provides 17
different SPC rules, each of which can be set to reject, warn, or off.

Note: See “SPC Rules: Tabular Summary” on page 157 for an overview of
the available SPC rules.

Laboratories perform statistical analysis using tools such as OPSpecs Charts,

critical-error graphs, and power function curves as described in numerous
publications. However, using the optional Westgard Advisor™ online automates
statistical analysis and suggests rules based on a selected performance goal,
historical data, and Unity™ Interlaboratory Program consensus group
information.

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 Apply QC Rules

Notes About Rule Evaluation

• UnityWeb™ rejects the entire row if any data within a run violates a SPC
rule with a status of reject.
• UnityWeb™ excludes rejected data rows when evaluating rules between
runs.

For example, a test is being evaluated using the 13s and 22s rules, both set to
reject. If run four violates the 13s rule and run five violates the 12s rule, the
second run is not rejected as violating the 22s rule.

Note: Excluding rejected data is based on the assumption the test system
was evaluated in response to the rejection and the laboratory took
corrective action. UnityWeb™ assumes subsequent data points reflect these
actions.

Rule Status

Note: Only point data is evaluated against SPC rules. Data inserted or
edited is not evaluated against SPC rules unless the data is on the last line
of the Data Entry dialog box.

Set SPC rules to any of the following status:

Note: Rules set to reject or warn are the active rules for the test.

• Reject
UnityWeb™ rejects data violating the SPC rule and excludes it from the
summary statistic calculations. The rule violated appears in the Rules
column on the Data Entry dialog box and on intralaboratory charts and
reports.
• Warn
UnityWeb™ accepts data violating the SPC rule. The rule violated appears
in the Rules column on the Data Entry dialog box and on intralaboratory
charts and reports.

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• Off
UnityWeb™ ignores the rule when evaluating data points.

UnityWeb™ begins evaluating point data against SPC rules with a status of
reject or warn after the test has the number of data points specified on the
Settings tab of the Rules/Settings dialog box. See “Set SPC Rules” on
page 150 for more information.

Note: Twenty data points is generally considered the minimum for statistical
significance and therefore is the default number used in the software.
Specify a fixed mean and SD to have rule evaluation begin immediately. See
“Use a Fixed Mean and Fixed SD with SPC Rules” on page 154 for more
information.

SPC Rules Precedence When Showing Rule

Violations
For the purpose of rules precedence, SPC rules are divided into the groups
shown in the columns in the table below. Rules are arranged in decreasing
order of severity within each group. If a data point violates more than one rule
in a group, UnityWeb™ shows only the most severe rule violation in the Rules
column on the Data Entry dialog box and on intralaboratory reports and
charts. UnityWeb™ evaluates the data against all active rules; however, rules are
sometimes truncated in the Rules column on the Data Entry dialog box to
simplify viewing.

Group 1 2 3 4 5 6 7
15s 22s 2 of 32s 12x 7T R4s 41s
Least severe rule violation

14s 12s 12s 10x – – 31s

13.5s – – 9x – – –

13s – – 8x – – –

12.5s – – 7x – – –

12s – – – – – –

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 Apply QC Rules

Set SPC Rules

UnityWeb™ applies a default set of SPC rules based on the number of levels
available for the control product being used when a test is created. However,
best practices recommend setting SPC rules for each test based on its quality
requirements.

Set SPC rules at the test level and/or the lot level. However, Bio-Rad strongly
recommends choosing SPC rules for each individual test. Using the optional
Westgard Advisor™ online is the best method for configuring and applying SPC
rules. See Chapter 18, “Westgard Advisor™ online” for more information.

Important: Best practices require laboratories to select rules on a

test-by-test basis.

Set SPC Rules at the Test Level

Note: View tests by lab number or by panel. Set up a panel before selecting
rules for the panel. See “Create a Panel and Add Tests” on page 142 for
more information.

1 Log in as a user with the Edit test settings/rules permission.

2 Click the Configure tab.
3 Click Rules/Settings.
4 Select the Lab or Panel option.
5 Select the lab number or panel name from the Lab or Panel list.
6 If using the Lab option, select the lot number from the Lot list.
7 Select the test from the Test list.
8 Click Rules.
9 Select an option (Reject, Warn, or Off) for each SPC rule.

Note: Click on the rules button to display information on rule application. If

the application of the rule is within or across control materials, click on the
radio button to view the applicable display.

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The status of each rule is indicated in the Status column using the
symbols shown below:

Reject

Warn

Off

Note: Click Disable SPC Rules to set all the rules to off. Click Default
Settings to return the rules to their default settings.

10 Click Save.

Set SPC Rules at the Lot Level

Note: View tests by lab number or by panel. Set up a panel before selecting
rules for the panel. See “Create a Panel and Add Tests” on page 142 for
more information.

1 Log in as a user with the Edit test settings/rules permission.

2 Click the Configure tab.
3 Click Rules/Settings.
4 Select the Lab or Panel option.
5 Select the lab number or panel name from the Lab or Panel list.
6 If using the Lab option, select the lot number from the Lot list.
7 Select a test from the Test list.
8 Click Rules.
9 Select an option (Reject, Warn, or Off) for each SPC rule.

Note: Click the rules button to display information on rule application. If the
application of the rule is within or across control material, click the option
button to view the applicable display.

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 Apply QC Rules

The status of each rule is indicated in the Status column using the
symbols shown below:

Reject

Warn

Off

10 Select the Apply to check box.

11 Select the appropriate option:
• Select the This lot option to apply the rules and/or settings to all
tests in the lot, or
• Select the All labs for this lot option to apply the rules and/or
settings to all tests run on this control material in the software.
12 Select the appropriate option to apply the changes:
• Select the Apply Rules/Settings option to apply the changes to
both the Rules and Settings.
• Select the Apply Rules only option to apply the changes to the
Rules only.
• Select the Apply Settings only option to apply the changes to the
Settings only.

Note: Click Disable SPC Rules to set all the rules to off. Click Default
Settings to return the rules to their default settings.

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13 Click Save.
• The following message appears if you selected the This lot option in
step 11:

Best practices in process control require laboratories to establish quality

specifications and set appropriate process control rules (Westgard
Rules) to meet those specifications for each test. In keeping with good
laboratory practice, Bio-Rad recommends that, where appropriate,
process control rules should be set on a test-by-test basis. Do you want
to apply these SPC rules to all tests within the current lab and lot?

• The following message appears if you selected the All labs for this
lot option in step 11:

Best practices in process control require laboratories to establish quality

specifications and set appropriate process control rules (Westgard
Rules) to meet those specifications for each test. In keeping with good
laboratory practice, Bio-Rad recommends that, where appropriate,
process control rules should be set on a test-by-test basis. Do you want
to apply these SPC rules to each test in the lot for all active lab
numbers?

14 Click OK.

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 Apply QC Rules

Use a Fixed Mean and Fixed SD with

SPC Rules
Most SPC rules evaluate data against a floating mean and standard deviation
(SD). For example, the 13s rule evaluates if the data point is ±3SD from the
mean.

Specify a fixed mean, fixed SD, or both for each test. Fixed statistics are more
sensitive than floating statistics. However, over time, cumulative statistics
stabilize and can simulate a fixed statistic. Consequently, cumulative statistics
provide a reasonable degree of sensitivity to shifts and trends.

Useful Facts about Fixed Mean and Fixed SD

• If using both a fixed mean and a fixed SD, UnityWeb™ begins SPC rule
evaluation immediately, even if the test does not have the specified
number of points before rule evaluation begins (default is twenty). If you do
not specify both a fixed mean and a fixed SD, rule evaluation begins after
the specified number of points are entered.
• When specifying a fixed mean and fixed SD, UnityWeb™ immediately
begins using these values as the evaluation mean and SD for any new
data points entered.
• UnityWeb™ continues using the fixed statistics until new values are
specified or the values are cleared.
• When not specifying a fixed mean or fixed SD, UnityWeb™ uses the floating
mean and/or floating SD.

Note: The fixed mean and fixed SD statistics are for your laboratory use
only. Fixed statistics are not transmitted to the Unity™ Interlaboratory
Program and do not appear on Unity™ Interlaboratory Reports.

• Duplicate the fixed means and/or fixed SDs when duplicating from the
existing to the new lot number as described in “Duplicate Lots” on
page 114.
• If you prefer, UnityWeb™ allows the use of a fixed percentage as the SD.

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 Apply QC Rules

Set a Fixed Mean and/or Fixed SD

1 Log in as a user with the Edit test settings/rules permission.
2 Click the Configure tab.
3 Click Rules/Settings.
4 Select the Lab or Panel option.
5 Select the lab number or the panel name from the Lab or Panel list.
6 If using the Lab option, select the lot number from the Lot list.
7 Select the test from the Test list.
8 Click the Fixed Mean and SD tab.
9 Type a Fixed mean and/or Fixed SD for each level of control material.
10 If using a fixed percentage for the SD, select the % check box and type
the desired percentage value in the Fixed SD field.

Note: The fixed mean and fixed SD are independent of each other. Fixed
statistics do not have to be used for all levels. A fixed mean can be set
without a fixed SD and vice versa.

11 Click Save.

Set Floating Statistics as a Fixed Mean and/or

Fixed SD
1 Log in as a user with the Edit test settings/rules permission.
2 Click the Configure tab.
3 Click Rules/Settings.
4 Select the Lab or Panel option.
5 Select the lab number or the panel name from the Lab or Panel list.
6 If using the Lab option, select the lot number from the Lot list.
7 Select the test from the Test list.
8 Click the Fixed Mean and SD tab.

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 Apply QC Rules

9 Select the Use floating statistics check box and select an option for the
floating statistics:
• Last 30 days
• Last 6 months
• Cumulative
• Date range
10 If using Date range, enter a From date and a To date.
11 Select the Apply to check boxes indicating the levels where you want to
apply the floating statistics.

Note: The Fixed mean and Fixed SD fields auto-populate based on the
selections made.

12 Click Save.

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SPC Rules: Tabular Summary

The following table summarizes the SPC rules available in UnityWeb™. See
“SPC Rules” on page 27 for more information.

SPC Rules: Tabular Summary

Rule Error type When violated Notes

12s Random or A single control When used as a

systematic observation is rejection rule, 12s yields
outside the ±2SD a high proportion of
limit. false rejections.

12.5s Random or A single control N/A

systematic observation is
outside the
±2.5SD limit.

13s Random or A single control While a value outside

the beginning observation is ±3SD may be
of large outside the ±3SD statistically significant, it
systematic limit. may not be biologically
or medically relevant
due to the fact that
modern laboratory
instruments are often
more precise than what
is needed medically.

13.5s Random and One control value This rule is applied

may also exceeds the within the run only.
indicate mean ±3.5SD.
systematic

14s Random and One control value This rule is applied

may also exceeds the within the run only.
indicate mean ±4SD.
systematic

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 Apply QC Rules

SPC Rules: Tabular Summary (continued)

Rule Error type When violated Notes

15s Random and One control value This rule is applied

may also exceeds the within the run only.
indicate mean ±5SD.
systematic

22s Systematic Two consecutive N/A

QC results are
outside the ±2SD
limit on the same
side of the mean.

2 of 32s Systematic Two of three This rule is a variation of

levels of control the 22s rule and is
within the same applicable when testing
run exceed ±2SD three or more levels of
on the same side control material.
of the mean.
R4s Random There is at least a Bio-Rad software uses
±4SD difference the exact within-run
between control difference between
values within a control values to
single run. determine if R4s is
violated.

31s Systematic Three N/A

consecutive
results exceed
±1SD on the
same side of the
mean.

41s Systematic Four consecutive N/A

results exceed
±1SD on the
same side of the
mean.

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SPC Rules: Tabular Summary (continued)

Rule Error type When violated Notes

7T Systematic Seven A “strict” increasing

consecutive data pattern is defined as a
points for a single series of points that
level of control increase incrementally
show either a from the previous point
“strict” increasing (each point greater than
or decreasing the last) without a break
pattern. in the pattern. A “strict”
decreasing pattern is
the same pattern in the
opposite direction.

7x, 8x, 9x Systematic X number of Because of the extreme

consecutive sensitivity of these rules,
results on the they should be used
same side of the sparingly, if at all.
mean.

10x Systematic Ten consecutive This rule has a lower

results on the probability for false
same side of the rejection than do the 7x,
mean. 8x, and 9x rules.
12x Systematic Twelve This rule has a lower
consecutive probability for false
results on the rejection than do the 7x,
same side of the 8x, 9x, and 10x rules.
mean.

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 CHAPTER
10
Enter Data

In This Chapter
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161
Overview of the Single Test Data Entry Dialog Boxes. . . . . . . . . . . . . . . . . . 163
Data Entry Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169
Single Test Point Data Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172
Single Test Summary Data Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177
Qualitative Data Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 180
Multi Test Data Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183

Overview
Manual data entry is a basic feature of UnityWeb™. Alternatively, use one of
Bio-Rad's connectivity solutions to automatically import data from an
instrument, Laboratory Information System (LIS), or other data management
system for which Bio-Rad has an interface.

Note: Contact your Bio-Rad Account Manager for more information on

Connectivity Solutions.

Reference Guide for UnityWeb™ 2.0 161

 Enter Data

UnityWeb™ provides data entry for the following:

• Single Test Point Data Entry (page 172)

• Single Test Summary Data Entry (page 177)
• Qualitative Data Entry (page 180)
• Multi Test Data Entry (page 183)

Note: This guide uses the term qualitative to refer to both qualitative and
semi-quantitative results.

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 Enter Data

Overview of the Single Test Data Entry

Dialog Boxes
UnityWeb™ Single Test data entry dialog boxes share a common look and
consist of the following areas:

• Lab, panel, lot, and test information (page 163)

• Command buttons and options (page 164)
• Data entry grid (page 166)
• Paging arrows (page 166)
• Summary statistics (page 167)
• Group statistics (page 167)
• Fixed Mean and SD (page 168)

Lab, Panel, Lot, and Test Information

2
1

4 5

The top section of the dialog box shows the following information:

1 Lab number and laboratory description or panel

2 Lot number, control product description, and control product expiration

date

3 Test information including analyte name, method, instrument, VITROS®

slide generation number (if applicable), reagent, unit, and temperature

4 Current rules, if applicable

5 Matrix

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Command Buttons and Options

1 2

1 Command buttons and options

• Go to Chart
Click Go to Chart to view a Levey-Jennings Chart for the test
(Single Test Point Data Entry dialog box only). See “View a
Levey-Jennings Chart” on page 170 for more information.

• Set Date
Click Set Date to use the Set Date feature. See “Use the Set Date
Feature” on page 169 for more information.

• Save
Click Save to save data.

• Edit check box

Select the Edit check box to enter or edit data (Single Test Point
Data Entry dialog box only).

• Group check box

Select the Group check box to view the Summary Statistics based
on the Group and cumulative statistics. See “Data Groups” on
page 145 for more information about data groups.

Clear the Group check box to view the Summary Statistics based
on monthly and cumulative statistics. See “Summary Statistics” on
page 167 for more information.

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2 Edit Data Key

Each data entry row provides the ability to edit data as follows:
• Click to add an action to the row of data or to view any existing
actions. A green arrow appears in the column when an action has
been added . Actions are only available for point data.
• Click to add a comment to the row of data or to view any
existing comments. A green arrow appears in the column when a
comment has been added .
• Click or the Information link to view extended information
about the test:
Floating mean/SD
(the evaluation mean and/or SD used to evaluate the row of data if
floating statistics are used)

Fixed mean/SD
(the evaluation mean and/or SD used to evaluate the row of data if
fixed statistics are used)

Rules
(the SPC rules used to evaluate the row of data)

Bench Review
(the person who reviewed the row of data, if applicable, in Bench
Review)

• Click or the Delete link to delete a row of data.

• Click or the Insert link to insert a row of data.
• Click or the Update link to update the Summary Statistics.

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Data Entry Grid

Manual data is entered and imported data appears in the data entry grid rows
and columns.

Each type of data (point and summary) has its own data entry grid. See the
following sections for more information:

• Point data entry grid (page 172)

• Summary data entry grid (page 178)

Paging Arrows
UnityWeb™ groups rows of data into pages based on the number of rows that
can be displayed at a time. Click the paging arrows to move through pages of
data or select a page number from the list.

Go to first row

Go to previous page

Go to next page

Go to last row

Select a page
from the list

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Summary Statistics
The Summary Statistics shows the monthly and cumulative mean, monthly and
cumulative standard deviation (SD), monthly and cumulative coefficient of
variation (CV), and monthly and cumulative number of points.

Tip: Set the default statistics to Summary or Group. See “Data Entry
Configuration” on page 83 for more information.

Example of Summary Statistics

Group Statistics
If data groups are set up, select the Group check box to view group and
cumulative statistics. (See “Data Groups” on page 145 for more information.)
The Group Statistics shows the group and cumulative mean, group and
cumulative SD, group and cumulative CV, and group and cumulative number of
points.

Tip: Set the default statistics to Summary or Group. See “Data Entry
Configuration” on page 83 for more information.

Example of Group Statistics

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Fixed Mean and SD

The fixed mean and fixed SD (if specified) appear below the Summary Statistics
(Single Test Point Data Entry dialog box only). These statistics do not
change as you select different rows of data. See “Fixed Statistics” on page 174
for more information.

Note: The fixed mean and fixed SD apply to point data only.

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Data Entry Features

Note: Enter data by lab number or by panel. Set up a panel before entering
data for the panel. See “Create a Panel and Add Tests” on page 142 for
more information.

Use the Set Date Feature

The Set Date feature is useful when manually entering several days of data.
After the date is set, UnityWeb™ increments the date by one day each time a
new row of data is added. UnityWeb™ continues to increment the date by one
day until you exit the software.

1 Click the Data Entry tab.

2 Click Set Date.
• Click any part of the date and type over to edit the date for the first
date of data entry, or

• Click the arrow located to the right of the date and select a date from
the calendar for the first date of data entry.

• Within the calendar click to go the previous month.

• Within the calendar click to go to the next month.

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3 Enter data.
The date increments by one day each time you add a new row.
4 Click Save.

Change the Date and Time for a Row of Data

Changing the date or time for a data entry row only applies to the current row.
For example, after editing the date and time of the last data entry row, the next
row added contains the current date-time.

• Click any part of the date and type over to edit the date:

View a Levey-Jennings Chart

When working in the Single Test Point Data Entry dialog box, click Go to
Chart to view a Levey-Jennings Chart for the test. Display one chart at a time.

View Rules and Settings

When working in the Single Test Point Data Entry dialog box:

• The current active SPC rules appear on the Rules line.

• The fixed mean and fixed SD (if specified) appear below the Summary
Statistics.
• Click the Information link to view historical information for a row of data,
including the SPC rules active when the data point was entered.

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Navigate the Single Test Data Entry Dialog

Boxes
In the Single Test Point Data Entry and Single Test Summary Data Entry
dialog boxes, navigate by clicking the buttons described below:

To... Click...

Go to the next test

Go to the previous test

Go to the next lot

(available only if the Lab option is selected)

Go to the previous lot

(available only if the Lab option is selected)

Go to the next lab

(available only if the Lab option is selected)

Go to the previous lab

(available only if the Lab option is selected)

Go to the next panel

(available only if the Panel option is selected)

Go to the previous panel

(available only if the Panel option is selected)

Clicking any of the navigation buttons will:

• Close the current Data Entry dialog box.

• Open the Data Entry dialog box for the next or previous item.

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Single Test Point Data Entry

Use the Single Test Point Data Entry dialog box to enter individual data
points. If using SPC rules, the data is evaluated against the SPC rules.

Single Test Point Data Entry Grid

The point data entry grid consists of rows and columns where manually
entered data and imported data appears.

2 3 4 5 6 7 8

1 Row number
UnityWeb™ numbers rows consecutively. If inserting or deleting a row of
data, the software renumbers the rows to maintain a consecutive order.
(UnityWeb™ does not number runs within a day.)

2 Date & Time

Date and time the data was manually entered. The testing date and time
appears for imported data.

3 Level (1, 2, 3)
The fields where the QC values are typed when manually entering data.
Values for imported data also appear in these fields.

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4 Y/N
If using SPC rules, this column indicates if the data point was accepted
(Y) or rejected (N) according to the active rule(s). UnityWeb™
automatically rejects a row of data if a data point within the row violates
a SPC rule with a status of reject. Users with the Edit data permission
can manually change the accept/reject status of a data point. See “Data
Permissions” on page 103 for more information.

5 Rules
Shows any active SPC rules the data point violated. If using multiple
rules, UnityWeb™ only shows the most serious rule violation. See “SPC
Rules Precedence When Showing Rule Violations” on page 149 for
more information.

6 z
The z-score indicates the number of standard deviations between a
result and the expected mean. The z-score calculation begins after the
specified number of points, before rule evaluation begins, are entered.
See “Select Test Settings” on page 129 for more information.

7 OP
For manual data entry, this column shows the initials of the user logged
into the software at the time data was entered. For imported data, this
column shows the initials defined in the import file, if any. If initials are
not defined in the import file, this column shows the initials defined in
the Operator Setup. If initials are not defined in the Operator Setup, this
column shows two asterisks (**). See “Operator Setup” on page 198 for
more information about Operator Setup.

8 Group
Group designation, if specified.

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Fixed Statistics
The fixed mean and/or fixed SD appear below the Summary Statistics. If fixed
statistics are not specified, the evaluation mean and SD fields are blank. Click
the Information link to view the evaluation mean and SD after the specified
number of points have been entered. Each level within a control material can
have different combinations of fixed and floating statistics.

A fixed mean and fixed SD can be specified independently. There are four
combinations as follows:

• Floating Mean/Floating SD (page 174)

• Floating Mean/Fixed SD (page 175)
• Fixed Mean/Fixed SD (page 175)
• Fixed Mean/Floating SD (page 175)

Important Facts
• The evaluation mean and SD appear for each control level.
• If either statistic is floating, rule evaluation begins after the specified
number of points have been entered.
• SPC rule evaluation begins with the first data point if both statistics are
fixed.

Floating Mean/Floating SD
The following figure illustrates information for a data point without a fixed mean
or fixed SD specified.

Floating
Floating SD
mean

• Rule evaluation begins after entering the specified number of points.

• The fixed mean/SD areas are blank because fixed statistics have not been
specified.

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Floating Mean/Fixed SD
The following figure illustrates information for a Level 1 data point with a floating
mean and fixed SD. Rule evaluation begins after the specified number of points
are entered.

Floating
Fixed SD
mean

Fixed Mean/Fixed SD
The following figure illustrates information for a Level 1 and Level 2 data point
with a fixed mean and fixed SD. Rule evaluation begins with the first data point
entered after defining the fixed mean and SD.

