UnityDesktop BioRad

Reference Guide for Easy QC
Data Management
with Unity Desktop
Contents
Getting Started
11
Welcome to Unity Desktop ................................................11

How to Contact Us .................................................12
Organization of this Guide ........................................12
Typographical Conventions .......................................13
A Note About Screen Shots........................................13
Service Packs........................................................13
Where Do I Begin? ...........................................................14
Essential Startup Tasks for New Users ...................................15
First Time Log In....................................................16
Add Users ............................................................16
Add a Lab Number..................................................17
Add a Lot Number ..................................................17
Add Tests ............................................................18
Enter Data ...........................................................18
Introduction to Quality Control Statistics
21
What is Quality Control? ...................................................21

How Are QC Results Used? ........................................22
Basic QC Statistics ..........................................................24
Mean ..................................................................25
Standard Deviation .................................................26
Calculating a Control Mean and Range ..........................27
Standard Deviation Index..........................................27
Bias ...................................................................28
Coefficient of Variation ...........................................29
Total Error and TEa ................................................30
Coefficient of Variation Ratio ....................................31
z-score ...............................................................31
SPC Rules .....................................................................31
1-2s ...................................................................32
1-2.5s.................................................................33
1-3s ...................................................................34
1-3.5s.................................................................34
1-4s ...................................................................35
2-2s ...................................................................35
R-4s ...................................................................36
3-1s and 4-1s ........................................................37
7-T ....................................................................38
Easy QC Data Management
N-x Rules ............................................................ 38
Choosing a QC Procedure
41
Recommended Steps ....................................................... 41

Determine Quality Requirements for the Test ................ 42
Evaluate Test Performance....................................... 43
Troubleshooting QC Results ............................................... 46
Good Habits ......................................................... 47
Keys to a Productive Review of the Laboratory Quality System
........................................................................ 50
Program Basics
53
Starting and Exiting the Program ........................................ 53

Current Lab, Lot, Test, and Panel ....................................... 53
Toolbars ...................................................................... 54
Unity Desktop Menu Bar ................................................... 55
Bio-Rad Laboratories From the Windows Start Menu ................. 57
Shortcut Keys................................................................ 57
Functions and Where to Find Them...................................... 59
User Profiles and Security
61
Defining, Modifying, and Deleting Users ................................ 61

To Add a User....................................................... 62
To Modify a User ................................................... 63
To Delete a User ................................................... 63
Passwords .................................................................... 63
To Change Your Password......................................... 65
Choosing Permissions....................................................... 65
Administration/Setup Permissions............................... 65
Data Permissions ................................................... 66
Database Permissions.............................................. 66
Rules and Settings Permissions .................................. 67
Labs, Lot, Tests, and Panels Permissions ...................... 67
Data Handling Permissions........................................ 68
Labs and Lots
69
Labs ........................................................................... 69
Adding and Updating Labs ........................................ 70
Duplicating Labs.................................................... 71
Deleting Labs ....................................................... 72
Opening and Closing Labs......................................... 72
4
Bio-Rad Laboratories
Contents
Lots............................................................................73
Adding Bio-Rad Lots ................................................73
Adding Non-Bio-Rad Lots ..........................................74
Duplicating Lots.....................................................75
Deleting Lots ........................................................77
Editing Lots ..........................................................77
Closing and Opening Lots..........................................78
Lot Expiration Notifications.......................................79
Tests
81
Overview of Tests ...........................................................81
Adding Tests .................................................................82
To Add Tests Manually .............................................83
Adding Tests With Instrument Setup ............................84
Adding Tests With an Other Code................................86
Test Rules and Settings ....................................................87
Rules Tab of the Test Settings Dialog Box ......................87
Settings Tab of the Test Settings Dialog Box ...................87
Duplicating Tests ............................................................88
Updating Tests...............................................................88
To Update a Test ...................................................88
Closing and Opening Tests .................................................89
To Close Tests.......................................................89
To Open Tests.......................................................90
Deleting Tests ...............................................................90
To Delete Tests .....................................................91
Sorting Tests .................................................................91
To Sort Tests in Lab Mode.........................................91
To Sort Tests in Panel Mode ......................................92
VITROS Slide Generations ..................................................92
Changing VITROS Slide Generations .............................93
Update VITROS Slide Generations................................94
Panels and Data Groups
95
Panels .........................................................................95
Panel Tests Dialog Box .....................................................95
To Add a Panel ......................................................97
To Update a Panel..................................................97
To Delete a Panel ..................................................97
To Sort Tests in a Panel ...........................................98
Data Groups ..................................................................98
To Change the Default Current Data Selection ................99
To Define or Edit a Group .........................................99
Applying QC Rules
101
Overview of Rule Evaluation .............................................101

Rule Statuses ......................................................102
Rule Precedence When Displaying Rule Violations...........103
Setting SPC Rules ..........................................................104
To Set SPC Rules at the Test Level.............................104
To Set SPC Rules at the Lot Level ..............................105
Using Fixed Means and SDs with SPC Rules ............................105
To Set a Fixed Mean and/or Standard Deviation .............106
SPC Rules: Tabular Summary ............................................107
Entering Data
109
Data Entry Overview ......................................................109

Useful Features of Data Entry ...........................................110
Navigating within Data Entry ....................................110
Viewing Charts and Reports within Data Entry ...............111
Viewing Rules/Settings and AGs within Data Entry ..........111
Changing a Data Row's Date-Time ..............................112
Specifying a Default Data Entry Mode .........................112
Set Date ............................................................113
Unity Desktop Data Screens..............................................114
Data Screen Header...............................................115
Data Entry Grid ....................................................115
Statistics/Chart Area .............................................115
Fixed Mean and SD (on Data Screens)..........................116
Point Data Entry ...........................................................117
Point Data Grid ....................................................118
Entering Point Data ...............................................122
Summary Data Entry ......................................................123
Entering Summary Data ..........................................124
Qualitative Data Entry ....................................................125
Adding Qualitative Tests .........................................125
Rejection Logs .....................................................126
Entering Qualitative Data........................................127
Sending Qualitative Data to the Unity Interlaboratory Program
.......................................................................128
Managing Your Data
129
Overview of Data Management ..........................................129

Changing Values and Date/Times .......................................130
To Edit the Date-Time............................................130
To Edit a Value ....................................................130
6
Contents
Changing a Data Point's Accepted/Rejected Status ................. 131

To Change the Accepted/Rejected Status.................... 131
Inserting Data Rows....................................................... 131
To Insert a Data Row............................................. 132
Deleting Data .............................................................. 132
To Delete a Row(s) of Data ..................................... 133
To Delete a Range of Data ...................................... 134
Reviewing and Annotating Data
135
Overview of Actions and Comments.................................... 135

Actions ............................................................. 136
Comments ......................................................... 139
Actions and Comments by Instrument......................... 139
Importing and Exporting Data
143
Importing Data............................................................. 143

Customizing Import .............................................. 144
Import File Status ................................................ 148
Autoimport ........................................................ 148
Rejection Logs .................................................... 149
Operator Setup ................................................... 149
Exporting Data............................................................. 152
Unity Desktop Charts
155
Viewing, Printing, and Saving Charts .................................. 155

Chart Options .............................................................. 156
General Chart Options ........................................... 157
Chart Headers..................................................... 157
Levey-Jennings Charts.................................................... 158
Customizing Your L-J Charts .................................... 158
Multi-L-J Charts ........................................................... 161
To Display Multi-L-J Charts ..................................... 161
Bar Charts .................................................................. 161
Youden Charts ............................................................. 162
Youden Chart Options............................................ 163
Using Youden Charts ............................................. 164
Unity Desktop Reports
165
Useful Features of Unity Desktop Reports ............................ 165

Choosing a Report Format....................................... 165
Selecting the Data to Appear on Reports ..................... 166
Configuring Intralaboratory Report Headers ................. 167
Documenting Report Reviews ...................................167

Individual Unity Desktop Reports ...............................168
Sending Data to the Unity Interlaboratory Program
173
Transmission Files .........................................................173

To Transmit Data Manually for Monthly Unity ................174
To Activate Automatic Monthly Transmission for Monthly Unity
.......................................................................174
Using Write Transmission File ...........................................174
To Write a Transmission File ....................................175
To Email a Transmission File to Bio-Rad.......................176
Unity Interlaboratory Reports
177
Overview of Unity Interlaboratory Reports ............................177

Viewing Interlaboratory Reports on QCNet ...................178
Standard Reports ..........................................................178
Monthly Evaluation Report.......................................178
Laboratory Performance Overview Report ....................179
Laboratory Comparison Report .................................180
Laboratory Histogram ............................................182
Bias and Imprecision Histogram Report........................183
Data Rejection Report............................................184
Optional Interlaboratory Reports .......................................185
Worldwide Report.................................................185
Manufacturer Report .............................................186
Statistical Profile Report.........................................187
Affiliated Reports..........................................................189
Affiliated Laboratory Comparison Report .....................190
Affiliated Laboratory Comparison Report: Abbreviated
Summary............................................................190
Affiliated Data Exception Report ...............................192
Contents
Urinalysis Reports ......................................................... 193
Regulatory Requirements and Reports
197
Overview of Regulatory Requirements and Reports ................. 197

CLIA Requirements........................................................ 198
Accreditation Requirements (Paraphrased)........................... 202
ISO 15189 ................................................................... 210
Unity Desktop Database Basics
211
Database Basics ........................................................... 211

Updating Database Information......................................... 211
Manual Database Updates ....................................... 212
Backup and Restore....................................................... 213
Condensing Data .......................................................... 214
To Condense Data by Lab, Lot, or Test ....................... 214
To Condense Data for All Labs.................................. 215
Reconciling Your Database .............................................. 215
Installation and Setup
217
Before You Begin .......................................................... 217

Installation ................................................................. 217
Activation Keys and Licensing........................................... 218
Activation Keys ................................................... 218
Licensing ........................................................... 220
Upgrading to Unity Desktop ............................................. 220
Upgrading from QC OnCall, Unity Plus/Pro, or Unity-PC ... 220
Upgrading From Unity Post...................................... 221
Steps to Import Historical Data ................................ 221
The Setup Dialog Box ..................................................... 222
The Configure Unity Desktop Tab .............................. 223
Unity Interlaboratory Reports Tab ............................. 225
Changing the Main Screen Graphics .................................... 226
To Change the Main Screen Graphics.......................... 226
Windows Hints
229
Tree Views ..................................................................229

Command Buttons .........................................................229
Check Boxes and Option Buttons ........................................230
Selecting Items in Lists ...................................................231
Available/Unavailable Items .............................................232
Drag-and-Drop Sorting ....................................................232
Paging Arrows ..............................................................233
Using Calendars ............................................................233
Creating Shortcuts.........................................................234
Setting a Short Date Format .............................................234
Removing Unity Desktop..................................................235
Supplemental Information
237
Manual Interfacing and Standard Import Files ........................237

Create a Properly Formatted Data File ........................238
Give Each File a Unique Name ..................................240
Define Paths for Interface Data.................................241
Alternatives to Interfacing ......................................242
Messages ....................................................................242
Rejection Log Messages ..........................................242
Action Messages ...................................................243
License, Warranty, and Trademark Information......................246
References
249
QC References .............................................................249
Glossary of Terms
251
Index
263
10
H A P T E R
Getting Started
In This Chapter
Welcome to Unity Desktop ............................................ 11
Where Do I Begin? ...................................................... 14
Essential Startup Tasks for New Users............................... 15
Welcome to Unity Desktop

Welcome to Unity Desktop. New users will find this powerful, user-friendly
software provides access to advanced tools and functions that are designed
to meet or exceed clinical laboratory quality requirements for data access,
analysis, review, management, storage, and reporting reliable results.
Existing users of other Bio-Rad programs will find the software provides
familiar functionality plus several new features, including:
Qualitative Data Entry (on page 125) that allows you to enter
qualitative and semi-quantitative data and send it to the Unity
Interlaboratory Program.
Automatic monthly transmission (see "To Activate Automatic Monthly

Transmission for Monthly Unity" on page 174) to ensure that your data
always arrives at Bio-Rad on time.
Notification when software updates are available with installation or

download.
Expanded charting options.
One of the most powerful utilities of Unity Desktop is its ability to connect
your laboratory to the worldwide clinical laboratory community. Bio-Rad's
Unity Interlaboratory Program collects data from thousands of labs
worldwide and combines it to create consensus groups to which your data is
compared.
How to Contact Us
We have made every attempt to ensure that this guide is accurate and
complete. However, if you need to contact Bio-Rad directly for assistance,
you can:
Search our knowledge base at support.qcnet.com.
Send an email to unity_support@bio-rad.com.
Inside the U.S., phone a Bio-Rad software support representative at 1800-854-6737, option 6. Software support representatives are available
Monday through Friday from 5 am to 5 pm (Pacific Standard Time).
If you phone Bio-Rad outside of normal working hours, please leave a
message and a software support representative will contact you,
typically within 24 hours.
Outside the U.S., please contact your local Bio-Rad software support
representative.
Organization of this Guide

This guide is organized with the information that you are expected to use
more frequently listed at the beginning of the guide and the information
that you are expected to use less frequently, or only when installing and
configuring Unity Desktop, at the end of the guide.
Because Unity Desktop's major function is to oversee your QC data, QC
information appears first in this guide; the mechanics of using the program
appear next; and installation and set up instructions appear last because
they are usually performed only once.
Please be aware of the following when using this guide:
Unity Desktop frequently provides multiple ways to access program

functions; however, this guide generally provides only the simplest way
to perform a task.
Windows instructions are provided based on Windows XP. If you are

using another operating system, such as Windows 2000, you may need
to adapt some instructions to suit your operating system.
When providing paths, installation is expected to be to the default

locations, usually to your local hard disc drive. So C:\ in the path
description refers to your local hard disc drive.
12
Getting Started
Typographical Conventions
This guide uses consistent styles to aid readability. Throughout this
document:
Items you see on the screen, such as check box names and dialog box
titles, are enclosed in double quotes. For example, the Setup dialog
box.
Menu items are shown in a bold font and appear in the order you select
them with each item separated by a vertical bar (|). For example, Tools
| Security | Administrator.
Buttons that you click appear in a bold font. For example, click Close to
exit the dialog box and return to the main screen.
Names of keys on the keyboard appear in bold and in all capital letters.
For example, CTRL, SHIFT, DELETE.
Keys that you press together (i.e. shortcut keys) appear in bold and are
separated by a plus sign (+). For example, "Press SHIFT+F11 to exit the
program."
Notes are separated from the surrounding text by horizontal lines above
and below the note. For example:
This feature is only available when the test is being evaluated by an
analytical goal.
Warnings are shown shaded. For example:

To prevent data loss, always archive or backup your database before
installing new software.
A Note About Screen Shots

The user interfaces for Unity Real Time and Unity Desktop are virtually
identical. (The appearance of the data entry screens vary only slightly.)
Because of this, screen shots of the two programs are used interchangeably
throughout this guide.
Service Packs
Occasionally, Bio-Rad releases updates for its existing software products.
When an update is available, Unity Desktop notifies you at login using one
of two screens based on whether or not you have selected the "Automatic
13
product updates" check box on the "Configure Unity Desktop" tab of the
"Setup" dialog box (see "The Setup Dialog Box" on page 222).
When the "Automatic product updates" check box is selected

The "Product Update" dialog box appears when you log in to Unity
Desktop. From the "Product Update" dialog box, you can:
Click Install to download and install the update.
Click Download to download the update to a location you specify

for installation at a later time.
Click Close to close the dialog box without taking any action. Unity
Desktop will notify you again of the update the next time you log
in.
When the "Automatic product updates" check box is not selected

A message that a service pack is available appears when you log in to
Unity Desktop. The message requests that you contact your Bio-Rad
software support representative. Your representative can give you
instructions on how to access the service pack.
Where Do I Begin?
Once you have completed Installation and Setup, what you do next depends
on what Bio-Rad QC data management software, if any, you were previously
using:
If you are a Unity-PC or Unity Plus/Pro user and want to move your
existing data into Unity Desktop, follow the instructions for moving the
data into Unity Desktop.
If you are a Unity Post user, contact your Bio-Rad software support
representative to request an import disk of data you have submitted to
the Unity Interlaboratory Program.
14
Getting Started
If Unity Desktop is your first Bio-Rad QC data management software,

you will need to define users, labs, lots and tests before you can begin
using Unity Desktop. Essential Startup Tasks for New Users (on page
15) should supply enough information to get you up and running quickly.
It also provides links to more information should you need it.
Essential Startup Tasks for New Users

If you have never submitted data to the Bio-Rad Unity Interlaboratory
Program using an earlier Bio-Rad software or Unity Post, you must perform
the tasks in the following list before you can start entering data into Unity
Desktop.
If you have ever submitted data to the Unity Interlaboratory Program by any
means, including Unity Post, see Upgrading From UNITY-PC and Unity
Plus/Pro, you may be able to avoid some or all of these tasks.
Essential Startup Tasks
First Time Log In (on page 16)
Add Users (on page 16)
Add a Lab Number (on page 17)
Add a Lot Number (on page 17)
Add Tests (on page 18)
Enter Data (on page 18)

Once you have created tests, you can begin data entry. Unity Desktop
begins evaluating a point data test against its default rules after the
test has the number of data points specified on the "Settings" tab of the
"Test Settings" dialog box.
If you want to begin rule evaluation with the first data point, you need
to specify a fixed mean and SD (see "Using Fixed Means and SDs with
SPC Rules" on page 105).
When the test has a statistically significant number of data points, you
might want to change the default rules as described in Choosing a QC
Procedure (on page 41). If your lab uses the optional Westgard Advisor, it
will suggest rules for you. (Twenty is generally considered the minimum
number of data points for statistical significance.)
15
If you laboratory wants to have rules suggested for you, contact your BioRad Representative to receive information regarding Unity Real Time
and the optional Westgard Advisor.
First Time Log In

Start Unity Desktop. The "Login" dialog box appears with "admin" in the
"User" field.
The "Password" field should be active (i.e. the cursor appears in it.) If
the password field is inactive, click in the field to select it.
Type sa in the password field, and click OK.
The default administrator login allows new users initial access to the
software. After you create other users, you should delete this user or
change the password.
Add Users
Unity Desktop uses passwords and user profiles to control which program
functions users can access. User initials appear on the data screen, with
actions and comments, and other areas within the software to document
which user performed the activity. User's initials, combined with audit
trails, document who did what and provide useful information when
investigating problems; hence, we strongly recommend that you create a
unique user profile and password for each person who uses Unity Desktop.
3
Log in to Unity Desktop as a user with permission to manage users. (The

admin/sa login provides this permission.)
Choose Tools | Security | Administrator or press ALT+F11. The

"Administrator" dialog box appears.
Click New in the User profile area. All fields on the dialog box are
cleared.
Type the user ID, user name, password, and initials you want to assign
to the new user.
Select the "Set password expiration period to" check box if you want the
user's password to expire after the number of months you choose from
the drop-down list.
16
Getting Started
Password expiration periods are entirely optional and their use depends
on the level of security required in your laboratory.
8
Click the "Administrator" check box to give the new user all permissions
or select the individual permissions you want the user to have.
Click Apply to create the new user and leave the dialog box open so
that you can add another user or click OK to create the user and close
the dialog box.
Add a Lab Number

You need to define a lab number before you can add lots to it. All lab
numbers must be provided by Bio-Rad.
Use the lab number included in your startup packet or contact your Bio-Rad
software support representative, who can provide you with additional lab
numbers.
10 Log in to Unity Desktop as a user with permission to manage labs, lots,
and tests. (The default admin/sa login provides this permission.)
11 Click the Lab icon on the toolbar. The "Lab" dialog box appears.
12 Type the requested information in each field. An asterisk (*) indicates a
required field.
13 Click Add when the information is complete and correct.
The lab number appears in the "Open labs" list. If this is the first lab
number you have added, this lab number becomes your primary lab
number and is shown in bold text.
14 At this point, you can:
Type a new lab number and edit the fields as necessary. Then click
Add to add an the lab number.
Click Lot to display the "Lot" dialog box to add a lot number(s) to
the lab number.
Click Close to exit the dialog box.
Add a Lot Number

1
Log in as a user with permission to manage labs, lots, and tests.
Select the lab number you want to add lots to in the navigation tree.
17
The navigation trees appear as tabs on the left of the main screen. The
"Lab" tree presents a hierarchical arrangement by lab numbers, lot
numbers, and tests. The "Panel" tree organizes tests by panel name. See
Tree Views (on page 229) for more information.
3
Click the Lot icon on the toolbar. The "Lot" dialog box appears. Notice
that the selected lab number and lab description appear under the
dialog box title.
Select a control product from the drop-down list under "Control

product." The list will contain all Bio-Rad control products and any
"Other" lots you have previously defined.
Select a lot number from the drop-down list under "Lot number." The
list will contain all unexpired lot numbers.
Click Add. The lot number appears in the open lots list.
Repeat steps 4 6 to add additional lots as needed.
When all lots are added, click Close to exit the dialog box or click Test
to add tests to the currently selected lot number.
Add Tests
1
Select the appropriate lab/lot combination in the "Lab" or "Panel"

navigation trees.
Click Test on the toolbar. The "Test" dialog box appears.
Make a selection for each item in the left "Test information" pane.
Click Add when your selections are complete and correct.
Alternatively you can add groups of tests for an instrument using Instrument
Setup. (This feature is not available when the RiLiBK module is installed.)
Enter Data
You can enter data for a test as individual data points (point data entry) or
as a monthly mean, SD, and number of points (summary data entry). Rule
evaluation occurs only for point data.
To Enter Point Data

See Point Data Entry for more information.
18
Getting Started
Double-click the test in either the "Lab" or "Panel" trees. (Nothing

appears in the "Panel" tree until you define a panel or panels.) The data
entry screen appears with either the "Point Data" or "Summary Data" tab
selected.
You can specify which tab is active from the "Configure Unity Desktop"
tab of the "Setup" dialog box. Choose Tools | Setup and click the Point or
Summary option under "Default data entry mode (see "Specifying a
Default Data Entry Mode" on page 112)".
Click the appropriate tab if not already displayed.

The first cell in the first blank data entry row will be the active cell and
is surrounded by a dark border. This is the cell where you will type your
value. If you do not have a value to enter for the selected level, you
can press Tab to move to the appropriate cell.
Type values for each level of control you have results for and press Tab
to move to the next data row.
Click Save when all your values are entered.
To Enter Summary Data

See Summary Data Entry for more information.
1
Double-click the test in either the Lab or Panel tree. The data entry
screen appears with either the "Point Data" or "Summary Data" tab
selected.
Click the "Summary Data" tab if not already displayed.
Type your mean, SD, and number of points for each level, pressing Tab
to move between the cells.
When all values for a row are entered, press Tab to move to the next
blank data entry row.
Click Save when all your values are entered.
19
H A P T E R
Introduction to Quality
Control Statistics
In This Chapter
What is Quality Control? ............................................... 21
Basic QC Statistics ...................................................... 24
SPC Rules................................................................. 31
What is Quality Control?

Quality control in the medical laboratory is a statistical process used to
monitor and evaluate the analytical process which produces 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 daily when patient testing is performed. If the test is stable for
less than 24 hours or some change has occurred which could potentially
affect the test stability, controls should be assayed more frequently. All
labs in the U.S. must comply with CLIA Requirements (on page 24).
Generation of QC results for evaluation

When a diagnostic test is performed 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)
or qualitative (positive or negative) or semi-quantitative (limited to a
few different values).
Unity Desktop currently provides QC rule evaluation only for
quantitative tests. (You can enter data from
qualitative/semiquantitative tests; however, the data is not evaluated
against any rules.)
How Are QC Results Used?

QC results are used to validate patient results. Once validated, patient
results can be used for diagnosis, prognosis, or treatment planning. For
example, when a patients serum is assayed (tested) for potassium, the test
result tells us how much potassium (what concentration) is present in the
blood. This result is then used by the physician to determine whether the
patient has a low, normal, or high potassium level.
Lets assume that the measured value of potassium in a patients 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.
But how does the person performing the test know that this result is truly
reliable? It could be possible that the instrument is out of calibration and
the patients true potassium value is 4.2 mmol/La normal result.
The question of reliability for most testing can be resolved by regular
testing of quality control materials and the application of statistical process
control values.
As you test QC materials, you develop a database of values from which you
can calculate a mean and range (i.e. mean 3SD). You can then compare
your QC results to this range using statistical process control (SPC) rules and
make decisions to accept or reject patient results based on the outcome of
rule evaluation.
Normal and Abnormal Controls

A normal control product contains normal levels for the analyte being
tested. 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 about 3.5 5.0 mmol/L. A normal control
would contain potassium at a level within this range. An abnormal control
would contain potassium at a level below 3.5 mmol/L or above 5.0 mmol/L.
22
The following example QC log shows normal and abnormal control results
and patient results for a seven-day period.
Test:
Potassium
Instrument:
Instrument No.1
Unit of measure: mmol/L

Level 1 (Normal
Control)
Level 2 (Abnormal
Control)
3.7-4.3 mmol/L
6.7-7.3 mmol/L
11/1
4.0
7.0
4.2, 4.0, 3.8, 5.0, 5.8, 4.2
11/2
4.1
7.0
3.8, 4.4, 4.6, 3.9, 4.6, 4.4,

3.9
11/3
4.0
6.9
4.4, 3.9, 3.7, 4.7
11/4
4.2
7.1
4.7, 5.6, 4.2, 3.7, 4.3
11/5
4.1
7.0
4.2, 4.3, 4.1, 4.3
11/6
4.1
7.0
4.6, 4.4, 5.5, 3.8, 3.2
11/7
4.2
8.0
2.8, 4.6, 4.2, 3.2, 3.9, 4.1,

6.0, 4.3
Range:
Date:
Patient Results
The acceptable range for the Level I (normal control) is 3.7 4.3 mmol/L.
The range for Level II (abnormal control) is 6.7 7.3 mmol/L. When the
daily QC result obtained for the normal control is compared to the range
calculated for the normal control, it becomes apparent that each result lies
somewhere within the expected range. This indicates that the analytical
process is "in control" at the normal level on that day of testing.
When the daily QC result for the Level II (abnormal control) is compared to
the defined range for the abnormal control, the analytical process is shown
to be in control for each day of testing except for the last day (11/7). On
November 1 through November 6, both controls were "in control," and
patient values could be reliably reported.
However, the laboratory was "out of control" for abnormal high potassiums
on November 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 that some error occurred which may have produced abnormally
high patient results that are unreliable. The laboratory should not report
any patient samples with an abnormally high potassium until the error is
resolved and the abnormally high sample(s) are re-tested.
23
Hence, it is now apparent that the range defined for each level of control is
fundamental to the quality control system. Basic QC Statistics (on page 24)
describes the calculations required to develop an acceptable control range.
CLIA Requirements
In the United States, the Clinical Laboratory Improvement Amendments of
1988 (CLIA), as modified by the final CLIA Rule, require two levels of control
(one normal and one abnormal) be assayed on each day the test is
performed for all non-waived tests, unless the Centers for Medicare &
Medicaid Services (CMS) approves the procedure specified in Appendix C of
the State Operations Manual that provides equivalent quality testing.
In other words, if you test patient samples for potassium on Wednesday, you
must assay at least one normal and one abnormal control product for
potassium on Wednesday unless an equivalent QC Procedure has been
approved by CMS. Blood gas testing is slightly different.
For instruments that verify calibration internally, the U.S. laboratory must
run one control every eight hours using a combination of materials that
include both low and high values on each day of testing.
If the instrument does not verify calibration internally, the laboratory must
assay these same controls with each patient sample.
As with any government regulation, these requirements can undergo change
as a result of the regulatory or political process.
Basic QC Statistics
A total QC system must control both trueness and precision. Your goal is for
a test to have both low bias and low imprecision. Since problems with
imprecision are less likely to cause analytical failure in the modern
laboratory because of computerization and mechanization of the analytical
process, bias is brought to the forefront.
The following figure illustrates low bias and low imprecision as a target,
where the center of the bulls eye represents the target value.
24
The following figures show two other possibilities:
The first figure illustrates the situation where your standard deviation
for a test is small (good precision), but is shifted away from the target
value (high bias).
The second figure represents poor precision and, believe it or not, low
bias because the average of the results is close to the bull's eye. Of
course, individually none of the points are close, and their individual z
scores would reflect this.
Bias and imprecision are most important at the clinical decision levels. For
example, -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).
Useful Statistics
Evaluation of a test's bias and imprecision utilizes several calculations.
Although Bio-Rad's QC evaluation software performs these calculations for
you, it's useful to understand the math behind the calculations, which
includes:
Mean (on page 25)
Standard Deviation (on page 26)
Standard Deviation Index (on page 27)
Accuracy (Bias) (see "Bias" on page 28)
Coefficient of Variation (on page 29)
Coefficient of Variation Ratio
Mean
The mean of a group of data points is simply their arithmetic average. Your
calculated mean provides your laboratorys best estimate of the analytes
"true" value for a specific level of control. The mean a predetermined
number of standard deviations represents the error you expect to see in a
test when the analytical system is stable.
25
The following formula is used to calculate the Mean:
Where =sum and Xn=all observed values
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 that you compare 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).
Obviously, we want repeated measurements of the same specimen to give
results that are as close to each other as possible. Good precision is
especially needed for tests which are repeated regularly on the same
patient to track treatment or disease progress. For example, a diabetic
patient in a critical care situation may have glucose levels run every 2 to 4
hours. In this case, it is important for the glucose test to be precise because
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.
Standard deviation is often abbreviated as SD or s.
The following formula is used to calculate the SD:
SD =
(x
x)
n 1
A high standard deviation can be attributed to:
Inherent variability in the test, which represents expected error
Analytical system malfunction, which represents unexpected error that

the laboratory must investigate and correct
Levey-Jennings Charts allow you to visually review data points plotted

against a 3SD range.
26
Calculating a Control Mean and Range

1
Collect a minimum of twenty data points for each level of control.
Data points should be obtained from twenty separate analytical

runs* which reflect variables such as calibration frequency, change
of reagent or reagent lot, operator technique,
temperature/humidity of testing location, daily/weekly
maintenance, etc.
*Based on the Clinical and Laboratory Standard Institute (CLSI)
recommendation for the minimum number of data points necessary
to calculate a range.
All new control products should be compared to previously

validated controls (parallel testing).
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 limits from the mean 2s and the
mean 3s.
Use product insert ranges only as guidelines. 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.
Standard Deviation Index

The Standard Deviation Index (SDI) is a measurement of bias (how close your
value is to the target value). Bio-Rad's Unity Interlaboratory Program uses
the consensus group value as the target value. The following formula is used
to calculate the SDI:
Meanlab Mean group

SDI =
SD group
27
Interpreting the SDI

The target SDI is 0.0, which indicates no difference between the lab mean
and the consensus group mean. An SDI greater than 1 indicates a possible
problem with the test.
The SDI essentially expresses bias as increments of standard deviation. An
SDI of -1.8 indicates that the laboratory has a negative bias of 1.8 standard
deviations from the group mean which is not a good situation.
Bias will increase or decrease the percentage of patients outside defined
reference limits. For example, a positive analytical bias will decrease the
percentage of patients normally outside the lower limit and increase the
percentage of patients normally outside the upper reference limit, creating
an increase in false positive test results. Negative bias has an opposite
effect, decreasing true positives and creating false negatives.
An SDI of 0.0 indicates a perfect comparison with the consensus group.
The following guidelines can be used to interpret SDIs:
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, which
can be determined by some reference value or estimated from outside
sources such as proficiency testing results or interlaboratory groups such as
Bio-Rads Unity Interlaboratory Program.
28
Bias (%) can be calculated as:
M lab M group
Lab Bias % =
M group
100
Where Mlab is your lab's mean and Mgroup is the reference value (i.e.
proficiency or interlaboratory value).
Coefficient of Variation
The Coefficient of Variation (CV) is the ratio of the standard deviation to
the mean and is expressed as a percentage as follows:
standard deviation
CV % =
100
mean
The CV allows the laboratorian to make easier comparisons of the overall

precision of two analytical systems.
The CV is a more accurate comparator than the standard deviation because
the standard deviation typically increases as the concentration of the
analyte increases. If the laboratorian is comparing precision for two
different methods and uses only the standard deviation, he or she can be
easily misled.
Using only the standard deviation to compare analytical systems (e.g. by
instrument, method, reagent, etc.) can be misleading.
For example, you need to compare a hexokinase and glucose oxidase
method for measuring glucose. The standard deviation for the hexokinase
method is 4.8 and 4.0 for glucose oxidase. Based on just the standard
deviation, you might conclude that the glucose oxidase method is more
precise than the hexokinase method.
However, a comparison of CVs might show that the methods are equally
precise. Assume the mean for the hexokinase method is 120 and the glucose
oxidase mean is 100. The CV then for both methods is 4%, and they are
equally precise.
29
Determining an Acceptable CV
How do you determine an acceptable CV? Several sources can 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 your CV for a test or when
comparing two test systems.
Total Error and TEa

The concepts of total error (TE) and total allowable error (TEa) are useful
when choosing the SPC rule(s) to apply to a test. Rules can be chosen to
alert you when the total error for a test exceeds a quality specification
(TEa) that you choose. Total error for a test includes both bias and
imprecision as shown by the following formula (at a 99% confidence
interval):
TElab = Labbias (%) + 2.33CVlab

TEa specifications are available from several sources as discussed in
Determine Quality Requirements for the Test (on page 42). Once you
have chosen a TEa, you can calculate a TEbudget as shown by the following
formula:
TE
TEbudget (%) = lab 100
TEa
The optional Westgard Advisor allows you to choose a TEa and then suggests
SPC rules based on your test data and Unity Interlaboratory information.
If you laboratory wants to have rules suggested for you, contact your BioRad Representative to receive information regarding Unity Real Time
and the optional Westgard Advisor.
30

