515127-A_EN

Reference Manual
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REFERENCE MANUAL
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Revision Table
Reference Date Version List of Changes
0932195 01/2015 5.3.6.3 Creation
0932195A 02/2017 5.10
Addition of sections on:

- Managing alerts
- Managing probationary QC lots
- Managing EQCs
- Automatic validation of QCs
- The dictionary of drugs
- The control time calculation accreditation
procedure
- The analyzer comparison accreditation procedure
- The reagent comparison accreditation procedure
- The stability accreditation procedure
- The reflex rules assistant
- Minimum screen resolution
Update of the sections on:

- Quality Controls
- Validation of patient results
- Test count
- Configuring tests
- Configuring the analyzer
Appendix 1 Syntax of reflex rules and calculations
0932195B 08/2017 5.10
Addition of subparagraphs in section 5.5 Managing probationary QC lots:

- Acquisition of QC values for a probationary lot

Use of values

0932195C 03/2018 6.0

Replacement throughout the document of the term "STA Coag Expert" with the term "the
application"

Update of the images on:

- Accreditation tools

Update of the sections on:

- Users
- Accreditation Tools

Addition of the following sections

 under "User identification"

- User account management

 under "Main Menu, Browsing"

- Management of process monitoring

 under "Workstation"

- Print
 under "Accreditation Tools"

- Management and display of the number of

decimal places
- Management of error values

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- Mechanism for rejecting and reincluding values
- Settings

Changes to the following paragraphs

 under "Accreditation Tools"

- Measurement uncertainties in the accreditation

tools
- Expert values
 under "Tests"

- General tab
 under "Other Parameters"

- User

0932195D 03/2019 7.0

Minor update on interface wording and screenshots (Configuring a test, Replacing a lot,
Users, Delta check)

Integration of the Coag.One installation mode, divisions

Addition of detail on the impact of choosing implicit and explicit mode on the application for
the Validation of patient results depends on validity of QC

Changes to printout headers according to the application being used, STA Coag Expert or
Coag.One

Changes to the monitoring of analyzer processes according to the application being used,
STA Coag Expert or Coag.One

Changes to fields in Patient Archives: addition of the "origin" field in detailed search,
changes to content of the "bench" field

Addition of restrictions in user rights

Addition of a note on the impossibility of creating a user account with a code that has
already been used

Addition of a note on the switching of results

Addition of a recommendation on Patient results validation dependent on QC

Addition of a note on the user rights needed to authorize division change

Addition of patient cost management

Changes to managing QC lots - Addition of paragraphs on deletion and on consultation of

current and archived lots

Changes to managing probationary lots

Changes to managing TAT alerts

Update of the number of files exported for the TAT

Addition of a section on Fast Manual Order Entry

Addition of a note on the unique name of procedures

Addition of details on QC test counting

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Table of Contents
1 Introduction.................................................................................................. 9
Presentation ............................................................................................................................ 9
Acquiring requests ................................................................................................................ 10
Processing requests.............................................................................................................. 10
1.3.1 Dashboard ............................................................................................................................. 10
1.3.2 Analyzer connection .............................................................................................................. 11
1.3.3 Validation of results ............................................................................................................... 11
1.3.4 Printing of results .................................................................................................................. 11
Returning results ................................................................................................................... 11
Traceability/QC ..................................................................................................................... 11
Notion of divisions for the Coag.One application .................................................................. 12
Header of printouts according to the application being used ................................................ 12

2 User identification ......................................................................................12

Authentication ....................................................................................................................... 12
2.1.1 User code and password ...................................................................................................... 12
2.1.2 Manual logout........................................................................................................................ 14
2.1.3 Automatic logout ................................................................................................................... 14
2.1.4 Exiting the application ........................................................................................................... 14
User rights ............................................................................................................................. 14
User account management ................................................................................................... 14
2.3.1 Password validity period ....................................................................................................... 14
2.3.2 Locking of user accounts ...................................................................................................... 15
2.3.3 Disabling/Deleting user accounts.......................................................................................... 15

3 Main Menu, Browsing .................................................................................17

Browsing principle ................................................................................................................. 17
3.1.1 Screen zone definitions ......................................................................................................... 18
3.1.2 Accessing a menu ................................................................................................................. 19
3.1.3 Browsing from a menu .......................................................................................................... 19
3.1.4 Managing alerts..................................................................................................................... 19
3.1.5 Management of process monitoring...................................................................................... 22
3.1.6 Division change ..................................................................................................................... 25
Main menu ............................................................................................................................ 25
3.2.1 Workstation ........................................................................................................................... 26
3.2.2 Quality Control ...................................................................................................................... 27
3.2.3 Tools...................................................................................................................................... 28
3.2.4 System .................................................................................................................................. 29

4 Workstation .................................................................................................30
Dashboard ............................................................................................................................. 30
4.1.1 Print ....................................................................................................................................... 31
4.1.2 Test Status ............................................................................................................................ 32
4.1.3 Tube status ........................................................................................................................... 33
4.1.4 General View ......................................................................................................................... 33
4.1.5 Counter View ......................................................................................................................... 35
4.1.6 Viewing a tube....................................................................................................................... 35
4.1.7 Viewing a test ........................................................................................................................ 37
4.1.8 Validation of results ............................................................................................................... 39
Creating requests .................................................................................................................. 42
4.2.1 [Manual Order Entry] menu ................................................................................................... 42

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4.2.2 Adding/Changing a patient .................................................................................................... 43
4.2.3 Adding a test ......................................................................................................................... 45
4.2.4 [Fast Manual Order Entry] menu........................................................................................... 45
Manual entry of results .......................................................................................................... 47
4.3.1 List of tubes ........................................................................................................................... 47
4.3.2 Entering values ..................................................................................................................... 49
Routing .................................................................................................................................. 49

5 Quality control ............................................................................................50

Definition – Environment ....................................................................................................... 50
Settings ................................................................................................................................. 53
5.2.1 Tests...................................................................................................................................... 54
5.2.2 Configuring QC lots ............................................................................................................... 56
5.2.3 Adding a lot manually ............................................................................................................ 58
5.2.4 Replacing a lot ...................................................................................................................... 59
5.2.5 Archiving/Stopping a lot ........................................................................................................ 61
5.2.6 Restoring a lot ....................................................................................................................... 61
5.2.7 Deleting a lot ......................................................................................................................... 62
5.2.8 Consulting/modifying a current lot by analyzer ..................................................................... 63
5.2.9 Consulting an archived lot ..................................................................................................... 63
Viewing by test ...................................................................................................................... 63
5.3.1 Selecting the test................................................................................................................... 63
5.3.2 Levey Jennings graph ........................................................................................................... 64
5.3.3 Viewing value graphs ............................................................................................................ 69
5.3.4 Table of values ...................................................................................................................... 71
Viewing by profile .................................................................................................................. 73
5.4.1 Current Values ...................................................................................................................... 73
5.4.2 Viewing by profile .................................................................................................................. 76
5.4.3 Quick Control ........................................................................................................................ 78
Managing probationary QC lots ............................................................................................ 79
5.5.1 Configuring probationary lots ................................................................................................ 79
5.5.2 Acquisition of QC values for a probationary lot ..................................................................... 80
5.5.3 Use of values ........................................................................................................................ 80
5.5.4 Activating the probationary lot ............................................................................................... 81
Moving average..................................................................................................................... 82
5.6.1 Definition ............................................................................................................................... 82
5.6.2 Moving average graph .......................................................................................................... 83
5.6.3 Rejecting points..................................................................................................................... 84
Managing EQCs .................................................................................................................... 84
5.7.1 Definition ............................................................................................................................... 84
5.7.2 Table of values ...................................................................................................................... 84
5.7.3 EQC connection .................................................................................................................... 86
5.7.4 EQC programs ...................................................................................................................... 86
5.7.5 Qualiris and sending EQC values ......................................................................................... 89
Automatic QC validation........................................................................................................ 91

6 Analyzer maintenance ................................................................................91

Definition ............................................................................................................................... 91
Analyzer maintenance operations to be carried out ............................................................. 93
Configuring an action ............................................................................................................ 95
Monitoring maintenance actions ........................................................................................... 97

7 Accreditation Tools ....................................................................................97

Definition ............................................................................................................................... 97
Management and display of the number of decimal places.................................................. 99

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Management of error values ............................................................................................... 102
Mechanism for rejecting and reincluding values ................................................................. 102
7.4.1 Mechanism for rejecting a line ............................................................................................ 102
7.4.2 Mechanism for reincluding a line ........................................................................................ 102
7.4.3 Comments on rejection and reinclusion .............................................................................. 102
Repeatability ....................................................................................................................... 103
7.5.1 Creating a repeatability procedure ...................................................................................... 103
7.5.2 Viewing a repeatability procedure ....................................................................................... 103
7.5.3 Repeatability procedure report ............................................................................................ 105
7.5.4 Closing a repeatability procedure ....................................................................................... 106
Reproducibility..................................................................................................................... 106
7.6.1 Creating a reproducibility procedure ................................................................................... 106
7.6.2 Viewing a reproducibility procedure .................................................................................... 107
7.6.3 Reproducibility procedure reports ....................................................................................... 109
7.6.4 Closing a reproducibility procedure..................................................................................... 110
Linearity ............................................................................................................................... 110
7.7.1 Creating a limit of linearity procedure ................................................................................. 111
7.7.2 Viewing a limit of linearity procedure .................................................................................. 111
7.7.3 Limit of linearity procedure report ....................................................................................... 112
7.7.4 Closing a limit of linearity procedure ................................................................................... 113
Analyzer comparison........................................................................................................... 114
7.8.1 Creating an analyzer comparison procedure ...................................................................... 115
7.8.2 Viewing an analyzer comparison procedure ....................................................................... 116
7.8.3 Analyzer comparison procedure report ............................................................................... 117
7.8.4 Closing an analyzer comparison procedure........................................................................ 120
Reagent comparison ........................................................................................................... 120
7.9.1 Creating a reagent comparison procedure ......................................................................... 121
7.9.2 Viewing a reagent comparison procedure .......................................................................... 122
7.9.3 Reagent comparison procedure report ............................................................................... 122
7.9.4 Closing a reagent comparison procedure ........................................................................... 126
Contamination ..................................................................................................................... 126
7.10.1 Creating a contamination procedure ................................................................................... 127
7.10.2 Viewing a contamination procedure .................................................................................... 128
7.10.3 Contamination procedure report ......................................................................................... 129
7.10.4 Closing a contamination procedure .................................................................................... 129
Measurement uncertainty ................................................................................................... 130
7.11.1 Creating a measurement uncertainty procedure ................................................................ 130
7.11.2 Viewing a measurement uncertainty procedure ................................................................. 130
7.11.3 Measurement uncertainty procedure report ........................................................................ 131
7.11.4 Closing a measurement uncertainty procedure .................................................................. 132
Stability ................................................................................................................................ 132
7.12.1 Creating a stability procedure ............................................................................................. 132
7.12.2 Viewing a stability procedure .............................................................................................. 133
7.12.3 Stability procedure report .................................................................................................... 134
7.12.4 Closing a stability procedure ............................................................................................... 135
Control time calculation procedure ..................................................................................... 135
7.13.1 Creating a control time calculation procedure .................................................................... 136
7.13.2 Viewing a control time calculation procedure ..................................................................... 136
7.13.3 Control time calculation procedure report ........................................................................... 140
7.13.4 Closing a control time calculation procedure ...................................................................... 140
Expert values ...................................................................................................................... 141
7.14.1 Customized table of values ................................................................................................. 142
7.14.2 Lab values ........................................................................................................................... 142
Settings ............................................................................................................................... 143
Import/Export ....................................................................................................................... 144

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7.16.1 Import from the IQCs........................................................................................................... 145
7.16.2 Import from a standard file .................................................................................................. 147
7.16.3 Importing a customized file ................................................................................................. 148
7.16.4 Exporting data ..................................................................................................................... 150

8 Other tools ................................................................................................153

Reference ranges................................................................................................................ 153
8.1.1 Selecting the test................................................................................................................. 153
8.1.2 Levey Jennings graph display ............................................................................................. 155
8.1.3 Displaying a value graph ..................................................................................................... 156
8.1.4 Value table display .............................................................................................................. 157
Internal Mail ......................................................................................................................... 158
8.2.1 Mailbox ................................................................................................................................ 158
8.2.2 Sending a message ............................................................................................................ 161
Test Count ........................................................................................................................... 161
8.3.1 Definition ............................................................................................................................. 161
8.3.2 Test count organized by origin (single origin to date) ......................................................... 163
8.3.3 Test count organized by Test .............................................................................................. 164
Total Analytical Time ........................................................................................................... 166
8.4.1 Exporting the TAT ............................................................................................................... 167
8.4.2 Tracking the TAT................................................................................................................. 167
8.4.3 TAT calibration .................................................................................................................... 169
8.4.4 TAT control .......................................................................................................................... 171
8.4.5 Advanced Tools .................................................................................................................. 172

9 Tests ..........................................................................................................172
Definition ............................................................................................................................. 172
General tab ......................................................................................................................... 173
Test report ........................................................................................................................... 178
Reference values ................................................................................................................ 179
9.4.1 Creating reference values ................................................................................................... 179
9.4.2 Delta check ......................................................................................................................... 181
Test Count/QC .................................................................................................................... 181
Connection .......................................................................................................................... 183
Automatic comments........................................................................................................... 186
Reflex test ........................................................................................................................... 188
Evaluation ........................................................................................................................... 189
Battery/Profile ...................................................................................................................... 193
Reflex rules ......................................................................................................................... 193
The reflex rules assistant .................................................................................................... 198
Tube types .......................................................................................................................... 204
Dictionary ............................................................................................................................ 204

10 Other Parameters .....................................................................................205

Analyzers ............................................................................................................................ 205
10.1.1 Definition ............................................................................................................................. 205
10.1.2 Configuration ....................................................................................................................... 206
10.1.3 List of tests .......................................................................................................................... 214
10.1.4 Mirroring management ........................................................................................................ 215
10.1.5 Products .............................................................................................................................. 216
10.1.6 Calibrations ......................................................................................................................... 217
10.1.7 Viewing a calibration ........................................................................................................... 218
Laboratory ........................................................................................................................... 218
10.2.1 Configuring the laboratory ................................................................................................... 220

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10.2.2 Communication lines ........................................................................................................... 223
10.2.3 Drugs ................................................................................................................................... 224
Users ................................................................................................................................... 224
10.3.1 User account ....................................................................................................................... 224
10.3.2 Levels and access rights ..................................................................................................... 225
10.3.3 Adding a user ...................................................................................................................... 229
10.3.4 Modifying a user account .................................................................................................... 231
10.3.5 Customizing user rights....................................................................................................... 231
Doctors ................................................................................................................................ 232
10.4.1 List of doctors ...................................................................................................................... 232
10.4.2 Adding a doctor ................................................................................................................... 233
Services .............................................................................................................................. 234
10.5.1 List of services .................................................................................................................... 234
10.5.2 Adding a service.................................................................................................................. 235

11 Archives/Traceability ...............................................................................235
Archives .............................................................................................................................. 235
11.1.1 Definition ............................................................................................................................. 235
Consulting the archives ....................................................................................................... 235
11.2.1 General search.................................................................................................................... 236
11.2.2 Viewing a patient's tube ...................................................................................................... 237
11.2.3 Viewing a test from the archives ......................................................................................... 239
11.2.4 Detailed search ................................................................................................................... 242
11.2.5 Exporting a selection from the archives .............................................................................. 243
11.2.6 Combining two patients ....................................................................................................... 244
Traceability .......................................................................................................................... 244
11.3.1 Use of directories ................................................................................................................ 244
11.3.2 Using the local database ..................................................................................................... 245
11.3.3 Log history ........................................................................................................................... 246
11.3.4 Alerts ................................................................................................................................... 247

12 Backup/End of day ...................................................................................248

Definition ............................................................................................................................. 248
Configuring an automatic backup ....................................................................................... 249
Manual backup .................................................................................................................... 252
12.3.1 Initiating a manual backup .................................................................................................. 252
End of day ........................................................................................................................... 252
12.4.1 Archiving ............................................................................................................................. 253
12.4.2 Removal of obsolete data ................................................................................................... 253
12.4.3 Analyzer connection ............................................................................................................ 253
12.4.4 Backup/verification of the base ........................................................................................... 253

13 Technical specification ............................................................................253

14 Appendix 1: Syntax for reflex rules and calculations ...........................253
15 Table of figures .........................................................................................257

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1 Introduction
This manual applies to the STA Coag Expert and Coag.One applications.
The application processes the data provided by the LIS before they are run on to the analyzers and data
transmitted by the analyzers before they are returned to the LIS.
This processing includes a set of management, validation and verification functions.

1.1 Presentation

Figure 1: Structural diagram

LIS CONNECTION
Communication driver
Data integration module
Results sending module

SOFTWARE application
Patient management
QC management
Tools
System
Other tools and Administration

Analyzer driver
ASTM protocol

The four major functions of the application are as follows:

- Acquiring requests.
- Processing requests.
- Returning results.
- Traceability/QC.

When the station is started, the required programs are automatically launched.
Figure 2: Task bar

In general, the following modules, determined by the installer, are available:

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 LOCAL
Local connection with the laboratory information system (LIS).

 ACQUISITION
Integration of requests into the database.

 ANALYZER
Connections with the analyzers, an icon for each connected analyzer.

 SOFTWARE application

COMMUNICATION PROBLEMS
In the event of a communication failure, the icon for the analyzer driver or for the local connection
driver shows a red cross.
Always ensure that the task bar icon is blue.

1.2 Acquiring requests

Requests for tests originate from:
- The local connection
- Manual creation from the user interface – See § 4.2 au-dessous
- Automatic creation by the analyzer driver (receipt of an unknown tube, for example)

The use of apostrophes is not permitted in the tube IDs from the local connection or when creating
a request.

Automatic creation by the analyzer driver:

On receipt of a result for an unknown tube, the analyzer connection driver attempts to create the
patient and tube based on the following information:
PID, Patient's surname, Patient's first name, Birth name, Gender, tube no.
- If the patient's name is unknown, a name is generated automatically according to:
NX- <Analyzer No.><Date in the format "yyMMddhhmmss">
- If the patient is adequately identified (PID + SURNAME or Surname + First Name
+ date of birth), a tube can be added for a patient who already exists.

Warning: In automatic creation, it is not possible to modify the patient identity, no archive search
for the patient who was created, therefore no history management.

1.3 Processing requests

1.3.1 Dashboard
Requests for tests are processed in several stages: managing tubes, loading analyzers, validating results and, if
applicable, printing results.
This module enables the following actions:
- Managing all the tubes and tests being performed.
- Viewing all the traceability of tests performed.
- Changing the content of a tube by adding or deleting one or more tests.
- Changing the status of the tube.
- Returning results to the LIS.
- Printing a tube report.

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- Validating and/or rerunning tests.

1.3.2 Analyzer connection

All the analyzers function in query mode.
 Reading sample barcodes and loading tubes on the analyzer.
The answer depends on the test panel of each analyzer.

 Receiving and saving results transmitted by the analyzer and the associated traceability information.

 Rerunning tests.
According to the configuration, requests can be sent for reruns on the analyzer that made the first
measurements.

 Receiving quality control results.

1.3.3 Validation of results

There are four validation modes for tests:
 Manual validation
Regardless of the result of the test and the patient background (age, gender, service, etc.), the result
must be technically validated by the user.

 Validation if normal results

The result is technically valid without the user's intervention if it is within a range set according to the
patient. There should be no blocking alarm generated by the analyzer.

 Validation if normal results and additional criteria passed

The result is technically valid without the user's intervention if it is within a range set according to the
patient and if the additional criteria set by the user are fulfilled. There should be no blocking alarm
generated by the analyzer.

 Black box validation

Regardless of the result of the test and the patient background (age, gender, service, etc.), technical
validation of the result takes place without the user's intervention.

1.3.4 Printing of results

The user can initiate the printing of patient results. The following printouts can be generated:
- Results for a single patient.
- Complete results, not yet printed (addition).
- Results for a service.
- Reprinting all patient results.

1.4 Returning results

Results are returned to the LIS.
The return of tests (RETURN) is automatic once the test is validated.

1.5 Traceability/QC
The application has different modules that enable complete management of the system's quality controls:
- Internal quality control with management of the Westgard rules.

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- Moving average with EWMA (Exponentially Weighted Moving Average) management.
- Patient reference values according to age and gender.
- External quality control management.
- Tools to verify methods and assistance with accreditation.
- Archiving patient results with all the traceability.

1.6 Notion of divisions for the Coag.One application

With Coag.One mode, setting divisions are applicable.
A division is a display restriction according to origin and analyzer.
Once a user session references a division, i.e., when a user logs in on a workstation installed in Coag.One mode
and the workstation defines a division at startup OR a particular division is selected from the [Division change]
window, the following display restrictions are applied:
- the origins shown in the drop down lists of the application menus are those of the current
division, and [All] corresponds to all the laboratories of the division
- the analyzers shown in the drop down lists of the application menus are those of the current
division, and [All] corresponds to all analyzers of the division

The display of data is updated according to the restrictions of the divisions.

The menus affected by these display restrictions are as follows:
- [Workstation]: [Dashboard], [Manual Results Entry], [Manual Order Entry]
- [Quality Control]: all sub-menus
- [Tools]: [Accreditation tools], [Maintenance Actions]
- Alerts: analyzer and QC
- [Monitoring processes]

For more information on setting divisions, see § 10.2.1

1.7 Header of printouts according to the application being used

For the STA Coag Expert, the header contains the information of the set laboratory: name, full address, zip code,
town, and telephone number.

In Coag.One, when the application references a division, the printout header provides the information of the
current division: name, full address, zip code, town, and telephone number. In the mode without a division, the
header contains only the laboratory name.

2 User identification

2.1 Authentication
Each time the application is started, the user is asked to log in with their login ID and password. The password is
case-sensitive (upper or lower case).
User authentication enables all the actions taken to be traced.
The connection history can be stored for a period defined in the configuration.

2.1.1 User code and password

Figure 3: Authentication

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Or

If a mistake is made during identification, whether in the login ID and/or the password, the following message is
displayed: [False authentification].
If the database used for this workstation is encrypted and the security key is missing or wrong, the following
error message may be displayed:

Figure 3: Security problem on login with an encrypted database

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If this error message is displayed on login, do not continue, select [Cancel] and contact a member of
Stago authorized personnel.
This may indicate a security vulnerability in saving the patient data.

2.1.2 Manual logout

The user can log out without exiting the application. The software returns to the authentication page, enabling
another user to log in.
This action is possible from all the sub-menus of the software.

Enables the user to log out

2.1.3 Automatic logout

For each user, the software administrator can set an automatic logout time (no keyboard or mouse action for X
minutes).
If no configuration is assigned to the user, the 5-minute default period is applied. A confirmation message must
then be validated.

2.1.4 Exiting the application

The user can exit the application from any user interface screen.
Enables the user to exit the application

2.2 User rights

There are four access levels for the entire application, including specific rights and those for lower levels. For
further details, please refer to the user rights defined in section 10.3.2.
An access is reserved for engineers duly authorized either by Stago or by one of its official distributors, which can
be used to define the administrator settings.

2.3 User account management

The options described below must be enabled/disabled with a member of authorized Stago personnel when user
accounts are being configured.

2.3.1 Password validity period

If the password validity period option is enabled and the password has expired, the user is warned on login that
their password has expired. They go to a window where they can enter and confirm a new password (with an
assessment of how strong it is).

Figure 4: Password expired

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The new password is subject to the usual verifications depending on the configuration enabled: strong password
and/or verification of previous passwords. See § 10.3.3

2.3.2 Locking of user accounts

If the option to lock user accounts is enabled, the user has a number of login attempts configured (incorrect login
and/or password) before their account is locked.
When the user reaches this number of authorized logins and their account is locked, the following message is
displayed:

Figure 5: Locking of user accounts

During this time, the user cannot log in to the application.

The lock counter is reset to zero when the disabling period has expired.

2.3.3 Disabling/Deleting user accounts

When the user account disabling/deletion option is set up, at least one user with full rights must be
configured so that this function can be managed.
When the disabled user or user to be deleted tries to log in, only users with full rights receive an alert
in their mailbox.
It is advisable to have at least two users with full rights (if one is absent, the other can re-enable
accounts).
Note: No user with full rights will have their account disabled/deleted.

2.3.3.1 Disabling the account

After the set period of time without a successful login, the user's account is disabled.
An account is disabled by default after 30 days of inactivity.

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When a user tries to log in with this account, users with full rights receive an alert in their mailbox and an error
message is displayed:

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Figure 6: Disabling a user account

The user will only be able to log in with their login ID/password once their account has been re-enabled by a user
with full rights.

2.3.3.2 Deleting the account

After the set period of time without a successful login, the user is informed that their account will be deleted.
By default, an account is considered for deletion after 90 days of inactivity.
When a user tries to log in with this account, users with full rights receive an alert in their mailbox and an error
message is displayed:

Figure 7: Deleting a user account

3 Main Menu, Browsing

The presence of the Coag.One or STA Coag Expert logo distinguishes the type of STAGO application. The type of
application is defined during installation.

3.1 Browsing principle

The application uses a single menu that provides access to all the functions.
The [MAIN MENU] has four sections.
 [Workstation] See § 4
 [Quality Control] See § 5
 [Tools] See § 6, 7, and 8
 [System] See § 9, 10, 11, and 12

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In general, the application windows fill the entire screen, except for some secondary windows centered on a gray
background, superimposed on the main window.

3.1.1 Screen zone definitions

Figure 8: Screen zone definitions

1. Upper panel.
Present in all the windows except in secondary windows (the panel is included in the window), and containing,
from left to right: the title and subtitle of the open window, the date and the time.

2. Right panel.
It has four zones:
 The button located above the tab provides access to online help.
 The buttons in the tab provide access to functions specific to the open window (print, export, set-up,
etc.)
 The buttons under the tab are permanent buttons that provide direct access to the sections in the main
menu and indicate the location in the application.
The disabled button corresponds to the open section.
 The last button, also available on all the application screens, enables the user to return to the previous
menu.

3. Main zone.
 Each window is described in the online help section corresponding to its function.

4. Lower panel.
It has various zones, including:

 Buttons to return to the [Main Menu], log out, change division, or exit the application, see § 3.1.3
 Managing alerts see § 3.1.4
 The name of the current user and the code of the division referenced by the Coag.One application with
at least one division configured

Figure 9: Example of the screen with the various zones

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3.1.2 Accessing a menu

The user can access a menu in two ways:
 From the [MAIN MENU], click the desired menu.
 From any window, by clicking the button for the section of interest in the panel on the right.

3.1.3 Browsing from a menu

From each menu, it is possible to carry out one of the following actions:

Stop the application.

Log the user out.

[Division change]
In Coag.One this enables the user to change division in order to apply filters to the origins and
analyzers relating to this division.

Return to the [MAIN MENU].

Return to the previous menu.

Access one of the four main menus.

3.1.4 Managing alerts

In the bottom panel, three icons indicate the presence of alerts:
Quality control alert(s)

Analyzer maintenance alert(s)

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TAT alert(s)

- Current alerts can be viewed by simply clicking the alert icon.

- Double-clicking the alert icon will allow direct access to the relevant menu without
clearing active alerts.
- Traceability for cleared alerts is available in the Traceability menu.

A mailbox icon indicates the presence of unread messages

3.1.4.1Quality control alerts

Three types of QC alerts are generated:

- "No value in the period" alert if no QC value was acquired in time, according to the QC validity
period defined for this test
- "Out of limit value" alert if the last QC value acquired for a level is out of specification, i.e.
higher than or equal to the low values and lower than or equal to the high values defined for
this QC level
- "Westgard alert" alert if the last QC value acquired for a level triggers a Westgard rule

- QC alerts are generated on the tests set in QC.

The test and the analyzer must be registered in the QC in the test and analyzer
settings.
The QC identifier and the control lot must be defined in QC Settings
- QC alerts do not concern probationary or discontinued QC lots
- In case of re-targeting:
QC alerts verify the QC values obtained in relation to current reference values.
Therefore, the values obtained prior to the last re-targeting are not evaluated.
For example: if the last re-targeting was on 05/23/2016 at 9:49 a.m., the Westgard
rules are only evaluated for QC results received after this date.