Fixed mean Fixed SD

Fixed Mean/Floating SD
The following figure illustrates information for a Level 1 data point with a fixed
mean and a floating SD. Rule evaluation begins after the specified number of
points are entered.

Fixed mean Floating SD

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Enter Single Test Point Data

1 Click the Data Entry tab.
2 Click Single Test Point Data Entry.
3 Select the lab number or panel name from the Lab or Panel list.
4 If using the Lab option, select the lot number from the Lot list.
5 Select the test from the Test list.
6 Click Set Date.
• Click any part of the date and type over to edit the date for the first
date of data entry, or
• Click the arrow located to the right of the date and select a date from
the calendar for the first date of data entry.
7 Click in the first Level field and type the value for the level.
8 Press the TAB or ENTER key on the keyboard to go to the next Level
field.
9 Repeat steps 7 and 8 as needed to enter data for all levels.
When pressing the TAB or ENTER key on the keyboard in the last level of
the row, UnityWeb™:
• Goes to the first field on the next row.
• Evaluates the data points against active SPC rules and indicates the
rule status (accept, warn, reject).
• Updates the Summary Statistics.
10 Continue entering data for the test.
11 Click Save after all data has been entered for the test.
12 Click the appropriate navigation button to continue entering data for other
labs, lots, and tests. Make sure to click Save before navigating to ensure
the data is saved.

Tip: See “Navigate the Single Test Data Entry Dialog Boxes” on page 171
for information about navigation buttons.

13 Repeat steps 7–9 to continue entering data for the test.

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Single Test Summary Data Entry

Entering single test summary data includes entering the mean, SD, and
number of points for each level for a calendar month. You can choose to enter
summary data if using quality control evaluation on an instrument or LIS for
daily quality control. Entering summary data allows participation in the Unity™
Interlaboratory Program.

Note: You can enter point and summary data for the same test. If doing so,
the Summary Statistics include both types of data.

• Data entered as summary data is not evaluated by SPC rules.

• Only the Bar Chart is available for summary data.

Note: If viewing a Levey-Jennings, Multi-LJ, or Youden Chart for a test with

only summary data, the chart displays but does not contain data points.

• The Set Date feature can be used for summary data. However, the date
does not increment by month, but instead increments by one day. See
“Use the Set Date Feature” on page 169 for more information.
• Comments are available for summary data.
• Actions are not available for summary data.

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Summary Data Entry Grid

The summary data entry grid consists of rows and columns where manually
entered data and imported data appears.

2 3

1 Row number
UnityWeb™ numbers rows consecutively. If inserting or deleting a row of
data, the software renumbers the rows to maintain a consecutive order.

2 Date & Time

Date and time the data was manually entered. The date assigned for
imported data is either the first or last day of the month depending on
how the Bio-Rad connectivity software is configured.

3 Mean, SD, Points per level

The fields where the values for the mean, SD, and number of points are
typed when manually entering data. Values for imported data also
appear in these fields.

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Enter Single Test Summary Data

1 Click the Data Entry tab.
2 Click Single Test Summary Data Entry.
3 Select the lab number or panel name from the Lab or Panel list.
4 If using the Lab option, select the lot number from the Lot list.
5 Select the test from the Test list.
6 Click Set Date.
• Click any part of the date and type over to edit the date for the first
date of data entry, or
• Click the arrow located to the right of the date and select a date from
the calendar for the first date of data entry.
7 Click in the first Mean field and type the value for the mean.
8 Press the TAB or ENTER key on the keyboard to go to the SD field.
9 Type the value for the SD.
10 Press the TAB or ENTER key on the keyboard to go to the Points field.
11 Type the number of points.
12 Repeat steps 8–12 as needed to enter data for all levels.
13 Click Save.
14 Click the appropriate navigation button to continue entering data. Make
sure to click Save before navigating to ensure the data is saved.

Tip: See “Navigate the Single Test Data Entry Dialog Boxes” on page 171
for information about navigation buttons.

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Qualitative Data Entry

Note: Enter qualitative data manually or import it in the same way as
quantitative data.

UnityWeb™ provides the capability to enter qualitative and semi-quantitative

data. Submit data for Bio-Rad urinalysis controls to Bio-Rad for comparison in
the Unity™ Interlaboratory Program.

Note: The Urinalysis Report is optional. Contact your Bio-Rad QC Program

Representative to request this report.

Qualitative data entry is available for the following Bio-Rad controls:

• Autoimmune
• Qualitative Urine Toxicology
• Urinalysis

The software contains all valid results for qualitative and semi-quantitative tests.
When entering qualitative data, select the appropriate result from the list for
each level of control. Add actions and comments to any row of qualitative data.

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Enter Qualitative Data

Note: Qualitative data is not evaluated against SPC rules.

1 Click the Data Entry tab.

2 Click Single Test Point Data Entry.

Note: Qualitative data can only be entered on the Single Test Point Data
Entry dialog box.

3 Select the lab number or panel name from the Lab or Panel list.
4 If using the Lab option, select the lot number from the Lot list.
5 Select the test from the Test list.
6 Click the down arrow located to the right of Set Date and select a starting
date for data entry.

7 Select the result for the qualitative data from the appropriate Level list.

8 Repeat step 7 until all results are entered.

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9 Click Save.
10 Click the appropriate navigation button to continue entering data.

Tip: See “Navigate the Single Test Data Entry Dialog Boxes” on page 171
for information about navigation buttons.

TM
Send Qualitative Data to the Unity
Interlaboratory Program
Qualitative and semi-quantitative data, including urinalysis data, is transmitted
to the Unity™ Interlaboratory Program the same as quantitative data. Urinalysis
data is due at the same time as all other data for inclusion in the Unity™
Interlaboratory Program.

Note: The Urinalysis Report is optional. Contact your Bio-Rad QC Program

Representative to request this report.

See Chapter 15, “Send Data to the Unity™ Interlaboratory Program” for more
information about submitting data to Bio-Rad.

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Multi Test Data Entry

Multi Test data entry provides a convenient way to enter a day’s worth of data
for all tests in a lot. Use Multi Test data entry for point and summary data.

Multi Test Data Entry Information

The top section of the Multi Test Data Entry dialog box shows the following:

2 3
1

4 5

7
6

1 Lab number and laboratory description or panel

2 Control material name and lot number

3 Set Date
Click to use the Set Date feature. See “Use the Set Date Feature” on
page 169 for more information.

4 Level check boxes

By default, all levels set up in UnityWeb™ are selected and available for
data entry. To remove a level, clear the appropriate Level check box.

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5 Display check boxes

Note: Make sure the Reagent check box is selected to view VITROS® slide
generation numbers.

Select or clear the check boxes to customize the information appearing

on the data entry grid. Available options are:
• Method
• Instrument
• Reagent
• Unit
• Temperature

Note: The Analyte option is selected by default and cannot be cleared.

6 Enter by options:
• Row
Use the Row option to enter data for all levels for a single test (left
to right).

• Level
Use the Level option to enter data for all tests by level (top to
bottom).

7 Show previous data rows.

Type a number for the previous rows of data to show in the data entry
grid. This is helpful for visually comparing previous data with the current
data.

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Multi Test Data Entry Grid

The Multi Test data entry grid consists of rows and columns where manually
entered data and imported data appears.

Note: The illustration below shows an example of the Multi Test Point data
entry grid. Click the Multi Test Summary Data Entry to enter summary
data.

1 2

1 Entered Date
Date and time the data was manually entered. The testing date and time
appears for imported data.

2 Level (1, 2, 3)
The fields where the QC values are typed when manually entering data.
Values for imported data also appear in these fields.

3 Test information
The information appearing depends on the Display options selected.
See “Display check boxes” on page 184 for more information.

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Enter Multi Test Data

1 Click the Data Entry tab.
2 Click Multi Test Point Data Entry or Multi Test Summary Data Entry.
3 Select the lab number or panel name from the Lab or Panel list.
4 If using the Lab option, select the lot number from the Lot list.
5 Click Set Date and click the calendar icon located to the right of the date
and select the date to use for the first date of data entry.

6 Select test entry configurations:

• Level
• Display
• Enter by
• Show number of rows of previous data
7 Enter data.
8 Click Save.

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11
Manage Data

In This Chapter
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187
Edit Data, Date, and Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189
Change a Data Point's Accepted/Rejected Status . . . . . . . . . . . . . . . . . . . 192
Insert Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 194
Delete Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 196
Operator Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 198

Overview

Change Data
Occasionally, edits to previously entered or imported data may need to be
made. In UnityWeb™ it is possible to edit data. However, when edits are made,
the software does not re-evaluate the edited data against any statistical
process control (SPC) rules unless the edited data is on the last line of all data
entered. The following list summarizes the actions which can be performed:

• Edit a value
• Edit the date/time associated with a value
• Change the accepted or rejected status of a data point (point data entry
only)
• Insert a value
• Delete data
• Delete a range of data

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Data Entry Permissions

Data entry permissions determine the extent to which edits can be made to
existing data:

• Users with the Edit all data permission can change any value.
• Users with the Edit last line of data permission can change only the last
line of data.
• Users with the Enter new data only permission or View data only
permission cannot make any changes to existing data.

When edits are made to data, UnityWeb™ sends the edits to the Unity™
Interlaboratory Program the next time data is submitted.

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Edit Data, Date, and Time

Data results and the date-times associated with the results can be edited. If
editing point data, UnityWeb™ automatically adds a comment to the row stating
“Inserted data is not evaluated against QC rules.”

Note: This comment is not added for summary or qualitative data because
summary and qualitative data are not evaluated against SPC rules.

Unless using the Set Date feature, UnityWeb™ assigns manually entered data to
the current date and time based on the computer clock. The date and time can
be edited; however, data points must be in ascending date and time order. If an
edited date and time violates this requirement, UnityWeb™ displays a message
stating Invalid-date-range.

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Edit Data
1 Log in as a user with the Edit all data permission.
2 Click the Data Entry tab.
3 Click the appropriate data entry dialog box:
• Single Test Point Data Entry
• Single Test Summary Data Entry

Note: You cannot edit previously saved data from the Multi Test Point
Data Entry dialog box or the Multi Test Summary Data Entry dialog box.

4 Select the Lab or Panel option.

5 Select the lab number or panel name from the Lab list or Panel list.
6 If using the Lab option, select the lot from the Lot list.
7 Select the test from the Test list.
8 Click in the field of the data to be edited.
9 Highlight the existing data and type in the new data.

Note: For point data only, UnityWeb™ automatically adds a comment to the
row noting edited data is not evaluated against SPC rules. A green arrow
appears in the C column designating the comment has been added.

10 Click Save.

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Edit the Date and Time

1 Log in as a user with the Edit all data permission.
2 Click the Data Entry tab.
3 Click the appropriate Data Entry dialog box, depending on the data to edit:
• Single Test Point Data Entry
• Single Test Summary Data Entry

Note: You cannot edit previously saved data from the Multi Test Point
Data Entry dialog box or the Multi Test Summary Data Entry dialog box.

4 Select the Lab or Panel option.

5 Select the lab number or panel name from the Lab list or Panel list.
6 If using the Lab option, select the lot from the Lot list.
7 Select the test from the Test list.
8 To edit the date, click the part of the date to edit and type over the date:

9 To edit the time, click the part of the time to edit and type over the time:

10 Click Save.

Note: You can edit the date and time; however, data points must be in
ascending date and time order. If an edited date and time violates this
requirement, UnityWeb™ displays a message stating Invalid-date-range.

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Change a Data Point's

Accepted/Rejected Status
UnityWeb™ automatically accepts or rejects point data based on the active
statistical process control (SPC) rules. When data violates a SPC rule set to
reject, an N appears in the Y/N column.

Point accepted–Included in monthly and cumulative statistics. Will

be included in monthly submission statistics for Unity™
Interlaboratory Reports.

Point rejected–Not included in monthly or cumulative statistics. Will

not be included in monthly submission for Unity™ Interlaboratory
Reports.

Note: SPC rule evaluation is by run rather than level. If any data point in a
run violates a rejection rule, UnityWeb™ rejects the entire row of data.

If manually changing an N to a Y, UnityWeb™ updates the summary statistics.

Conversely, if manually changing a Y to an N, UnityWeb™ updates the summary
statistics to exclude the value.

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Change the Accepted/Rejected Status

Note: Only point data is evaluated by SPC rules. Summary and qualitative
data screens do not have a Y/N column.

1 Log in as a user with the Edit all data permission.

2 Click the Data Entry tab.
3 Click Single Test Point Data Entry.
4 Select the Lab or Panel option.
5 Select the lab number or panel name from the Lab list or Panel list.
6 If using the Lab option, select the lot from the Lot list.
7 Select the test from the Test list.
8 Click the arrow located to the right of the Y or N and change the status.
9 Click Save.

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Insert Data
A row of data can be inserted between existing rows of point data, summary
data, and qualitative data.

Note the following when inserting data:

• Only one row of data can be inserted at a time.

• Inserted point data is not evaluated against statistical process control
(SPC) rules. UnityWeb™ automatically adds a comment noting inserted
data is not evaluated against SPC rules. A green arrow appears in the C
column designating the comment has been added.
• UnityWeb™ inserts the row above the selected row and assigns the row
the same date and time. You can edit the date and time; however, data
points must be in ascending date and time order. If an edited date and
time violates this requirement, UnityWeb™ displays a message stating
Invalid-date-range.

Insert a Data Row

1 Log in as a user with the Edit all data permission.
2 Click the Data Entry tab.
3 Click the appropriate Data Entry dialog box:
• Single Test Point Data Entry
• Single Test Summary Data Entry
4 Select the Lab or Panel option.
5 Select the lab number or panel name from the Lab list or Panel list.
6 If using the Lab option, select the lot from the Lot list.
7 Select the test from the Test list.
8 Click (plus sign) or the Insert link located to the right of the row to be
inserted.
A new row appears.
9 If necessary, edit the date and time of the row maintaining the sequential
date and time order.

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10 Type the data for the new row.

Note: For point data only, UnityWeb™ automatically adds a comment to the
row noting inserted data is not evaluated against SPC rules. A green arrow
appears in the C column designating the comment has been added.

11 Click Save.

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Delete Data
UnityWeb™ provides two ways to delete data:

• By row in the Data Entry dialog box (page 196)

• A range of data (page 197)

Delete a Row of Data from the Data Entry dialog

box
1 Log in as a user with the Edit all data permission.
2 Click the Data Entry tab.
3 Click the appropriate Data Entry dialog box:
• Single Test Point Data Entry
• Single Test Summary Data Entry
4 Select the Lab or Panel option.
5 Select the lab number or panel name from the Lab list or Panel list.
6 If using the Lab option, select the lot from the Lot list.
7 Select the test from the Test list.
8 Click or the Delete link located to the right of the row to be deleted.
A message appears asking for confirmation of the deletion.
9 Click OK.
10 Click Save.

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Delete a Range of Data

Important: Deleting a range of data permanently deletes the data from the
software. Deleted data cannot be retrieved. Bio-Rad recommends exporting
the data to another file before deleting it. See “Export Data” on page 87 for
more information.

1 Log in as a user with the Edit all data permission.

2 Click the Tools tab.
3 Click Utilities.
4 Click Delete Range of Data.
5 Click the arrow located to the right of the From date and select a
beginning date for the range of data to be deleted.

6 Click the arrow located to the right of the To date and select an ending
date for the range of data to be deleted.
7 Select a lab from the Lab number list or select All to delete all data from
UnityWeb™ for the date range selected.
8 Select a lot from the Lot number list or select All.
9 Select a test from the Test list or select All.
10 Click OK.
A message appears asking for confirmation of the deletion.
11 Click OK.

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Operator Setup
UnityWeb™ allows the specification of operator initials for imported data.
UnityWeb™ uses the following cascade when importing data to determine the
initials to appear in the OP column of the Data Entry dialog box:

• UnityWeb™ places initials contained in the import file in the OP column.

• UnityWeb™ uses any initials defined in Operator Setup if the import file
does not contain initials.
• UnityWeb™ places two asterisks in the OP column, indicating the operator
is unknown, when the import file does not contain any initials nor are
initials defined in Operator Setup.

Click the Tools tab, click Utilities, and then click Operator Setup to open the
Operator Setup dialog box. From the dialog box the following options are
available:

• Choose how to assign operator initials; All data, Labs and Lots, or
Instrument.
• Specify the number of work Shifts (from one to eight) in use in your lab.

Important: Set the number of Shifts before making other selections. The
numbers in the Shift column list will be limited to this number.

• Make selections from the lists to assign Operator initials.

(Different columns appear depending on your choice of how to define
operator initials.)

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Operator Setup Shifts

The default setting is one; however, you can define up to eight shifts per day
and assign a different operator to each shift. The setting for shifts is global and
applies to all tests in the database.

UnityWeb™ divides the 24-hour day evenly among the number of shifts set.

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 CHAPTER
12
Review and Annotate
Data

In This Chapter
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201
Bench Review. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202
InstantQC™ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 208
Actions and Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 209
Require Audit Trail Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 222

Overview
UnityWeb™ provides features to simplify documentation of QC review:

• Bench Review (page 202)

• InstantQC™ (page 208)
• Actions and Comments (page 209)
• Audit Trail Comments (page 222)

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Bench Review
Regulatory agencies frequently require the documentation of QC data review.
The Bench Review simplifies this process and provides an electronic trail of the
review:

• Bench Review
The laboratory personnel performing the testing reviews QC results before
verifying patient results.

Using Bench Review, data points violating a statistical process control (SPC)
rule with a status of “reject” are highlighted in red and data points violating a
SPC rule with a status of “warn” are highlighted in yellow. The following
warning appears if any data point violates an active SPC rule.

In addition, the Bench Review sends data to Bio-Rad for inclusion in

InstantQC™ Reports and Charts on [Link] for prospective data
review.

Note: By default, data transmission from the Bench Review for InstantQC™
Reports and Charts is activated. See “Activate Transmission for InstantQC™”
on page 260 for more information.

UnityWeb™ documents the Bench Review using the Data Review Report which
you can print or save to a file. See “Data Review Report” on page 245 for more
information.

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Perform Bench Review

Note: Bench Review is restricted to users with the Bench Review

permission. See “User Permissions” on page 100 for more information.

The major steps of Bench review are:

• Select a data set (page 204).

• Review the data (page 205).
• Indicate review of all data points or individual data points (page 202).
• Save the review and, optionally, send data to the Unity™ Interlaboratory
Program for inclusion in InstantQC™ Reports and Charts on
[Link] (page 207).

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Select a Data Set

Note: Create Bench Review by lab number or by panel. Set up a panel

before selecting a data set for the panel. See “Create a Panel and Add
Tests” on page 142 for more information.

1 Log in as a user with the Bench review permission.

2 Click the Review tab.
3 Click Bench Review.
4 Select the Lab or Panel option.
5 Select the option for the data to review:
• All data
By default, the All data option is selected. The Bench Review shows
all data, regardless if the data violated any active SPC rules.
• Suspect data
The Bench Review shows only rejected data points and data points
violating an active (reject or warn) SPC rule.

Note: Click the appropriate option to switch between All data and Suspect
data.

6 Select a lab number from the Lab number list or select All.
7 Select a lot number from the Lot number list or select All.

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8 Select an instrument from the Instrument list or select All.

• UnityWeb™ shows the data in the selected data set and includes any
items selected in the Show Columns dialog box (value, evaluation
mean, evaluation standard deviation (SD), and/or any attached
actions and comments). See “Manage Columns” below for more
information.
• Data violating a SPC rule with a status of reject is highlighted in red.
• Data violating a SPC rule with a status of warn is highlighted in yellow.
• Data not violating a SPC rule but within the same run as a data point
violating a SPC rule with a status of reject or warn is highlighted in
white.
• Non-suspect data or accepted runs are is highlighted in white.
9 Continue with the next section, “Review Data.”

Review Data
1 Click located to the left of a test to view a Levey-Jennings Chart for
the test.
2 Click located to the left of a test to open the Data Entry dialog box
for the test.
• Change Y/N
• Add a comment or action
3 Close the Levey-Jennings Chart or Data Entry dialog box to return to the
data review.

Manage Columns
Customize the data shown on the Bench Review.

1 On the Bench Review dialog box, click Manage Columns.

2 On the Show Columns dialog box, select a check box to display the
corresponding column in the Bench Review, or clear a check box to hide
the column.
3 Click OK.

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Document the Review

Document the review according to the All data option.

All Data Option

1 Select the All data option:
• Click Review Current Page to indicate review of all data points on
the page.
• Click the individual Reviewed check box located to the left of the test
to indicate review of the data in the row.
2 Click Save or Save and Transmit depending on the transmission option
selected for InstantQC™. See “Save and Transmit” on page 207 for more
information.
3 Repeat steps 1 and 2 until all data on each page has been reviewed.

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Save and Transmit

When each page of the Bench Review is complete, click Save or Save and
Transmit. The Data review transmission check box selection in the Setup
dialog box (on page 85) determines which button appears. By default, the Data
review transmission check box is selected.

• If the check box is selected, the Save and Transmit button appears and
data is saved to the Data Review Report and sent to the Unity™
Interlaboratory Program for inclusion in InstantQC™ Reports and Charts on
[Link].
• If the check box is cleared, the Save button appears and data is saved to
the Data Review Report but is not sent to the Unity™ Interlaboratory
Program for inclusion in InstantQC™ Reports and Charts on
[Link].

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InstantQC TM

Utilize InstantQC™ Reports and Charts to compare your results to the results of
other laboratories at any time, without any applicable deadlines for data
submission. Accessed from [Link], InstantQC™ Reports and Charts
provide easy access to peer group comparison statistics.

Due to the rapid report turnaround times, InstantQC™ is particularly useful for
troubleshooting problems with test system performance as they occur. Clicking
Save and Transmit sends Bench Review data to the Unity™ Interlaboratory
Program. The reviewed data points appear on InstantQC™ Reports and Charts
on [Link] after a short processing time.

Note: See “InstantQC™ Reports and Charts” on page 293 for more
information.

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Actions and Comments

UnityWeb™ provides features to simplify documentation of QC review:

• Actions (page 209)

• Comments (page 216)
• Actions and comments by instrument (page 218)
• Audit Trail Comments (page 222)

Actions
UnityWeb™ includes a library of commonly used actions. These pre-defined
messages help standardize the documentation of the steps taken to correct an
error situation. Customize actions for optimal use in your laboratory.

The symbol next to an action in the Action(s) list indicates the action is in
use. You cannot edit or delete used actions. Therefore, Bio-Rad recommends
reviewing the list of pre-defined actions prior to use. See “Action Log
Messages” on page 349 for more information.