The Coefficient of Variation Ratio (CVR) compares your lab's precision for a
specific test to that of other laboratories performing the same test. This
comparison is useful for comparing your laboratory's precision to that
obtained by other labs.
The CVR is calculated using the following formula:
CVR =
CVlab
CVgroup
The CVR appears on several Unity Interlaboratory reports, including:
Laboratory Comparison Reports
Monthly Evaluation Reports
Affiliated Laboratory Comparison Report: Abbreviated Summary

includes CVRs based on your affiliated group as well as the peer and
method consensus groups.
z-score
The z-score is the number of standard deviations a control result is from the
expected mean and is calculated as follows:
Result observed Meanexpected

z score =
SDexpected
A z-score of 2.3 indicates that the observed value is 2.3 SD away from the
expected mean. A data point with this z-score would violate the 1-2s rule,
but not the 1-3s rule. The z-score appears on the point data screen.
SPC Rules
In 1981 Dr. James Westgard of the University of Wisconsin published an
article on laboratory quality control that set 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
31
scheme: 1-3s, 2-2s, R-4s, 1-2s, 4-1s, and 10x. These rules are used
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 1-2s rule for run
rejection
Increase error detection over that provided when applying just the 1-3s
rule for run rejection
Include rules to detect and distinguish random and systematic error (13s and R-4s to detect random error and 2-2s, 4-1s, 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. Thus, 1-3s
represents a control rule that is violated when one control observation
exceeds the 3s control limits.
1-2s
The 1-2s rule is usually a warning rule that is violated when a single control
observation is outside the 2s limits.
Some laboratories consider any quality control value outside its 2s limits to
be out of control, and therefore incorrectly decide that 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 2s QC limits but within the 3s QC limits.
Approximately 4.5% of all valid QC values will fall somewhere between 2
and 3 standard deviation limits. Laboratories that universally reject values
outside the 2s limit end up rejecting good runs too frequently.
The 1-2s 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 2 standard deviations in a manual application of
Westgard rules, you should 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 1-2s rule is usually not necessary.
32
Using this rule alone in performing quality control tests causes frequent
rejection of valid runs. According to Dr. Westgard, failure to allow for valid
points between 2s and 3s 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 mean that patient samples are repeated

unnecessarily; labor and materials are wasted; and patient results are
unnecessarily delayed.
The following figure shows an L-J chart with a data point between +2s and
+3s.
1-2.5s
Violation of the 1-2.5s rule indicates random error and may also point to
systematic error. This rule is applied within the run only. The following
figure shows an L-J chart with a data point outside the 2.5s limits.
33
1-3s
The 1-3s rule identifies unacceptable random error or possibly the beginning
of a large systematic error. Any QC result outside 3s violates this rule.
Since only 0.3% or 3 out of 1000 points will fall outside the 3s limits, any
value outside of 3s is usually considered to be associated with a significant
error condition.
While a value outside 3s 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.
The following figure shows an L-J chart with a data point outside the 3s
limits.
1-3.5s
Violation of the 1-3.5s 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 3.5s. This rule is applied within the run only. The
following figure shows an L-J chart with a data point outside the 3.5s
limits.
34
1-4s
Violation of the 1-4s 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 4s. This rule is applied within the run only. The
following figure shows an L-J chart with a data point outside the 4s limits.
2-2s
The 22s rule detects systematic error only.
The 2-2s rule is violated when two consecutive QC results are:
Greater than 2s
On the same side of the mean
The rule is applied both within a run and across runs:
Within run violationTwo control values in the same run are >2s on the
same side of the mean. Violation of the within run application indicates
that systematic error is present that potentially affects the entire
analytical curve.
Across run violationIn one run, a single level of control is >2s from the
mean and, in the next run, the same level of control is >2s on the same
side of the mean. Violation of the across run application indicates that
systematic error is present, but affects only a single portion of the
analytical curve.
The following figures show an L-J chart with a data point violating the 2-2s
rule, within and across a run.
35
Within run violation:
Across run violation:
R-4s
The R-4s rule identifies random error only and is applied only within the
current run. This rule is violated when there is at least a 4s difference
between control values within a single run.
For example, assume both Level I and Level II have been assayed within the
current run. Level I is +2.8s above the mean and Level II is -1.3s below the
mean. The total difference between the two control levels is greater than
4s (i.e. +2.8s (-1.3s) = 4.1s).
36
The following figure shows an L-J chart with two points that violate the R-4s
rule.
3-1s and 4-1s

These rules are violated when three or four consecutive results:
Exceed 1s
Are on the same side of the mean
The 3-1s and 4-1s rules can be violated both within a control material (e.g.
all Level I control results) and across control materials (e.g. Level I, II, and
III control results in combination).
Violations within a control material indicate systematic bias in a single

area of the method curve.
Violations across control materials indicate systematic error over a

broader range of concentrations.
The following figures show an L-J chart with a data point violating the 3-1s
rule within a run and a 4-1s rule across a run.
3-1s Within Run
37
4-1s Across Run
7-T
The 7-T 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 that
increase 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 a negative direction.
The following figure shows an L-J chart with points that violate the 7-T rule.
N-x Rules
The N-x 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 material (e.g. all
Level 1 control results) or across control materials (e.g. Level 1, 2, and 3
control results in combination).
38
Within a control material violations indicate systematic bias in a single area

of the method curve while violation of the across control materials
application indicates systematic bias over a broader concentration.
The 7-x control rule is far more sensitive to analytical bias than the 12-x
rule, and the chances of finding seven consecutive control observations on
one side of the mean are much higher than finding twelve.
The following figures show an L-J chart with data points that violate the 8-x
rule within a run and the 9-x rule across a run.
8-x Within Run
9-x Across Run
39
H A P T E R
In This Chapter
Recommended Steps ................................................... 41
Troubleshooting QC Results ........................................... 46
Recommended Steps
Ensuring that your SPC Rules (on page 31) are chosen to maximize error
detection while minimizing false rejections is crucial when setting up your
QC system. CLSI (C24-A2, section 5) recommends that you follow these steps
when setting up your QC system:
1
Determine quality requirements for the test
Evaluate test performance
Identify possible QC procedures, which include determining the:
Rules to apply
Control materials to be used
Number of control samples to be analyzed in each run
Location in the run where the control samples are tested (e.g. at
the beginning, in the middle, at the end, or distributed throughout
the run)
Predict the performance of the identified QC procedures (This step

requires probability calculations or computer simulations.)
Choose goals based on your required quality
Select a QC procedure
Obviously, this is not a simple process, which may explain why many
laboratories fall back on the 1-2s rule. Although the 1-2s rule produces too
many false alarms, it feels safe.
The optional Westgard Advisor makes this arduous task easier.
Determine Quality Requirements for the Test

How good does a test need to be? Answering this question will help you
determine the total allowable error (i.e. the error that the test can have
and still be considered "in control"). There are several models you can use
for quality specifications, including:
1
Medical usefulness requirements based on the effect of analytical

performance on clinical decisions:
Biological variation information
Clinicians' opinions
Published professional recommendations from:
National and international expert bodies and agencies
Expert local groups or individuals
Performance goals set by:
Regulatory bodies and agencies
Organizers of External Quality Assessment (EQA) schemes
Goals based on the current state of the art, including:
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.
When available and appropriate, models higher in the list are preferred to
those lower in the list.
In general, proficiency testing requirements define the minimum standards
for performance, because they are based on requirements needed to
maintain accreditation. However, proficiency testing may be appropriate
for some tests. Medical usefulness requirements are usually more stringent,
but may be required for some tests.
42
Evaluate Test Performance

After you determine the quality required for a test, you need to evaluate
the test's bias and imprecision in order to quantify its total error (TE). Unity
Desktop uses the following formula to calculate laboratory total error (TE)
for p<0.01:
TE = |Lab bias| + 2.33 Lab CV
Looking at this formula, you can easily see that you can have a higher bias
as long as your CVs, which measure imprecision, are low and vice versa. The
overall objective is to limit the total error in patient test results.
Six Sigma provides a convenient way to monitor the performance capability
of a testing system. If you are using the Westgard Advisor, the sigma value
appears on the "Grid" tab of the "Design QC Rules" tab. You can also
evaluate a test's bias and imprecision using the SDI and CVR, which are
available on data analysis grids and several Unity Interlaboratory reports.
(Westgard Advisor is an optional module available only to Unity Real Time
users.)
As scientists, laboratorians must be concerned with which component (bias
or imprecision) is contributing to error, in what amount, and how that
components performance can be improved. However, as long as patient
test results have no more than the allowable total error (TEa), you should
not be overly concerned about the reliability of those results. When
analytical error exists, the question becomes whether it is critical and that
depends on the quality requirements you choose for the test.
Six Sigma
Sigma metrics are useful for quantifying test performance. During the
1980s, Motorola set out to improve their manufacturing process so that
virtually no defective product would be produced. They 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.
43
SD range
Defect rate (%)
Defects per million
2 SD
4.5
45,400
3 SD
< 0.27
4 SD
~2,700
0.0063
63
5 SD
0.0057
0.57
6 SD
0.000002
0.002
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 our processes would be six sigma, and we could monitor
them with very simple QC.
Unfortunately, not all processes are six sigma, and, as process capability
decreases, our choice of QC procedures becomes increasingly important in
detecting significant errors. In fact, some processes may have such low
process capacity (i.e. high total error) that they cannot be controlled to a
defined level of quality. This condition would trigger a maximum QC
condition within the optional Westgard Advisor.
For clinical lab tests, the total error (TE) for a test provides an indication of
the test's process capability, because it combines bias and imprecision. This
allows us to calculate sigma using the following formula:
Sigma =
TEa Bias
CV
The optional Westgard Advisor calculates and displays sigma based on your
data for a test and your selected TEa and consensus group.
We can correlate sigma with the TEa as shown in the following table. (The
table assumes that 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
When bias is not zero, the sigma classification of a process decreases as its
bias increases.
44
The information in this chapter was abstracted from the Six Sigma Quality
Management and Desirable Laboratory Precision lesson available on
Westgard.com. Dr. Westgard provides an eye-opening correlation between
CLIA performance requirements and those required for a 5 or 6-sigma
process. As Dr. Westgard concludes, "Six Sigma Quality Management sets
demanding standards of performance for laboratory testing processes."
How Do I Use 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
lab tests are below six sigma processes.
So how do we get to six sigma? The obvious answer is to choose a test
method whose process is six sigma. Labs can take steps to control precision
(e.g. proper training, instrument maintenance, etc.) However, to a large
extent, method precision is a function of instrument methodology.
While you may not be able to control method precision, you can choose a
QC procedure that detects small changes in the testing system so you reject
runs having defects and perform corrective actions to prevent further
defects.
The optional Westgard Advisor calculates sigma values and displays them on
both the "Grid" and "Chart" tabs of the "Design QC Rules" tab. The sigma
value also appears on Westgard Advisor Reports.
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 may also be used to evaluate bias, some laboratories prefer
proficiency report data for this purpose.
Participants in Bio-Rads 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 that laboratories can use as a qualitative assessment of their
laboratory bias and imprecision:
CVR (coefficient of variation ratio)-represents a peer-based evaluation

of imprecision.
This ratio is calculated as the laboratory CV for the test divided by the
average CV reported for the consensus group.
45
SDI (standard deviation index)-provides a relative peer-based estimate

of bias.
SDI describes or quantifies bias (difference between the laboratorys
observed mean and the consensus group mean) in terms of standard
deviation.
OPSpecs Charts and sigma values, which are available if you are using the
optional Westgard Advisor, provide information about a test's maximum
allowable bias (inaccuracy) and imprecision.
Troubleshooting QC Results
Inevitably, your QC system will eventually indicate an out-of-control
situation. What do you do then? In a lesson titled "QC - The Out-of-Control
Problem" available on Dr. Westgard's web site (Westgard.com), Elsa F. Quam
BS, MT (ASCP) discusses two prevalent bad habits and then provides five
good habits to develop when troubleshooting QC problems.
The two bad habits listed by Ms. Quam will be familiar to anyone working in
a clinical laboratory. They represent the incorrect, yet easy-way-out
approach to solving QC problems.
Repeat the Control

In the past, labs frequently applied the 1-2s 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. Using the 1-2s rule, it might
be reasonable to simply repeat the test for the control. However, with
carefully chosen rules, this approach is unnecessary. For example, the false
rejection rate for a 1-3s rule is only 0.3 %. It is also important to remember
that even if the repeat value is within control limits, allowing us to accept
the run, we could be ignoring a problem until a future run.
Try a New Control

Another poor approach is to test a different vial of control and repeat it
until it falls within range. A bad vial of control material is unlikely, although
it can occur, such as when controls are not properly reconstituted, are
stored improperly, are used beyond their expiration date, etc. These are
issues that should be addressed by training. Cost is another issue. A new vial
of control material is usually much less expensive than repeating a patient
run.
46
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."
Recalibrate
A third risky habit not mentioned by Ms. Quam is frequent recalibration.
Laboratories should be concerned about the number of times a test is
recalibrated because each calibration or recalibration potentially introduces
new or additional systematic errors. Frequent recalibrations may indicate a
defective SPC protocol (rules applied, mean, and range in use) set by the
laboratory, instrument malfunction, sub-optimal reagent quality, or failure
to follow the manufacturers instructions and schedule for maintenance.
So what are the good habits?
Good Habits
If we eliminate the bad habits, what do we replace them with? In her article
"QC - The Out-of-Control Problem ", Ms. Quam lists five good habits:
1
Inspect the control charts or rules violated to determine type of error.
Relate the type of error to possible causes.
Consider factors in common on multitest systems.
Relate the problem to recent changes.
Verify the solution and document the remedy.
A sixth good habit, not mentioned by Ms. Quam, is to perform a regular

review of your quality system to assess its effectiveness. Keys to a
Productive Review of the Laboratory Quality System (on page 50)
provides a list of questions that may be helpful for these reviews.
Determine the Type of Error

Determining the type of error (random or systematic) is a good first step
when investigating a QC problem. Different rules are sensitive to different
error types. For example:
47
The 1-3s and the R-4s rules usually indicate increased random error
because they test the tails or width of a distribution
The 2-2s, 4-1s, and 10-x rules usually indicate systematic error,
because they examine consecutive QC results that exceed the same
limit
Looking at L-J charts will also indicate the type of error.

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 your acceptable range or unacceptable
(unexpected) random error, which is any data point outside the
expected population of data (e.g. a data point outside the 3s limits).
Random errors may 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, etc.
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", because they aren't really caused by a
change in the imprecision of the method, but rather represent an
occasional disaster. It is very difficult to catch flyers by QC. Patient
replicate determinations may be a better way of detecting these kinds
of events.
48
Consider Common Factors on Multitest Systems

When using a multitest system, you may have a problem with a single test
or with several tests.
Only one test involved

Apply the first two steps (i.e. determine the type of error and relate it
to possible causes).
Several tests involved

Consider what, if anything, the tests have in common.
The following list includes some questions you might want to ask:
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 (endpoint vs. rate,
MEIA vs. FPIA)?
Do all the tests have certain mechanical components in common or

certain optical components in common?
Relate the Problem to Recent Changes

A good question to ask yourself when QC problems arise is, "What changed?"
You should have already classified the error as random or systematic, which
gives you clues about what to investigate first.
Use a systematic logical troubleshooting approach in isolating the cause,
making only one change at a time and documenting each action taken.
Systematic Error
If you observe a sudden shift, inspect the reagent, calibration, and
maintenance records, and note recent actions. For example, if the shift
occurred immediately following a reagent replacement, verify that the lot
number is correct and has been checked out or calibrated, and that the
reagent has been prepared properly, that the reagent is indeed the correct
reagent.
If you observe a systematic trend, review 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
49
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 much 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,
or improperly mixed/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, you can consult
troubleshooting guides and manufacturer recommendations.
If you repeat the run, and the controls are acceptable, but you are still
concerned that a problem may exist, you may want to perform a precision
run using 10 back-to-back determinations on the same patient sample. This
precision run may identify further imprecision problems. Duplicate analysis
of patient specimens is also recommended when monitoring random error
problems.
Verify and Document

After you identify and correct a problem, the correction should be verified
by retesting controls. Generally, you will run controls at the beginning of a
run. If the new QC values are in control, you should repeat patient samples
from the out-of-control run as necessary. Finally, document the out-ofcontrol event along with the corrective action.
Troubleshooting reports, especially for unusual problems, provide useful
information for future problem solving.
You can correlate problems with your reports including intralaboratory,
InstantQC, and Unity Interlaboratory reports.
Keys to a Productive Review of the Laboratory

Quality System
Your laboratory quality system should include regular reviews of your QC
results. CAP-accredited laboratories must review and document QC
50
performance at least weekly. These reviews, which are often done

retrospectively, offer an excellent opportunity to critically assess the SPC
rules applied to a test.
Issues that reviewers should consider include:
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
total allowable error are jointly considered?
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 the laboratory focus its efforts on removing or
reducing analytical bias?
Is the appropriate consensus group (Peer, Method, All Laboratories)

being used to estimate the laboratorys comparative bias for the test?
Are the performance goals for imprecision and bias for the test, which
also affect total allowable error, appropriately set?
How frequently do SPC error flags occur for the test during this review
period? Across review periods? Are these frequent error flags due to
inappropriate selection of SPC rules, larger than expected imprecision,
or the presence of bias, do 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.
51
H A P T E R
Program Basics
In This Chapter
Starting and Exiting the Program .................................... 53
Current Lab, Lot, Test, and Panel ................................... 53
Toolbars .................................................................. 54
Unity Desktop Menu Bar ............................................... 55
Bio-Rad Laboratories From the Windows Start Menu ............. 57
Shortcut Keys............................................................ 57
Functions and Where to Find Them.................................. 59
Starting and Exiting the Program

If you created a shortcut when installing Unity Desktop, simply doubleclick the shortcut on your desktop to display the "Login" dialog box.
Otherwise, choose Start | All Programs | Bio-Rad Laboratories | Unity Desktop.
If you did not create a shortcut during installation, the following steps
describe how to create a shortcut from the Windows Start menu.
1
Select Start | All Programs | Bio-Rad Laboratories | Unity Desktop.
Right-click Unity Desktop. A popup menu appears.
Select Create Shortcut. The shortcut appears on the desktop.
Current Lab, Lot, Test, and Panel

The left pane of the Unity Desktop screen has tabs for the lab and panel
navigation trees. The lab, lot, or test selected in the tree is the current lab,
lot, or test. See Tree Views (on page 229) for additional information.
Because trees are hierarchical:
Selecting a test also determines the current lab and lot.
Selecting a lot number also determines the current lab, but there is no
current test.
Selecting a lab number determines only the current lab. There is no

current lot or current test.
The current lab, lot, and test selections determine the active lab, lot, and
test. For example, if you select a test in the tree and then click the L-J icon
on the toolbar, Unity Desktop displays the Levey-Jennings chart for the
selected test.
Because selecting a test also determines the current lab and lot, these
items will be active if you access the "Lab" or "Lot" dialog boxes. In addition,
menu and toolbar items become available or unavailable depending on
which item (lab, lot, or test) is selected in the tree. For example, charts
and reports are available only when a test is selected in the tree. Similarly,
selecting a lot selects its associated lab number.
Toolbars
The Unity Desktop toolbar contains icons (buttons) that you click to
activate specific program functions. The icons themselves are selfexplanatory, especially when using large icons, but you can hover your
mouse over an icon to display a short description. The default toolbar
contains commonly used icons; however, you can customize your toolbar to
contain the functions you use most frequently.
When you choose View | Toolbar, the "Toolbar" dialog box appears.
54
Program Basics
Your current toolbar icons appear below the dialog box's title bar. The
"Large toolbar" and "Small toolbar" option buttons control the appearance of
the toolbar icons. Small icons take up less room on the screen; however,
large icons contain labels, which may be useful until you become familiar
with the program. In the preceding figure, the "Large toolbar" option is
selected.
The lower part of the dialog box contains an "Available list" and a "Selected
list" of icons with several buttons:
AddSelect an icon in the "Available list", and click Add to move the
icon to the "Selected list."
RemoveSelect an icon in the "Selected list" and click Remove to

remove the icon from the "Selected list". The icon reappears in the
"Available list."
CTRL + Click and SHIFT + Click are active and operate as described in
Selecting Items in Lists (on page 231).
RefreshClick to change the icon display under the title bar to your
current selections.
DefaultClick to return the selections to the program defaults.
OKClick to save your changes.
CancelClick to cancel any changes and close the dialog box.
Unity Desktop Menu Bar

The Unity Desktop menu bar contains menus each of which opens to a
submenu. The menu bar is not customizable. This section provides a
reference for which items are accessible from each main menu. Functions of
each menu item are discussed elsewhere in this guide.
55
Menu Item
Submenus
File
Open
Save ChartViewing, Printing and Saving Charts
Print Chart
Exit
Select
Lab
Lot
Test
Panel
View
Status Bar
Refresh
Toolbar
Advisors
Westgard AdvisorThis items appears only to notify you that

the module is available if you upgrade to Unity Real Time.
Reports
General
Supervisory
Charts
Listings
Configure
Tools
Security
Unity Interlab
Utilities
Actions and Comments
Setup
Help
Help Topics
Bio-Rad on the Web
QCNet on the Web
About Unity Desktop
User Guide
56
Program Basics
Bio-Rad Laboratories From the Windows

Start Menu
Choose Start | All Programs | Bio-Rad Laboratories from the Windows Start menu
to display a menu with several items:
Application UtilitiesSelect Acrobat Reader Setup if you need to install

Adobe Acrobat Reader as described below.
FlowchartSelect to start an interactive program that asks you

questions about QC rule violations to diagnose random and systematic
error.
Unity DesktopClick to start the Unity Desktop user application.
User GuideClick to display the User Guide as a PDF file.
Acrobat Reader Setup

Unity Desktop requires that you have Adobe Acrobat Reader 5.5 or later
installed. If you need to install the Reader, you can do so from Acrobat
Reader Setup as follows:
1
Choose Start | All Programs | Bio-Rad Laboratories | Application Utilities |Acrobat

Reader Setup from the Windows Start menu.
Wait while the Reader setup file is recomposed. This may take several
minutes.
When the "Adobe Reader 6.0.1 - Setup" dialog box displays, follow the
Wizard to install Adobe Acrobat Reader.
Shortcut Keys
The following table summarizes the shortcut keys available in Unity
Desktop. In the table, the Key column indicates the function key, while
the remaining columns indicate any additional keys that need to be pressed
along with the function key. For example, to open Bench Review, press the
CTRL key and the F2 key simultaneously. In this guide, CTRL+F2 indicates
these keys (i.e. the two keys to be pressed are shown with a plus sign [+]
between them).
57
Key Plain
F1
CTRL
ALT
Help
Log off
F2
F3
Shift
Open "Test"
dialog box
Open "Lot"
dialog box
Open "Lab"
dialog box
Open "Panel"
dialog box for
selected test
Exit Unity
Desktop
F4
F5
Next test
Previous test
F6
Net lot
Previous lot
F7
Next lab
Previous lab
F8
Next panel
Previous panel
F9
L-J chart for

selected test
Point Data
Report
F10
Supervisor
Report
F11
Set Initial
Date in data
entry
F12
58
Youden chart
for selected
test
Bar chart for

selected test
Statistical Report
"Administrator" "Archive/Restore"
dialog box
dialog box
Import utility
Program Basics
Functions and Where to Find Them

Name
Where is it?
Acrobat Reader Setup Start | All Programs | Bio-Rad

Laboratories | Application
Utilities | Acrobat Reader
Setup
Action log library
See
Acrobat Reader Setup (see
"Activation Keys and Licensing"
on page 218)
Tools | Actions and Comments Actions (on page 136)

| Configure Action Logs
Actions/comments by Tools | Actions and Comments Actions and Comments by

instrument
Instrument (on page 139)
| Action/Comment by
Instrument
Activation key
Tools | Security | Update

Activation Key
Activation Keys and Licensing

(on page 218)
Archive/Restore
Tools | Utilities |
Archive/Restore
Archive and Restore
Automatic action logs Tools | Setup
Automatic Action Logs
Automatic
Tools | Setup
transmission, monthly
To Activate Automatic
Monthly Transmission (see "To
Activate Automatic Monthly
Transmission for Monthly Unity"
on page 174)
Code list updates,

automatic
Tools | Setup
Database Updates (on page

224)
Create new lots if

necessary
F12
Import Check Boxes (on page

146)
Create new tests if

necessary
F12
Import Check Boxes (on page

146)
Database updates,
automatic
Tools | Setup
Automatic Database Updates
Default data entry

mode
Tools | Setup
Specifying a Default Data

Entry Mode (on page 112)
Email transmission
file to Bio-Rad
Tools | Unity Interlab | Write

Transmission File
To Email a Transmission File

to Bio-Rad (on page 176)
Export
Tools | Utilities | Export All

Labs
Exporting Data
Import
F12
Import Overview
Operator Setup
Tools | Utilities | Operator

Setup
Operator Setup (on page 149)
59

Passwords, change
your own
Tools | Security | Change

Password
Password expirations
Tools | Security | Administrator User Profiles and Security (on

page 61)
PDF reports
Tools | Setup
Choosing a Report Format (on

page 165)
Rejection log
Tools | Utilities | Import | View

Rejection Log
The Rejection Log (see "Using

Write Transmission File" on
page 174)
Restore from Archive
Tools | Utilities |
Archive/Restore
Archive and Restore
Send/Receive data
Tools | Unity Interlab |

Send/Receive Data
Transmissions Files
Toolbar, customize
View | Toolbar
Customize Your Toolbar
Transmission,
automatic monthly
Tools | Setup
To Activate Automatic
Monthly Transmission (see "To
Activate Automatic Monthly
Transmission for Monthly Unity"
on page 174)
Transmission, manual

Send/Receive Data
To Transmit Data Manually
Unity Interlab Report

frequency and
language
Tools | Setup and click the

"Unity Interlab" Report tab
The Setup Dialog Box (on page

222)
Update database

Send/Receive Data
Updating Database
Information (on page 211)
Write transmission
file

Send/Receive Data
Using Write Transmission File

(on page 174)
60
To Change Your Password (on

page 65)
H A P T E R

In This Chapter
Defining, Modifying, and Deleting Users ............................ 61
Passwords ................................................................ 63
Choosing Permissions................................................... 65
Defining, Modifying, and Deleting Users

Unity Desktop utilizes user profiles with passwords and permissions to
control individual user access to program features. Each person using Unity
Desktop should have an assigned user name and password. Menu items and
command buttons for which the user does not have permission will appear
dimmed.
Only administrators and users with permission to "Manage users" can create,
modify, and delete users. You do so in the Administrator dialog box.
Choose Tools | Security | Administrator or press ALT+F11 to access the dialog
box.
From the "Administrator" dialog box, you can:
Define, modify, and delete user profiles for individual users, including
their passwords and permission profiles.
Select the "Administrator" check box to create users with all

permissions.
Define password expiration periods.
A check in the Administrator check box automatically selects all user

permissions and sets the Data option to "Edit all data." Removing the check
from the Administrator check box clears all user permissions and sets the
data entry option to "View data only."
See Choosing Permissions (on page 65) for an explanation of the functions
each permission controls.
The user profile section of the Administrator dialog box consists of the
users ID, name, password, and initials.
The User ID can contain any combination of letters and numbers up to

55 characters.
The User Name can contain any combination of letters and numbers up
to 60 characters.
The User Password can contain between 2 and 16 characters, can

consist of any combination of letters and numbers, and is casesensitive.
The User Initials (up to three characters) appear in the Op column of

the data entry screen to identify the user (operator) who entered the
data. User initials are also appended to action and comment messages.
To Add a User
1
Log in as a user with permission to manage users.
Choose Tools | Security | Administrator.
Click New.
Under "User profile," type the User ID, User name, Password, and
Initials of the new user.
If desired, select the "Set password expiration period to" check box and
select a time period from the drop-down list. See Passwords (on page
63) for more information.
Select an option to apply the expiration period to all users or just to

the current user.
Select the individual permissions to be assigned to the user.

To select a permission, click the check box next to the desired
permission. To clear a permission, click the check box again. See
Choosing Permissions (on page 65) for an explanation of what each
permission controls.
Select the "Administrator" check box only if you want to give the new
user access to all available Unity Desktop functions.
Select a data entry option. Only one data entry option can be chosen at
any given time.
Click Apply to save your changes.
10 Click New to add another user or OK to close the Administrator

dialog box.
62
To Modify a User
1
Log in as a user with permission to manage users.
Press ALT+F11 to access the "Administrator" dialog box.
Select the user to be modified from the drop-down list under "User ID."
Change the users profile, permission, and data entry option as desired.
To select a permission, click the check box next to the desired

permission. To clear a permission, click the check box again.
To change the user's data entry permission, select another option.
Click Apply to save your changes.
Click OK to return to the main menu.
To Delete a User
Deleting a user removes the user's associated User ID and Password from the
"Login" and "Administrator" dialog boxes. However, the user's initials will
still appear in the OP column of data entry screens for any data points that
the user previously entered.
1
Login as a user with permission to manage users.
Press ALT+F11 to access the "Administrator" dialog box.
Select the user to be deleted from the drop-down list under "User ID."
Click Delete.
The screen displays a message asking you to confirm that you want to
delete the user.
Click Yes to delete the user.
Click OK to return to the main menu.
Passwords
Creating Passwords
Please be aware of the following password facts:
63
Passwords can contain between 2 and 16 characters.
Passwords can contain any combination of letters and numbers.
Passwords are case-sensitive.
Passwords can be set to expire in 3, 6, or 9 months. By default,

password expiration periods are set to "Never;" you must select a time
period to activate them.
Default Administrator Passwords

When installed, Unity Desktop creates a default administrator with the
following user profile:
User ID - admin
User name - admin
Password - sa
Initials - sa
The default administrator login allows new users initial access to the
software. After you create other users, you should delete this user or
change the password.
At least one user must have administrator privileges. If only one user on the
system has administrator privileges, the program will not allow you to
delete this user or to clear (uncheck) the Administrator check box until
you define another user with administrator privileges.
Additional users can be given administrator privileges as required; however,
giving all, or even most, users these privileges eliminates the security
precautions gained by using passwords. (Unity Desktop also creates a default
database password as described in Default Database Passwords.)
Password Expiration
Unity Desktop allows users with permission to manage users to specify that
passwords expire after a set length of time. Use of this feature is entirely
optional; however, you may want to use it for added security or to satisfy
regulatory requirements.
You will probably want to set the password expiration period as you add
new users; however, you can update users to add or change the expiration
period. When you apply a password expiration period, you can choose to
apply it to only the current user or to all users.
64
If every user will have the same expiration period, it is obviously easier to
specify it once and apply it to all users. In addition, specifying "Never" as
the period and applying it to all users is a convenient way to cancel the use
of the password expiration feature.
To Change Your Password

All users, regardless of their permissions, can change their own password.
1
Log in to Unity Desktop.
Choose Tools | Security | Change Password.
Type your new password. Then type it again to confirm.
Click OK to save your changes.
Choosing Permissions
The user permissions section of the "Administrator" dialog box (ALT+F11)
contains check boxes for a number of program functions. To give a user
permission to perform a particular function, click inside the box next to the
function to place a check mark in it. To clear the permission, click inside
the box again. Assigning permissions allows you to customize what functions
each user has access to.
A check in the Administrator check box automatically selects all user
permissions and sets the Data option to "Edit all data." Removing the check
from the Administrator check box clears all user permissions and sets the
data entry option to "View data only."
Unity Desktop divides permissions into groups which are described in the
following sections.
Administration/Setup Permissions
The Administration/Setup group of permissions contains the following
individual permissions:
Manage users
Users with permission to manage users can:
Create new users and set password expiration periods

65
Modify existing user profiles
Modify an existing users permissions
Delete users
Access the Operator report
Edit action log

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

Users with this permission can:
Make changes on the Setup dialog box. See The Setup Dialog Box
(on page 222) for more information.
Specify password expiration intervals.
Operator setup
Users with this permission can use operator setup to define the
operator initials to appear on the data entry screen for imported data
when the import file does not contain operator initials.
Data Permissions
The Data section of the "Administrator" dialog box contains option buttons
to allow the Administrator to assign a data entry and editing category.
Enter new data onlyThe user can enter new data but cannot edit or
delete any data.
Edit last lineThe user can enter new data and can edit the last line of
data entered.
Edit all dataThe user can enter new data and can edit any line of data.
View data onlyThe user can view data on the screen but cannot enter,
edit, or delete data.
Database Permissions
The Database group of permissions contains the following individual
permissions:
Archive and restore

Users with this permission can archive the database and then, when
necessary, restore the database from this archive.
66
Condense data
The condense data feature allows you to convert point data to
summarized data within your database. The condense feature is
unavailable when the RiLiBK module is installed.
Reconcile data
The reconcile data feature should only be used when you are instructed
to do so by a Bio-Rad software support representative. This feature will
re-transmit your entire data history to the Unity Interlaboratory
Program instead of just recent changes. This makes the file size much
larger.
The reconcile feature is unavailable when the RiLiBK module is installed.
Rules and Settings Permissions

Users with permission to edit test settings/rules can:
Make changes to test settings (including changing the number of levels

in use and 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.
Activate an analytical goal (available with Unity Real Time only).
Access the Westgard Advisor (optional module for Unity Real Time
only).
Edit Total Error-BV bias and imprecision goals when manually specifying
a target value.
Labs, Lot, Tests, and Panels Permissions

The labs, lots, tests, and panels group of permissions contains the following
individual permissions:
Manage labs/lots/tests
Users with permission to manage labs/lots/tests can:
Add and delete valid Bio-Rad lab numbers. (You cannot delete your
primary lab number.)
Edit lab profiles.
Add, edit, delete, open, and close lot numbers.