Figure 10: Viewing QC Alerts

Viewing the different QC alerts with the following for each line:
- The option to select a line to clear it.
- Analyzer/Test/ID number and code and name of the QC level/Details of the alert.
- Date and time the alert was generated.

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Clears all the selected alerts.

Direct access to the IQC menu.

In Coag.One, when the application references a division, only the [QC Alerts] associated with the
analyzers of the division are displayed.

3.1.4.2 Analyzer Maintenance Alerts

Two types of analyzer maintenance alerts are generated:

- Delay alert if a scheduled maintenance action was not carried out on time (to the nearest day,
i.e. D+1).
- Informative alert if this maintenance has never been carried out before.

Figure 11: Viewing Analyzer Alerts

Viewing the different analyzer maintenance alerts with the following for each line:
- The option to select a line to clear it.
- The analyzer number and code with the details of the alert.
- Date and time the alert was generated.

Clears all the selected alerts.

Direct access to the menu Maintenance Actions – To Do.

In Coag.One, when the application references a division, only the alerts from analyzers of the division
are displayed.

3.1.4.3 TAT Alerts

A TAT alert is generated on pending files, for each test and for each tube for which a rule defined for the TAT has
a deadline that has expired or will soon expire.

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- For definition of TAT rules. See § 8.4.3.

- In the event of a rerun, the TAT alert is not calculated on each run for a test, but
globally (receipt time for the last result or validation time).

Figure 12: Viewing TAT Alerts

Viewing the different TAT alerts with the following for each line:
- The option to select a line to clear it.
- Test code, tube number, wording of the alert, start and end times specified in the TAT rule,
and calculated period between these two stages.
- Date and time the alert was generated.

Clears all the selected alerts.

Direct access to the TAT menu, time tracking.

In Coag.One, when the application references a division, only the TAT alerts of the division are
displayed.

3.1.5 Management of process monitoring

Process monitoring enables real-time oversight of the status of one or more local connections as well as one or
more analyzer drivers.

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If process monitoring is set up in the application, it can be accessed directly from any application main window
using 2 icons located to the left of the alert icons in the panel at the bottom of the application.

Figure 13: Viewing process monitoring icons in the panel

These icons are "plain" if the processes being monitored are operating correctly and are not in error or aborted.
These icons are displayed with a "stop" sign if the processes being monitored are in one of the following statuses:
- Could not start
- Has been aborted
- A communication error has occurred

The table below lists the meaning of each of the icons.

Local connection monitored and operational

Analyzer driver(s) monitored and operational

Local connection monitored and non-operational

Analyzer driver(s) monitored and non-operational

Clicking one of these two icons displays the process monitoring viewing window.

In Coag.One with divisions, only the processes of analyzers belonging to the current division will be
taken into account. In Coag.One mode without a division, the processes of all the analyzers are
viewed.

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Figure 14: Viewing the process monitoring window

Using [(re)Start all] and [Stop all] will have this effect (start or stop) on all the processes displayed.

- The status of the icons, the actions possible on the buttons and the information text
in this viewing window are updated a maximum of 2 minutes after a real change in
the status of a process on the relevant machine.
- If it is not possible to view all the processes on the first page, the single arrows can
be used to navigate page by page, to the left or right.
- The double arrows are used to navigate to the first or last page.

Figure 15: Viewing a process block

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For each process, there is an option to use the following:
- to start this process if it has aborted, or to restart it if it was already started.

- to stop this process, if it has started

- The date and time next to the status bullet correspond to the latest update to the
status of the process being monitored.

Hovering over the bullet gives information on the status of the process being monitored.

Process started/Active for less than 2 minutes

Process aborted/Inactive for more than 2 minutes

Temporary stop (manual) of the process

Start-up problem with this process

Communication error for which the process is responsible (LIS or Analyzer)

Process monitoring refresh problem detected for this process

3.1.6 Division change

For Coag.One with a division configured, a button to change division is visible throughout the application.
Clicking this button opens a window listing all the available divisions.
Figure 16: Division change

The user can change the division by selecting one of the divisions. The division name, located below the
username, is updated. In addition, if the current window is among those affected by the division change, it will
be reset.

3.2 Main menu

The [MAIN MENU] is automatically displayed after the user is identified. This window is also accessible from any
menu screen.
From this window, the user accesses all the user interface menus.

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The application version and the UDI (Unique Device Identification) number appear at the top right of the [MAIN
MENU].
Figure 17: Main menu

Four main menus:

 [Workstation]
Groups together tube and patient management.

 [Quality Control]
Groups together all the modules related to quality control as well as the patients' moving average.

 [Tools]
Groups together a set of tools used occasionally.

 [System]
Groups together the configuration of the entire software and the tools related to traceability.

3.2.1 Workstation
Figure 18: Workstation

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 [Dashboard]
In this menu, the user finds all the information related to the management of tubes: display of what is
pending, validation of results, printing out of reports and viewing of the traceability of technical tests
(reagent lot, cuvettes, etc.).

 [Manual Order Entry]

Managing patient requests: creating requests, list of patients, changing patient demographic data,
adding tests and tubes, deleting patient files.

 [Manual Results Entry]

Manual entry of results of tests requested.

RISK OF ERRONEOUS RESULTS.

Manual entry can be a source of entry errors. It should only be used when communications with
the LIS and/or the analyzers are interrupted.
Manual entries are entirely the user's responsibility.
Results entered manually are identified in the system's traceability files.

 [Routing Samples]
Viewing the analyzers on which the tube should be placed to fill the entire order, taking into
consideration the list of tests for the tube, and the analyzer exclusions.

3.2.2 Quality Control

Figure 19: Quality Control

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 [IQC]
Viewing all the internal quality control values, with full management of the configured rules and the
traceability.

 [Current Values]
Viewing current values or those for a period for validation or the difference in IQC results.

 [Work by QC profile]
Viewing the results of all the tests belonging to the selected profiles on the same screen.

 [Moving Patient Average]

Viewing the equal-weighted or exponentially weighted moving averages (EWMA).

 [EQC]
External quality control management.

 [Settings]
Configuration of the different quality control levels, with the associated values.

 [Quick Control]
Rapid viewing of errors or absence of results, if any, for all tests.

3.2.3 Tools
Figure 20: Tools

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This menu has five sub-menus accessible to the user and one sub-menu (Advanced Tools) specifically for
personnel duly authorized by Stago or its official representatives.
 [Maintenance Actions]
Management of the maintenance actions related to analyzers. Users can create their own actions or
take them directly from the analyzer connection (the required protocol is ASTMV3).

 [Accreditation tools]
Management of all the protocols related to performance verifications (repeatability, reproducibility,
comparison of methods, contamination, and uncertainty calculation), as well as writing the method
verification file.

 [Patient Reference Ranges]

Access to statistical values on the patients' test values. Reference values can also be determined from
this menu.

 [Internal Mail]
Management of internal messages between application users.

 [Test Count]
For each test, viewing of the precise number of tests performed, reruns, and quality controls for a given
period.

 [TAT]
Total Analytical Time
To define, for a test or for an analyzer, the completion time between two steps (receipt of the file, time
of collection, receipt of the result, sending of the result). Other criteria can be added, such as the service
or the notion of urgency.

 [Advanced Tools]
This menu is reserved for engineers duly authorized either by Stago or by one of its official distributors.

3.2.4 System

Figure 21: System

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 [Tests]
Configuring tests (test code and name, decimals, automated reruns, Transmission Rank, Delta Check,
etc.).

 [Analyzers]
Viewing the configuration of connected analyzers, activation/deactivation of a test (exclusion mode),
transmission rank, configuration of the communication line.

 [Laboratories]/[Divisions]
Configuring the host laboratory (name, address, telephone, fax, e-mail), the communication line, and
the divisions if the application being used is Coag.One.

 [Other Parameters]
Configuring user accounts (code, password and access rights).
The user can also view the service and prescriber directories.

 [Patient Archives]
Access to all traceability related to a test performed over the previous days (number of archiving days
set in the application; 2000 days by default). This menu can be used to search for tests on the basis of
various criteria (period, reagent, result value, etc.).

 [Backups]
Access to the configuration of backup files as well as the launch of a manual or automatic backup.

 [Traceability]
Access to the management of result file, quality control and accreditation assistance directories, as well
as to changes made in the database (deletion of tests, deletion of tubes, change in the configuration,
etc.).

4 Workstation

4.1 Dashboard
All the functions related to specific bench processing actions can be accessed from the workstation.
 Home page.
 Analyzer loading list.

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 Entry and validation of results.
 Return of the results to requester(s).

In the context of the workstation, the dashboard presents the tubes being processed at their different stages of
progress.
- In Coag.One, when the application references a division, the dashboard display is restricted to the
current division: only tubes belonging to laboratories of the division or tubes processed on
analyzers of the division are visible.

- The list of tubes and their status is not updated automatically.

When the Laboratory Information System (LIS) sends new requests for patients, the refresh button

should be used:

Figure 22: Workstation

Print.

Viewing tubes.

Creating requests.

Manual entry of results.

Access to routing of tubes.

4.1.1 Print
Clicking the "Print" button on the upper panel opens the panel [In process list] giving access to 4 printout modes:

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 [List]:
Printout of patient tubes meeting the selection criteria for display, in list form.

 [Table]:
Printout of patient tubes meeting the selection criteria for display, in tabular form.

 [Condensed]:
Printout of patient tubes meeting the selection criteria for display, in condensed form.

 [Rerun tests]:
Printout of validated or transmitted tubes rerun manually from the application.

Figure 23: Choice of printout mode

4.1.2 Test Status

A test passes successively through several statuses:

 [Pending]
For this test, a value has been entered but not validated.

 [To be validated]
At least one value has been obtained for this test, either by manual entry or by analyzer acquisition.

 [Validated]
The test was validated by a user or by an analyzer driver algorithm on receipt of the result.
It might be returned to its laboratory of origin.

 [Rerun]
On validation, the "Rerun" button was activated for this test. The test will maintain this status until the
"Rerun" button is activated again.

 [Transmitted]
After validation, the test was sent back to its origin.

Specific examples:
A "Calculation"-type test is directly included with [To be validated] status. In fact, since its value depends on the
values of other tests, it is not accessible to the user during manual entry.
An "Alpha Complementary" or "Numerical Complementary"-type test is directly included with [To be validated]
status. In fact, its value will only be obtained at the time of biotechnical validation.

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4.1.3 Tube status

A given tube passes through several successive statuses according to the status of its constituent tests.
 [Transmitted]
All the tests for this tube have been transmitted to the performing laboratory.

 [To be validated]
At least 1 test for this tube has a "To be validated" status.

 [Validated]
All the tests for this tube have a "Validated" or "Returned" status.

 [Rerun]
At least 1 test for this tube has a "Rerun" status, regardless of the status of the other tests.

4.1.4 General View

In the context of the workstation, the dashboard presents the tubes being processed at their different stages of
progress.

Figure 24: Dashboard (general view)

This list can be selective:

- For one particular source laboratory (origin) for the patient or [All]
- For one particular analyzer or [All]
- For one particular service or [All]
- For one particular test or group of tests or [All]
- By tube status
- By the notion of urgency of tubes

By clicking the column header, this list can also be sorted by:

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 [Origin] only if the application is Coag.One
Number of the patient's source laboratory

 [Sample ID]
Tube number transmitted by the LIS.

 [Name]
Patient's surname transmitted by the LIS.

 [First name]
Patient's first name transmitted by the LIS.

 [Status]
Tube status that changes according to the progress of the test comprising it.
Several choices can be made simultaneously.

 [On Board]
Tubes that have been queried by an analyzer.

 [Bench]
Code of the Analyzer that processed the testing of the tube.
In certain cases, this column may contain:
MANU In the case of manual entry of results
… When several tests from the tube are processed on different analyzers (including manual
entry)

 [ ]
The notion of urgency associated with the tube.

 [Date/time]
Date and time the request was sent by the LIS, or the date the request was created on the interface.

Searching for a patient tube by name.

Entering a character string enables the user to display all the patient tubes
containing this character string.

Searching for a patient tube by tube number.

Entering a character string enables the user to display all the patient tubes
containing this character string.

When searching for a tube in the Coag.One application, if the tube is found outside the division, it is displayed in
the search window with the note [Off Restrictions Analyzer] or [Off Restrictions Origin]

- [Off Restrictions Analyzer] corresponds to a tube for which at least one test was processed on an analyzer outside the division
- [Off Restrictions Origin] corresponds to a tube where the patient source laboratory is outside the division
- If the origin of a tube does not belong to the current division and no test has been processed on an analyzer from that division, only the note [Off Restrictions origin]
is displayed

[Patient Result Report]

Access to printouts of patient reports.

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[Change Status]
Change in the status of the tube and all the tests it contains. The status of tests can only be "retrograded": a test
can go from a [Validated] status to a [Pending] status.
The opposite is not possible: a test that is [Pending] cannot be changed to a [Validated] status.

[Delete]
Deletion of tubes and all the tests comprising them.
The tube will no longer be accessible anywhere in the software.
In the event of incorrect handling, the request must be sent again from the LIS.

4.1.5 Counter View

The user can see the number of tests remaining, in real time for each test, on the basis of the various stages of
progress.

Figure 25: Dashboard (counter view)

4.1.6 Viewing a tube

Double-clicking a tube from the General tab on the Table allows the tube details to be viewed.
Technical validation works on tubes with a [Rerun], [To do], [In progress] or [To be validated] status, on condition
that at least one of the tube tests has a [To be validated] status.

Figure 26: Validating a tube

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1. Information on the patient and on the tube.

The [Pre-analytical] zone gives the Hemolysis ("H"), Icterus ("I"), Lipemia ("L") and "Volume control"
values that are returned by the analyzer.
The drug treatment is associated with the tube. In case of multiple tubes for the same patient file,
the drug treatment and its use in the reflex tests is applicable tube by tube.

2. Overview of all the tests. Each test includes the following information:
- The name of the test.
- The current result obtained.
- The unit.
- The previous result, if the test was rerun from the workstation.
- The launch of the test rerun.
- The alarm code and the error code.
- The presence of a comment.
- The value and date of the patient's last test.
- The traceability for the test (reagent, cuvette, cleaner, etc.).

[Patient Result Report]

Printout of the patient report.

[Sample History]
Enables viewing of all the stages of the tube at the bottom of the window.
Hides/shows the tests for intermediate calculations.
This button is present when at least one patient tube test is set to not "visible in
validation".

Moves to the previous tube or the next tube.

Runs all the tube tests in the "urgent" status.

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[New]
Adds one or more tests to the tube.

[Delete]
Deletes one or more tests from the tube.

To rerun a test, the user must select the [Rerun] checkbox for the chosen test and click [Save]. If the test belongs
to a group, all the tests in the group will be rerun.

Validating or rerunning a test that belongs to a group results in the validation or rerunning of all the tests for this group.

Switches results after clicking [Prev. res.].

NB: Switching results should be done manually for each test in a group.

4.1.7 Viewing a test

When a patient tube is being viewed, double-clicking the test name provides access to all the information related
to performance of the test.

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Figure 27: Details of a test

1. Information about the test:

- Current and previous results.
- Alarm and error flags.
- Request creation date.
- Date and time the result was obtained.
- The analyzer that performed the test.

2. Information about the reagents and consumables used.

3. QC report.

4. History of the actions entered/validation.

CAUTION in case of calculated results: for accurate traceability of the analyzer responsible for the
result in the action history, the intermediate results used for the calculation should come from the
same analyzer. If this is not the case, the analyzer for the first result included in the calculation will
be the one that is traced.

Viewing all the runs of the test on the analyzers.

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Figure 28: Runs for a tube

4.1.8 Validation of results

Figure 29: Patient tube validation window

When the validation window is opened, certain tests are pre-checked as [Validate].
For a test to be eligible for validation, it is required to have a "to be validated" status and must have valid QC
values (if patient result validation dependent on QC is enabled).
In Coag.One, validation is restricted to tubes for which at least one test had results processed by an analyzer
belonging to the current division. All tubes that have had a result entered manually (or calculation-type or
complementary result) are eligible for validation.
For a tube eligible for validation, tests that were processed on an analyzer outside the division can be
distinguished by their color matching the background color of the page, except for the [Result] column.
This checkbox can be manually selected/deselected. Clicking [Save] enables validation of these tests.

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Tests from the same group or the same battery of tests are connected together. The [Validate]
checkbox for these tests is therefore pre-checked as "Validate" only when all the tests in this group
or this battery have a "to be validated" status and all the tests have valid QC values (if validation of
patient results dependent on QC is enabled)

4.1.8.1 Parallelism of factors:

Provides access to the parallelism of factors curve during results validation

- This icon is only displayed if the tube has a minimum of two tests that refer to the
same calibration, with at least one of them set as the main test for the calibrations.

All the tests used for the parallelism of factors must be set with "View calibration curves".

- In the context of reflex rules with a result report from a test or calculation, the
detailed results interface shows no error code or alarms in the [Flag] column.
Nevertheless, the application always transmits the reported result to the
Laboratory Information System (LIS) with the error code A (for Validated result) and
the alarm code @ (for no alarm).

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Figure 30: Parallelism of factors

4.1.8.2 Patient results validation dependent on QC

For each analyzer, the validation of patient results is subject to an evaluation of the QC validity for this test. This
function can be enabled by the Stago service engineer at installation.
When using Coag.One, setting up validation dependent on QC on all the analyzers is strongly
recommended.

When this function is enabled, the following settings are examined:

- Verification that the last QC values are acquired on time in relation to the QC validity period
set for this test
- Verification that the number of QC levels required for this test has been reached.

 If at least one of the conditions is not met, a red bullet to the left of the result
indicates that the QC conditions for this test are not valid. In this case, the result
is highlighted in orange and the "Validate" checkbox for the result is not pre-
checked for validation.  If the test is part of a group/battery, results blocking
applies to the group.
 If both these conditions are valid, a green bullet to the left of the result
indicates that the QC conditions for this test are valid and the "Validate"
checkbox for the result is pre-checked for validation.
 A gray bullet will be displayed only under the following conditions: Patient
results validation is enabled on at least one analyzer AND disabled on all the other
analyzers.

For the "number of QC levels required" condition to be valid, the values of the QCs obtained must
be validated beforehand:
- either manually by the user in the QC menu
- or automatically with the automatic validation of QCs. See § 5.8
Caution: changing the QC status is not retroactive: validation of a QC after the event does not imply
automatic validation of the patient result.

Double-clicking the bullet to the left of the result gives access to the QC conditions report for this test.

Figure 31: Example of an invalid QC report (red bullet)

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This QC report is created in the following manner:

Line 1: Rules for evaluating the QC condition:
"evaluation date for this report" - QC - "Analyzer no."/"test name"/Reported on "QC result reported date"/Levels
to be verified: "Number of levels required for this analysis" - "QC validity period for this test"
Lines 2 to N: Detail of lines for verified QCs:
"report date of QC" - "level name"/"level ID"/"lot"/"result"

Last line of the report: 4 possible conclusion types:

- Invalid: no valid level found
- OK
- Invalid
- Invalid: not enough valid levels found (x/y)
If the QC conditions are not met, the tube remains blocked in validation and the test remains in the "To
be validated" status. The result is not sent to the LIS without manual validation of the result.
Only a user with full rights can then:
 Either force the validation of this result by validating a clearing message with traceability in the
details of the test.
 Or cancel the processing of this tube, then carry out the operations required in terms of the QC
values (validate the lines, for example) and resume the operation.

There are several QC results validation modes, see § 5.1

4.2 Creating requests

4.2.1 [Manual Order Entry] menu

This menu gives access to the list of pending files. All the actions are available:
- Deletion.
- Changing a patient.
- Changing their prescription.

The entry point for creating requests is the patient list. This list is presented by default in alphabetical order but
this choice can be changed by clicking one of the columns.

Figure 32: Creating the request

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Can be used to search for a patient by name or PID.

When searching for a tube using the Coag.One application, if the tube is found outside the division,
it is displayed in the search window as outside of restriction with the note [Off Restrictions Analyzer]
or [Off Restrictions origin]

[New]
Enables the user to add a patient.

[Delete]
Enables the user to delete a patient.

Deleting a patient deletes both the patient and all the patient's tubes. In the event of an error, the
request should be sent again from the LIS.

4.2.2 Adding/Changing a patient

Figure 33: Adding a patient

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21
1
1
1
1

1. Search in the archives

2. General information
3. Additional information

[Validate]
Validate the creation of a patient.

[Validate and New]

Validate the entire entry and reinitialize the fields to include another patient.

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4.2.3 Adding a test

Figure 34: Adding a test

This grid enables quick entry of the entire prescription either by double-clicking in the list on the tests to be
added or by directly entering the code in [Fast test entry] and then pressing Enter.
When all the tests have been selected, click [Validate].
The test panel is broken down according to the types of samples and the distribution of the tests on the analyzers.
Tube numbering is suggested according to the general configuration information. This can be modified either
manually or by using the bar code scanner if the tubes are already labeled.

When creating a tube, the use of apostrophes in tube IDs is forbidden.

4.2.4 [Fast Manual Order Entry] menu

Double-clicking the create request icon opens the [Fast Manual Order Entry] window, which enables the user to
create with just a few clicks a set of tubes to which the same series of tests applies.

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Figure 35: Creating a fast request

- Check the laboratory of [Origin]. It will be the same for all the tubes.
- Enter (or scan) the tube numbers.
The list of tubes appear in the associated grid.

- The [QC] checkbox is used to indicate whether or not the tubes created should be considered QC tubes

- Patients are created with the minimum information:

-Three options for the PID:
 The four letters "PID-" followed by the tube number
 The unchanged tube number
 Adding the chosen prefix
- Three options for the patient name:
 The eight letters "PATIENT-" followed by the tube number
 The unchanged tube number
 Adding the chosen prefix

If a patient with the same Origin + PID + Name is found, the new tube will be associated with that patient, and if
not, a new patient will be created.

- For entering a joint order:

 If necessary, refine the selection of the set of tests by specifying the reference
analyzer
 Enter the name of the test
or
Use a battery (in green) or profile (in black), although using a profile is not
recommended here.
or
Click directly on the test.

- Click on [Validate] to complete the entry and launch patient/tube/test creation.

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- A summary of the operations is shown if the [Show report] checkbox is selected

Using these menus in failsoft mode (in the event of emergency or backup of the LIS)

4.3 Manual entry of results

Manual entry works on tubes with [Rerun], [To do] or [In progress] status.
All the tests are displayed. However, the results for those that do not correspond to the desired status are
displayed in gray and cannot be modified.
For example: the result of a “Calculation”-type test is not accessible. The result of a test that is already
validated is not accessible.

4.3.1 List of tubes

Figure 36: List of tubes for which manual entry is applicable

In Coag.One, when the application references a division, the list of tubes whose origin belongs to the current
division is displayed. In Coag.One without a division display restriction or in STA Coag Expert, all the tubes are
displayed.
Several display choices are possible from this screen:
 The list can be sorted according to the following information:
- Patient name.
- Tube number.
- Urgent status.

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 Entering the results of a test.
Tubes for which this test is not included are not displayed on the list.

 Entering the results of a group of tests.

Tubes for which at least one of the group of tests is not included are not displayed on the list.

 Choice of tubes from a laboratory.

The other tubes are not shown on the list.

 Access to results entry by double-clicking the line for the selected tube.

Entering the tube number in the search box provides access to all the known tubes that are in progress.
In Coag.One, if the tube is outside the division, it is displayed with the note [Off Restrictions Analyzer] and/or
[Off Restrictions origin], and the results can be entered manually.

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4.3.2 Entering values

Figure 37: Manual entry screen

The user must enter the result in the [Result] column corresponding to the test line.
 [Save]
Validates entries across the entire window.

 [Save and next sample]

Validates the window entry and moves on to the next tube according to the selection criteria for the
list of tubes.

4.4 Routing
The objective is to obtain the distribution of tubes per analyzer according to the tests prescribed. A search for
the best placement of the tube is carried out to optimize its technical course, i.e., running it on a minimum of
analyzers.
In Coag.One, if a division is configured, the list of analyzers shown is restricted to those of the division.

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Figure 38: Routing

Distribution and technical course.

Two types of markers can be displayed for the placement of a tube:
 A green cross indicates a mandatory placement.
One, several or all of the tests should be carried out on the analyzers indicated by these
crosses.

 A blue cross indicates that the tube can be placed on any of the analyzers.
The list of possible analyses is displayed for each analyzer.

The cursor remains on the tube number entry.

If there is a new entry or a new scan by bar code scanner, the screen is automatically updated.

5 Quality control

5.1 Definition – Environment

The application manages all of the internal quality control for the multi or mono-parametric lots and ensures
centralized viewing of IQCs taking into account the Westgard rules set for each analysis.
Integration of the results of IQCs transmitted by the analyzers, as well as the information related to the lots (lot
number, expected values), is automatic for the analyzers that transmit this information.
QC values can be integrated under the same conditions as patient tubes by using specific tube numbers, with a
prefix or a suffix, see § 10.1.2, QC tab.
Storage of all the data can be configured by site (2,000 days by default). Throughout this period, management of
quality control lots enables the graphs to be recreated, with the target values and standard deviations associated
with the results.
The software also enables management of external quality control programs in order to be able to prove
traceability, as well as to include them automatically in the uncertainty calculations.

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Finally, each analysis can be set to display a graph of the moving averages according to two methods: EWMA, or
equally weighted.

The mechanism for validating QCs is as follows:

- When [implicit validation for QC] is enabled, the "Validated" status for a QC line is ignored
For QC results received from an analyzer or entered manually, the QC condition is always considered valid except
in cases where the QC validity period has passed and the number of levels has not been reached. The user does
not need to validate QCs in the daily controls.
This means that even if the Westgard rules are broken and/or the QC is out of range, the QC is considered valid,
i.e., applicable in validation and eligible for sending to the SGL.

- When [implicit validation for QC] is disabled, the "Validated" status for a QC line is required
Two possible configurations:
o [QC automatic validation] is disabled in the analyzer settings:
The user must manually validate or reject the QC values from the [Current Values] menu. The user can
decide to validate QC values even if they are considered out of range, exceeding time limits, or breaking
Westgard rules. (See § 5.4.1).
o [QC automatic validation] is enabled in the analyzer settings: The application performs automatic
validation of the QC values according to the standard rules (See § 5.8). If necessary, the user can manually
validate any QC values that were entered manually using the [Current Values] menu.

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Figure 39: Quality Control menu

Access to values by test, by period (IQC)

Access to the Current Values

Access to viewing of the QC by profile

Access to quality control settings (Settings, QC lots, Profiles)

Access to the additional quality control menu (Quick Control, moving average, EQC)

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Figure 40: Quality Control menu (continued)

Access to Quick Control

Access to the Moving average

Access to the EQCs

Access to quality control settings (Settings, QC lots, Profiles)

Return to the quality control main menu (IQC, Current values, QC by profile)

In Coag.One, all of the sub-menus are affected by the divisions. For more information on the
functioning of divisions, See § 1.6.

5.2 Settings
This menu provides the list of tests set for the management of IQCs, with the different levels for each test.
The tests are grouped by analyzer/in alphabetical order. A test that appears on several analyzers is displayed for
each one of them. For a test to be on the list, it must be checked as being part of the quality control and
corresponding to the two selection criteria ([Analyzers]/[Profile]).

Figure 41: Quality control settings

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Enables the user to toggle between the IQC values and the current values.

Access to the test settings for IQCs.

Access to the configurations for quality control lots.

Access to the configurations for profiles.

[Add a test to QC]

Enables the reintegration of a test that was removed.

[Remove test from QC]

Enables the removal of a test from quality control processing.
Selecting the analyzer or [All], selecting a profile or [All], and then double-clicking on a test provides access to its
quality control configuration grid.

5.2.1 Tests
5.2.1.1 Overview

Figure 42: Settings for quality control tests

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2

1. Gives access to the archived levels (archived lot for this level).
2. Gives access to re-targeted levels (previous expected values for this lot).
3. Enables the user to create/modify/view the probationary level associated with this level.
[Validate]
Validates all the entries in the configuration grid.

Enables the user to scroll through the levels.

[Level name]
An order number is allocated to each level. Each level can have a name.
The notion of Low, Avg. or High is used, if applicable, to match the lot described in the experts’ reference tables.