If using actions, the actions appear in the following:

• Bench Review
• Data Entry dialog boxes
• Point Data Report
• Data Review Report
• Supervisor Report
• Levey-Jennings Chart

Note: The Levey-Jennings Chart must be configured to show actions. See

“Select Levey-Jennings Chart Options” on page 231 for more information.

View Actions
If an action is added to a row of data in any of the Data Entry dialog boxes, a
green arrow appears to the right of the A in the A Column: . Position the
mouse over the to view the comment.

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Configure Actions

Add a Custom Action

Note: Only a user with the Edit action log permission can add a new
custom action to the Action Log. Bio-Rad recommends limiting the number
of users with the Edit action log permission. This prevents an abundance
of non-standard actions which is important when reviewing reports and the
Levey-Jennings Chart.

1 Click the Tools tab.

2 Click Utilities.
3 Click Configure Action Logs.
4 Clear the existing text and type the text for the custom action in the
Action(s) box.
5 Click Add.
The action is added in alphabetical order. The software assigns a code
number to the action based on the next available number.

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Edit an Action

Note: Only a user with the Edit action log permission can edit an action. A
symbol next to an action in the Action(s) list indicates the action is in
use and cannot be edited.

1 Click the Tools tab.

2 Click Utilities.
3 Click Configure Action Logs.
4 Select the action to edit in the Action(s) list.
5 Edit the text in the Action(s) field.
6 Click Update.
The edited action appears in the Action(s) list.

Delete an Action

Note: Only a user with the Edit action log permission can delete an action.
A symbol next to an action in the Action(s) list indicates the action is
in use and cannot be deleted.

1 Click the Tools tab.

2 Click Utilities.
3 Click Configure Action Logs.
4 Select the action to delete in the Action(s) list.
5 Click Delete.
The edited action is removed from the Action(s) list.

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Add, Edit, and Delete Actions in the Data Entry Dialog

Boxes

Add an Existing Action to a Row of Data

1 Click in the A column of the row in the Data Entry dialog box to add the
action.
The Action dialog box appears.

Note: Make sure the Edit check box is selected if nothing occurs when
clicking A.

2 Locate the action to add in the Action(s) list and click to apply the
action.
The selected action appears in the Existing Action dialog box.

Tip: If necessary, click the page numbers to page through the Action(s) list.

3 Click OK.
The action is added to the row of data.
4 Click Save.

Add a New Action to a Row of Data

Note: Only a user with the Edit action log permission can add a new
action to a row of data.

1 Click in the A column of the row in the Data Entry dialog box to add the
action.
The Action dialog box appears.

Note: Make sure the Edit check box is selected if nothing occurs when
clicking A.

2 Click .

Tip: Regardless of where in the list you add an action, the software arranges
actions in alphabetical order.

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3 Type the text for the new action.

4 Click .
A message appears asking for confirmation.
5 Click OK.
6 Select the action to add in the Action(s) list and click to apply the
action.

Tip: If necessary, click the page numbers to page through the Action(s) list.

7 Click OK.
The action is added to the row of data.
The action is added in alphabetical order in the Action(s) list. The
software assigns a code number to the action based on the next available
number.

Edit the Action List from the Data Entry Dialog Box

Note: Only a user with the Edit action log permission can edit an action in
a row of data.

1 Click in the A column of the row in the Data Entry dialog box to edit the
action.

Note: The symbol next to an action indicates the action is in use. You
cannot edit used actions.

The Action dialog box appears.

Note: Make sure the Edit check box is selected if nothing occurs when
clicking A.

2 Select the action to edit in the Action(s) list.

Tip: If necessary, click the page numbers to page through the Action(s) list.

3 Click .
4 Edit the text for the action.

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5 Click .
A message appears asking for confirmation.
6 Click OK.

Delete an Action from the Action List from the Data Entry Dialog
Box

Note: Only a user with the Edit action log permission can delete an action
from a row of data.

1 Click in the A column of any data entry row in the Data Entry dialog box.

Note: The symbol next to an action indicates the action is in use. You
cannot delete used actions.

The Action dialog box appears.

Note: Make sure the Edit check box is selected if nothing occurs when
clicking A.

2 Select the action to delete in the Action(s) list.

Tip: If necessary, click the page numbers to page through the Action(s) list.

3 Click .
A message appears asking for confirmation.
4 Click OK.

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Automatic Action Logs

Note: Automatic action logs are only available for manually entered point
data.

Use Automatic Action Logs to require the addition of an action whenever a

user enters a data point violating a SPC rule set to reject.

Set Up Automatic Action Logs

Note: Only a user with the Edit setup options permission can set up
automatic action logs.

1 Click the Tools tab.

2 Click Setup.
3 Click the Configure UnityWeb™ tab.
4 Select the Automatic action logs check box in the Actions/comments
section.
5 Select the Require action logs check box.
6 Click Save.

Turn Off Automatic Action Logs

Note: Only a user with the Edit setup options permission can turn off
automatic action logs.

1 Click the Tools tab.

2 Click Setup.
3 Click the Configure UnityWeb™ tab.
4 Clear the Automatic action logs check box in the Actions/comments
section.
5 Click Save.

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Comments
A comment is text added to a data point for documentation purposes. Adding
a comment is an easy way to detail events or actions in the laboratory that
effect quality control data.

Using comments together with actions provides a good method for

documenting changes in the test system or steps taken in response to a rule
violation. For example, when performing corrective maintenance, add a
comment to the “Maintenance: corrective” action to describe the specific
maintenance performed.

When added, comments appear in the following locations:

• Bench Review
• Data Entry dialog boxes
• Point Data Report
• Data Review Report
• Supervisor Report

Note: Once a comment is added, it cannot be deleted.

View Comments
If a comment is added to a row of data in any of the Data Entry dialog boxes,
a green arrow appears to the right of the C in the C column: .
Position the mouse over the to view the comment.

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Add a Comment to a Row of Data

1 Click in the C column of the row in the Data Entry dialog box to add the
comment.

Note: Existing comments for the row appear in the Existing Comment list.

The Comment dialog box appears.

Note: The symbol next to an action indicates the action is in use. You
cannot delete used actions.

2 Type the comment in the New comment field and click OK.
3 Click Save.

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Actions and Comments by Instrument

Simplify the documentation process by adding an action or comment one time
and applying it to all tests performed on an instrument.

Tip: This is a time saver for documenting actions such as instrument

maintenance and calibration which apply to all tests performed on an
instrument.

Actions and comments by instrument can be applied to:

• Instrument
Applies the action/comment to all tests (including all lab and lot numbers)
performed on the instrument regardless of how many instruments of the
same model are in the laboratory.

• Lab number
Applies the action/comment to all tests performed on the selected
instrument/lab number combination.

• Lot number
Applies the action/comment to all tests performed in the selected
instrument/lab number/lot number combination.

Note: If there is not any data within the selected date-range and scope, the
software inserts a blank data row and adds the actions/comments to the
blank row.

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Add an Action by Instrument

1 Click the Tools tab.
2 Click Utilities.
3 Click Action/Comment by Instrument.
4 Select the Action check box.
5 Click Add.
6 Select the action to add to the instrument in the Action(s) list.
7 Repeat step 6 to add another action.
8 Click Apply.
9 Click Close.
10 Click the up or down arrows located to the right of the Start date to select
a beginning date for the action.
11 Click the up or down arrows located to the right of the End date to select
an ending date for the action.
12 Select the instrument, lab number, or lot number in the Scope tree.
• Click + (plus sign) to the left of the instrument to view the labs.
• Click + (plus sign) to the left of the lab number to view the lots.
13 Click Save.

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Add a Comment by Instrument

1 Click the Tools tab.
2 Click Utilities.
3 Click Action/Comment by Instrument.
4 Select the Comment check box.
5 Click in the comment box and type the comment.
6 Click the up or down arrows located to the right of the Start date to select
a beginning date for the comment.
7 Click the up or down arrows located to the right of the End date to select
an ending date for the comment.
8 Select the instrument, lab number, or lot number in the Scope tree.
• Click + (plus sign) to the left of the instrument to view the labs.
• Click + (plus sign) to the left of the lab number to view the lots.
9 Click Save.

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Add an Action and Comment by Instrument

1 Click the Tools tab.
2 Click Utilities.
3 Click Action/Comment by Instrument.
4 Select the Action check box.
5 Click Add to open the Action(s) dialog box.
6 Select the action to add in the Action(s) list.
7 Click Apply.
8 Click Close.
9 Select the Comment check box.
10 Click in the comment box and type the comment.
11 Click the up or down arrows located to the right of the Start date to select
a beginning date for the action and comment.
12 Click the up or down arrows located to the right of the End date to select
an ending date for the action and comment.
13 Select the instrument, lab number, or lot number in the Scope tree.
• Click + (plus sign) to the left of the instrument to view the labs.
• Click + (plus sign) to the left of the lab number to view the lots.
14 Click Save.

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Require Audit Trail Comments

The Audit Trail keeps track of events that can change how data points are
evaluated. Audit Trail Events are automatically applied by the software. For
example, the software applies the Data inserted Audit Trail Event when
inserting a row of data. UnityWeb™ includes a library of Audit Trail Events. See
“Audit Trail Events” on page 351 for more information.

Configure the software to require the addition of a comment whenever the

software applies an Audit Trail Event.

Require Audit Trail Comments

Note: Only a user with the Edit setup options permission can require audit
trail comments.

1 Click the Tools tab.

2 Click Setup.
3 Click the Configure UnityWeb™ tab.
4 Select the Require audit trail comments check box in the
Actions/comments section.
5 Click Save.

Turn Off the Require Audit Trail Comments Feature

Note: Only a user with the Edit setup options permission can turn off
require audit trail comments.

1 Click the Tools tab.

2 Click Setup.
3 Click the Configure UnityWeb™ tab.
4 Clear the Require audit trail comments check box in the
Actions/comments section.
5 Click Save.

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13
UnityWeb Charts
TM

In This Chapter
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 223
General Chart Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 224
Save and Print Charts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 228
Levey-Jennings Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 230
Multi-LJ Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 235
Bar Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 236
Youden Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 238

Overview
UnityWeb™ provides a variety of charts for investigating, troubleshooting, and
documenting review of suspect data. The following charts are available:

• Levey-Jennings Chart (page 230)

• Multi-LJ Chart (page 235)
• Bar Chart (page 236)
• Youden Chart (page 238)

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General Chart Options

There are a variety of options available for customizing charts. Some options
apply to all charts and some options apply only to specific charts.

For information about options that apply to specific charts, see the section for
the specific chart:

• Levey-Jennings Chart options (page 231)

• Bar Chart options (page 236)
• Youden Chart options (page 238)

Fill background
Fill background for the ±1SD, ±2SD, and ±3SD ranges apply to all charts.

Important: UnityWeb™ shows data points violating a statistical process

control (SPC) rule with a status of “warning” in orange and data points
violating a SPC rule with a status of “reject” in red. Therefore, Bio-Rad
recommends not using orange or red for fill colors as it could make these
data points difficult to see.

Select Fill Background

1 Click the Charts tab.
2 Click Options.
3 Click General.
4 Select the Show background check box.
5 Click (ellipsis button) for the SD Fill and select the background color
from the palette.
6 Repeat step 5 for each SD Fill color.
7 Click Save.

Note: Click Default to return to the default settings.

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Grid Lines and Color

The grid lines designate ±1SD, ±2SD, and± 3SD above and below the mean
and apply to the following charts:

• Levey-Jennings Chart
• Multi-LJ Chart
• Youden Chart

Note: You can edit the grid line dash style and color.

Edit Grid Lines and Color

1 Click the Charts tab.
2 Click Options.
3 Click General.
4 Select the SD grid line dash style from the list.
5 Click (ellipsis button) for the SD grid line color and select the color
from the palette.
6 Repeat steps 4 and 5 to change each SD grid line dash style and SD
grid line color.
7 Click Save.

Note: Click Default to return to the default settings.

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Chart Header Options

Customize chart headers to contain specific information. The selections apply
to all charts.

Note: Header options are for customization only. Regardless of the options
selected, the size of the header is always the same.

Example of a Chart Header

Levey-Jennings Chart for SPC Rules Period: 04/26/2007 – 06/25/2007
Lab: 99999, Your Lab Name, Lab Contact, Lab Department
Lot: 14130, Assayed Chemistry, Serum, Bio-Rad, 03/31/2008
Potassium, ISE indirect, Beckman Coulter LX 20, Dedicated Reagent, mmol/L, No Temperature
Cum Mean/SD: [1] 2.04/0.07, [2] 3.78/0.06, Fixed Mean/SD: [1] 2.00/0.10, [2] 3.80/0.10
Graph against: Your laboratory, Current lab number, Evaluation Mean/SD
19. Maintenance: semi-annual

Available header options

• Lab number • Unit

• Lab name • Temperature name

• Contact • Lot number

• Department • Lot name

• Analyte name • Lot expiration date

• Method name • Product manufacturer

• Instrument name • Matrix

• Reagent name • Print date

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Select Chart Header Options

1 Click the Charts tab.
2 Click Options.
3 Click Header.
4 Select the check box for each item to appear in the chart header.
5 Clear the check box to omit an item from the chart header.
6 Click Save.

Note: The software applies the selection(s) to all charts. Click Default to
return to the default settings.

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Save and Print Charts

1 Click Save/Print after creating the chart.
2 Select the range of data for the chart from the Range list.

Note: The Range list is not available for the Multi-LJ Chart.

The range of available data for the chart depends on the Lab or Panel
option when the chart was created.

• Lab options – Current Test

– Current Lot
– Current Lab
– All Data

• Panel options – Current Panel

– All Data

3 Select the Print background color check box to print the chart
background as it appears on the screen.

Tip: To conserve toner when printing charts, clear the Print background
color check box.

4 Click OK.
The chart opens in a separate window in PDF format.

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5 Click the appropriate icon to print or save the chart.

Click to print

Click to save

Note: Depending on the version of Adobe® Reader® installed on your

computer, the icons may look slightly different.

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Levey-Jennings Chart
UnityWeb™ uses fixed statistics, if defined. Otherwise, the software uses
cumulative statistics.

Note: The Levey-Jennings Chart plots laboratory data points for a specified
time period against the fixed or cumulative (floating) mean ±3SD range of a
user defined data set.

How to Use the Levey-Jennings Chart

Using statistics to evaluate QC values assumes new control measurements
have a similar distribution to past measurements while the system is stable and
the distribution of values is Gaussian (normal).

Using these assumptions, 95.5% of values should be within ±2SD of the mean
and 99.7% of values should be within ±3SD of the mean. A value outside
±3SD of the mean would be expected only 0.3% of the time when the system
is stable.

The Levey-Jennings Chart is helpful to visually identify these data points as well
as shifts (sudden changes) and trends (gradual changes) in laboratory data.

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Select Levey-Jennings Chart Options

Note: The options selected for a Levey-Jennings Chart also apply to the
Multi-LJ Chart.

1 Click the Charts tab.

2 Click Options.
3 Click Levey-Jennings.
4 Select the Days on charts option.
• The default is 60 days.
• Select a number from 1 to 90.
5 Select the X-axis type:
• Date
The X-axis shows a vertical column for each day. Each data point
collected during that day appears in this column so the individual data
points appear to be stacked.
Selecting the Include point representing mean of data points for
the day check box adds a large point representing the daily mean
and shows the individual data points as smaller points.
• Sequence
Each data point appears in its own column.

Note: Selecting the Sequence option makes the Include point

representing mean of data points for the day check box unavailable.

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6 Select the Action check box to include an action (if any) in the
Levey-Jennings Chart header. The action number and description appear
in the chart header and at the top of the chart corresponding to the date
of the action.

Action number and

description

7 Each control level has a default symbol to represent the level’s data. To
change the default symbol, select a Symbol for each Level point from
the list.

Tip: The different symbols help visually distinguish the levels when printing in
black and white. An arrow represents data points that are off the scale,
regardless of the level symbol selected.

8 Select the Size for each Symbol.

• The default is 6.
• Select a size from 1 to 10 (pixels).
9 Select the Fill check box to select a fill color for each level symbol.

Tip: The different colors help visually distinguish the levels when viewing the
chart on a color monitor.

10 Click (ellipsis button) for the fill and select the background color from
the palette.

Important: UnityWeb™ shows data points violating a statistical process

control (SPC) rule with a status of “warning” in orange and data points
violating a rule with a status of “reject” in red. Therefore, Bio-Rad
recommends not using orange or red for fill colors as it could make these
data points difficult to see.

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11 Select the Connect line check box to draw a line connecting the data
points on the chart.
12 Repeat steps 7 through 11 as needed for each level.

Note: The line connects the mean of the points for the day and only appears
if the Include point representing mean of data points for the day
check box is selected.

13 Click Save.

Note: Click Default to return to the default settings.

Levey-Jennings Chart Legend

Note: The Levey-Jennings Chart legend also applies to the Multi-LJ Chart.

The Levey-Jennings Chart contains an optional legend with the symbol and
color for each level of control. Select an option to display the legend at the top
or bottom of the chart. By default, the legend appears above the chart.

1 Click the Charts tab.

2 Click Options.
3 Click General.
4 Select the Show legend check box.
5 Select the option for where the legend will appear on the chart:
• Display on top
• Display on bottom
6 Click Save.

Note: Click Default to return to the default settings.

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Other Options
There are other options that apply to the Levey-Jennings Chart. See the
following sections for more information:

• “Fill background” (page 224)

• “Grid Lines and Color” (page 225)
• “Chart Header Options” (page 226)

Create a Levey-Jennings Chart

1 Click the Charts tab.
2 Click Levey-Jennings.
3 Select the Lab or Panel option.
4 Select the lab number or panel name from the Lab or Panel list
depending on the option selected in step 3.
5 If using the Lab option, select the lot from the Lot list.
6 Select the test from the Test list.
7 Click the arrow located to the right of the From (date) and select a
beginning date for the data on the chart.
8 Click the arrow located to the right of the To (date) and select an ending
date for the data on the chart.
9 By default, the Overlay levels check box is selected. Clear the Overlay
levels check box to view each level on a separate chart.
10 By default, all levels are selected for the chart. To remove a level, clear the
appropriate Level check box.
11 To save or print the chart, see “Save and Print Charts” on page 228.

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Multi-LJ Chart
The Multi-LJ Chart provides an easy way to compare tests, such as the same
analyte run on two different instruments or on two different lot numbers of
control material. The Multi-LJ Chart shows a Levey-Jennings Chart for up to 18
tests.

Select Multi-LJ Chart Options

Note: The options selected for a Levey-Jennings Chart also apply to the
Multi-LJ Chart. See “Select Levey-Jennings Chart Options” on page 231 for
more information.

Create a Multi-LJ Chart

1 Click the Charts tab.
2 Click Multi-LJ.
3 Click the Lab or Panel tab.
4 In the Lab or Panel navigation tree, select up to 18 tests to display on the
chart.
• Click + (plus sign) to the left of the lab number to view the lots.
• Click + (plus sign) to the left of the lot number to view the tests.
5 Click Plot.
6 By default, all levels set up in UnityWeb™ are selected for the chart. To
remove a level, clear the appropriate Level check box.
7 To change the arrangement of the individual charts:
• Click to view the charts in a single column.

• Click to view the charts in two columns.

8 To save or print the chart, see “Save and Print Charts” on page 228.

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Bar Chart
The Bar Chart shows the laboratory mean for 13 months plotted against one of
the following:

• Cumulative mean (if no fixed mean is specified)

The Bar Chart is overlaid onto the cumulative mean ±3SD range. The
cumulative mean determines the scale of the Y-axis (mean ±3SD).
• Fixed mean (if a fixed mean is specified)
The Bar Chart is overlaid onto the fixed mean ±3SD range specified for the
test. The fixed mean determines the scale of the Y-axis (mean ±3SD).

The Bar Chart also shows the SD, CV, and number of points for each monthly
mean.

Tip: The Bar Chart plots monthly means against a ±3SD range. Therefore,
the Bar Chart is helpful to visualize long-term shifts and trends.

Select Bar Chart Options

1 Click the Charts tab.
2 Click Options.
3 Click Bar.
4 Select the Months on charts option.
• The default is 13 months.
• Select a number from 1 to 13.
5 Click (ellipsis button) for the Level Fill and select a color from the
palette.
6 Repeat step 5 for each level.
7 Click Save.

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Other Options
There are other options that apply to the Bar Chart. See the following sections
for more information:

• “Fill background” (page 224)

• “Chart Header Options” (page 226)

Create a Bar Chart

Note: Create a Bar Chart by lab number or by panel. Set up a panel before
creating a chart for the panel. See “Create a Panel and Add Tests” on
page 142 for more information.

1 Click the Charts tab.

2 Click Bar.
3 Select the Lab or Panel option.
4 Select the lab number or panel name from the Lab or Panel list,
depending on the option selected in step 3.
5 If using the Lab option, select the lot from the Lot list.
6 Select a test for the chart from the Test list.
7 Click the arrow located to the right of the From (date) and select a
beginning date for the data on the chart.
8 Click the arrow located to the right of the To (date) and select an ending
date for the data on the chart.
9 By default, all levels set up in UnityWeb™ are selected for the chart. To
remove a level, clear the appropriate Level check box.
10 To save or print the chart, see “Save and Print Charts” on page 228.

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Youden Chart
The Youden Chart is a graphical representation used to plot paired data (Level
1 and Level 2, Level 1 and Level 3, and so on) for a given time period on an
X- and Y-axis.

Note: The Youden Chart can be used for any two levels of a control
material.

Data points are plotted on the graph and fall within one of four fields:

• Within ±1SD of the mean

• Within ±2SD of the mean
• Within ±3SD of the mean
• Outside ±3SD of the mean

How to Use the Youden Chart

The center of the Youden Chart represents the optimum target. The more
tightly points are clustered around the center of the target, the better the
precision of the control levels.

Tip: When viewing a Youden Chart, pause the mouse pointer on an

individual data point to view the two associated values, date and time, any
SPC rules violations, and any attached actions or comments.

Select Youden Chart Options

1 Click the Charts tab.
2 Click Options.
3 Click Youden.
4 Select the Days on charts option:
• The default is 60 days.
• Select a number from 1 to 90.

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5 Select the Symbol for the Point.

6 Select the Size for the Symbol.
• The default is 6.
• Select a size from 1 to 10 (pixels).
7 Select the Fill check box to select a fill color for the point symbol.
8 Click (ellipsis button) and select the fill color from the palette.

Important: UnityWeb™ shows data points violating a statistical process

control (SPC) rule with a status of “warning” in orange and data points
violating a rule with a status of “reject” in red. Therefore, Bio-Rad
recommends not using orange or red for fill colors as it could make these
data points difficult to see.