67
Add, delete, update, open, and close tests.
Use Instrument Setup.
Edit Summary Data Entry dates.
Close the primary lab number.
Manage panels
Users with permission to manage panels can add, edit, and delete
panels.
Data Handling Permissions

The data-handling group of permissions contains the following individual
permissions:
Communicate with the Unity Interlaboratory Program

Users with permission to communicate with the Unity Interlaboratory
Program can send information to and receive information from the
Unity Interlaboratory Program. This includes sending and receiving
data, updating database information, and writing transmission files.
Import data
Users with this permission can manually import data. Autoimport (e.g.
directly from a LIS or third-party peripheral) runs as a background
process and is not controlled by permissions.
Export data
Users with this permission can manually export data.
68
H A P T E R
Labs and Lots

In This Chapter
Labs ....................................................................... 69
Lots ....................................................................... 73
Labs
The Unity Interlaboratory Program uses a hierarchical structure of lab
number, lot number, and test codes to uniquely identify each test in your
laboratory. You must have at least one lab number in order to use Unity
Desktop. Lab numbers are a unique set of 6 digits assigned to your lab by
Bio-Rad. To get started, use the lab number provided with your startup
package. If you need additional lab numbers, contact your Bio-Rad software
support representative.
All lab numbers must be provided by Bio-Rad Laboratories.
Primary Lab Numbers

The first lab number you define in Unity Desktop becomes your primary lab
number. You can close your primary lab number, but you cannot delete it.
Contact Bio-Rad if you need to change your primary lab number designation.
Within the Lab dialog box, your primary lab number is shown in bold.
Additional Lab Numbers

You may choose to use multiple lab numbers within your organization. In
fact, labs frequently assign each instrument its own lab number. Individual
lab numbers can also be used to identify different departments or shifts.
Affiliated Lab Numbers

If you belong to a group of labs and would like the Unity Interlaboratory
reports based on your combined lab numbers, contact your Bio-Rad software
Adding and Updating Labs

You add and update lab profiles from the Lab dialog box. Within the "Lab"
dialog box, an asterisk identifies required fields. If you attempt to exit the
dialog box without providing all required information, the screen displays a
message prompting you to supply the missing information.
If you need to define several lab numbers that have similar information, you
can create the first lab (including lots and tests, if desired), duplicate it to
the additional lab numbers, and then edit the additional lab numbers as
necessary.
To Add a Lab Number

1
Log in as a user with permission to manage labs/lots/tests.
Click the Lab button on the toolbar.
Type the six-digit laboratory number provided by Bio-Rad. (If you need
a lab number or cannot remember your lab number, contact your BioRad software support representative.)
Type the appropriate information in each category. An asterisk

identifies required fields.
Click Add. (If you click Add without completing a required field, a
message will prompt you to supply the missing information.) The lab
number appears in the "Open labs" list.
Click Close to return to the main screen or Lot to define the lot
numbers to be used under this lab number.
To Update a Lab Number

You can change and update any element of your laboratory profile except
for the lab number.
1
70
Labs and Lots
In the "Open labs" list, select the lab number to be updated. (You
cannot update information for a closed lab. You must reopen it first.)
Type the appropriate changes in each category.
Click Update.
Click Close to return to the main screen or Lot to go to the Lot dialog
box.
Duplicating Labs
Unity Desktop allows you to copy information defined for one lab number
into a second lab number. After duplication, you can update the Lab profile
for the second lab number as required. Only open lab numbers can be
duplicated.
Duplicating a lab number creates a copy that contains all open lots and tests
in the original lab number. The SPC rule and analytical goal profiles are also
copied for open tests. In addition, you can choose whether or not to
duplicate fixed means and/or fixed SDs.
Duplicating a lab number does not copy QC data.
To Duplicate a Lab Number

You cannot duplicate a closed lab number; you must reopen it first.
1
Select the lab number to be duplicated from the "Open labs" list.
The selected lab's profile appears. (You cannot duplicate a closed lab
number. You must open it first.)
Click Duplicate. The screen displays the "Duplicate Lab dialog box.
Type the target lab number. (Until you type a valid lab number, the OK
button is unavailable and appears dimmed.)
If you would like to copy fixed means and/or SDs, you can select either
or both of the "Duplicate Fixed Mean" and "Duplicate Fixed SD" check
boxes. These check boxes operate independently so that you can copy
just fixed means or fixed SDs.
Click OK. The target lab number appears in the "Open labs" list.
If necessary, edit the Lab profile information and click Update.

71
Deleting Labs
Deleting a lab number deletes all data for all tests within the deleted lab
number. Information within the deleted lab number cannot be retrieved at
a later date. If you want to make a lab number inactive while retaining its
information, use the Close Lab feature of the program. You can also export
its data as a text, delimited, or import file before you delete it.
To Delete a Lab Number

1
Select the lab number to be deleted from the "Open labs" list. (You
cannot delete a closed lab. You must reopen it first.)
Click Delete. A message appears asking you to confirm that you want to
delete the lab number.
Click OK to delete the lab number or Cancel to cancel.
Opening and Closing Labs

Lab numbers can exist in two statesopen and closed. Open lab numbers
are available for data entry and results for their lot numbers appear on your
Unity Interlaboratory reports. When you close a lab, its data remains in the
Unity Desktop database, but is it not available for data entry and is
excluded from your Unity Interlaboratory reports. If you need to begin using
the lab number again, you can reopen it at any time. In addition, you can
delete any lab number except your primary lab number. When you delete a
lab number, all its information, including lot, tests, and data are
permanently deleted from Unity Desktop.
To summarize, closed labs:
Are not deleted from the system.
Are ignored by Unity Desktop (i.e. data located within the closed lab
number cannot be viewed, printed, or changed.)
Are omitted from Unity Interlaboratory reports.
Can be reopened if you decide to use the lab number at a future date.
To Close a Lab Number

1
72

Labs and Lots
Select the lab number to be closed from the "Open labs" list.
Click Close Lab. The lab number appears in the "Closed labs" list.
To Open a Lab Number

1
Select the lab number to be opened from the "Closed labs" list.
Click Open Lab. The lab number appears in the "Open labs" list.
Lots
You can use both Bio-Rad and non-Bio-Rad lots with Unity Desktop.
However, Unity Interlaboratory reports are only available for Bio-Rad
products.
Adding Bio-Rad Lots

Bio-Rad master lot numbers are composed of five digits ending in zero. You
can find the lot number of a Bio-Rad quality control product printed on the
outside of the box containing the control product, on the label of the
control product, and in the package insert.
The "Control name" and "Lot number" lists in the Lot dialog box within
Unity Desktop contain all unexpired Bio-Rad control product/lot number
combinations based on the code list contained in your database. If the BioRad control product or lot number you are using does not appear in one of
these lists, download the current code list from Tools | Unity Interlab |
Send/Receive Data or from QCNet.com.
For each individual control level, the final zero of the master lot number is
changed to a number specifying the control level (e.g. one, two, three, or
four designating level 1, level 2, level 3, or level 4).
Unity Desktop limits test evaluation to four levels. This means that you can
choose any four levels of a control material to use to evaluate a test against
statistical process control (SPC) rules. For non-Bio-Rad controls, you can
specify up to nine levels; however, Unity Desktop imposes the same 4-level
test-evaluation limit on non-Bio-Rad controls.
73
To Add a Bio-Rad Lot

1
Click the Lot button on the toolbar to display the Lot dialog box.
Select the appropriate Bio-Rad control from the "Control name" dropdown list.
Select the lot number of the control from the "Lot number" drop-down
list.
Click Add. The lot number appears in the "Open lots" list.
Click Close to return to the main screen or, to begin defining tests,
select the lot in the "Open lots" list, and then click Test.
Adding Non-Bio-Rad Lots

Unity Desktop can be used for intralaboratory performance tracking of nonBio-Rad control products, and all Unity Desktop reports and charts are
provided in this case. However, 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, Unity Desktop will
prevent you from assigning a Bio-Rad lot number to a non-Bio-Rad control.
Because of this, you should avoid assigning five-digit lot numbers that end in
zero to non-Bio-Rad controls.
To Add a Non-Bio-Rad Lot

1
Select "Other" from the "Control name" list.
Click Add. The "Non-Bio-Rad Control" dialog box appears.
Complete each requested field:
74
Control nameEnter a free-text name for your control.
ManufacturerEnter a free-text manufacturer's name.
MatrixMake a selection from the drop-down list.
LevelsMake a selection from 1 9. (Although a control can contain

up to 9 levels, Unity Desktop limits the number of levels that can be
used for evaluating a test to four.)
Labs and Lots
Expiration dateLeave the default selected, or click the down

arrow to display a calendar. See Using Calendars (on page 233) for
more information.
When setting an expiration date, the expiration date will default to one
year, specifically, the last day of the current month plus one year. For
example, if you create a lot on March 13, 2007, its default expiration
date will be March 31, 2008 at midnight (11:59:59).
6
Click Add. The lot number appears in the "Open lots" list of the Lot
dialog box.
Click Close to return to the main screen or select the lot in the "Open
lots" list, and click Test to begin defining tests.
Duplicating Lots
Duplicating lot numbers allows you to create a new lot number with the
tests and test parameters in an existing lot, greatly simplifying lot changes.
(If you import data, Unity Desktop can create new lots for you based on the
lot number in the import file. To activate this feature, you must select the
"Create new lots if necessary" check box on the "Import" dialog box. (Press
F12 to access this dialog box.))
When you duplicate a lot, the new lot number will be configured exactly the
same as the old lot number but will contain no data.
You can duplicate both Bio-Rad and Non-Bio-Rad lot numbers.
If you want to duplicate a closed lot, you must re-open it first. The original
closed lot can then be re-closed so that it is ignored by Unity Desktop and is
omitted from your Unity Interlaboratory reports.
Items Automatically Duplicated

When you duplicate a lot, Unity Desktop duplicates the:
Open tests within the lot (Closed tests are not duplicated.)
Test settings (levels in use, decimal places, etc.)
Rule selections for SPC rules and analytical goals
Optional Items When Duplicating

You can choose whether or not to duplicate the following, when you are
using them:
75
Fixed mean
Fixed SD
Manually defined analytical goal target values
RiLiBK target values
RiLiBK test parameters (i.e. maximum inaccuracy, maximum

imprecision, and mzA)
Only labs in Germany are required to use RiLiBK rules to evaluate
tests.
To Duplicate a Bio-Rad Lot Number

1
In the "Open lots" list, select the lot to be duplicated. The product
name and lot number appear under "Lot information."
Click Duplicate. The "Duplicate Lot dialog box appears.
Select the lot number you want to duplicate to from the drop-down list.
Only unexpired lot numbers in the same product group will appear in
the list.
Select the check boxes for each test parameter that you want to
duplicate.
Click OK. The new lot number appears in the "Open lots" list. The lot
that you duplicated from is unchanged.
To Duplicate a Non-Bio-Rad Lot Number

1
In the "Open lots" list, select the lot to be duplicated. The product
name and lot number appear under "Lot information."
Click Duplicate. The "Non-Bio-Rad Control" dialog box appears.
Specify a name and expiration date for the lot. The new lot appears in
the "Open lots" list.
76
Labs and Lots
Deleting Lots
You can delete lot numbers at any time. You do not have to wait until after
the lots expiration date. Be aware, however, that deleting a lot number
erases all data in all tests in the deleted lot.
As an alternative to deleting the lot number, you can close it so that it no
longer appears in the navigation tree or on your Unity Interlaboratory
reports. If you choose to delete a lot, you might want to export its data
before deleting it.
Deleting a lot number permanently erases all data in all tests in the
deleted lot.
To Delete a Lot Number

1
Click the Lot button on the toolbar to access the Lot dialog box.
Select the lot you want to delete in the "Open lot" list.
Click Delete. A message box appears asking you to confirm the

deletion.
Click OK.
Editing Lots
You can edit both Bio-Rad and non-Bio-Rad lots, even if the lot contains
data.
Editing a Bio-Rad Lot

1
Select the Bio-Rad lot you want to update in the navigation tree.
Click the Lot button on the toolbar. The Lot dialog box appears with
the lot selected.
Click Edit. The "Edit Bio-Rad Lot dialog box appears.
Select the correct lot number from the drop-down list. Only lots in the
same product group appear in the list.
77
Click OK.
Editing a Non-Bio-Rad Lot

1
Select the non-Bio-Rad lot you want to update in the navigation tree.
Click the Lot button on the toolbar. The Lot dialog box appears with
the lot selected.
Click Edit. The "Non-Bio-Rad Control" dialog box appears.
Enter a new master lot number and expiration date, then click OK.
Closing and Opening Lots

Unexpired lot numbers can be open or closed, and you can toggle a lot
between the open and closed states.
Open lot numbers are available for data entry and appear on your Unity
Interlaboratory reports.
Closed lots are locked for data entry and you cannot view, print, or change
data contained within the closed lot number. The lot number is not deleted
from the system; however, it is ignored by Unity Desktop and is omitted
from your Unity Interlaboratory reports. Closed lots can be reopened if you
want to be able to view, print, or change data.
Closing a lot number locks its data, but the data remains in the database.
Deleting a lot number permanently erases the lot and all of its data.
To Close a Lot
1
Select the lot you want to close from the navigation tree.
Click the Lot button on the toolbar. The Lot dialog box appears
within the lot selected in the "Open lots" list.
Click Close Lot. The lot appears in the "Closed lots" list.
Click Close to return to the main screen.
To Open a Lot
1
78

Labs and Lots
Select the lab number containing the closed lot in the navigation tree.
Select the lot number to be opened from the "Closed lots" list.
Click Open Lot. The lot number appears in the "Open lots" list.
Click Close to return to the main menu.
Lot Expiration Notifications

If you want Unity Desktop to notify you when a lot will expire in 30 or fewer
days, you can select the "Expired lot notification" check box on the
"Configure Unity Desktop" tab of the "Setup" dialog box. (Choose Tools | Setup
to access this feature.)
When the "Expired lot notification" check box is selected, Unity Desktop will
display a notification that the lot will expire in 30 or fewer days each time
you open data entry for a test in the lot. Select the "Do not display this
message again" check box to stop the notifications.
79
H A P T E R
Tests
In This Chapter
Overview of Tests....................................................... 81
Adding Tests ............................................................. 82
Test Rules and Settings ................................................ 87
Duplicating Tests ....................................................... 88
Updating Tests .......................................................... 88
Closing and Opening Tests ............................................ 89
Deleting Tests ........................................................... 90
Sorting Tests............................................................. 91
VITROS Slide Generations ............................................. 92
Overview of Tests
Unity Interlaboratory Program defines tests using six parameters. Used
with the lab and lots numbers, these codes uniquely identify your tests in
the Unity Interlaboratory Program.
The six parameters are:
Analyte
The analyte is the constituent being measured (e.g. albumin, calcium,
glucose, etc.).
Instrument/Kit
When using RIA kits, code for the kit rather than the gamma counter.
Reagent type
Dedicated reagent or kit

Choose "Dedicated reagent or kit" when the reagent manufacturer is
the same as the instrument manufacturer. For VITROS analyzers
that use slide generations, leave "Dedicated reagent or kit"
selected, and type your slide generation number in the "VITROS
slide generation number" field.
Alternate formulation /standardization
Alternate formulation/standardization is the applicable reagent

selection when you are using a dedicated reagent and a
manufacturer update or revision of the product results in a shift of
your quality control data.
Your Bio-Rad software support representative may request that you
use this option to ensure that 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 software
support representative to move your data to the Dedicated reagent
or kit category.
Factored
Factored is applicable when your quality control data is
mathematically altered to simulate results obtained on another
instrument or at another temperature.
More reagents
More reagents is applicable if you are not using a reagent supplied
by the instrument manufacturer. Click "More reagent selections",
and then select the appropriate reagent under "More reagents." If
the reagent you are using does not appear, choose "Other", and
type a free-text reagent name.
Method
Only methods that Bio-Rad considers "valid" for the selected analyte
appear in the list. If your method does not appear, please contact your
Bio-Rad software support representative.
Unit of measure
Only units that Bio-Rad considers "valid" for the selected analyte appear
in the list. If your unit does not appear, please contact your Bio-Rad
software support representative.
Temperature
For enzymes, you can choose an available temperature. For all other
analytes, the temperature defaults to "no temperature" and cannot be
changed.
Adding Tests
You can add tests to Unity Desktop both directly and indirectly. Direct
methods include manual addition and instrument setup; indirect methods
82
Tests
include duplication of labs or lots, the create new tests import features,
and changing VITROS slide generation.
Direct Methods of Adding Tests

Both manual test addition and instrument setup occur from the Test
dialog box and their results are immediately visiblethe new tests appear in
the "Open test" list.
When you manually define tests, you select the required parameters from
lists in the "Test" dialog box. When you use Instrument Setup, Unity Desktop
supplies the codes based on information in the Method Guide for Selected
Instruments.
Indirect Methods of Adding Tests

The following functions will create tests in the background:
Duplication of labs or lots

When you duplicate a lab, its associated open lots and their open tests
are duplicated. When you duplicate a lot, its associated open tests are
duplicated. Closed lots and closed tests are not duplicated.
Create new tests import feature

If an import file contains codes for valid Bio-Rad lots or for tests that
are not already defined in your database, the import utility creates
them and then imports the data. Create new tests if necessary is
selected by default. To use Create new lots if necessary you must
select its check box on the Import dialog box. Within Unity Desktop,
press F12 to display the dialog box. See Import Check Boxes (on page
Changing VITROS slide generations

Changing VITROS Slide Generations (on page 92) creates a new test
with the new slide generation.
To Add Tests Manually

1
Select the lot to which you want to add tests in the navigation tree.
Click the Test icon on the toolbar to display the "Test" dialog box.
Make a choice from each of the following drop-down lists:
Analyte
83
Instrument/Kit
Method-Unity Desktop limits this list to methods it considers valid.
Unit of Measure-Unity Desktop limits this list to units it considers

valid.
Temperature (for enzymes only)-For other analytes, "No

Temperature" is automatically selected and cannot be changed.
Select an option for Reagent type:
Dedicated reagent or kit

Use this selection, which is the default, when the reagent
manufacturer and the instrument/kit manufacturer are the same.
Alternate formulation/standardization
You will usually only select this option when asked to do so by your
Bio-Rad software support representative or when you receive a
notice asking you to change the reagent type for a test.
Factored
Select factored when your quality control data is mathematically
altered to simulate results obtained on another instrument or at
another temperature.
More reagents
If you choose this option, a comprehensive list of reagents appears.
Simply select a reagent from the list.
When your selections are correct, click Add. The new test appears in
the Open tests list.
If a code you need to use is missing, you may need to update your code list
as described in Updating Database Information (on page 211).
Adding Tests With Instrument Setup

Instrument Setup is a convenient way to define groups of tests on an
instrument. This feature creates tests and assigns test codes based on
information in the Method Guide for Selected Instruments. (You can view,
print, or download a copy of the Method Guide from QCNet.com. Log in and
choose QC References | Method Guide.)
When you click Instrument Setup in the "Test" dialog box, Unity Desktop
displays a list of available instruments and check boxes to allow you to
choose SI or Conventional units.
84
Tests
When you select an instrument and units (Conventional is the default),

Unity Desktop displays a list of the tests available for the instrument. Tests
that you have previously defined for the instrument in the lab/lot
combination are omitted from the list.
Each test in the list is preceded by a check box. When a check box is
selected, Unity Desktop creates the test when you click OK in the
Instrument Setup dialog box. You can select and clear check boxes
individuallyjust click the check box. In addition, you can click Clear All to
clear (uncheck) all the check boxes or Select All to select (check) all the
check boxes.
Only instruments that appear in the Method Guide are available in
Instrument Setup. If your instrument does not appear, you can contact your
Bio-Rad software support representative and ask that it be added.
Limitations of Instrument Setup
Instrument Setup assumes that you are using dedicated reagents. If

your test codes are different, you will need to edit the tests.
Instrument Setup assigns 00 as the slide generation for VITROS tests.

You will need to edit the slide generation to what you are using in your
lab.
Instrument Setup assigns 37 as the temperature code for all enzymes.

All non-enzyme tests are assigned a "No Temperature" code.
You cannot define tests with a mixture of SI and Conventional units at the
same time when using Instrument Setup. You can, however, use the
function twice to add tests using both unit types.
To Add Tests Using Instrument Setup

1
Select the lot to which you want to add tests in the navigation tree.
Click the Test icon on the toolbar. The Test dialog box appears.
Click Instrument Setup. The "Instrument Setup" dialog box appears with
a list of available instruments.
Select an instrument from the drop-down list.
Select units as SI or Conventional. (Conventional is selected by default.)
85
Click OK. The Instrument Setup dialog box appears with a list of all
available tests from the Method Guide. A selected check box preceding
a test indicates that the test will be created. (The Clear All button will
deselect all the check boxes while the Select All button will select all
the check boxes.)
Select and clear the check boxes so that only the tests you want to add
are selected.
Click OK. A message appears with the number of tests added.
10 Click OK to return to the Test dialog box. The newly added tests
appear in the "Open tests" list.
If you added tests for a VITROS instrument, be sure to change your
VITROS Slide Generations (on page 92).
Adding Tests With an Other Code

If a test code you need to use does not appear on the code list, you can
specify "Other" for it, and type a free-text name. However, you should first
download the latest code list to see if the code appears. Bio-Rad updates its
code lists at least monthly. If you define a test using an other code and
later discover that your desired code is available, you can update the test
to the correct code.
Please be aware that Unity Interlaboratory reports are not available for
tests using "Other" codes.
To ensure that you have the latest code list, select the Automatic code list
updates check box on The Setup Dialog Box (on page 222), and Unity
Desktop will automatically update your database whenever a new code list
becomes available. Choose Tools | Setup to access the "Setup" dialog box.
To Add Tests With an Other Code

1
Click the Test icon on the toolbar to display the Test dialog box.
Make a selection for each test code from the drop-down lists. Select
"Other" for any code that does not appear. (Type the letter O to move
to the correct area of the list.)
When all selections are made, click Add. The Other dialog box
appears.
86
Tests
Type a free-text name in each available field, and then click OK.
Because the Unity Interlaboratory Program does not create reports for tests
that use "Other" codes, the use of "Other" codes should be considered a
stop-gap measure, and we request that you also contact your Bio-Rad
software support representative to request that "Other" codes be added to
the code list.
Test Rules and Settings

Unity Desktop allows you to specify several settings to customize how your
tests are displayed and evaluated. You make these selections from the
Settings dialog box, which you can access from the "Lot" or "Test" dialog
boxes. The "Settings" dialog box has two tabsRules and Settings.
Rules Tab of the Test Settings Dialog Box

You select the SPC rules to be applied to tests from this tab as discussed in
Setting SPC Rules (on page 104).
Settings Tab of the Test Settings Dialog Box

You can access the "Settings" dialog box from the "Lot" or "Test" dialog box.
The following list summarizes the items available on the "Settings" tab:
Number of data points before rule evaluation

Unity Desktop defaults the number of data points that must be entered
before quality control rule evaluation begins to 20. If you do not specify
a fixed mean and standard deviation, Unity Desktop begins evaluating
data points when this number of points have been collected. While you
can change this number, you may prefer to set a fixed mean and fixed
standard deviation to evaluate your data while collecting the first 20
data points.
This item is available from either the "Lot" or "Test" dialog boxes.
Levels in use
Levels in use defaults to the number of levels available for the control
product. Change this selection if you do not use all available levels.
When you clear a level's check box, the level is omitted from the data
entry screen, which simplifies tabbing during manual data entry.
This item is available from both the "Lot" or "Test" dialog boxes.
87
Decimal places
You are allowed to specify the number of decimal places (zero to four)
to which you will report results for a level. You can specify different
decimal formats for each level.
This item is available from both the "Lot" or "Test" dialog boxes;
however, it is not usually possible to accurately assign decimal places at
the lot level. If you use a certain number of decimal places for most
analytes, you might want to set this number at the lot level and modify
individual tests as necessary at the test level.
Fixed mean and SD

The specification of fixed means and SDs are independent. That is, you
can specify a fixed mean with no fixed SD or vice versa. For more
information, see Using Fixed Means and SDs (see "Using Fixed Means
and SDs with SPC Rules" on page 105).
Fixed means and SDs can only be defined at the "Test" level, not at the
Lot level. The fixed mean and SD settings are available only in the
"Test" dialog box.
Duplicating Tests
You cannot duplicate individual tests from the Test dialog box. However,
duplicating a lab or lot number duplicates its tests.
Updating Tests
You can change any test code for an existing test, even if the test contains
data. This feature is useful if you make a mistake in coding a test or if your
Bio-Rad software support representative asks you to make a change (e.g. to
alternate formulation/standardization).
You cannot update a qualitative test to quantitative tests or vice versa.
See Update VITROS Slide Generations (on page 94) for information specific
to tests using slide generation.
To Update a Test
1
88
Select the test you want to update in the navigation tree.

Tests
Change the selections from the appropriate test code lists (analyte,
instrument/kit, reagent, method, unit, and temperature).
Click Update when all selections are correct. The "Update Test" dialog
box appears.
Select the range of identical tests that you want to update:
All LabsChoose this option to update all identical tests in all lab
numbers. (This option updates all identical tests in the database.)
Current LabChoose this option to update all identical tests in all

lots within the current lab number.
Selected testChoose this option to update just the test you

selected in the navigation tree. (This is the default selection.)
Identical tests are those that have the same Unity test codes for
analyte, instrument/kit, reagent, method, unit, and temperature.
6
Click OK.
Closing and Opening Tests

Like lab and lot numbers, tests can exist in two statesopen and closed.
Closed tests and their data remain in the Unity Desktop database, but they
are not available for data entry and do not appear on Unity Interlaboratory
reports. You can reopen the tests at any time to resume data entry.
To Close Tests
1
Select a test you want to close in the navigation tree.
Select the test(s) you want to close.

The Test dialog box supports both SHIFT+Click and CTRL+Click so
you can select multiple tests at a time for opening and closing. See
Selecting Items in Lists (on page 231) for more information.
Click Close Test. The tests are removed from the "Open tests" list and
appear in the "Closed tests" list. Closed tests are also removed from the
navigation tree.
89
To Open Tests
1
Click the Lab icon on the toolbar and select the lab number containing
the closed tests from the "Open labs list."
Click Lot to display the "Lot" dialog box.
Select the lot number containing the closed tests from the "Open lots"
list.
Click Test to display the "Test" dialog box.
Select the test(s) you want to open.

Click Open Test. The tests are removed from the "Closed tests" list.
The tests now appear in the "Open tests" list and the navigation tree
and become available for data entry.
Deleting Tests
You can delete tests at several levels:
Lab
Deleting a lab also deletes its associated lots and tests. See Deleting
Labs (on page 72).
Lot
Deleting a lot deletes its associated tests. See Deleting Lots (on page
77).
Test
Within the Test dialog box, you can delete tests that you select.
You can delete both open and closed tests.

Deleting a test permanently removes it and its associated test data from the
Unity Desktop database. Because data for deleted tests cannot be
retrieved by ordinary means, you might want to export a test's data before
deleting the test. Alternatively, you can close the test so that it remains in
the database but is unavailable for data entry and is omitted from your
Unity Interlaboratory reports. In addition, if you made a coding mistake
when creating the test, you can update it as described in Updating Tests
(on page 88).
90
Tests
Please notice that the "Test" dialog box has two delete buttonsone in
the "Open tests" list and the other in the "Closed tests" list. Which Delete
button you click determines the test(s) that are deleted. Be careful to
click the button in the correct area to avoid inadvertently deleting a
test.
To Delete Tests
1
Log in as a user with permission to manage labs, lots, and tests.
Access the "Test" dialog box for the lab/lot containing the test(s) you
want to delete.
Select the test(s) you want to delete from the "Open tests" or "Closed
tests" lists. (If you want to delete both open and closed tests, you will
need to select them separately.)
Click Delete.
Click Yes to complete the deletion or No to cancel.
Sorting Tests
You can sort tests for display in both lab mode and panel mode. For lab
mode, the order the tests appear in the Open tests list of the Test
dialog box controls the order on the lab navigation tree as well as on the
reports and charts. The Open test list order also controls the nextprevious assignments when using Shortcut Keys.
For panel mode, the order tests appear in the Selected tests list of the
Panel Tests dialog box controls the order on the lab navigation tree as
well as on reports and charts. The Selected tests list order also controls
next-previous assignments when using shortcut keys.
To Sort Tests in Lab Mode

1
Select the lab/lot combination for which you want to sort tests in the
lab navigation tree.
Click the Test icon on the toolbar to access the "Test" dialog box.
91
Select a test and drag it to the location where you want it to appear.
Then release the mouse button to drop the test. See Drag-and-Drop
Sorting (on page 232) for more information.
Repeat until the tests appear in the desired order.
Click Close to return to the main screen.
To Sort Tests in Panel Mode

1
Click the Panel icon on the toolbar to display the "Panel" dialog box.
Select the panel you want to sort in the "Panels" list.
Click Update/Sort to display the "Panel Tests" dialog box.
Select a test and drag it to the location where you want it to appear.
Then release the mouse button to drop the test. See Drag-and-Drop
Sorting (on page 232) for more information.
Repeat until the tests appear in the desired order.
Click OK.
Click OK again to return to the main screen.
VITROS Slide Generations

The Unity Interlaboratory Program uses the VITROS slide generation when
determining consensus groups. To ensure accurate reports, your VITROS
slide generation for each test must be correct.
When you Change VITROS Slide Generations (see "Changing VITROS Slide
Generations" on page 93) for a test, the software actually creates a new
test or tests with the new slide generation and allows you to choose what to
do with the old (existing test) and the range of tests to which to apply the
new slide generation.
You can also Update VITROS Slide Generations (on page 94), which simply
updates the slide generation of the selected test. No new tests are created
and the existing test remains available for data entry. Follow this procedure
if you made a mistake when coding the slide generation or used Instrument
Setup and need to update the slide generation from 00 to the correct one.
Instrument Setup assigns 00 as the slide generation. Be sure to Update
VITROS Slide Generations (on page 94) before reporting results to the
Unity Interlaboratory Program.
92
Tests
Changing VITROS Slide Generations

When you change slide generations, you also choose what to do with the old
(existing test) and the range of tests to which to apply the new slide
generation.
Change to old test

Your choices for the existing test include:
RetainChoose this option if you want to leave the existing test open
and available for data entry. This is the default selection.
CloseChoose this option if you want to stop data entry for the existing
test and eliminate it from the navigation tree and your Unity
Interlaboratory reports.
DeleteChoose this option to delete the existing test.
Apply new slide generation to
Selected testChoose this option to apply the new slide generation only
to the currently selected test. This is the default selection.
Current labChoose this option to apply the new slide generation to all
identical tests within the current lab number.
All labsChoose this option to apply the new slide generation to all
identical tests within the current database.
To Change VITROS Slide Generations

1
Click the Test icon on the toolbar to open the "Test" dialog box.
Select the appropriate test in the "Open tests" list.
Click Change Slide Generation.
In the "Change Slide Generation" dialog box, make a selection for each
of the following:
VITROS slide generation numberUse the up and down arrows to

select a number from 1 to 99.
Change to old testSelect an option to retain, close, or delete the

old test.
Apply new slide generation toSelect an option from selected test,

current lab, or all labs.
Click OK when all selections are correct.

93
Update VITROS Slide Generations

When you need to correct slide generations, you should update the test
rather than changing the slide generation. If a slide generation is incorrect
and you have already entered data for the test, updating the test will
correct the coding issue within Unity Desktop. In addition, the test will be
updated in the Unity Interlaboratory Program the next time you transmit
data. You will also need to update slide generations after using Instrument
Setup, which arbitrarily assigns slide generation 00 to each test it creates.
When you update a slide generation, you are prompted to select the range
of the test the change should be applied to. However, you are not prompted
to specify what happens to the existing test, because it remains open and
only the slide generation is updated.
To Update VITROS Slide Generations

1
Select the VITROS test you want to modify in the navigation tree.
Click the Test icon on the toolbar to open the "Test" dialog box.
Information for the test you selected in the navigation tree appears
under "Test information."
Locate the "VITROS slide generation number" field under "Test

information" on the left side of the dialog box.
Do not use Change VITROS Slide Generations (see "Changing VITROS

Slide Generations" on page 93) to correct a slide generation.
4
Use the up and down arrows to change the slide generation.
Click Update. The "Update Test" dialog box appears.
Select an option for the range of tests to apply the new slide generation
to.
7
94
Selected testChoose this option to apply the new slide generation

only to the currently selected test. This is the default selection.
Current labChoose this option to apply the new slide generation to

all identical tests within the current lab number.
All labsChoose this option to apply the new slide generation to all
identical tests within the current database.

H A P T E R

In This Chapter
Panels .................................................................... 95
Panel Tests Dialog Box ................................................. 95
Data Groups ............................................................. 98
Panels
Panels and data groups allow you to customize tests for data entry and
display. A panel is a user-defined group of tests organized for simplified
data entry across lab and lot numbers. Panels provide a useful way to
customize the organization of 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.
Unity Desktop allows you to create any number of panels. 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 you open a data entry screen for a test from the Panel tab of the
navigation tree, the program is in panel mode, and the shortcut keys for
navigating in data entry apply to the tests in the panel. The panel name
appears with the current status information.
You can delete a panel at any time. Because panels are simply a way of
organizing tests for data entry, tests within a panel are not deleted when
the panel is deleted.
Panel Tests Dialog Box

You manage panels from the "Panel Tests" dialog box, which has four main
areas:
Panel field-for you to type a free-text name for the panel
Available tests tree-with the familiar lab, lot, and test hierarchy
Selected tests area-that displays the tests assigned to the panel
Add, Add All, Remove, and Remove All buttons
The Available Tests Tree

Using the Available tests tree, you can:
Select a lab number in the tree, and click Add to add all the tests in
the lab number.
Select a lot number in the tree, and click Add to add all the tests in the
lot number.
Select an individual test, and click Add to add the test. Alternatively,
you can double-click the test to add it.
Double-click a collapsed lab or lot in the tree to expand it. See Tree Views
(on page 229) for more information.
Buttons in the "Panel Tests" Dialog Box
AddClick to add the selected item (lab, lot, or test) to the panel.
Add AllClick to add all tests in the system to the panel.
RemoveClick to remove the tests selected in the "Selected tests" list.
Remove AllClick to remove all the tests currently assigned to the

panel.
96
To Add a Panel
1
Log in as a user with permission to manage panels.
Click Add to display the "Panel Tests" dialog box.
Type a name for the panel.
Under "Available Tests," select the first test you want to add to the
panel. (Click the + signs to the left of the lab and lot numbers as
necessary to expand the tree to the test level.)
Click Add. (Alternatively, double-click the test.)
The test appears under "Selected tests." To remove a test from the
panel, select it, and click Remove.
Continue until the panel contains the desired tests.
Click OK to create the new panel and close the "Panel Tests" dialog box.
The "Panel" dialog box displays with the new panel in the "Panel" list.
To Update a Panel
1
Use the features described in The "Panel Tests" Dialog Box (see "Panel
Tests Dialog Box" on page 95) to modify the panel.
To Delete a Panel
1
Select the panel you want to delete in the "Panels" list.
Click Delete. A message appears asking you to confirm the deletion.
Click OK to delete the panel. The "Panel" dialog box appears with the
panel deleted.
Click OK again to return to the main screen.