[Analyzer]
Selects the analyzer to which the level will be allocated. In Coag.One with a division referenced, only analyzers
from the division appear in the list.

[ID]
Identifies the vial corresponding to the control identification number.
Each level has its own identification but several tests can be found for the same identification.
The same test can be defined for several analyzers with the same identifier. This information is always given by
the analyzer. If the analyzer does not give the "lot number" information, this identification is then used to find
it. If the test is performed at several levels, identification is required to distinguish them.

[Lot Number]
Current lot number. If the analyzer does not return this information when connected, it must be entered.

[Profiles]
If necessary, selects the profile to which this test belongs for this level.

[Expected values]
To determine whether the QC values obtained are valid, the threshold values (lower and upper) must be set for
this level. The target value and the standard deviation are automatically calculated according to the low and high
values entered. The definition of these settings is important because they are used in particular for automatic
validation of QCs, QC alerts and Quick Control.

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The expected threshold values can be adjusted either from this interface, or directly on the analyzer. In both
cases, modification of these threshold values generates re-targeting for this lot.

For the Max analyzer (except for the STA Satellite Max), with each change of lot on the analyzer, the transmission of a QC result automatically
modifies the level concerned, with the new lot and its associated values.
Once the expected values for a QC lot, received via connection with the analyzer, change, the threshold values are updated and generate a re-
targeting event.
For the STA Satellite Max, the threshold values will need to be entered manually or will have lot propagation management from other analyzers
from the Max range.

5.2.1.2 Settings for probationary lots

When the probationary lot is created, the probationary levels are automatically created for the associated
current lot/analyzer pairings, but the user can still manually manage the probationary levels from the QC level
configurations (see point 3 in Figure 42: Settings for quality control tests and see § 5.2.1.1).

[Create a level for evaluation]

Enables the user to create and view the probationary level associated with this level.

[Show the level in evaluation]

Enables the user to view the probationary level associated with this level and make the desired changes.
When a probationary level is created, the ID and analyzer for the current QC level are preserved by default, and
the user must choose the probationary lot from a drop-down list with only the active probationary lots.

The probationary level has information that is distinct from the current level:
- Level name,
- QC ID,
- QC lot,
- Expected values (lower, target, upper, standard deviation and CV).

All these settings can be modified later.

For further information on the management of probationary lots, see § 5.5.

5.2.2 Configuring QC lots

The control lot identifies the production line for the control lot and is required to ensure the traceability of
controls.
It is therefore important that this notion is always present and is associated with the quality control result.
The lot number is not necessarily given by the analyzer when it is not launched from the quality control menu of
the Max analyzer. In this case, it is essential to enter and manage it from this menu.
When the analyzer gives a QC result and the lot number is not given, it is the current lot number for this test and
this tube identification that is recorded.

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Figure 43: List of quality control lots

Lots are separated into 4 lists:

 [Current Lots]
Lots for which the [Expiry date] has not passed.

 [Archived Lots]
Lots archived manually or via connection, and lots for which the [Expiry date] has passed.

 [Lots with errors]

Lots for which the expiry date has passed but which are still set in the QC levels.

 [Lots in evaluation]
QC lot in an evaluation period before the control lot is changed.
During this period and according to SH GTA 06, this new "probationary" lot is analyzed like a patient
sample. The compliance of the technique is ensured by the current control lot.
See 5.5.2 for acquisition of the probationary value.

A control lot is characterized by the following information:

- Its number.
- The analyzer on which it is configured.
- Its activation date.
- Its expiry date.
- A comment that enables its identification, if necessary [Information about this lot: full name,
manufacturer, etc.].

The search can be refined by directly entering the lot number or simply a part of the number.
 Double-clicking on a line corresponding to a lot/analyzer pairing enables access to its configuration.

[Replace]
Access to the replacement of a lot.

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[Archive/Stop]
Archive or stop a lot.

[New]
Add a lot manually.

[Delete]
Permanent deletion of a lot.

Deleting a lot results in the deletion of all the levels that refer to this lot (whether or not they are
archived).

5.2.3 Adding a lot manually

A new control lot must be entered once it is activated. This will enable an exact match between the control values
received from the analyzer and the current control lot.

To enter the new control lot, the lot number, its activation date and expiry date, and the associated analyzer(s)
must be entered and, if applicable, it can be associated with a comment to enable quick identification in
[Information about this lot: full name, manufacturer, etc.].

All the analyzers from the environment are selected by default, but it is possible to choose only particular
analyzers.
All the settings entered will apply to all of the lot/analyzer pairings selected when creating the lot.

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Figure 44: Adding a quality control lot

The [Test QC lot] checkbox enables the user to enter the settings of a probationary lot/analyzer pairing.
For details on creating a probationary control lot, see § 5.5.1.

5.2.4 Replacing a lot

This is an automatic action for the analyzers that transfer control lots along with their configuration (expiry date,
lower and upper values). The old lot is then archived, with storage of all the values for the levels concerned.
When the analyzer does not transmit the lots, it is the user's responsibility to change the lot.

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Figure 45: Replacing a lot

To replace a lot:
 Select a lot created previously from [New lot].
 Select the lot to be replaced in [Old lot].
 Select the analyzers for which the lot needs to be replaced.

In the example in Figure 45: Replacing a lot:

- The old lot 444555 will be archived.
- The tests that refer to the old lot 444555 now refer to the new lot 444888.
- "Replaced by lot 444888" appears in [Information about this lot: full name, manufacturer,
etc.] for lot 444555.

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5.2.5 Archiving/Stopping a lot

Stopping or archiving a lot enables the user to archive the lot for one or more analyzers. Its stop date is the
current date and all the levels that correspond to this lot are archived with their reference values.

Figure 46: Stopping a lot

5.2.6 Restoring a lot

A lot that has been stopped or archived can be restored. This action is only possible from the list of archived lots.

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Figure 47: Restoring a lot

If the expiry date has passed, an error message appears and asks the user to confirm the expiry date of the lot.
[Information about this lot: full name, manufacturer, etc.] can be completed and it will store the history of the
comment present before restoration of the lot.

5.2.7 Deleting a lot

The user can delete a lot from one analyzer or from several analyzers by choosing a lot/analyzer pairing from
the available list.

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Figure 48: Deleting a lot

Deleting a lot from the analyzer(s) results in the deletion of all the associated QC levels.

5.2.8 Consulting/modifying a current lot by analyzer

Double-clicking on a line from the list of [Current Lots] enables the user to consult the settings associated with a
current lot for this analyzer.
If needed, the [Start date] and [Exp. date] can be adjusted by analyzer from this window.

5.2.9 Consulting an archived lot

Double-clicking on a line from the list of [Archived Lots] enables the user to consult the settings associated with
an archived lot for this analyzer.

5.3 Viewing by test

All the tests included in quality control processing are shown, and processing can be carried out over any period.

5.3.1 Selecting the test

The test can be selected either:
- By the test/analyzer pairing.
- For all the analyzers on which the quality control was performed.

Figure 49: Selecting a test in quality control

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5.3.2 Levey Jennings graph

5.3.2.1 Overview

This menu enables quality control management by test, for a specified period (by default, the last 60 days can be
viewed).
The selection can be made according to the following information:
- The expected values (set by the user) or the values of the series for the period indicated.
- The status of the IQC result (validated, rejected, or pending).
- The current or archived levels for the specified period.
- The control lots, if several lots were used during the specified period.
- Levey Jennings graphs, value graphs, value tables.

On the graphs, it is possible to show/hide the following with dotted lines:

- changes in [Reagent Lots] for the test - red dotted line.
- [Analyzers Maintenance] operations - with a brown dotted line.

If there was a re-targeting on the QC level, the re-targeting date is always shown with a black dotted line.
If the QC lot was in a probationary period, the activation date is always shown with a dotted line in the color of
the series.
Finally, it is possible to show/hide the legend that provides a summary of the QC values associated with this level.

Figure 50: Levey Jennings graph of a test

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The list of active rules for the test appears in red at the bottom of the window. These are the rules set in the test
file.
Each point ringed in red indicates the generation of a Westgard rule.
Keeping the cursor on the point will display a context window with the following information:
- The date and time the result was obtained.
- The value of the deviation from the mean.
- The value of the result.
- The status of the result (validated, rejected, or pending).
- The comment associated with the result.
- The reagent lot, if the analyzer transmits this information.

Right-clicking one of the points enables the following actions:

 [Validate]
Changes the status of the IQC result to be validated.

 [Reject]
Rejects this value. It will no longer be taken into account for the different calculations of the IQC but
might be visible on the Levey Jennings graphs.
Following the rejection, the user is required to make a comment.

 [Unvalidate]
Changes the status of the result to [Pending].

 [Comment]
Enables the user to add a comment to a value, regardless of the status.

5.3.2.2 Levey Jennings viewed according to the different re-targeting periods

– available only in "work with expected values" mode with the "one graph per level" option –

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The Levey Jennings QC values can be viewed according to the expected values for each re-targeting period for
the QC lot.

o On the Levey Jennings graph, when there has been at least one re-targeting in the displayed
period, the date of the re-targeting(s) is shown by a vertical, black dotted line.
When the cursor is placed on this vertical dotted line, a context window indicates the date and
time of the re-targeting and the applicable reference values prior to re-targeting (target, lower
value, upper value, standard deviation and CV):
For example: "10/20/2016 10:28:19
Expected values prior to re-targeting (STA-SYST CONT N)
--> Target 2.60 (2.43 – 2.76)
--> Stdev 0.082
--> CV% 3.173"

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Figure 51: Viewing QC values in a Levey Jennings graph with the current expected values

When the menu is accessed, by default, the expected values considered are the current values.
- The points received before the last re-targeting are filled in in white. No Westgard rule is
evaluated for these points.
- The points received after the last re-targeting are filled in in color.

o The user can choose to view the Levey Jennings graphs according to the expected values for a
previous re-targeting by clicking to the left or right of the dotted line and showing the re-targeting
via the cursor.

or

Figure 52: Viewing QC values in a Levey Jennings graph with the expected values for the previous re-targeting

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Figure 53: Viewing QC values in a Levey Jennings graph with the initial expected values for the lot

- During the period that corresponds to the chosen re-targeting, the QC values are filled in in
color, with, if applicable, the Westgard rules generated in this period.
- The QC values obtained outside the period that corresponds to the chosen re-targeting are
filled in in white.
- If the user clicks on "Legend", the expected values correspond to the target values, standard
deviation and CV for the selected re-targeting period (i.e., to the "colored" values). As for the
values for the series, they are calculated for all the displayed values ("colored" and "white"
values).

When the menu is accessed, if the user views the Levey Jennings graphs according to a date range
that does not allow for viewing of the latest current re-targeting (re-targeting from "QC Settings", or
reissuing of a known QC value in connection):
all the QC values are filled in in white, to indicate to the user that he/she is viewing QC values from
before the current re-targeting.

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5.3.3 Viewing value graphs

5.3.3.1 Overview

Figure 54: Value graph of a test

Keeping the cursor on the point will display a context window with the following information:
- The date and time the result was obtained.
- The value of the deviation from the mean.
- The value of the result.
- The status of the result (validated, rejected, or pending).
- The comment associated with the result.
- The reagent lot, if the analyzer transmits this information.

No action can be taken from this menu on a point. Only consultation is possible.

The following information can be displayed for each graph and for the specified period:
- The calculated mean.
- The expected mean.
- The calculated standard deviation.
- The expected standard deviation.
- The calculated limits.
- The expected limits.

5.3.3.2 Value graphs viewed according to the different re-targeting periods

– available only in the "one graph per level" option –

As is the case for the Levey Jennings graphs, the QC values in value graphs can be viewed according to the
expected values for each re-targeting period for the QC lot.

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o On the value graphs, if there was at least one re-targeting in the displayed period, the date of the
re-targeting(s) is shown by a vertical, black dotted line.
When the cursor is placed on this vertical dotted line, a context message indicates the date and time of
the re-targeting and the reference values prior to re-targeting (target, lower value, upper value,
standard deviation and CV):
For example: "10/20/2016 10:28:19
Expected values prior to re-targeting (STA-SYST CONT N)
--> Target 2.60 (2.43 – 2.76)
-->Stdev 0.082
--> CV% 3.173"

Figure 55: Viewing QC values in a value graph with the current expected values

When the menu is accessed, by default, the expected values considered are the current values.
- The points received before the last re-targeting are filled in in white.
- The points received after the last re-targeting are filled in in color.

o The user can choose to view the Levey Jennings graphs according to the expected values for a
previous re-targeting by clicking to the left or right of the dotted line and showing the re-targeting
via the cursor.

or

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Figure 56: Viewing QC values with the expected values for the previous re-targeting

Figure 57: Viewing QC values with the initial expected values for the lot

- During the period that corresponds to the chosen re-targeting, the QC values are filled in in
color.
- The QC values obtained outside the period that corresponds to the chosen re-targeting are
filled in in white.
- If the user clicks on "Legend", the expected values correspond to the target values, standard
deviation and CV for the selected re-targeting period (i.e., to the "colored" values). As for the
values for the series, they are calculated for all the displayed values ("colored" and "white"
values).

When the menu is accessed, if the user views the value graphs according to a date range that does
not allow for viewing of the latest current re-targeting (re-targeting from "QC Settings", or reissuing
of a known QC value in connection):
all the QC values are filled in in white, to indicate to the user that he/she is viewing QC values from
before the current re-targeting.

5.3.4 Table of values

Figure 58: Table of values

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According to the selection, the user views all the lines related to the quality control results.

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5.4 Viewing by profile

5.4.1 Current Values

Figure 59: Current quality control values

Enables the user to toggle between IQC values.

Access to the Current Values.

Access to viewing of the QC by profile.

Access to the configuration of QC tests.

Access to the additional quality control menu (Quick Control, moving average, EQC).

Figure 60: Selecting the quality control period

The user can choose the QC lines to display by selecting the following information:
- A specific day.
- A specific period.
- Pending QC results.
- QC results already validated.
- Rejected QC results.

A grid is displayed with all the QC lines relevant to the selection. The following data are displayed for each line:

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- The status, with V for validate, X for reject, [ ] for not processed.
- The date and time of the result.
- The test code.
- The analyzer code.
- The identifier.
- The control lot number.
- The value of the result.
- The unit of the result.
- The reagent used (if the analyzer returns this information).
- The alarm code and the error code.
- A comment, if the user has already entered a comment.

Figure 61: Selecting value statuses

For the selection of chosen lines or for any displayed line, the user can carry out the following actions:
 Validate the selection.
All lines will change to validated status.

 Invalidate the selection.

All the validated lines will go back to not processed status.

 Reject the selection.

All validated or non-processed lines will change to rejected status. These results will remain visible on
the graphs but will no longer be taken into account for the different calculations (CV, mean, etc.)

[MyExpertQC]
Gives access to the export of QC values via MyExpertQC.
For the function to be available, MyExpertQC must be enabled on the application according to the configuration
defined at installation. In the event of a problem with sending, ensure that the EIQC.exe program has been
started.
When you click [MyExpertQC], a window is displayed:

Figure 62: MyExpertQC export window

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The send mode can be selected for these search criteria:

- [Send complement]: to send values that have not yet been sent
- [Return rows already sent]: to resend ONLY what has already been sent
- [Send/Resend All]

[QC transmission]
Access to the QC sending menu.

[Send complement] enables the user to identify the values sent to the LIS and to only send values that have not already been sent for the next
time

[Send/Resend All] enables the user to send all the QC values to the LIS (however, it does not enable the user to identify the values as sent for
the next time)

[New]
Manual addition of QC values.

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Figure 63: Adding a quality control line

To enter a new value, the user must:

- Select the analyzer.
- Select the test.
- Enter a value.
- Select an identifier in the list configured for the test, if the [ID] checkbox is selected.
- Enter an identifier if the [ID] checkbox is not selected.
- Enter a lot number.
- Enter the flag (optional).

[OK and another]

Enables the user to validate the entry and enter a new value for the same test and the same analyzer.

[OK and End]

Enables the user to validate the entry and exit the menu.

[End]
Enables the user to exit without saving the entry.

5.4.2 Viewing by profile

This menu enables the user to view all the IQC results for the tests configured with the profile, on a single graph.
The user can select several profiles on this graph.
The value/target value difference is calculated as a number of deviations from the target value. These deviation
values are then presented in a histogram with positive or negative values. For this to be possible, the target value
and the deviation percentage must be available for all the tests in the profile.
Figure 64: Viewing by profile

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The user can select the day (by default, the current date).
- Pending QC results.
- QC results already validated.
- Rejected QC results.

The user can select one or more profiles. A list of the relevant tests is then displayed, as well as a grid with all the
lines of relevant results.
A grid is displayed with all the QC lines relevant to the selection. The following data are displayed for each line:
- The status, with V for validate, X for reject, [ ] for not processed.
- The date and time of the result.
- The test code.
- The analyzer code.
- The name of the QC level.
- The QC level identifier.
- The control lot number.
- The value of the result.
- The unit of the result.
- The Westgard alerts generated by the current result.
- The number of values.
- The mean.
- The standard deviation.
- The lower value.
- The upper value.
- The value of the deviation.
- The reagent kit used (if the analyzer returns this information).
- The alarm code and the error code.
- A comment, if the user has already entered a comment.

Double clicking a line enables the user to directly view a test.

Each point on the graph ringed in red signifies that the value has generated at least one Westgard rule. The user
can find out which Westgard rule(s) was/were generated by placing the cursor on the point.
By double-clicking the graph, the user directly accesses the same graph in full-screen mode.
The user can return to the initial layout by clicking the icon at the top of the window.

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Behavior when re-targeting on a QC level:

- The QC menu by profile is always displayed according to the current reference values for
the test and the level.
- As is the case for Quick Control, only the values located after the last re-targeting are taken
into account for the calculation of Westgard rules.
- The values obtained prior to re-targeting are shown filled in in white, and the [Westgard
alerts] column contains the re-targeting date that re-initializes the calculation of the
Westgard rules.

5.4.3 Quick Control

All the tests scheduled for the QC are found and the following verifications are carried out:
- An identification exists for the level.
- A QC value exists for the validity period.
- Compliance.

The value must be close to the target (equal to the target value +/- 2 standard deviations).
The values for the mean, the standard deviation and the coefficient of variation are displayed.
If the value is compliant, the Westgard rules are applied over the period to the manufacturer's values or the
values of the series (according to the application settings).

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Figure 65: Quick Control

For each line with an error, the following information is displayed:

- The test code.
- The reason that the line has an error.
- No result within the set deadlines, or generation of a Westgard rule.

Behavior when re-targeting on a QC level:

Quick Control verifies the QC values obtained in relation to current reference values. Therefore, the
values obtained prior to the last re-targeting are not evaluated.
For example: if the last re-targeting was on 05/23/2016 at 9:49 a.m., the Westgard rules are only
evaluated for QC results received after this date.
Probationary lots:
Probationary QC values are not eligible for Quick Control

5.5 Managing probationary QC lots

When the user wants to activate a new QC lot, the QCs must be systematically run in duplicate, once with the
current lot and once with the "probationary" lot.
To differentiate the QCs run with the probationary lot from those run with the current lot, according to SH GTA
06, the user must run the probationary QCs as patient values for which a specific tube number is used.

5.5.1 Configuring probationary lots

Probationary QC lots are configured from the "QC lot configuration" menu.
When a QC lot is being qualified as a [Test QC lot], the current associated lot must be specified. For the rest of
this section, Lot "555222" will be used as an example of a probationary lot with "Lot A" as the current associated
lot.

Figure 66: Creating a probationary lot

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When the creation of a probationary lot is being validated, the probationary QC levels are automatically
generated for each QC level that uses the selected current lot/analyzer(s) pairings. A message indicates the
number of probationary levels created. These probationary levels can be viewed from the [Settings] menu – see
§ 5.2.1.

When a lot is defined as probationary:

- it can only change status with the activation of the probationary lot.
- it can only be deleted if the lot is already configured for a probationary level.

5.5.2 Acquisition of QC values for a probationary lot

The QC values for a probationary lot must be run as patient values. Recognition of a QC value for a probationary
lot is based on the tube number, which is formed as follows:
- the "QC run as patient" pattern predefined in configuring the analyzer – see § 10.1.2.
- the probationary QC level identifier.
- a special string "--".
- the probationary lot number.
For example: using tube number QC12355--Lot B.
- For the QC run as patient pattern = QC*.
- The QC level identifier = 12355.
- The probationary lot = Lot B.

5.5.3 Use of values

In the IQC module: the values for the current lot and the probationary lot can be viewed at the same time,
superposed and compared.
Mean, CV and standard deviation are calculated over the probationary period.

Figure 67: Viewing Lot A (current lot) and lot B (probationary lot)

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Once activated, when the current lot was in a probationary period, a vertical line automatically separates the
values obtained before and after this lot was activated.

Westgard rules are not applied to the probationary QC values.

It is not possible to view the probationary QC values in the QC by profile.

5.5.4 Activating the probationary lot

When the probationary period is over, an "Activation" operation for the probationary lot can be carried out from
the lot configuration module.
Activation takes place only once for all the analyzers/tests/probationary levels that reference this lot.

During activation, the following actions are performed by the application:

o Current associated lot (Lot A in our example).
- Lot A is archived on the current date.

o Probationary QC lot (Lot B in our example).

- Lot B is no longer probationary and the current date becomes the activation date (= the end date
of the probationary period).

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- It is suggested that the series values be used as reference values for Lot B for each level that
references Lot B as probationary. In case of a positive response, the application assigns the series
values to the expected values and if not, the reference values are applied.
In addition, in the event of a positive response, the user is required to transfer the threshold values to the
analyzer; otherwise, the application considers that there is re-targeting as of the first QC value corresponding to
the activated lot.

o Probationary period report.

The application presents the PDF report including a summary with:
- One graph per test/analyzer.
- Per probationary level, the expected values, and the series values, as well as the expected values
for the corresponding level (Lot A in our example).
- The QC results.
The probationary period report can then be consulted from the Traceability menu, in the "Directory exploration"
tab, "Quality Control" type under the name "ProbationaryQClot-<LotName-<LotName>-<ActivationDate>".

5.6 Moving average

5.6.1 Definition
This module enables the user to view the linearity of the values returned on the patient samples.
The moving average is calculated on all the successive values returned by an analyzer for the patient samples;
there can be several runs per patient.
The tests taken into account are those for which the following are entered in the test configuration:
- The total number of points taken into account.
- The number of points per group.

Figure 68: Moving Average

Access to Quick Control.

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Access to the moving average.

Access to the EQCs.

Access to quality control settings (Settings, QC lots, Profiles).

Return to the quality control main menu (IQC, Current values, QC by profile).

5.6.2 Moving average graph

The graph makes available the following choices of representations:
- The last X values as they are.
- The equal-weighted moving (sliding) averages of the last Y points on the last X values.
- The exponentially-weighted moving (sliding) averages of the last X values.

Figure 69: Viewing the moving average

On the graph the user can select the information to be displayed:

- All values (in green on the graph).
- The overall average.
- The equal-weighted moving averages (in blue on the graph).
- EWMA (in purple on the graph).

In the bottom table, for each value transferred by the analyzer the corresponding values for the equal-weighted
average and the EWMA (Exponentially Weighted Moving Average) are displayed.

Equal-weighted average:
Principle: from the "Yth" point, the mean of the previous Y points is calculated.
∑𝑡𝑖=𝑡−N 𝑋𝑖
𝑀𝑜𝑦𝑀𝑜𝑏𝑡 =
𝑁
𝑖=𝑡−𝑌

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EWMA (Exponentially Weighted Moving Average)
Principle: for the exponential weighting the first point is the first value.
𝐸𝑊𝑀𝐴0 = 𝑋0
Starting from the second, each average is deduced from the previous calculation according to the
following principle:
𝐸𝑊𝑀𝐴𝑡 = (1 − 𝜆)−1 + 𝜆𝑋𝑡
For the moment, 𝜆 has a value of 0.2 and cannot be altered.

5.6.3 Rejecting points

Some points can be permanently or temporarily eliminated from the moving average.
Left-clicking one of the points in the values graph (in green) enables the user to temporarily exclude a point.
Confirmation is proposed for each rejected point.
Once at least one point is rejected, a button appears that can be used to permanently exclude the point(s).
[Permanently validate exclusions]
Enables the user to permanently exclude the temporarily excluded points.

5.7 Managing EQCs

5.7.1 Definition
This module enables the management of external controls, either by manual entry or by integration from the
analyzer connection.
This module ensures the management of external control programs that can group together one or more tests.

Figure 70: External control

5.7.2 Table of values

[Table of values]
Access to the EQC values.

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[Connection mode]
Access to EQC identification criteria for the analyzer connection.
[EQC programs]
Access to management of the different EQC programs.
[New]
Addition of a line for manual entry of an external control.
[Delete]
Deletion of the selected line. The data will be permanently lost.

The user can select the following display criteria:

- EQC programs in progress/ended/both
- Date range
- Analyzer
- Program
- Test

A grid is displayed with all the external control results entered manually or provided by the analyzer connection,
for the previous three criteria.
The table of values can be displayed by clicking a line. The user can complete each element and validate their
entry.
When the user clicks "New", a window is shown at the bottom of the table of values requesting that the following
be specified:
- The date
- The analyzer
- The test
- The ID
- The value

Figure 71: External control value

On entry, [Date]/[Analyzers]/[Test]/[ID] and [Value] are required fields. Therefore, if the user does not fill them
in, visual information on the missing field is shown:
The "Program" field cannot be modified and is filled in automatically if a program is defined for this analyzer,
this test, and this date.
If the value comes from the connection, then, according to the same criteria, the program field is filled in if a
corresponding program is found.
If, during an addition/modification, there is no corresponding program for the selected analyzer and this test
and this date, then the program box remains empty and, by default, the value is not shown in the table of
values as long as the user has not selected [Without programs] in the program filter.

Figure 72: Without programs

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When the [Without programs] filter is selected, the table of values then ONLY summarizes the EQC values
without a program.

5.7.3 EQC connection

Figure 73: External control connection

The user must choose their criteria for identification of the external controls returned by the analyzer.
- The name of the patient.
- The tube number.

The user must enter the selected identifier value. For each result transmission by the analyzer, any identification
with this value is included in the application EQC.
A star enables definition of the variable part of the identification criterion for the EQC tube
To define, for example:
*099 for tube IDs such as: 12345099; abcdef099; etc.
099* for tube IDs such as: 09912345; 099abcdef; etc.
*099* for tube IDs such as: 12099345; abc099def; etc.

There is a forbidden criterion: "**". If the user tries to enter this pattern, a visual indication warns them and they
cannot validate it.
Several functions are available:
[New]
Addition of a new identification criterion.
[Delete]
Deletion of the selected identification criteria.
The connection driver will no longer include external controls with this identification criterion.

5.7.4 EQC programs

The user can configure external control programs to which they have agreed.

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Figure 74: EQC programs

[New]
Enables the user to add a program.
[Delete]
Enables the user to delete a program.

For each new program, several items of information are displayed:

- The name of the program
- 4 items of free information
- The activation date
- The stop date for the program (empty by default)

When the user clicks a program line, it is possible to modify the connected analyzer as well as the tests for this
analyzer and program. (see Figure 75: Adding a test to the program).
When modifications in a program are validated, the lines in the table of values are updated with the
saved program identifier if they meet the criterion for this program.

The analyzer must be selected by double-clicking. The list of available tests is thereby updated according to this
analyzer.
There can only be one analyzer/test pairing for a given period of dates.
For example: There can only be one program in progress for analyzer 007 – COAG, as of November, with the FIB
test.
Visually, when adding a test for a program, tests already used in other programs are grayed out (see Figure 75:
Adding a test to the program and FIB test).

Figure 75: Adding a test to the program

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By double-clicking the test, the user adds this test to the program concerned.

Enables the user to delete the selected test program.

[Validate]
Validates changes to the program (change of analyzer and/or tests).
[Cancel]

Figure 76: Entering the program name and information

Cancels modifications to this program.