Other Options
There are other options that apply to the Youden Chart. See the following
sections for more information:

• “Fill background” (page 224)

• “Grid Lines and Color” (page 225)
• “Chart Header Options” (page 226)

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Create a Youden Chart

Note: Create a Youden Chart by lab number or by panel. Set up a panel

before creating a chart for the panel. See “Create a Panel and Add Tests” on
page 142 for more information.

1 Click the Charts tab.

2 Click Youden.
3 Select the Lab or Panel option.
4 Select the lab number or panel name from the Lab or Panel list.
5 If using the Lab option, select the lot from the Lot list.
6 Select a test from the Test list.
7 Click the arrow located to the right of the From (date) and select a
beginning date for the data on the chart.
8 Click the arrow located to the right of the To (date) and select an ending
date for the data on the chart.
9 By default, all levels set up in UnityWeb™ are selected for the chart. To
remove a level, clear the appropriate Level check box.
10 To save or print the chart, see “Save and Print Charts” on page 228.

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 CHAPTER
14
UnityWeb Reports
TM

In This Chapter
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 241
Save and Print Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 242
Data Review Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 245
Point Data Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 246
Summary Data Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 247
Statistical Report. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 248
Supervisor's Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 249
Operator Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 251
Audit Trail Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 253
Listings Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 255

Overview
UnityWeb™ intralaboratory reports are a valuable addition to the monthly Unity™
Interlaboratory Reports. The following UnityWeb™ reports are available for
creation at any time:

• Data Review Report (page 245)

• Point Data Report (page 246)
• Summary Data Report (page 247)
• Statistical Report (page 248)
• Supervisor's Report (page 249)
• Operator Report (page 251)
• Audit Trail Report (page 253)
• Listings reports (page 255)

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Save and Print Reports

Reports appear in Crystal Report® format after clicking Show report.

Save Reports

Note: The following directions apply to Exporting the Report to a PDF

format. Depending on the version of Adobe® Reader® installed on the
computer, the icons may look slightly different.

The report appears in Crystal Report® format after clicking Show report.

1 Click the export icon.

The Export the Report dialog box appears in a separate window.

2 Select a format for the report from the File Format list.
• Crystal Reports® (RPT)
• Adobe® Acrobat® (PDF)
• Microsoft® Excel 97-2000 (XLS)
• Microsoft® Excel 97-2000 - Data Only (XLS)
• Microsoft® Word (RTF)
• Microsoft® Word - Editable (RTF)
• Rich Text Format (RTF)
3 Select the Page Range option.
4 Click OK.

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5 Click the save icon.

The Save a Copy dialog box appears.

6 Navigate to the desired location on the hard drive or network.
7 Click Save.

Print Reports

Note: Depending on the version of Adobe® Reader® installed on the

computer, the icons may look slightly different.

The report appears in Crystal Report® format after clicking Show report.

1 Click the printer icon.

The Print the Report dialog box appears in a separate window.

2 Select the Page Range option.
3 Click OK.
The report appears in PDF format in a new window.

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4 Click the printer icon.

The Print dialog box appears.

5 Select the appropriate options for the printer and click OK.

Document Report Reviews

At the end of each report is a signature line and a section to document
corrective actions needed.

Note: UnityWeb™ does not support electronic signatures. However, you can
use a third-party software product such as Adobe® Reader®.

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Data Review Report

The Data Review Report documents the review of point data from the Bench
Review.

The Data Review Report contains the following information for each data point:

• Date/time
• Operator initials
• Value (result)
• Attached actions and comments, if any
• Accept/reject status
• Initials of the person performing Bench Review, if available
• Date/time of the Bench Review

Create a Data Review Report

1 Click the Reports tab.
2 Click Data Review.
3 Select the lab number from the Lab list.
If using All Labs, go to step 6.
4 Select the lot number from the Lot list.
If using All Lots, go to step 6.
5 Select the instrument from the Instrument list or select All Instruments.
6 Click the arrow located to the right of the From date and select a
beginning date for the report.
7 Click the arrow located to the right of the To date and select an ending
date for the report.
8 Click Show report.
9 To save or print the report, see “Save and Print Reports” on page 242.

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Point Data Report

The Point Data Report is useful for reviewing all point data for a specific date
range such as a month or quarter. Data entered as summary data does not
appear on the report.

Point Data Report Options

Note: Create the Point Data Report by lab number or by panel. Set up a
panel before creating a report for the panel. See “Create a Panel and Add
Tests” on page 142 for more information.

Create a Point Data Report

1 Click the Reports tab.
2 Click General.
3 Click Point Data Report.
4 Select the Lab or Panel option.
5 Select a test in the navigation tree.
• Click + (plus sign) to the left of the lab number to view the lots.
• Click + (plus sign) to the left of the lot number to view the tests.
6 Click the arrow located to the right of the From date and select a
beginning date for the report.
7 Click the arrow located to the right of the To date and select an ending
date for the report.
8 Select an option for the data in the report from the Report range list.

Note: The Report range options depend on the option selected in step 4.

9 Click Show report.

10 To save or print the report, see “Save or Print Reports” on page 242.

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Summary Data Report

The Summary Data Report shows the monthly and cumulative mean, SD, CV,
and number of data points for each test in the selected data set. These
statistics combine both point and summary data and provide a quick way to
review large amounts of data.

Summary Data Report Options

Note: Create the Summary Data Report by lab number or by panel. Set up a
panel before creating a report for the panel. See “Create a Panel and Add
Tests” on page 142 for more information.

Create a Summary Data Report

1 Click the Reports tab.
2 Click General.
3 Click Summary Data Report.
4 Select the Lab or Panel option.
5 Select a test in the navigation tree.
• Click + (plus sign) to the left of the lab number to view the lots.
• Click + (plus sign) to the left of the lot number to view the tests.
6 Click the arrow located to the right of the From date and select a
beginning date for the report.
7 Click the arrow located to the right of the To date and select an ending
date for the report.
8 Select an option for the data in the report from the Report range list.

Note: The Report range options depend on the option selected in step 4.

9 Click Show report.

10 To save or print the report, see “Save and Print Reports” on page 242.

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Statistical Report
The Statistical Report shows the percentage of point data that did not violate
any active statistical process control (SPC) rule. The Statistical Report is a
helpful overview of how well the laboratory is meeting its performance goals.
The report shows:

• Cumulative statistics for the test.

• Statistics for each calendar month.

Statistical Report Options

Note: Create the Statistical Report by lab number or by panel. Set up a
panel before creating a report for the panel. See “Create a Panel and Add
Tests” on page 142 for more information.

Create a Statistical Report

1 Click the Reports tab.
2 Click General.
3 Click Statistical Report.
4 Select the Lab or Panel option.
5 Select a test in the navigation tree.
• Click + (plus sign) to the left of the lab number to view the lots.
• Click + (plus sign) to the left of the lot number to view the tests.
6 Click the arrow located to the right of the From date and select a
beginning date for the report.
7 Click the arrow located to the right of the To date and select an ending
date for the report.
8 Select an option for the data in the report from the Report range list.

Note: The Report range options depend on the option selected in step 4.

9 Click Show report.

10 To save or print the report, see “Save and Print Reports” on page 242.

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Supervisor's Report
Use the Supervisor's Report to view data points that:

• Violate a rejection rule.

• Violate a warning rule.
• Have an attached action or comment.

Supervisor's Report Options

Note: Create the Supervisor's Report by lab number or by panel. Set up a

panel before creating a report for the panel. See “Create a Panel and Add
Tests” on page 142 for more information.

Create a Supervisor’s Report

1 Click the Reports tab.
2 Click Supervisor’s Report.
3 Click Supervisor’s Report.
4 Select the Lab or Panel option.
5 Select a test in the navigation tree.
• Click + (plus sign) to the left of the lab number to view the lots.
• Click + (plus sign) to the left of the lot number to view the tests.
6 Click the arrow located to the right of the From date and select a
beginning date for the report.
7 Click the arrow located to the right of the To date and select an ending
date for the report.
8 Select an option for the data in the report from the Report range list.

Note: The Report range options depend on the option selected in step 4.

9 By default, the Reject check box is selected. Clear the Reject check box
to exclude rejected data from the report.

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To view additional data:

• Select the Warn check box.
• Select the Action or Comment check box.
10 Click Show report.
11 To save or print the report, see “Save and Print Reports” on page 242.

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Operator Report
The Operator Report shows the following statistics for each test separated by
operator:

• Mean
• SD
• CV
• Number of data points

Note: The Operator Report is only available to users with the Manage
users permission.

Operator Report Options

Note: Create the Operator Report by lab number or by panel. Set up a

panel before creating a report for the panel. See “Create a Panel and Add
Tests” on page 142 for more information.

Create an Operator Report

1 Click the Reports tab.
2 Click Supervisor’s Report.
3 Click Operator Report.
4 Select the Lab or Panel option.
5 Select a test in the navigation tree.
• Click + (plus sign) to the left of the lab number to view the lots.
• Click + (plus sign) to the left of the lot number to view the tests.
6 Click the arrow located to the right of the From date and select a
beginning date for the report.
7 Click the arrow located to the right of the To date and select an ending
date for the report.

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8 Select an option for the data in the report from the Report range list.

Note: The Report range options depend on the option selected in step 4.

9 Click Show report.

10 To save or print the report, see “Save and Print Reports” on page 242.

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Audit Trail Report

The Audit Trail Report is a convenient tool to identify events that changed how
data points were evaluated. When first creating the Audit Trail Report, the
report contains all events for all labs, lots, and tests. Filter the report by any of
the following criteria:

• Date range
• Lab number
• Lot number
• Test
• Event

Audit Trail Events

The Event list contains auditable events that have been performed. The
following information appears for each event:

• Initials of the person performing the auditable event.

• Original value or setting.
• New value or setting.
• Comments entered in the Audit Trail Comment dialog box.

Note: When Audit Trail comments are required, the New Comment dialog
box appears whenever users perform an action triggering an Audit Trail
Event. See “Require Audit Trail Comments” on page 222 for more
information.

Create an Audit Trail Report

1 Click the Reports tab.
2 Click Audit Trail.
The Audit Trail report appears and shows all events for all labs, all lots, and
all tests.

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3 Complete any of the following steps to narrow the information in the

report.

Note: The Audit Trail report refreshes on the screen with each selection
made. Click Show report to save or print the report after any selection. See
“Save and Print Reports” on page 242.

4 Click the arrow located to the right of the Start date and select a
beginning date for the report.
5 Click the arrow located to the right of the End date and select an ending
date for the report.
6 Select a lab number from the Lab number list to narrow the report by lab.
7 Select a lot number from the Lot number list to narrow the report by lot.
8 Select a test from the Test information list to narrow the report by test.
9 Select an event from the Event list to narrow the report by event.
10 Click Show report.
11 To save or print the report, see “Save and Print Reports” on page 242.

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Listings Reports
The Listings Reports are helpful to view all the information set up in the
UnityWeb™ software. Listings Reports are available for the following information:

• Labs
Shows all lab numbers, organized by open and closed lab numbers.

• Lots
Shows all open lab numbers and associated lot numbers, whether open
or closed.

• Tests
Shows all lab numbers (open and closed) and associated tests organized
by lot number. Closed lots and associated tests are not shown.

• Panels
Shows all panels with associated tests organized by lab number and lot
number.

• Test Code Report

The Test Code Report shows the Unity™ codes for each test based on the
specified criteria. This report includes the Unity™ codes for the:
• Analyte
• Method
• Instrument/kit
• Reagent
• Unit
• Temperature

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Listings Report Options

Note: Create a Listings Report by lab number or by panel. Set up a panel

before creating a report for the panel. See “Create a Panel and Add Tests”
on page 142 for more information.

Create a Listings Report

1 Click the Reports tab.
2 Click Listings.
3 Click the type for the Listings Report:
• Labs
• Lots
• Tests
• Panels
• Test Code Report
4 To save or print the report, see “Save and Print Reports” on page 242.

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 CHAPTER
15
Send Data to the Unity TM

Interlaboratory Program

In This Chapter
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 257
Submit Data Monthly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 258
Submit Data from the Bench Review. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 260

Overview
Comparing your data to other laboratories worldwide is a major benefit of the
Bio-Rad Unity™ Interlaboratory Program. The Unity™ Interlaboratory Program
provides a variety of reports to help meet regulatory requirements. (See
Chapter 16, “Unity™ Interlaboratory Reports” for more information.) There are
two options for submitting data to the Unity™ Interlaboratory Program:

• Submit data monthly (page 258)

• Submit data from the Bench Review (page 260)

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 Send Data to the Unity™ Interlaboratory Program

Submit Data Monthly

Submit monthly data manually or by using the automatic monthly transmission
feature. Monthly transmission ensures data is transmitted for inclusion in
monthly Unity™ Interlaboratory Reports.

Note: Using the automatic monthly transmission feature ensures all data is
sent for inclusion in the monthly Unity™ Interlaboratory reports. Bio-Rad
recommends activating automatic monthly Unity™ transmission to ensure
data is sent on time.

Submit Data Manually

Send data manually at any time even if using the automatic monthly
transmission feature.

1 Log in as a user with the Communicate with Unity™ Interlab

permission.
2 Click the Tools tab.
3 Click Unity™ Interlab.
4 Click Send Data to Bio-Rad.
A message appears asking for confirmation of the data submission.
5 Click OK.

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Activate Automatic Monthly Transmission

Note: If using the automatic monthly transmission feature, the UnityWeb™

software must be running in order to submit data.

1 Log in as a user with the Edit setup options permission.

2 Click the Tools tab.
3 Click Setup.
4 Click Configure UnityWeb™.
5 Select the Automatic monthly transmission check box within the
Transmission section.
The Day of the month list becomes available.
6 Select the day of the month for automatic transmission to occur from the
Day of the month list.

Note: The day of the month options are 1 through 7. As a general rule, you
must send your data to Bio-Rad by the fifth business day of the following
month. Data received after the 7th is late.

7 Click Save.

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Submit Data from the Bench Review

To receive InstantQC™ Reports, submit point data from the Bench Review. If
entering only point data, substitute the InstantQC™ transmission for monthly
transmission. See Chapter 12, “Review and Annotate Data” for more
information about Bench Review.

TM
Activate Transmission for InstantQC
1 Log in as a user with the Edit setup options permission.
2 Click the Tools tab.
3 Click Setup.
4 Click Configure UnityWeb™.
5 Select the Data review transmission (for InstantQC™) check box
within the Transmission section.
6 Click Save.

Note: UnityWeb™ sends point data to the Unity™ Interlaboratory Program

each time a Bench Review is approved. After a short processing time, the
data appears on the InstantQC™ Reports on [Link].

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 CHAPTER
16
Unity Interlaboratory
TM

Reports

In This Chapter
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 261
Monthly Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 266
Comprehensive Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 278
Optional Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 281
Affiliated Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 285
Urinalysis Report. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 290
InstantQC™ Reports and Charts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 293

Overview
Unity™ Interlaboratory Reports show comparative results between laboratories
and are used to determine values and assess test methods. Unity™
Interlaboratory Reports help ensure the reliability and precision of test systems
and improve laboratory analytical performance.

Laboratories participating in the Unity™ Interlaboratory Program submit data on

a monthly basis for each control product tested. This data is combined with
data from other laboratories worldwide using the same consensus group. The
Unity™ Interlaboratory Program generates reports for all data submitted by the
monthly due date. A notification e-mail is sent when Unity™ Interlaboratory
Reports are available on [Link]. (See page 264 for more information
about Consensus groups.)

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 Unity™ Interlaboratory Reports

Important: As a general rule, data must be sent to Bio-Rad by the fifth

business day of the following month. Reports are not automatically
generated for data received after the due date. Contact your Bio-Rad QC
Program Representative to request late reports.

The Unity™ Interlaboratory Program provides the following types of reports:

• Monthly reports
• Comprehensive reports
• Optional reports
• InstantQC™ reports

Monthly Reports
The Unity™ Interlaboratory Program automatically generates the following
reports for each month you submit your data. These reports compare your
laboratory data to the data of your consensus group.

• Monthly Evaluation Report (page 266)

• Data Rejection Report (page 268)
• Bias and Imprecision Histogram Report (page 276)

The Unity™ Interlaboratory Program generates the following reports according

to the frequency (monthly, quarterly, or never) specified in UnityWeb™.

• Laboratory Performance Overview Report (page 270)

• Laboratory Comparison Report (page 272)
• Laboratory Histogram Report (page 274)

Note: See “Configure Unity™ Interlaboratory Report Frequency” on page 86

for more information.

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Comprehensive Reports
The Unity™ Interlaboratory Program provides the following comprehensive
reports. These reports show comparative data for all Peer and Method group
statistics.

• Worldwide Report (page 278)

• Manufacturer Report (page 280)

Optional Reports

Note: Additional optional reports are available by request. Contact your

Bio-Rad QC Program Representative for more information.

• Statistical Profile Report (page 281)

• Affiliated Reports (page 285)
• Urinalysis Report (page 290)

TM
InstantQC Reports and Charts

Note: When sending data to the Unity™ Interlaboratory Program from Bench
Review, the reviewed data points appear on InstantQC™ Reports and Charts
on [Link] after a short processing time. See “InstantQC™
Reports and Charts” on page 293 for more information.

• InstantQC™ Report (page 293)

• InstantQC™ Chart (page 295)

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Consensus Groups
The Unity™ Interlaboratory Program consists of the following consensus groups:

• Peer (most specific)

The Peer consensus group is the ideal group for comparison. It is
composed of all laboratories using the same instrument, lot number, level,
reagent, analytical method, units, and temperature of a test.

• Method (next specific)

Choose the Method consensus group when there is an insufficient number
of laboratories in the Peer group. It is composed of all laboratories using
the same lot number, level, analytical method, units, and temperature of a
test.

• All Labs (least specific)

The All Labs consensus group is composed of data from all laboratories
using the same lot number, level, units, and temperature of a test.

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View and Print Interlaboratory Reports

1 Start an Internet browser window and navigate to [Link].
2 Log on with your QCNet™ user ID and Password.
3 Point to Unity™ Interlab and then click Unity™ Reports.
4 Point to Reports, and then click My Reports.
5 Make selections for the lab number, lot number, report type, and period.
The selected report appears in Adobe® Reader®.
6 Click the printer icon.
The Print dialog box appears.
7 Select the appropriate options for the printer and click OK.

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Monthly Reports
Important: As a general rule, data must be sent to Bio-Rad by the fifth
business day of the following month. Reports are not automatically
generated for data received after the due date. Contact your Bio-Rad QC
Program Representative to request late reports.

Monthly Evaluation Report

The Monthly Evaluation Report provides an overview of your laboratory
performance for the month.

How to Use This Report

The Monthly Evaluation Report:

• Validates your monthly laboratory performance compared to the

consensus group.
• Identifies when your laboratory's monthly performance does not
statistically compare with or was not accepted into the Unity™ database.
• Notifies your laboratory when your laboratory's data was not received in
time for the standard worldwide comparison. Late reports are available
upon request from your Bio-Rad QC Program Representative.
• Contains a signature line and a section to document corrective actions
needed. Alerts you when your SDI (a peer-based measure of bias) or CVR
(a peer-based measure of imprecision) exceeds threshold limits. The
default threshold is 2.0 for both CVR and SDI. These limits can be
customized upon request.

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Example Monthly Evaluation Report

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Data Rejection Report

The Data Rejection Report identifies data that has been rejected and therefore
excluded from the Unity™ Interlaboratory Program.

How to Use This Report

The Unity™ Interlaboratory Program does not include data outside of a standard
statistical range based on the previous month's consensus group standard
deviation. The rejected data points are not included in cumulative statistics or in
statistical comparisons. If a rejection is due to data entered in error, correct the
error and Unity™ Interlaboratory Reports can be regenerated upon request to
your Bio-Rad QC Program Representative.

Data points may be rejected for two reasons:

• Based on consensus group mean or coefficient of variation (CV) the data

points lie outside the standard statistical window.
• An incorrect code (for example, invalid unit, invalid method, and so on)
was used when reporting data.

Limits for the Mean

• Mean ≤ 5.0
The allowable statistical window is ±4SD from the previous month's
consensus group cumulative mean.
• Mean > 5.0
The allowable statistical window is ±3SD from the previous month's
consensus group cumulative mean.

Limits for the CV

• Data is rejected when your CV is ≥ 40%.
• Data is accepted when your CV is < 40%.

Note: The window of acceptable values appears below the rejected values
on the report. The CV limit may be different for some analytes.

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Example Data Rejection Report

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Laboratory Performance Overview Report

The Laboratory Performance Overview Report shows your monthly bias and
imprecision for a test compared to the Peer and Method consensus groups.

Tip: The monthly standard deviation index (SDI) is a peer-based measure of

bias. The monthly coefficient of variation ratio (CVR) is a peer-based
measure of imprecision.

How to Use This Report

The SDI and CVR are combined as X-Y coordinates located within one of three
performance zones shown by increased levels of shading:

• No shading - Acceptable performance.

• Slight shading - Acceptable to marginal performance.
May indicate the need to investigate test system bias and imprecision.
• Darkest shading - Marginal performance.
May need to perform a corrective action.
• Outside of graph - Unacceptable performance.
Requires corrective action.

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The center of the graph (SDI and CVR both equal to zero) represents perfect
agreement between your laboratory's values and your consensus group (Peer
or Method) statistics. Your bias and imprecision increase as your values move
further away from the center of the graph.

The report contains a signature line and a section to document corrective

actions needed.

Example Laboratory Performance Overview Report

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Laboratory Comparison Report

The Laboratory Comparison Report allows you to compare your results to
those of the Peer and Method consensus groups. This report includes many
vital statistics and is often the very first report reviewed by Unity™ participants.

For VITROS® instruments, the Laboratory Comparison Report provides

statistics for your laboratory, Peer group, and Method group based on the slide
generation numbers you report.

Note: Method group statistics may not be available for all analytes.

How to Use This Report

For each test, the report contains the following monthly and cumulative
statistics:

• Mean
• Standard deviation (SD)
• Coefficient of variation (CV)
• Number of points
• Coefficient of variation ratio (CVR) for the Peer and Method consensus
groups
• Standard deviation index (SDI) for the Peer and Method consensus groups

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The Laboratory Comparison Report also shows the monthly and cumulative
Peer and Method group statistics for:

• Mean
• Standard deviation (SD)
• Coefficient of variation (CV)
• Number of points reported
• Number of labs reported

Example Laboratory Comparison Report

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Laboratory Histogram Report

The Laboratory Histogram shows information for each analyte you have
reported for the past 12 months. The histogram has a bar for each calendar
month as well as a cumulative bar. Each level of control has a separate bar
chart. The Laboratory Histogram plots your monthly means against the current
cumulative Peer group mean ±2SD range. For each bar, the Laboratory
Histogram shows:

• Mean
• Standard deviation (SD)
• Coefficient of variation (CV)
• Number of points

How to Use This Report

The Laboratory Histogram provides a visual comparison of your laboratory’s
performance to your consensus group over time. This report helps identify
shifts (abrupt changes in values) and trends (gradual changes in values).