97
To Sort Tests in a Panel

1
Drag and drop tests in the "Selected tests" list until all tests are in the
order you want them to appear. See Drag-and-Drop Sorting (on page
Data Groups
Categorizing tests by group name is a useful way to denote tests having
"something in common. For example, tests having the same lab and lot
number can be grouped according to reagent type. In this case, all tests
using a specific reagent (say Reagent 1) may be grouped into Group 1 while
all tests using another reagent (say Reagent 2) may be grouped into Group
2. Similarly, tests may also be grouped according to calibrators, the
standardization matrix of a kit, etc.
Overview of groups
The Month and Group options are available for both point data entry
and summary data entry.
From the point/summary data entry screen, select or clear the Group
check box to toggle between Month and Group displays.
When you change the display to Group only, the Summary Statistics
area is changed. Unity Desktop does not arrange data entry rows into
groups.
Until you define a data group, Unity Desktop assigns all data points to
group 0 (zero).
Your Default data entry mode selection from the Setup dialog box
is global (it applies to all tests).
Because you can toggle between Month and Group on the

point/summary data entry screen, you may choose not to change the
Current Data default even if you use groups to manage data.
When no Group has been defined for a test, the Summary Data based on
Group will be the same as that based on Cumulative.
98
To Change the Default Current Data Selection

Because you can toggle between Month and Group on the point/summary
data entry screen, you may choose not to change the Current Data default
even if you use groups to manage data.
1
Log in as a user with permission to edit setup options.
Choose Tools | Setup to display the "Setup" dialog box.
On the "Configure Unity Desktop" tab, select the "Group" option under
"Current data."
Click OK to save your selection.
To Define or Edit a Group

1
Open a point/summary data entry screen for the test.
Select (check) the Group check box. The data screen refreshes and a
"Group" column appears.
Do one of the following:
If the test has no data points, enter a row of data. Then Tab to the
"Group" column and type a group name, which can be
alphanumeric. As you continue to enter data, Unity Desktop will
assign the group name to each new data entry row, until you assign
another group name.
If the test has data points, you can add group names or edit existing
group names.
Unity Desktop assigns successive data entry rows to the same group
until you type another group name in the Group column.
4
If desired, click in the "Comments" column, and type a free-text

comment describing the group.
Continue entering data or click Save to close the data entry screen.
99
H A P T E R
Applying QC Rules
In This Chapter
Overview of Rule Evaluation .......................................... 101
Setting SPC Rules ....................................................... 104
Using Fixed Means and SDs with SPC Rules ......................... 105
SPC Rules: Tabular Summary ......................................... 107
Overview of Rule Evaluation

Unity Desktop allows you to monitor tests using both SPC Rules (on page
31) and Analytical Goals. (RiLiBK rules are available only when the RiLiBK
module is installed.) Unity Desktop evaluates data points against the active
SPC rules to determine whether to accept or reject them. The program
provides 17 different SPC rules, each of which can be set to reject, warn, or
off.
See SPC Rules: Tabular Summary (on page 107) for a quick overview of the
available rules.
As described in Choosing a QC Procedure (on page 41), selecting which
rule(s) to apply to a test is no simple matter. You can do the statistical
analysis using tools such as OPSpecs charts, critical-error graphs and power
function curves as described in numerous publications or you can use the
Westgard Advisor. This optional tool (available with Unity Real Time)
automates the analysis and suggests rules based on a quality goal you
select, your historical data, and Unity Interlaboratory Program consensus
group information. Contact your Bio-Rad Representative to receive
information on Unity Real Time and the optional Westgard Advisor.
Deciding which rules to use is the hard partsetting the rules within Unity
Desktop is simple.
Rule Evaluation Notes
If any point within a run violates a rejection rule, Unity Desktop rejects
the entire row.
When evaluating rules "between runs", Unity Desktop excludes rejected

data rows.
For example, a test is being evaluated using the 1-3s and 2-2s rules,
with both rules set to reject. If run 4 violates the 1-3s rule and run 5
violates the 1-2s rule, the second run is not rejected as violating the 22s rule.
Exclusion of the rejected data is based on the assumption that you

evaluated the test system in response to the rejection and took corrective
action, if indicated. Unity Desktop assumes subsequent data points reflect
these actions.
Rule Statuses
Only point data is evaluated against active SPC rules; summary data is not
evaluated. In addition, inserted or edited data points that are not on the
last line of data are not evaluated.
Each SPC rule can have one of three statuses:
Reject
Unity Desktop rejects data points that violate the rules and excludes
them from summary statistic calculations. The rule(s) violated appear in
the "Rules" column on the data entry screen.
102
Applying QC Rules
Warn
Unity Desktop accepts data points that violate the rule and the violated
rule appears in the "Rules" column of the data entry screen.
Rules set to reject or warn are the active rules for the test.
Off
Unity Desktop ignores the rule when evaluating data points.

Rule evaluation begins after the number of points specified on the "Settings"
tab of the "Test Settings" dialog box have been collected. The default
number of points before rule evaluation is 20 when using a floating mean or
SD. If you set a fixed mean and SD, rule evaluation begins immediately.
(Click the SPC Rules icon on the toolbar to access the "Test Settings" dialog
box.)
As you enter individual data points, Unity Desktop evaluates them using SPC
rules with a reject or warn status (i.e. the active rules). When any data
point in a row violates a rejection rule, Unity Desktop rejects all values in
the row.
Rule Precedence When Displaying Rule

Violations
For the purpose of rule precedence, SPC rules can be divided into the
groups shown in the columns on the following table. Within each group,
rules are arranged in decreasing order of severity. If a data point violates
more than one rule in a group, Unity Desktop displays only the most severe
violation on the data entry screen and on reports and charts.
Unity Desktop evaluates the data against all active rulesbut the display is
truncated to simplify review of the violated rules.
Group 1
Group 2
Group 3
Group 4
Group 5
Group 6
Group 7
1-5s
2-2s
(2 of 3)2s
12-x
7T
R-4s
4-1s
1-4s
1-2s
1-2s
10-x
1-3.5s
9-x
1-3s
8-x
1-2.5s
7-x
3-1s
1-2s
103
(Group numbers in the table are for clarity only and do not imply any
assignment of rules to artificial groups.)
Setting SPC Rules

When you create a test, Unity Desktop applies a default set of SPC rules
based on the number of levels available in the control product you are
using. These rules are arbitrary and you should set rules for each test based
on its quality requirements.
Unity Desktop allows you to set rules at both the test and the lot level;
however, we strongly recommend that you follow the Recommended Steps
(on page 41) and choose SPC rules for each individual test or use the
optional Westgard Advisor.
Although Unity Desktop allows you to specify rules at both the lot and
test levels, best practices in process control require that labs select rules
on a test-by-test basis.
When you click Rules/Settings from either the "Lot" or "Test" dialog box, the
"Tests Settings" dialog box appears.
To Set SPC Rules at the Test Level

1
Close any open data entry screens. (You can view a test's settings while
in data entry, but you cannot make changes.)
Select the appropriate test in the navigation tree.
Click the SPC Rules icon on the toolbar to open the "Test Settings"
dialog box.
On the "Rules" tab, click an option (reject, warn, or off) for each rule.
Click Disable SPC Rules to set all the rules to off.
Click Default Settings to return the rules to their default settings.
Optionally, select the "Apply to all lab numbers" check box to apply the
selected profile to all identical tests defined in the database. (Identical
tests in this context are those that share the same Unity codes for
analyte, instrument/kit, reagent, method, unit, and temperature.)
104
Applying QC Rules
To Set SPC Rules at the Lot Level

1
Close any open data entry screens. (You can view a test's settings while
in data entry, but you cannot make changes.)
Select a lot number in the navigation tree.
Click the Lot icon on the toolbar. The "Lot" dialog box displays with the
lot selected. (You can change your lot selection at this time, if
desired.)
Click Rules/Settings to display the "Test Settings" dialog box.
On the "Rules" tab, click an option (reject, warn, or off) for each rule.
Click Disable SPC Rules to set all the rules to off.
Click Default Settings to return the rules to their default settings.
Optionally, select the "Apply to all lab numbers" check box to apply the
selected profile to the selected lot number in all lab numbers in which
it is defined.
Click OK to save your changes. A message displays asking you to confirm

the rule settings at the lot level. (Best practices in process control
require that you establish quality requirements and set appropriate
rules for each test, rather than setting them at the lot level.)
Click Yes to apply your changes or No to cancel.
Using Fixed Means and SDs with SPC

Rules
Most SPC rules evaluate data points against a mean and SD. For example,
the 1-3s rule asks if the data point is more than three SD from the mean.
For each test, Unity Desktop lets you specify a fixed mean, a fixed SD, or
both. Using fixed statistics is more sensitive than using floating statistics.
Over time, however, cumulative statistics stabilize and can simulate a fixed
statistic. Consequently, cumulative statistics provide a reasonable degree of
sensitivity to shifts and trends.
The most sensitive scale is one based on fixed statistics.
105
Useful Facts about Fixed Means and SDs
If you set both a fixed mean and a fixed SD, Unity Desktop begins SPC
rule evaluation immediately, even if the test does not have the
specified number of points before rule evaluation. If you do not specify
both a fixed mean and a fixed SD, rule evaluation begins after you have
collected the specified number of points before rule evaluation.
When you specify a fixed mean and/or SD, Unity Desktop uses the
values for new data points entered for the day you set the fixed
statistic(s).
Unity Desktop continues using these values until you either specify new
values or clear a value. When a fixed mean or fixed SD field is blank,
Unity Desktop uses the "floating" mean and/or "floating" SD/percentage.
On the data entry screen, click the + in any data row to view the
evaluation statistics used to evaluate the row.
The fixed mean and fixed standard deviation/percentage statistics are
for your internal use only. They are not transmitted to the Unity
Interlaboratory Program and do not appear on Unity Interlaboratory
reports.
If you duplicate an existing lot number, you can choose to duplicate the
fixed means and/or SDs from the existing lot to the new lot as
described in Duplicating Lots (on page 75).
To Set a Fixed Mean and/or Standard

Deviation
1
Close any open data entry screens. (You can view a test's rules and
settings while in data entry, but you cannot make changes.)
Select the appropriate test in the navigation tree.
Click the SPC Rules icon on the toolbar to open the "Test Settings"
dialog box.
Click the "Settings" tab to select it.
Type a fixed mean and/or SD for each level of control material for
which you want to use fixed statistics.
The fixed mean and fixed SD fields are independent of each other. You
can use them for some levels and not others just as you can set a fixed
mean without a fixed SD and vice versa.
106
Applying QC Rules
Click OK to save your changes and close the dialog box or Apply to save
your changes and leave the dialog box open.
SPC Rules: Tabular Summary

The following table summarizes the SPC rules available in Unity Desktop.
See SPC Rules (on page 31) for a more complete discussion.
Rule
Usual status
Error type
When violated
Notes
1-2s
Warning
Random or
systematic
A single control
observation is
outside the 2s
limits
When used as a
rejection rule, 1-2s
will yield a high
proportion of false
rejections.
1-3s
Rejection
Random or
the
beginning
of large
systematic
A single control
observation is
outside the 3s
limits
While a value outside

3s 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
2-2s
Rejection
Systematic
Two consecutive
QC results are
outside the 2s
limits on the
same side of the
mean
R-4s
Rejection
Random
There is at least a
4s difference
between control
values within a
single run
3-1s
Warning
Systematic
Three consecutive
results exceed 1s
on the same side
of the mean
Bio-Rad software uses

the exact within-run
difference between
control values to
determine whether or
not R-4s is violated.
107
Rule
Usual status
Error type
When violated
Notes
4-1s
Rejection
Systematic
Four consecutive
results exceed 1s
on the same side
of the mean
Low probability of
false rejections as
long as the betweenrun SD is low. False
rejections increase as
the between-run SD
becomes larger.
(2 of
3) 2s
Warning
Systematic
Two of three
levels of control
within the same
run exceed 2s on
the same side of
the mean
This rule is a
variation of the 2-2s
rule and is applicable
when testing 3 or
more levels of control
material.
7, 8,
and
9-x
Warning
Systematic
x number of
consecutive
results on the
same side of the
mean
Because of the
extreme sensitivity of
these rules, they
should be used
sparingly, if at all.
10-x
Rejection
Systematic
10 consecutive
results on the
same side of the
mean
This rule has a lower

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

probability for false
rejection than do the
7, 8, 9, and 10-x
rules.
108
H A P T E R
10
Entering Data
In This Chapter
Data Entry Overview ................................................... 109
Useful Features of Data Entry ........................................ 110
Unity Desktop Data Screens ........................................... 114
Point Data Entry ........................................................ 117
Summary Data Entry ................................................... 123
Qualitative Data Entry ................................................. 125
Data Entry Overview

Data entry and import are the basic features of Unity Desktop. You will
probably want to use Bio-Rad's SoftConnect connectivity solution to
automatically import (interface) your data from an instrument, Laboratory
Information System (LIS), or other data management system for which BioRad has an interface. Of course, you can also enter data manually. In
addition, manual data entry allows you to insert, edit, and delete data.
Unity Desktop provides data screens for quantitative data (point/summary)
and qualitative/semiquantitative data. When you double-click a test in the
navigation tree, Unity Desktop opens either the point/summary data screen
or the qualitative data screen based on the test's unit. When you import
data, Unity Desktop automatically distributes it to the appropriate data
screen(s).
Once a test is added with a qualitative unit, you cannot update the unit to a
quantitative one. Conversely, you cannot update a quantitative unit to a
qualitative one.
Point/Summary Data Screens (see "Unity Desktop Data Screens" on

page 114)
This screen has tabs for point and summary data entry:
Point data
Use this tab to enter individual data points. Point data can be
evaluated by both statistical process control rules (SPC rules) and
analytical goals.
Summary data
Use this tab to enter a monthly mean, standard deviation, and
number of data points. Summary data is not evaluated by SPC rules
or analytical goals.
Qualitative Data Screens (see "Entering Qualitative Data" on page 127)

This screen appears when you open data entry for a test with
"qualitative" as its unit. From this screen, you enter both qualitative
(results that are reported as positive or negative) and semiquantitative
data (results for tests that have a limited number of reporting options
such as small, moderate, large, +1, +2, etc.) Bio-Rad control products
to which qualitative data entry is applicable include: Urinalysis,
Autoimmune, and Qualitative Urine Toxicology.
For simplicity, this document uses "qualitative" to refer to both qualitative

and semiquantitative data.
Useful Features of Data Entry

Navigating within Data Entry
Next and previous designations are determined by the order labs, lots and
tests appear in the navigation tree, whether in lab or panel mode.
110
Entering Data
Within data entry, you can navigate among the tests using the shortcut keys
shown in the following chart:
Shortcut
Action
Within
F5
Next test
Lab and panel modes
SHIFT+F5
Previous test
Lab and panel modes
F6
Next lot
Lab mode only
SHIFT+F6
Previous lot
Lab mode only
F7
Next lab
Lab mode only
SHIFT+F7
Previous lab
Lab mode only
F8
Next panel
Panel mode only
SHIFT+F8
Previous panel
Panel mode only
Pressing any of these shortcut keys will:
Save data for the current test.
Close its data entry screen.
Open a data entry screen for the next/previous test.
Viewing Charts and Reports within Data Entry

Charts are available while in data entry. Simply click the chart icon on the
toolbar. Only one chart type can be displayed at a time. To change the
chart type, first close the open chart, and then click another chart icon.
Reports cannot be viewed while in data entry. You must first close the data
screen and then select the report from the Reports menu.
Viewing Rules/Settings and AGs within Data

Entry
While in data entry, you can click the SPC Rules icon to view the active SPC
rules and current settings for a test. However, you cannot make any
changes.
111
Changing a Data Row's Date-Time

This topic explains how to change the date-time of a single data entry row.
Your change will apply only to the row you edit. For example, if you edit
the date-time of the last data entry row and then tab to the next row, the
date-time for the new row will be the current date-time.
If you want to increment or maintain the date when entering data, use the
Set Date (on page 113) feature.
When the calendar displays, you can:
Click any day to select it.
Click the single chevron (< or >) to change the month.
Click the double chevron (<< or >>) to change the year.
See Using Calendars (on page 233) for more information.
Specifying a Default Data Entry Mode

Unity Desktop defaults the data entry mode to pointwhen you open a
data screen, the "Point Data" tab is selected. If you enter summarized data
for most of your tests, you can change the default to summary so that the
"Summary Data" tab is selected when you open a data screen.
112
Entering Data
To Specify Point or Summary as the Default Data Entry

Mode
1
Choose Tools | Setup. The Setup dialog box appears.
On the Configure Unity Desktop tab, select a Default data entry mode
option (Point or Summary).
Click OK to save your changes or Cancel to exit with saving changes.
Your selection applies to all tests. You cannot specify a default data entry
mode at the lab, lot, or test levels.
Set Date
Set Date, which can be useful if you manually enter data for several days at
a time, allows you to choose to increment or maintain the date.
Choose Increment if you run each control level only once per day.
Increment increases the day by one each time you move to a new row.
Choose Maintain if you run each control level more than once per day.
Maintain applies the same date/time to each row as you add data rows.
When you are ready to move to the next day, click Set Date, and select
Increment.
You can toggle between the two selections within the same data entry
session.
Once you have chosen a set date, Unity Desktop maintains it until you do
one of the following:
Click Reset to apply the current date/time.
Exit Unity Desktop. If you close a data screen for a test and open
another data screen, the original set date remains in effect, unless the
test has data points entered after the set date. For tests that have data
points entered after the set date, Unity Desktop applies the current
calendar date/time to the active data entry row.
To Use Set Date: Incrementing the Date

1
Open a data entry screen for the desired test.
Click Set Date to display the "Set Date" dialog box.

113
Select the part of the date you want to change and use the up and
down arrows to change the date to that of the earliest data point you
want to enter.
Select the Increment option, if not already selected. (Increment is the

default.)
Click OK to return to the data entry screen.
Enter your data points. Unity Desktop increments the date by one each
time you move to a new data entry row.
When all data points are entered, click Save.
To Use Set Date: Maintaining the Date

1
Open a data entry screen for the desired test.
Click Set Date to display the "Set Date" dialog box.
Click the down-arrow in the date field and select the correct date from
the calendar.
Select the "Maintain" option.
Click OK to return to the data entry screen.
Enter your data points.

Unity Desktop maintains the date you set as you add additional rows.
When you are ready to move to the next days data points, click Set
Date, and choose "Increment" BEFORE you tab to the next row. If you
tab to a blank row, click Set Date, and choose "Increment", Unity
Desktop maintains the date from the current row and increments the
date when you move to the next row.
When all data points are entered, click Save.
Unity Desktop Data Screens

Unity Desktop data screens share a common look and feel and contain the
following areas:
Data Screen Header Contains lab, lot, and test information.
Data Screen Command/Navigation BarProvides tools for you to quickly

navigate through your historical data.
Data Entry Grid (on page 115)Presents data in rows identified by a

date/time stamp. This is the area where you type your data when
entering data manually. Imported data also appears in the grid.
Statistics/Chart Area (on page 115)Has two tabs:
114
Entering Data
Statistics
Displays the mean, SD, CV and number of data points. Select and
clear the "Group" check box to toggle between displaying
monthly/cumulative statistics and group/cumulative statistics for
point data.
Chart
Displays a Levey-Jennings chart based on the available point data.
If you have entered only summarized data, the chart will be blank.
Fixed Mean and SD (on Data Screens) (on page 116)Displays the
fixed mean and/or SD defined on the "Settings" tab of the "Test
Settings" dialog box. Used for evaluation of point data only.
Data Screen Header

The header for each data screen provides the following test information:
Lab number and lab description
Lot number with matrix and expiration date
Unity codes used to define the test (i.e. analyte, method, instrument,
reagent, unit, and temperature)
Data Entry Grid

Because each data entry type (point, summary, and qualitative) has its own
data grid, these areas are discussed individually.
Point Data Grids
Summary Data Grids (see "Entering Summary Data" on page 124)
Qualitative Data Screens (see "Entering Qualitative Data" on page 127)
Statistics/Chart Area
The Statistics/Chart area of data entry screens has two tabs"Statistics" and
"Chart."
115
Statistics
Displays the mean, SD, CV, and number of data points. Select and clear the
"Group" check box to toggle between displaying monthly/cumulative
statistics and group/cumulative statistics for point data.
Chart
The chart option displays a Levey-Jennings chart based on the available
point data. If you have entered only summarized data, the chart will be
blank. Because the display shows the statistics for the currently selected
data row, it is dynamic and changes as you tab through rows of data.
Fixed Mean and SD (on Data Screens)

The current fixed mean and/or SD, if any, appears in this area. These
statistics are not dynamic and do not change as you select different data
rows. To view the Evaluation Means and SDs (on page 120) for a specific
data row, click its plus (+) sign to display extended information for the row.
116
Entering Data
Point Data Entry

The point data entry screen allows you to enter individual data points and
have these data points evaluated by SPC rules. The most obvious feature of
the point-data-entry screen is the data entry grid where your imported and
manually entered data appears. As shown in Example Point Data Grid (on
page 119), the point data grid provides a great deal of information. This
section lists point data items and a brief explanation with links to more
information when appropriate.
Row numberUnity Desktop numbers rows consecutively. If you insert or

delete a row of data, it will renumber the data rows to maintain a
consecutive order. (Unity Desktop does not number runs within a day.)
Date & Time
ValueThe cell where you type your QC value when entering data
manually. Imported values also appear in this cell.
Y/NIndicates whether the data point was accepted (Y) or rejected (N).
Unity Desktop automatically rejects any data row that contains a point
that violates a rejection rule. If you have permission to edit data, you
can manually change the accepted/rejected status of a data point as
described in Changing a Data Point's Accepted/Rejected Status (on
page 131).
RulesLists the active rules, if any, that the data point violated. For
simplicity, Unity Desktop divides rules into groups and only displays the
most serious violation in each group. See Rule Precedence When
Displaying Rule Violations (on page 103) for more information.
OPFor manual data entry, these are the initials of the logged in user
when data entry occurs. For imported data, Unity Desktop uses the
initials defined in the import file, if present. Otherwise Unity Desktop
checks Operator Setup (on page 149), and if no initials are defined
there, it places two asterisks in the column.
A columnClick in this column to add an action to the data row or to

view any existing actions. Three asterisks appear in the column when an
action is present.
C columnClick in this column to add a free-text comment to the data

row or to view any existing comments. Three asterisks appear in the
column when a comment is present.
For more information on actions and comments, see Annotating Data
with Actions and Comments.
117
Point Data Grid

As shown in Example Point Data Grid with Explanations, the point data grid
provides a great deal of information. This section lists Point Data Grid items
with a brief explanation, and links to more information, when appropriate.
Row numberUnity Desktop numbers rows consecutively. If you insert

or delete a row of data, it will renumber the data rows to maintain a
consecutive order. (Unity Desktop does not number runs within a day.)
Additional test informationClick the plus sign (+) to display the additional
information. Click the minus sign () to hide it. See Additional Test
Information on the Point Data Grid for more details.
Date & Time
ValueThe cell where you type your QC value when entering data
manually. Imported values also appear in this cell.
Y/NIndicates whether the data point was accepted (Y) or rejected (N).
Unity Desktop automatically rejects any data row that contains a point
that violates a rejection rule. If you have permission to edit data, you
can manually change the accepted/rejected status of a data point as
described in Changing a Data Point's Accepted/Rejected Status (on
page 131).
RulesLists the active rules, if any, that the data point violated. For
simplicity, Unity Desktop divides rules into groups and only displays the
most serious violation in each group. See Rule Precedence When
Displaying Rule Violations (on page 103) for more information.
zThe data point's z score, which indicates the number of SDs the point
data is from the evaluation mean.
OPFor manual data entry, these are the initials of the logged in user
when data entry occurs. For imported data, the software uses the
initials defined in the import file, if present. Otherwise the software
checks Operator Setup (on page 149), and if no initials are defined
there, it places two asterisks in the column.
A columnClick in this column to add an action to the data row or to

view any existing actions. Three asterisks appear in the column when an
action is present.
C columnClick in this column to add a free-text comment to the data

row or to view any existing comments. Three asterisks appear in the
column when a comment is present.
For more information on actions and comments, see Annotating Data with
Actions and Comments.
118
Entering Data
Example Point Data Grid
Extended Row Information on the Point Data Grid

For point data, each row has a plus sign (+) between the row number and
date & time. Click the plus sign to display the following additional
information:
Floating Mean/SD
Fixed Mean/SD
These columns will contain the mean and SD used to evaluate the data
point, which is potentially confusing because you can specify a fixed
mean for a control level and not an SD and vice versa. Evaluation
Means (see "Evaluation Means and SDs" on page 120) explains which
values appear more completely.
Active rulesThe rules against which the data point was evaluated.
These rules are not necessarily the rules that appear in the header,
which are the rules active for the current date/time. This apparent
discrepancy occurs because you can change the rules applied to a test
at any time.
You can expand any number of data rows to compare their information; you
do not need to collapse a row to expand another.
119
Evaluation Means and SDs

The additional information display contains a column for Floating Mean/SD
and a column for Fixed Mean/SD. When you specify a fixed statistic (mean
or SD), it appears in the Fixed Mean/SD column. If you do not use fixed
statistics, the evaluation mean and SD appear in the Floating Mean/SD
column after you have collected the number of points specified before rule
evaluation.
As discussed in Using Fixed Means and SDs (see "Using Fixed Means and SDs
with SPC Rules" on page 105), you can specify fixed means and SDs
independently, which allows four combinations for each data level as
follows:
Floating Mean/Floating SD (on page 120)
Floating Mean/Fixed SD (on page 121)
Fixed Mean/Fixed SD (on page 121)
Fixed Mean/Floating SD (on page 122)
Use of fixed statistics depends on the level of control material. This means
that each level within a control material can have different combinations of
fixed and floating statistics. For simplicity, we will provide examples only
for situations where the fixed statistic choices are the same for each level
within the control material.
Important Facts
The evaluation mean and SD will both display for each control level.
The column the mean and SD appear in is determined by whether the
statistic is fixed or floating.
If either statistic is floating, rule evaluation begins after you have

collected the number of points specified before rule evaluation.
When both statistics are fixed, rule evaluation begins with the first data
point.
Floating Mean/Floating SD
The preceding figure illustrates extended information for a data point with
no fixed mean or fixed SD specified. In this case:
120
Entering Data
Rule evaluation begins after the number of points specified on the

"Settings" tab of the "Test Settings" dialog box are collected.
Until these data points are collected, the Floating mean/SD column will
be blank. (However, the Active Rules column is always populated.)
z-score calculation begins after the number of points specified on the

"Settings" tab of the "Test Settings" dialog box are collected. The zscore appears on the data entry screen.
The Fixed Mean/SD column is blank because you have not specified
either of these values.
Floating Mean/Fixed SD
a fixed mean but no fixed SD specified. In this case:

z score calculation begins with the third data point because Unity
Desktop uses the first two data points to calculate a mean.
The evaluation mean appears in the Floating Mean/SD column.
The evaluation SD appears in the Fixed Mean/SD column.
Fixed Mean/Fixed SD
both a fixed mean and fixed SD specified. In this case:
The evaluation mean and SD appear in the Fixed Mean/SD column.
Rule evaluation begins with the first data point.
z-score calculation begins with the first data point.
The Floating Mean/SD column is blank because you are not using
floating values.
121
Fixed Mean/Floating SD
a fixed mean and a floating SD. In this case:

z-score calculation begins with the third data point. (Unity Desktop uses
the first two data points to calculate an SD.)
The evaluation SD appears in the floating column.
The evaluation mean appears in the fixed column.
Entering Point Data

1
Double-click a test in the Lab or Panel navigation trees. Unity Desktop

opens data entry for the test in lab or panel mode.
If necessary, click the "Point Data" tab to display it. The first data entry
cell on the last line of data will be selected.
See Specifying a Default Data Entry Mode (on page 112) for
instructions to make point data entry your default data entry mode.
Enter data in the selected cell or click another cell.
Type a value.
Press Tab or Enter. The active selection moves to the next data entry
cell.
Type a value for this level of control or press Tab or Enter again to
leave the level blank.
When you press Tab or Enter in the last level of the row, Unity Desktop:
7
122
Moves to the first cell on the next row.
Saves the data.
Evaluates the data points against active rules and indicates their
accepted/rejected status.
Updates the Summary Statistics at the bottom of the screen.
Continue entering data until all data points you want to enter for the
test appear.
Entering Data
At this point, you have several options:
Click Save to close the data entry screen and save your data.
Click a navigation shortcut key to open data entry for another test
as described in Navigating within Data Entry (on page 110).
Double-click another test in the lab or panel navigation tree.
Each of these actions saves data for the test and closes its data entry
screen.
Summary Data Entry

In addition to entering data as individual data points, Unity Desktop allows
you to enter a value that summarizes a calendar months data into a mean,
standard deviation, and number of points. You may choose this option if you
use the QC available on your instrument or LIS for day-to-day QC but still
want to participate in the Unity Interlaboratory Program.
The software does not prevent you from entering both point and
summarized data for the same test. If you do so, the summarized statistics
will include both types of data.
Limitations of Summary Data Entry
Data entered as summary data is not evaluated by SPC.
Only Bar Charts (on page 161) are available for summary data.
If you view an L-J, Youden, or Yundt chart for a test that has only
summary data, the chart will display but contain no data points. This
includes the L-J chart available within data entry.
Data Groups (on page 98) are not applicable to summary data. If you
select the "Group" check box on the "Summary Data" tab,
<Program_Name> switches to the "Point Data" tab.
Set Date (on page 113) can be used; however, it will increment the
date by one. The set date does not increment by month for summary
data entry.
Actions are not available for summarized data, although free-text

comments are.
123
Entering Summary Data

1
Double-click a test in the lab or panel tree.
Click the "Summary Data" tab if not already displayed. You can make
summary data your default data entry mode as described in Specifying
a Default Data Entry Mode (on page 112).
Move the active cell selection to the first blank data entry line.
Click in the Mean column. (A solid border will surround the active cell.)
Type the mean for the group of values.
Press Tab or Enter to move the cell selection to the SD column.
Type the standard deviation for the group of values.
Press Tab or Enter to move the cell selection to the Pts column.
Type the number of points for the group of values.
10 Press Tab or Enter to move the cell selection to the next Mean column.
11 Follow the previous steps to enter the Mean, SD, and number of points
for the levels you are using. If you are entering data for a single month,
press Save. If you are entering data for several months, press Tab or
Enter to start a new data row.
12 Press Tab or Enter. The cell selection moves to the first Mean column on
the next data entry line.
13 When you complete data entry for the test, you have several options:
Click Save to exit data entry.
Double-click another test in the lab or navigation tree.
Use shortcut navigation keys to move through tests as described in

Navigating within Data Entry (on page 110).
Each of these actions saves data for the test and closes its data entry
screen.
124
Entering Data
Qualitative Data Entry

Unity Desktop provides support for qualitative and semi-quantitative data
storage. Additionally, data for Bio-Rad Urinalysis controls may be submitted
to Bio-Rad for interlaboratory comparison.
Qualitative data entry is available for both Bio-Rad and non-Bio-Rad lots and
specifically supports the following Bio-Rad product types:
Autoimmune
Qualitative Urine Toxicology
Urinalysis
Adding Qualitative Tests

To set up a qualitative or semi-quantitative test in the software, you must
first set up a lab number (or use one that you already have set up) and the
lot of control for the qualitative or semi-quantitative tests. Then, in the
Test dialog box, define the parameters for the test you are using.
If, when adding a test, you receive the message: "This combination of test
codes cannot currently be used to create a qualitative test. Please contact
your Bio-Rad software support representative," first check to see that you
selected the correct analyte, method, instrument and reagent type. If this
information is correct, please contact your Bio-Rad software support
representative to add the valid responses for your qualitative or semiquantitative tests to Unity Desktop.
125
So that the software recognizes your test as qualitative or semiquantitative, it is important to define your test properly and define your
unit selection as Qualitative. Continue this process for each of the tests
you are using.
When a test has qualitative as its unit, the software automatically opens the
qualitative data screen when you double-click the test from either the lab
or panel navigation tree.
Qualitative data is not evaluated by SPC rules.
Rejection Logs
All data points that Unity Desktop cannot import are sent to a rejection log,
which is available by choosing Tools | Utilities | Import | View Rejection Log.
The rejection log will have the following information:
Date-Timedate-time Unity Desktop processed the import file
File Namecomplete path, including file name, of the import file

containing the rejection
Rejected Dataerror that caused the rejection followed by the rejected

data row. See Rejection Log Messages (on page 242) for a complete
list of causes.
The rejection log lists each error on its own line within the file. Therefore,
a single data row may have multiple entries in the rejection logone for
each error occurring in the data row. This allows you to correct errors
individually.
For example, you might filter the log by the "Lot closed" message; open the
closed lot(s); and then filter the log by the "Date out of range" message and
correct any problems. When you've made all required corrections, you can
click Save Import File and Unity Desktop will create an import file to be
reimported.
You will probably need to use the rejection log only for manually imported
data or when you specify your own interface. If you are using SoftConnect,
you will have resolved these errors prior to importing the file.
126
Entering Data
Entering Qualitative Data

Qualitative data can be imported in the same way as quantitative data.
Entering data for qualitative and semi-quantitative tests is simple. Unity
Desktop automatically opens the qualitative data screen when you doubleclick a test with "qualitative" defined as its unit. From the data screen, you
can enter new data or make changes to existing data.
Because qualitative tests have a limited number of valid responses, entering
qualitative data is simply a matter of choosing your response from a dropdown list. All of the valid responses for qualitative and semi-quantitative
tests are preprogrammed into the software for qualitative and semiquantitative tests.
To enter data, select the appropriate result from the drop-down list for
each level. You may also document corrective actions or comments for any
row of data. Once you enter your data for the selected test, you may use
the shortcut keys, including F5, to take you to the next test in the lot or
panel.
If you are manually entering several days' data, you might want to use the
Set Date (on page 113) feature. The selected Set Date will apply to all
qualitative tests that you enter data for. Note that the date/time of each
row of data must be in chronological order.
To Enter Qualitative Data

1
Double-click a qualitative test from the lab or panel navigation trees.

Unity Desktop opens the qualitative data screen based on the test
having "qualitative" defined as its unit.
127
Click in the cell where you want to enter data. Then click the downarrow to display the list of available result choices.
Select the appropriate choice.
Press Tab to move to the next data entry cell.
Continue entering data until all values are entered.
Click Save to close the data screen.
Sending Qualitative Data to the Unity

Qualitative and semi-quantitative data, including urinalysis data, is
transmitted to the Bio-Rad Unity Interlaboratory Program along with your
quantitative results. You do not need to do anything special.
Data for Urinalysis controls is also transmitted, and you can receive Unity
Interlaboratory reports on QCNet.com that compare your data to your
consensus groups. Urinalysis data is due at the same time as all other BioRad control data for inclusion in the Unity Interlaboratory Program.
Although there are several ways to submit data, the simplest way is to
select the Tools|Unity Interlab| Send\Receive Data menu item, select the "Send
data to Bio-Rad" option button and click OK. You may also automate your
data submission from the Tools | Setup menu item by selecting the
"Automatic monthly submission" check box and the day you would like to
have your data automatically submitted to Bio-Rad. This option will
automatically send your data to Bio-Rad when you log in to Unity Desktop
for the first time on or after the day you selected to have your data
submitted.
128
H A P T E R
11
Managing Your Data

In This Chapter
Overview of Data Management ....................................... 129
Changing Values and Date/Times .................................... 130
Changing a Data Point's Accepted/Rejected Status ............... 131
Inserting Data Rows .................................................... 131
Deleting Data............................................................ 132
Overview of Data Management