When the user adds a program, they must enter the program name and its start date.
To improve traceability, the user can enter the information in the four fields called [Information] X.
The user must validate their entry to add this program or cancel to avoid adding it to the list of programs in
progress.
If a program with the same name already exists, visual information alerts the user and validation is impossible
with this same name.
The user can double-click a program line to modify the program information and access two additional actions:

Figure 77: Details of an EQC program

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[End and duplicate]
Ends the program in progress and makes a copy based on the date and time (accurate to the nearest second)
when the user clicked, in order to duplicate it.
[End]
Ends the program in progress.

Ending a program updates the program end date in the list, and "releases" the tests used in the program so that
they are accessible by other programs, from the program closing date.
When a program is ended and copied, another program is automatically created with the same features as the
program that was ended!
- Same program name
- Same analyzer, same tests
- The start date is the closing date of the program that was ended

The old program is renamed as NAME_PROGRAM_YYYYMMDD_HHMMSS, where YYYYMMDD_HHMMSS

corresponds to the closure date and time of this program.
Programs that have been ended can be consulted in the list when the user selects "ended programs".

5.7.5 Qualiris and sending EQC values

The user can choose to export EQC values via Qualiris. This action is possible on the basis of two conditions:
- The Qualiris function is enabled in the application
- There are values to be sent for an analyzer configured for Qualiris

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Figure 78: Qualiris

Activating the QUALIRIS button opens a window for filtering the sending of values based on criteria similar to the
EQC table of values screen.
When this window is displayed, the filters for the EQC table of values screen are copied identically.
This enables the user to send what they are viewing in the table of values.

Figure 79: Sending via Qualiris

The filters are the same as for the EQC table of values screen:
- EQC programs in progress/ended/both
- Date range
- Analyzer
- Program
- Test

It is possible to include values that do not belong to any program.

As is the case for MyExpertQC, several sending modes are available:

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- Send complement: to send values that have not yet been sent.
- Resend lines already sent: to resend ONLY what has already been sent.
- Send/Resend all.

5.8 Automatic QC validation

Automatic validation of QCs is the action of validating the QC lines as soon as they arrive on connection, if they
are considered to be normal.
This function can be configured on the analyzer. Automatic validation of QCs is particularly useful when validation
of patient results is dependent on the QC.
Automatic validation of QCs evaluates three conditions:
- Verification of the QC value in relation to the lower and upper values defined for the QC level.
- Verification that the last QC value acquired for a level does not trigger a Westgard rule.
- Verification that the QC value is not in error, i.e., the value is non-numerical or associated
with an error code sent by the analyzer.

Behavior when re-targeting on a QC level:

Automatic validation of QCs verifies the QC values obtained in relation to current reference values.
Therefore, the values obtained prior to the last re-targeting are not used to evaluate the Westgard
rules.
For example: if the last re-targeting was on 05/23/2016 at 9:49 a.m., the Westgard rules are only
evaluated for QC results received after this date.
Probationary lots:
Probationary QC values are not eligible for automatic validation of QCs.

6 Analyzer maintenance

6.1 Definition
This menu enables the user to describe a set of tasks to be carried out periodically for analyzer maintenance.
This set of tasks is left to the user's initiative, with each user creating their personal catalog of tasks according to
the specific nature of the analyzers.

Figure 80: Analyzer maintenance

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A list of coded tasks, configured by default, enables users to retrieve all the maintenance operations carried out
on the analyzers from the connection.

Access to the list of analyzer maintenance operations to be carried out.

Access to analyzer maintenance settings.

Access to monitoring of analyzer maintenance operations.

In Coag.One, when the application references a division, the analyzers shown in the drop-down list
are those of the current division.

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6.2 Analyzer maintenance operations to be carried out

Figure 81: Maintenance to be carried out (list mode)

The user must choose an analyzer in the selection box. Once the analyzer is chosen, the list of maintenance
actions is displayed in different colors according to their status and the date when they should next be carried
out.
 In red.
If the action is late. The action should already have been carried out according to the schedule
established when the action was configured.

 In orange.
If the action should be carried out the same day according to the schedule established when the action
was configured.

 In green.
If the action was carried out that day according to the schedule established when the action was
configured.

 In white.
If the action was carried out within the deadline according to the schedule established when the action
was configured.
Double-click one of the lines to save the maintenance action.

The analyzer sends the maintenance actions that were carried out from the analyzer user menu.

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Figure 82: Maintenance to be carried out (schedule mode)

Figure 83: Carrying out a maintenance action

[Validate Action]
This option is used to save the action as completed.
It updates the schedule for this action.

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[Cancel]
This option enables the user to quit the window without saving the action.

The user sees the following information:

- The name of the maintenance action.
- The date of the last occurrence.
- The name of the user who performed the last action.
- If this action can be viewed on the IQC graphs.

The user can enter a comment related to the action. The user is free to choose the text, and the traceability is
stored.

6.3 Configuring an action

The operations to be carried out are entered in an operations catalog. Select them from a list of predefined
actions or create a new operation that will be added to the catalog.
The user enters the frequency of the action or defines this action as corrective. The user chooses whether this
action can be viewed in the QC graphs.

Figure 84: Configuring a maintenance action

[New]
Adds a maintenance action.
[Delete]
Deletes the selected maintenance action.

The user must configure the action:

 [Frequency - Every]
Determines the frequency of the operation in terms of the number of days, weeks, months or years.
If the action is defined as corrective, the user no longer has access to the frequency.

 [Report template]
A specific report template can be defined and associated with a task.

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This report is completed when the action is performed, and then archived.
The report templates are left to the user's initiative.

The report can be a .txt, .rtf or .doc file.

It is recommended (but not required) that the report templates be saved in the current directory of the
application and sub-directory:
Activity\MonitoringQualityAnalyzers\ReportTemplates

Figure 85: Selecting a maintenance action

The choice of analyzer type displays a list of predefined actions, some of which are coded, which can be retrieved
with the connection of the analyzer.
Each action has a default configuration (frequency, can be displayed in the IQC) that the user can modify, except
for settings defined by Stago.

Enables the user to create a new action.

Figure 86: Adding a maintenance action

The user must enter a code and a name for the new action.
This action will be displayed in the list of maintenance actions.

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6.4 Monitoring maintenance actions

This menu enables the user to view, for an analyzer and a period, all the maintenance actions performed either
by the user via the interface, or automatically via the analyzer connection.

Figure 87: Monitoring maintenance actions

After choosing the analyzer and the search period, the list of relevant actions is displayed. The following
information is specified on each line:
- The date and time of completion.
- The analyzer.
- The user who validated the action.
- The name of the action with the associated report name, if applicable.

When a maintenance action is performed late, this information is saved. For example: [Maintenance
completed] - [delay]: 3 [days]

7 Accreditation Tools
7.1 Definition
This menu provides access to a set of tools for validating the laboratory techniques required for Quality
monitoring.
The aim is to verify the reliability of results, notably by calculating the measurement uncertainty, verifying the
precision and accuracy.

The following procedures are available:

- Repeatability.
- Reproducibility (or intermediate precision).
- Stability.
- Limit of linearity.
- Analyzer comparison.

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- Reagent comparison.
- Contamination.
- Measurement uncertainty.
- Control time calculation.

In Coag.One, when the application references a division, the analyzers shown in the drop-down list
are those of the current division.
If the user selects an analyzer, the tests in the drop-down list are those connected to the chosen
analyzer.

The test, type of protocol, period and tube identifier(s) must be entered for each procedure.
- The application has a comparison with the expert values or the lab values if the connection is
possible.

- The printable and exportable report is automatically archived on closure of the procedure.

- It is possible to work directly with the results returned by the analyzer (if the tube identifier is
recognized) or to enter them manually.

- A set of customizable diagnoses can be defined.

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Figure 88: Verifying performance

Access to the method validation main menu.

Access to the method validation folder menu.

Access to the expert values menu.

Access to the settings menu.

Access to the method validation import/export menu.

7.2 Management and display of the number of decimal places

The number of decimal places displayed is consistent with the number set for the test for displaying results in:
- the content of the procedure
- the procedure reports
- the print previews and the generated files

NB: as the results are calculated using the raw values stored in the software, the results displayed on
screen may be different as a result of the rounding applied, due to the number of decimal places
taken into consideration.

The number of decimal places applied for calculating the mean is consistent with the number set for the test in:
- the procedure reports
- the print previews and the generated files

Three (3) decimal places are applied for calculating the CV in:
- the procedure reports

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- the print previews and the generated files

The number of decimal places applied for calculating the standard deviation is the same as the number set for
the test, plus one decimal place, in:
- the procedure reports
- the print previews and the generated files

When manually entering the value in the content of an Accreditation Tools procedure, the number of decimal
places to be applied is shown next to the entry field. The user can enter the value with no limitations:
- If the number of decimal places entered manually is greater than the number of decimal
places set, the application rounds up to the next number if the next number is at least 5.
- If the number of decimal places entered manually is lower than the number of decimal places
set, the application adds one or more zeros.

The number of decimal places used for reports and printouts of measurement uncertainty procedures is as
follows:
Parameter Comment
Mean Displayed with the number of decimal places set for
the test

u (C) Displayed with the number of decimal places set for

the test
With at least 1 decimal place

u(EQA) Displayed with the number of decimal places set for

the test
With at least 1 decimal place

U(IQC) Displayed with the number of decimal places set for

the test +1

CV Displayed with the number of decimal places set for

the test

The number of decimal places used for reports and printouts of comparison procedures is as follows:
Parameter Comment
Correlation Coefficient Displayed with 3 decimal places

Slope Displayed with 2 decimal places

Intercept Displayed with the number of decimal places set for

the test
> with a minimum of one decimal place if the test has
no decimal places

Min and max values for each series (AnalyzerY, Displayed with the number of decimal places set for
AnalyzerX or ReagentY, ReagentX) the test for X and/or Y
> with a minimum of one decimal place if the test has
no decimal places

Mean of Y values Displayed with the number of decimal places set for
the test for Y
> with a minimum of one decimal place if the test has
no decimal places

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Mean of X values Displayed with the number of decimal places set for
the test for X
> with a minimum of one decimal place if the test has
no decimal places

Mean of the means Displayed with the minimum number of decimal

places set for the tests for X and Y
> with a minimum of one decimal place if the test has
no decimal places

Mean of the differences Displayed with the number of decimal places set for
the tests for X and Y
> with a minimum of one decimal place if the test has
no decimal places

Standard deviation of the differences Displayed with the minimum number of decimal
places set for the test for X and Y + 1

Mean % of differences Displayed with the number of decimal places set for
the tests for X and Y
> with a minimum of one decimal place if the test has
no decimal places

According to the configuration of the comparison Displayed with the minimum number of decimal
procedure, the mean bias calculated as a percentage places set for the tests for X and Y
- Compared to the mean of the reference > with a minimum of one decimal place if the test has
values (mean X) no decimal places
- Compared to the mean of the means (mean
Xi, Yi)

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7.3 Management of error values

For procedure content:
- Error values are shown grayed out in the "Measured values" table of values.
- Error values cannot be rejected from the procedure.

For the report and printouts:

- Error values are shown grayed out in the table of values in the report. These error values are
not taken into account in the statistical calculations in the report.
- Error values are not shown in the report graphs.

This management of error values is applicable for all procedure types.

7.4 Mechanism for rejecting and reincluding values

This mechanism for rejecting and reincluding a line is applicable to all procedure types.

7.4.1 Mechanism for rejecting a line

A value can be rejected from procedure content. Rejection is indicated by the presence of an [X] in the [X] column.
For analyzer and reagent comparison procedures, it is possible to reject only an X line, only a Y line, or an X and
Y line.
Rejected lines are shown in the [X] column in the report and in printouts. Rejected values are not represented in
the graphs and are not taken into account in the statistical calculations.
It is not possible to reject a value once the procedure is closed.

7.4.2 Mechanism for reincluding a line

A line rejected from procedure content can be reincluded. In this case, the [X] in the [X] column is deleted.
Reincluded lines are shown in the graphs and are taken into account in the statistical calculations.
It is not possible to reinclude a value once the procedure is closed.

7.4.3 Comments on rejection and reinclusion

When the user rejects or reincludes a line, they can enter a free text comment giving the reason for the rejection
or reinclusion (maximum 50 characters). A comment icon in the "C" column indicates whether a comment is
present for a rejected or reincluded result line. Clicking this comment icon displays the note panel.
Comments on rejection and reintegration are aggregated.

Figure 89: Mechanism for rejection and reinclusion

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7.5 Repeatability
The aim of this procedure is to verify the closeness of agreement (precision) by measuring successive results
(ideally 30) obtained for the same sample under the same conditions, within as short a period as possible.
It is estimated by calculating the coefficient of variation (CV%) from the mean and standard deviation.
It is this CV that is compared with the reference maximum CV of the expert values.

7.5.1 Creating a repeatability procedure

Figure 90: Repeatability procedure

When a new repeatability is created, the following context must be set: test(s), analyzer, start and end dates,
and the tube identifier.
For the application, the tube identifiers transmitted by the analyzer as part of a repeatability procedure must be
suffixed with a hyphen.
For example, if the Sample ID entered in the application is REPETA, the analyzer should return REPETA-x, where
x ranges from 1 to n.
Several tests can be set in the same procedure.

All the results from the analyzer that are not included between the start and end dates are
automatically lost for the procedure.

7.5.2 Viewing a repeatability procedure

The values (entered manually, obtained from the analyzer or imported from the QC) are accessible once the
procedure has been created.

Figure 91: Result of a repeatability procedure

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The user can manually add a line by entering the following information:
- The date and time of the result.
- The identification.
- The value of the result.

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Figure 92: Adding a repeatability value

7.5.3 Repeatability procedure report

[Report]
Displays the procedure report.

Figure 93: Repeatability procedure report

On the Levey Jennings graph:

- When the mouse is hovered over a point on a graph, the corresponding line is selected in the
results matrix (there is no selection in the matrix for the bar chart).
- When a line is selected in the results matrix, the point is highlighted in red on the graph.
There is no identification of error lines and rejected lines.
The following information is included in this report:
- General statistics [Number of values], [Mean], [Standard deviation], [CV].
- Table of values [Date], [Sample ID], [Result], [Reagents], [Anlsr/Manu]: "M" if entered
manually.
- Expert [Reference values].
- Levey Jennings graph.
- Value distribution graph.
- Customizable diagnosis.
- [AUTOMATIC CONCLUSION].

The calculated CV is compared to the expert CV: 𝐶𝑉𝑐𝑎𝑙𝑐𝑢𝑙𝑎𝑡𝑒𝑑 < 𝐶𝑉𝑒𝑥𝑝𝑒𝑟𝑡

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There are 3 possible automatic conclusions:
- if there is a CV for the procedure, the Automatic Conclusion compares the CV value for the
procedure with the CV for the expert table(s)
- if the CV is not supplied in the expert table, it is the value of the standard deviation for the
procedure that is compared to the standard deviation value for the expert table
- if the standard deviation is not supplied either, the CV for the procedure is compared with
0.75 x reproducibility CV
- Indices (1), (2), and (3) displayed in the automatic conclusion reference the order of priority
specified by the checkboxes selected in the [Reference values] panel.

7.5.4 Closing a repeatability procedure

[Terminate]
Closes the procedure.

The procedure switches to [Completed] status.

 The report (pdf format) is automatically saved in the directory:
"activity\MonitoringQualityAnalyzers\YYYY-MM".

 The filename is saved in the form ProcedureName-ddHHmmss.pdf.

For example:
FIB_RÉPÉT_STAR1_20140113-15120224.pdf
- The repeatability procedure for FIB, STAR1 started on 01/13/2014 was closed on 01/15/2014
at 12:02:24.

 The operation is traced and accessible from the [Traceability] menu.

7.6 Reproducibility
The aim of this procedure is to verify the closeness of agreement between the results obtained, by varying the
measurement conditions (e.g. over a period of 15 days, with 30 results, on a minimum of 2 levels).
The calculation principle is exactly the same as for repeatability, only the reference values are different.

7.6.1 Creating a reproducibility procedure

Figure 94: Reproducibility procedure

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When a new reproducibility procedure is created, the following context must be set: test(s), analyzer, start and
end dates and the tube identifier.
Several tests can be set in the same procedure.
By default, the suggested end date is 30 days after the creation date. This date can be changed on creation or at
any other time by calling up the procedure.

All results from the analyzer that are not included between the start and end dates are automatically
lost for the procedure.

7.6.2 Viewing a reproducibility procedure

The values (entered manually, obtained from the analyzer or imported from the QC) are accessible once the
procedure has been created.

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Figure 95: Result of a reproducibility procedure:

The user can manually add a line by entering the following information:
- The date and time of the result.
- The identification.
- The value of the result.

Figure 96: Adding a reproducibility value

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7.6.3 Reproducibility procedure reports

[Report]
Displays the procedure report.

Figure 97: Reproducibility procedure report

On the Levey Jennings graph:

- when the mouse is hovered over a point on a graph, the corresponding line is selected in the
results matrix (there is no selection in the matrix for the bar chart).
- When a line is selected in the results matrix, the point is highlighted in red on the graph.
There is no identification of error lines and rejected lines.
The following information is included in this report:
- General statistics [Number of values], [Mean], [Standard deviation], [CV].
- Table of values [Date], [Sample ID], [Result], [Reagent], [Anlsr/Manu]: "M" if entered
manually.
- Expert [Reference values].
- Levey Jennings graph.
- Value distribution graph.
- Customizable diagnosis.
- [AUTOMATIC CONCLUSION].

The calculated CV is compared to the expert CV: 𝐶𝑉𝑐𝑎𝑙𝑐𝑢𝑙𝑎𝑡𝑒𝑑 < 𝐶𝑉𝑒𝑥𝑝𝑒𝑟𝑡

There are 3 possible automatic conclusions:
- if there is a CV for the procedure, the Automatic Conclusion compares the CV value for the
procedure with the CV for the expert table(s) selected in ParamsInstal
- if the CV is not supplied in the expert table, it is the value of the standard deviation that is
compared to the standard deviation value for the expert table
- if the standard deviation is not entered either, the automatic conclusion will be "no conclusion
possible for lack of reference values"
- Indices (1), (2), and (3) displayed in the automatic conclusion reference the order of priority
specified by the checkboxes selected in the [Reference values] panel.

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7.6.4 Closing a reproducibility procedure

[Terminate]
Closes the procedure.

The procedure switches to [Completed] status.

 The report (pdf format) is automatically saved in the directory:
"activity\MonitoringQualityAnalyzers\YYYY-MM".

 The filename is saved in the form ProcedureName-ddHHmmss.pdf

For example:
FIB_REPRO_STAR1_20140113-15120224.pdf.
- The reproducibility procedure for FIB, STAR1 started on 01/13/2014 was closed on
01/15/2014 at 12:02:24.

 The operation is traced and accessible from the [Traceability] menu.

7.7 Linearity
The principle is to observe values according to a dilution range and in parallel with the different known
concentrations.
It enables the user to determine, for a given analysis method, the analyte concentration beyond which the
relationship between the determined concentration and the theoretical concentration is no longer linear.
A series of theoretical values must therefore be defined in order to associate them with the observed values.

Dilutions are managed directly on the Stago analyzers.

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7.7.1 Creating a limit of linearity procedure

Figure 98: Limit of linearity procedure

7.7.2 Viewing a limit of linearity procedure

Figure 99: Result of a limit of linearity procedure

In "Measured values", the user can manually add a line by entering the following information:

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- The date and time of the result.
- The identification.
- The value of the result.

Figure 100: Adding a measured value for the limit of linearity

In "Theoretical values associated",

To associate a series that has already been created:
Select the desired series, then click [Select this series].

To create a new series:

Click [New series], then define the name and validate.

To add a new value:

Click [Add], then define its order, concentration and result.

Figure 101: Adding an associated theoretical value for the limit of linearity

When creating a series, it is not possible to enter two identical tube IDs or two identical concentrations.

7.7.3 Limit of linearity procedure report

The report can only be accessed if:
- The theoretical values have been reconciled with the measured values by means of the
[Sample ID].
- All the valid [Measured values] have been reconciled with a [Theoretical value].
- The [Sample ID] of the valid [Measured values] (excluding rejected and error lines) are unique
(no duplicates).

Otherwise, an error message informing the user of the [Mismatch between the number of theoretical values and
the number of real values] appears.
Any [Th. Val.] that have not been reconciled are excluded from the [Report].
[Report]
Displays the procedure report.

Figure 102: Limit of linearity procedure report

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Two graphs are displayed:

- The first represents the % ratios to the theoretical values, with limits at 10%.
𝑅𝑒𝑠𝑢𝑙𝑡
× 100
𝑇ℎ𝑒𝑜𝑟𝑒𝑡𝑖𝑐𝑎𝑙 𝑣𝑎𝑙𝑢𝑒
- The second represents the relationship between the measured values and the theoretical
values.
The regression line equation (least squares method) is calculated and the representation displayed on
the graph.

On both these graphs:

- when the mouse is hovered over a point on a graph, the corresponding line is selected in the
results matrix
- when a line is selected in the results matrix, the point is highlighted in red
There is no identification of error lines and rejected lines.

7.7.4 Closing a limit of linearity procedure

[Terminate]
Closes the procedure.

The procedure switches to [Completed] status.

 The report (pdf format) is automatically saved in the directory:
"activity\MonitoringQualityAnalyzers\YYYY-MM".

 The filename is saved in the form ProcedureName-ddHHmmss.pdf.

For example:
FIB_LIMIT_STAR1_20140113-15120224.pdf
- The limit of linearity procedure for FIB, STAR1 started on 01/13/2014 was closed on
01/15/2014 at 12:02:24.
 The operation is traced and accessible from the [Traceability] menu.

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7.8 Analyzer comparison

The principle is to acquire/enter a series of identified tubes with the most extensive range of results possible, for
the same test on two different analyzers.

The last comparison (method and remote) is still available and can be consulted but is replaced by
the new analyzer comparison.

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7.8.1 Creating an analyzer comparison procedure

Figure 103: Analyzer comparison procedure

To define an analyzer comparison:

 Select the test(s) and the two analyzers to be compared
 Select the following parameters:
- Comparison with [To the reference] or with [To the mean] for the 2 values
- The difference type, Y-X or X-Y.
 Provide the list of identifiers used (press Enter for each entry in the zone).

[Monitoring limits]
It is possible to set monitoring limits on 3 levels by clicking the + button. Once these limits have been calculated,
they will be shown in red on the difference graphs. If a level is left blank and a higher level is defined, the data
will be automatically cascaded down to the lower levels.
If there are associated expert values for this test, the customized monitoring limits will take precedence over the
limits for the expert values.
Depending on the data entered (level values and standard deviation), the monitoring limits are calculated
according to the rules defined in SH GTA-04
There are two possible formulas:
- If the reproducibility standard deviations for (X) and (Y) are entered, the standard formula is
used:

- If just one line is entered with the reproducibility standard deviation for (X) or (Y), because
the user thinks that the standard deviation of these two methods is similar, the following
formula is used: +/- 4.24 x Standard Deviation.

By default, the start and end dates are identical. The user can change the end date at any time.

All the results from the analyzer that are not included between the start and end dates are
automatically lost for the procedure.

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7.8.2 Viewing an analyzer comparison procedure

The values (entered manually, obtained from the analyzer or imported from the QC) are accessible once the
procedure has been created.

Figure 104: Result of an analyzer comparison procedure

The principle for integrating results can be different from one analyzer to another (the values of one analyzer
may be entered manually while the values for the second may be transmitted by the connection).

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Figure 105: Adding an analyzer comparison value

7.8.3 Analyzer comparison procedure report

The report can only be accessed if there is just a single line of results per sample ID.

Figure 106: Analyzer comparison procedure report

The table collates the values of the two analyzers for the analysis and calculations (deviations, differences, out
of range).
The "Out of range" values (indicated by *) are those values beyond 2 standard deviations of the differences in
relation to the mean (i.e. outside the concordance limits on the Bland-Altman graph).
Four additional graphs: linear regression and, in order to consider the values obtained in context, a graph of
ratios, a graph of differences and a Bland-Altman graph.

 Search for linearity - Linear regression (least squares method).

This graph gives an idea of the mean overall correlation between the techniques. The application
searches for the equation of the line (Y = aX + b) that passes closest to the points on the graph.

 Graph of ratios.
The Y/X ratios are represented as a percentage in relation to X. The limits at +/- 10% are represented as
red dotted lines.

 [Difference graph] or [Difference graph in %].

The Y-X or X-Y differences (according to the configuration of the procedure) are represented in relation
to X. The monitoring limits found in the imported expert theoretical values are represented as red
dotted lines. If the customized monitoring limits have been entered, they will take precedence over the
limits for the expert values. The monitoring limit is only displayed on the difference graph.

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Visually verify that the points are not located outside the set limits.

 Bland-Altman graph.
The Y-X or X-Y differences (according to the configuration of the procedure) are represented according
to the mean (X+Y)/2.
The [Mean of the differences] corresponds to the [Average bias] between the 2 methods. The
confidence interval of the bias, shown as red dotted lines, is located at 1.96 standard deviations of
differences around this mean. Based on the hypothesis that the differences follow normal distribution,
95% of the values must be included in this interval. This mean can nonetheless be considered as a
systematic difference between the two analyzers rather than as a real bias.
The confidence interval of the bias, shown as green dotted lines, is evaluated by the Student's t-
distribution value for a probability of 0.05 (5%) with a degree of freedom (df) equal to n-1 in the t-
distribution table. It is equal to the mean of differences ± (t 0,05 x bias standard deviation).

In these four graphs:

- when the mouse is hovered over a point, the corresponding line is selected in the results
matrix.
- when a line is selected in the results matrix, the corresponding point is highlighted in red.
There is no identification of error lines, rejected lines, or the line representing the means of the results.
Clicking the "+" button displays the statistical values.

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Figure 107: Statistical values - Analyzer comparison

The statistical values displayed are:

- [Correlation coefficient]
- [Mean of the means]
- [Mean of the differences]
- [Standard deviation of the differences]
- [Mean of % of differences]
- [Average bias] as a % calculated either in relation to the mean of the reference values, or in
relation to the [Mean of the means], depending on the configuration
- [Linear regression equation (least square method)]
- [Slope]
- [Intercept]
- [Number of values]
- For each data series (X and Y)
o [Minimum]
o [Maximum]
o [Mean]

The + button under [Conclusion] - [Details] is used to display the automatic conclusion.

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Figure 108: Automatic conclusion - Analyzer comparison

The automatic conclusion allows for comparison of the value obtained for the procedure with the values from
the expert table(s) (selected in ParamsInstal), for the following parameters:
- the [Correlation coefficient]
- the [Average bias] as a %
- the [Average bias] as a raw value: compare to the mean of the differences
- the [Slope]

The color code is as follows:

- Green: below the tolerated limit and correct
- Red: above the tolerated limit and incorrect
- Grey dash: no value configured in the corresponding expert table

7.8.4 Closing an analyzer comparison procedure

[Terminate]
Closes the procedure.

The procedure switches to [Completed] status.

 The report (pdf format) is automatically saved in the directory:
"activity\MonitoringQualityAnalyzers\YYYY-MM".

- The filename is saved in the form ProcedureName-ddHHmmss.pdf

For example:
FIB_COMP-I_STAR1_20140113-15120224.pdf
The analyzer comparison procedure for FIB, STAR1 started on 01/13/2014 was closed on
01/15/2014 at 12:02:24.

7.9 Reagent comparison

The principle is to acquire/enter a series of identified tubes with the most extensive range of results possible, for
the same analyzer for two different tests.

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7.9.1 Creating a reagent comparison procedure

Figure 109: Reagent comparison procedure

To define a reagent comparison:

 Choose the analyzer (the only one in this case), 2 tests.
 Select the following parameters:
- comparison with [To the reference] or with [To the mean] for the 2 values
- the difference type, Y-X or X-Y

[Monitoring limits]
It is possible to set monitoring limits on 3 levels by clicking the + button. Once these limits have been
calculated, they will be shown in red on the difference graphs. If a level is not entered and a higher
level is defined, the data will be automatically cascaded down to the lower levels.
If there are associated expert values for this test, the customized monitoring limits will take
precedence over the limits for the expert values.

Depending on the data entered (level values and standard deviation), the monitoring limits are calculated
according to the rules defined in SH-GTA-04
There are two possible formulas:

- If the reproducibility standard deviations for (X) and (Y) are entered, the standard formula is
used:

- If just one line is entered with the reproducibility standard deviation for (X) or (Y), because
the user thinks that the standard deviation of these two methods is similar, the following
formula is used: +/- 4.24 x Standard Deviation.