Note: If a month does not have any data points, then either there were not
any values submitted, values were submitted late, or submitted values were
outside of the statistical range and therefore rejected by the Unity™
Interlaboratory Program. If data points were rejected by the Unity™
Interlaboratory Program, a description appears on the Data Rejection
Report.

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Example Laboratory Histogram Report

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Bias and Imprecision Histogram Report

The Bias and Imprecision Histogram Report was developed based on the work
of Dr. Carmen Ricos, and others in Clinica Chimica Acta in 2004. This report
provides a graphical representation of your laboratory’s bias and coefficient of
variation (CV) for a lot number of Bio-Rad control product. Your monthly CV is
represented as a bar and your bias is represented as a diamond with lines
connecting each diamond.

How to Use This Report

The primary use of the Bias and Imprecision Histogram is to detect changes in
performance over time and to identify if changes in performance are due to
bias, imprecision, or both.

Although you can use this report to detect abnormal CV or bias, the Bias and
Imprecision Histogram Report does not contain specific thresholds for
allowable bias or allowable imprecision.

The determination of whether a shift in performance is meaningful or

problematic can be made from other metrics, including the standard deviation
index (SDI) or coefficient of variation ratio (CVR) provided on the Laboratory
Comparison Report or by using biological variation values for allowable bias
and imprecision.

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Example Bias and Imprecision Histogram Report

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Comprehensive Reports

Worldwide Report
The Worldwide Report summarizes all data submitted to the Unity™
Interlaboratory Program. This report is available for each lot number of Bio-Rad
control product.

How to Use This Report

The Worldwide Report is a good reference to use when starting a new lot
number. Compare your first few data points against the consensus group
already using the lot number. The Worldwide Report is also a good reference to
use when evaluating a new instrument, kit, or method.

The Worldwide Report is updated every month and includes:

• All Peer group and Method group statistics.

• All tests (including all instruments, all methods, and so on) reported to the
Unity™ Interlaboratory Program by all laboratories reporting on the same lot
number.
• Monthly and cumulative statistics (mean, standard deviation, coefficient of
variation, number of points, and number of laboratories) for each level of
control.

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Example Worldwide Report

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Manufacturer Report
The Manufacturer Report is a modified format of the Worldwide Report. The
Manufacturer Report is identical to the Worldwide Report except it lists only the
statistics for a particular manufacturer’s instruments. The Manufacturer Report
is updated every month.

How to Use This Report

The Manufacturer Report is a good reference to use when evaluating a new
instrument, kit, or method.

Example Manufacturer Report

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Optional Reports

Statistical Profile Report

Note: The Statistical Profile Report is optional. Contact your Bio-Rad QC

Program Representative to request this report.

The Statistical Profile Report allows you to compare your laboratory's statistics
to the Peer, Method, and All Labs consensus group statistics for selected time
periods. The Statistical Profile Report also provides two histograms
summarizing how your laboratory’s mean and coefficient of variation (CV)
compare to the range of mean and range of CVs calculated for each
consensus group.

How to Use This Report

The Statistical Profile Report contains four major sections:

• Laboratory 2SD and 3SD Ranges

• Summary Statistics
• Frequency Histograms
• Percentile Distribution Table

Laboratory 2SD and 3SD Ranges

The Statistical Profile Report includes your laboratory’s ±2SD and ±3SD ranges
for the current quarter and this year.

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Example Laboratory 2SD and 3SD Ranges

Summary Statistics
The Statistical Profile Report includes summary statistics for your laboratory
and the Peer, Method, and All Labs consensus groups for the current quarter
and the year.

Example Summary Statistics

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Frequency Histograms
The frequency histogram section of the Statistical Profile Report contains two
frequency histograms which show the location of:

• Your laboratory’s means for the quarter plotted on the range of means for
the Method and All Labs consensus groups.
• Your laboratory’s coefficient of variation (CV) for the quarter plotted on the
range of CVs for the Method and All Labs consensus groups.

Each histogram has an arrow indicating your laboratory’s mean and CV values.

Example Frequency Histogram

The arrow represents your laboratory’s
performance so you can visually
determine where your laboratory fits in the
distribution of consensus groups means
and CVs.

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Percentile Distribution Table

Note: If reporting fewer than six data points during the quarter, your
laboratory is not included in the Percentile Distribution Table.

The Percentile Distribution Table shows the laboratory distribution in percentiles

for absolute bias, standard deviation (SD), and coefficient or variation (CV) for
each consensus group (Peer, Method, and All Labs).

How to Use This Report

Compare the absolute bias, SD, or CV to the table to see your approximate
position in the percentile distribution and find out how many laboratories have
better or worse performance than your laboratory.

Example Percentile Distribution Table

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Affiliated Reports
Note: Affiliated Reports are optional. Contact your Bio-Rad QC Program
Representative to request Affiliated Reports.

Affiliated Reports allow a group of laboratories to compare results, essentially

creating their own consensus group. The Unity™ Interlaboratory Program
provides the following Affiliated Reports:

• Affiliated Laboratory Comparison Report (page 285)

• Affiliated Laboratory Comparison Report: Abbreviated Summary
(page 287)
• Affiliated Data Exception Report (page 288)

Note: It is likely an affiliated group’s standard deviation index (SDI) and

coefficient of variation ratio (CVR) will be different from the Bio-Rad
consensus groups since the affiliated group most likely has more in
common than the Bio-Rad consensus groups. For example, the laboratories
in an affiliated group probably use the same reagent or calibrator lots.

Affiliated Laboratory Comparison Report

The Affiliated Laboratory Comparison Report summarizes the performance of
each participating affiliated laboratory in a single report. Statistics are provided
for your laboratory and all affiliated laboratories and include:

• Mean
• Standard deviation (SD)
• Coefficient of variation (CV)
• Coefficient of variation ratio (CVR) and Standard deviation index (SDI)
• Lab to Peer Group
• Lab to Lab Group (affiliated group)

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• Number of points

Tip: If your laboratories report results in both conventional and SI units,

request this report in one or the other unit rather than both.

How to Use This Report

This report is designed for the Laboratory Manager or Quality Control
Coordinator who is responsible for multiple sites. Use this report to compare
multiple instruments made by the same manufacturer, across or within multiple
sites.

Note: Each participating affiliated laboratory, Laboratory Manager, or Quality

Control Coordinator can request to receive this report.

Example Affiliated Laboratory Comparison Report

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Affiliated Laboratory Comparison Report:

Abbreviated Summary
This report is designed for a quick review and focuses on key statistics to
provide a performance summary for multiple laboratories. This report
summarizes the performance of each participating affiliated laboratory in a
single report. For each test, this report shows:

• Mean
• Standard deviation (SD)
• Coefficient of variation (CV)
• Number of points
• Coefficient of variation ratio (CVR) compared to the Peer, Method, and
Affiliated consensus groups
• Standard deviation index (SDI) compared to the Peer, Method, and
Affiliated consensus groups

Tip: If laboratories report results in both conventional and SI units, request

this report appear in one or the other unit rather than both.

How to Use This Report

Use this report to statistically compare your laboratory to the Peer, Method,
and Affiliated consensus groups. This report is designed for the Laboratory
Manager or Quality Control Coordinator who is responsible for multiple sites.

Note: Each participating affiliated laboratory, Laboratory Manager, or Quality

Control Coordinator can request to receive this report.

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Example Affiliated Laboratory Comparison Report:

Abbreviated Summary

Affiliated Data Exception Report

For all laboratories within the affiliated laboratory consensus group, this report
shows any analyte:

• Exceeding a specified standard deviation index (SDI) or coefficient of

variation ratio (CVR) warning limit compared to the consensus group.
• Rejected by the Unity™ Interlaboratory Program.
• Containing a suspected coding error such as invalid unit, invalid method,
and so on.

How to Use This Report

This report, in combination with the other Affiliated Reports, is ideal for a
Laboratory Manager or Quality Control Coordinator who manages multiple sites
or multiple instruments of the same make and model.

Note: Each participating affiliated laboratory, Laboratory Manager, or Quality

Control Coordinator can request to receive this report.

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Example Affiliated Data Exception Report

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Urinalysis Report
Note: The Urinalysis Report is optional. Contact your Bio-Rad QC Program
Representative to request this report.

Customers submitting data for a Bio-Rad urinalysis product to the Unity™

Interlaboratory Program receive a qualitative report consisting of the following:

• Cover page
• Dual level chemistry report for each instrument submitted
• Dual level microscopy report for each data entry set submitted

The Urinalysis Report displays only one set of results per day. If submitting
multiple sets, this report includes the one with the most recent date-time
stamp.

Chemistry Section
The chemistry section of the Urinalysis Report provides a simulation of the
laboratory responses versus a simulation of the group responses using the
visual color changes of reagent strips. On this report, arrows identify the
majority group response. The following figure shows a portion of the report.

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The complete report includes leukocytes, nitrite, urobilinogen, protein, pH,

blood, specific gravity, ketone, bilirubin, glucose, and hCG.

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Microscopy Section
Graphics on the report simulate your average response and the group's
average response. Your daily responses appear above the graphics with an
arrow to indicate the majority group response.

The following figure shows a portion of the report. The complete report
includes RBC, WBC, and crystals.

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TM
InstantQC Reports and Charts
Note: When sending data to the Unity™ Interlaboratory Program from Bench
Review, the reviewed data points appear on InstantQC™ Reports and Charts
on [Link] after a short processing time. See “InstantQC™” on
page 208 for more information.

TM
InstantQC Reports
The InstantQC™ Report is provided in HTML format. Select from a list of
Period, Group Type, and Group By options using the lists provided.

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Comparison Statistics Shown:

• SDI: a measurement of your bias compared to your selected consensus

group
• Bias: a measurement of how far your observed value is from the target
value
• TEB%: a measurement of your total error (bias and imprecision) compared
to the total allowable error limits based on biological variation

How to Use This Report

This report provides summary statistics based on your selections for your
laboratory and the consensus group. Comparison statistics between your
laboratory and selected consensus groups are also provided.

TM
View InstantQC Reports
1 Start an Internet browser window and navigate to [Link].
2 Log on with your QCNet™ User ID and password.
3 Point to Unity™ Interlab and then click Unity™ Reports.
4 Point to Reports, point to InstantQC™, and then click Reports.
5 Make a selection from each of the following lists:
• Lab
• Lot
• Period-1 day, 7 days, 30 days, 1 month, 3 months, 6 months
• Group Type-Worldwide, Country, Affiliate
• Group By-Peer, Method, All Labs
The selected report appears.

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TM
InstantQC Chart
The InstantQC™ Chart plots your data points for your selected date range
against your selected consensus group’s mean and ±3SD range.

How to Use This Report

The InstantQC™ Chart is provided in HTML format. This allows you to select
from a list of Period, Group Type, and Group By options using the lists
provided.

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TM
View InstantQC Charts
1 Start an Internet browser window and navigate to [Link].
2 Log on with you QCNet™ User ID and password.
3 Point to Unity™ Interlab and then click Unity™ Reports.
4 Point to Reports, point to InstantQC™, and then click Charts.
5 Make a selection from each of the following lists:
• Lab
• Lot
• Period-1 day, 7 days, 30 days
• Group Type-Worldwide, Country, Affiliate
• Graph By-Peer, Method, All Labs
The selected chart appears.

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 CHAPTER
17
Regulatory Requirements
and Reports

In This Chapter
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 297
CLIA Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 298
CAP Accreditation Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 306
ISO 15189 Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 320

Overview
Comparing your data to other laboratories worldwide is a major benefit of the
Bio-Rad Unity™ Interlaboratory Program. The Unity™ Interlaboratory Program
provides a variety of reports to help meet regulatory requirements. (See
Chapter 16, “Unity™ Interlaboratory Reports” for more information.)

UnityWeb™ also provides a variety of intralaboratory reports and charts to help

meet regulatory requirements. (See Chapter 13, “UnityWeb™ Charts” and
Chapter 14, “UnityWeb™ Reports” for more information.)

The following pages show available reports and charts and their recommended
use according to Clinical Laboratory Improvement Amendments (CLIA), College
of American Pathologists (CAP), and International Organization for
Standardization (ISO) 15189.

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CLIA Requirements
Note: The information in this section is extracted and paraphrased from Part
III Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Centers for Disease Control and Prevention, 42 CFR
Part 493 Medicare, Medicaid, and CLIA Programs; Laboratory
Requirements Relating to Quality Systems and Certain Personnel
Qualifications, Final Rule, Friday, January 24, 2003.

CLIA Requirements–Paraphrased

Requirement:
Have a record of test system performance.

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CLIA Requirements–Paraphrased (continued)

• Intralaboratory Reports and Charts:

Point Data Report
Summary Data Report
Supervisor's Report
Operator Report
Data Review Report
Levey-Jennings Chart
• Unity™ Interlaboratory Reports:
Monthly Evaluation Report
Data Rejection Report
Laboratory Performance Overview
Laboratory Comparison Report
Laboratory Histogram Report
Bias and Imprecision Histogram
Statistical Profile Report
Affiliated Data Exception Report
Affiliated Laboratory Comparison Report
• InstantQC™ Reports and Charts:
InstantQC™ Report
InstantQC™ Chart

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CLIA Requirements–Paraphrased (continued)

Requirement:
Monitor the accuracy of the analytical process.

• Intralaboratory Reports and Charts:

Levey-Jennings Chart
• Unity™ Interlaboratory Reports:
Monthly Evaluation Report
Laboratory Performance Overview
Laboratory Comparison Report
Laboratory Histogram Report
Bias and Imprecision Histogram
Statistical Profile Report
Affiliated Data Exception Report
Affiliated Laboratory Comparison Report
• InstantQC™ Reports and Charts:
InstantQC™ Report
InstantQC™ Chart

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CLIA Requirements–Paraphrased (continued)

Requirement:
Monitor the precision of the analytical process.

• Intralaboratory Reports and Charts:

Levey-Jennings Chart
• Unity™ Interlaboratory Reports:
Monthly Evaluation Report
Laboratory Performance Overview
Laboratory Comparison Report
Laboratory Histogram Report
Bias and Imprecision Histogram
Statistical Profile Report
Affiliated Data Exception Report
Affiliated Laboratory Comparison Report
• InstantQC™ Reports and Charts:
InstantQC™ Report
InstantQC™ Chart

Requirement:
Detect immediate errors.

• Intralaboratory Reports and Charts:

Point Data Report
Supervisor's Report
Operator Report
Data Review Report
• InstantQC™ Reports and Charts:
InstantQC™ Report
InstantQC™ Chart

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CLIA Requirements–Paraphrased (continued)

Requirement:
Establish or verify the criteria for acceptability of all control materials.

• Intralaboratory Reports and Charts:

Levey-Jennings Chart
• Unity™ Interlaboratory Reports:
Monthly Evaluation Report
Data Rejection Report
• InstantQC™ Reports and Charts:
InstantQC™ Chart

Requirement:
Establish statistical parameters for each batch and lot number of control
materials.

• Intralaboratory Reports and Charts:

Summary Data Report
Levey-Jennings Chart
• Unity™ Interlaboratory Reports:
Laboratory Comparison Report
Statistical Profile Report
• InstantQC™ Reports and Charts:
InstantQC™ Report
InstantQC™ Chart

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 Regulatory Requirements and Reports

CLIA Requirements–Paraphrased (continued)

Requirement:
Document all control procedures performed.

• Intralaboratory Reports and Charts:

Data Review Report
Point Data Report
Supervisor’s Report
Levey-Jennings Chart
• InstantQC™ Reports and Charts:
InstantQC™ Chart

Requirement:
Document that at least once each day patient specimens are assayed or
examined, test two control materials of different concentrations.

• Intralaboratory Reports and Charts:

Data Review Report
Point Data Report
Summary Data Report
Levey-Jennings Chart
• InstantQC™ Reports and Charts:
InstantQC™ Chart

Requirement:
For blood gas analyses, document that one sample of control material is
tested each eight hours of testing using a combination of control materials
that include both low and high values on each day of testing.

• Intralaboratory Reports and Charts:

Data Review Report
Point Data Report

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CLIA Requirements–Paraphrased (continued)

Requirement:
Evaluate and define the relationship between test results for the same analyte
using different methodologies, instruments, or testing sites.

• Unity™ Interlaboratory Reports:

Affiliated Data Exception Report
Affiliated Laboratory Comparison Report

Requirement:
Document all corrective actions taken as a result of QC.

• Intralaboratory Reports and Charts:

Data Review Report
Point Data Report
Supervisor’s Report
• Unity™ Interlaboratory Reports:
Monthly Evaluation Report

Requirement:
Document all analytic systems assessment activities.

• Intralaboratory Reports and Charts:

Data Review Report
Point Data Report
Supervisor’s Report
• Unity™ Interlaboratory Reports:
Monthly Evaluation Report
Laboratory Performance Overview
Laboratory Comparison Report
Laboratory Histogram Report
Bias and Imprecision Histogram
Statistical Profile Report

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CLIA Requirements–Paraphrased (continued)

Requirement:
Document that, over time, control material testing is rotated among all
operators who perform the test.

• Intralaboratory Reports and Charts:

Data Review Report
Point Data Report
Supervisor’s Report
Levey-Jennings Chart

Requirement:
Document that control material testing is performed after a complete change
of reagent, major preventive maintenance, or when any critical part is
replaced.

• Intralaboratory Reports and Charts:

Data Review Report
Point Data Report
Supervisor’s Report

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 Regulatory Requirements and Reports

CAP Accreditation Requirements

Note: The information in this section is extracted and paraphrased from
requirements published by the College of American Pathologists and the
Joint Commission on Accreditation of Healthcare Organizations.

CAP Accreditation Requirements–Paraphrased

Requirement:
Document validation of new reagent lots or shipments of reagents.

• Intralaboratory Reports and Charts:

Point Data Report
Summary Data Report
Supervisor's Report
Operator Report
Data Review Report
Levey-Jennings Chart

Requirement:
Document calibration or recalibration when controls fail to meet established
criteria.

• Intralaboratory Reports and Charts:

Point Data Report
Supervisor's Report
Data Review Report

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CAP Accreditation Requirements–Paraphrased (continued)

Requirement:
Use data to make changes to improve performance and patient safety.

• Intralaboratory Reports and Charts:

Point Data Report
Summary Data Report
Supervisor's Report
Operator Report
Data Review Report
Levey-Jennings Chart
• Unity™ Interlaboratory Reports:
Monthly Evaluation Report
Data Rejection Report
Laboratory Performance Overview
Laboratory Comparison Report
Laboratory Histogram Report
Bias and Imprecision Histogram
Statistical Profile Report
Affiliated Data Exception Report
Affiliated Laboratory Comparison Report
• InstantQC™ Reports and Charts:
InstantQC™ Chart

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CAP Accreditation Requirements–Paraphrased (continued)

Requirement:
For quantitative tests, document use of control materials at more than one
concentration (level) at least daily.

• Intralaboratory Reports and Charts:

Point Data Report
Summary Data Report
Supervisor's Report
Data Review Report
Levey-Jennings Chart
• InstantQC™ Reports and Charts:
InstantQC™ Chart

Requirement:
For numeric QC data, document calculation of QC statistics at specified
intervals to define analytic imprecision.

• Intralaboratory Reports and Charts:

Summary Data Report
• Unity™ Interlaboratory Reports:
Laboratory Comparison Report
Bias and Imprecision Histogram
Statistical Profile Report
Affiliated Laboratory Comparison Report
• InstantQC™ Reports and Charts:
InstantQC™ Report
InstantQC™ Chart

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CAP Accreditation Requirements–Paraphrased (continued)

Requirement:
Demonstrate that QC and instrument maintenance are performed and
evaluated.

• Intralaboratory Reports and Charts:

Point Data Report
Supervisor's Report
Data Review Report
• Unity™ Interlaboratory Reports:
Monthly Evaluation Report
• InstantQC™ Reports and Charts:
InstantQC™ Chart

Requirement:
Document verification results of controls for acceptability before reporting
patient test results.

• Intralaboratory Reports and Charts:

Point Data Report
Supervisor's Report
Data Review Report
Levey-Jennings Chart

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CAP Accreditation Requirements–Paraphrased (continued)

Requirement:
For hematology, document testing of two different stabilized control
specimens and record results during each 24 hours of analyzer use.

• Intralaboratory Reports and Charts:

Point Data Report
Summary Data Report
Supervisor's Report
Data Review Report
Levey-Jennings Chart
• InstantQC™ Reports and Charts:
InstantQC™ Chart

Requirement:
If commercially assayed controls are used for hematology instruments, verify
the target values (mean and QC ranges).

• Intralaboratory Reports and Charts:

Operator Report
• Unity™ Interlaboratory Reports:
Laboratory Comparison Report
Laboratory Histogram Report
Statistical Profile Report
• InstantQC™ Reports and Charts:
InstantQC™ Report
InstantQC™ Chart

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CAP Accreditation Requirements–Paraphrased (continued)

Requirement:
If unassayed controls are used in hematology, establish a statistically valid
target mean and range for each lot by repetitive analysis.

• Intralaboratory Reports and Charts:

Operator Report
• Unity™ Interlaboratory Reports:
Laboratory Comparison Report
Laboratory Histogram Report
Statistical Profile Report
• InstantQC™ Reports and Charts:
InstantQC™ Report
InstantQC™ Chart

Requirement:
Fully define and document tolerance limits (numeric and nonnumeric) for all
hematology and coagulation control procedures.

• Intralaboratory Reports and Charts:

Point Data Report
Summary Data Report
Supervisor's Report
Operator Report
Data Review Report
Levey-Jennings Chart
• InstantQC™ Reports and Charts:
InstantQC™ Chart

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CAP Accreditation Requirements–Paraphrased (continued)

Requirement:
Monitor precision data for significant changes.

• Intralaboratory Reports and Charts:

Levey-Jennings Chart
• Unity™ Interlaboratory Reports:
Monthly Evaluation Report
Data Rejection Report
Laboratory Performance Overview
Laboratory Histogram Report
Bias and Imprecision Histogram
Affiliated Data Exception Report
Affiliated Laboratory Comparison Report
• InstantQC™ Reports and Charts:
InstantQC™ Report
InstantQC™ Chart

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CAP Accreditation Requirements–Paraphrased (continued)

Requirement:
Document review and assessment of quality control data at least monthly.