Changing Data
From time to time, you may need to make changes to previously entered or
imported data. Unity Desktop allows data changes; however, it does not
re-evaluate the changed data against any QC rules unless it is on the last
line of data. The following list summarizes the actions you can perform:
Edit a value.
Edit the date/time associated with a value.
Insert a value.
Delete data.
Change the accepted/rejected status of a data point (point data entry

only).
Delete a range of data from the Lab, Lot, or Test dialog boxes.
Data Entry Permissions

Your data entry permission determines the extent to which you can make
changes to existing data:
Users with permission to "Edit all data" can change any value.
Users with permission to "Edit last line of data" can change only the last
line of values entered.
Users with permission to "Enter new data only" or "View data only"
cannot make any changes to existing values.
When you make changes to data, Unity Desktop transmits these changes to
the Unity Interlaboratory Program in the next transmission file you send.
Changing Values and Date/Times

You can edit both data values and the date-times associated with values.
Unless you are using Set Date, Unity Desktop assigns manually entered
data to the current date and time based on your computer clock. You can
edit either the date or time. However, Unity Desktop requires that data
points be in ascending date/time order. If an edited date-time violates this
requirement, the software displays an Invalid-date-range message.
To Edit the Date-Time

1
Double-click the test in the navigation tree to open its data screen.
You have two basic options for changing the date-time of a data row:
To change the date and/or time, click the portion of the date-time
you want to change and type over it, or use the small up and down
arrows to change it.
To change only the date, click in the "Date and Time" column, and
click the large down arrow to display a calendar from which you can
select the date as described in Using Calendars (on page 233).
To Edit a Value
1
Click in the cell of the value you want to change.
Type the new value over the old value.
Continue editing data points as necessary.
When all changes are complete, click Save.
130
Managing Your Data
Changing a Data Point's

Accepted/Rejected Status
Unity Desktop automatically accepts or rejects point data based on your
active SPC rules. When a value fails an SPC rule that is set to reject, an "N"
appears in the "Y/N" column for the values.
Acceptance and rejection of SPC rules is by run rather than level; therefore,
if any data point in a run violates a rejection rule, Unity Desktop rejects the
entire data row.
If you manually change an "N" to a "Y", Unity Desktop updates the summary
statistics to include it. Conversely, if you manually change a 'Y' to an 'N',
Unity Desktop updates the summary statistics to exclude the value.
To Change the Accepted/Rejected Status

1
Click in the "Y/N" column. A down-arrow appears.

Only point data is accepted or rejected. Summary and qualitative data
screens do not include a "Y/N" column.
Click the down arrow to display a list containing two choicesY for
accepted and N for rejected. (The current selection will be
highlighted.)
Select the appropriate choice from the list.
Click Save when your changes are complete.
Inserting Data Rows

Unity Desktop allows you to insert a data row between two existing data
rows for point, summary, and qualitative data.
Please be aware of the following when inserting data:
131
You can only insert a single data row at a time. If you want to add
multiple data entry rows, you must insert them one row at a time.
Inserted point data is not evaluated against any QC rules.
Unity Desktop updates the summary statistics to include inserted data

rows.
Unity Desktop inserts the blank row above the row that you select and
assigns it the same date and time. You can edit the date-time, but data
rows must be in sequential date-time order. If you attempt to assign the
row an out-of-sequence date or time, the software displays a message
and does not save your change.
To Insert a Data Row

1
Within data entry, move the mouse pointer to the left-most column of
the data entry screen in the row where you want to insert the data
point. The mouse pointer changes to a horizontal arrow.
Click to select the entire row.
Press the Insert key on the keyboard. The program inserts a blank row
above the row selected in Step 2 and assigns a row number to maintain
sequential row numbers. The inserted row will have the same date-time
as the row you selected in step 2.
Type data into the blank row.
Press Tab until the active cell selection moves to the next data entry
row.
Unity Desktop does not evaluate inserted data against QC rules.
If necessary, edit the date-time of the row making sure to maintain a

sequential date-time order.
Deleting Data
Unity Desktop allows you to delete data from the data screen or from the
"Lab", "Lot", and "Test" dialog boxes.
Deleting Rows from the Data Screen

From the data screen, you can select a single row or multiple rows and then
press Delete on the keyboard. See Selecting Items in Lists (on page 231)
for more information.
132
Managing Your Data
Delete Range of Data from the "Lab", "Lot", and "Test" dialog
boxes
We strongly suggest that you create a database backup or archive before
using this function at the lot, lab, or all data levels. Alternatively, you
could export the data to another application or as an import file. See
Database Archives and Backups.
If you need to delete a larger amount of data, you can click Delete Range
of Data from the "Lab", "Lot" or "Test" dialog boxes. The "Delete Range of
Data" dialog box appears and allows you to select a date range of data to be
deleted and an option for the scope of the data to be deleted. Which
options are available depends on the dialog box from which you clicked
Delete Range of Data.
"Lab" dialog boxThe all data and current lab options will be available.
"Lot" dialog boxThe all data, current lab, and current lot options will
be available.
"Test" dialog boxThe all data, current lab, current lot, and current
test options will be available.
To Delete a Row(s) of Data

1
Open data entry for the test.
Move the mouse pointer to the row number column of a row you want
to delete. The row number column is the left-most column of the data
entry screen. The mouse pointer changes to a horizontal arrow.
Click to select the entire row.
At this point, you can:
Leave the single row selected OR
Hold down the SHIFT key, and select additional contiguous rows OR
Hold down the CTRL key, and select additional contiguous or noncontiguous rows
See Selecting Items in Lists (on page 231) for more information.
5
When the ,row(s) you want to delete are selected, press the Delete key
on the keyboard. The screen displays a message asking you to confirm
that you want to delete the selected data.
Click Yes to delete the row(s) or No to cancel.

133
To Delete a Range of Data

We strongly suggest that you create a database backup or archive before
using this function at the lot, lab, or all data levels. Alternatively, you
could export the data to another application or as an import file. See
Database Archives and Backups for further information.
1
From the "Lab", "Lot", or "Test" dialog boxes, click Delete Range of
Data. The "Delete Range of Data" dialog box appears.
Select a date range for the data to be deleted.
Select an available option for the scope of data to be deleted. Available

options depend on which dialog box ("Lab", "Lot" or "Test") you were in
when you clicked Delete Range of Data and include:
All data
Current lab
Current lot
Current test
All data is never selected by default and you should use this feature
with extreme caution and only after creating a database archive or
backup.
4
Specify a date range for the data to be deleted. The current date is the
default.
Leave the default option selected or click another option.
Click OK when your selections are correct. A message displays asking

you to confirm the deletion.
Click Yes to delete the data or No to cancel the deletion.
134
H A P T E R
12
Reviewing and Annotating

Data
In This Chapter
Overview of Actions and Comments ................................. 135
Overview of Actions and Comments

Free-text comments and precoded actions allow you to add information to
data entry rows. Used together, actions and comments provide a powerful
way for you to document items such as changes in the test system or actions
taken in response to a rule violation. For example, you might apply the
action "Maintenance: corrective" and then use a free-text comment to
describe the maintenance you performed.
The actions-and-comments-by-instrument feature allows you to apply
actions and comments to all tests performed on an instrument, which is a
great way to document instrument maintenance that affects all tests
performed on the instrument.
Universal Actions and Comments

Actions and comments are "universal" in that they appear in each of the
following locations regardless of the area on the user interface they were
entered at:
Data entry screens
Point Data Reports
Supervisor Reports
Actions
Action logs are intended to standardize documentation of events that occur
repeatedly. Unity Desktop comes with a library of commonly used actions.
You can customize the library for use in your laboratory. However, limiting
the users who have permission to edit actions should also limit the
proliferation of "nonstandard" action logs, which can be important when
reviewing Action Levey-Jennings charts.
Action logs provide a way for you to document actions taken when a
particular data point fails a performance challenge. As such, they are
available only for point data entry.
Unity Desktop provides a library of predefined messages that have been
carefully compiled to provide standardized documentation of most events.
These predefined messages appear in the Action Log dialog box, which is
easily viewed by clicking in a cell within the Action column of the
standard data entry screen.
In the Action Log dialog box, a red check mark next to an action indicates
that it is in use and cannot be deleted or modified. Unity Desktop uses the
action's number code when generating Action Levey-Jennings charts.
Adding and Editing Action Messages

To Add an Existing Action to a Data Entry Row
Asterisks in the A column indicates an existing action.
1
Open a data entry screen for the test.
Click in the A column of the row where you want to add the action. A
message box appears with any previously entered actions.
Click Add. The Action Log dialog box appears.
Select an action from the list and click Apply. The message box
reappears with your newly added action.
Click Close to exit the message box or Add to append another action.
You cannot delete an action once it is attached to a data row.
136
To Edit the Action Library

If you have permission to edit action logs, you can also add new actions or
update and delete unused actions from the Action Log dialog box. A red
check next to an action indicates that it has been used and cannot be
updated or deleted.
1
Log in as a user with permission to edit action logs.
Choose Tools | Actions and Comments | Configure Action Logs. The Action
Log dialog box appears with buttons to allow you to:
Add: Type the new log in the Action field and click Add. The new
message displays in the lower section of the dialog box.
Update: Select the log you want to change; edit the message in the
Action field; and click Update.
Delete: Select the log you want to delete and click Delete. The
message is removed from the list of actions.
When your changes are complete, click Close.

In the Action Log dialog box, a red check mark next to an action
indicates that it is in use and cannot be deleted or modified. Unity
Desktop uses the action's number code when generating Action LeveyJennings charts.
Automatic Action Logs

Automatic action logs apply only to manually entered data. They do not
apply to imported data.
If you select the "Automatic action logs" check box on the "Setup" dialog
box, Unity Desktop automatically displays the "Action Log" dialog box when
you enter a data point that violates an SPC rule set to reject. By default,
the "Automatic action logs" check box is not selected, so you must select it
to use this feature. When you select the "Automatic action logs" check box,
the "Require actions logs" check box becomes available. If you select this
check box, users will not be able to close the "Action" dialog box without
appending an action.
Action logs are not available for summary data, because they are intended
to document action taken in response to an error condition.
137
When a data point violates a rejection rule:
An 'N' appears in the Y/N column of the data entry screen.
The violated rule(s) appear in the Rules column.
The Action Log dialog box appears if the Automatic action logs
check box is selected.
If the "Require action logs" dialog box is selected, users cannot close
the "Action Log" dialog box without appending an action to the data
row.
The "Automatic action logs" and "Require action logs" check boxes appear on
the The Setup Dialog Box (on page 222).
When the "Action Log" dialog box appears, you can:
Select a predefined message from the list under Action.
Type a free-text message to attach to the data point. This message will
not be added to the list of predefined messages unless you click Add
before clicking OK to close the dialog box.
Click Cancel to exit the Action Log dialog box without appending a
message as long as the "Require action logs" check box is not selected.
You can also click in the Action column for any row to display the Action
Log dialog box. Within the dialog box, all users can select a predefined
message from the drop-down list.
Only users with permission to edit action logs can create new messages to
be included in the "Action Log" list.
To Enable/Disable Automatic Action Logs

1
Log in as a user with permission to edit action logs.
Close any open data entry screens.
Choose Tools | Setup.
On the Configure Unity Desktop tab:
138
Select (check) the Automatic action logs check box to enable

automatic action logs.
Clear (uncheck) the Automatic action logs check box to disable

automatic action logs.
Click OK to save your change.
Comments
Comment logs are free-text messages that you add to a data row on a data
entry screen. When you click in the C column, Unity Desktop displays the
"Comment" dialog box, which will display any existing comments and allow
you to add additional comments.
To Add a Comment to a Data Row

Asterisks in the C column indicate an existing comment.
1
Open a data entry screen for the test.
Click in the C column of the row where you want to append the
comment. The "Comment" dialog box appears with the cursor in the
new comment area.
Type your free-text comment and click OK to add the comment or

Cancel to exit without adding the comment.
You cannot delete comments once they are added to a data row.
Actions and Comments by Instrument

Using actions and comments by instrument, you can enter an action or
comment one time and apply it to all tests performed on an instrument.
This is a real time saver for documenting actions such as instrument
maintenance and calibration, which apply to all tests performed on an
instrument.
When you choose Tools | Actions and Comments | Action/Comment by Instrument,
the "Action and Comment by Instrument" dialog box appears with three
areas:
An upper section with two check boxesAction and Comment. You can
select one or both check boxes.
A middle section that allows you to choose a date range of data to

which the action or comment will be applied.
A scope section that lists the instruments defined in the database.
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This section uses a hierarchical tree structure of instrument, lab

number and lot number. You can apply your action/comment at any of
these levels. The item you select in the tree determines how the
action/comment is applied.
For example, you can apply the actions/comments:
To all tests performed on the instrument model regardless of how

many of the given instrument model you have in your lab (e.g. you
might have five Abbott AEROSETs).
To all tests in a selected instrument/lab combination.
To all tests performed on an instrument/lab/lot combination.
If there is no data within your selected date-range and scope, the software
inserts a blank data row and appends your actions/comments to it.
To Attach an Action by Instrument

1
Choose Tools | Action/Comment by Instrument. The "Action and Comment by

Instrument" dialog box appears.
Select the "Action" check box.
Click Add. The "Action Log" dialog box appears.
Select an action from the list and click Apply. At this point, you can
click Add again to attach another action.
All other functions of the "Action Log" dialog box are available as
described in To Edit the Action Library (on page 137).
Choose a start and end date for the action(s). These dates will probably
be a single day. By default, the action is applied to the current date
only.
Choose the scope of the action by selecting an item from the "Scope"
tree.
7
140
Select an instrument to apply the action to all tests performed on

the instrument. This will include all lab and lot numbers.
Select a lab number under the instrument to apply the action to all
tests performed in the selected instrument/lab number
combination.
Select a lot number under an instrument/lab number to apply the

action to all tests performed in the selected instrument/lab
number/lot number combination.
Click OK to append the action(s) and close the dialog box.

To Attach a Comment by Instrument

1
Choose Tools | Action/Comment by Instrument. The "Action and Comment by

Select the "Comment" check box.
Click in the free-text area and type your comment.
Choose a start and end date for the comment. By default, these dates
will be set to the current date. You could apply a comment like
"Instrument out of service" to multiple dates.
Choose the scope of the action by selecting an item from the Scope
tree.
Select an instrument to apply the comment to all tests performed

on the instrument. This will include all lab and lot numbers.
Select a lab number under the instrument to apply the comment to

all tests performed using the selected instrument/lab number
combination.

comment to all tests performed in the selected instrument/lab
number/lot number combination.
Click OK to append the comment and close the dialog box.
To Attach Both an Action and a Comment by Instrument

1
Choose Tools | Action/Comment by Instrument, the "Action and Comment by

Select both the "Action" and the "Comment" check boxes.
Click in the free-text area and type your comment.
Click Add to display the "Action Log" dialog box.
Select an action from the list.
Click Apply to return to the "Action and Comment by Instrument" dialog

box. (You can click Apply again to add another action.)
Choose a start and end date for the action and comment. By default,
these dates will be set to the current date.
Choose the scope of the action and comment by selecting an item from
the Scope tree.
Select an instrument to apply the action/comment to all tests

performed on the instrument. This will include all lab and lot
numbers.
141
142
Select a lab number under the instrument to apply the

action/comment to all tests performed in the selected
instrument/lab number combination.

action/comment to all tests performed in the selected
instrument/lab number/lot number combination.
Click OK to append the action and comment and close the dialog box.
H A P T E R
13
Importing and Exporting

Data
In This Chapter
Importing Data .......................................................... 143
Exporting Data .......................................................... 152
Importing Data
The Unity Desktop import utility provides both autoimport and manual
import. As a separate utility, import can run in the background and not
interfere with normal operations of the software.
Please be aware that imported data takes precedence over manually
entered dataif you enter data manually concurrently with an import
process, Unity Desktop will save the imported data rather than your
manually entered data.
Within Unity Desktop, choose Tools | Utilities | Import | Import Data or press F12
to display the "Import" dialog box. The dialog box has two panesthe left
pane allows you to customize how your data is imported and the right pane
displays the status of imported files.
In addition, the "Import" dialog box has the following command buttons:
StartBegins the import process, which runs as a background utility.
StopStops the import process. You may need to stop the import
process in order to create an import file from the rejection log and
correct it. If you do not stop the import utility before clicking Save in
the rejection log, Unity Desktop will create the import file and
immediately re-import it.
Reset StatusClears the right pane of the "Import" dialog box. This
pane lists the folders, file names, and status of imported files.
Customizing Import
The left pane of the "Import" dialog box allows you to customize how Unity
Desktop imports your data. When you access this dialog box, you will notice
that each item has a default setting. Typically, you will not need to change
these settings. If you are being assisted by Bio-Rad Connectivity personnel,
they will let you know if any changes are necessary.
The dialog box contains the following, listed in the order they appear:
Import Data Archive (on page 144)
QC Output File Folder (on page 144)
Run Length (on page 145)
Data Retention (on page 145)
File Retention (on page 145)
Import Check Boxes (on page 146)
Import Data Source (on page 146)
Import File Format Selections (on page 147)
Import Data Archive

After processing, Unity Desktop saves import files to this folder with a .SAV
extension. Unity Desktop maintains the file for the length of time specified
for File Retention (on page 145).
The default path is C:\Program Files\Bio-Rad
Laboratories\Unity Desktop\ImportArc\.
Unlike the InstrumentImport path, you can only specify one folder at a time
for archiving data.
You can edit the path to point to a different folder. You cannot, however,
point the path to more than one folder. In addition, remember that the
path name must end with a backslash (\).
QC Output File Folder

If you have selected the "QC output file" check box, Unity Desktop places a
copy of a file containing the original information in the import file plus the
accepted/rejected status of each data point and QC rules violated, if any.
You can use this file to make real-time QC decisions.
144
Run Length
Unity Desktop assigns data points to runs based on their date-time stamp.
Because the software cannot predict how your laboratory will perform QC
testing, it allows you to specify the time during which you want your
imported data points assigned to the same run. (Runs are used for within
and between evaluations of statistical process control rules.) Unity Desktop
defaults the run length to 15 minutes.
The default run length is 15 minutes, but you can define a run length from 1
to 1440 minutes. (1440 minutes is 24 hours.)
Unity Desktop assigns data points that are within the run length-interval to
the same data entry row (run). Timing for the run length interval begins
with the date-time stamp of the first data point assigned to the run,
regardless of its level.
Unity Desktop starts a new run when:
The date-time stamp for the incoming point exceeds the run-length
interval, measured from the date-time stamp of the first data point in
the active run.
It receives a data point for a level which already contains a value.
The active run contains values for all available levels as defined on the
"Settings" tab of the "Test Settings" dialog box.
Data Retention
This setting determines how long Unity Desktop retains data on the
rejection log before automatically deleting it. The default is 60 days, but
you can choose Tools | Utilities | Import | Delete Rejection Log at any time to
delete the rejection log.
File Retention
This setting determines how long Unity Desktop retains the .SAV files in the
"Import data archive" folder. The default is 30 days, but you can specify
from zero to 90 days.
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Import Check Boxes
Create New Tests if Necessary

To import data for tests that do not already exist in Unity Desktop,
select the Create new tests if necessary check box. If the Create
new tests if necessary check box is not selected and the import file
contains data for a test that is not defined in Unity Desktop, the data
will be rejected. The Create new tests if necessary check box is
selected by default.
Create New Lots if Necessary

Historically, Lot not found was the most common rejection log
message for imported data. The Create new lots if necessary check
box allows you to avoid this error. By default, the Create new lots if
necessary check box is not selected and you must select it if you want
to use this feature.
If the Create new lots if necessary check box is not selected and the
import file contains data for a lot that is not defined in Unity Desktop,
the data will be rejected.
QC Output File
Select this check box if you want Unity Desktop to create a file
containing the information in the original file plus each data points
accepted/rejected status and QC rules violated, if any. Unity Desktop
places the file in the folder you specified as the "QC output file" folder.
Sort Import Files

Select this check box if the data in the import file is not sorted into
date-time order. This will prevent out-of-sequence errors.
Redundant Data Filter

The Redundant Data Filter (RDF) will eliminate data points that are
presented multiple times when an LIS or third-party peripheral appends
data points to the same file throughout the day. Removing these data
points before Unity Desktop imports the file prevents both duplicate
data points on the data entry screen and unnecessary entries in the
rejection log.
Import Data Source

The Import Data Source defines the path to the folder(s) from which Unity
Desktop will import files.
146
The default Import Data Source path points to a single folder named
"InstrumentImport" that is created by the program. Although the default
path will be C:\Program Files\Bio-Rad Laboratories\Unity
Desktop\InstrumentImport\. You can edit the path to point to a
different folder or to several folders as described in the example below.
You can create multiple folders and specify each folder in the "Import data
source path". Multiple folders are useful when you have several instruments
and want to separate the data files. If you create multiple folders for data
files, you must specify the complete path to each folder in the "Import Data
Source" path and separate individual paths with a comma (,).
For example:
You installed Unity Desktop to the default folder. (C:\Program Files\Bio-Rad
Laboratories\Unity Desktop.)
Within the Unity Desktop folder on drive C, you created three data folders
(named Inst1, Inst2, and Inst3) into which three instruments will place data.
The path to Inst1 will be C:\Program Files\Bio-Rad

Laboratories\Unity Desktop\Inst1\.


Your "Import data source" path will then be:

C:\Program Files\Bio-Rad Laboratories\Unity
Desktop\Inst1\, C:\Program Files\Bio-Rad
Laboratories\Unity Desktop\Inst2\, C:\Program Files\BioRad Laboratories\Unity Desktop\Inst3\.
The individual path names all end with a backslash (\) and are separated by
commas. The last path defined, even if there is only one, must end with a
backslash.
Import File Format Selections

The following settings tell Unity Desktop how your import file is formatted
so that Unity Desktop can import it correctly:
147
Field separator
Choose a Field separator to specify how your file is formatted (i.e. Tab,
Semicolon, Comma, Space, Vertical bar, or Other).
String delimiter
Choose the String delimiter (Double quote, Single quote, Space, or
Other), if any, used in your file. String delimiters may be required when
the character used as the field separator is also used within the string.
Decimal point
Choose the character (Comma, Dot, or Other) used to represent a
decimal point.
Polling separator
Choose vertical bar or comma.
Import File Status

The right pane of the "Import" dialog box lists files that Unity Desktop has
processed and contains the following information for each file:
Source folderThis column contains the complete path to the folder that
contains the import file.
File nameThis column contains the name of the imported file.
StatusFor each import file, this column contains a message that the
import process has started and a message that the import process has
completed.
Click Reset Status to clear this pane.
Autoimport
The Import Utility allows you to import data files from your instrument or
LIS that have been translated to a standard format that Unity Desktop can
import. Bio-Rad has a CIS (Connectivity Implementation Services) group
whose sole purpose is to assist you with interfacing.
Contact your Bio-Rad software support representative if you are interested
in using Bio-Rads Connectivity Services. Alternatively, you or your IT group
can develop an interface, which requires that your data be formatted as a
Bio-Rad standard import file as described in Manual Interfacing and
Standard Import Files.
148
Rejection Logs
All data points that Unity Desktop cannot import are sent to a rejection log,
which is available by choosing Tools | Utilities | Import | View Rejection Log.
The rejection log will have the following information:
Date-Timedate-time Unity Desktop processed the import file
File Namecomplete path, including file name, of the import file

containing the rejection
Rejected Dataerror that caused the rejection followed by the rejected

data row. See Rejection Log Messages (on page 242) for a complete
list of causes.
The rejection log lists each error on its own line within the file. Therefore,
a single data row may have multiple entries in the rejection logone for
each error occurring in the data row. This allows you to correct errors
individually.
For example, you might filter the log by the "Lot closed" message; open the
closed lot(s); and then filter the log by the "Date out of range" message and
correct any problems. When you've made all required corrections, you can
click Save Import File and Unity Desktop will create an import file to be
reimported.
You will probably need to use the rejection log only for manually imported
data or when you specify your own interface. If you are using SoftConnect,
you will have resolved these errors prior to importing the file.
Operator Setup
Unity Desktop allows you to specify operator initials for imported data.
When importing data, Unity Desktop uses the following cascade to
determine the initials to appear in the OP column of the data entry screen:
If the import file contains initials, Unity Desktop places them in the OP
column.
If the import file does not contain initials, Unity Desktop uses the
initials defined in Operator Setup, if any.
If the import file does not contain initials and the operator is not
defined in Operator Setup, Unity Desktop places two asterisks in the OP
column, indicating that the operator is unknown.
149
Choose Tools | Utilities | Operator Setup to access the "Operator Setup" dialog
box. From the dialog box you can:
Choose how to assign operator initials. Your options are all data, lab
and lot, or instrument.
Make selections from drop-down lists to assign operator initials.

(Different columns appear depending on your choice of how to define
operator initials.)
Specify the number of work shifts (from one to eight) in use in your lab.
Set the number of shifts before making other selections. The numbers in
the "Shift" column list will be limited to this number.
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. Your setting for shifts is
global and applies to all tests in the database.
When you set a number of shifts, Unity Desktop divides the 24-hour day
evenly among them. You can edit the starting time of each shift after shift
1; however:
150
You cannot edit the start time of shift 1; shift 1 must begin at 12:00
AM.
You cannot edit the end time of any shift. Unity Desktop assigns the
end time based on the start time you specify for the following shift.
The last shift of the day must end at 11:59 PM because the first shift
must begin at 12:00 AM.
Defining Initials With Operator Setup

1
Choose Tools | Utilities | Operator Setup.
Verify that the number of shifts is correct and change it if necessary.

This number determines the numbers available in the drop-down "Shift"
list.
Select one of the following options:
All data
When you choose all data, the selection grid will have columns for
you to choose a shift number and operator initials. The operator
initials will be applied to all tests imported during the assigned
work shift.
Labs and lots

When you choose labs and lots, the selection grid will have columns
to allow you to choose a lab number, lot number, and the operator
initials for each shift.
Instruments
When you choose instruments, the selection grid will have columns
for you to choose an instrument and the operator initials for each
shift. (The list of instruments will contain all instruments in the
code list, not just instruments for which you have already created
tests.)
Make a selection in each column of the grid. (Which columns appear

depends on your selection in Step 3.)
When you click in a cell, a drop-down list of available choices appears.
Initially, the display will contain two rows. As you complete one row
and click in the next row, Unity Desktop adds an available row at the
bottom.
When your selections are complete, click OK to save your changes.
151
Exporting Data
One of the most useful features of Unity Desktop is its ability to export
data files in formats compatible with popular business software applications
such as Microsoft Access, Microsoft Excel, and Microsoft Word.
Selecting the Data to be Exported

Unity Desktop allows you to export data for:
All open labs: Choose Tools | Utilities | Export All Labs.
An individual lab number: Select an open lab number in the Lab dialog
box and click Export. Complete the requested information in the
Export Current Lab dialog box and click OK.
An individual lot number: Select an open lot number in the Lot dialog
box and click Export. Complete the requested information in the
Export Current Lot dialog box and click OK.
A single test: Select an open test in the Test dialog box and click
Export. Complete the requested information in the Export Current
Test dialog box and click OK.
Completing Requested Export Information
152
Regardless of the area from which you requested the import, Unity Desktop
displays a dialog box requesting the information shown in the preceding
figure including:
File
Choose one of the following options for the export file format:
Text fileChoose this option to create a file for use with word
processing programs. Unity Desktop uses American Standard Code
for Information Interchange (ASCII) characters for exporting text
files.
Delimited fileChoose this option to create a file for use with

database or spreadsheet programs.
Import fileChoose this option to create a Unity Desktop standard

format import file.
File name
If you type a file name in this field, Unity Desktop will save the file to
the last location to which you saved an export file. You might want to
create a folder to store these types of files. Alternatively, you can click
the ellipsis (...) and browse to a folder.
Date range
Make selections for from and to dates to export the desired data.
Data
Choose an option (point or summary) that the data should be exported
in. Your choice here applies only to data entered as point data.
Obviously, data that was entered as summarized data cannot be
exported as point data.
153
H A P T E R
14

In This Chapter
Viewing, Printing, and Saving Charts ................................ 155
Chart Options............................................................ 156
Levey-Jennings Charts ................................................. 158
Multi-L-J Charts ......................................................... 161
Bar Charts................................................................ 161
Youden Charts........................................................... 162
Viewing, Printing, and Saving Charts

Viewing Charts
To view a chart, select the desired test in the navigation tree and then click
the chart's icon on the toolbar. If you are in data entry, close the chart and
the data entry screen reappears.
Several functions appear above the chart:
From and to datesChange the dates to include more or fewer days on

the chart.
Paging arrowsClick the forward or backward arrows to page through

the chart in the time interval specified by the from and to dates.
Options buttonCustomize your chart's appearance as described in

Chart Options.
Level check boxesEach level you are using has a check box. Selecting
and clearing the check boxes displays or hides the chart for the level.
Overlay (for L-J charts only)When the check box is selected, all levels
of control appear on a single chart. When the check box is cleared,
each level has its own chart.
Printing Charts
Display the chart and then select File | Print Chart. Select the range of charts
you want to print from the drop-down list. Your choices in lab mode are:
All dataPrints the chart for all tests in the database for the from-to
date range.
Current labPrints the chart for the selected lab for the from-to date
range.
Current lotPrints the chart for the selected lot for the from-to date
range.
Current testPrints the chart for the selected test for the from-to date
range.
Your choices in panel mode are current test and current panel.
Saving Charts
1
Display the chart.
With the chart displayed, choose File | Save Chart. The "Save As" dialog
box appears allowing you to choose a location, file name, and file
format (JPG, GIF, BMP, or PDF) in which to save the file.
Click Save to create and save the file.
Chart Options
All Unity Desktop chart options include "Header" and "General" tabs. The
selections you make from these tabs will apply to all charts. In addition,
each chart type includes a tab specific to it. Finally, Levey-Jennings Charts
include an additional tab (Lines). The following lists summarize the tabs
available for each chart type:
Levey-Jennings Charts
General (see "General Chart Options" on page 157)
Levey-Jennings Tab (on page 158)
Header (see "Chart Headers" on page 157)
Lines (see "Lines Tab for L-J Charts" on page 160)
Bar Charts
Bar Chart Options (see "Selecting the Data to Appear on Reports" on
page 166)
Youden Charts
156
Youden Chart Options (on page 163)

General Chart Options

From within a chart, click the Options button. Then click the "General" tab.
Your choices on this tab will apply to all chart types.
The "General" tab has three sections:
Fill background
Grid line colors and dash style
Legend
Click the Default button to return to the original Unity Desktop settings.
Fill background
If the "Show background" check box is selected, you can select fill colors for
the 1, 2, and 3 SD ranges from their drop-down lists. If you are printing
charts and want to conserve toner, you can clear (uncheck) the check box
from either the "Print Chart" dialog box or from chart options.
Grid lines
Your selections here determine the color and dash style of the grid lines
marking 1, 2, and 3 SD above and below the mean.
Legend
Applies only to L-J charts. Select the "Show legend" check box if you want
the chart to contain a legend with the symbol and color for each level of
control. You can also select an option to display the legend at the top or
bottom of the chart. By default, the legend appears above the chart.
Chart Headers
Unity Desktop chart headers contain quite a lot of information, some of
which you may not need to include. Unity Desktop allows you to configure
your chart headers to contain just the information you want.
157
From within a chart, click Options. Then click the "Header" tab. The tab
contains check boxes that you can select (check) or clear (uncheck). When
an item is checked, it appears in your chart headers. When an item is
unchecked, it is omitted. Unity Desktop applies your selections to all charts.
Displaying and hiding items on the chart header is for readability only.
Hiding an item does not resize the headerthe space where the item would
have appeared remains.
Levey-Jennings (L-J) charts plot your lab's data points for a specified time
period against your lab's fixed or cumulative (floating) mean and 3s range.
Unity Desktop uses your fixed mean and standard deviation, if defined.
Otherwise it uses the cumulative statistics.
As discussed in QC Assumptions, using statistics to evaluate QC values
assumes that new control measurements will have a similar distribution to
past measurements while the system is stable and that the distributions of
values is Gaussian (normal).
Using these assumptions, 95.5% of values should be within 2s of the mean
and 99.7% of values should be within 3s of the mean. A value outside 3s of
the mean would be expected only 0.3% of the time if the system is stable.
L-J charts allows you to visually identify these data points as well as shifts
(sudden changes) and trends (gradual changes) in your data.
Customizing Your L-J Charts

In addition to the General (see "General Chart Options" on page 157)
options available for all charts, Unity Desktop has two additional tabs for
customizing the appearance of your L-J charts:
Levey-Jennings Tab (on page 158)
Lines Tab (see "Lines Tab for L-J Charts" on page 160)
Levey-Jennings Tab
The following options appear on the Levey-Jennings tab:
158
Days on Charts
By default, days on charts is set to 120, but you can select any number
from 1 to 360.
X-axis Type
You have two options for the x-axis:
Date
When you choose the Date option, the x-axis will have a vertical
column for each day. Each data point collected during that day will
appear in this column, so that the individual data points appear to
be stacked. If you choose this option and select (check) the "Include
point representing mean of data points for the day" check box,
Unity Desktop adds a large point representing the daily mean and
shows the individual data points as smaller points.
Sequence
When you choose the Sequence option, each data point appears in
its own column and the "Include point representing mean of data
points for the day" check box is unavailable.
Action Check Box

When you select the "Action" check box, a number identifying the
attached action(s) appears at the top of the chart. The identifying
number and its associated text appears in the chart header as shown in
the following figure.
Action Messages (on page 243) lists Unity Desktop's default action
messages and their associated numbers. As you add new actions, Unity
Desktop numbers them sequentially.
Symbol
Each control level has a drop-down list that allows you to choose a
symbol to represent that level's data.
159
An arrow represents points that are off the scale regardless of your
level-symbol choice.
Size
Allows you to specify the size (1-10 pixels) of each level's symbol.
Fill Check Box

Each control level has a "Fill" check box. If you select the check box,
the level's symbol will be filled with the color you select from the dropdown list. Unity Desktop color codes points that violate a warning rule
in orange and points that violate a rejection rule in red. These colors
will replace your selected fill color.
We suggest that you do not select orange or red as fill colors because
this would remove the utility of orange for warning and red for
rejection colors.
Each level also has an assigned shape, which visually distinguishes the
level when you print in black and white.
Level 1 points display as circles
Level 2 points display as squares
Level 3 points display as diamonds
Level 4 points display as plus signs (+)
Connect Line
Select this check box if you want Unity Desktop to draw a line
connecting the data points on the chart. When displaying by date, the
line connects the mean of the points for the day and only appears when
the "Include point representing mean of data points for the day" check
box is selected.
Default
Click Default to return to the original Unity Desktop selections.
Lines Tab for L-J Charts

This tab has check boxes for a number of lines that you might want to
appear on your Levey-Jennings charts. Lines appear for the items that are
selected. The tab also has drop-down lists that let you choose a dash style
and color for each selected item.
Except for Group lines, the lines you select will appear only when displaying
individual charts for each control level. They will not appear when
displaying the levels overlayed onto the same chart. Group lines appear on
both display types.
160
Multi-L-J Charts
The Multi-L-J feature of Unity Desktop allows you to select up to 18 tests
and display their Levey-Jennings charts on a single screen. This feature
provides an easy way to compare tests, such as the same analyte run on two
different instruments or lot numbers of control material. Like other Unity
Desktop charts, you can customize Multi-L-J charts as described in Chart
Options and Levey-Jennings Chart Options.
Selections you make for standard L-J charts are applied to Multi-L-J charts
and vice versa.
Multi-L-J charts always appear with the levels overlayed on a single chart.
You can, however, select and clear the level check boxes to show or hide
levels.
To Display Multi-L-J Charts

1
Click the Multi-L-J icon on the toolbar.
Select the tests you want to display from the lab or panel trees. (You
can select up to 18 tests.)
If desired, change the arrangement of the individual charts:
to display the charts in a single column. (This is the

Click
default display)
Click
to display the charts in two columns.
Click
to display the charts in three columns.
Bar Charts
By default, the Bar Chart displays 13 monthly means for the selected test as
vertical bars. The chart also includes a bar for the fixed mean, when
defined, or the cumulative mean when no fixed mean is defined. The fixed
or cumulative mean also determines the scaling of the Y-axis (mean 3SD).
161
Because Bar Charts plot monthly means against a 3SD range, the Bar chart
allows you to visualize long-term shifts and trends.
You can change the months on the chart and fill colors for each level from
the "Bar Chart" tab of the "Options" dialog box.
Selecting a Bar Chart and Changing Options

1
Select the appropriate test in the lab or panel navigation trees.
Click the Bar icon on the toolbar. Unity Desktop displays the chart for
the selected test.
To change chart options, click Options to display the "Options" dialog

box.
Click the Bar tab.
Make changes as desired. You can change the:
Months on chart
Level fill colors
Click OK to save your changes and close the dialog box.
See Chart Options for information on making changes that will apply to all
charts.
Youden Charts
The Youden chart is a graphical representation used to plot paired Level 1
and Level 2 (or Level 1 and Level 3, etc.) data for a given time period on an
X and Y-axis.
Data points are plotted on the graph and fall within one of four fields:
Within one standard deviation of the mean.
Within two standard deviations of the mean.
Within three standard deviations of the mean.
Outside three standard deviations of the mean.
Pause the mouse pointer on an individual data point to display its two
associated values, their date and time stamp, any violated SPC rules, and
any attached actions or comments.
162
Youden charts can be used for any two levels of a control material.
Youden Chart Options

You can customize the following items on Youden Charts:
Months on chartsDefaults to two months, but you can choose any

number from one to twelve.
Point
SymbolChoose a symbol from the drop-down list.