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By default, the start and end dates are identical. The user can change the end date at any time.
All the results from the analyzer that are not included between the start and end dates are
automatically lost for the procedure.

7.9.2 Viewing a reagent comparison procedure

Once the procedure is created, the values of test results returned by the connection must be imported.

Figure 110: Result of a reagent comparison procedure

The principle of integrating results is different from the analyzer comparison procedure.
[Import] means results for the 2 tests can be imported for the same tube.
The principle of a reagent comparison is to routinely run patient sample tubes with two different reagents
(corresponding to the two tests set up in the procedure) over a given period.
Import into the procedure therefore allows for all the patient sample tubes that have obtained results for both
tests during the specified period to be retrieved.
Only the patient sample tubes created via the LIS or via the [Manual Order Entry] menu are thus eligible for
import.
Therefore, the values can be viewed but cannot be modified.
When [Import] is clicked, the previous results are overwritten by the import. If lines were deleted,
they will be present once again, because they are re-imported.

7.9.3 Reagent comparison procedure report

The report can only be accessed if there is just a single line of results per [Sample ID].
Figure 111: Reagent comparison procedure report

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The table collates the values of the analyzer, the 2 tests and the calculations (deviations, differences, out of
range).

The "Out of range" values (indicated by *) are those values beyond 2 standard deviations of the differences in
relation to the mean (i.e. outside the concordance limits on the Bland-Altman graph).

Four additional graphs: linear regression and, in order to consider the values obtained in context, a graph of
ratios, a graph of differences and a Bland-Altman graph.

 Search for linearity - Linear regression (least squares method).

This graph gives an idea of the mean overall correlation between the techniques. An algorithm searches
for the equation of the line (Y = aX + b) that passes closest to the points on the graph.

 Graph of ratios.
The Y/X ratios are represented as a percentage in relation to X. The limits at +/- 10% are represented as
red dotted lines.

 Difference graph or difference graph in %.

The Y-X or X-Y differences (according to the configuration of the procedure) are represented in relation
to X. The monitoring limits found in the imported expert theoretical values are represented as red
dotted lines. If the customized monitoring limits have been entered, they will take precedence over the
limits for the expert values. The monitoring limit is only displayed on the difference graph.
Visually verify that the points are not located outside the set limits.

 Bland-Altman graph.
The Y-X or X-Y differences (according to the configuration of the procedure) are represented according
to the mean (X+Y)/2.
The mean of the differences corresponds to the mean bias between the two methods. The confidence
interval of the bias, shown as red dotted lines, is located at 1.96 standard deviations of differences
around this mean. Based on the hypothesis that the differences follow normal distribution, 95% of the
values must be included in this interval. This mean can nonetheless be considered as a systematic
difference between the two analyzers rather than as a real bias.
The confidence interval of the bias, shown as green dotted lines, is evaluated by the Student's t-
distribution value for a probability of 0.05 (5%) with a degree of freedom (df) equal to n-1 in the t-

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distribution table. It is equal to the mean of differences ± (t 0,05 x bias standard deviation).

In these four graphs:

- When the mouse is hovered over a point on a graph, the corresponding line is selected in the
results matrix.
- When a line is selected in the results matrix, the point is highlighted in red on the graphs.
There is no identification of error lines, rejected lines, or the line representing the means of the results.
Clicking the "+" button displays the statistical values.

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Figure 112: Statistical values - Reagent comparison

The statistical values displayed are:

- [Correlation coefficient]
- [Mean of the means]
- [Mean of the differences]
- [Standard deviation of the differences]
- [Mean of % of differences]
- The [Average bias] as a % calculated either in relation to the mean of the reference values, or
in relation to the [Mean of the means], depending on the configuration
- [Linear regression equation (least square method)]
- [Slope]
- [Intercept]
- [Number of values] taken into account in all these calculations
- For each data series (X and Y)
o [Minimum]
o [Maximum]
o [Mean]

Clicking a "+" button under [Conclusion] - [Details] displays the automatic conclusion.

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Figure 113: Automatic conclusion - Reagent comparison

The automatic conclusion allows for comparison of the value obtained for the procedure with the values from
the expert table(s), for the following parameters:
- the [Correlation coefficient]
- the [Average bias]
- the [Average bias] as a raw value: compare to the [Mean of the differences]
- the [Slope]

The color code is as follows:

- Green: below the tolerated limit and correct
- Red: above the tolerated limit and incorrect
- Grey dash: no value configured in the corresponding expert table

7.9.4 Closing a reagent comparison procedure

[Terminate]
Closes the procedure.

The procedure switches to [Completed] status.

 The report (pdf format) is automatically saved in the directory:
"activity\MonitoringQualityAnalyzers\YYYY-MM".

 The filename is saved in the form ProcedureName-ddHHmmss.pdf

For example:
FIB_COMP-R_STAR1_20140113-15120345.pdf.
- The reagent comparison procedure for FIB, STAR1 started on 01/13/2014 was closed on
01/15/2014 at 12:03:45.

7.10 Contamination
The aim is to verify non-contamination of a sample by the previous one. Contamination primarily concerns
parameters that are sensitive to this type of influence.

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After rinsing the analyzer, the principle is to measure three samples with a high value consecutively during the
same sequence, and then three samples with a low value.
The sequences can be repeated several times (5 times) in order to establish the mean of the low values and the
mean of the high values.

7.10.1Creating a contamination procedure

Figure 114: Contamination procedure

When defining the procedure, choose the names of the high and low levels as well as the corresponding tube
identifications (limited to a maximum of three tubes per level).
By default, the start and end dates are identical. The user can change the end date at any time.

All the results from the analyzer that are not included between the start and end dates are
automatically lost for the procedure.

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7.10.2Viewing a contamination procedure

Figure 115: Result of a contamination procedure

The values (entered manually, obtained from the analyzer or imported from the QC) are accessible once the
procedure has been created.
The user can either obtain the results transmitted by the analyzer or manually enter their own results.

Figure 116: Adding a contamination value

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7.10.3Contamination procedure report

Figure 117: Contamination procedure report

After rinsing the analyzer, three samples with high values HIGH1, HIGH2 and HIGH3 with a MeanHigh mean
(depending on the name defined for the high level) are measured during the same sequence, followed by samples
with low values LOW1, LOW2 and LOW3 (depending on the name defined for the low level).
The high and low values are assigned in the sequences based on the order of tube identification entered in the
configuration.

Error or rejected values will result in a blank cell and will not be taken into consideration.

Blank sequences corresponding to a set of three incorrect values (potentially generated by rejected or
error values) will be deleted.

The sequences (HIGH1, HIGH2, HIGH3, LOW1, LOW2, LOW3) can be repeated several times (5 times) in order to
determine the mean of the L1s (MeanLO1) and the mean of the L3s (MeanLO3).

 Bias observed = (MeanLO1 – MeanLO3)

 Contamination (as a %) =(MeanLO1 – MeanLO3)/(MeanHI – MeanLO3) x 100

- This contamination level must be close to 0.

7.10.4Closing a contamination procedure

[Terminate]
Closes the procedure.

The procedure switches to [Completed] status.

 The report (pdf format) is automatically saved in the directory:
"activity\MonitoringQualityAnalyzers\YYYY-MM".

 The filename is saved in the form NomProcedure-ddHHmmss.pdf

For example:
FIB_CONTA_STAR1_20140113-15120224.pdf

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- The contamination procedure for FIB, STAR1 started on 01/13/2014 was closed on
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7.11 Measurement uncertainty

There are two calculation methods.
 IQC method + Supplier Standard.
The components are: the uncertainty related to the method (intermediate precision of the IQCs) and
the uncertainty related to the indications provided with the analytical system standard.

 IQC/EQA method.
This method is based on the use of internal data (IQC – Internal Quality Control) and external data such
as the EQA (External Quality Assessment) or outsourced IQCs.

7.11.1Creating a measurement uncertainty procedure

Figure 118: Measurement uncertainty procedure

The user can choose between two calculation methods:

 [IQC/EEQ Method]
The IQC tube identifier must be defined for the intermediate precision calculations.
To use the EQA it is possible to work from date to date, or to use the last "X" values.

 [IQC/standard supplier method]

The value provided by the manufacturer must be entered.
By default, the start and end dates are identical. The user can change the end date at any time.

7.11.2Viewing a measurement uncertainty procedure

Figure 119: Result of a measurement uncertainty procedure

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The values (entered manually, obtained from the analyzer or imported from the QC) are accessible once the
procedure has been created.
The user can either obtain the IQC results transmitted by the analyzer or manually enter their own results.

Figure 120: Adding internal control values

The user can either obtain EQA results transmitted by the analyzer or manually enter their own results by
entering the date, the tube ID, the lot number, the result, and the reference value provided.

Figure 121: Adding external control values

7.11.3Measurement uncertainty procedure report

Figure 122: Measurement uncertainty procedure report

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The report includes the different IQC/EQA values as well as all the calculations, including the formulas used that
appear on a white background:
- Use of IQCs.
- Use of EQAs.
- Compound uncertainty.
- Expanded uncertainty.

7.11.4Closing a measurement uncertainty procedure

[Terminate]
Closes the procedure.

The procedure switches to [Completed] status.

 The report (pdf format) is automatically saved in the directory:
"activity\MonitoringQualityAnalyzers\YYYY-MM".

 The filename is saved in the form ProcedureName-ddHHmmss.pdf.

For example:
FIB_CALCU_STAR1_20140113-15120224.pdf
- The measurement uncertainty procedure for FIB, STAR1 started on 01/13/2014 was closed on
01/15/2014 at 12:02:24.

7.12 Stability
The stability procedure consists in evaluating the stability of "sensitive" reagents or reagents that are "loaded"
onboard the analyzers, for example. In this case, a standard with a high concentration level can be analyzed as
an unknown sample at regular intervals between D1 and Dn. The number of tests between these two dates
depends on the expected storage period to obtain a minimum of 10 results.

7.12.1Creating a stability procedure

Figure 123: Stability procedure

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When defining the procedure, choose the names of the high and low levels as well as the corresponding tube
identifications.
By default, the start and end dates are identical. The user can change the end date at any time.
All the results from the analyzer that are not included between the start and end dates are
automatically lost for the procedure.

7.12.2Viewing a stability procedure

Figure 124: Result of a stability procedure

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The values (entered manually, obtained from the analyzer or imported from the QC) are accessible once the
procedure has been created.
The user can either obtain the results transmitted by the analyzer or manually enter their own results.
Figure 125: Adding a stability value

7.12.3Stability procedure report

Figure 126: Stability procedure report

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The report includes a graph depicting the changes in measured values over time in relation to the expected
theoretical value.
On the graph:
- When the mouse is hovered over a point on a graph, the corresponding line is selected in the
results matrix.
- When a line is selected in the results matrix, the point is highlighted in red on the graph.
There is no identification of error lines and rejected lines.

7.12.4Closing a stability procedure

[Terminate]
Closes the procedure.

The procedure switches to [Completed] status.

 The report (pdf format) is automatically saved in the directory:
"activity\MonitoringQualityAnalyzers\YYYY-MM".

 The filename is saved in the form ProcedureName-ddHHmmss.pdf.

For example:
FIB_LIMIT_STAR1_20140113-15120224.pdf
- The stability procedure for FIB, STAR1 started on 01/13/2014 was closed on 01/15/2014 at
12:02:24.
 The operation is traced and accessible from the [Traceability] menu.

7.13 Control time calculation procedure

The control time is an important variable in the calculation of the INR and the APTT P:C ratio. Each laboratory
must specify their own control time, for each new lot of reagents and/or change of analyzer.
For example: for a selection of 20 healthy adult subjects, balanced in terms of age and gender, who take no
treatment that might interfere with clotting (VKA, Heparins, Antibiotics, etc.) the PT and/or the APTT is measured
for each tube. The control time corresponds to the geometric mean of the PT and/or APTT measured for all the
selected samples, according to the formula: n Va1 x a2 x a3... x an.
The values cannot be entered manually in this procedure. They are imported from archived patient files and/or
from the connection. Values cannot be imported from a procedure if it has been closed.

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7.13.1Creating a control time calculation procedure

Figure 127: Control time calculation procedure

When the procedure is being defined, choose the high/medium/low levels.

By default, the start and end dates are identical. The user can change the end date at any time.

7.13.2Viewing a control time calculation procedure

Figure 128: Results of a control time calculation procedure

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Once the procedure is created, the values (acquired from the archived files and imported from the add window
– see below – and/or from the connection) are accessible.
The user can only import results from the files transmitted by the analyzer and already archived. Access to a
panel of filters is available for this purpose.
[Import]
Access this panel of filters to import the results.

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Figure 129: Adding values for the control time calculation procedure

[Date of result validation]

The range of result validation dates corresponds to the dates set when the procedure was created.

[Gender]
Filters by patient gender.

[Age]
Filters by patient age range.
If the left limit is not entered, the search will be performed on ages below the value entered in the right limit.
If the right limit is not entered, the search will be performed on ages above the value entered in the left limit.

[No medication]
Filters on the presence or absence of drug treatment.

[Reagent]
Filters on the reagent lot for the test.

[Result]
Filters on the value of the test result.

[Another test]
The user can also select 3 other tests with result value ranges.
The application then searches, by tube, for results for the 1, 2 or 3 selected tests.

To select 1, 2 or 3 additional test(s), a result range must be entered for the test.

[Check all]
Checks all the lines currently displayed on this screen.

[Check the] XXX [first lines]

Checks only the first XXX lines of the list.
> To use this function, the [Name], [First name], [Date of birth], [Gender] and [Sample ID] columns can be sorted

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in ascending or descending order.

[Preview]
This function gives a preview of the control time calculation procedure report with the currently selected values.

[Add]
Adds values to the values that already exist in the control time procedure.

[Replace]
Overwrites the values that already exist in the procedure and replaces them with those currently selected.

[Cancel]
Does not save any modifications and returns to the previous screen.

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7.13.3Control time calculation procedure report

Figure 130: Control time calculation procedure report

On the Levey Jennings graph:

- When the mouse is hovered over a point on a graph, the corresponding line is selected in the
results matrix (there is no selection in the matrix for the bar chart).
- When a line is selected in the results matrix, the point is highlighted in red on the graph.
There is no identification of error lines and rejected lines.
The following information is presented in this report:
- General statistics [Number of values], arithmetic and [Geometric mean], arithmetic and
[Standard deviation], arithmetic and geometric [CV], arithmetic and geometric [Reference
interval].
- Table of values [Date], [Sample ID], [Result], [Units], [Reagents], [Anlsr/Manu]: "M" if entered
manually.
- Levey Jennings graph.
- Value distribution graph.
- Customizable diagnosis.

7.13.4Closing a control time calculation procedure

[Terminate]
Closes the procedure.

The procedure switches to [Completed] status.

 The report (pdf format) is automatically saved in the directory:
"activity\MonitoringQualityAnalyzers\YYYY-MM".

 The filename is saved in the form ProcedureName-ddHHmmss.pdf

For example:
FIB_CALCU_STAR1_20140113-15120224.pdf

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01/15/2014 at 12:02:24.

7.14 Expert values

The expert tables enable determination of the correspondence between the workstation tests and the values
provided in the reference tables.

Personal values can be defined.

They will be matched with the results of the different procedures and may be used as a basis for
comparison/evaluation.

These values are used in the conclusions of procedures for:

- reagent comparison
- analyzer comparison
- uncertainty
- contamination
- repeatability
- reproducibility

The expert tables of values shown below are the "basic" tables provided to be enabled in the software.
Customized tables of values can be configured when the software is installed.

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7.14.1Customized table of values

Depending on the configuration defined at installation, one or two customized tables can be used.
Accordingly, the customized tables shown below are called "GFHT_95" and "GRAAL_FR".

Figure 131: Customized table - in this example "GFHT_95"

Clicking in the [Local Code] column brings up a drop-down list of the mnemonic codes for the existing tests to be
associated with the name of the customized table.
If the customized table units and the units configured for the tests are not identical, the conversion factor to be
applied to the values of the personalized table must be determined.

Clicking on > brings up two columns to be entered for all the tests concerned:
 [Multiplier]
This is used to switch from the customized table unit to the local test unit.

 [Local Units]
This displays the unit configured for the local test.

For example:
If "GFHT_95" uses mmol/L and the application uses g/L, for the TEST analysis.
Since the molecular mass of the TEST analysis is 180 g/mol, the conversion is done using the
following calculation:
1 mmol/L=0.001 mol/L=0.001 mol/L x 180 g/mol = (0.001 x 180) g/L = 0.18 g/L

7.14.2Lab values
Enables the user to define the personal values of the laboratory by directly completing the chosen boxes.

Figure 132: Laboratory values

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7.15 Settings
This menu is only accessible with full rights and provides access to the following functions:
- customize the names of procedure types
- customize the short texts of the procedure names
- choose whether, for each procedure, the procedure name is automatic.

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Figure 133: Accreditation tool settings

The customized name of a procedure type is displayed in all the windows of the Accreditation Tools menu as well
as in the reports.
The short text comprises a unique combination of five letters and is used to generate the automatic name for
the procedure. If the short text is less than five letters long, the text will be automatically supplemented with "_"
characters.
If the "Automatic name" option is enabled, the procedure name is created as follows:
<Test name>_<abbrev. type>_<AnalyzerCode>_<creation date YYMMDD>
where <abbrev. type> is the short text associated with the procedure type.
If the "Automatic name" option is not enabled, the procedure name is blank and must be entered by the
operator.
A procedure must have a unique name. When creating a procedure, if the name of the procedure
already exists, the message [This name already exists] appears on the screen. The name of the
procedure must then be modified manually, disabling the [Automatic name] option, if necessary.

If a customized procedure type name does not meet the criteria for validation, the name will be shown in red
font.

7.16 Import/Export
Once a procedure is implemented, the values are obtained from the analyzer and can be used immediately.
If the values were run on the analyzer before the procedure was created, it is possible to retrieve the values.
- From the saved Quality Control data.
- From an external source.
Figure 134: Import/Export accreditation tools

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7.16.1Import from the IQCs

The import can be filtered according to different criteria:
- Period.
- Test.
- Analyzer.
- Tube identifier.

Depending on this filter, a selection is displayed.

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Figure 135: Import of internal values

[Import all lines]

Retrieves all the lines displayed in the Accreditation Tools module.
Each line can be used for one or more procedures.

[Import selection]
Retrieves all the lines selected by the user in the Accreditation Tools module.
Each line can be used for one or more procedures.

A line that has already been imported will no longer be displayed in this grid. Only lines that have
never been imported can be selected.

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7.16.2Import from a standard file

Figure 136: Import from a standard file

[Select file]
Enables the user to select a file using a browser.

The file format is strict and specified. It corresponds to the format obtained by the Standard data export:
- Header line.
- 13 columns separated by semi-colons with, in the following order:
- line number
- test RETURN (or UPLOAD) code
- result, using the period as a decimal symbol "."
- date/time, format yyyy-MM-dd HH:mm:ss
- tube identifier
- analyzer number
- patient ID (not used)
- control lot number-
- plain text name of the test
- "X" if value rejected (not used)
- comment (not used)
- reagent (not used)

For example:
Line;CodeA;Result;Date;Tube;Analyzer;PatientID;CtrlLot;Test;Rejected;comment;reagent
1;1;54.4;2014-03-17 09:28:41;Tube292;35;;20458; PT;;;
2;1;56.4;2014-03-17 09:29:30;Tube292;35;;20458;;PT;;;
3;1;57.4;2014-03-17 09:29:30;Tube292;35;;20458;;PT;;;

Once the file is selected the data are displayed line by line as they were read. The user must select the analyzer
to which they want to attach the lines. They can then select them so that they can be used for one or more
procedures.

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By default, only lines that do not already exist in the performance verification table are included.
Nevertheless, the user can include the lines in duplicate, by forcing their inclusion in the performance
verification module.

7.16.3Importing a customized file

Displays the configuration window for importing a customized file.

Figure 137: Importing a customized file

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Figure 138: Format of the import file

1. The user must:

- Copy one line of the imported file.
- Define the field delimiter and provide the number of the first line to be processed.

Once these two parameters are entered, the different fields appear in the lower part of the window.

2. The user can choose different solutions for processing the identification:
 [the value defined in the process].
This proposes the identification entered in the procedure concerned by the import.

 [the value of the field defined as 'ID'].

This proposes the identifier that appears in the file as the identifier used in the procedure in question.

 [Follow with].
This enables the user to add a suffix to the file identifier. It is therefore the identifier that is tracked in
this field that will be processed in the procedure concerned.

 [followed by the field defined as 'Level'].

This enables tracking of the identifier for the field set as the level of the drop-down menu.

 Depending on the configuration, the value of the identification appears in the [Example] window.

3. For each field read in the file, the user must define the corresponding field in the drop-down menu.

Figure 139: Selecting the fields for the import file

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For the date field, the user must provide the file format as well as the separators.

Once the field selection has been set, the user must validate their entry, return to the previous menu and, via
the browser, choose the file to be imported.

7.16.4Exporting data
The values included or entered in the performance verification are exported to a .csv file with the specified name.

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Figure 140: Exporting data

The user must select the lines to be exported. There are several selection criteria:
 [Ignore processes]. Carry out the following actions:
- Choose the analyzer or all the analyzers.
- Choose the test or all the tests.
- Define an identifier. If the field is left blank, all the identifiers are selected.
- Define a period.

 [By process]. Carry out the following actions:

- Choose a type of procedure.
- Choose the analyzer or all the analyzers.
- Choose the test or all the tests.
- Define an identifier. If the field is left blank, all the identifiers are selected.
- Define a period.

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Figure 141: Result of the data export

[Export all lines]

Exports all the lines selected in the grid.

A window appears that enables the user to specify the folder where the export file will be saved.
Figure 142: Selecting lines to be exported

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8 Other tools

8.1 Reference ranges

This module works with values that are more related to epidemiology.
For the chosen period, the patient values can be displayed by test. The values are found in the archives and in
the pending files.
Only the validated patient results (patient with a date of birth and a gender (F, M or U)) are saved
for the different calculations.
If there are multiple runs on the analyzer, only the value validated by the user is relevant.

There are three possible display and printout modes:

- Levey Jennings.
- Value graph.
- Table of values.

8.1.1 Selecting the test

Figure 143: Patient reference ranges

Other menus cannot be accessed from this menu.

The user can select their test from the drop-down menu on the home page of this module.

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Figure 144: Selecting graphs

Enables the user to toggle from one graph to another at any time.

Figure 145: Selecting points

Enables the user to toggle the display between all the values or a daily
average at any time.

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8.1.2 Levey Jennings graph display

Figure 146: Levey Jennings display

Several results are displayed according to the period:

- The maximum value.
- The mean.
- The minimum value.
- The standard deviation.
- The coefficient of variation.
- The number of points used for these calculations.

It is possible to exclude all the points above a value and/or the points below a value.

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8.1.3 Displaying a value graph

Figure 147: Value display

Several results are displayed according to the period:

- The maximum value.
- The mean.
- The minimum value.
- The standard deviation.
- The coefficient of variation.
- The number of points used for these calculations.

It is possible to exclude all the points above a value and/or the points below a value.

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8.1.4 Value table display

Figure 148: Value table display

The table on the left side has a line for each value, with:
- The date the result was obtained.
- The value of the result.
- The analyzer that performed the test.
- The reagent kit, if the analyzer transmits this information.

The right section has a graph of the distribution of values around the mean, as well as a distribution by
age/gender.

It is possible to change the interval value for each graph (the default value is 10).

The graph of the distribution around the mean can be presented in either bars or curves.

For the graph of the distribution by age group, it is possible to choose the display as follows:
 [No gender distinction]
The values for women appear in red and those for men in blue.

 [All]
The values for both genders may or may not be stacked.

 [Males]
Only the values for men are displayed.

 [Females]
Only the values for women are displayed.

Several results are displayed according to the period:

- The maximum value.
- The mean.

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- The minimum value.
- The standard deviation.
- The coefficient of variation.
- The number of points used for these calculations.

It is possible to exclude all the points above a value and/or the points below a value.

8.2 Internal Mail

From this menu, it possible to manage the sending and receipt of messages between listed users of the
application.

Figure 149: Internal Mail

Other menus cannot be accessed from this menu.

[New Message]
Enables the user to write a new message.

[Delete]
Enables the user to delete the selected messages.

The current user is the originator of the information sent.

Only messages for the current user are displayed in the mailbox.

8.2.1 Mailbox
As is the case for a standard mailbox, all the messages appear in the same window, in bold for unread messages
and in plain text for messages already read, with the name of the sender and the subject of the message.

Figure 150: Mailbox

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Double-clicking the selected line opens the message.

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Figure 151: Viewing a message

[Reply]
Sends a message back to the sender.

[Reply to All]
Sends a message to all the users who were recipients of the message.

[Print]
Prints the message.

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8.2.2 Sending a message

The user can choose one or more recipients for their message. They must enter a subject, and their message.

Figure 152: Sending a message

[To]
Displays the list of all possible recipients.
The user must select one or more recipients from the available list.

[Send]
Once the message is entered, enables the user to send it to the selected recipients.

8.3 Test Count

8.3.1 Definition
Tests are counted for each result transmitted by the analyzer or entered by the user.
For each test that is counted, the following information is saved:
- Test code.
- Requesting laboratory number.
- Return date.
- Number of first runs.
- Number of technical controls.
- Number of calibrations.

This information remains in the database and is available for all processing until the counting lines are purged.
For counting to function correctly, all the data related to tests, analyzers and laboratories must be
present in the database. Therefore, it is inadvisable to delete a test, analyzer or laboratory once the
item is no longer used.

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Figure 153: Test Count

Other menus cannot be accessed from this menu.

The user can select the following information:
- One or more analyzers.
- One or more tests.
- One or more origins.
- One counting period.

QC test counting is related to the laboratory; a single laboratory, for which the [Send QC by LIS link
(only a single lab)] option enabled, performs the transmission for all the laboratories. The default is
laboratory 001.

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8.3.2 Test count organized by origin (single origin to date)

Figure 154: Test count organized by origin

The following information is displayed for each laboratory selected:

- Origin.
- The test LOINC code.
- The number of tests performed for the selected tests.
- The number of QCs run.
- The number of EQCs run.
- The number of reruns (decided by the user on validation).
- The number of replicates run.
- The number of calculations.
- The number of errors.
- The number of dilutions.
- The total number of tests.

[Show details]
Provides this same information, but for each test selected.

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Figure 155: Detailed test count organized by origin

The [Test] and [Analyzer] columns are then entered.

8.3.3 Test count organized by Test

Figure 156: Test count organized by test

The following information is displayed for each laboratory selected:

- The test code.

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- The test LOINC code.
- The number of tests performed for the selected tests.
- The number of QCs run.
- The number of EQCs run.
- The number of reruns (decided by the user on validation).
- The number of replicates run.
- The number of calculations.
- The number of errors.
- The number of dilutions.
- The total number of tests.

[Show details]
Provides this same information, but for each test selected.

Figure 157: Detailed test count organized by test

The [Origin] and [Analyzer] columns are then entered.

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8.4 Total Analytical Time

The principle of the TAT is to establish the mean test performance time frames, between a time T and a time
T+1, and to provide the bases for two types of calculations:
 Calculations in real time.
Carried out in pending files, giving an indication of whether current operations and operating alerts, if
applicable, are running smoothly.
 Statistical calculations.
They enable the comparison of performance over time and identify factors that led to an improvement
or deterioration in the performance.

There are four possible calculation times, to be combined two by two:

- The sample collection date (if it is known).
- The arrival date of the request.
- The date the last result, analyzer or manual entry was obtained.
- The validation date of the result, analyzer or validation.

This is according to the requesting laboratory and/or requesting service.

This module is general for the application, i.e., it is possible to calculate and view the performance
time frames for all the laboratories and analyzers configured on the application without division
restrictions.

"Date" signifies the complete date: day + hour + minute. The time frame is always defined in minutes.

Figure 158: TAT

Enables the user to export the TAT in a file.

Provides access to the TAT tracking window.

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Provides access to the TAT calibration window.

Provides access to the TAT control window.

8.4.1 Exporting the TAT

From this module, it is possible to export all the set rules with their different values to a .csv file.