• Intralaboratory Reports and Charts:

Summary Data Report
Supervisor's Report
Levey-Jennings Chart
• Unity™ Interlaboratory Reports:
Monthly Evaluation Report
Data Rejection Report
Laboratory Performance Overview
Laboratory Comparison Report
Laboratory Histogram Report
Bias and Imprecision Histogram
Statistical Profile Report
Affiliated Data Exception Report
Affiliated Laboratory Comparison Report
• InstantQC™ Reports and Charts:
InstantQC™ Report
InstantQC™ Chart

Requirement:
Verify manufacturer's calibrations with control materials appropriate for the
system.

• Intralaboratory Reports and Charts:

Data Review Report

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CAP Accreditation Requirements–Paraphrased (continued)

Requirement:
Document that the photo-optical coagulation testing system (for PT, aPTT,
and so on) is checked with two different levels of control material during each
eight hours of patient testing and each time there is a change in reagents.

• Intralaboratory Reports and Charts:

Point Data Report
Supervisor's Report
Data Review Report

Requirement:
Document that the manual coagulation system is checked with two different
levels of control material in duplicate during each eight hours of patient
testing and each time there is a change of reagents.

• Intralaboratory Reports and Charts:

Point Data Report
Supervisor's Report
Data Review Report

Requirement:
Document ongoing evaluation of (QC) records, instrument maintenance and
function, temperature, etc.

• Intralaboratory Reports and Charts:

Data Review Report
• Unity™ Interlaboratory Reports:
Monthly Evaluation Report
Laboratory Performance Overview
• InstantQC™ Reports and Charts:
InstantQC™ Chart

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CAP Accreditation Requirements–Paraphrased (continued)

Requirement:
Organize and present QC data so that it can be evaluated daily by the
technical staff to detect problems, trends, etc.

• Intralaboratory Reports and Charts:

Point Data Report
Summary Data Report
Supervisor's Report
Levey-Jennings Chart
• InstantQC™ Reports and Charts:
InstantQC™ Report
InstantQC™ Chart

Requirement:
Document that at least one quality control specimen for pH, pCO2, and pO2
(tonometered sample or liquid control material) is tested at least every eight
hours of operation when patient specimens are tested.

• Intralaboratory Reports and Charts:

Point Data Report
Supervisor's Report
Data Review Report

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CAP Accreditation Requirements–Paraphrased (continued)

Requirement:
Document that control materials for pH, pCO2, and pO2 represent both high
and low values on each day of patient testing.

• Intralaboratory Reports and Charts:

Point Data Report
Supervisor's Report
Data Review Report
Levey-Jennings Chart
• InstantQC™ Reports and Charts:
InstantQC™ Report
InstantQC™ Chart

Requirement:
Document that one sample of control material for pH, pCO2, and pO2 is
included each time patient samples are tested, except for automated
instruments that internally calibrate at least once every 30 minutes of use.

• Intralaboratory Reports and Charts:

Point Data Report
Supervisor's Report
Data Review Report

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CAP Accreditation Requirements–Paraphrased (continued)

Requirement:
Document the review for acceptability of quality control results.

• Intralaboratory Reports and Charts:

Point Data Report
Summary Data Report
Supervisor's Report
Operator Report
Data Review Report
Levey-Jennings Chart
• Unity™ Interlaboratory Reports:
Monthly Evaluation Report
Laboratory Performance Overview
Bias and Imprecision Histogram

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CAP Accreditation Requirements–Paraphrased (continued)

Requirement:
Collect and analyze pertinent data to monitor and assess performance.

• Intralaboratory Reports and Charts:

Point Data Report
Summary Data Report
Supervisor's Report
Operator Report
Data Review Report
Levey-Jennings Chart
• Unity™ Interlaboratory Reports:
Monthly Evaluation Report
Data Rejection Report
Laboratory Performance Overview
Laboratory Comparison Report
Laboratory Histogram Report
Bias and Imprecision Histogram
Statistical Profile Report
Affiliated Data Exception Report
Affiliated Laboratory Comparison Report
• InstantQC™ Reports and Charts:
InstantQC™ Report
InstantQC™ Chart

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CAP Accreditation Requirements–Paraphrased (continued)

Requirement:
Use data to identify unwanted trends.

• Intralaboratory Reports and Charts:

Point Data Report
Summary Data Report
Supervisor's Report
Operator Report
Data Review Report
Levey-Jennings Chart
• Unity™ Interlaboratory Reports:
Monthly Evaluation Report
Data Rejection Report
Laboratory Performance Overview
Laboratory Comparison Report
Laboratory Histogram Report
Bias and Imprecision Histogram
Statistical Profile Report
Affiliated Data Exception Report
Affiliated Laboratory Comparison Report
• InstantQC™ Reports and Charts:
InstantQC™ Report
InstantQC™ Chart

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 Regulatory Requirements and Reports

ISO 15189 Requirements

ISO 15189 Requirements

Requirement:
Design internal quality control systems to verify the intended quality of
results.

• Intralaboratory Reports and Charts:

Point Data Report
Summary Data Report
Supervisor's Report
Operator Report
Data Review Report
Levey-Jennings Chart
• Unity™ Interlaboratory Reports:
Monthly Evaluation Report
Data Rejection Report
Laboratory Performance Overview
Laboratory Comparison Report
Laboratory Histogram Report
Bias and Imprecision Histogram
Statistical Profile Report
Affiliated Data Exception Report
Affiliated Laboratory Comparison Report
• InstantQC™ Reports and Charts:
InstantQC™ Report
InstantQC™ Chart

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ISO 15189 Requirements (continued)

Requirement:
Provide staff members with clear and easily understood information on which
to base technical and medical decisions.

• Intralaboratory Reports and Charts:

Point Data Report
Summary Data Report
Supervisor's Report
Operator Report
Data Review Report
Levey-Jennings Chart
• Unity™ Interlaboratory Reports:
Monthly Evaluation Report
Data Rejection Report
Laboratory Performance Overview
Laboratory Comparison Report
Laboratory Histogram Report
Bias and Imprecision Histogram
Statistical Profile Report
Affiliated Data Exception Report
Affiliated Laboratory Comparison Report
• InstantQC™ Reports and Charts:
InstantQC™ Report
InstantQC™ Chart

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 CHAPTER
18
Westgard Advisor online
TM

In This Chapter
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 323
Configure Westgard Advisor™ online . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 326
Generate Rules with Westgard Advisor™ online . . . . . . . . . . . . . . . . . . . . . . 332
Apply Rules with Westgard Advisor™ online . . . . . . . . . . . . . . . . . . . . . . . . . 339
Westgard Advisor™ online Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 341
Delete Historical Suggestions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 343
OPSpecs Chart. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 344

Overview
Westgard Advisor™ online is an optional feature of UnityWeb™ that identifies the
tests needing improvement and the tests routinely achieving the required
quality. Westgard Advisor™ online uses the following information to recommend
statistical process control (SPC) rules, and the number of control samples per
run:

• Data for the test

• A selected TEa
• A selected consensus group
The consensus group can be a date range of the laboratory's data or a
Unity™ Interlaboratory consensus group (Peer, Method, or All Labs).

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Using Westgard Advisor™ online, it is possible to generate rules based on

different combinations of these selections, display the OPSpecs Chart, and
apply the suggested SPC rules.

Westgard Advisor™ online always provides suggestions. However, if a method

has poor performance, Westgard Advisor™ online is not able to recommend a
set of SPC rules that will solve performance problems. When no multirule
meets the quality specification, Westgard Advisor™ online reports a maximum
QC condition and recommends all available multirules.

Note: The rules suggested by Westgard Advisor™ online are

recommendations only. Conditions in the laboratory may make some rules
impossible to use.

View Existing QC Rules

1 Click the Advisors tab.
2 Click Existing QC Rules.
The Existing QC Rules dialog box shows the rules currently applied.

Note: If SPC rules have not been previously generated and applied using
Westgard Advisor™ online, the default rules appear based on the levels of
control material set up in UnityWeb™.

3 If more than one lab number is set up in the software, select a lab from the
Lab Number list to view the existing rules for another lab number.
4 If more than one lot number is set up in the software, select a lot from the
Lot Number list to view the existing rules for another lot number.

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View Lab Data and Group Statistics

1 Click the Advisors tab.
2 Click Lab Data and Group Stats.
3 Select a lab number from the Lab number list.
4 Select a lot number from the Lot number list.
5 Select a test from the Test list.
6 Select an option for the data:
• Lab Data
Shows the mean, coefficient of variation (CV), and number of points
for each available level by calendar month for the selected lab number
and test.
• Group Statistics
Shows the cumulative mean, coefficient of variation (CV), Bias (%),
number of labs, and number of points for the laboratory and the
mean, coefficient of variation (CV), Bias (%), number of labs, and
number of points for each consensus group from the Unity™
Interlaboratory Program.

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Configure Westgard Advisor online
Before generating rules for a test, configure the quality requirements (total
allowable error) for the test and specify the data requirements.

Total Allowable Error (TEa) Options

Westgard Advisor™ online uses a default TEa for each test. To change the
default TEa, choose one of the following TEa options.

Note: Not all options are available for all tests.

• ±3SD limits based on the data for the test

• Biological Variation (BV) Desirable
• Biological Variation (BV) Minimum
• Biological Variation (BV) Optimal
• CLIA (USA)
• QMP-LS (Canada–Ontario)
• RCPA limits (Australia)

Note: Limits such as BV, CLIA, QMP-LS, and RCPA are only available when
published.

• User Defined
• Tightest (smallest TEa available)
• Loosest (largest TEa available)
• State of the Art based on the median coefficient of variation (CV) of a
selected consensus group

Note: When generating rules, Westgard Advisor™ online displays a message

if statistics are not available for a consensus group.

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View TEa Details

1 Click the Advisors tab.
2 Click Configure TEa.
3 In the Detail column, position the mouse on top of the detail.
The values for the TEa selection appear in a box.

TEa detail

Configure the TEa for an Analyte

1 Click the Advisors tab.
2 Click Configure TEa.
Each analyte appears with the current TEa selection.

Note: An asterisk (*) indicates the default TEa options.

3 Select a TEa from the list to change the default TEa for the analyte.

Note: Limits such as BV, CLIA, QMP-LS, and RCPA are only available when
published.

4 Click Save.

Note: Westgard Advisor™ online uses the TEa selections when generating
rules with the Wizard or the Advanced method. If using the Default method,
Westgard Advisor™ online uses the default TEa options regardless of the
selections made.

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Configure the TEa for All Analytes

1 Click the Advisors tab.
2 Click Configure TEa.
Each analyte appears with the current TEa selection.

Note: An asterisk (*) indicates the default TEa options.

3 Select a TEa from the list located to the left of For All Analytes.

Note: Limits such as BV, CLIA, QMP-LS, and RCPA are only available when
published.

4 Click For All Analytes to apply the TEa selection to all analytes for which
it is available.

Note: If the TEa is not available for the analyte (for example CLIA limits for
zinc), the existing selection remains unchanged.

5 Click Save.

Note: Westgard Advisor™ online uses the TEa selections when generating
rules with the Wizard or the Advanced method. If using the Default method,
Westgard Advisor™ online uses the default TEa options regardless of the
selections made.

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Return TEa Selections to the Default

1 Click the Advisors tab.
2 Click Configure TEa.
Each analyte appears with the current TEa selection.

Note: An asterisk (*) indicates the default TEa options.

3 Click Set All to Default.

Note: Westgard Advisor™ online uses the TEa selections when generating
rules with the Wizard or the Advanced method. If using the Default method,
Westgard Advisor™ online uses the default TEa options regardless of the
selections made.

4 Click Save.

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Data Requirements
Westgard Advisor™ online provides a default set of data requirements to use for
suggesting rules; however, you can customize data requirements.

Important: Westgard Advisor™ online will not generate rules for a test until
the minimum data requirements are met.

• Lab data points (default–minimum of 20)

• Consensus group data points (default–minimum of 100)
• Consensus group labs (default–minimum of 5)

Note: See “Viewing Lab Data and Group Statistics” on page 325 to view
consensus group data. If consensus group data does not appear for a test
or if the consensus group is unexpectedly small, confirm that the test
parameters (analyte, instrument, method, and so on) are correct. If
necessary, update the test. See “Update Tests” on page 132 for more
information.

Specify Data Requirements

1 Click the Advisors tab.
2 Click Preferences.
3 Type the minimum number of data requirements in each of the Minimum
Number boxes.
4 Click Save.

Note: Click Default to return to the default settings.

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Grid Display Options

Grid Display Options determine the information appearing on the Design QC
Rules dialog box. The software provides a default set of options; however, you
can customize Grid Display Options.

Select Grid Display Options

1 Click the Advisors tab.
2 Click Preferences.
3 Select the check box for each item to appear on the Design QC Rules
dialog box. Clear the check box to remove an item.
4 Click Save.

Note: Click Default to return to the default settings.

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Generate Rules with

TM
Westgard Advisor online
There are three methods for generating SPC rules with Westgard Advisor™
online:

• Westgard Advisor™ online Wizard

Westgard Advisor™ online guides you through the process by presenting a
series of dialog boxes from which you select options.

Tip: The Westgard Advisor™ online Wizard contains text in each dialog box
explaining the options. As a result, it is a good method to use when
unfamiliar with Westgard Advisor™ online.

• Advanced option
Westgard Advisor™ online displays a single dialog box for selecting all
options.

Tip: This advanced option is a good choice when familiar with Westgard
Advisor™ online since this option does not provide any explanatory text.

• Defaults
Westgard Advisor™ online generates rules based on its default options.
The default selections are:
• Peer consensus group
• 6-months (date range for data)
• Smallest TEa

Note: Changes cannot be made when using the default method.

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Consensus Groups
Westgard Advisor™ online uses consensus groups from the Unity™
Interlaboratory Program to calculate performance estimates.

Note: Westgard Advisor™ online will not be able to generate rules for a test if
there are not any statistics available for the selected consensus group.

The following consensus groups are available:

• Peer (most specific)

The Peer consensus group is the ideal group for comparison. It is
composed of all laboratories using the same instrument, lot number, level,
reagent, analytical method, units, and temperature of a test.

• Method (next specific)

Choose the Method consensus group when there is an insufficient number
of laboratories in the Peer group. It is composed of all laboratories using
the same lot number, level, analytical method, units, and temperature of a
test.

• All Labs (least specific)

The All Labs consensus group is composed of data from all laboratories
using for the same lot number, level, units, and temperature of a test.

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Use the Westgard Advisor online Wizard
1 Click the Advisors tab.
2 Click Design QC Rules.
3 Select the lab number from the Lab number list.
4 Select the lot number from the Lot number list.
5 Click the Generate Rule Suggestions link.
The Westgard Advisor Configure Rule Selection dialog box appears.
6 Select the Wizard option and click OK.
7 The Configure Rule Selection Wizard – Step 1 of 4 dialog box appears
with two rule generation options:
• All lot numbers
Select this option to generate rules for all identical tests in all lot
numbers within the lab number.
• Specific lot number
Select this option to generate rules only for tests within the selected
lab and lot combination.
8 Click Next.
The Configure Rule Selection Wizard – Step 2 of 4 dialog box appears
with the following message:

What date range should be used to compute performance estimates

from your laboratory data?

9 Click the arrow located to the right of First Date and select a beginning
date for the range of data.

Important: The data within the Lab Data Range is used to compute
performance estimates such as the mean and coefficient of variation (CV) of
the laboratory. Select a representative sample of laboratory data that
correlates with the performance expected to achieve in the future.

10 Click the arrow located to the right of Last Date and select an ending
date for the range of data.
11 Click Next.

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The Configure Rule Selection Wizard – Step 3 of 4 dialog box appears

with the following message:

Which level should be used to compute performance estimates from

your laboratory data?

SPC rules are suggested by analyte. If testing more than one level of
control, select a single level to compute performance estimates for the
analyte.
12 Select an option for the lot:
• By Level
Select this option to specify a control level to use for the calculations.
The level selected is used for all tests. Select a level from the By
Level list.
• By Performance
Select this option for Westgard Advisor™ online to evaluate
performance statistics from all available levels for each analyte and
select an option for the performance:
– Highest Total Error (resulting in conservative settings)
– Lowest Total Error (resulting in optimistic settings)
13 Click Next.
The Configure Rule Selection Wizard – Step 4 of 4 dialog box appears
with the following message:

Which Group do you want to compare to?

Performance estimates can include bias if a consensus group is selected

for comparison. Select This Lab to omit bias from the performance
estimates. Otherwise, select Peer, Method, or All Labs for the
appropriate consensus group comparison.
14 Select a consensus group option and click Finish.
By default, the Grid option of the Design QC Rules dialog box appears
and shows the suggested rules and other statistics.
15 Select the Chart option to view the OPSpecs Chart for the suggested
rules. See “OPSpecs Chart” “OPSpecs Chart” on page 344 for more
information.

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Use the Advanced Option

1 Click the Advisors tab.
2 Click Design QC Rules.
3 Select the lab number from the Lab number list.
4 Select the lot number from the Lot number list.
5 Click the Generate Rule Suggestions link.
The Westgard Advisor Configure Rule Selection dialog box appears.
6 Select the Advanced option and click OK.
The Westgard Advisor Advanced Rule Selection dialog box appears.
7 Select a Lot Number Selection option:
• All Lot Numbers
Select this option to generate rules for all identical tests in all lot
numbers within the lab number.
• Lot number NNNNN (where NNNNN is a specific lot number)
Select this option to generate rules only for tests within the selected
lab and lot combination.
8 Select a Lot Selection option:
• By Level
Select this option to specify a control level to use for the calculations
and then select a level from the By Level list.
• By Performance
Select this option for Westgard Advisor™ online to evaluate
performance statistics from all available levels for each analyte and
select an option for the performance:
– Use level with lowest Total Error (resulting in optimistic
settings)
– Use level with highest Total Error (resulting in conservative
settings)

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9 Click the arrow located to the right of First Date and select a beginning
date for the range of data.

Important: The data within the Lab Data Range is used to compute
performance estimates such as the mean and coefficient of variation (CV) of
the laboratory. Select a representative sample of laboratory data that
correlates with the performance expected to achieve in the future.

10 Click the arrow located to the right of Last Date and select an ending
date for the range of data.
11 Select a Group option.
Performance estimates can include bias if a consensus group is selected
for comparison. Select This Lab to omit bias from the performance
estimates. Otherwise, select Peer, Method, or All Labs for the
appropriate consensus group comparison.
12 Select a Group Data Range option:
• Monthly
• 6 months
• Cumulative
13 Click OK.
By default, the Grid option of Design QC Rules dialog box appears and
shows the suggested rules and other statistics.
14 Select the Chart option to view the OPSpecs Chart for the suggested
rules. See “OPSpecs Chart” on page 344 for more information.

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TM
Use the Westgard Advisor online Defaults

Note: Changes cannot be made to any selections or changes when using

the default method.

1 Click the Advisors tab.

2 Click Design QC Rules.
3 Select the lab number from the Lab number list.
4 Select the lot number from the Lot number list.
5 Click the Generate Rule Suggestions link.
The Westgard Advisor Configure Rule Selection dialog box appears.
6 Select the Use Defaults option and click OK.
By default, the Grid option of Design QC Rules dialog box appears and
shows the suggested rules and other statistics.
7 To view the OPSpecs Chart for the suggested rules, select the Chart
option. See “OPSpecs Chart” on page 344 for more information.

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Apply Rules with Westgard

TM
Advisor online
After Westgard Advisor™ online generates rules, the recommendations appear
in the Suggested Rules column on the Design QC Rules dialog box.

Apply Rules
1 Click the Advisors tab.
2 Click Design QC Rules.
3 Select the lab number from the Lab number list.
4 Select the lot number from the Lot number list.
5 Select the desired Historical Suggestion.
6 Make sure the Grid option is selected.
7 Click the Apply Suggested Rules link.
The Westgard Advisor Apply Suggested Rules dialog box appears
and shows the statistics, existing rules, suggested rules, and performance
information for each analyte.
By default, the check box located to the left of each analyte is selected.
This indicates the suggested rules will be applied to each analyte.

Note: If Westgard Advisor™ online is unable to generate rules for a test, the
check box is cleared and the Suggested Rules column shows the reason
rules could not be generated. If there are not any rules available, the check
box cannot be selected.

8 Clear the check box or click Select None to clear all check boxes. A
cleared check box indicates there will not be any rules applied.
9 Click Apply.
10 Repeat steps 5–9 to make additional changes based on other Historical
Suggestion selections.

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11 The new rule selection(s) appear on the Rules tab of the Rules/Settings
dialog box and UnityWeb™ evaluates new data points against the rules.
(See Chapter 9, “Apply QC Rules” on page 147 for more information
about the Rules tab.)

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TM
Westgard Advisor online Report
The Westgard Advisor™ online Report summarizes the options used each time
SPC rules are generated with Westgard Advisor™ online. The Westgard
Advisor™ online Report shows the information from the Grid and Chart options
of the Design QC Rules dialog box. Print the report to document the selected
rules.

Note: The Westgard Advisor™ online Report is only available for tests for
which rules have previously been generated.

TM
Print the Westgard Advisor online Report
1 Click the Advisors tab.
2 Click Design QC Rules.
3 Select the Chart option.
4 Click the Print Chart link.
5 The Westgard Advisor Print Chart dialog box appears.
6 Select an option for the range of tests to print:
• Current Test
Select this option to print the report for the selected test.
• All Tests
Select this option to print the report for all tests in the lot number.
7 Click Print to PDF.
The Westgard Advisor™ online Report appears in a separate window in
PDF format.

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8 Click the printer icon.

The Print dialog box appears.

9 Select the appropriate options for the printer and click OK.

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Delete Historical Suggestions

Rules suggestions are saved each time SPC rules are generated using
Westgard Advisor™ online. Delete the suggestions if they are no longer needed.

Note: Deleting historical suggestions does not delete any applied rules.

1 Click the Advisors tab.

2 Click Design QC Rules.
3 Select the lab number from the Lab number list.
4 Select the lot number from the Lot number list.
5 Click the Delete Historical Suggestions link.
A separate dialog box opens and shows the Date Generated, Lab Data
Range, Lot Selection, and Group.
6 Select the check box located to the left of the historical selection to delete
or click Select All to delete all historical selections.
7 Click Delete.

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OPSpecs Chart
An OPSpecs (operational process specifications) Chart plots the allowable bias
versus the allowable imprecision. An OPSpecs Chart describes the
imprecision, bias, SPC rules, and number of runs required to assure a defined
quality requirement will be achieved with a known level of analytical quality
assurance (AQA). An OPSpecs Chart provides the information needed to select
appropriate quality control procedures and is therefore an integral part of
Westgard Advisor™ online.

Use the OPSpecs Chart to:

• Identify an appropriate quality control procedure for a test.

• Consider how improving a test's precision and accuracy will change the
Operating Point of the method, and therefore result in simpler and less
expensive quality control.
• Estimate the maximum allowable imprecision for a test from the
X-intercepts of the operating lines for the QC procedures being
implemented.