163
SizeDefaults to 6 points, but you can choose any number from one
to ten.
Fill check boxSelect to apply a fill color to the point; then choose
a color from the drop-down list.
See Chart Options for information on making changes that will apply to all
charts.
Using Youden Charts

The center of the Youden chart can be thought of as the bull's eye of a
target. The more tightly points are clustered around the bull's eye, the
better the precision of the the control levels displayed.
164
H A P T E R
15

In This Chapter
Useful Features of Unity Desktop Reports .......................... 165
Useful Features of Unity Desktop Reports

You can generate Unity Desktop reports and charts at any time, so they
are valuable additions to your periodic Unity Interlaboratory reports. You
can print the reports or save them as a file (e.g. PDF, Word, Excel).
This section discusses the following features:
Choosing a Report Format (on page 165)
Selecting report data (see "Selecting the Data to Appear on Reports"

on page 166)
Configuring Intralaboratory Report Headers (on page 167)
Documenting Report Reviews (on page 167)
Choosing a Report Format

If you want your reports to appear as PDF files by default, select the
"Generate PDF reports" check box on the "Setup" dialog box. (Choose Tools |
Setup.)
You must have Adobe Acrobat 5.5 or later installed, regardless of
whether or not the "Generate PDF reports" check box is selected. The
Unity Desktop installation CD includes Adobe Acrobat 6.0. Acrobat
Reader Setup provides instructions for installing this version.
Alternatively, you can download the latest version of this free software
from the Adobe web site.
When the check box is selected

Unity Desktop automatically generates your reports as PDF files and you
can perform the functions available on the Acrobat Reader toolbar,
which include printing and saving a copy of the file. Refer to the
program's online help for additional information.
When the check box is cleared

Unity Desktop generates your reports using Crystal Reports (*.rpt files).
The Crystal Reports toolbar provides the following functions:
Export ReportClick to save a copy of the report in a number of

different formats including Crystal Reports, Adobe Acrobat (PDF),
Microsoft Excel, or Microsoft Word.
Print ReportClick to print a copy of the report.
RefreshClick to rebuild the report to include any newly added

information.
PagingAllows you to page through the report using Paging Arrows

(on page 233).
Display SizeAllows you to increase or decrease the size of the

report on the screen.
Pause the mouse over an icon on the Crystal Reports toolbar to display a
short description of the item.
Selecting the Data to Appear on Reports

When you request a report, a dialog box appears that allows you to select
both the:
Date range for the included data
Scope of data to be included as:
All data
Current lab
Current lot
Current test
Current panel
If you select the test from the Lab tree, the first four options are available,
and Current panel is unavailable. If you select the test from the Panel tree,
only the "Current panel" option is available.
166
Configuring Intralaboratory Report Headers

Unity Desktop report headers contain quite a lot of information, some of
which you may not need to include. Unity Desktop allows you to configure
your report headers to contain just the information you want. You can
customize your report headers from the "Configure" dialog box, which
contains tabs for the lab, lot, and test profiles. Each tab contains check
boxes that you can select (check) or clear (uncheck). When an item is
checked, it appears in your report headers. When an item is unchecked, it is
omitted.
Unity Desktop applies your selections to all reports.
Displaying and hiding items on the report header is for readability only.
Hiding an item does not resize the headerthe space where the item would
appear remains.
To Configure Intralaboratory Reports

1
Choose Reports | Configure to display the "Configure" dialog box.
Notice that the dialog box contains three tabs:
Lab Profile (This will be the active tab when you open the dialog
box.)
Lot Profile
Test Profile
Each tab has check boxes for items that appear in the report header.
3
Click a tab and clear (remove check) or select (add check) individual
items. Note:
Checked items appear in the header.
Unchecked items are omitted from the header.
Repeat for remaining tabs if necessary.
Documenting Report Reviews

Each Unity Desktop report contains an area for a reviewer's signature and
the review date.
167
Unity Desktop does not support the use of electronic signatures. However,
you can use a third-party software, such as Adobe Acrobat to implement
electronic signatures.
Individual Unity Desktop Reports

Unity Desktop provides a variety of Unity Intralaboratory Reports. Because
these reports are based on your labs data, you can generate them at any
time. You can also print the report, export it in a variety of formats
(including Microsoft Excel and Word), or save it as a PDF (Portable
Document Format) file that can be read using Adobe Acrobat Reader. All
Unity Desktop reports and charts are available from the Reports menu.
The Reports menu opens to several submenus, some of which have their
own submenus:
General, which includes the following:
Point Data Report
Summary Data Report (on page 169)
Supervisory, which includes the following:
168
Supervisor's Report
Charts, which includes the following:
Multi-L-J Charts (on page 161)
Bar Charts (on page 161)
Youden Charts (on page 162)
Listings for Labs, Lots, Tests, and Panels (on page 171)
Labs
Lots
Tests
Panels
Configure, which opens to a dialog box that allows you to select the
items to appear in report headers. See Configuring Intralaboratory
Report Headers (on page 167).
Point Data Report

The Point Data Report is useful when you want to review 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.
To Call a Point Data Report

1
Close any open data entry screens.
Select a test in the Lab or Panel trees. (Your test selection determines
the choices available for the data set.)
Choose Reports | General | Point Data Report. A dialog box appears allowing
you to select a date range and data set for the report.
Select from and to dates for the report. (You can either click the downarrow to display a calendar from which you can select a date or select
the day, month, or year, and type over it.)
Select the data set to include on the report.

If the selected test is on the Lab tree, the following choices are
available:
All data
Current lab
Current lot
Current test
If the selected test is on the Panel tree, the only choice is current
panel.
6
Click OK to display the report.
Summary Data Report

Summary Data Reports provide the monthly and cumulative mean, SD, CV,
and number of data points for each test in your selected data set. These
statistics combine both point and summary data and provide a quick way to
review large amounts of data.
To Display a Summary Data Report

1
Choose Reports | General | Summary Data Report.
Select from and to dates for the report. (You can either click the downarrow to display a calendar from which you can select a date or select
the day, month, or year, and type over it.)
169
Select the data set to include on the report.

If you selected the test from the Lab tree, the following choices are
available:
All data
Current lab
Current lot
Current test
Notice that "Current panel" appears dimmed and is unavailable.

If you selected the test from the Panel tree, current panel and current
tests are the only available choices. All other options appear dimmed
and are unavailable.
4
Click OK to display the report.
Supervisor's Report
The Supervisor's Report allows you to filter a data set to include only data
points that:
Violate a rejection rule
Violate a warning rule
Have an attached action or comment
When you press CTRL+F10 to request the report, the "Supervisor's Report"
dialog box appears.
170
By default, the "Reject" check box is selected and the report includes points
that violated SPC rules set to reject. Select or clear the check boxes to
include points that violated a warning rule or have an attached action or
comment.
Listings for Labs, Lots, Tests, and Panels

Choose Reports | Listings to view or print information on the labs, lots, tests,
and panels defined in your database.
Labs - shows all lab numbers, divided into open and closed lab numbers.
Lots - shows all open lab numbers and their associated lot numbers,
whether open or closed.
Tests - shows all lab numbers (open and closed) and their associated
tests organized by lot number. Closed lots and their associated tests
are not displayed.
Panels - shows all panels with their associated tests organized by lab
and lot number.
171
H A P T E R
16
Sending Data to the Unity

In This Chapter
Transmission Files ...................................................... 173
Using Write Transmission File ........................................ 174
Transmission Files
Because Unity Desktop allows you to specify automatic transmission of
your data, participation in the Unity Interlaboratory Program is almost
effortless.
Submitting your data allows you to compare your laboratory's data with that
of other labs worldwide, which is a major benefit of Bio-Rad's Unity
Intralaboratory Program. The Unity Intralaboratory Program provides both
instant and monthly intralaboratory reports.
Because Unity Desktop allows you to specify automatic transmission of
your data, participation in the Unity Interlaboratory Program is almost
effortless. Activating automatic transmission is as easy as choosing Tools |
Setup and selecting (checking) the "Automatic monthly transmission" check
box.
Monthly Transmission
Monthly transmission ensures that all your data is transmitted for inclusion
in monthly Unity Interlaboratory reports. (These reports appear as PDF files
on QCNet.com.)
Although we refer to manual transmission from the "Send/Receive Data"
dialog box as monthly transmission, you can send data at any time during
the month. If you send another file later, it will contain only new and
changed data.
Write transmission file provides an alternative to monthly transmission

and can be used if you want to email your data to Bio-Rad.
Unity Desktop does not support modem transmission.
To Transmit Data Manually for Monthly Unity

You can transmit data manually at any timeeven if you have activated
automatic transmission. Manual transmission may be necessary if you make
changes to your data after the transmission occurs and is required if you do
not activate automatic transmission.
1
Log in as a user with permission to communicate with the Unity

Choose Tools | Unity Interlab | Send/Receive Data. The Send/Receive Data

dialog box appears when the Send data to Bio-Rad option is selected.
Click OK to transmit.
To Activate Automatic Monthly Transmission for

Monthly Unity
1
Choose Tools | Setup to access the "Settings" dialog box.
Select (check) the "Automatic monthly transmission" check box. The

"Day of the month" list becomes available.
Select the day of the month on which you want automatic transmission
to occur. (The day selections are limited to 1 through 7, because the
Unity Interlaboratory Program considers data received after the 7th to
be late.)
Click OK to save your settings.

Write Transmission File DOES NOT transmit a data file to Bio-Rad.
174
Sending Data to the Unity Interlaboratory Program
The data files created with this procedure must be received at Bio-Rad via
email or on diskettes by the QC Data due date indicated on the Bio-Rad QC
Calendar in order for the data to be included in your monthly/quarterly
Unity Interlaboratory reports.
Transmission files will:
Include new data entries and any changes in data history since the
previous file or diskette was created.
Contain all data that has been changed since the last transmission and
mark the data so that it will not be transmitted in subsequent
transmission files.
Be automatically assigned a unique file name made up of the user's

primary lab number and the sequence number. The sequence number is
advanced (003, 004, etc.) each time a successful transmission file is
created, allowing Bio-Rad to detect missing files.
When you select Write Transmission File, the transmission file is written to
a file or diskette and the sequence number is advanced. A second file or
diskette, created immediately after the first, will not contain the same
information, because the QC data has been marked as "transmitted" and
thus is not written the second time.
You must send all transmission files to the Unity Interlaboratory
Program, which will generate an error message if it detects a gap in
transmission sequence numbers.
To Write a Transmission File

1
If you want to write the transmission file to your hard disk drive or to a
network drive, create a folder in which to store the file.
Choose Tools | Unity Interlab | Write Transmission File.
In the "Destination folder" field, type a drive specification (A:\ is

specified by default) or type the path to the folder you created in step
1. Alternatively, click the ellipsis (...), and select the folder or drive
from the directory.
Click OK to create the transmission file. A message displays that the

transmission file was created successfully.
Click OK to close the message box.
175
Because write transmission file DOES NOT transmit to the Unity

Interlaboratory Program, you must send the files to Bio-Rad, either by
email or by sending diskettes.
To Email a Transmission File to Bio-Rad

If you do not have an Internet Service Provider, you might want to email
your transmission file directly to your Bio-Rad software support
representative for processing.
1
Create a file using "Write Transmission File."
Compress the file using a compression software such as WinZip or

PKZip.
Email the zipped file as an attachment to your Bio-Rad software

Data files sent to Bio-Rad by email must have a .ZIP extension.
176
H A P T E R
17
Unity Interlaboratory
Reports
In This Chapter
Overview of Unity Interlaboratory Reports ......................... 177
Standard Reports ....................................................... 178
Optional Interlaboratory Reports .................................... 185
Affiliated Reports....................................................... 189
Urinalysis Reports....................................................... 193
Overview of Unity Interlaboratory Reports

The Unity Interlaboratory Program will automatically generate the
following "standard" reports for each month that you submit your data:
Monthly Evaluation Report (on page 178)
Laboratory Performance Overview Report (on page 179)*
Laboratory Comparison Report (on page 180)*
Laboratory Histogram Report (see "Laboratory Histogram" on page

182)*
Bias and Imprecision Histogram Report (on page 183)
Data Rejection Report (on page 184)
*You can specify the frequency (monthly, quarterly, or never) of these

reports as described in the Unity Interlab Reports Tab (see "Unity
Interlaboratory Reports Tab" on page 225).
Additional optional reports are available by request. Contact your Bio-Rad
software support representative to request a copy of an optional report.
To be included in interlaboratory reports, data usually must be received at

Bio-Rad on or before the data due date, which is usually the fifth business
day of the following calendar month. The Unity QC Program Calendar also
lists data due dates. Calendars are available from your Bio-Rad software
Reports are not automatically generated for data received after the due
dateContact your software support representative to request late
reports. You may want To Activate Automatic Monthly Transmission
(see "To Activate Automatic Monthly Transmission for Monthly Unity" on
page 174) to ensure that your data arrives at Bio-Rad on time.
Additional optional reports are available as discussed in Optional Interlab
Reports (see "Optional Interlaboratory Reports" on page 185) and Affiliated
Reports (on page 189).
Viewing Interlaboratory Reports on QCNet

Unless you have unenrolled, you will receive an email each month notifying
you that your Unity Interlaboratory reports are available on QCNet.com.
After you receive the email, you can view the reports as follows:
1
Start Internet Explorer and log in to QCNet.com.
Click the Unity Interlab tab.
Click Reports.
Click My Reports.
Make selections for lab number, lot number, report type, and period.
The selected report displays in Adobe Acrobat Reader.
Standard Reports
Monthly Evaluation Report
The Monthly Evaluation Report provides a quick overview of lab
performance by lot number of control and serves three purposes:
178
Validates your monthly laboratory performance as compared to the

peer group.
Identifies when your laboratorys monthly performance does not

statistically compare with or was not accepted into the Unity database.
Notifies your laboratory when your laboratorys data was not received
in time for the standard worldwide comparison.
The Monthly Evaluation Report includes a section at the bottom of the

report to document any corrective actions and to sign off on the report.
Example Report
Laboratory Performance Overview Report

The Laboratory Performance Overview Report allows you to evaluate both
your bias and imprecision for a test compared to the peer and method
consensus groups. (Your monthly SDI is a peer-based measure of bias, and
your monthly CVR is a peer-based estimator of imprecision.)
The SDI and CVR are combined as X-Y coordinates located within one of
three performance zones designated by increased levels of shading:
179
Acceptable performance (no shading)
Acceptable to marginal performance (slight shading)May indicate the

need to investigate test system bias and imprecision.
Outside of acceptable and marginal performance (darkest shading)You

may need to institute a corrective action.
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. Bias and imprecision increase as your values move
further away from the center of the graph.
The reverse side of this report has a comment section where you can record
any observations or changes in your system in response to the results of this
report.
Example Report
Laboratory Comparison Report

The Laboratory Comparison Report allows you to compare your results to
those of the peer and method consensus groups.
For VITROS instruments, the Laboratory Comparison Report provides
statistics for your laboratory, your peer group, and your method group
based on the slide generation numbers that you report for your laboratory.
For certain analytes, method group statistics may not be available.
180
For each test, the report contains the following monthly and cumulative
statistics:
Lab mean
Lab SD
Lab CV
Number of points the lab reported
CVR for the Peer and Method groups
SDI for the Peer and Method groups
The report also contains the following monthly and cumulative Peer and
Method group statistics:
Mean
SD
CV
Number of points reported
Number of labs reporting
Example report
181
Laboratory Histogram
The Laboratory Histogram contains information for each analyte the lab has
reported on in the last 12 months. The histogram has a bar for each
calendar month plus a cumulative bar. The Laboratory Histogram plots the
labs monthly means against the current cumulative peer group mean 2s
range. For each bar, the report also lists the labs mean, SD, CV, and
number of points. Each level of control has a separate bar chart.
The report provides a visual performance comparison, which is useful for
identifying both shifts (abrupt changes in values) and trends (gradual
changes in values).
If a month has no data points, then either no values were submitted, late
values were submitted, or all submitted values were outside of the
statistical window and rejected by the Unity Interlaboratory Program data
filters.
Example report
182
Bias and Imprecision Histogram Report

The Bias and Imprecision Histogram Report was developed based upon the
work of Dr. Carmen Ricos, et al. in Clinica Chimica Acta in 2004. The report
provides a graphical representation of your labs bias and CV for a lot
number of Bio-Rad control product. On the chart, your monthly CV is
represented as a bar and your bias is represented as a diamond with lines
connecting each diamond.
Using the Report
The Bias and Imprecision Histogram Report is intended for labs to detect
changes in performance over time, and to identify whether the change in
performance is due to imprecision, bias, or both. Although it can be used to
detect aberrant CVs or bias, this Bias and Imprecision Histogram Report does
not contain specific thresholds for allowable bias or allowable imprecision.
The primary use of this report is to detect changes in performance over
time. The determination of whether a shift in performance is meaningful or
problematic can be made from other metrics, including the SDI or CVR
provided on the Lab Comparison Report or by using biological variation
values for allowable bias and imprecision.
Example Report
183
Data Rejection Report

The Data Rejection Report identifies data that has been excluded from the
Unity Interlaboratory database. Rejected data points are not included in
cumulative statistics or statistical comparisons.
Data points may be rejected for two reasons:
They lie outside the standard statistical window, based on consensus

group mean or CV.
They were reported using an incorrect code (i.e. invalid units, invalid
method, etc.)
The Unity Interlaboratory Program excludes customer data that is outside of

a standard statistical window based on the previous months consensus
group standard deviation and SD.
Limits for means

Mean < 5.0The allowable statistical window is 4 standard deviations from
last month's consensus group cumulative mean.
Mean > 5.0 The allowable statistical window is 3 standard deviations from
last month's consensus group cumulative mean.
Limits for CVs

When your CV is > 40%, data will be rejected.
When your CV is < 40%, data will be accepted. The window of acceptable
values appears below the rejected values on the report.
The CV limit may be different for selected analytes.
184
Example Report
Optional Interlaboratory Reports

Worldwide Report
The Worldwide Report is a specialized report that is available on QCNet.com
or by special request. (Contact your Bio-Rad software support
representative for a copy of this report). This report includes all peer and
method group statistics and is, therefore, a simplification of the Laboratory
Comparison Report, which also includes your laboratorys statistics.
This comprehensive report includes all tests (including all instruments, all
methods, etc.) reported to the Unity Interlaboratory Program by all labs
reporting for the same lot number. This report includes monthly and
cumulative statistics (Mean, SD, CV, number of points, and number of labs)
for each level of control.
Using the Report

This report can be used as a reference, for example, when evaluating a new
instrument or kit.
185
Example Report
Manufacturer Report
The Manufacturer Report is a type of Worldwide Report that is further
separated by instrument manufacturer. This report can be used as a
reference, for example, when evaluating a new instrument or kit.
Example Report
186
Statistical Profile Report

You must contact your Bio-Rad software support representative to request
this quarterly report.
The Statistical Profile Report allows you to compare your laboratorys
statistics to the peer, method, and all lab statistics for selected time
periods. The Statistical Profile Report also provides two histograms that
summarize where your labs Mean and CV values fall with respect to the
Range of Mean and Range of CV values calculated for each desired
consensus group.
Sections of the Statistical Profile Report

The Statistical Profile Report has four major sections:
A table displaying your labs 2SD and 3SD range for this quarter and last
quarter.
A table displaying your labs and your consensus group and summary
statistics for this quarter and last quarter.
Histograms showing the location of your labs mean plotted on the

range of means for all labs in the consensus group and your labs CV
plotted on the range of CVs for all labs in the consensus group.
A Percentile Distribution table includes the following peer, method, and

all lab statistics for this quarter and last quarter: absolute bias, SD, and
CV.
The Unity Interlaboratory Program excludes labs that report fewer than 6
data points during the quarter from the percentile distribution.
Your Lab's Two and Three SD Ranges

The following figure shows the Statistical Profile Report header, disclaimer,
and your lab's 2SD and 3SD ranges for this quarter and last quarter.
187
Summary Statistics
The following figure shows the Statistical Profile Report summary statistics
table for your laboratory and Bio-Rad's three consensus groups (peer,
method, and all labs).
Histograms
The frequency histogram section of the Statistical Profile Report contains
two frequency histograms:
Lab means for this quarter.
Lab CVs for this quarter.
On both histograms, an arrow indicates your lab's value (mean or CV).
188
Percentile Distribution Table
Affiliated Reports
Affiliated reports allow a group of labs to compare their resultsessentially
becoming their own consensus group. It is likely that an affiliated group SDI
and CVR will be different (probably smaller) than Bio-Rad peer groups
because your affiliated group has "more in common" than the peer
consensus group. For example, your affiliated group may be using the same
reagent or calibrator lots.
Contact your Bio-Rad software support representative to request these
reports.
The Unity Interlaboratory Program provides the following affiliated reports:
Affiliated Laboratory Comparison Report (on page 190)
Affiliated Laboratory Comparison Report-Abbreviated Summary

(see "Affiliated Laboratory Comparison Report: Abbreviated Summary"
on page 190)
Affiliated Exception Report (see "Affiliated Data Exception Report" on

page 192)
189
Affiliated Laboratory Comparison Report

The Affiliated Laboratory Comparison Report summarizes the performance
of each participating affiliated laboratory in a single report and is designed
for the quality control coordinator or the laboratory manager responsible
for multi-site quality control performance. Each site (participating affiliated
lab, quality control coordinator, lab manager) may request to receive a
copy of the report. This report is also useful for comparing multiple
instruments made by the same manufacturer within a laboratory site.
This report includes statistics generated for all tests reported to the Unity
Interlaboratory Program by all affiliated labs. Monthly and cumulative
statistics are provided for each level of control. Statistics provided for your
affiliated laboratory/all affiliated laboratories include the mean, standard
deviation (SD), coefficient of variation (CV), and the number of points used
to calculate your laboratorys/all affiliated laboratory statistics
respectively. This report allows you to statistically compare through
calculation of a CVR and SDI your laboratorys results to your Worldwide
Peer Group (a.k.a. Peer Group); to statistically compare your laboratorys
results (CVR, SDI) to your Worldwide Affiliated Lab Group (a.k.a. Lab
Group); and to statistically compare your Worldwide Affiliated Lab Group
results to the Worldwide Peer Group. If you are a laboratory that reports
results in both Conventional and SI units, you can request that the report
appear in one or the other units, rather than a mixture of both.
The contents and layout of the report are similar to the Affiliated
Laboratory Comparison Report: Abbreviated Summary as shown in the
Example Report (on page 192).
Affiliated Laboratory Comparison Report:

Abbreviated Summary
The Affiliated Laboratory Comparison Report: Abbreviated Summary is a
simplified version of the Affiliated Laboratory Comparison Report (on
page 190). This report is designed for quick review and focuses on key
statistics to provide a performance summary for multiple lab numbers.
This report, which is organized by analyte, lists statistics for all affiliated
labs for all tests reported to the Unity Interlaboratory Program for each
level of control and allows you to compare your laboratorys statistics to
those statistics obtained for all affiliated laboratories. For each test, the
report contains the:
190
Lab mean
Lab SD
Lab CV
Number of Points the lab reported
CVR for the Peer, Method, and Affiliated groups
SDI for the Peer, Method, and Affiliated groups
The following additional information appears for the Peer, Method, and
Affiliated groups:
Mean
SD
CV
Number of points reported
Number of labs reporting
Using the Affiliated Laboratory Comparison Report:

Abbreviated Summary Report
The Affiliated Laboratory Comparison Report: Abbreviated Summary is a
specialized report available only by request. Contact your Bio-Rad software
support representative to activate this report for your lab group.
This report summarizes the performance of each participating affiliated
laboratory in a single report and is designed for the quality control
coordinator or the laboratory manager responsible for multi-site quality
control.
Each site (participating affiliated lab, quality control coordinator, lab
manager) wishing to receive this report is assigned a unique lab number,
and each site receives its own set of reports. This report is also useful for
multiple instruments made by the same manufacturer.
This report provides the CVR and SDI for the peer, method, and affiliated
group, which allows you to statistically compare your lab to each of these
groups.
If your laboratory reports results in both Conventional and SI units, you can
request that the report appear in either SI or Conventional units, rather
than a mixture of both.
191
Example Report
Affiliated Data Exception Report

The Affiliated Data Exception Report, in combination with the Affiliated
Data Reports, is ideal for laboratory managers or quality control
coordinators who either manage multiple lab sites and/or multiple
instruments of the same make and model.
For all laboratories within the affiliated lab group, this report lists any
analyte that:
192
Exceeds specified SDI or CVR warning limits compared to the consensus

group.
Is rejected by a Unity Interlaboratory Program data filter.
Contains a suspected coding error.
Example Report
Urinalysis Reports
If you submit data for a Bio-Rad urinalysis product to the Unity
Interlaboratory Program, you will receive a qualitative report that consists
of a:
193
Cover page
Dual level chemistry report for each instrument submitted
Dual level microscopy report for each data entry set submitted
The Urinalysis Report can display only one set of results per day. If you
submit multiple sets, this report include(s) 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.
The complete report includes leukocytes, nitrite, urobilinogen, protein, pH,
blood, specific gravity, ketone, bilirubin, glucose, and hCG.
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.
194
The following figure shows a portion of the report. The complete report
includes RBC, WBC, and crystals.
195
H A P T E R
18
Regulatory Requirements
and Reports
In This Chapter
CLIA Requirements ..................................................... 197
Accreditation Requirements (Paraphrased) ........................ 201
ISO 15189 ................................................................ 210
Overview of Regulatory Requirements and

Reports
Bio-Rad offers an extensive set of instant (on demand) and monthly
interlaboratory reports that can help you meet regulatory requirements.
Comparing your data with that of other labs worldwide is a major benefit of
Bio-Rads Unity Interlaboratory Program. The Unity Interlaboratory reports
include, but are not limited to the following: Monthly Evaluation Report,
Laboratory Performance Overview Report, Laboratory Comparison Report,
Laboratory Histogram, Bias and Imprecision Histogram Report, and the Data
Rejection Report. The following optional Unity Interlaboratory reports are
also available by request: Worldwide Report and Manufacturer Report,
Statistical Profile Report, Affiliated Report, Affiliated Laboratory
Comparison Report, Affiliated Exception Report, and Urinalysis Report.
Unity Real Time also offers local charts and reports that help meet
regulatory requirements as well.
The following table outlines the available charts and reports and their
recommended use under CLIA, CAP, and ISO 15189.
CLIA Requirements
Have a record of
test system
performance
Monitor the
accuracy of the
analytical process
Monitor the
precision of the
analytical process
Detect
immediate
errors
InstantQC Analyte
Report
InstantQC LJ WebChart
Unity Affiliated Data

Exception Report
Unity Affiliated
Laboratory Comparison
Reports
Unity Bias &

Imprecision Histogram
Unity Data Rejection

Report
Unity Laboratory
Comparison Report
Unity Laboratory
Histogram
Unity Laboratory
Performance Overview
Unity Monthly
Evaluation
Unity Statistical Profile
Unity Real Time Data

Review Report
Unity Real Time Levey

Jennings Charts
Unity Real Time

Operator Report
Unity Real Time Point

Data Report
Unity Real Time

Summary Data Report
Unity Real Time

Supervisor's Report
z
z
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.
198
Establish or
verify the
criteria for
acceptability
of all control
materials
InstantQC Analyte
Report
InstantQC LJ
WebChart
Establish
statistical
parameters for
each batch and lot
number of control
materials
Document
all control
procedures
performed
Document that at least

once each day patient
specimens are assayed or
examined, test two
control materials of
different concentrations
z
z
Unity Affiliated
Data Exception
Report
Unity Affiliated
Laboratory
Comparison Reports
Unity Bias &
Imprecision
Histogram
Unity Data
Rejection Report
Unity Laboratory
Comparison Report
Unity Laboratory
Histogram
Unity Laboratory
Performance
Overview
Unity Monthly
Evaluation
Unity Statistical
Profile
Unity Real Time

Data Review Report
Unity Real Time
Levey Jennings
Charts
Unity Real Time

Operator Report
Unity Real Time
Point Data Report
Unity Real Time
Summary Data
Report
Unity Real Time

Supervisor's Report
199
For blood gas analyses,

document that one sample
of control material is
tested each 8 hours of
testing using a combination
of control materials that
include both low and high
values on each day of
testing
Evaluate and define the

relationship between test
results for the same
analyte using different
methodologies,
instruments, or testing
sites
Document all
corrective
actions taken as
a result of QC
InstantQC Analyte
Report
Exception Report
Unity Affiliated
Reports
Unity Bias &

Report
Unity Laboratory
Comparison Report
Unity Laboratory
Histogram
Unity Laboratory
Unity Monthly
Evaluation

Review Report

Jennings Charts
Unity Real Time
Operator Report
Data Report
Unity Real Time
Summary Data Report
Unity Real Time
Supervisor's Report
200
Document all
analytic
systems
assessment
activities
Document that, over

time, control material
testing is rotated
among all operators
who perform the test
Document that control material

testing is performed after a
complete change of reagent,
major preventive maintenance,
or when any critical part is
replaced
InstantQC Analyte
Report
Exception Report
Unity Affiliated
Reports
Unity Bias &

Report
Unity Laboratory
Comparison Report
Unity Laboratory
Histogram
Unity Laboratory
Unity Monthly
Evaluation

Review Report

Jennings Charts
Unity Real Time

Operator Report
Data Report
Unity Real Time

Summary Data Report
Unity Real Time
Supervisor's Report
201
Accreditation Requirements (Paraphrased)

Document validation
of new reagent lots
or shipments of
reagents
Document calibration or
recalibration when controls
fail to meet established
criteria
Use data to make

changes to improve
performance and
patient safety
InstantQC Analyte
Report

Exception Report
Unity Affiliated
Reports
Unity Bias &


Report
Unity Laboratory
Comparison Report
Unity Laboratory
Histogram
Unity Laboratory
Unity Monthly
Evaluation

Review Report

Jennings Charts
Unity Real Time

Operator Report

Data Report
Unity Real Time

Summary Data Report
Unity Real Time

Supervisor's Report
z
z
Extracted and paraphrased from requirements published by the College of

American Pathologists and the Joint Commission on Accreditation of
Healthcare Organizations.
202
For quantitative tests,

document use of
control materials at
more than one
concentration (level) at
least daily
For numeric QC data,

document calculation of
QC statistics at specified
intervals to define
analytic imprecision
InstantQC Analyte
Report
Demonstrate that
QC and instrument
maintenance are
performed and
evaluated
z
z

Exception Report
Unity Affiliated
Reports
Unity Bias &


Report
Unity Laboratory
Comparison Report
Unity Laboratory
Histogram
Unity Laboratory
Unity Monthly
Evaluation

Review Report

Jennings Charts
Unity Real Time

Operator Report
Data Report
Unity Real Time

Summary Data Report
Unity Real Time

Supervisor's Report
z
z
z
203
Document
verification results
of controls for
acceptability before
reporting patient
test results
For hematology, document

testing of two different
stabilized control
specimens and record
results during each 24
hours of analyzer use
InstantQC Analyte
Report
If commercially
assayed controls are
used for hematology
instruments, verify
the target values
(mean and QC ranges)
z

Exception Report
Unity Affiliated
Reports
Unity Bias &
Report
Unity Laboratory
Comparison Report
Unity Laboratory
Histogram
Unity Laboratory
Unity Monthly
Evaluation