8.4.2 Tracking the TAT

From this module it is possible to find tubes exceeding a set value, thereby providing a real-time indication of
the smooth running of current operations.

Figure 159: Tracking the TAT

The filters enable the selection of the following information:

- The test to be audited.
- The first time.
- The second time.
- A laboratory, if applicable.
- A service, if applicable.

The period may concern the following information:

- Pending files. These are tests that have not yet been archived.
- Archives. These are tests that have already been archived.

The results are displayed in a graph, with dates on the X-axis and time frame on the Y-axis. Each value is
represented by a green dot.
A blue line shows the mean value calculated for the period. A red line is present if a rule was set for these

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conditions.
A summary table provides the following information for each value:
- The tube identification.
- The name of the laboratory.
- The service.
- Time 1.
- Time 2.
- The time frame.

A summary table on two lines provides the results calculated for the period. The calculated mean (in blue on the
graph) and the expected mean, if a rule was set for these conditions (in red on the graph). The following
information is provided for each line:
- The mean.
- The percentage of tubes above the mean.
- The number of tubes above the mean.

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8.4.3 TAT calibration

By searching in the archives, calibration will make it possible to establish a base value (or reference value) for a
parameter between two times.

Figure 160: TAT calibration

All the rules set for the chosen test appear in the window. The following information is displayed for each rule:
- Time 1
- Time 2
- The set time frame
- The relevant laboratory for the rule.
- The relevant service for the rule.

[New]
Creates a new rule.

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Figure 161: Adding a TAT rule

The user must enter:

- Time 1 (required).
- Time 2 (required).
- The laboratory (optional).
- The service (optional).
- The evaluation period (required).

[Evaluate / calculate]
Enables the user to obtain the graph for the information previously entered.

If this procedure was already completed, the system displays the current mean with the date it was obtained.
The calculated mean is proposed. This value can be modified manually by the user.

[Save]
Saves the new mean in place of the current mean.

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8.4.4 TAT control

In this module it is possible to find out the progress of the tube in relation to the rules set in the TAT, for all the
tests.

Figure 162: TAT control

The user can narrow down the selection with the following information:
- Analyzer.
- Test.
- Laboratory.
- Service.
- The pending tests, all or only the urgent tests.
- The archived tests.

Enables the user to select the different test statuses.

 Red
Tests that have exceeded the time limit.

 Yellow
Tests that are 5 minutes from exceeding the time limit.

 Gray
Tests for which the TAT could not be calculated (lack of time).

 Green
On-time tests.

Figure 163: Viewing a test in the TAT

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Double-clicking on a line provides access to the chosen tube, with the details of the rule concerned for each test.

8.4.5 Advanced Tools

This menu is reserved for engineers duly authorized either by Stago or by one of its official distributors.
It groups together the modules for import/export and the sending of specific requests to analyzers.

9 Tests

9.1 Definition
Each test represents a result line and may or may not be connected to one or more analyzers. A test belongs to
a single type of sample and to a single analyzer.

Figure 164: List of tests

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Each test is referenced by an internal Stago code. The code used on the site remains configurable.

Enables the user to manage the configuration of tests.

Enables the user to manage reflex rules.

Enables the user to manage the types of tubes.

Enables the user to manage dictionaries.

One filter per group of tests is possible. If a group is selected, only the tests belonging to this group are displayed.
Double-clicking on the chosen test line provides access to its configuration file.
Direct access is possible by entering the test code (site test code) or by entering its transmission code (code used
between the LIS and the application).

9.2 General tab

Figure 165: General tab for the test

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From this menu it is possible to enter the general information for the test.

 [Code]
Short-form test code as it will be presented in all the application functions. It must not contain spaces.

Certain characters and sequences are not permitted when creating or renaming the test code:
Exf, Exclsf, @, D@, P@, V@, FLG-, FGE-, FGA, ², SiNonNul, SiEx, å, siF, siH, HEM, LIP, ICT, CHCKVOL,
PRSNT, PRSNTT, NONPRSNT, NONPRSNTT, DISPO, DISPOTT, NONDISPO, NONDISPOTT, LOG-, LOG10-,
EXPN-, ANLSR-

 [Transmission code]
Coding the test for exchanges with the LIS.
A name can be given in the next field. It will be sent after the code in case of local ASTM connections.

 [STAGO Code]
Code cannot be modified by the user who makes the links for imports and exports. This is the internal
Stago universal test code.

 [LOINC]
Standard LOINC (Logical Observation Identifiers Names and Codes) ID, code that cannot be modified by
the user, used for counting tests.

 [Text]
Text to be printed when reports are being printed.

 [Bench]
Select the bench on which the test will be performed. In case of a mirroring analyzer (several analyzers
can perform the test), only the reference analyzer is displayed.

 [Fluid type]
Select the type of tube on which the test is performed. Type of tube corresponding to a SINGLE tube
number allocation.

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 [Battery or profile]
Indicate whether this test is broken down into N basic tests. In this case, a table will be provided that
can be used to create a battery of a maximum of 24 basic tests.

A Profile is an entry shortcut that, for the creation of a request, makes it possible to enter a set of
tests all at once (which can include different types of tubes or be configured on different analyzers)
for one or more tubes.
A Battery only comprises tests considered to be compatible; i.e., tests with the same type of tube
that can be carried out in the same tube, for the same analyzer.
> A Profile must only contain individual tests; therefore it cannot contain a battery, nor be a true test
(contain itself).
> A Battery can contain itself but must not contain a profile.

 [Transmission code for extra test]

Transmission code for a test to be created systematically by the ACQUISITION module. The code for a
battery or a profile can be specified here.

 [Linked document]
Section not accessible to the user. Indicates if there is a graph or a report associated with the result of
this test. A graph or report can be associated with any type of result other than "Text". (Not used in
hemostasis).

 [Group of tests (validation)]

Assigns the test to a group of tests (enables filtering during validation).

Enables the creation of a new group of tests.

It is possible to view all the tests attached to an existing group.

 [Show test in validation mode]

Indicates whether this test should be visible in validation: enables masking/viewing of the intermediate
calculations.

 [Result to send]
Indicates whether after processing, the value of this test should be returned to the LIS. In all cases, this
test is archived in the application. If the result is NI, specify whether this test should or should not be
returned.

 [View calibration curves]

Indicates whether it is possible to view information concerning calibration for this test in validation
mode.

Calibration information is only displayed if the tube has a minimum of two tests that refer to the
same calibration, and for which at least one is configured as the main test for the calibrations.

 [Print]

Configuring tests for the reports:

- 0 Result.No result will be printed for this test.

- 1 Result.
Only the validated result will be printed.

- 2 Results.
In addition to the validated result, the second last result will be printed.

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- Long form correspondence.
For coded comments, the long form of the comment will be printed.

- Short form correspondence.

For coded comments, the short form of the comment will be printed.

 [Type]
- N (Numerical)
A numerical result is a result that has been signed off, to 0, 1, 2, or 3 decimal places.
The default value is shown as a manual entry.
A numerical result cannot have any characters besides 0–9. Any other character will be rejected. The <
and > signs are detected automatically.
Literal transformation, proper decimal formatting, the application of factors, interpretation, and the
verification of minimum and maximum values are applied.
For example:
For an "N"-type result with 2 decimal places
Value returned by the analyzerFinal value
184,0 184.00
> 184,0 184.00

- A (Alphanumerical)
A short alphanumerical result is a result that is 12 positions in length, containing any character.
The default value is shown as a manual entry.

- B (Coded numerical)
Numerical result as specified above, but which can take an alphanumerical value representing a code,
if applicable.
The default value is shown as a manual entry.
The values obtained for this type of test are subject to the same processing as the "Numerical" values if
they are numerical and the same processing as the "Alphanumerical" values if they are not.
For a "B"-type result with 2 decimal places
Value returned by the analyzerFinal value
184,0 184.00
> 184,0 >184.00

- D (Text numerical)
Numerical result as specified above, but which can take any alphanumerical value, if applicable.
This type of result, except for the return coding, is processed in an IDENTICAL manner to the B (coded
numerical)-type result.

- C (Calculation)
A calculation result is a numerical result for which the value is calculated from one or more results of
other tests.
Results of this type cannot be modified directly.
The default value in manual entry is "Calculation" and is only evaluated at the time of validation.
The syntax of the calculation formula is explained in the reflex tests section.
 See also § 9.8.

- E (Code)
A coded result is an alphanumerical result for which the name is a "shortcut" to a more complete text.
These texts can be accessed using the DICTIONARY.
The default value is shown as a manual entry.
Values of this type are processed in exactly the same way as alphanumerical values.

- T (Text)
Text type result, 5 lines with a maximum of 100 characters.

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No default value.

- O (Alpha complement)
A result of this type is a short alphanumerical result for which the value is only provided at the time of
validation. This result is never returned by the analyzer.
The test is not accessible by manual entry.
The default value is shown in validation.

- Q (Numerical complement)
A result of this type is a numerical result for which the value is only provided at the time of validation.
This result is never returned by the analyzer.
The test is not accessible by manual entry.
The default value is shown in validation.

- K (Coded complement)
A result of this type is an alphanumerical result for which the name is a "shortcut" to more a complete
text, for which the value is only provided at the time of validation. This result is never returned by the
analyzer.
The test is not accessible by manual entry.
The default value is shown in validation.

- X (Text complement)
A result of this type is a text result (5 lines of a maximum of 100 characters) for which the value is only
provided at the time of validation. This result is never returned by the analyzer.
The test is not accessible by manual entry.
The default value is shown in validation.

- F (Fictive)
A result of this type is a result that, once it is integrated into the database, switches to transmitted
status.

 [Units]
Free text that specifies the test unit.

 [Decimals]
Number of decimal places applied to display results in the application,
initially set to 0 and configurable from 0 to 9 decimal places.

As the results calculated in the application are calculated using the raw values stored in the software,
the results displayed on screen may be different to one decimal place as a result of the rounding
applied.

A change in the number of decimal places affects the display of current, future and previous data
(including QC and archive data) but the raw values are still stored in the database.

 [Length]
By default, the length of results is set at 12 positions, but can nevertheless be modified.

 [Default value]
Default value of the test (as long as its result has not been obtained) for numerical, alphanumerical or
complementary tests.

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 [ACQUISITION - Integration formula]
Enables the user to define the operations to be applied to the tests when requests are obtained.

Displays the integration formula

- Type 2: enter a date beyond which the previous results will be ignored.
- Type 3: enter a number of days beyond which the previous results will be ignored.

9.3 Test report

Figure 166: Test report tab

Printing patient test reports groups together tests by title and then by subtitle.

Within a subtitle, the position of the test determines the presentation.

Each result line can be preceded by five fixed lines of free text entry, and then followed by six fixed lines of free
text entry.

Provides access to the management of titles and subtitles.

Figure 167: Report titles

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The user can create their own titles by providing a sequence number. When it comes to printing, the titles are
printed from the smallest to the largest sequence number.
The user can create subtitles by providing a sequence number. When it comes to printing, the subtitles are
printed inside their title, from the smallest to the largest sequence number.

9.4 Reference values

Reference ranges for each test can be distinguished from this menu according to gender, age, service, and the
patient's source laboratory.
It is also possible to define a delta check for each test (if there are previous results for the patient).

9.4.1 Creating reference values

Figure 168: Test reference value tab

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[New]
Adds one line to the configuration.

[Delete]
Deletes one or more lines from the configuration.

The following information must be entered for each new line:

- The patient [Gndr].
Choose between the values (F) for Female, (M) for Male, (U) if the patient's gender is
unknown.

- The [Min] value.

The minimum limit; it must have the same units as the maximum limit.

- The [Max] value.

The maximum limit; it must have the same units as the minimum limit.

- [Units] of the minimum and maximum values.

Choose from days, months and years.

Regardless of the unit, the calculations are all performed in number of days. For example, 5 years
will be converted to 1825 (365 x 5 days). Therefore, for tests with several limits for the same gender
the minimum limit must be equal to the previous maximum limit.

- One [Service] or all if there is no distinction to be configured.

The list of services retrieved by the connection with the LIS appears.

- One [Origin] laboratory or all if there is no distinction to be configured.

The list of laboratories configured appears.

- [Low value].
Lower limit value for the expected results.

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- [High value].
Upper limit value for the expected results.

- [VERY LOW value].

Alarm value for the lower limit. Any result lower than this value appears in red on validation.

- [VERY HIGH value].

Alarm value for the upper limit. Any result higher than this value appears in red on validation.

9.4.2 Delta check

A delta check can be set for each test.

Figure 169: Delta check

The user must therefore enter the values for the following information:
 [Delta check]
Percentage between the current result and the most recent previous result.

 [% with a minimum of]

Minimum delta check value for the calculation to be valid. This value is used to avoid drift on very low
values, where the percentage quickly rises and is non-significant.
In a majority of cases, the setting should always be zero. Nevertheless, if the result values are very low,
it is recommended that the configuration be entered with "with a minimum of" for the Delta Check with
a value other than zero.

 [Delta check validity]

Valid number of days between the current result and the most recent previous result. If the most recent
previous result is older than this number of days, the calculation is not performed.

9.5 Test Count/QC

This menu enables the user to define the test environment for the IQC, the test count, and the moving average.
The analyzer must be registered in the QC for this configuration to be taken into account (the
analyzer configuration is the authority).
For Quick Control: if the Quick Control is inactive for the analyzer, it remains inactive regardless of
the test configuration.

Figure 170: QC test count tab

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 [QC for this test]

- If active: The test is eligible for QC.
Once the test is registered in QC, the QC validity period takes the 24-hour value by default.

- If inactive: the test is not eligible for QC but can use the QC of another test as a reference with
[For QC values, treat this test the same as].

Note:
- the drop-down menu only shows the tests registered in the QC for the same analyzer.
- The analyzer must be registered in the QC for this configuration to be taken into account
(the analyzer configuration is the authority).

 [Minimum number of valid QC levels required to validate a patient result].

By default, the value is zero ("0") and is equivalent to disabling the validation of patient results dependent on
the QC for this test.
If the validation dependent on the QC is active for the analyzer, this setting indicates the number of different
levels required (mandatory) for the QC condition to be met.
If the validation dependent on the QC is inactive for the analyzer, this setting is only taken into account for the
search of associated QC values (QC report).

 [Quick Control]
The Quick Control can be enabled/disabled for a test.
In inactive mode, it makes it possible not to carry out Quick Controls or QC alerts for this test.

 [Delta check validity]

If the test is registered in the QC, three configuration modes are available for the QC validity period:
- value set at the analyzer level.
- QC period value by default (manufacturer's value).
- value is defined at the test level (default mode).

The value must be between 0 and 99 hours; the default value is 24 hours.

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 [Westgard rules enabled]
Defines the Westgard rules to be applied.
Two rules can be configured (number of “x” and number of “T”).

 [Moving average]
Defines the number of points to take for a moving average, the number of points for the group, and the
acceptable drift percentage.

 [Test count display]

Defines whether this test will be in the selection mask by test count default.

 [Rerun rate]
Defines the number of runs required to calculate the test, and the alert threshold as an acceptable
percentage.

9.6 Connection
From this menu it is possible to define all the analyzer connection settings (connection, validation mode, result
transformation).

Figure 171: Test connection tab

 [DOWNLOAD]
Codes that enable downloading of the test on the analyzer. There are 9 possible codes.

 [UPLOAD]
Codes that enable transmission of the test result. There are 2 possible codes.

 [Main test]
Makes it possible to define the reference test to view factor parallelization information in Validation.

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 [Denominator of dilution for the corresponding calibration point]
Denominator of the calibration associated with the test – used for factor parallelization

 [Transformations]

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Figure 172: Transforming results

This type of transformation concerns the uncorrected result returned by the analyzer, but after a transformation
of this type it is considered that the result "can be validated". It does not go through subsequent controls for
minimum and maximum values.

The value obtained is considered as final and can be automatically validated on request.

The raw result from the analyzer is stored.

The following operators are possible:

- [lower] than value 1.
- [higher] than value 1.
- [between] value 1 and value 2.
- [=] to value 1.

The value of the result is free text.

[New]
Adds one line of configuration.

[Delete]
Deletes one line of transformation.

Figure 173: Specific test processing

Specify whether the test must be created automatically by the analyzer interface.
It is added if it is not already present and is defined with the same sample type as the tube.
Initiate a comparison of two successive values returned by the analyzer with the generation of a flag named "!",
in the event of results exceeding the specified settings. A percentage between the two runs and a minimum value
enables the user to ignore this calculation for low values.

Figure 174: Automatic rerun

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There are three types of automatic reruns for a test:

- The test is rerun if the most recent previous results are present within the time frame and if
the delta check generates an alarm.
- The test is rerun if there are no prior results or if they are too old and the current result is not
within the normal range.
- Specify up to five conditions, respecting the syntax of the standard evaluation and calculation
formulas. See also § 9.8.

Figure 175: Validation option

 [To Be Validated]
The test is always visible in validation.

 [Validate in black box mode]

Immediately available for RETURN, without any checks.

 [Validate if normal value]

The test is immediately considered to be validated if:
- This is a first run.
- There is no analyzer alarm.
- The (Delta Check is OK OR the Delta Check cannot be calculated and the value is within the
normal range).

 [Validate if normal value and meets this condition]

The test is immediately considered to be validated if:
- First run.
- AND there is no analyzer alarm.
- AND (the Delta Check is OK OR the Delta Check cannot be calculated and the value is within
the normal range).
- AND the condition is met (specify up to five conditions, respecting the syntax of the standard
evaluation and calculation formulas). See also § 9.8.

9.7 Automatic comments

A comment is a coded text that accompanies the result in the traceability as well as in the connection with the
LIS. This comment can be added manually by the user during validation but can also be configured so that it
receives a value on the basis of a condition.
Figure 176: Test comment tab

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Each line has an order number, a condition and a value for the comment.

 [Order]
Order in which the expressions will be checked.

 [Condition]
Check(s) to be performed to determine whether or not the value zone comment should be entered as
a validation comment.
The syntax is given in the appendix.
See also § 9.8.

 [Value]
Either a literal value to be entered as it is in a validation comment (e.g. To be verified) or the code of a
comment predetermined in the dictionary but which should start with "COMM" (e.g. COMMFIB which
will generate "FIB Low value").

[New]
Adds a new condition and its value.

[Delete]
Deletes the selected condition.

Figure 177: Adding a comment

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The user must enter the following fields:

 [Order]
The user must assign numbers in increments of 10 to enable subsequent addition of intermediate
conditions.

 [Condition]
The user must enter the checked condition, respecting the syntax.

 [If this condition is met, the test receives as comment]

The user must enter the value of the comment that corresponds to the condition.

 Entry help panel

The details of the functioning of this panel are given in § 9.12.

The program processes the conditions from the lowest order number to the highest.
It stops processing at the first true condition and assigns the corresponding value to the comment.

9.8 Reflex test

A rule is a set of conditions that, for every true condition, executes the set scenario.
Each scenario has one or more actions.
The user can choose the rule to be executed according to the stage of the test processing:
- [During connection].
- [During manual entry].
- [PRE validation].
- [POST validation].

Figure 178: Reflex functions

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The user must select the time when the rule is to be applied by clicking the time arrow that corresponds to
their choice.
They must then select one of the rules already set.
Once the rule is selected, the list of conditions with their scenarios is displayed.

Figure 179: Choosing a reflex function

The black triangle shows the selected time.

 [During connection]
The reflex functions are activated each time a result transmitted by the analyzer is received.

 [During manual entry]

The reflex functions are activated at the end of the manual entry by the user.

 [PRE validation]
The reflex functions are activated just before the page being validated is displayed, and warn the user
before the page is validated.

 [POST validation]
The operations are carried out after validation by the user.

9.9 Evaluation
The evaluation is a coded text through which the value of a conclusion can be entered. This evaluation can be
added manually by the user during validation but can also be set so that it receives a value according to a

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condition.
For this tab to be accessible, the test must be set as an alphabetical complement. In addition, in the general test
tab, the user must enter an evaluation name starting with "evalxxx".

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Figure 180: Test evaluations tab

Each line has an order number, a condition and a value for the evaluation.
 [Order]
Order in which the expressions will be checked.

 [Condition]
Check(s) to be performed to determine whether or not the value zone evaluation must replace the
validation result.
The syntax is given in the appendix. See also § 9.8.

 [Value]
Literal value to validate as is.

[New]
Adds a new condition and its value.

[Delete]
Deletes the selected condition.

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Figure 181: Adding an evaluation

The user must enter the following fields:

 [Order]
The user must assign numbers in increments of 10 to enable subsequent addition of intermediate
conditions.

 [Condition]
The user must enter the checked condition, respecting the syntax.

 [If this condition is met, the test received as result]

The user must enter the value of the comment that corresponds to the condition.

 Entry help panel

The details of the functioning of this panel are given in § 9.12.

The program processes the conditions from the lowest order number to the highest.
It stops processing at the first true condition and assigns the corresponding value to the evaluation.

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9.10 Battery/Profile
This menu enables the user to set the basic tests comprising the battery or profile.

Figure 182: Profile/Battery of tests tab

Indicate whether this test is broken down into N basic tests. In this case, a table will be provided that can be used
to create a battery of a maximum of 24 basic tests.

[A PROFILE is a shortcut for manual entry, generating, in a single code, tests from a different bench].
[A BATTERY is a set of tests to be run on the same sample, on the same analyzer, and to be
transmitted in a group].

9.11 Reflex rules

The application has two types of reflex rules.
- Expert rules.
These rules cannot be modified by the user regardless of their rights. By default, they are not
enabled.

- The user rules configured by a user with full rights.

A rule is a set of conditions, each with an associated scenario. This scenario may have one or more actions.
Figure 183: Reflex rules

A rule simulator enables the user to test their rules before implementation.

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The user can select a rule to display the rules concerning this test.

[New]
Adds a rule.

[Delete]
Deletes a rule.

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Figure 184: Adding a reflex rule

The user must enter the name of the rule to be added and, if necessary, a description.

[New]
Adds a condition and its associated scenario.

[Delete]
Deletes a condition.

Figure 185: Entering a reflex rule

The user must enter the following fields:

 [Order]
It is recommended that the user assign numbers in increments of 10 to enable the subsequent addition

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of intermediate conditions.

 [Condition]
The user must enter the checked condition respecting the syntax.

 [Scenario]
The user must choose a scenario from the existing list (the actions associated with this scenario are
displayed) or choose the [New] scenario to create a new one. The user must then enter a scenario name
(an explicit name is recommended).

 [Assistant]
Assistant for help with the entry of reflex rules. The details of the panel function accessible via this button are
given in § 9.12.

Figure 186: Adding an action

[Add an action]
Enables the addition of an action to the scenario.

[Remove an action]
Enables the deletion of an action from the scenario.

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Figure 187: List of actions

The user can choose one of the actions proposed in the scenario. The number of actions per scenario is not
limited.

Actions proposed:
 [Create analysis]
Adds the test selected in the tube of the test on which the rule was initiated.

 [In the same sample, delete analysis]

Deletes the test selected in the tube of the test on which the rule was initiated.

 [In all the patient’s samples, delete analysis]

Deletes the test selected in the tube of the test on which the rule was initiated. If this test is not found,
the application tries to delete it from another tube for the same patient.

 [Modify current analysis]

Enables the user to modify the result of the test on which the rule was initiated. The user must enter
the value to be substituted for the result.

 [In the same sample, modify analysis]

Enables the user to modify the result of a test to be selected. The user must enter the value to be
substituted for the result.

 [In the same sample, modify another analysis + To be VALIDATED]

Enables the user to modify the result of a test to be selected. The user must enter the value to be
substituted for the result. The progress status will change to [To be validated] for this test.

 [In all the patient's samples, modify another analysis + VALIDATED]

Enables the user to modify the result of a test to be selected. The user must enter the value to be
substituted for the result. The progress status will change to [Validated] for this test.

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 [All tubes , put (another) analysis to rerun]
Enables the user to rerun the selected test.

 [Rerun all analysis of sample]

Reruns all the tests of the tube for the current test.

 [Generate a warning]
Enables the generation of an alert during validation. This alert can be a simple warning or a block. This
type of action cannot be used over time [During connection].

 [Validate all analysis of sample if normal + To be VALIDATED (CX only)]

Enables the user to validate all the tests for the tube, if all the tests have a status of [To be validated],
AND the values for all the tests fall between the lower value and the upper value of their configuration.

 [Validate a group of analysis if normal + To be VALIDATED (CX only)]

Enables the user to validate all the tests from the selected group, if all the tests have a status of [To be
validated], AND the values for all the tests fall between the lower value and the upper value of their
configuration.

 [Modify an analysis in any sample, and VALIDATE if NORMAL (CX only)]

Enables the user to modify the result of a selected test, and change its status to [Validated].

Unlike comments and evaluations, a true condition does not stop the processing of a rule. All the
conditions of a rule are processed. To stop a rule, there is a predetermined scenario [No more action].

9.12 The reflex rules assistant

The help tool for entering reflex rules makes it possible to devise the conditions to be met by the tests in a flexible
and intuitive way.
This condition (1) is broken down by the assistant into sub-conditions separated by logic operators (2), and the
details of each sub-condition are given in a design panel with its main constituent elements (3).

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9.12.1.1 Accessibility of the assistant

The assistant for help entering reflex rules is available from the following menus in the test configuration:
 [Connection] tab
- [Rerun on condition] in the [Automatic rerun at connection time] section

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- [Validate if normal value and meets this condition] in the [Test status when uploaded by
analyzer] section

For the assistant to open, you must first click one of the five suggested conditions before clicking the [Assistant]
button

 [Automatic Comments] tab

By double-clicking an existing condition (1) or after clicking the [New] button (2).

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 [Evaluations] tab
By double-clicking an existing condition (1) or after clicking the [New] button (2).
Reminder: to access the Connection tab, the type of Test must first be defined in "(C) Calculation" and entered
in "eval" in the evaluation formula field.

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 From the reflex rules configuration

By double-clicking an existing condition (1) or after clicking the [New] button (2).

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And after clicking the [Assistant] button (3).

9.12.1.2 Using the assistant

A condition can be entered directly in the [Condition] field (1) without the assistant being open. When the
assistant is opened, the condition is broken down into sub-conditions (2). The sub-condition design panel is
placed on "..." by default (new) and is updated only after a sub-condition (3) is selected.
If the assistant is open, the condition is automatically updated as it is being written.
The condition is limited to 255 characters.

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Entering a condition from the assistant:

List of associated controls and functions

Control Functions
Makes it possible to:
- List all the sub-conditions
- Select a sub-condition to modify
- Initialize the sub-condition design panel in order to insert a
new sub-condition (click "...")
- Modify the logic operator that connects two sub-conditions
(double-click the logic operator concerned)

Makes it possible to:

- Raise the selected sub-condition by one level as well as the
logic operator that precedes it.
Makes it possible to:
- Lower the selected sub-condition by one level as well as the
logic operator that precedes it.
Makes it possible to:
- Insert a new sub-condition by preceding it with an "OR" logic
operator ( | ).
- Validate the modification of the selected sub-condition (the
button is accessible if the sub-condition is preceded by an
"OR" logic operator).
Makes it possible to:
- Insert a new sub-condition by preceding it with an "AND" logic
operator (&).
- Validate the modification of the selected sub-condition (the
button is accessible if the sub-condition is preceded by an
"AND" logic operator).

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Makes it possible to:
- Delete the selected sub-condition.