Each time Westgard Advisor™ online generates rules for a test based on
different TEa and consensus group selections, the rules recommendations are
saved. View the OPSpecs Chart for rule recommendations, compare the charts
for different QC procedures, and select the most appropriate options.

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 Westgard Advisor™ online

OPSpecs Chart Components

An OPSpecs Chart shows the operational limits for bias and imprecision for the
specified candidate QC procedure at either 90%, 50%, or 25% analytical
quality assurance (AQA or error detection).

1 2
OPSpecs Chart TEa 25 % with 90 % AQA (SE)
25.0
Allowable Inaccuracy (BiasTotal %)

20.0
1-3
s

15.0 6
5
4
10.0
7
5.0

0.0
0.0 2.0 4.0 6.0 8.0 10.0 12.0
3 Allowable Imprecision ( Smeas%)

Magnesium
Bias meas = 8.89% Pfr = 0.004
S meas = 2.95% N =2

1 TEa

Total allowable error. The quality requirement for the test.

In the example above, the TEa is 25%.

2 AQA (SE)

Analytical quality assurance for systematic error. The percentage of

error detection. In the example above, the AQA is 90%.

3 Allowable Imprecision (x-axis)

The allowable imprecision (bias) scaled from 0 to 0.5 TEa.

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4 Allowable Inaccuracy (y-axis)

The allowable inaccuracy (bias) scaled from 0 to TEa.

5 Maximum limits of a stable process

The highest line on the chart describes the maximum limits of
inaccuracy and imprecision for a method that is perfectly stable and
does not need any quality control.

6 Limits of bias and imprecision for suggested QC procedure

(Operating Limits line)
The lowest line on the chart describes the limits of bias and imprecision
for the suggested QC procedure with the selected quality control
procedure. The line is labeled with the suggested QC rules (13s in the
example on page 345). The Operating Point should be below this
line.

7 Operating Point
The Operating Point shows where the test’s bias and imprecision
intersect and shows the observed performance of the measurement
procedure. The Operating Point is plotted by obtaining estimates for
imprecision and inaccuracy and using them as X (imprecision) and Y
(inaccuracy) coordinates on the chart.

Operational limits depend on the guarantee of quality built into the process. For
example, operational limits for 90% AQA are more demanding than those for
50% AQA. Lower assurance, or lower error detection, may be acceptable for
very stable testing processes with a very low frequency of errors. However, in
general it is best to aim for 90% AQA.

If any of the lines in the OPSpecs Chart are above the Operating Point, they
meet or exceed the level of quality assurance listed in the chart's title. For
example, if the Operating Limits line is above the Operating Point in a 90%
AQA Chart, the control rule and N (the recommended number of control
determinations) corresponding to that line assures 90% or more analytical
quality assurance or error detection.

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 Westgard Advisor™ online

How to Interpret an OPSpecs Chart

The lines on the OPSpecs Chart divide the chart into three sections.

OPSpecs Chart TEa 25 % with 90 % AQA (SE)

25.0
Allowable Inaccuracy (BiasTotal %)

20.0

1-3
15.0 s
4
10.0

5.0

0.0
0.0 2.0 4.0 6.0 8.0 10.0 12.0
Allowable Imprecision ( Smeas%)

Solid Shallow Deep

Ground Water Water

Dr. James Westgard describes the three sections using the following terms.

• Solid ground
This is the area below the line for Limits of bias and imprecision for
suggested QC procedure (Operating Limits line). This is where the
Operating Point should appear. The position of the Operating Point
varies depending on the rule(s) it represents. Use different TEa and
consensus group criteria to generate multiple sets of rules. Review the
OPSpecs Chart before deciding which rules to apply.

• Shallow water
This is the area between the Maximum limits of a stable process line
and the Limits of bias and imprecision for suggested QC procedure
(Operating Limits line) line representing the suggested QC procedure. If
the Operating Point appears in this area, it is best to consider other rule
combinations and try to improve the test method performance.

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 Westgard Advisor™ online

• Deep water
This is the area above the Maximum limits of a stable process line. If
the Operating Point is in this area, consider other rule combinations and
attempt to improve the test method performance. If the Operating Point
is in this area, Westgard Advisor™ online will most likely recommend a
maximum QC procedure.

TM
When Westgard Advisor online Recommends a
Maximum QC Procedure
To maximize error detection, the recommended rules for maximum QC include
all available SPC rules. The recommended number of control determination (N)
is also increased. If the laboratory does not have the resources to implement
the recommendation, apply the most stringent rules possible. Also consider
ways to improve test method performance (bias and CV). Consider replacing
the method with a better one.

Important: The maximum QC procedure is not capable of 50% error

detection. Do not rely on the control rules alone to provide QC for the
method. Use non-statistical factors to improve QC for the test.

348 Bio-Rad Laboratories, Inc.

 CHAPTER
19
Supplemental
Information

In This Chapter
Action Log Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 349
Audit Trail Events. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 351
Rejection Log Messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 353

Action Log Messages

The following is a list of the pre-defined action messages and their code
number. If you add custom action messages, the action is added in
alphabetical order. The software assigns a code number to the action based on
the next available number.

Action Log Messages

1 Calibrator: changed
2 Calibrator: new lot
3 Control: reconstituted new
4 Control: repeated level 1
5 Control: repeated level 2
6 Control: repeated level 3
7 Control: repeated level 4
8 Filter: performed maintenance
9 Filter: regulatory
10 Instrument: bleached

Reference Guide for UnityWeb™ 2.0 349

 Supplemental Information

Action Log Messages (continued)

11 Instrument: calibrate
12 Instrument: electrode/cartridge change
13 Instrument: enzyme cleaner
14 Instrument: membrane changed
15 Instrument: service
16 Maintenance: corrective
17 Maintenance: daily
18 Maintenance: monthly
19 Maintenance: semi-annual
20 Maintenance: weekly
21 Mean: established new
22 Pipette: calibrate
23 Proficiency testing
24 QC: reviewed for day
25 QC: reviewed for month
26 QC: reviewed for week
27 Range: established new
28 Reagent: changed
29 Reagent: new lot
30 Test/assay repeated
31 Test: calibrate

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 Supplemental Information

Audit Trail Events

The following is a list of events tracked by the Audit Trail Report. See “Audit
Trail Report” on page 253 for more information.

Audit Trail Events

Fixed Mean added or changed

Fixed standard deviation added or changed

Data deleted using Delete Range of Data

Number of decimal places changed

Number of points before rule evaluation changed

Data point date/time changed

Data deleted from within data entry

Data point edited

Designer lot edited

Lab profile updated

Lot number edited after data entry

Data inserted

Accepted/rejected status changed

SPC rule change: 1-2s

SPC rule change: 1-2.5s

SPC rule change: 1-3s

SPC rule change: 2-2s

SPC rule change: 2/3-2s

SPC rule change: R-4s

SPC rule change: 3-1s

SPC rule change: 4-1s

SPC rule change: 7-T

SPC rule change: 7-x

SPC rule change: 8-x

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 Supplemental Information

Audit Trail Events (continued)

SPC rule change: 9-x

SPC rule change: 10-x

SPC rule change: 12-x

SPC rule change: 1-3.5s

SPC rule change: 1-4s

SPC rule change: 1-5s

352 Bio-Rad Laboratories, Inc.

 Supplemental Information

Rejection Log Messages

The following is a list of the messages that appear on the Rejection Log to
correct errors from a connectivity solution.

Rejection Log Messages

Analyte code invalid
Create new lots if necessary disabled
Create new tests if necessary disabled
Data entry locked for this test
Date earlier than test creation date
Date out of range
Date out of sequence
Date/Time invalid
Failed validity check
Instrument code invalid
Invalid Day
Invalid Hour
Invalid level number
Invalid Mean
Invalid Minute
Invalid Month
Invalid number of Points
Invalid SD
Invalid Second
Invalid Time
Invalid Value
Invalid Year
Lab closed
Lab number undefined
Lot closed
Lot expired

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 Supplemental Information

Rejection Log Messages (continued)

Lot number undefined
Method code invalid
Method invalid for selected analyte
No code-fulfillment test ID defined
No Target Value defined
Reagent code invalid
Record type invalid
Result invalid
Temperature code invalid
Temperature invalid for selected analyte
Test not defined
Time out of sequence
Unable to create new test
Unit code invalid
Unit invalid for selected analyte

354 Bio-Rad Laboratories, Inc.

 CHAPTER
20
References

In This Chapter
QC References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 355

QC References

Articles
1 Elsa F. Quam, BS, MT(ASCP), QC–The Out-Of-Control Problem, retrieved
June 6, 2006, from the Basic QC Practices Lessons section of Dr. James
O. Westgard’s Web site at [Link]
2 Westgard J.O., Burnett RW. Precision requirements for cost-effective
operation of analytical processes. Clin Chem 1990; 36:1629-1632.
3 Westgard, J.O. et al., Combined Shewhart–CUSUM Control Chart For
Improved Quality Control In Clinical Chemistry; CLIN. CHEM. 23/10,
1881-1887 (1977).
4 Westgard, J.O.; Barry, P. L.; Hunt M.R.; Groth, T; A Multi-Rule Shewhart
Chart For Quality Control In Clinical Chemistry; CLIN. CHEM. 27/3
493-501 (1981).
5 Westgard, J.O.; Koch, D.D.; Oryall, J.J.; Quam, E. F.; Feldbruegge, D. H.;
Dowd, D. E.; Barry, P.L.; Selection Of Medically Useful Quality Control
Procedures For Individual Tests Done In A Multi Test System; CLIN.
CHEM. 36, 230 (1990).

Reference Guide for UnityWeb™ 2.0 355

 References

Books
1 Cembrowski, G.S.; Carey, R.N.; Laboratory Quality Management: QC &
QA, ASCP Press (1989).
2 Cooper G., Gillions T, Producing Reliable Test Results in the Medical
Laboratory: Using a Quality System Approach and ISO 15189 to Assure
the Quality of Laboratory Examination Procedures, Bio-Rad Laboratories,
Inc., 2007.
3 Davies, O.L.; Goldsmith, P.L. Statistical Methods In Research and
Production, New York (1984).
4 Howanitz, Peter J and Joan H., Laboratory Quality Assurance,
McGraw-Hill Book Company (1987).
5 Weisbrot, M.D., Statistics For The Clinical Laboratory; J.B. Lippincott
Company, Philadelphia (1985).
6 Westgard J.O. Basic QC Practices; second edition; (2002).
7 Westgard, J.O. Assuring the Right Quality Right. Westgard QC, Inc.
Madison, WI, 2007.
8 Westgard, J.O., Barry Patricia L, Cost Effective Quality Control: Managing
the Quality and Productivity of Analytical Processes. AACC Press 1995.
9 Westgard J.O. Basic Planning for Quality: Training in Analytical Quality
Management for Healthcare Laboratories, Westgard Inc., 2000.

Guidelines
1 C24. Statistical Quality Control for Quantitative Measurement Procedures:
Principles and Definitions. Clinical and Laboratory Standards InstituteTM,
(formerly NCCLS) Wayne, PA, 2006.
2 National Committee for Clinical Laboratory Standards. Evaluation of
precision performance of clinical chemistry devices - Second Edition;
Tentative Guideline. NCCLS document EP5-T2 (ISBN 1-56238-145-8).
NCCLS, 771 East Lancaster Avenue, Villanova, Pennsylvania, 19805,
1992.

356 Bio-Rad Laboratories, Inc.

Glossary

accuracy

The closeness of agreement between a result and the accepted reference

value. Accuracy, when applied to a set of test results, involves a combination of
random components and a common systematic error or bias component.

active rule
A SPC rule with a status of warn or reject.

Affiliated Data Exception Report

Note: Affiliated Reports are optional. Contact your Bio-Rad QC Program

Representative to request Affiliated Reports.

For all laboratories within the affiliated laboratory consensus group, this report
shows any analyte:

• Exceeding a specified SDI or CVR warning limit compared to the

consensus group.
• Rejected by the Unity™ Interlaboratory Program.
• Containing a suspected coding error such as invalid unit, invalid method,
and so on.

affiliated group
A group of laboratories in the Unity™ Interlaboratory Program comparing their
results and essentially become their own consensus group. Contact your
Bio-Rad QC Program Representative to request any of the available Affiliated
Reports.

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 Glossary

Affiliated Laboratory Comparison Report

Note: Affiliated Reports are optional. Contact your Bio-Rad QC Program

Representative to request Affiliated Reports.

The Affiliated Laboratory Comparison Report summarizes the performance of

each participating affiliated laboratory in a single report. Statistics are provided
for your laboratory and all affiliated laboratories and include:

• Mean
• Standard deviation (SD)
• Coefficient of variation (CV)
• Coefficient of variation ratio (CVR) and Standard deviation index (SDI)
• Lab to Peer Group
• Lab to Lab Group (affiliated group)
• Number of points

Affiliated Laboratory Comparison Report: Abbreviated Summary

Note: Affiliated Reports are optional. Contact your Bio-Rad QC Program

Representative to request Affiliated Reports.

This report is designed for a quick review and focuses on key statistics to
provide a performance summary for multiple laboratories. This report
summarizes the performance of each participating affiliated laboratory in a
single report. For each test, this report shows:

• Mean
• Standard deviation (SD)
• Coefficient of variation (CV)
• Number of points
• Coefficient of variation ratio (CVR) compared to the Peer, Method, and
Affiliated consensus groups
• Standard deviation index (SDI) compared to the Peer, Method, and
Affiliated consensus groups

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 Glossary

Affiliated Reports

Note: Affiliated Reports are optional. Contact your Bio-Rad QC Program

Representative to request Affiliated Reports.

Affiliated Reports allow a group of laboratories to compare results, essentially

creating their own consensus group. The Unity™ Interlaboratory Program
provides the following Affiliated Reports:

• Affiliated Laboratory Comparison Report

• Affiliated Laboratory Comparison Report: Abbreviated Summary
• Affiliated Data Exception Report

all labs group

One of the available Unity™ Interlaboratory Program consensus groups. The All
Labs consensus group is composed of data from all laboratories reporting for
the same lot number, level, units, and temperature of a test.

analyte
A substance or chemical constituent being analyzed such as glucose, TSH,
and so on.

analytical process
A series of steps taken in the analysis or testing of patient specimens or
samples.

audit trail
A secure, computer generated electronic record allowing reconstruction of the
course of events relating to the creation, modification, and deletion of an
electronic record.

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 Glossary

bias
Bias measures how far an observed value is from a target value and is
expressed as a percentage. Bias is determined by a reference value or
estimated from an outside source such as proficiency testing results or the
Bio-Rad Unity™ Interlaboratory Program. Use the following formula to calculate
bias:

Laboratory Mean – Consensus Group Mean

Laboratory Bias % = × 100
Consensus Group Mean

Note: Bias is the total systematic error as contrasted to random error. There
may be one or more systematic error components contributing to the bias.
A larger systematic difference from the accepted reference value is reflected
by a larger bias value. [ISO 3534-I]

Bias and Imprecision Histogram Report

The Bias and Imprecision Histogram Report is one of the Unity™ Interlaboratory
Reports. This report provides a graphic representation of a laboratory’s bias
compared to the current cumulative consensus group mean and a laboratory’s
CV. On the chart, the monthly CV is represented as a bar and the bias is
represented as a diamond with lines connecting each diamond. The Bias and
Imprecision Histogram Report helps to detect changes in performance over
time and to identify if the change in performance is due to imprecision, bias, or
both.

Note: The Bias and Imprecision Histogram Report does not contain specific
thresholds for allowable bias or allowable imprecision.

360 Bio-Rad Laboratories, Inc.

 Glossary

CLIA
Acronym for the Clinical Laboratory Improvements Amendments of 1998 which
regulate laboratory practice in the United States.

CLSI
Acronym for the Clinical and Laboratory Standards Institute. Formerly the
NCCLS.

consensus group
A group of laboratories submitting data to the Unity™ Interlaboratory Program.
Carefully select a consensus group for comparison as statistical outcomes can
be quite different based on the nature of the grouping. When choosing a
consensus group, always choose the most specific group for which statistics
are available.

The available Unity™ Interlaboratory Program consensus groups are:

• Peer (most specific)

The Peer consensus group is composed of all laboratories using the same
instrument, lot number, level, reagent, analytical method, units, and
temperature of a test. This is the ideal group for comparison.
• Method (next specific)
The Method consensus group is composed of all laboratories using the
same lot number, level, analytical method, units, and temperature of a test.
Use the Method group if there is an insufficient number of laboratories in
the Peer group.
• All Labs (least specific)
The All Labs consensus group is composed of data from all laboratories
reporting for the same lot number, level, units, and temperature of a test.

cumulative mean
Also known as floating mean. The mean of all accepted data points entered for
a test. If a fixed mean is not defined, the software uses the cumulative (floating)
mean for rule evaluation.

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 Glossary

CV (coefficient of variation)
The coefficient of variation is the standard deviation expressed as a percentage
of the mean. Use the following formula to calculate the CV:

Standard Deviation
CV % = × 100
Mean

CVR (coefficient of variation ratio)

The coefficient of variation ratio compares a laboratory’s precision to that of
other laboratories in a consensus group. Use the following formula to calculate
the CVR:

Laboratory CV
CVR =
Consensus Group CV

data group
A user-defined set of data points having something in common, such as a
calibrator lot. Define data groups on the Single Test Point Data Entry dialog
box and the Single Test Summary Data Entry dialog box.

Data Rejection Report

The Data Rejection Report is one of the Unity™ Interlaboratory Reports and is
only generated when data is rejected by the Unity™ Interlaboratory Program.
The rejected data points are not included in cumulative statistics or in statistical
comparisons. Data points may be rejected for two reasons:

• The data points are outside the standard statistical range, based on
consensus group mean, SD range, or CV.
• The data points were reported with an incorrect code (for example, invalid
units, invalid method, and so on).

362 Bio-Rad Laboratories, Inc.

 Glossary

evaluation mean/SD
The mean and SD UnityWeb™ uses to evaluate a data point. When using
cumulative (floating) statistics, these values can be different for each data point.
View the evaluation statistics by clicking for a row of data on the Single
Test Point Entry dialog box.

fixed statistics
Fixed statistics refers to specifying (fixing) the evaluation mean and/or SD for a
test.

floating mean
Also known as cumulative mean. The mean of all accepted data points entered
for a test. If a fixed mean is not defined, the software uses the floating
(cumulative) mean for rule evaluation.

imprecision
Imprecision is a term to describe the dispersion or spread of a set of values
about the mean value of a normal or gaussian distribution. It is usually
expressed as a SD or CV.

inactive rule
A SPC rule with a status of off.

TM
InstantQC
An instant laboratory program option for comparing point data submitted via
the Bench Review to other laboratories’ data on demand. InstantQC™ Reports
and Charts are available on [Link].

TM
InstantQC Chart
When sending data to the Unity™ Interlaboratory Program from Bench Review,
the reviewed data points appear on InstantQC™ Reports and Charts on
[Link] after a short processing time. The InstantQC™ Chart plots
your data points for your selected date range against your selected consensus
group’s mean and ±3SD range.

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 Glossary

TM
InstantQC Report
When sending data to the Unity™ Interlaboratory Program from Bench Review,
the reviewed data points appear on InstantQC™ Reports and Charts on
[Link] after a short processing time. The Comparison Statistics
Shown are:

• SDI: a measurement of your bias compared to your selected consensus

group.
• Bias: a measurement of how far your observed value is from the target
value.
• TEB%: a measurement of your total error (bias and imprecision) compared
to the total allowable error limits based on biological variation.

interlaboratory
Comparative results between laboratories used to determine values and
assess test methods.

intralaboratory
Within a single laboratory.

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 Glossary

Laboratory Comparison Report

The Laboratory Comparison Report is one of the Unity™ Interlaboratory Reports
and shows the monthly and cumulative statistics for the laboratory, Peer group,
and Method group for all tests reported. The Laboratory Performance Overview
Report is automatically generated each month you submit data; however, you
can specify a different report frequency. See “Configure Unity™ Interlaboratory
Report Frequency” on page 86 for more information.

Use the Laboratory Comparison Report to compare results to those of the

Peer and Method consensus groups. For VITROS® instruments, the Laboratory
Comparison Report provides statistics for the laboratory, Peer group, and
Method group based on the slide generation numbers reported for the
laboratory.

The Laboratory Comparison Report contains the following monthly and

cumulative statistics for each test:

• Laboratory mean
• Laboratory SD
• Laboratory CV
• Number of points reported by the laboratory
• CVR for the Peer and Method groups
• SDI for the Peer and Method groups

The Laboratory Comparison Report also contains the monthly and cumulative
Peer and Method group statistics for:

• Mean
• SD
• CV
• Number of points reported
• Number of laboratories reporting

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 Glossary

Laboratory Histogram Report

The Laboratory Histogram Report is one of the Unity™ Interlaboratory Reports
and is a bar chart showing up to a 12 month summary of the laboratory’s
monthly means against the current cumulative consensus group means ±2SD
range. The Laboratory Histogram Report is automatically generated each
month you submit data; however, you can specify a different report frequency.
See “Configure Unity™ Interlaboratory Report Frequency” on page 86 for more
information.

The report shows the laboratory’s mean, SD, CV, and number of points for
each bar. Each level of control has a separate bar chart.

The Laboratory Histogram Report provides a visual comparison which is useful

to identify shifts (abrupt changes in values) and trends (gradual changes in
values).

Laboratory Performance Overview Report

The Laboratory Performance Overview Report is one of the Unity™
Interlaboratory Reports and allows you to visually evaluate the bias and
imprecision for each test compared to the Peer and Method consensus groups
on a modified Youden Chart. The Laboratory Performance Overview Report is
automatically generated each month you submit data; however, you can
specify a different report frequency. See “Configure Unity™ Interlaboratory
Report Frequency” on page 86 for more information.

The SDI and CVR are combined as X-Y coordinates located within one of three
performance zones designated by increased levels of shading:

• No shading
Acceptable performance.

• Slight shading
Acceptable to marginal performance. This may indicate the need to
investigate test system bias and imprecision.

• Darkest shading
Outside of acceptable and marginal performance.
Corrective action may be needed.

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 Glossary

• Outside of graph
Unacceptable performance.
Requires corrective action.

The center of the graph (SDI and CVR both equal to zero) represents perfect
agreement between the laboratory's values and the consensus group (Peer or
Method) statistics. Bias and imprecision increase as values move further away
from the center of the graph.

level
When referring to QC materials, level refers to the concentration of analytes
within the control material. Controls are usually bi-level (low and high) or tri-level
(low, normal, and high).

levels in use
The levels of a control product used in the laboratory (for example, level 1, level
2, level 3). Unused levels of a control material are omitted from intralaboratory
and Unity™ Interlaboratory Reports.