Review Report

Jennings Charts
Unity Real Time

Operator Report
Data Report
z
z
Unity Real Time

Summary Data Report
Unity Real Time
Supervisor's Report
204
z
z
If unassayed controls are

used in hematology,
establish a statistically valid
target mean and range for
each lot by repetitive
analysis
InstantQC Analyte
Report
Fully define and document

tolerance limits (numeric
and non-numeric) for all
hematology and
coagulation control
procedures
Monitor
precision
data for
significant
changes
z
z

Exception Report
Unity Affiliated
Reports
Unity Bias &


Report
Unity Laboratory
Comparison Report
Unity Laboratory
Histogram
Unity Laboratory
Unity Monthly
Evaluation

Review Report

Jennings Charts
Unity Real Time

Operator Report

Data Report
z
z
Unity Real Time

Summary Data Report
Unity Real Time

Supervisor's Report
205
Document
review and
assessment of
quality control
data at least
monthly
InstantQC Analyte
Report

Exception Report
Unity Affiliated
Reports
Unity Bias &


Report
Unity Laboratory
Comparison Report
Unity Laboratory
Histogram
Unity Laboratory
Unity Monthly
Evaluation
Verify
manufacturer's
calibrations
with control
materials
appropriate for
the system
Document that the photo-optical

coagulation testing system (for PT,
aPTT, etc.) is checked with two
different levels of control material
during each 8 hours of patient testing
and each time there is a change in
reagents
Unity Statistical Profile z

Review Report
Jennings Charts
Unity Real Time

Operator Report
Data Report
Unity Real Time

Summary Data Report
Unity Real Time

Supervisor's Report
206
Document that the manual

coagulation system is checked
with 2 different levels of
control material in duplicate
during each 8 hours of patient
testing and each time there is
a change of reagents
Document ongoing
evaluation of (QC)
records,
instrument
maintenance and
function,
temperature, etc.
InstantQC Analyte
Report
Organize and
present QC data so
that it can be
evaluated daily by
the technical staff
to detect problems,
trends, etc.
z

Exception Report
Unity Affiliated
Reports
Unity Bias &
Report
Unity Laboratory
Comparison Report
Unity Laboratory
Histogram
Unity Laboratory
Unity Monthly
Evaluation

Review Report

Jennings Charts
z
z
Unity Real Time

Operator Report
Data Report
Unity Real Time

Summary Data Report
Unity Real Time
Supervisor's Report
207
Document that at least 1

quality control specimen
for pH, pCO2, and pO2
(tonometered sample or
liquid control material) is
tested at least every 8
hours of operation when
patient specimens are
tested
Document that
control
materials for
pH, pCO2, and
pO2 represent
both high and
low values on
each day of
patient testing
InstantQC Analyte
Report
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

Exception Report
Unity Affiliated
Reports
Unity Bias &
Report
Unity Laboratory
Comparison Report
Unity Laboratory
Histogram
Unity Laboratory
Unity Monthly
Evaluation
Review Report

Jennings Charts
Unity Real Time

Operator Report
Data Report
Unity Real Time

Supervisor's Report
208
Unity Real Time

Summary Data Report
Document the review for

acceptability of quality
control results
Collect and analyze

Use data to
pertinent data to monitor identify
and assess performance
unwanted trends
InstantQC Analyte
Report

Exception Report
Unity Affiliated
Reports

Report
Unity Laboratory
Comparison Report
Unity Laboratory
Histogram
Unity Bias &

Unity Laboratory
Unity Monthly
Evaluation

Review Report

Jennings Charts
Unity Real Time

Operator Report

Data Report
Unity Real Time

Summary Data Report
Unity Real Time

Supervisor's Report
209
ISO 15189
Design internal quality control
systems to verify the intended
quality of results
Provide staff members with clear and

easily understood information on
which to base technical and medical
decisions
InstantQC Analyte
Report

Exception Report
Unity Affiliated
Reports
Unity Bias &


Report
Unity Laboratory
Comparison Report
Unity Laboratory
Histogram
Unity Laboratory
Unity Monthly
Evaluation

Review Report

Jennings Charts
Unity Real Time

Operator Report

Data Report
Unity Real Time

Summary Data Report
Unity Real Time

Supervisor's Report
210
H A P T E R
19
Unity Desktop Database

Basics
In This Chapter
Database Basics ......................................................... 211
Updating Database Information ...................................... 211
Archive and Restore .................................................... 213
Condensing Data ........................................................ 214
Reconciling Your Database ............................................ 215
Database Basics
The Unity Desktop installation creates a single Microsoft Access
database named QCDAO.MDB on your local hard drive. If you would like to
use multiple databases, contact your Bio-Rad software support
representative as you may want to upgrade to Unity Real Time.
Updating Database Information

Bio-Rad continually updates Unity Desktop program information including:
Code list information

At least monthly, Bio-Rad updates its code list, which contains the
latest lot numbers, analytes, instruments/kits, reagents, methods,
units, and temperature. You should periodically update your code list
information, especially before adding lots or tests.
Instrument Setup information
You can specify to automatically update code list and instrument setup
information from the "Setup" dialog box as described in Database Updates
(on page 224). Alternatively, you can update this information manually.
To view the dates of your last database update, choose Help | About Unity
Desktop. The "About Unity Desktop" dialog box displays a list of database
items and their revision dates.
Manual Database Updates

If you choose not to activate Automatic Database Updates, you can
manually download the information using an Internet Service Provider (ISP)
or by requesting a CD from your Bio-Rad software support representative.
To Download Database Information

1
Go to the computer where the database is installed.
Log in as a user with permission to communicate with the Unity

Close any open date entry screens.
Choose Tools | Unity Interlab | Send/Receive Data.
Click the "Receive data" option button.
Select the check boxes for the items you need to download. (You can
select any combination of the check boxes.)
Receive code list
Receive Analytical Goal's information
Receive instrument setup
Unity Desktop will check for any available updates and install them.
This search may take several minutes, depending on your download
speed. To decrease download times, you might want to download the
items separately.
7
Click OK when a message appears stating that the update has

completed.
To Install Database Information from a CD

If you do not have an ISP or you find download time unacceptably long, you
can request a CD from your Bio-Rad software support representative or local
Bio-Rad office. The CD will contain code list, analytical goal, and instrument
setup information. To install the CD information, complete the following
steps:
1
212
Copy the CD-ROM to your local hard drive or network, if desired.

Go to the computer where the database is installed.
Close all open data entry windows.
Choose Tools | Unity Interlab | Update Database.

The "Update Database Information" dialog box displays on the screen.
Select Code lists, analytical goals, and/or Instrument setup.
Click the "Information source folder" ellipsis (...), and navigate to your
CD-ROM drive or to the folder where you copied the information.
Click OK. Unity Desktop updates your program information.
Backup and Restore

Overview
You can backup Unity Desktop to your local hard disk drive, to a network
drive or to a removable disk drive. You cannot backup to diskettes because
of the size of the database. We suggest that you backup before adding new
labs, lots, or tests. Before upgrading Unity Desktop or installing a Service
Pack, you should backup your existing database.
Restoring the database to the default location overwrites any existing
data. Data entered after the backup was created will be lost.
To Backup Your Database

1
Use the Microsoft Windows Explorer to browse to your database folder

location. If you installed the Unity Desktop database to the default
location, it will be "C:\Program Files\Bio-Rad Laboratories\Unity
Desktop\Database".
Copy the QCDAO.MDB file to a separate location. It is recommended

that this separate location is not on your local hard disc drive; this
location should be a network folder or a compact disc, in the event that
your local hard disc develops challenges.
To Restore Your Database

1
Copy your backup file to the default location.
213
An alternate solution is to change the database location at login. Click

the Change button on the login screen and browse to your backup file
location.
Log in to Unity Desktop and enter any data since you backed up your
database.
You must have "read/write" access to the database location. If you saved
your database backup to a network folder, you must have "read/write"
permission to the network folder. If you saved your database backup to a
compact disc, the file will be "read-only"; you must copy the database
file to your local hard disc drive or to a network folder.
Condensing Data
Condense data converts individual point data entries for each calendar
month into a single summarized entry. Users who enter point data can elect
to condense data to conserve disk space. Condensed data points are
removed from the Point Data Entry tab of the data entry screen and are
added to the Summary Data Entry tab. You can condense data from the
"Lab", "Lot" or "Test" dialog boxes or choose Tools | Utilities | Condense All Labs
to condense all data in the current database.
Once you have condensed a group of data points, you cannot retrieve the
individual data points. Therefore, you might want to export the data to
another application before condensing it. See Exporting Data (on page
152).
The condense procedure DOES NOT change the monthly summarized data
values; therefore, it is not necessary to retransmit condensed data to BioRad.
To Condense Data by Lab, Lot, or Test

Condensed data is NOT reversible!
1
Log in as a user with permission to condense data.
Determine the scope of the data you want to condense and click the
appropriate icon (lab, lot, or test) on the toolbar.
Click Condense. The "Condense Data" dialog box displays.
214
Choose a start and end date for the range of data you want to
condense.
Click OK. The program displays the message: Individual data points will
be reduced to a single summarized point. This operation is NOT
reversible. Do you want to continue?
Click Yes to continue or No to cancel.
To Condense Data for All Labs

1
Log in as a user with permission to condense data.
Choose Tools | Utilities | Condense All Labs. The "Condense Data" dialog box
displays.
Choose a start and end date for the range of data you want to
condense.
Click OK. The program displays the message: Individual data points will
be reduced to a single summarized point. This operation is NOT
reversible. Do you want to continue?
Click Yes to continue or No to cancel.
Reconciling Your Database

The Reconcile feature creates a transmission file that includes all quality
control data currently on the Unity Desktop workstation and is used to send
quality control data to Bio-Rad if a transmission file is lost. You can
reconcile data for a lab number, lot number, or all labs in the database.
When you reconcile, the transmission file created replaces any existing data
in the Unity Interlaboratory Program with its data.
Use the reconcile feature only upon request from your Bio-Rad software
support representative. This feature is not intended for routine use. Your
Bio-Rad software support representative will give you instructions if you are
requested to perform a reconcile.
Use Reconcile only when requested to do so by your Bio-Rad software
215
H A P T E R
20

In This Chapter
Before You Begin ....................................................... 217
Installation............................................................... 217
Activation Keys and Licensing ........................................ 218
Upgrading to Unity Desktop ........................................... 220
The Setup Dialog Box................................................... 222
Changing the Main Screen Graphics.................................. 226
Before You Begin

Before you install Unity Desktop, please take a few minutes to complete
the following steps:
1
Create a backup or archive of any data in an earlier Bio-Rad QC

software such as Unity PC, Unity Plus/Pro, or QC OnCall.
Verify that your computer meets the Unity Desktop system

requirements.
Installation
1
Insert the Unity Desktop CD into your CD-ROM drive. The Choose
Setup Language dialog box appears.
Select a language from the drop-down list and click OK.
Wait while setup prepares the InstallShield Wizard and configures the
Microsoft .NET Framework. A welcome message displays.
Click Next to continue the installation.
Click Yes to accept the license agreement. (If you click No, the
installation will stop.)
Select your country from the list of available countries and click Next.
If your country does not appear, please contact your Bio-Rad software
support representative. The Choose Destination Location dialog box
appears.
Leave the default location (C:\Program Files\Bio-Rad

Laboratories\Unity Desktop) selected and click Next. The
Select Program Folder appears.
Leave the default folder (Bio-Rad Laboratories) selected and click

Next.
Wait while Unity Desktop configures your new software installation.
10 Click Yes when prompted to create a shortcut on the desktop.

11 Wait while your component registration is updated. A message appears
that installation is complete.
12 Click Finish.

Unity Desktop uses an Activation Key to enforce license periods, to restrict
access to program functions, to control the number of users, and to control
the number of databases the user can use.
If you have more users or databases than are visible on your Unity
Desktop drop-down menus, please contact your Bio-Rad software support
representative to obtain a new activation key.
Activation Keys
Unity Desktop installation automatically provides a 60-day trial period for
all license types. During this trial period, all license types have access to all
program features, except the Westgard Advisor. However, at some time
during the trial period, you must obtain and enter your Activation Key:
218
If you have not entered your activation key when 15 days remain in
your trial period, the program will begin to warn you that your trial
period is going to expire and that you should contact Bio-Rad
Laboratories for an activation key.
If you do not enter your activation key before the end of your 60-day
trial period, you will not be able to use Unity Desktop until you enter it.
You can update your activation key from the "Update Activation Key" dialog
box (Tools | Security | Update Activation Key).
Updating Your Activation Key

To Obtain an Activation Key
1
Choose Tools | Security | Update Activation Key, and make a note of the
serial key.
If you plan to email Bio-Rad, you can copy (Ctrl+C) the serial key and
paste (Ctrl+V) it into your email message.
Have your purchase order number available.
Contact Bio-Rad Laboratories by using one of the following methods:
Phoning technical support at (949) 598-1300 or 1-800-854-6737,

extension 1300.
Sending an email to UNITY_Support@Bio-Rad.com (include your

Serial Key and purchase order number).
Contacting your local Bio-Rad office.
To Enter Your Activation Key

1
Contact Bio-Rad to obtain your activation key. (If you email us for your
activation key, you can use the shortcut keys Ctrl+C to copy the Serial
Key from the "Update Activation Key" dialog box. Then use Ctrl+V to
paste it into your email.)
Choose Tools | Security | Update Activation Key.
Type the activation key, or copy and paste it from your email.
Click OK.
219
Licensing
You must accept the Unity Desktop license agreement (see "License,
Warranty, and Trademark Information" on page 245) to complete the
installation process. In addition, you agree to the license each time you log
in to Unity Desktop.
To determine your license type and period, choose Tools | Security | Update
Activation Key. The screen displays the "Update Activation Key" dialog box,
which contains your license type and license period.
Each time you start Unity Desktop, your license expiration date appears in
the "Login" dialog box.
Upgrading to Unity Desktop

When you begin using Unity Desktop, you may want to include data from a
previous Bio-Rad QC software (e.g. QC OnCall, Unity Plus/Pro, Unity PC,
or Unity Post).
Upgrading from QC OnCall, Unity Plus/Pro, or

Unity-PC
It is not possible to convert data in QC OnCall, Unity Plus/Pro, or UnityPC directly into Unity Desktop; however, you have two options for
bringing your historical data into the program:
Export the data from QC OnCall, Unity Plus/Pro, or Unity-PC, and then
import it into Unity Desktop. This strategy will preserve your point
data.
Contact Bio-Rad and request an import file containing your historical

data from the Unity Interlaboratory Program. Because the Unity
Interlaboratory Program contains only your summarized data, any point
data will have been condensed to a monthly mean, SD, and number of
points. You should also use this option if you have submitted data from
Unity Post.
To prevent out-of-sequence errors, do not enter any new data until after
you import your historical data.
220
Upgrading From Unity Post

Contact Bio-Rad and request an import file containing your historical data
from the Unity Interlaboratory Program. Because the Unity Interlaboratory
Program contains only your summarized data, any point data will have been
condensed to a monthly mean, SD, and number of points. See Steps to
Import Historical Data for instruction on using the import file.
To prevent out-of-sequence errors, DO NOT enter any new data until
after you import your historical data.
Steps to Import Historical Data

1
Export Data from QC OnCall, Unity Plus/Pro, or Unity-PC

Follow the instructions for the software being sure to export the data as
an import file.
This step is not necessary if you are using an import file from the Unity
Create an archive or backup of your existing data

Your existing QC OnCall, Unity Plus/Pro, or Unity-PC data is not
affected by the Unity Desktop installation. However, it is always a good
idea to create an archive or backup of your data before installing any
new software.
Install Unity Desktop
Create the lab numbers in the import file within Unity Desktop
You must create lab numbers in the import file manually. Unity Desktop
will reject any data from lab numbers that are not defined in its
database. See Adding and Updating Labs (on page 70).
Select the "Create new lots if necessary" check box in the Import Dialog box
From within Unity Desktop, press F12 to display the "Import" dialog
box.
Select (check) the "Create new lots if necessary" check box so that
Unity Desktop will automatically create the unexpired lots in your
import file.
Notice that the "Create new tests if necessary" check box is
selected by default so that Unity Desktop will also create tests for
you. See Import Check Boxes (on page 146) for a more detailed
discussion of available import features.
221
Start the import process
While still in the "Import" dialog box, click Start.

Import data into Unity Desktop
Place a copy of the import file into the InstrumentImport folder.

The default location is:
C:\Program Files\Bio-Rad Laboratories\Unity
Desktop\InstrumentImport
Unity Desktop will automatically import the file and write any data it
cannot import to the rejection log.
Data from expired lots will not be imported because Unity Desktop
cannot create these lot numbers.
The Setup Dialog Box

Once you have installed Unity Desktop, you should access the Setup
dialog box (Tools | Setup) and take a few minutes to personalize your
program. Unity Desktop allows you to specify several setup/configuration
items.
You can use Unity Desktop without changing any settings/configurations
the software will simply use the default selections.
The Setup dialog box has two tabs:
222
Configure Unity DesktopFrom this tab, you customize how the software
operates. Users with permission to edit the setup options can edit the
following using this tab:
Data entry configuration
Database updates
Notifications
Reports
Transmission
Internet Service Provider
ReportsFrom this tab, you specify which Unity Interlaboratory

Reports are generated for your lab, their frequency, units (SI or
Conventional), and language. (By default, your reports will be in the
language you selected when installing Unity Desktop.)
All selections you make from the Setup dialog box are globalThey apply
throughout the program.
The Configure Unity Desktop Tab

Data Entry Configuration
The "Data entry configuration" section of the "Setup" dialog box allows you
to choose options for:
Current dataYour selection here controls the summary statistics

display on the point/summary data screen.
If you select Month, the summary statistics will be those for the
current calendar month plus your cumulative statistics. Month is
the default selection.
If you select Group, the summary statistics will be those for the
current data group plus your cumulative statistics.
You can also toggle between the Month and Group displays by selecting and
clearing the "Group" check box on the point/summary data screen.
Default data entry modeselect an option to determine which tab

(Point or Summary) of the point/summary data screen appears by
default when you open data entry for a quantitative test.
Select Point if you most frequently enter or import point data.

(Point is the default selection.)
Select Summary if you most frequently enter or import summary

data.
For details, see Specifying a Default Data Entry Mode (on page
112).
Actions and Comments

The "Actions/comments" section of the "Setup" dialog box contains three
check boxes:
223
Automatic action logs

Select this check box if you would like the "Action" dialog box to
automatically appear each time you manually enter a point that
violates an active QC rule.
Require action logs

When you select the "Automatic action logs" check box, the "Require
action logs" dialog box becomes available. If you select this check box,
users will not be able to close the "Action" dialog box without appending
an action.
None of these check boxes is selected by default. You must select them
to activate the features.
Database Updates
You must have Internet access in order to utilize these features.
The "Database updates" section of the "Setup" dialog box contains check
boxes to control the following:
Automatic code list updates
Automatic instrument setup updates
When you select one of these check boxes, Unity Desktop will automatically
update the selected item when the files are updated in the Unity
Interlaboratory Program. Selecting these check boxes ensures that you
always have the most up-to-date information.
None of these dialog boxes are selected by default. You must select them to
activate this feature.
If you choose not to activate the database update check boxes, you should
periodically update the files you use as described in Updating Database
Information (on page 211). Everyone should regularly update their code list
files; however, if you do not use analytical goals or instrument setup, you
might choose not to update these files.
Notifications
The "Notifications" section of the "Setup" dialog box contains a single check
box that controls whether or not Unity Desktop displays a message each
time you open data entry for a test in a lot that will expire in 30 or fewer
days. Select the "Do not display this message again" check box to stop the
message.
224
Reports
The "Reports" section of the "Setup" dialog box contains the "Generate PDF
reports" check box. If you select this check box, Unity Desktop will generate
intralaboratory reports as Adobe Acrobat PDF files. These files can be saved
and read using the free Acrobat Reader. If you leave the check box
unselected, Unity Desktop will generate reports that can be printed or
exported to a file using Crystal Report *.rpt format.
Transmission
The "Transmission" section of the "Setup" dialog box has two check boxes:
Automatic monthly transmission

This check box controls whether or not monthly data is automatically
transmitted on a day of the month you select. See To Activate
Automatic Monthly Transmission (see "To Activate Automatic Monthly
Transmission for Monthly Unity" on page 174).
Internet Service Provider

This area displays the IP address of the Bio-Rad server you are transmitting
to.
DO NOT remove or change the displayed IP address unless instructed to
do so by your system administrator.
Unity Interlaboratory Reports Tab

From the "Unity Interlab Reports" tab, you specify which Unity
Interlaboratory Reports are generated for your lab, their frequency, and
language. (By default, your reports will be in the language you selected
when installing Unity Desktop.)
For the following reports, you can specify the frequency as monthly,
quarterly, or never:
Laboratory Performance Overview
Laboratory Histogram
225
Changing the Main Screen Graphics

Once you start the software, you will notice the landscape scenes that
appear on the main screen. The software comes with several graphics files
that it displays in this area. Most users will probably want to keep the
original graphics. However, you can replace the graphics with other files.
You might want to use your company logo or pictures from your National
Lab Week celebration.
To Change the Main Screen Graphics

If you want to save the original graphics, rename them or move them to
a different folder before beginning this procedure.
This procedure affects only the graphics on the machine where you replace
the original graphics. The graphics on other machine are not changed. You
must exit and restart Unity Desktop to begin using the new graphics.
To Use Different Main Screen Graphics

1
Create six JPEG files and name them backgrd1 through backgrd6.
(These are the file names the software looks for when displaying the
main screen graphic.)
Right-click the Windows Start button and select EXPLORER from the popup menu.
Browse to C:\Program Files\Bio-Rad Laboratories\Unity

Desktop\Bitmaps. If you have not removed or renamed the files, the
folder will contain 6 JPEG files named backgrd1 through backgrd6.
Drag the new files you created into the Bitmaps folder.
If the Bitmaps folder contains files with the same names, the software
asks if you want to overwrite the existing files with the new ones. Click
OK to overwrite the files.
To Use No Main Screen Graphic

Follow this procedure if you want no graphic to appear on the main screen.
This procedure will display a blank white screen.
226

Desktop\Bitmaps.
Delete all the graphics files in the folder.
To Use a Single Main Screen Graphic

Follow this procedure if you want the same graphic to always appear on the
main screen.
1
Choose the JPEG file you want to use and create a total of 6 copies of
it.
Name the copies backgrd1 through backgrd6. (These are the file
names the software looks for when displaying the main screen graphic.)
Right-click the Windows Start button and select EXPLORER from the popup menu.

Desktop\Bitmaps. If you have not removed or renamed the files, the
folder will contain 6 JPEG files named backgrd1 through backgrd6.
Drag the new files you created into the Bitmaps folder.
If the Bitmaps folder contains files with the same names, the software
asks if you want to overwrite the existing files with the new ones. Click
OK to overwrite the files.
227
H A P T E R
21
Windows Hints
If you are entirely new to Windows-based programs, the hints in this
chapter may be helpful to you. These hints are just to get you started
and not intended to replace documentation provided by Microsoft.
In This Chapter
Tree Views ............................................................... 229
Command Buttons ...................................................... 229
Check Boxes and Option Buttons ..................................... 230
Selecting Items in Lists ................................................ 231
Available/Unavailable Items .......................................... 232
Drag-and-Drop Sorting ................................................. 232
Paging Arrows ........................................................... 233
Using Calendars ......................................................... 233
Creating Shortcuts ...................................................... 234
Setting a Short Date Format .......................................... 234
Removing Unity Desktop ............................................... 235
Tree Views
Items in a tree can be collapsed or expanded. Collapsed items are indicated
by a plus sign (+). Expanded items are indicated by a minus sign (-). Doubleclick a collapsed item to expand it.
Command Buttons
Common Command Buttons
When you click a command button, you are telling the software to perform
an action (e.g. execute a command). The most common command buttons
are:
OKClick to save your changes and close the dialog box.
CancelClick to ignore your changes and close the dialog box.
ApplyClick to save your changes and leave the dialog box open.
Default Command Buttons

Default command buttons are surrounded by a bold border. If you press
Enter on the keyboard, the program performs the action specified by the
default command button.
In the following figure, pressing Enter will send data to Bio-Rad because OK
is the default command button.
Unavailable Command Buttons

As described in Available/Unavailable Items (on page 232), command
buttons appear dimmed when they are unavailable.
Check Boxes and Option Buttons

Check boxes generally represent a list of choices. You can select any
combination of the available check boxes. Click a cleared (unchecked)
check box to select it. Click the check box again to clear it.
230
Windows Hints
Option buttons allow you to choose only one of the available options. If you
have selected an option and then click another option, the original option is
cleared automatically. Unselected option buttons appear as hollow circles.
Selected option buttons have a solid circle within the hollow one.
Selecting Items in Lists

The key combinations SHIFT+Click and CTRL+Click allow you to select
multiple items in a list.
To select contiguous (side-by-side) items in a list, press and hold the SHIFT
key, and click the first and last items you want to select. For the following
example, the user held down the SHIFT key and clicked Creatinine and then
Ammonia to select these two items and the items between them. Please
note that pressing Ammonia and then Creatinine will select the same items.
To select noncontiguous items, press and hold the CTRL key, and click
individual items in the list. For the following example, the user held down
the CTRL key and then clicked Albumin, Creatinine, and Magnesium. Items
can be clicked in any order.
231
Available/Unavailable Items
When an item is not available to you, it appears dimmed. Items that may
appear dimmed include menus, toolbar icons, and command buttons. Items
may be dimmed because you do not have permission to perform them or you
need to perform some action before they become available.
In the Reports menu shown in the following figure, RiLiBK Reports is
dimmed and unavailable because the RiLiBK module is not installed.
Drag-and-Drop Sorting
You can sort tests in both the "Lab" and "Panel Tests" dialog boxes using
Windows drag-and-drop sorting.
1
Open the dialog box with the items you want to sort.
Click an item in the list.
Keeping the mouse button pressed, drag the item to the location where
you want it to appear.
Release the mouse button to drop the item in the new location.
Repeat for additional items as necessary.
232
Windows Hints
Paging Arrows
When the data screen or a report has multiple pages, you can use the
paging arrows to move quickly through the pages.
| Click to go to the first page.
| Click to go to the last page.
Click to go to the previous page.
Click to go to the next page.
Using Calendars
Several areas within Unity Desktop provide calendars to allow you to
quickly change the date. Within the program, you will use two types of
calendars: one to change the date-time of a data row in data entry; the
other calendar is in several areas (including set date on the data entry
screen, adding an "Other" lot, and selecting report and chart date ranges).
Data Entry Date-Time Calendar

Because this calendar type is used only for manually changing a data point's
date-time, it is discussed in Changing a Data Row's Date-Time (on page
112).
233
General Use Calendar
Creating Shortcuts
The following instructions detail how to create a shortcut for Unity Desktop;
however, the instructions can be applied to any other program on the
Windows Start menu.
1
Select Start | All Programs | Bio-Rad Laboratories | Unity Desktop.
Right-click Unity Desktop. A popup menu appears.
Select Create Shortcut. The shortcut appears on the desktop.
Setting a Short Date Format

The following instructions are for Microsoft Windows XP. The
instructions may vary slightly for other operating systems.
1
Click Start | Control Panel.
Double-click Regional and Language Options.
In the Regional and Language Options dialog box, click Customize.
Click the Date tab to select it.
Select a Short date style that uses four digits to specify the year. We
recommend that U.S. customers choose MM/dd/yyyy as the Short date
style.
234
Windows Hints
Click Apply.
Removing Unity Desktop

To completely remove Unity Desktop, you need to remove both of the
following:
Unity Desktop user application
Unity Desktop Database Utilities
If you installed both components on the same machine (e.g. express install),
the two components will appear one after the other in the "Currently
installed programs" list. In some cases, you may want to remove one or the
other component but not both.
Add or Remove Programs

1
From the Windows Start menu, click Control Panel.
Double-click Add or Remove Programs. The "Add/Remove Programs"

dialog box appears.
Locate the first component you want to remove, and click on the
component to select it. If you need to remove both the application and
the database utilities, it does not matter which you remove first.
Click Change/Remove. Wait while the Wizard prepares to remove the

software. A message appears asking you to confirm removal.
Click Yes to proceed or No to cancel. A message appears, stating that

the program was removed.
Click OK to close the message box. The "Add/Remove Programs" dialog

box reappears, allowing you to select and remove the second
component.
235
H A P T E R
22
In This Chapter
Manual Interfacing and Standard Import Files ..................... 237
Messages ................................................................. 242
License, Warranty, and Trademark Information ................... 245
Manual Interfacing and Standard Import

Files
If you choose not to use Bio-Rad's interfacing solution, SoftConnect, you
can manually configure an interface between Unity Desktop and a
laboratory information system (LIS) or instrument. However, this manual
configuration involves several procedures, each of which must be completed
before automatic importation of data files can begin:
Create a Properly Formatted Data File (on page 238)

Your output files must be converted to Bio-Rad's standard import
format.
Give Each File a Unique Name (on page 240)

To prevent the accidental overwriting of data files, all files placed
within the same folder must have unique file names.
Define Paths for Interface Data (on page 241)
Place the file in a folder specified in the Import Data Source path
Because Unity Desktop periodically polls folders in the Import Data Source
path and imports any new data files found there, all data files to be
imported must be placed in one of these folders. This procedure is defined
in the Import utility.
Create a Properly Formatted Data File

Data files can be created for point or summarized data. Each line (data
record) of the file contains fields for a single test. These fields must be in a
distinct sequence that identifies the lab number, lot number and test
specified with Unity codes. Each test is identified by codes for analyte,
method, instrument, reagent, unit and temperature.
The fields are delimited by a vertical bar (7C hex) or by another printable
character, such as a comma or tilde (~). The first field identifies the line as
point or summarized data, and the subsequent fields of codes identify the
test.
Fields are represented using the ASCII (ISO 646) character set. Characters
used to delimit fields should be different from the characters used within
fields, such as a comma or period to represent a decimal point. Fields may
be enclosed in quotation marks.
Data records for a particular test must appear in increasing date-time
order to avoid being rejected.
Point Data Record

Point | date-time | run | level | lab | lot | analyte | method | instrument |
reagent | unit | temperature | operator| action| comment | value |
Example of a point data record
Point | 20041210080000 | 1 | 1 | 999988 | 15010 | 166 | 063 | 0421 | 0006
| 93 | 6 | JTL | | | 10 |
Summary Data Record

Summary | date-time | run | level | lab | lot | analyte | method |
instrument | reagent | unit | temperature | operator| reserved| comment
| mean | sd | n |
Example of a summary data record
Summary | 20041210 | 1 | 1 | 999988 | 15010 | 166 | 063 | 0421 | 0006 |
93 | 6 |JTL | | | 35.6 | 2.1 | 25 |
238
Fields in Import Files
Point or Summary: Specify Point or Summary to indicate the type of

data. The first letter, (P or S) must be upper case, followed by lowercase letters.
date-time: Date (and, optionally, time of day) the test was performed,
specified in the form yyyymmdd [hh[mm[ss[.xx]]] |. Characters
enclosed in brackets ([ ]) are optional. This format conforms to the
ASTM E 1238-91 (6.6.19.1) and ASTM E 1394-91 (6.6.2) specifications.
run: Analytical run number with which the test is to be identified.
level: Level number of the control being tested (the number 1, 2, or 3).
lab: Lab number assigned by Bio-Rad for use with the test (6 digits).
lot: Lot number for the control (5 digits). The fifth digit must be a zero
(0).
analyte: Unity code for the analyte (3 digits).
method: Unity code for the method (3 digits).
instrument: Unity code for the instrument (4 digits).
reagent: Unity code for the reagent (4 digits).
unit: Unity code for the unit of measure (2 digits).
temperature: Unity code for the temperature (1 digit).
Operator initials: you can place the initials of the operator performing
the test in this field. This field can be blank.
action: you can place a pre-defined action log here. This field can be
blank.
comment: you can place a free-text comment here. This field can be
blank.
reserved: Reserved field, do not use.
value: (Point record only) The value of the test result, specified as a
positive number less than or equal to 99999.0 with up to 3 decimal
places. The characters > (greater than) and < (less than) are not valid.
mean: (Summary record only) The mean of the test results expressed as
a positive number less than or equal to 99999.0 with up to 3 decimal
places.
sd: (Summary record only) the standard deviation of the test results
expressed as a non-negative number less than or equal to 99999.0 with
up to 3 decimal places.
n: (Summary record only) The number of data values used to calculate

the corresponding mean and standard deviation expressed as a positive
integer greater than 0 and less than or equal to 32767.
239
Give Each File a Unique Name

You can use one of the naming conventions suggested here or develop your
own. If you choose to develop your own file naming convention, it is
essential that all data files placed in the same folder have unique file
names. Otherwise, data may be accidentally overwritten.
Unity Desktop supports long, Windows-style file names. File names can
contain up to 255 characters composed of any alphanumeric character,
including spaces, except the following illegal characters: / \ : * ? " < > |.
Suggested File Naming Conventions

Naming Convention 1
The simplest file naming convention uses the instrument name followed by a
sequencing number that increments by one as the instrument or LIS outputs
each data file.
For example:
DiaSTAT001.txt
DiaSTAT002.txt
DiaSTAT003.txt and so forth
This naming convention can be used if you have only one of the same
instrument or if you create a separate folder for each instrument and define
the path to each folder in the Import Data Source path.
If you have more than one of the same instruments and choose not to create
a separate folder for each one, you can add a number designation for each
instrument to the file name.
240
For example, a laboratory with three Bio-Rad DiaSTAT instruments could

assign file names as follows:
First Instrument
Second Instrument
Third Instrument
DiaSTAT1001.txt
DiaSTAT2001.txt
DiaSTAT3001.txt
DiaSTAT1002.txt
DiaSTAT2002.txt
DiaSTAT3002.txt
DiaSTAT1003.txt
DiaSTAT2003.txt
DiaSTAT3003.txt
Naming Convention 2
Another simple file naming convention uses the current date and time in the
file name.
For example:
200201010820.txt
200201010825.txt
200201010855.txt and so forth
Define Paths for Interface Data

When installed, Unity Desktop creates a folder named Bio-Rad Laboratories
that is placed on your local hard disk drive (or the folder you specified
during installation of the program).
The program also creates two paths for interfacing and storage of data
imported from an outside source such as an instrument or LIS:
Import Data Source defaults to the InstrumentImport folder
Import Data Archive defaults to the ImportArc folder