List of controls and breakdown of the sub-condition design panel

The sub-condition design panel has controls that are displayed according to the selected key word.
Control Functions
Makes it possible to:
- Provide information on the sub-condition affected by the
modification
- Remember that you are in "add a new sub-condition" mode
- Display error messages, if any
Makes it possible to:
- Select an operation type.
- Define the controls to be displayed (described below)
according to the operation chosen.
Makes it possible to:
- Provide information on the syntax associated with the type
of operator selected.
Makes it possible to:
- Select one or more tests (*).
- Select one or more drugs (*).
(*) according to the type of operator selected
Only concerns the list of drugs
Replaces the list of relevant drugs with "***"

Makes it possible to:

- Select an arithmetic operator
Makes it possible to enter a value that can be:
- Numerical
- Other than numerical (automatic addition of {})
- A technical comment (added to the list of comments)
- An evaluation

List of types of operations available and associated syntax

Type of operation Description/Syntax

[free expression] Enables the user to enter a custom expression not related to any key
word
[Test result - all samples] Select A SINGLE test, one arithmetic operator and one value to
compare.
Example return: 'Analyse' = 42
[Test result - current sample only] Select A SINGLE test, one arithmetic operator and one value to
compare.
Example return: ‘ExclsfAnalyse’=42
[Test result , with 'NUL' replaced by Select A SINGLE test, one arithmetic operator and one value to
zero] compare.
Example return: ‘SiNonNulAnalyse’=42
[Test result , with 'NUL' (or not Select A SINGLE test, one arithmetic operator and one value to
found) replaced by zero- all compare.
samples] Example return: SiExAnalyse’ =42
[Test result , with 'NUL' ( or not Select A SINGLE test, one arithmetic operator and one value to
found) replaced by zero- current compare.
sample only] Example return: ‘F+Analyse’ =42

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[Previous result] Select A SINGLE test, one arithmetic operator and one value to
compare.
Example return: ‘@Analyse’ =42
[Delay since previous result] Select A SINGLE test, one arithmetic operator and one value to
compare.
Example return: ‘D@Analyse’ =42
[Delta check value] Select A SINGLE test, one arithmetic operator and one value to
compare.
Example return: ‘V@Analyse’ =42
[Delta check value] % Select A SINGLE test, one arithmetic operator and one value to
compare.
Example return: ‘P@Analyse’ =42
[Initial instrument result] Select A SINGLE test, one arithmetic operator and one value to
compare.
Example of a return: ‘²Analyse’ =42
[Gender] Select one arithmetic operator and one value to compare.
Example return: ‘SEXE’ ={M}
[Age in days] Select one arithmetic operator and one value to compare.
Example return: ‘AGEJ' = 42
[Age in years] Select one arithmetic operator and one value to compare.
Example return: ‘AGE' >42
[Weight] Select one arithmetic operator and one value to compare.
Example return: ‘POIDS' < 42
[Size] Select one arithmetic operator and one value to compare.
Example return: 'TAILLE' > 42
[Service] Select one arithmetic operator and one value to compare.
Example return: 'SERV' = {Pneumo}
[Origin] Select one arithmetic operator and one value to compare.
Example return: 'ORIG' # {LABO1}
[Hemolysis] Select one arithmetic operator and one value to compare.
Example return: 'HEM' = 42
[Lipemia] Select one arithmetic operator and one value to compare.
Example return: 'LIP' = 42
[Icterus] Select one arithmetic operator and one value to compare.
Example return: 'ICT' = 42
[Check volume] Select one arithmetic operator and one value to compare.
Example return: 'CHCKVOL' = 42
[error flag] Select A SINGLE test, one arithmetic operator and one value to
compare.
Example return: 'FGE-ABC' = {A}
[alarm flag] Select A SINGLE test, one arithmetic operator and one value to
compare.
Example return: 'FGA-ABC' = {1}
[Analyzer] Select A SINGLE test, one arithmetic operator and one value to
compare.
Example return: ‘ANLSR-Analyse1’={0103}
[Result available - all samples] Select one (or more) test(s).
Example return: DISPOTT('Analyse1','Analyse2')
[Result available - current sample Select one (or more) test(s).
only] Example return: DISPO('Analyse1','Analyse2')
[Result unavailable - all samples] Select one (or more) test(s).
Example return: NONDISPOTT('Analyse1','Analyse2')
[Result unavailable - current sample Select one (or more) test(s).
only] Example return: NONDISPO('Analyse1','Analyse2')
[Test found - all samples] Select one (or more) test(s).
Example return: PRSNTT('Analyse1','Analyse2')

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[Test found - current sample only] Select one (or more) test(s).
Example return: PRSNT('Analyse1','Analyse2')
[Test not found - all samples] Select one (or more) test(s).
Example return: NONPRSNTT('Analyse1','Analyse2')
[Test not found - current sample Select one (or more) test(s).
only] Example return: NONPRSNT('Analyse1','Analyse2')
[Drug code(s)] Select one (or more) drug(s).
Example return:
- Drugs checked: MEDIC.IN({ASPIR},{DOLI})
- No drugs checked: MEDIC.IN({})
- "Indifferent" box checked: MEDIC.IN({***})
[Current result (CX only - automatic Select one arithmetic operator and one value to compare.
validation)] Example return: 'RESUCX' = 42

9.13 Tube types

Each test can only belong to a single type of fluid. The types of fluid required are set and non-modifiable.

Figure 188: Tube type

9.14 Dictionary
The dictionary is a set of terms, codes and names intended to facilitate the entry of results and/or the comments
for tests in validation.

Figure 189: Adding a comment

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The user must enter the following information:

- The test code.
If the code or description is specific to this test.

- The code or name.

A code with the prefix COMM should be used to make the association with a long comment.

- The name.
For an automatic comment, if the code starts with COMM, it is replaced by this name.

10 Other Parameters

10.1 Analyzers
This menu enables the user to specify all the analyzers connected to the application. The operating mode of each
analyzer is defined by a group of settings.
Incorrect configuration can result in a non-functioning connection. These actions must be carried out
with the assistance of a Stago approved representative.

10.1.1Definition
Each analyzer is referenced by a number. For mirrored analyzers, the numbers of the subsequent analyzers
should have the same tens and units as the reference analyzer.
For example:
- Reference analyzer 1.
- First mirrored analyzer 101.
- Second mirrored analyzer 301.
- Etc.

- The analyzer numbers between 201 and 209 are reserved for bar code printers.
- A maximum of 99 reference analyzers can be defined

Figure 190: Analyzers

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Access to the analyzer settings.

Access to the analyzer products.

Access to the calibrations.

[Configuration]
Access to the configuration of the selected analyzer.

[Tests]
Access to the list of tests configured for the reference analyzer.

[Mirroring Management]
Access to the management of mirrors.

10.1.2Configuration
Figure 191: Analyzer configuration

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Several fields are grayed out with default values. These fields will be used in future versions.

 [Owner]
Number of the laboratory with this analyzer.

 [Bar Code type]

For sites with a barcode printer, the type of barcode to be printed must be selected.

 [Barcode printer]
For sites with a barcode printer, the printer that will print the barcodes must be selected.

 [Connection mode]
Enables the user to define the mode of connection with the analyzer. For Stago analyzers, query must
be selected.

 [Download mode]
Enables the user to load or to choose not to load the analyzer for additions and/or reruns.

Figure 192: Test display order

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To validate and return results, the user can choose the display order:
 [Chrono. order]
Follows the same chronological order of how the LIS requests were sent.

 [Alpha. Order]
Follows the alphabetical order of tests.

 [Order specified]
Follows the order defined for each test.

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Figure 193: Analyzer protocol

This window relates to the configuration of the communication driver established during installation and requires
no modification by the user.

The "Code for sending" field contains the settings for the H frame of the ASTM protocol.
For example, for an analyzer ASTMV2: "99^2.10".
for an analyzer ASTMV3: "<name Analyzer>^99^3.00".

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Figure 194: Analyzer communication line

This window relates to the configuration of the communication driver established during installation and requires
no modification by the user.

The installer will have defined the values for each field:
- Port (RS232, TCP/IP Server, TCP/IP Client, USB)
- Transmission speed (300, 2400, …, 28800)
- Bit rate (7 or 8)
- Stop bits (1 or 2)
- Parity (Even, odd, none)
- Flow control (None, Xon/Xoff, RTS, Xon/RTS)

The default configuration is as follows:

Port RS232
Speed 8
Bit 1
Parity None
Flow control None

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Figure 195: Configuring the QC for the analyzer

 [Quality control activated]

Enables retrieval of quality controls from the connection.
This checkbox must be selected to enable quality control management on the application.

If Quality Control is inactive for the analyzer:

- All the tests connected to this analyzer are not taken into account for the QC even if they are
registered individually in the QC.
- No QC automatic Validation possible
- No Quick Control
- No patient result validation dependent on the QC
- No outsourced IQC

 [QC automatic validation]

Automatically validates QC results if they are considered to be normal – see § 5.8.

 [QC lines are caracterised by the content of the "H" segment, and/or by sample ID]
Identifies the QCs run as a patient, the star represents the variable part of the identifier entered
To define for example:
*099 for patient IDs of type: 12345099; abcdef099; …
099* for patient IDs of type: 09912345; 099abcdef; …
*099* for patient IDs of type: 12099345; abc099def; …
With a pattern such as 099*, on receipt of a result for tube 09912345, the application incorporates a
result for patient 09912345 and a QC for the QC identifier 12345.

 [MyExpertQC]
Enables the internal Quality control outsourced for this analyzer.

 [Validation of patient results depends on validity of QC].

Enables patient results validation dependent on the QC.
When the function is enabled:
- The analyzer drivers only proceed with the automatic validation of a patient result if the QC
conditions are met for the test.

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- This affects tests with "VALIDATED" status to be returned when exiting the connection and
reflex tests such as "Validate whole group".
- To manually validate the results, if the QC condition is not met for a test, it is highlighted in
red and a warning message is generated for the user if they want to force the validation of
the patient result – see § 4.1.8.2.

 [Quick Control] - [Active]

Defines whether Quick Control and the management of alerts are enabled for this analyzer.
Quick Control is performed for all the tests connected to this analyzer with "Quick Control Active".
If the option is enabled, specify the validity period for the QC values as a number of hours. This period
can be fine-tuned for each test, if necessary.

If Quick Control is inactive for the analyzer, there is no Quick Control nor any QC alerts for the tests
connected to this analyzer, even if they are configured for active Quick Control for the test.

 [Duration of QC validity]
If either of the previous 2 options is enabled, this setting must be specified, and by default, takes the
value "24".
The value in hours must be between 0 and 999 hours.

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Figure 196: Identifying the analyzer

The user can enter several pieces of information about the analyzer. This information is used for performance
verification procedure reports, QUALIRIS, MyExpertQC and Test Count.

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10.1.3List of tests
For each analyzer, the user can view the list of all the set tests.

Figure 197: List of analyzer tests

The following information is displayed for each test:

- The test code.
- The type of test result.
- The number of decimal places.
- The sample type code.
- The position for the display provided during validation and the print order.
- The upload code to the analyzer.
- The second upload code to the analyzer.
- The download code from the analyzer.
- The second download code from the analyzer.
- The type of validation during return of the results.
 "2" To be validated.
 "3" Validate if normal value.
 "10"’ Validate in black box mode.
- Automatic rerun for tests for which an automatic rerun is scheduled.
- Included if the test is performed by default on this analyzer.

[Add for analyzer]

From this menu it is possible to add one of the tests in the general dictionary for the application to this analyzer.

[Remove from analyzer]

From this menu it is possible to delete the test from the analyzer and keep the test in the general dictionary for
the application.

[Mirroring Management]
From this menu it is possible to display the table for all the analyzers affected by mirroring and to select/deselect
a test for an analyzer, if necessary.

[Print]
This menu enables printing of the list of tests configured for this analyzer.

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10.1.4Mirroring management
The user can enable or disable one or more tests on the analyzer in real time.

Figure 198: Mirroring management

When several analyzers are "mirrored", the distribution of the tests must be specified:
- A green check mark enables the test on the analyzer.
- A red cross disables the test on the analyzer.
- A gray check mark indicates that the test has no interaction with the analyzer.
[Print]
Prints the distribution of tests per analyzer.

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10.1.5Products
The user can view the information on the products used by the analyzer.

Figure 199: Managing products

The products monitored are:

- [Calibrators]
- [Diluents]
- [Reagents]
- [Cuvettes]
- [Desorb]
- [Cleaners]
- [Offset]

The following information is accessible for each product:

- The product ID
- The product name
- The lot number (if known)
- The activation date
- The expiry date

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10.1.6Calibrations
The user can view the information on the calibrations used by an analyzer.

Figure 200: Calibration

For each calibration:

- Internal calibration number - unique per analyzer.
- Analyzer number and code.
- Calibration status.
- Date and time of validation.
- Date disabled

A calibration is disabled on receipt of a new calibration for the same test, or when there is a
calibration failure on an analyzer.

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Figure 201: Calibration search filters

Filters are applicable for the display of calibrations:

- by analyzer
- by test (one or all)
- by status: validated or disabled

In Coag.One, when the application references a division, only the analyzers from that division can be
selected.

A direct search can be carried out, by entering:

- The internal calibration number.
- The period.

10.1.7Viewing a calibration
After double-clicking a calibration, the user views all the information related to the calibration.

Figure 202: Calibration details

10.2 Laboratory

Figure 203: Laboratories in STA Coag Expert configuration

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Figure 204: Laboratories in Coag.One configuration

Laboratories displayed in light yellow on the list of laboratories correspond to those defined as a division.

Provides access to the laboratory settings.

Provides access to the settings for the communication line with the LIS.

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Provides access to the LIS lookup tables.

Provides access to the drugs lookup table.

Double-clicking the laboratory line provides access to the laboratory configuration windows.

10.2.1Configuring the laboratory

The [Laboratory] window enables the user to enter all the administrative information about the laboratory.

Figure 205: Laboratory settings

The user can enter the following information:

- Address.
- Telephone.
- Fax
- Stago customer number
- Software license serial number (dongle)
- E-mail.

In Coag.One, the [Name] and [Software licence SN] settings are defined at installation and cannot be modified
for all the laboratories.

The [CPRR] setting enables the user to identify whether or not Patient Cost Result Returned is enabled for this
laboratory or division. This configuration is reserved for persons authorized by Stago.

The [Requests] and [Results] tabs are reserved for persons authorized by Stago.
There are two configuration modes for returning results:

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- [Full tubes only.]
When the complete return mode is selected, all the tests for a patient sample tube must be
validated for them to be transmitted to the LIS.

- [Partial tubes]
When the partial sending mode is selected, when one (or more) test(s) is (are) validated for a
patient file, it (they) is (are) transmitted to the LIS.

A modification in either of these two windows can prevent the application from receiving requests
from the LIS.

In Coag.One, the [Divisions] tab enables the user to define the laboratory as a division and to select:
- one or more source laboratories (origins) belonging to this division from the list of laboratories
specified in the [System]/[Laboratories] menu
- one or more analyzers belonging to this single division from the list of analyzers specified in
the [System]/[Analyzers] menu
If an analyzer already belongs to another division, it cannot be selected.

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Figure 206: Configuring divisions

At least one analyzer and one origin must be selected in order to confirm the creation of a division.

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10.2.2Communication lines
This window provides access to the configuration for the communication line with the LIS.
Double-clicking the line provides access to the physical configuration of the line.

Figure 207: Laboratory communication line

The user can specify the characteristics of the communication line with the following information:
- [Transmission speed]
- [Port]
- [Bitrate]
- Stop bits
- [Parity]
- [Flow control]
- [Time out]
(software loop time)
- [Log file]
(between 0 and 9 for the highest) for the details of the communication log.

The default configuration is as follows:

Transmission speed 9600
Port RS232 – COM5
Bit rate 8
Stop Bits 1
Parity None
Flow control None
Tempo 10
Trace 5
Code LOCAL
Name LIS Link
Protocol ASTM 1381

The remaining settings are reserved for persons authorized by Stago.

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10.2.3Drugs

Figure 208: Drugs

The drugs table makes the connection between the different drug codes used in the LIS, the technical support
centre, and the STAGO reference:

- [Code] Internal wording used on display in the application to identify

drugs.

- [STAGO Code] Invariant, predefined by STAGO.

- [Laboratory Description] Code or wording used by the LIS.

- Explanatory wording Free entry to facilitate configuration.

The correspondence between these drug codes then enables the use of the patient's drug treatment
in reflex tests or for the control time calculation procedure in Accreditation Tools.
If the laboratory wording sent by the LIS is not configured in this lookup table, the code displayed in
the application at the patient information level is replaced by "???" to indicate an unknown
treatment.

10.3 Users

10.3.1User account
To access the application, each user must have a code with an associated password.
A "level of rights" is also associated with each user, which gives access to certain functions of the software.
A user with full rights has access to all the features of the software except for the system tools menu.
Only users with full rights can view the list of users.

Figure 209: Users

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Users who do not have these rights can only see their own account.

[New]
Enables the user to add a user account.

[Delete]
Enables the user to delete a user account.

The following information is displayed for each user:

 [Code]
The user code that is entered whenever identification is required.
This code can never be modified.

 [Name]
The user's name is not to be entered and will appear on the traceability records.

 [Access rights]
The level of rights set for the user.

10.3.2Levels and access rights

The four user rights levels are as follows:
- [Standard]
- [Extended]
- [Extended 2]
- [Full]

 The action
Figure 210: User rights

may be performed by the user.

 The action may not be performed by the user.

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[Standard] [Extended] [Extended 2] [Full]
Dashboard
Deleting a test    
Deleting a tube    
Validation    
Forcing the "Validate" box for a result    
for which automatic validation was
blocked
Printing a report    
Creating requests
Adding a patient    
Deleting a patient    
Deleting a test    
Deleting a tube    
Quick entry    
Manual entry
Entry of a value    
Entry of an analyzer flag    
Routing
Routing a tube    
Internal QC by test
Viewing graphs    
Validation, deviation in values    
Adding QC values    
Internal QC by profile
Viewing graphs    
Validation, deviation in values    
QC configuration
Adding a test    
Deleting a test    
Adding/deleting a level    
Modifying the settings of a test in the    
QC
Creating a lot    
Replacing a lot    
Configuring a probationary lot    
Activating a probationary lot    
Modifying expected re-targeting    
values
EQC
Access to EQC program    
Connection mode    
Configuring the identification criterion    
for an EQC pattern
Configuring the pattern for an EQC    
pattern

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[Standard] [Extended] [Extended 2] [Full]
Manual entry of values (addition,    
deletion, modification)
Moving average
Viewing graphs    
Quick Control
Viewing values    
Accessing the QC configurations by    
double-clicking
Analyzer maintenance
Adding a maintenance action    
Viewing the schedule    
Entering a scheduled or corrective    
action (saved as done)
Accreditation tools
Setting expert values    
Creating/deleting a procedure    
Adding a value to/deleting a value    
from the procedure
Closing a procedure    
Accessing the Settings Submenu    
Patient Reference Ranges
Viewing graphs    
Mailbox
Reading a message    
Writing and sending a message    
TAT
Calibration (creating a new rule)    
Viewing graphs    
Advanced Tools
Access to menus    
Test settings
Adding a test    
Modifying a test    
Setting reference values for a test    
Setting the delta check    
Adding a tube type    
Status when exiting the connection    
Main test    
Access to calibration curves in    
validation
Dilution name    
Tests visible in validation    
Adding to/Modifying the Dictionary    
Changing the number of decimal    
places
Changing the unit    

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[Standard] [Extended] [Extended 2] [Full]
Analyzer settings
Adding an analyzer    
Modifying the analyzer settings    
Modifying the analyzer's    
communication line
Configuring the automatic validation of    
QCs
Laboratory settings
Adding a laboratory    
Modifying a laboratory    
Modifying the communication line    
settings
Configuring the sending mode    
Drug settings
Creating a drug (local code, SGL    
wording, explanatory wording, except
for STAGO code)
Modifying a drug (local code, SGL    
wording, explanatory wording, except
for STAGO code)
Other parameters
Adding a user    
Modifying a user    
Modifying a user’s password    
User accounts subject to    
disabling/deletion
Deleting a user account    
Block another user from changing the    
division
Archives
Viewing patient archives    
Delete a patient    
Modify a patient    
Delete a tube    
Combine two patients    
Backup
Perform a manual backup    
Add a backup file    
Configure a new backup line    
Traceability
View the traceability    
Purge the tracking    

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10.3.3Adding a user
This action is only possible for a user with full rights.

Figure 211: Adding a user

The user must enter the following fields:

 [User code]
This is the login that the user must enter for any identification.

 [Name]
This is the name of the user that appears on the printouts and on the panel at the bottom of the
application.

 [Password]
This is the string of characters that the user must enter after their code for every identification. The
password is case-sensitive.
If the [Mandatory complex passwords] option is enabled, the password must contain 8 characters,
including at least 1 upper case letter, 1 lower case letter and 1 digit.

 [Confirm]
The user must enter the password a second time. The software verifies that the two entries match and
displays the level of security of the password that was entered. (Weak, medium or strong).

 [Duration of the session]

The number of minutes without keyboard or mouse activity after which the user session is closed.
The number can range from 1 to 99 minutes.
[Standard]
Default time defined at installation

[Custom]
Choose a time between 1 and 99 minutes.

 [Access rights]
The user must choose an access level for the new user account.

 [Restrictions] See 10.3.5.

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A user cannot be created with the same "User code" as an existing user.

Users with full rights must not know the passwords of the different users.
When the user account is created, it is recommended that a standard password (12345 for example)
be entered and that the new user then be asked to change their password.

If the [Mandatory complex passwords] option is enabled and the user enters a password that does not meet the
criteria, a message is displayed showing the nature of the error:
- Password too short.
- Password not strong enough.

The user must then once again enter a strong password that complies with the following rules:
- Contains at least 8 characters.
- Contains at least 1 upper case letter, 1 lower case letter, 1 digit.

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10.3.4Modifying a user account

Every user can change the password for their own account.
Users with full rights can modify the user accounts of all users, except for the [User code].

Figure 212: Modifying a user

The [Restrictions] button is only present in Coag.One (see 10.3.5)

When the password is changed, if the option to verify old passwords is enabled and the user enters a password
they have already used, an error message is displayed.

Figure 213: Password verification

The user is asked to enter a new password they have not used before.

10.3.5Customizing user rights

Users with at least full rights can use the [Restrictions] button to open a window that enables customization of a
user right.
When using Coag.One, once the application references a division, a user with full rights can authorize/block
division change actions for each user.
Authorization and blocking is done by clicking in the first column so that either a green tick (for authorization) or
a red tick (for blocking) appears.
Figure 214: Customizing a user's rights

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If a restriction is placed on a user's rights prohibiting them from changing the division, when that user logs in to
the Coag.One application, the division change button will be disabled (grayed out).
When creating a new user, regardless of their access level, the right to change division is enabled by
default.

10.4 Doctors

10.4.1List of doctors
Each new request received from the LIS automatically creates the doctor if the code is not known in the
application database.
A doctor can be added manually by the user.
The list of doctors can be used for manual entry. This information, which is sometimes sent to the analyzer, may
be required for certain management actions.

Figure 215: Doctors

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[New]
Adds a doctor.

[Delete]
Deletes a doctor.

Double-clicking the selected doctor line provides access to the doctor’s file so that it can be modified.

10.4.2Adding a doctor

Figure 216: Adding a doctor

The user must enter a code at least. The following information can then also be entered:
- Code.
- Doctor's last name.
- Doctor's first name.
- Address (on two lines).
- Doctor's zip code and town.

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10.5 Services

10.5.1List of services
Each new request received from the LIS automatically creates the service if the code is not known in the
application database.
A service can be added manually by the user.
The list of services can be used for manual entry. This information can be taken into account in the reference
values of a test and in the expert rules.

Figure 217: Services

[New]
Enables the user to add a service.

[Delete]
Enables the user to delete a service.

Double-clicking the selected service line provides access to the file for the service being modified.

Figure 218: Searching for a service

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The user can search for a service either by its code or by its name.
The first few letters of the code or name are sufficient for the search.

Initiates a search

10.5.2Adding a service
Figure 219: Adding a service

The user must enter a code at least. The following information can then also be entered:
- Code.
- Name of the service.
- Address (on two lines).
- Zip code and town of the service.

11 Archives/Traceability

11.1 Archives

11.1.1 Definition
The application provides the option of managing patient archiving.
Archiving is carried out at the end of the day. Files with at least one tube returned to the LIS are archived. Tubes
that have been deleted before their return to the LIS are not archived. Patients are matched according to the
following specific criteria:
- Either in relation to the PID if this is unique.
- Or by last name, first name, birth date, if the PID is not unique.

The default storage time is 2000 days in the database.

Data that are stored are related to the patient, the patient's tubes, tests and all their runs on the analyzer.

11.2 Consulting the archives

Figure 220: Archiving

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1
1
1
1
1
1
2
2
1
1
1
1
1

1: Search criteria
2: Search results in alphabetical order of patients

[Export]
From this menu, the result data obtained can be exported after application of the different filters.

[Merge patients]
From this menu, two patients can be combined.

[Delete]
From this menu, a patient can be permanently deleted with all corresponding tubes from the archives.

11.2.1General search

Figure 221: Scrolling through archive dates

This window displays the total number of patients archived. By default, only the first thousand are displayed.

Provides access to the next thousand results.

Provides access to the last thousand results.

Figure 222: Archive search

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Enables the user to run a search after entering the search criteria.

The user can search using the following information:

- The patient's last name or birth name.
- Birth name.
- Fill in all or part of the fields for these three criteria.
- The PID, if known.
- The tube number.

A tube number can be present for several patients for a period of 2000 days. The application manages
these duplicates for different patients.

11.2.2Viewing a patient's tube

Figure 223: Patient archive

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Double-clicking a line in the grid provides access to the patient's archives.

All the patient's archived tubes are displayed in chronological order, with the result and the test units for each
tube.

Double-clicking one of the tubes displays the detailed information for the tube.

Access to the calibration for the test

Figure 224: Details of an archived tube

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The following data are displayed:

- The date the tube was created.
- The date the file was created.
- The date the tube was archived.
- [Analyzer]: contains the reference analyzer if the tube was processed by the same analyzer
for all tests, "MANU" if the results were entered manually for all tests, or "..." if the tube was
processed by several analyzers and/or had some results entered manually.
- The laboratory of origin of the tube (which may be different to the laboratory of origin of the
patient).
- The date and time of collection.
- The prescriber and service of the patient.
- The prescriber and service of the tube.

A patient can change services and prescriber over time.

The tube data are always stored; the patient data are the last ones known.

The tube history provides access to the following information:

- The date and origin of its creation (manual entry or request from the LIS).
- The different assays by the analyzers.
- The date the tube was returned to the LIS, which corresponds to the date and time the last
test was returned.

11.2.3Viewing a test from the archives

Double-clicking a line in the grid provides access to the patient's archives.

Figure 225: Details of an archived test

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All the patient's archived tubes are displayed in chronological order, with the result and the test units for each
tube.
Double-clicking one of the tests displays the detailed information for the test.

Provides access to the calibration for this test

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Figure 226: Viewing the calibration and parallelism of factors in the archives

Figure 227: Details of an archived test

[Detail for analysis]

This menu enables the following information to be viewed:
- The tube number.
- The request number.
- The prescriber.

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This button is used to display the graph of the patient's previous results for this test.

This button is used to display all the runs of the test on the analyzers.

This button is used to display all the operations carried out during validation for this test.(Rerun and
validation).

[Results]
The following information can be viewed from this menu:
- The value of the validated result.
- The unit of the validated result.
- The value of the previous result.
- The analyzer flag for the validated result.
- The value of the preliminary result if the LIS sent this value.
- The short- and long-form comments.

[Tech]
The following information can be viewed from this menu:
- The date and time the result was obtained.
- The origin of the entry (user code for a manual entry, CXAnalyzer for an analyzer).
- The date and time the result was validated.
- The origin of the validation (user code for a manual validation, CXAnalyzer for an analyzer).

[Analyzer]
The following information can be viewed from this menu:
- The code and name of the analyzer responsible for the validated result.
- The date and time the result was returned for the analyzer.
- The position of the tube on the analyzer.
- The reagents used by the analyzer for this test.

[QC]
The following information can be viewed from this menu:
- The results of the control by level that preceded the test.

11.2.4Detailed search
By using the detailed search mode, the search can be extended to more technical criteria.

Figure 228: Detailed search in the archives

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The user can combine several search criteria, which consist of the following:
- The search period.
- The files entered during this period, or the files archived during this period.
- The last name or part of the last name.
- The first name.
- The PID.
- A predefined service.
- A predefined prescriber.
- A test.
- The test LOINC code.
- A reagent lot.
- A quality control lot.
- The test validator's code.
- By analyzer.
- By group of analyzers that includes all the mirrored analyzers.
- By laboratory of origin.

Enables the user to run a search after entering the search criteria.

The list of patients matching all the search criteria entered is displayed in the grid.

11.2.5Exporting a selection from the archives

After entering the different criteria, a list of results is displayed. The user can then export all the relevant patients
in a structured file.
A screen with a review of the selection criteria is displayed.