Levey-Jennings Chart
A graphical chart used to plot successive quality control results, either
day-to-day or run-to-run.

Manufacturer Report
The Manufacturer Report is provided through the Unity™ Interlaboratory
Program and is a subset of the information from the Worldwide Report
separated by the instrument manufacturer. The Manufacturer Report is a good
reference to use when evaluating a new instrument or kit and is updated every
month.

master lot number

For Bio-Rad controls, the master lot number is the 5-digit lot number, ending in
zero, which includes all levels of the control product (for example, 40910). To
identify the levels of a control product, the final zero is changed to the level
number (for example, 40911 is level 1, 40912 is level 2, and 40913 is level 3).

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 Glossary

matrix
The substance containing the analyte being tested (for example, serum, urine,
spinal fluid, whole blood).

maximum QC
The condition existing when Westgard Advisor™ online is unable to suggest
rules meeting your quality specification (TEa). This condition indicates the test
process has such a low process capacity (high total error) it cannot be
controlled to a defined level of quality. The default maximum QC procedure is a
Westgard multirule applying every possible rule.

mean
The mean for a group of data points is simply the arithmetic average. The
mean provides a laboratory's best estimate of the analyte's “true” value for a
specific level of control. The mean ± a predetermined number of standard
deviations represents the error expected in a test when the analytical system is
stable. Use the following formula to calculate the mean:

Xn
Mean = ∑n
where: ∑ = sum
Xn = each value in the data set
n = the number of values in the data set

median
The middle value in a distribution, above and below which lie an equal number
of values.

method
The way by which an analyte is measured (for example, hexokinase).

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 Glossary

method group
One of the available Unity™ Interlaboratory Program consensus groups. The
Method consensus group is composed of all laboratories using the same lot
number, level, analytical method, units and temperature of a test. Use the
Method group when there is an insufficient number of laboratories in the Peer
group.

Monthly Evaluation Report

The Monthly Evaluation Report is automatically generated each month you
submit data. The Monthly Evaluation Report validates the monthly laboratory
performance as compared to the Peer group. This report identifies when the
monthly laboratory performance does not statistically compare with or was not
accepted into the Unity™ database. Also, the Monthly Evaluation Report notifies
the laboratory when its data was not received in time for the comparison.

operating point
The point on an OPSpecs Chart representing the intersection of bias and
imprecision for a test. The Operating Point represents the current performance
of a test.

OPSpecs (operational process specifications) Chart

OPSpecs Charts are an integral part of Westgard Advisor™ online. In general,
an OPSpecs Chart is a tool for assisting a laboratory to select appropriate SPC
rules and the number of control measurements for a QC procedure. OPSpecs
Charts are plots of the allowable inaccuracy versus allowable imprecision. The
highest line on the chart describes the maximum limits for inaccuracy and
imprecision for a stable process. The lower line describes operational limits
with the selected QC procedure. The Operating Point appears where the
accuracy and precision of the test intersect.

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 Glossary

panel
A user-defined group of tests organized to make data entry and review easier.
Create a panel to customize the organization of tests in a convenient way. For
example, a panel can be created to group a number of different tests
performed on a single instrument, or a panel can be created to group the same
test performed on multiple instruments.

peer group
One of the available Unity™ Interlaboratory Program consensus groups. The
Peer consensus group is composed of all laboratories using the same
instrument, lot number, level, reagent, analytical method, units, and
temperature of a test. This is the ideal group for comparison.

percent AQA (SE)

The percent of analytical quality assurance (AQA) for systematic error (SE) is
the chance of detecting medically important systematic errors. Percent AQA
(SE) is synonymous with probability of error detection (Ped).

point data
A single value generated as a result of testing an analyte within a control
material.

precision
A measurement of how close a set of measurements are to each other. The
measurements may or may not be close to the “true” answer. See “accuracy”
on page 357.

probability of false rejection (Pfr)

A QC performance characteristic describing how often a run is rejected when
there are no errors.

QC (quality control)
In the clinical laboratory, QC is a system designed to increase the probability
each result report is valid and can be used with confidence by a health care
provider when making diagnostic or therapeutic decisions.

370 Bio-Rad Laboratories, Inc.

 Glossary

random error
A random deviation from the laboratory mean. “Expected” or “acceptable”
random error is generally between ±3SD of the mean. A deviation greater than
±3SD is considered “unacceptable” random error. Because of its random
nature, this type of error is unpredictable.

range
The difference between the largest and the smallest observed value of a
quantitative characteristic or statistical limit.

rejection rule
A SPC rule with a status of reject. When a data point violates a SPC rule with a
reject status, the point is not accepted and is excluded from monthly and
cumulative statistics and is not reported to the Unity™ Interlaboratory Program
for consensus group comparison.

run
A set of QC values UnityWeb™ groups together for statistical profile rule
evaluation (for example, within run and between run).

shift
A type of systematic error evidenced by an abrupt change in the mean of the
control values.

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 Glossary

SD (standard deviation)
The standard deviation measures a test's precision, or how close individual
measurements are to each other. (The standard deviation does not measure
bias, which requires comparing results to a target value such as the Peer
consensus group.) The standard deviation provides an estimate of how
repeatable a test is at specific concentrations. Test repeatability can be
consistent (low standard deviation, low imprecision) or inconsistent (high
standard deviation, high imprecision). Use the following formula to calculate the
SD:

∑ ⎛ X − X⎞
⎜
⎝ n
⎟
⎠
SD =
n −1

where: x = mean (average) of the QC values

∑(xn- x )2 = the sum of the squares of differences between
individual QC values and the mean
n = the number of values in the data set

SDI (standard deviation index)

The standard deviation index is a measurement of bias (how close a value is to
the target value). The Unity™ Interlaboratory Program uses the consensus
group value as the target value. Use the following formula to calculate the SDI:

Laboratory Mean – Consensus Group Mean

SDI =
Consensus Group Standard Deviation

SPC (statistical process control) rules

A set of rules which use statistics to monitor and evaluate a process. SPC rules
include the original six Westgard rules as well as additional rules.

372 Bio-Rad Laboratories, Inc.

 Glossary

Statistical Profile Report

Note: The Statistical Profile Report is optional. Contact your Bio-Rad QC

Program Representative to request this report.

The Statistical Profile Report allows you to compare your laboratory's statistics
to the Peer, Method, and All Labs consensus group statistics for selected time
periods. The Statistical Profile Report also provides two histograms
summarizing how your laboratory’s mean and CV compare to the range of
mean and range of CVs calculated for each consensus group.

summary data
The mean, SD, and number of points for a data set comprised of the control
material results for testing an analyte over a specific time range (for example,
October 2007).

suspect data
Data points violating any SPC rule set to reject or warn.

systematic error
A trend or shift away from the laboratory mean. Small amounts of systematic
error are tolerable. Systematic error remains until corrective action is taken.

Bio-Rad Laboratories, Inc. 373

 Glossary

TE (total error)
Total error is the overall error that may occur in a test result due to the
imprecision and bias present in the testing procedure. Use the following
formula to calculate the TE:

Laboratory TE = [Laboratory Bias (%)] + z-score × (Laboratory Imprecision %)

TEa specifications are available from several sources as described in

“Determine Quality Requirements for the Test” on page 43.

• Total error < total allowable error = test results are generally considered
reliable.
• Total error > total allowable error = corrective action should be taken as
quality specifications are not being met.

TEa (total allowable error)

Total allowable error is a quality requirement setting limits for the imprecision
and bias allowable in a test result. After choosing a TEa, the TE budget can be
calculated. Use the following formula to calculate the TEa:

TEa = z-score × (Desirable Imprecision %) + [Desirable Bias %]

trend
A type of systematic error causing a gradual, often subtle increase or decrease
in control values and possibly patient results.

Urinalysis Report

Note: The Urinalysis Report is optional. Contact your Bio-Rad QC Program

Representative to request this report.

374 Bio-Rad Laboratories, Inc.

 Glossary

Customers submitting data for a Bio-Rad urinalysis product to the Unity™

Interlaboratory Program receive a qualitative report consisting of the following:

• Cover page
• Dual level chemistry report for each instrument submitted
• Dual level microscopy report for each data entry set submitted

The Urinalysis Report displays only one set of results per day. If submitting
multiple sets, this report includes the one with the most recent date-time
stamp.

warn rule
A SPC rule with a status of warn. When a data point violates a SPC rule with a
warn status, the data point is accepted and is included in monthly and
cumulative statistics and is reported to the Unity™ Interlaboratory Program for
consensus group comparison.

Westgard rules
A laboratory QC system based on a set of six core statistical rules, each having
statistical power to detect random and systematic deviations from the norm.

Worldwide Report
The Worldwide Report is provided through the Unity™ Interlaboratory Program.
The Worldwide Report contains all Peer group and Method group statistics and
is a good reference to use when evaluating a new instrument or kit. The
Worldwide Report includes:

• All Peer group and Method group statistics.

• All tests (including all instruments, all methods, and so on) reported to the
Unity™ Interlaboratory Program by all laboratories reporting on the same lot
number.
• Monthly and cumulative statistics (mean, SD, CV, number of points, and
number of laboratories) for each level of control.

Bio-Rad Laboratories, Inc. 375

 Glossary

z-score
The z-score is the number of standard deviations a control result is from the
expected mean. Use the following formula to calculate the z-score:

Observed Result – Expected Mean

z-score =
Expected Standard Deviation

A z-score of ±2.3 indicates the observed value is ±2.3SD away from the
expected mean. A data point with this z-score would violate the 12s rule, but
not the 13s rule. The z-score appears on the Single Test Point Data Entry
dialog box.

376 Bio-Rad Laboratories, Inc.

License Agreement, Warranty
Information, and Trademark
Notices

In This Chapter
License Agreement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 377
Warranty Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 378
Trademark Notices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 379

License Agreement
Bio-Rad hereby grants to you, and you hereby accept, a non-exclusive license
to use the Unity Real Time software program (“Software”), and the related
materials provided in this package. If you do not agree to the terms hereof,
promptly return the Software and all other related materials provided in this
package to the place of purchase. Except for the limited license granted herein,
Bio-Rad owns all copyright, trade secret, patent and other proprietary rights,
and all other right, title and interest, in and to the Software and related
materials.

You may not copy, reproduce, or transmit any part of the Software or other
related materials including but not limited to the user manual or reference guide
in any form or by any means (including translation to another language,
computer language, or format). For user manuals provided electronically such
as a PDF file, it is permissible to print these for use by the Purchaser. You may
not reverse engineer, decompile, disassemble, or otherwise reduce the
Software to any human perceivable forms. You may not modify, adapt,
translate, rent, lease, loan, resell for profit, transfer, export or create derivative
works based upon the Software or any part thereof. You agree to keep

Reference Guide for UnityWeb™ 2.0 377

 License Agreement, Warranty Information, and Trademark Notices

confidential, and use your best efforts to prevent the unauthorized disclosure
and use of, the contents of the Software and related materials.

The Software is licensed for use only to medical laboratories worldwide using
Bio-Rad quality control products and is not for sale to the general public unless
otherwise specified. The information contained in the user manual and
reference guide is subject to changes and updates at Bio-Rad's discretion.

Warranty Information
The Purchaser must notify Bio-Rad of its claim of any defect. If the Software is
found to be defective by Bio-Rad, Bio-Rad's sole obligation under this warranty
is to remedy such defect in a manner consistent with Bio-Rad's regular
business practices. For a defect which materially adversely affects the
performance of the Software, Bio-Rad shall use commercially reasonable
efforts to cure such defect as soon as reasonably practicable after receipt of
Purchaser's notice, and for minor defects, Bio-Rad shall use commercially
reasonable efforts to correct such minor defects in the next release of its
Software. If, however, Bio-Rad is unable to cure a major defect, the
Purchaser's sole remedy shall be the option to cancel this Agreement,
whereupon Bio-Rad shall refund only the Software fees paid, and Bio-Rad shall
have no other liability whatsoever.

The warranties set forth in this Agreement are in lieu of all other representations
and warranties, express or implied, including warranties of merchantability and
fitness for a particular purpose, any warranty of non-infringement, and any
other statutory or common-law warranty. Bio-Rad on its own behalf hereby
expressly disclaims and excludes any and all such other representations and
warranties. Liability of Bio-Rad to the Purchaser, if any, for breach of warranty,
or any other claim relating to this Agreement shall in no event exceed the total
amount of Software fees paid by the Purchaser to Bio-Rad. In no event shall
Bio-Rad be liable for incidental or consequential damages (including but not
limited to damages to any laboratory instruments, computer equipment or data
arising from the use of the Software), loss of business or profits, special or
indirect damages of any nature whatsoever, even if Bio-Rad has knowledge of
the potential loss or damage. Bio-Rad accepts no responsibility for misuse of
the Software or its data modifying capabilities.

378 Bio-Rad Laboratories, Inc.

 License Agreement, Warranty Information, and Trademark Notices

Trademark Notices
DirectConnect, InstantQC, QCNet, SoftConnect, UnityWeb, Unity
Interlaboratory Program, Unity Real Time, Unity Desktop, WebConnect, and
Westgard Advisor are trademarks or registered trademarks of Bio-Rad
Laboratories, Inc.

All other trademarks and registered trademarks used in this guide are the
property of other companies.

Please consult the individual manufacturers for specific information.

Bio-Rad Laboratories, Inc. 379

 License Agreement, Warranty Information, and Trademark Notices

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380 Bio-Rad Laboratories, Inc.

Index apply rules with Westgard Advisor™
online, 339
arrange and sort lots, 119
audit trail events, 253, 351
Numerics
audit trail report, 253
12.5s rule, 29
12s rule, 27
13.5s rule, 30 B
13s rule, 29 bar chart, 236
14s rule, 31 basic QC statistics, 17
15s rule, 31 bench review, 202
2 of 32s rule, 34 bias and imprecision histogram
22s rule, 32 report, 276
31s and 41s rule, 36 buttons, 9
7T rule, 38
C
A CAP accreditation requirements, 306
action log messages, 349 change a data point’s
actions, 209 accepted/rejected status, 192
actions and comments, 84, 209 change a password, 99
actions and comments by instrument, change data, 187
218 change the accepted/rejected status,
activate automatic monthly 193
transmission, 259 change the current data option, 146
activate transmissions for change the date and time for a row of
InstantQC™, 260 data, 170
add a Bio-Rad lot, 112 change the VITROS® slide generation
add a comment to a row of data, 217 number, 138
add a lab number, 107 chart header options, 226
add a user, 94 check boxes, 9
add and update lab numbers, 107 chemistry section, 290
add non-Bio-Rad lots, 112 choose goals based on required
add tests, 124 quality, 52
add tests manually, 125 CLIA requirements, 16, 298
add tests using instrument setup, 127 close a lab number, 109
add tests with a code of “other”, 128 close a lot, 118
add tests with instrument setup, 126 close a test, 133
additional lab numbers, 106 close and open lots, 118
administration/setup permissions, close and open tests, 133
100 command buttons and options, 164
affiliated data exception report, 288 comments, 216
affiliated lab numbers, 106 comprehensive reports, 263, 278
affiliated laboratory comparison condense data, 89
report, 285 configure Unity™ Interlaboratory report
abbreviated summary, 287 frequency, 86
affiliated reports, 285 configure UnityWeb™, 82
apply rules, 339 configure Westgard Advisor™ online,
326

Reference Guide for UnityWeb™ 2.0 381

 Index

consensus groups, 264, 333 download Adobe® Reader®, 77

contact Bio-Rad, 3 duplicate a Bio-Rad lot number, 115
create a bar chart, 237 duplicate a lab number, 108
create a data review report, 245 duplicate a non-Bio-Rad lot number,
create a Levey-Jennings chart, 234 116
create a listings report, 256 duplicate lots, 114
create a multi-LJ chart, 235 duplicate tests, 132
create a panel and add tests, 142
create a point data report, 246 E
create a statistical report, 248 edit data, 190
create a summary data report, 247 edit data, date, and time, 189
create a supervisor’s report, 249 edit lot numbers, 117
create a Youden chart, 240 edit the date and time, 191
create an audit trail report, 253 enter multi test data, 186
create an operator report, 251 enter qualitative data, 181
current lab, panel, lot, and test, 66 enter single test point data, 176
enter single test summary data, 179
D essential startup tasks for new users,
data entry configuration, 83 6
data entry features, 169 evaluate test performance, 45
data entry grid, 166 example lists, 66
data entry permissions, 188 export data, 87
data groups, 145
data handling permissions, 103 F
data permissions, 103 fill background, 224
data rejection report, 268 first time log in, 6, 63
data requirements, 330 fixed mean and SD, 168
data review permissions, 101 fixed statistics, 174
data review report, 245 functions and where to find them, 71
database permissions, 101
define or edit a group, 146 G
define, modify, and delete users, 93 general chart options, 224
delete a panel, 144 generate rules with Westgard
delete a range of data, 91, 197 Advisor™ online, 332
delete a row of data from the data good laboratory habits, 55
entry dialog box, 196 grid display options, 331
delete a test, 136 grid lines and color, 225
delete a user, 96 group login ID and password, 97
delete data, 196 group statistics, 167
delete historical suggestions, 343
delete lab numbers, 110
delete lot numbers, 120
delete tests, 136
determine quality requirements for the
test, 43
direct method of adding tests, 124
document report reviews, 244

382 Bio-Rad Laboratories, Inc.

 Index

H M
how are QC results used?, 14 manufacturer report, 280
how to interpret an OPSpecs chart, menu items, 8
347 microscopy section, 292
how to use the Levey-Jennings chart, modify a user, 95
230 monthly evaluation report, 266
how to use the Youden chart, 238 monthly reports, 262, 266
multi test data entry, 183
I multi test data entry grid, 185
identify appropriate QC materials, 44 multi test data entry information, 183
identify possible QC procedures, 50 multi-LJ chart, 235
indirect method of adding tests, 124
insert data, 194 N
InstantQC™, 208 navigate the single test data entry
InstantQC™ chart, 295 dialog boxes, 171
InstantQC™ reports, 293 normal and abnormal controls, 15
InstantQC™ reports and charts, 263, notes about rule evaluation, 148
293 notifications, 85
ISO 15189 requirements, 320 Nx rules, 38
issues to consider, 60
O
K open a closed lot, 119
keys to a productive review of the open a lab number, 109
laboratory quality system, 60 open a test, 133
open and close lab numbers, 109
L operator report, 251
lab, panel, lot, and test information, operator report options, 251
163 operator setup, 198
laboratory comparison report, 272 OPSpecs chart, 344
laboratory histogram report, 274 OPSpecs chart components, 345
laboratory performance overview optional reports, 263, 281
report, 270 options, 9
labs, lots, tests, and panels organization of this guide, 4
permissions, 102 overview of data entry, 161
Levey-Jennings chart, 230 overview of data entry dialog boxes,
license agreement, 357 163
limitations of instrument setup, 126 overview of data groups, 145
links, 8 overview of data management, 187
listings report options, 256 overview of reviewing and annotating
listings reports, 255 data, 201
lists, 9 overview of rule evaluation, 147
log off the software, 65 overview of tests, 121
lot expiration notifications, 120 overview of Unity™ Interlaboratory
lots, 111 reports, 261
overview of UnityWeb™ charts, 223
overview of UnityWeb™ reports, 241

Bio-Rad Laboratories, Inc. 383

 Index

P select SPC rules, 129

paging arrows, 166 select test settings, 129
panels, 141 select Youden chart options, 238
password requirements, 97 selecting multi-LJ chart options, 235
passwords, 97 send qualitative data to the Unity™
perform bench review, 203 Interlaboratory Program, 182
perform bench review or supervisor set a fixed mean and/or fixed SD, 155
review, 203 set floating statistics as a fixed mean
point data report, 246 and/or fixed SD, 155
point data report options, 246 set SPC rules, 150
predict the performance of the QC set SPC rules at the lot level, 151
procedures, 51 set SPC rules at the test level, 150
primary lab number, 106 set up user permissions, 104
print reports, 243 single test point data entry, 172
print the Westgard Advisor™ online single test point data entry grid, 172
report, 341 single test summary data entry, 177
program hints, 8 six sigma, 46
sort panel names, 143
Q sort tests, 134
QC configuration, 7 sort tests for a lab number, 134
QC references, 355 sort tests in a panel, 135, 142
qualitative data entry, 180 SPC rules-tabular summary, 157
qualitative evaluation of a test’s bias statistical profile report, 281
and imprecision, 49 statistical report, 248
statistical report options, 248
submit data from the bench review,
R
260
R4s rule, 35
submit data manually, 258
recalibrate, 55
submit data monthly, 258
recommended steps for a QC
summary data entry grid, 178
system, 41
summary data report, 247
regular log on and log off process, 65
summary data report options, 247
rejection log messages, 353
supervisor’s report, 249
remove tests from a panel, 143
supervisor’s report options, 249
rename a panel, 143
system requirements, 78
require audit trail comments, 222
rules and settings permissions, 102
rules status, 148

S
save and print charts, 228
save and print reports, 242
save reports, 242
scroll bars and scroll arrows, 10
select a QC procedure, 53
select bar chart options, 236
select Levey-Jennings chart options,
231

384 Bio-Rad Laboratories, Inc.

 Index

T V
tabs, 8 view a Levey-Jennings chart, 170
test rules and settings, 129 view and print interlaboratory reports,
total allowable error (TEa) options, 265
326 view database information, 85
trademark notices, 359 view existing QC rules, 324
transmission, 85 view lab data and group statistics,
transmission overview, 257 325
try a new control, 54 view rules and settings, 170
types of lab numbers, 105 VITROS® slide generation numbers,
typographical styles and conventions, 138
4
W
U warranty information, 358
unavailable items, 11 welcome, 1
understand the navigation tree, 67 Westgard Advisor™ online overview,
UnityWeb™ tabs and functions, 68 323
update lab number information, 107 Westgard Advisor™ online report, 341
update tests, 132 what is quality control?, 13
update the license, 79 worldwide reports, 278
update the license via an XML file, 80
update the license via the Internet, 79 Y
update the VITROS® slide generation Youden chart, 238
number, 140
upgrade to UnityWeb™, 81
urinalysis report, 290
use a fixed mean and fixed SD with
SPC rules, 154
use a fixed mean and SD, 130
use the advanced option, 336
use the set date feature, 169
use the Westgard Advisor™ online
defaults, 338
use the Westgard Advisor™ online
wizard, 334
useful facts about fixed mean and
fixed SD, 154
useful statistics, 18
user permissions, 100

Bio-Rad Laboratories, Inc. 385

 Index

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386 Bio-Rad Laboratories, Inc.