These interface paths must be different from each other to prevent
accidental overwriting of data.
Users with permission to edit setup options can change the default paths
from the import utility. Within Unity Desktop, press F12 to access the
Import utility. Outside of Unity Desktop, choose Start | All Programs | Bio-Rad
Laboratories | Import.
241
Alternatives to Interfacing
If you are unable to connect your LIS directly to Unity Desktop, you may be
able to use another program such as Microsoft Excel to reformat the
generated file to the standard format required by Unity Desktop. Using the
following steps:
1
Save the file as a comma-delimited file from a spreadsheet program or

as a text file with line breaks from a word processing program.
Refer to the Excel program software user guide for the necessary
procedure.
Once you have a file in the standard format, place it in the

InstrumentImport folder for processing.
Messages
Rejection Log Messages
The following messages appear on the rejection log to allow you to identify
and correct import errors:
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
242
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
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
Action Messages
The following list contains the default action messages and their identifying
number. As you add actions, Unity Desktop numbers them sequentially and
appends them to this list.
1
Calibrator: new lot
Calibrator: changed
243
Control: repeated level 1
Controls: reconstituted new
Filter: performed maintenance
Inspection: regulatory
10
Instrument: bleached
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
244
26
QC: reviewed for week
27
Range: established new
28
Reagent: changed
29
Reagent: new lot
30
Test/assay repeated
31
Test: calibrate
245
License, Warranty, and Trademark

Information
License Agreement
Bio-Rad hereby grants to you, and you hereby accept, a non-exclusive
license to use the Unity Desktop 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 rights, 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 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-Rads
discretion.
246
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-Rads sole obligation
under this warranty is to remedy such defect in a manner consistent with
Bio-Rads 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 Purchasers notice, and for minor defects, BioRad 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 Purchasers 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 noninfringement, 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.
Trademark Notices
DirectConnect, InstantQC, QCNet, SoftConnect, UnityWeb, Unity
Interlaboratory Program, Unity Desktop, Unity Real Time 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.
247
H A P T E R
23
References
In This Chapter
QC References .......................................................... 249
QC References
1
C24-A2. Statistical Quality Control for Quantitative Measurements:

Principles and Definitions; Approved Guideline - Second Edition.
National Committee for Clinical Laboratory Standards, Wayne, PA, 1999.
Cembrowski, G.S.; Carey, R.N.; Laboratory Quality Management: QC &

QA, ASCP Press (1989).
Davies, O.L.; Goldsmith, P.L. Statistical Methods In Research and

Production, New York (1984).
Howanitz, Peter J and Joan H., Laboratory Quality Assurance,

McGraw-Hill Book Company (1987).
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.
National Committee for Clinical Laboratory Standards. Internal Quality

Control: Principles and Definitions; C-24A.
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. Westgards Web site @
http://www.westgard.com/lesson17.htm
Weisbrot, M.D., Statistics For The Clinical Laboratory; J.B. Lippincott

Company, Philadelphia (1985).
Westgard JO, Basic QC Practices; second edition; (2002).
10 Westgard JO, Burnett RW. Precision requirements for cost-effective

operation of analytical processes. Clin Chem 1990; 36:1629-1632.
11 Westgard, J. O. et al., Combined Shewhart CUSUM Control Chart For

Improved Quality Control In Clinical Chemistry; CLIN. CHEM. 23/10,
1881-1887 (1977).
12 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).
13 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).
250
Glossary of Terms
A
Accuracy
The closeness of agreement
between a result and the
accepted reference value. The
term accuracy, when applied to a
set of test results, involves a
combination of random
components and a common
systematic error or bias
component. [ISO 3534-I]
Active cell
The cell in the data-entry grid
where values will appear as you
type. A solid border surrounds
the active cell.
Active rules
SPC rules with a status of reject
or warn.
Affiliated group
A group of labs that the Unity
Interlaboratory Program groups
together to form an ad hoc
consensus group for which it
generates specific Affiliated
Reports (on page 189). You must
contact your Bio-Rad software
support representative to request
inclusion in an affiliated group.
All labs group

The Unity Interlaboratory
Program consensus group of all
users reporting values for an
analyte/matrix combination. Of
peer, method and all labs, this is
the least specific consensus
group.
Analyte
The constituent or characteristic
of the sample to be measured.
Note: this includes any element,
ion, compound, substance,
factor, infectious agent, cell,
organelle, activity (enzymatic,
hormonal, or immunological) or
property, the presence or
absence, concentration, activity,
intensity or other characteristics,
of which are to be determined.
Reproduced with permission from
NCCLS publication NRSCL8-P3,
Terminology And Definitions For
Use In NCCLS Documents Third
Edition, Proposed Standard.
Copies of the current edition may
be obtained from: NCCLS, 940
West Valley Road, Suite 1400,
Wayne, Pennsylvania 19087, USA.
Analytical process
A series of steps taken in the
analysis or testing of patient
specimens or samples.
B
Bias
Close
The difference between the

expectation of the test results
and an accepted reference value.
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]
A measurement of accuracy,
which quantifies how far an
observed value is from the "true"
value. In the following formula,
the mean of a selected consensus
group is used as the "true" value,
which, in this case, is more
accurately defined as a target
value.
M lab M group
100
LabBias % =
M
group
C
CIS
Connectivity Implementation
Services
Removing a lab, lot, or test from

active data entry status. Closed
labs, lots, and tests do not
appear on the navigation tree;
however, their data remains in
the database. Contrast with
delete.
CLSI
Clinical and Laboratory Standards
Institute. Formerly NCCLS.
Concentration
A measure of the amount of
dissolved substance per unit of
volume.
Reproduced with permission,
from NCCLS publication NRSCL8P3, Terminology And Definitions
For Use In NCCLS Documents
Third Edition, Proposed Standard.
Copies of the current edition may
be obtained from: NCCLS, 940
West Valley Road, Suite 1400,
Wayne, Pennsylvania 19087, USA.
Connectivity
Implementation Services
CLIA
Abbreviation for the Clinical
Laboratory Improvement
Amendments of 1988, which
regulate laboratory practice in
the U.S.
252
Context: closing a lab, lot, or

test
CIS: A Bio-Rad customer service

group whose sole purpose is to
assist you in interfacing your LIS
and/or instruments.
Glossary of Terms
Consensus group
A group of labs submitting data
to the Unity Interlaboratory
Program. In order of decreasing
specificity, the groups are peer,
method, and all labs.
D
Data conversion
The process that copies your user
profiles, labs, lots, tests, and
test data from earlier Bio-Rad QC
software into Unity Desktop.
Constituent
Data due date
1) component of a sample; 2)
analyte.
The fifth business day of the next

calendar month. The date by
which your data must be received
at Bio-Rad to ensure that your
Unity Interlaboratory reports are
generated. When mailing results,
be sure to allow sufficient time
for delivery to Bio-Rad before the
due date.
Cumulative mean
Used synonymously with floating
mean. The mean of all accepted
data points entered for a test. If
you do not define a fixed mean,
Unity Desktop uses the
cumulative (floating) mean for
rule evaluation.
CV
A measure of precision expressed
as a percent.
standard deviation
CV % =
100
mean
CVR
Coefficient of variation ratioa
statistic that compares your lab's
precision to that of other labs in
a consensus group.
CVR =

Program does not
automatically generate
reports for late dataYou
must contact your Bio-Rad
software support
representative and request
them.
Data group
A user-defined set of data points
that have something in common,
such as a calibrator lot.
Frequently shorted to group. See
Data Groups (on page 98).
CVlab
CVgroup
253
Data Sets
Groups of data points that have
some elements in common (e.g.
their lab or lot numbers, panel
assignments, entry dates etc.)
The terms Data Set A and Data
Set B (or DS:A and DS:B) are used
to refer to the two data sets
compared on Data Analysis Grids.
The "Graph Against" tab of the "LJ Options" tab also allows you to
specify a data set.
DBA
E
Evaluation Mean/SD
The mean and SD that Unity
Desktop used to evaluate a data
point. When using cumulative
(floating) statistics, these values
can be different for each data
point. You can view the
evaluation statistics by clicking
the plus sign (+) for the data row.
F
Fixed statistics
Within this guide, fixed statistics
refers to specifying (fixing) the
evaluation mean and/or SD for a
test.
Database Administrator
DirectConnect
One of Bio-Rads connectivity
solutions, whereby QC data from
an instrument, LIS, or
middleware solution can be
imported into Unity Real Time,
with a hardware solution,
immediately for run-time
decisions.
DSN
Data Source Name. The Data
Source Name provides
connectivity to a database
through an ODBC driver. The DSN
setup to a database allows the
Unity Desktop application to call
information from the database.
Floating mean
Used synonymously with
cumulative mean. The mean of
all accepted data points entered
for a test. If you do not define a
fixed mean, Unity Desktop uses
the floating (cumulative) mean
for rule evaluation.
G
Global
Within this document, global
means that a selection is applied
to all lab numbers, lot numbers,
and tests.
Group
Data group. A user-defined set of
data points that have something
in common, such as a calibrator
lot. See Data Groups (on page
98).
254
Glossary of Terms
I
Identical tests
L
Level
Tests that share the same Unity

codes for analyte,
instrument/kit, reagent, method,
unit, and temperature.
When referring to QC materials,

level refers to the concentration
of analytes within the control
material based on normal human
ranges. Controls are usually bilevel or tri-level. For example, an
Immunoassay control may have
three levelslow, normal, and
high.
Imprecision
Imprecision (%) expresses how far
apart numbers are from each
other. Unity Desktop calculates
lab imprecision using the
following formula:
standard deviation
Lab I% =
100
mean
In control
Used as a adjective, indicates
that the analysis of patient
samples is reliable.
Levels in use
The levels (e.g. level 1, level 2,
level 3) of a control product that
the customer is using in the lab.
Customers define the levels in
use as part of the test setup.
Unused levels of a control
material are omitted from data
screens and Unity Desktop
reports.
Levey-Jennings chart
Inactive rule
An SPC or analytical goal rule
with a status of off. (See Active
rule.)
A graphical chart used to plot

successive quality control results,
day-to-day or run-to-run.
LIME
InstantQC
An instant interlaboratory
program option that allows you to
compare point data submitted via
Bench/Supervisor Review to
other lab's data on demand.
InstantQC reports and charts are
available on QCNet.com.
Acronym for Laboratory Internal

Margin of Error. LIME statistics
(mean and SD) are used for
RiLiBK daily precision testing
using the 1-3s rule.
ISP
Internet Service Provider. A
company that provides access to
the Internet.
255
M
Master lot number
Median
An alphanumeric string of 15 or
fewer characters that uniquely
identifies a lot number.
Traditionally, 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 (e.g.
40910). To identify levels of a
control product, the final zero is
changed to the level number
(e.g. 40911 is level 1 of master
lot number 40910).
Matrix
The base to which the
constituents of a control material
are added (e.g. serum, urine,
spinal fluid, whole blood, etc.)
Maximum QC
The condition that exists when
the Westgard Advisor is unable to
suggest rules that meet your
quality specification (e.g. TEa).
This condition indicates that the
test process has such low process
capacity (i.e. high total error)
that 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 arithmetic average of a set
of data points.
256
The middle value in a

distribution, above and below
which lie an equal number of
values. The midpoint of a range
of numbers that are arranged in
order of value (or the average of
the middle two in an evennumbered set). For example, the
median value of 17, 20, and 36 is
20.
Medically relevant error

A degree of error which can
adversely affect or change the
patient diagnosis, prognosis, or
treatment plan.
Method
Analytical methodthe means by
which an analyte is measured, for
example hexokinase. The Unity 3digit method code is one of the 6
codes used to define a Test.
Method group
consensus group of labs reporting
an analyte using the same
method code (e.g. all customers
reporting glucose by hexokinase).
N
N
The total number of control
measurements per analytical run.
An N of two could refer to 2
control measurements on a single
control material (e.g. level) or to
one measurement on each of two
control levels.
Glossary of Terms
O
Open
P
Panel
Context: opening a lab, lot, or

test. Returning a closed lab, lot
or test to active data-entry
status. Open labs, lots, and tests
appear on the navigation tree
and on your Unity Interlaboratory
reports.
A user-defined group of tests

organized for simplified data
entry across lab and lot numbers.
Panels provide a useful way to
customize the organization of
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.
Operating point
The point on an OPSpecs chart
that represents the intersection
of a test's bias and imprecision.
The operating point represents
the current performance of a
test.
Path
A chart plotting the operating

point for a test against the
allowed inaccuracy and
imprecision and containing lines
representing the operating limits
for stable and unstable
processes.
The route the program follows

from the root directory through
the hierarchical structure to
locate a file. A path is indicated
by the drive name, followed by a
colon and a backslash, then the
name of each folder, in the order
you would open them, separated
by a backslash. For example,
C:\Program Files\Bio-Rad
Laboratories\Unity
Desktop\.
Out of control
Peer group
Used as an adjective, indicates

that the analysis of patient
samples is unreliable.
The ideal consensus group

where all six Unity codes for a
test match those that the user
has defined for a test.
OPSpecs chart
Percent AQA (SE)

The percent of Analytical Quality
Assurance (AQA) for Systematic
Error (SE) is the chance of
detecting medically important
systematic errors. AQA (SE) is
synonomous with the Probability
of Error Detection (Ped).
257
Precision
Quality Control Product(s)
A measurement of how similar

(close to each other) a set of
measurements are. The
measurements may or may not be
close to the "true" answer. See
Accuracy.
Liquid or freeze-dried materials

of human, animal, or chemical
origin that are used to monitor
the quality and consistency of the
analytical process.
Probability of False
Rejection
Abbreviated as Pfr.
A QC performance characteristic
that describes how often a run is
rejected when these are no
errors.
Pupil
The inner circle on Yundt plots
that represent either the Data
Set A or Data Set B CVR,
depending on which is smaller.
Q
QC
Quality Control. In the clinical
laboratory, QC is a system
designed to increase the
probability that each result
report is valid and can be used
with confidence by a health care
provider when making diagnostic
or therapeutic decisions.
QCNet
QCNet.com. A Web portal for
clinical laboratory information
that provides QC management
tools. For example, from
"UnityWeb Interlab" tab of
QCNet, you can view reports and
enter data.
258
R
Random error
Any random deviation from the
laboratory mean. There is
"expected" or "acceptable"
random error which generally lies
anywhere between 3s of the
mean. It follows that any
deviation greater than 3s is
considered "unacceptable"
random error. Because of its
random nature, this type of error
is unpredictable.
Range
largest and the smallest observed
value of a quantitative
characteristic or statistical limit.
Reject rule
(Also known as a rejection rule) A
QC rule with Reject assigned as
the rule status. When a data
point violates a QC rule with a
Reject status, the point is not
accepted and is excluded from
routine QC calculations.
RiLiBK table
A table of analyte/matrix
combinations that labs in
Germany are required to QC
using the RiLiBK QC protocol.
Glossary of Terms
RiLiBK test
A test being evaluated by RiLiBK
rules. (Contrast with standard
test.)
Run
1
Analytical run, which is

expected to include both QC
and patient samples.
A set of QC values that Unity

Desktop groups together for
Statistical Profile rule
evaluation (e.g. within and
between run). See also Run
length.
Run length
The customer-specified time
interval in which QC values are
assigned to the same run during
autoimport as long as there is no
value already existing in the run
for the level. Values do not need
to be received in level-number
order to be assigned to the same
run.
S
Series
Used for RiLiBK tests.
A "sequence of determinations of
the same measurable quantity
performed with the same
measuring instrument and the
same calibration under identical
conditions.
In automated analysis where
human intervention does not
occur during the measurement
process, a series cannot exceed
one work shift." (Deutsches
rzteblatt, Vol. 98, No 42, 19
October 2001, pp. A2747 to A
2759.)
Set Date
A Unity Desktop mechanism that
allows customers to specify a
starting date/time for manual
data entry. When using set date,
customers can specify whether to
increment the date (increase it
by one each time the user tabs to
a new row) or maintain the date
until the user changes it.
Shift
A type of systematic error caused
by a sudden and eventually stable
change in control values and
possibly patient values.
SoftConnect
Whereby QC data from an
instrument, LIS, or middleware
solution can be imported into
Unity Real Time.
SPC rules
Statistical Process Control rules.
This terminology encompasses
the original Westgard rules and
additional rules not included in
the original six Westgard rules.
259
Standard deviation
Statistical process control
Abbreviated as SD or s. The SD
quantifies the degree of
dispersion of data points around
the mean and is defined by the
formula:
A set of rules which uses

statistics to monitor and evaluate
a process
SD =
(x
x)
Data points that violated any QC

rule (SPC or analytical goal) set
to reject or warning.
n 1
Systematic error
Where:
SD=standard deviation
x= mean (average) of the QC

values
=the sum of the squares of

differences between
individual QC values and the
mean
Suspect Data
n=the number of values in

the data set
Standard Test
A test being evaluated by SPC
rules and possibly an analytical
goal. A test not defined as a
RiLiBK test.
Statistical limits
1
A defined range of data

calculated from quality
control data using the mean
and standard deviation.
Used to differentiate an
analytical process that is in
control from one that is not
in control.
A trend or shift away from the

laboratory mean. Small amounts
of systematic error are tolerable.
Systematic error will remain until
corrective action is taken.
T
Test
Unity Desktop and the Unity
Interlaboratory Program define a
test using six codes: analyte,
instrument/kit, reagent, method,
unit, and temperature.
Trend
A type of systematic error
causing a gradual, often subtle,
increase or decrease in control
values and possibly patient
values.
Statistical process
A series of steps that results in
production of one or more
statistics.
260
Glossary of Terms
Trueness
Westgard Rules

expectation of the test results
and an accepted reference value.
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]
A QC system based on a set of six

core statistical rules, each having
statistical power to detect
random and systematic deviations
from the norm. Within this
document the term Statistical
Process Control Rules
encompasses rules not included
in the original six Westgard rules.
U
UnityWeb Interlab
A tab within QCNet.com where
your Unity Interlaboratory reports
are posted and from which you
can generate monthly
interlaboratory and InstantQC
reports and charts. The
"UnityWeb Interlab" tab also
allows point and summary data
entry.
Z
z-score
The number of standard
deviations a control result is from
the expected mean, calculated
as:
Result observed Meanexpected

z score =
SDexpected
W
WA
Abbreviation for Westgard
Advisor.
Westgard Advisor
An optional module within Unity
Real Time that suggests SPC rules
for tests based on a quality
specification you select and your
labs imprecision. Abbreviated as
WA.
261
Index
1
1-2.5s 33
1-2s 32
1-3.5s 34
1-3s 34
1-4s 35
2
2-2s 35
3
3-1s and 4-1s 37
Adding Non-Bio-Rad Lots 74

Adding Qualitative Tests 125
Adding Tests 82
Adding Tests With an Other Code
86
Adding Tests With Instrument
Setup 84
Administration/Setup Permissions
65
Affiliated Data Exception Report
189, 192
Affiliated group 251
Affiliated Laboratory Comparison
Report 189, 190
Abbreviated Summary
189, 190
7
7-T 38
A
A Note About Screen Shots 13
Accreditation Requirements
(Paraphrased) 202
Accuracy 251
Action Messages 159, 243
Actions 59, 136
Actions and Comments 223
Actions and Comments by
Instrument 59, 139
Activation Keys 218
59, 218
Active cell 251
Active rules 251
Add a Lab Number 15, 17
Add a Lot Number 15, 17
Add Tests 15, 18
Add Users 15, 16
Adding and Editing Action
Messages 136
Adding and Updating Labs 70,
221
Adding Bio-Rad Lots 73
Affiliated Reports 178, 189, 251

All labs group 251
Alternatives to Interfacing 242
Analyte 251
Analytical process 251
Applying QC Rules 101
Archive and Restore 213
Autoimport 148
Automatic Action Logs 137
Available/Unavailable Items
230, 232
B
Bar Charts 123, 161, 168
Basic QC Statistics 24
Before You Begin 217
Bias 25, 28, 252
Bias and Imprecision Histogram
Report 177, 183
Bio-Rad Laboratories From the
Windows Start Menu 57
C
Calculating a Control Mean and
Range 27
Changing a Data Point's

117, 118, 131
Changing a Data Row's Date-Time
112, 233
Changing the Main Screen
Graphics 226
Changing Values and Date/Times
130
Changing VITROS Slide
Generations 92, 93, 94
Chart Headers 156, 157
Chart Options 156
Check Boxes and Option Buttons
230
Choosing a QC Procedure 15,
41, 101
Choosing a Report Format 60,
165
Choosing Permissions 61, 62, 65
CIS 252
CLIA 252
CLIA Requirements 21, 24, 198
Close 252
Closing and Opening Lots 78
Closing and Opening Tests 89
CLSI 252
Codes, other 86
Coefficient of Variation 25, 29
31
Command Buttons 229
Comments 139
Concentration 252
Condensing Data 214
Configuring Intralaboratory
Report Headers 165, 167, 168
Connectivity Implementation
Services 252
Consensus group 253
Consider Common Factors on
Multitest Systems 49
Constituent 253
Create a Properly Formatted Data
File 237, 238
Creating Shortcuts 234
Cumulative mean 253
Current Lab, Lot, Test, and Panel
53
264
Customizing Import 144

Customizing Your L-J Charts 158
CV 253
CVR 253
D
Data conversion 253
Data due date 253
Data Entry Configuration 223
Data Entry Grid 114, 115
Data Entry Overview 109
Data group 253
Data Groups 98, 123, 253, 254
Data Handling Permissions 68
Data Permissions 66
Data Rejection Report 177, 184
Data Retention 144, 145
Data Screen Header 115
Data Sets 254
Database Basics 211
Database Permissions 66
Database Updates 59, 211, 224
DBA 254
Define Paths for Interface Data
237, 241
Defining Initials With Operator
Setup 151
Defining, Modifying, and Deleting
Users 61
Deleting Data 132
Deleting Labs 72, 90
Deleting Lots 77, 90
Deleting Tests 90
Determine Quality Requirements
for the Test 30, 42
Determine the Type of Error 47
Determining an Acceptable CV
30
Documenting Report Reviews
165, 167
Drag-and-Drop Sorting 92, 98,
232
DSN 254
Duplicating Labs 71
Duplicating Lots 75, 106
Duplicating Tests 88
Index
E
Editing a Bio-Rad Lot 77
Editing a Non-Bio-Rad Lot 78
Editing Lots 77
Email 176, 219
Enter Data 15, 18
Entering Data 109
Entering Point Data 122
Entering Qualitative Data 110,
115, 127
Entering Summary Data 115,
124
Essential Startup Tasks for New
Users 15
Evaluate Test Performance 43
Evaluation Mean/SD 254
Evaluation Means and SDs 116,
119, 120
Example Point Data Grid 117,
119
Example Report 190, 192
Exporting Data 152, 214
Extended Row Information on the
Point Data Grid 119
F
File Retention 144, 145
First Time Log In 15, 16
Fixed Mean and SD (on Data
Screens) 115, 116
Fixed Mean/Fixed SD 120, 121
Fixed Mean/Floating SD 120,
122
Fixed means and SDs 105
Fixed statistics 254
Floating mean 254
Floating Mean/Fixed SD 120,
121
Floating Mean/Floating SD 120
Functions and Where to Find
Them 59
G
General Chart Options 156,
157, 158
Getting Started 11
Give Each File a Unique Name

237, 240
Global 254
Good Habits 47
Group 254
H
Histograms 188
How Are QC Results Used? 22
How Do I Use Six Sigma? 45
How to Contact Us 12
I
Identical tests 255
Import Check Boxes 59, 83,
144, 146, 221
Import Data Archive 144
Import Data Source 144, 146
Import File Format Selections
144, 147
Import File Status 148
143
Importing Data 143
Imprecision 255
In control 255
Inactive rule 255
Individual Unity Desktop Reports
168
Inserting Data Rows 131
Installation 217
Installation and Setup 217
InstantQC 255
Internet Service Provider 225
Interpreting the SDI 28
Introduction to Quality Control
Statistics 21
ISO 15189 210
ISP 255
K
Keys to a Productive Review of
the Laboratory Quality System
47, 50
L
177, 180
265
Laboratory Histogram 177, 182

Laboratory Performance
Overview Report 177, 179
Labs 69
Labs and Lots 69
Labs, Lot, Tests, and Panels
Permissions 67
Level 255
Levels in use 255
Levey-Jennings chart 255
Levey-Jennings Charts 158
Levey-Jennings Tab 156, 158
License, Warranty, and
Trademark Information 220,
246
Licensing 220
LIME 255
Lines Tab for L-J Charts 156,
158, 160
Listings for Labs, Lots, Tests, and
Panels 168, 171
Lot Expiration Notifications 79
Lots 73
M
Managing Your Data 129
Manual Database Updates 212
Manual Interfacing and Standard
Import Files 237
Manufacturer Report 186
Master lot number 256
Matrix 256
Maximum QC 256
Mean 25, 256
Median 256
Medically relevant error 256
Messages 242
Method 256
Method group 256
Monthly Evaluation Report 177,
178
Multi-L-J Charts 161, 168
N
N 256
Navigating within Data Entry
110, 123, 124
266
Normal and Abnormal Controls

22
Notifications 224
N-x Rules 38
O
Open 257
Opening and Closing Labs 72
Operating point 257
Operator Setup 59, 117, 118,
149
Operator Setup Shifts 150
OPSpecs chart 257
Optional Interlaboratory Reports
178, 185
Organization of this Guide 12
Out of control 257
Overview of Actions and
Comments 135
Overview of Data Management
129
Overview of Regulatory
Requirements and Reports
197
Overview of Rule Evaluation
101
Overview of Tests 81
Overview of Unity Interlaboratory
Reports 177
P
Paging Arrows 166, 233
Panel 257
Panel Tests Dialog Box 95, 97
Panels 95
Panels and Data Groups 95
Passwords 62, 63
Path 257
Peer group 257
Percent AQA (SE) 257
Percentile Distribution Table
189
Point Data Entry 117
Point Data Grid 118
Point Data Report 169
Precision 258
Probability of False Rejection
258
Index
Product Inserts 27
Program Basics 53
Pupil 258
Q
QC 258
QC Output File Folder 144
QC References 249
QCNet 258
Qualitative Data Entry 11, 125
Qualitative Evaluation of a Test's
Bias and Imprecision 45
Quality Control Product(s) 258
R
R-4s 36
Random error 258
Range 258
Recommended Steps 41, 104
Reconciling Your Database 215
References 249
Regulatory Requirements and
Reports 197
Reject rule 258
Rejection Log Messages 126,
149, 242
Rejection Logs 126, 149
Relate the Error to Possible
Causes 48
Relate the Problem to Recent
Changes 49
Removing Unity Desktop 235
Reports 225
135
RiLiBK table 258
RiLiBK test 259
Rule Precedence When Displaying
Rule Violations 103, 117, 118
Rule Statuses 102
Rules and Settings Permissions
67
Rules Tab of the Test Settings
Dialog Box 87
Run 259
Run length 259
Run Length 144, 145
Sections of the Statistical Profile

Report 187
Selecting Items in Lists 55, 89,
90, 91, 132, 133, 231
Selecting the Data to Appear on
Reports 156, 165, 166
Sending Data to the Unity
Interlaboratory Program 173
Sending Qualitative Data to the
Unity Interlaboratory Program
128
Series 259
Service Packs 13
Set Date 112, 113, 123, 127,
259
Setting a Short Date Format 234
Setting SPC Rules 87, 104
Settings Tab of the Test Settings
Dialog Box 87
Shift 259
Shortcut Keys 57
Six Sigma 43
Sorting Tests 91
SPC rules 259
SPC Rules 31, 41, 101, 107
Tabular Summary 101,

107
Specifying a Default Data Entry

Mode 19, 59, 112, 122, 124,
223
Standard deviation 260
Standard Deviation 25, 26
Standard Deviation Index 25, 27
Standard Reports 178
Standard Test 260
Starting and Exiting the Program
53
Statistical limits 260
Statistical process 260
Statistical process control 260
Statistical Profile Report 187
Statistics/Chart Area 114, 115
Steps to Import Historical Data
221
Summary Data Entry 123
Summary Data Report 168, 169
267
Summary Statistics 188

Supervisor's Report 170
Supplemental Information 237
Suspect Data 260
Systematic error 260
T
Test 260
Test Rules and Settings 87
Tests 81
The Configure Unity Desktop Tab
223
The Setup Dialog Box 14, 60,
66, 86, 138, 222
To Activate Automatic Monthly
Transmission for Monthly Unity
11, 59, 60, 174, 178, 225
To Add a Bio-Rad Lot 74
To Add a Lab Number 70
To Add a Non-Bio-Rad Lot 74
To Add a Panel 97
To Add a User 62
To Add an Existing Action to a
Data Entry Row 136
To Add Tests Manually 83
To Add Tests Using Instrument
Setup 85
To Add Tests With an Other Code
86
To Attach a Comment by
Instrument 141
To Attach an Action by
Instrument 140
To Attach Both an Action and a
Comment by Instrument 141
To Call a Point Data Report 169
To Change the
131
To Change the Default Current
Data Selection 99
To Change the Main Screen
Graphics 226
To Change VITROS Slide
Generations 93
To Change Your Password 60,
65
To Close a Lab Number 72
To Close a Lot 78
268
To Close Tests 89
To Condense Data by Lab, Lot, or
Test 214
To Condense Data for All Labs
215
To Configure Intralaboratory
Reports 167
To Define or Edit a Group 99
To Delete a Lab Number 72
To Delete a Lot Number 77
To Delete a Panel 97
To Delete a Range of Data 134
To Delete a Row(s) of Data 133
To Delete a User 63
To Delete Tests 91
To Display a Summary Data
Report 169
To Display Multi-L-J Charts 161
To Duplicate a Bio-Rad Lot
Number 76
To Duplicate a Lab Number 71
To Duplicate a Non-Bio-Rad Lot
Number 76
To Edit a Value 130
To Edit the Action Library 137,
140
To Edit the Date-Time 130
To Email a Transmission File to
Bio-Rad 59, 176
To Enable/Disable Automatic
Action Logs 138
To Enter Qualitative Data 127
To Insert a Data Row 132
To Modify a User 63
To Open a Lab Number 73
To Open a Lot 78
To Open Tests 90
To Set a Fixed Mean and/or
Standard Deviation 106
To Set SPC Rules at the Lot Level
105
To Set SPC Rules at the Test
Level 104
To Sort Tests in a Panel 98
To Sort Tests in Lab Mode 91
To Sort Tests in Panel Mode 92
To Transmit Data Manually for
Monthly Unity 174
To Update a Lab Number 70
Index
To Update a Panel 97
To Update a Test 88
To Update VITROS Slide
Generations 94
To Use Set Date
Incrementing the Date

113
Maintaining the Date 114
To Write a Transmission File

175
Toolbars 54
Total Error and TEa 30
Transmission 225
Transmission Files 173
Tree Views 18, 53, 96, 229
Trend 260
Troubleshooting QC Results 46
Trueness 261
Typographical Conventions 13
U
Unity Desktop Charts 155
Unity Desktop Data Screens
109, 114
211
Unity Desktop Menu Bar 55
Unity Desktop Reports 165
177
Unity Interlaboratory Reports Tab
177, 225
UnityWeb Interlab 261
Update VITROS Slide Generations
88, 92, 94
Updating Database Information
60, 84, 211, 224
Updating Tests 88, 90
Updating Your Activation Key
219
Upgrading from QC OnCall, Unity
Plus/Pro, or Unity-PC 220
Upgrading From Unity Post 221
Upgrading to Unity Desktop 220
Urinalysis Reports 193
Useful Features of Data Entry
110
Useful Features of Unity Desktop

Reports 165
User Profiles and Security 60,
61
Using Calendars 75, 112, 130,
233
Using Fixed Means and SDs with
SPC Rules 15, 88, 105, 120
Using the Affiliated Laboratory
Comparison Report
Abbreviated Summary
Report 191

60, 174
Using Youden Charts 164
V
Verify and Document 50
Viewing Charts and Reports
within Data Entry 111
Viewing Interlaboratory Reports
on QCNet 178
Viewing Rules/Settings and AGs
within Data Entry 111
Viewing, Printing, and Saving
Charts 155
VITROS Slide Generations 83,
86, 92
W
WA 261
Welcome to Unity Desktop 11
Westgard Advisor 261
Westgard Rules 261
What is Quality Control? 21
Where Do I Begin? 14
Windows Hints 229
Worldwide Report 185
Y
Youden Chart Options 157, 163
Youden Charts 162, 168
Your Lab's Two and Three SD
Ranges 187
Z
z-score 31, 261
269

UnityDesktop BioRad

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UnityDesktop BioRad

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Reference Guide for Easy QC

Welcome to Unity Desktop ................................................11

Introduction to Quality Control Statistics

What is Quality Control? ...................................................21

Easy QC Data Management

N-x Rules ............................................................ 38

Recommended Steps ....................................................... 41

Starting and Exiting the Program ........................................ 53

User Profiles and Security

Defining, Modifying, and Deleting Users ................................ 61

Labs and Lots

Panels and Data Groups

Easy QC Data Management

Overview of Rule Evaluation .............................................101

Data Entry Overview ......................................................109

Managing Your Data

Overview of Data Management ..........................................129

Changing a Data Point's Accepted/Rejected Status ................. 131

Reviewing and Annotating Data

Overview of Actions and Comments.................................... 135

Importing and Exporting Data

Importing Data............................................................. 143

Unity Desktop Charts

Viewing, Printing, and Saving Charts .................................. 155

Unity Desktop Reports

Useful Features of Unity Desktop Reports ............................ 165

Easy QC Data Management

Documenting Report Reviews ...................................167

Sending Data to the Unity Interlaboratory Program

Transmission Files .........................................................173

Unity Interlaboratory Reports

Overview of Unity Interlaboratory Reports ............................177

Urinalysis Reports ......................................................... 193

Regulatory Requirements and Reports

Overview of Regulatory Requirements and Reports ................. 197

Unity Desktop Database Basics

Database Basics ........................................................... 211

Installation and Setup

Before You Begin .......................................................... 217

Easy QC Data Management

Tree Views ..................................................................229

Manual Interfacing and Standard Import Files ........................237

Welcome to Unity Desktop

Automatic monthly transmission (see "To Activate Automatic Monthly

Notification when software updates are available with installation or

Expanded charting options.

Easy QC Data Management

Search our knowledge base at support.qcnet.com.

Send an email to unity_support@bio-rad.com.

Organization of this Guide

Unity Desktop frequently provides multiple ways to access program

Windows instructions are provided based on Windows XP. If you are

When providing paths, installation is expected to be to the default

Warnings are shown shaded. For example:

A Note About Screen Shots

Easy QC Data Management

When the "Automatic product updates" check box is selected

Click Install to download and install the update.

Click Download to download the update to a location you specify

When the "Automatic product updates" check box is not selected

If Unity Desktop is your first Bio-Rad QC data management software,

Essential Startup Tasks for New Users

Essential Startup Tasks