Figure 229: Selection criteria

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For all the results, the user can choose to export the run of the validated result on the analyzer or all the runs of
the tests concerned.
The user must specify the file format (.txt or .csv) and the access path for sending the export file.

11.2.6Combining two patients

This is an optional operation and subject to special permissions implemented by Stago authorized personnel.
Two patients that the user recognizes as the same person can be combined. In this case, the first patient chosen
is removed and the second remains. The known batteries for the first patient are reassigned to the second
patient.

11.3 Traceability

11.3.1Use of directories
Documents related to application activity are kept on the workstation. They can then be periodically stored on
their computer hard drive.
These documents are divided between the \driver\activity directory and the following sub-directories:
- A sub-directory per data category.
- A sub-sub-directory per year.
- A sub-sub-sub-directory per month.

Figure 230: Exploring directories

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The user can select:

 [Results]
The operation at the end of the day backs up all the patient results sent. The files are deleted from
pending lists and archived.
These files are stored in PDF format for an unlimited period.

 [Quality Control]
As the old values are deleted in the current database, they are stored day by day in this directory.
List of notable actions carried out on the QC values: modification of values, value deviation, addition of
values, etc.

 [Accreditation tools]
Closures of performance verification procedures generate PDF files that are stored in this directory.

 [End of Day]
Each end of the day generates a summary file of actions taken that is stored in this directory.

 [Miscellaneous]
All manipulations on the database tables as well as acquisition errors (existing tube for another patient,
incompatible type of fluid) are stored in this directory.

11.3.2Using the local database

Traceable information of all the actions taken on the application database.

Figure 231: Traceability (Local)

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The user can select a period and make a request by test or by the patient's name.
Not entering a value in the [Test name] field is the same as selecting all tests.
Not entering a value in the [Name] field is the same as selecting all patients.

The user can narrow down the selection by choosing either:

 [Patient Archives]
All the actions performed in the patient archives for the selected patient or the selected test.

 [Archives (general)]
Not used.

 [Current Records]
All the actions performed in the dashboard for the selected patient or the selected test.

 [Modify Tests]
All the modifications in the test settings for the selected test.

 [Analyzer Mngmnt]
All the actions taken in the analyzer maintenance module for the selected test.

 [Accreditation tools]
All the actions taken in the performance verification module for the selected test.

 [Others]
Summarizes all the information from the different modules.

11.3.3Log history
Makes it possible to consult users' login/logout histories on the application.

Figure 232: Traceability (login history)

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A filter is used to display the [Successful connections] or [Failed connections] over a given [Period].

The following information is displayed for each login:

- The login date and time.

- The logout date and time. If the user was unable to log out, or if the workstation was turned
off before logging out, nothing is displayed in the field.
- The name of the user.
- The name of the workstation (since the application can be started from several workstations).

11.3.4Alerts
Makes it possible to trace the date and time as well as the user who cleared alerts such as QC, TAT and Analyzer
Maintenance.

Figure 233: Traceability (Alerts)

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12 Backup/End of day

12.1 Definition
Daily backup containing the Base and the Context is carried out by the user at the time of the day specified with
the installation service engineer, usually the end of the day.
The user can customize other backups via an interface.
This backup takes place on a configurable medium.

This backup is entirely configurable and usually contains the following information:
- The application log.
- The database.
- The site's activity traces.
- The workstation network settings.
- The .ini and .txt file of the configuration.
- The list of scheduled tasks.

Figure 234: Backups

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The data must be backed up on an external medium because of various risks (fire, etc.).
In the event of hardware failure, the backup can be restored and enable the site to be started up again.

[Manual Backup]
This menu provides access to initiation and configuration of manual backups.

[Automatic backup]
This menu provides access to the configuration of automatic backups (content of the backup and start time).

A report of the last backup is displayed, with the time of execution and the associated configuration file.

The backup status includes the following information:

- The date and time of the last daily automatic backup.
- The scheduled time for the daily backup.
- The date and time of the last manual backup.

12.2 Configuring an automatic backup

Figure 235: Automatic backup settings

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The user must specify whether this backup will be launched automatically by indicating the start time for the
daily backup.

The name of the file containing the settings for the daily backup cannot be modified. It is always in this form.
- Chrono "machine name".ini

A grid is displayed with all the order lines configured for this backup.

[New]
Enables the addition of order lines for this backup.

Figure 236: Adding a backup line

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Provides access to the browser

The user can then choose the target file and the destination for the backup.

[Source]
The user must specify the folder in which the files to be backed up are located.

[Target]
The user must specify the folder in which the selected files will be backed up.

[Extension]
The user must specify the type of files to be backed up by entering the file extension (*.txt, *.ini, etc.). To back
up all the files in the folder, the user must enter *.

[Diary]
This menu enables the user to choose whether or not to include the day (from Monday to Sunday) in the target
path.
 [No]
Systematically overwrites the version from the day before.

 [Yes - Day before last dir.]

Places the day (Monday, Tuesday, etc.) just before the last target directory.

 [Yes - Start of day]

Places the day at the start of the target path.

Example for a backup for which the target is:

- e:\Stago\backup
With no: e:\Stago\backup
Day before: e:\Stago\backup\Monday
Day before start: e:\Monday\Stago\backup

The user can also back up a log key by specifying whether this key is located:
- In the current user.
- In the local machine.

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The user can also back up the result of a program with or without an argument.

12.3 Manual backup

12.3.1Initiating a manual backup

Figure 237: Choosing a manual backup

[Start]
The selected manual backup can be launched from this menu.

This button enables the addition of a new backup in the selection.

The user must enter a name (the name extension must be .ini).

This button enables the deletion of a backup from the selection.

This button enables the addition or deletion of order lines

in the selected backup.

To create a new backup file, a backup must be added and then modified according to the choices.

12.4 End of day

This operation is run automatically by the system at a time specified during installation. Under no circumstances
can the user initiate this procedure from the user interface, regardless of their access level.

The EOD is a set of customized functions that are used to:

- Carry out daily tasks: archiving, creation of traceability files.
- Delete obsolete data.
- Tidy up and compact the database.

A screen that can only be accessed by Stago authorized personnel enables the user to configure the end of day.
The end of day involves several phases.
- Archiving.
- Removal of obsolete data.
- Analyzer connection.

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- Backup/verification of the base.

12.4.1Archiving
All tubes for which all the tests were returned to the LIS are archived. There is a configuration that enables the
user to only archive tubes if all the patient's tubes have been returned.

12.4.2Removal of obsolete data

 Archives and test count.
Old data that are not included in the specified period are removed.

 Purging pending data.

Tests outside the time limit are deleted according to the number of days set.

 Deleting sent tubes.

Tubes that are completed and archived are permanently deleted.

 Deleting files.
Patient files for which all the tubes have been deleted are also deleted.

 Deleting analyzer traces more than 7 days old.

12.4.3Analyzer connection
This involves resetting the "queried by the analyzer" flag to zero. A tube that has been queried by an analyzer
can respond to a request by the analyzer for each of its uncompleted tests.

12.4.4Backup/verification of the base

The first action of the end of day is to back up the database and verify its different tables.
Regularly performing this operation optimizes the use of the database and can improve the performance of the
system.

13 Technical specification
Touchscreen
- Technology: LCD
- Active area diagonal: 22" or 21.5"
- Minimum resolution: 1680 x 1050

14 Appendix 1: Syntax for reflex rules and calculations

This syntax is applicable for different modules in the application:
- The reflex rules (User and supplier).
- The calculation formulas for "C"-type tests.
- Reruns with conditions.
- Validate on normal value and conditions.
- Automatic comments.
- Evaluations.

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The calculation formula can contain various logical or arithmetic operators, miscellaneous constants and internal
operators.

 Logical operators
= equal to
# different from
> greater than
< less than
» (alt 175) greater than or equal to
« (alt 174) less than or equal to
& logical AND
| logical OR

 Arithmetic operators with two operands

+,- Addition, subtraction
*,/ Multiplication, division
\ Integer division
Mod Modulus
Exp, ^ Exponent, power
Write: Operand1 operator Operand2

 Arithmetic operators with 1 operand only (not to be used alone)

Neg Negative value of
Write ‘FIB’ + neg 1
LOG- Napierian logarithm
Write ‘LOG-FIB’ + 2
LOG10- Decimal logarithm
Write ‘LOG10-FIB’ + 2
Expn Exponential
Write ‘EXPN-FIB’ + 2

 Variables expressed as: quote, test code name, unquote.

E.g.: 'FIB' > 20

 Miscellaneous constants
- Numerical
E.g.: 'FIB' = 0.12

- Alphanumericals expressed between brackets (alphabetical comparison)

E.g.: 'FIB' = {Sup. Limite}

 Calculations expressed between brackets

E.g. ['@FIB' * 0.6 ] > 'FIB'

Special keywords that enable the use of a patient's gender, age, weight or height, the service or source of the
tube, or the raw result of the test in a calculation.

- ‘SEXE’ Patient's gender (M, F or U).

- ‘AGE’ Patient's age in number of years.
- ‘AGEJ’ Patient's age in number of days.
- ‘POIDS’ Patient's weight in kilos
- ‘TAILLE’ Patient's height in cm.
- ‘SERV’ Patient's tube service.

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- ‘ORIG’ Patient's sampling laboratory.
- ‘HEM’ Hemolysis value (transmitted in connection).
- ‘ICT’ Icterus value (transmitted in connection).
- ‘LIP’ Lipemia value (transmitted in connection).
- ‘CHCKVOL’ Check volume (transmitted in connection).

 Internal operators
Special keywords enable the use of the prior history of the test, the test flag, and the presence of the test in the
tube in a calculation.

- 'RESUCX' takes the raw value of the analyzer for the current test.
E.g. ‘RESUCX'
Note: to be used for an automatic validation condition in connection mode only.

Test attributes

- SiNonNul to replace a 'NULL' value with zero.

E.g. ‘SinonNulAnalyse'

- SiEx to replace a value not found or a 'NULL' value with zero.

E.g. ‘SinonNulAnalyse'

- Exclsf or Exf to indicate that the test value is to be taken in the current tube only
E.g. ‘ExfFIB’

Checks related to prior results

- @ for "previous value of",

E.g. ‘@FIB’ > 2.50
If no history, the expression is always false

- D@ for "number of days history of",

E.g. ‘D@FIB’
If no history, the expression is always true
V@ for "absolute value of the difference between the prior value and the current value",
E.g. ‘V@FIB’ > 0.10
If no history, the expression is always false

- P@ for "percentage difference between the prior value and the current value",
E.g. ‘P@FIB’ > 1.5
If no history, the expression is always false

Checks related to results

- ANLSR- to retrieve the code of the analyzer that returned a test

E.g.: ‘ANLSR-FIB’={0103}
- FGE- to retrieve the error Flag given by the analyzer for the test
E.g. ‘FGE-FIB'={3}
- FGA- to retrieve the alarm Flag given by the analyzer for the test
E.g. ‘FGA-FIB'={@}

Note: FGE- and FGA- cannot be used in an automatic validation condition on connection

Checks related to the list of patient drugs

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- MEDIC.IN ({medic1},{medic2}, etc.) to test for the presence of the text "medic1" or "medic2" in the
"Drugs" field. The comparison is case-sensitive.

MEDIC.IN({***}) returns true if at least one drug is found (patient on treatment). The term ‘ALL’, is
dependent on the current language.

MEDIC.IN({})returns true if no drug is found (patient without treatment). The term ‘NONE’, is
dependent on the current language.

Checks related to the status of tests

- DISPO (‘Analyse1’, analyse2’,…)

to verify whether tests are available in the current tube:
a test is available if it has at least one value and is not NOT PROCESSED, or PENDING, or IN
CONTROL. (i.e. TO BE VALIDATED, VALIDATED, TRANSMITTED).

DISPOTT (‘Analyse1’, analyse2’,…) the same thing, but the tests to be verified are searched for in
the current tube, then in all the tubes for this patient that are in pending, if not found in this one.

- NONDISPO (‘Analyse1’, analyse2’,…) to verify the unavailability of tests in the current tube:
A test is unavailable if it is NOT PROCESSED or TO BE RERUN

- NONDISPOTT (‘Analyse1’, analyse2’,…)the same thing, but the tests to be verified are searched for
in the current tube, then in all the tubes for this patient that are in pending, if not found in this
one.

Checks related to the presence of tests

- PRSNT (‘Analyse1’, analyse2’,…) verifies the presence of tests in the current tube

- PRSNTT (‘Analyse1’, analyse2’,…) the same thing, but the test to be verified is searched for in the
current tube, then in all the tubes if not found in this one.

- NONPRSNT (‘Analyse1’, analyse2’,…) verifies the non-presence of tests in the current tube

- NONPRSNTT (‘Analyse1’, analyse2’,…)the same thing, but the tests to be verified are searched for
in the current tube, then in all the tubes if not found in this one.

 EXAMPLES
‘FIB’ > 20
Verifies whether the result for Fibrinogen is above 20.

‘FIB’ = {< 1.20}

Verifies whether the result for Fibrinogen is equal to the reference: < 1.20.

‘FIB’ > 30 | ‘FIB’ < 10

Verifies whether the result for Fibrinogen is below 10 or above 30.

‘FIB’ > 30 & [‘FIB’ / ‘@FIB’] > 1.20 & ‘D@FIB’ < 30
Verifies whether the result for Fibrinogen is above 30 and whether this result is an increase of more
than 20% in relation to a prior result less than 30 days old.

‘SERV’ = {REA} & ‘FIB’ > 20 & ‘SEXE’ = {M} & ‘AGE’ > 30
Checks for a male patient over 30 years of age from an intensive care unit with a Fibrinogen result
above 20.

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15 Table of figures
Figure 1: Structural diagram ................................................................................................................ 9
Figure 2: Task bar ................................................................................................................................ 9
Figure 3: Security problem on login with an encrypted database ....................................................... 13
Figure 4: Password expired ............................................................................................................... 14
Figure 5: Locking of user accounts ..................................................................................................... 15
Figure 6: Disabling a user account ..................................................................................................... 17
Figure 7: Deleting a user account....................................................................................................... 17
Figure 8: Screen zone definitions ....................................................................................................... 18
Figure 9: Example of the screen with the various zones ..................................................................... 18
Figure 10: Viewing QC Alerts ............................................................................................................. 20
Figure 11: Viewing Analyzer Alerts .................................................................................................... 21
Figure 12: Viewing TAT Alerts ............................................................................................................ 22
Figure 13: Viewing process monitoring icons in the panel .................................................................. 23
Figure 14: Viewing the process monitoring window ........................................................................... 24
Figure 15: Viewing a process block .................................................................................................... 24
Figure 16: Division change ................................................................................................................. 25
Figure 17: Main menu ....................................................................................................................... 26
Figure 18: Workstation...................................................................................................................... 26
Figure 19: Quality Control ................................................................................................................. 27
Figure 20: Tools................................................................................................................................. 28
Figure 21: System.............................................................................................................................. 29
Figure 22: Workstation...................................................................................................................... 31
Figure 23: Choice of printout mode ................................................................................................... 32
Figure 24: Dashboard (general view) ................................................................................................. 33
Figure 25: Dashboard (counter view) ................................................................................................. 35
Figure 26: Validating a tube............................................................................................................... 35
Figure 27: Details of a test ................................................................................................................. 38
Figure 28: Runs for a tube ................................................................................................................. 39
Figure 29: Patient tube validation window ........................................................................................ 39
Figure 30: Parallelism of factors ........................................................................................................ 41
Figure 31: Example of an invalid QC report (red bullet) ...................................................................... 41
Figure 32: Creating the request ......................................................................................................... 42
Figure 33: Adding a patient ............................................................................................................... 43
Figure 34: Adding a test .................................................................................................................... 45
Figure 35: Creating a fast request ...................................................................................................... 46
Figure 36: List of tubes for which manual entry is applicable ............................................................. 47
Figure 37: Manual entry screen ......................................................................................................... 49
Figure 38: Routing ............................................................................................................................. 50
Figure 39: Quality Control menu........................................................................................................ 52
Figure 40: Quality Control menu (continued) ..................................................................................... 53
Figure 41: Quality control settings ..................................................................................................... 53
Figure 42: Settings for quality control tests........................................................................................ 54
Figure 43: List of quality control lots .................................................................................................. 57
Figure 44: Adding a quality control lot ............................................................................................... 59
Figure 45: Replacing a lot .................................................................................................................. 60
Figure 46: Stopping a lot ................................................................................................................... 61
Figure 47: Restoring a lot .................................................................................................................. 62
Figure 48: Deleting a lot .................................................................................................................... 63
Figure 49: Selecting a test in quality control ...................................................................................... 63
Figure 50: Levey Jennings graph of a test ........................................................................................... 64
Figure 51: Viewing QC values in a Levey Jennings graph with the current expected values ................. 67
Figure 52: Viewing QC values in a Levey Jennings graph with the expected values for the previous re-
targeting ................................................................................................................................... 67
Figure 53: Viewing QC values in a Levey Jennings graph with the initial expected values for the lot ... 68
Figure 54: Value graph of a test ......................................................................................................... 69

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Figure 55: Viewing QC values in a value graph with the current expected values ................................ 70
Figure 56: Viewing QC values with the expected values for the previous re-targeting ........................ 71
Figure 57: Viewing QC values with the initial expected values for the lot ........................................... 71
Figure 58: Table of values .................................................................................................................. 71
Figure 59: Current quality control values ........................................................................................... 73
Figure 60: Selecting the quality control period ................................................................................... 73
Figure 61: Selecting value statuses .................................................................................................... 74
Figure 62: MyExpertQC export window ............................................................................................. 74
Figure 63: Adding a quality control line ............................................................................................. 76
Figure 64: Viewing by profile ............................................................................................................. 76
Figure 65: Quick Control .................................................................................................................... 79
Figure 66: Creating a probationary lot ............................................................................................... 79
Figure 67: Viewing Lot A (current lot) and lot B (probationary lot) ..................................................... 80
Figure 68: Moving Average ................................................................................................................ 82
Figure 69: Viewing the moving average ............................................................................................. 83
Figure 70: External control ................................................................................................................ 84
Figure 71: External control value ....................................................................................................... 85
Figure 72: Without programs ............................................................................................................ 85
Figure 73: External control connection .............................................................................................. 86
Figure 74: EQC programs ................................................................................................................... 87
Figure 75: Adding a test to the program ............................................................................................ 87
Figure 76: Entering the program name and information .................................................................... 88
Figure 77: Details of an EQC program ................................................................................................ 88
Figure 78: Qualiris ............................................................................................................................. 90
Figure 79: Sending via Qualiris .......................................................................................................... 90
Figure 80: Analyzer maintenance ...................................................................................................... 91
Figure 81: Maintenance to be carried out (list mode)......................................................................... 93
Figure 82: Maintenance to be carried out (schedule mode) ............................................................... 94
Figure 83: Carrying out a maintenance action .................................................................................... 94
Figure 84: Configuring a maintenance action ..................................................................................... 95
Figure 85: Selecting a maintenance action ......................................................................................... 96
Figure 86: Adding a maintenance action ............................................................................................ 96
Figure 87: Monitoring maintenance actions....................................................................................... 97
Figure 88: Verifying performance ...................................................................................................... 99
Figure 89: Mechanism for rejection and reinclusion ......................................................................... 102
Figure 90: Repeatability procedure.................................................................................................. 103
Figure 91: Result of a repeatability procedure ................................................................................. 103
Figure 92: Adding a repeatability value ........................................................................................... 105
Figure 93: Repeatability procedure report ....................................................................................... 105
Figure 94: Reproducibility procedure............................................................................................... 106
Figure 95: Result of a reproducibility procedure: ............................................................................. 108
Figure 96: Adding a reproducibility value......................................................................................... 108
Figure 97: Reproducibility procedure report .................................................................................... 109
Figure 98: Limit of linearity procedure ............................................................................................. 111
Figure 99: Result of a limit of linearity procedure ............................................................................ 111
Figure 100: Adding a measured value for the limit of linearity ......................................................... 112
Figure 101: Adding an associated theoretical value for the limit of linearity ..................................... 112
Figure 102: Limit of linearity procedure report ................................................................................ 112
Figure 103: Analyzer comparison procedure .................................................................................... 115
Figure 104: Result of an analyzer comparison procedure ................................................................. 116
Figure 105: Adding an analyzer comparison value ........................................................................... 117
Figure 106: Analyzer comparison procedure report ......................................................................... 117
Figure 107: Statistical values - Analyzer comparison ........................................................................ 119
Figure 108: Automatic conclusion - Analyzer comparison................................................................. 120
Figure 109: Reagent comparison procedure..................................................................................... 121
Figure 110: Result of a reagent comparison procedure .................................................................... 122
Figure 111: Reagent comparison procedure report .......................................................................... 122

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Figure 112: Statistical values - Reagent comparison ......................................................................... 125
Figure 113: Automatic conclusion - Reagent comparison ................................................................. 126
Figure 114: Contamination procedure ............................................................................................. 127
Figure 115: Result of a contamination procedure............................................................................. 128
Figure 116: Adding a contamination value ....................................................................................... 128
Figure 117: Contamination procedure report................................................................................... 129
Figure 118: Measurement uncertainty procedure ............................................................................ 130
Figure 119: Result of a measurement uncertainty procedure ........................................................... 130
Figure 120: Adding internal control values....................................................................................... 131
Figure 121: Adding external control values ...................................................................................... 131
Figure 122: Measurement uncertainty procedure report ................................................................. 131
Figure 123: Stability procedure........................................................................................................ 132
Figure 124: Result of a stability procedure ....................................................................................... 133
Figure 125: Adding a stability value ................................................................................................. 134
Figure 126: Stability procedure report ............................................................................................. 134
Figure 127: Control time calculation procedure ............................................................................... 136
Figure 128: Results of a control time calculation procedure ............................................................. 136
Figure 129: Adding values for the control time calculation procedure .............................................. 138
Figure 130: Control time calculation procedure report ..................................................................... 140
Figure 131: Customized table - in this example "GFHT_95" .............................................................. 142
Figure 132: Laboratory values ......................................................................................................... 142
Figure 133: Accreditation tool settings ............................................................................................ 144
Figure 134: Import/Export accreditation tools ................................................................................. 144
Figure 135: Import of internal values ............................................................................................... 146
Figure 136: Import from a standard file ........................................................................................... 147
Figure 137: Importing a customized file ........................................................................................... 148
Figure 138: Format of the import file ............................................................................................... 149
Figure 139: Selecting the fields for the import file............................................................................ 149
Figure 140: Exporting data .............................................................................................................. 151
Figure 141: Result of the data export............................................................................................... 152
Figure 142: Selecting lines to be exported ....................................................................................... 152
Figure 143: Patient reference ranges ............................................................................................... 153
Figure 144: Selecting graphs ............................................................................................................ 154
Figure 145: Selecting points............................................................................................................. 154
Figure 146: Levey Jennings display .................................................................................................. 155
Figure 147: Value display ................................................................................................................ 156
Figure 148: Value table display ........................................................................................................ 157
Figure 149: Internal Mail ................................................................................................................. 158
Figure 150: Mailbox ........................................................................................................................ 158
Figure 151: Viewing a message ........................................................................................................ 160
Figure 152: Sending a message ........................................................................................................ 161
Figure 153: Test Count .................................................................................................................... 162
Figure 154: Test count organized by origin....................................................................................... 163
Figure 155: Detailed test count organized by origin ......................................................................... 164
Figure 156: Test count organized by test.......................................................................................... 164
Figure 157: Detailed test count organized by test ............................................................................ 165
Figure 158: TAT ............................................................................................................................... 166
Figure 159: Tracking the TAT ........................................................................................................... 167
Figure 160: TAT calibration.............................................................................................................. 169
Figure 161: Adding a TAT rule .......................................................................................................... 170
Figure 162: TAT control ................................................................................................................... 171
Figure 163: Viewing a test in the TAT ............................................................................................... 171
Figure 164: List of tests ................................................................................................................... 172
Figure 165: General tab for the test ................................................................................................. 173
Figure 166: Test report tab .............................................................................................................. 178
Figure 167: Report titles .................................................................................................................. 178
Figure 168: Test reference value tab ................................................................................................ 179

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Figure 169: Delta check ................................................................................................................... 181
Figure 170: QC test count tab .......................................................................................................... 181
Figure 171: Test connection tab....................................................................................................... 183
Figure 172: Transforming results ..................................................................................................... 185
Figure 173: Specific test processing ................................................................................................. 185
Figure 174: Automatic rerun ........................................................................................................... 185
Figure 175: Validation option .......................................................................................................... 186
Figure 176: Test comment tab ......................................................................................................... 186
Figure 177: Adding a comment ........................................................................................................ 187
Figure 178: Reflex functions ............................................................................................................ 188
Figure 179: Choosing a reflex function ............................................................................................. 189
Figure 180: Test evaluations tab ...................................................................................................... 191
Figure 181: Adding an evaluation .................................................................................................... 192
Figure 182: Profile/Battery of tests tab............................................................................................ 193
Figure 183: Reflex rules ................................................................................................................... 193
Figure 184: Adding a reflex rule ....................................................................................................... 195
Figure 185: Entering a reflex rule ..................................................................................................... 195
Figure 186: Adding an action ........................................................................................................... 196
Figure 187: List of actions ................................................................................................................ 197
Figure 188: Tube type ..................................................................................................................... 204
Figure 189: Adding a comment ........................................................................................................ 204
Figure 190: Analyzers ...................................................................................................................... 205
Figure 191: Analyzer configuration .................................................................................................. 206
Figure 192: Test display order ......................................................................................................... 207
Figure 193: Analyzer protocol .......................................................................................................... 209
Figure 194: Analyzer communication line ........................................................................................ 210
Figure 195: Configuring the QC for the analyzer ............................................................................... 211
Figure 196: Identifying the analyzer ................................................................................................ 213
Figure 197: List of analyzer tests...................................................................................................... 214
Figure 198: Mirroring management ................................................................................................. 215
Figure 199: Managing products ....................................................................................................... 216
Figure 200: Calibration .................................................................................................................... 217
Figure 201: Calibration search filters ............................................................................................... 218
Figure 202: Calibration details ......................................................................................................... 218
Figure 203: Laboratories in STA Coag Expert configuration .............................................................. 218
Figure 204: Laboratories in Coag.One configuration......................................................................... 219
Figure 205: Laboratory settings ....................................................................................................... 220
Figure 206: Configuring divisions ..................................................................................................... 222
Figure 207: Laboratory communication line ..................................................................................... 223
Figure 208: Drugs ............................................................................................................................ 224
Figure 209: Users ............................................................................................................................ 224
Figure 210: User rights .................................................................................................................... 225
Figure 211: Adding a user ................................................................................................................ 229
Figure 212: Modifying a user ........................................................................................................... 231
Figure 213: Password verification .................................................................................................... 231
Figure 214: Customizing a user's rights ............................................................................................ 231
Figure 215: Doctors ......................................................................................................................... 232
Figure 216: Adding a doctor ............................................................................................................ 233
Figure 217: Services ........................................................................................................................ 234
Figure 218: Searching for a service .................................................................................................. 234
Figure 219: Adding a service ............................................................................................................ 235
Figure 220: Archiving ...................................................................................................................... 235
Figure 221: Scrolling through archive dates ..................................................................................... 236
Figure 222: Archive search .............................................................................................................. 236
Figure 223: Patient archive .............................................................................................................. 237
Figure 224: Details of an archived tube............................................................................................ 238
Figure 225: Details of an archived test ............................................................................................. 239

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Figure 226: Viewing the calibration and parallelism of factors in the archives .................................. 241
Figure 227: Details of an archived test ............................................................................................. 241
Figure 228: Detailed search in the archives ...................................................................................... 242
Figure 229: Selection criteria ........................................................................................................... 243
Figure 230: Exploring directories ..................................................................................................... 244
Figure 231: Traceability (Local) ........................................................................................................ 245
Figure 232: Traceability (login history) ............................................................................................. 246
Figure 233: Traceability (Alerts) ....................................................................................................... 247
Figure 234: Backups ........................................................................................................................ 248
Figure 235: Automatic backup settings ............................................................................................ 249
Figure 236: Adding a backup line ..................................................................................................... 250
Figure 237: Choosing a manual backup ............................................................................................ 252

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