User Guide • P/N 00011100263 • Rev.

01 • March, 2018
Copyright ©2018 Instrumentation Laboratory

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Instrumentation Laboratory Company - Bedford, MA 01730-2443 (USA)

Instrumentation Laboratory SpA - V.le Monza 338 - 20128 Milano (Italy)
 GEMweb Plus500 User Guide • P/N 00011100263
Table of Contents
1 - INTRODUCING GEMWEB PLUS500 CUSTOM CONNECTIVITY 3
2 - ACCESSING DATA MANAGEMENT 6
3 - MONITORING NETWORKED ANALYZERS 10
4 - DASHBOARD 17
5 - SEARCHING SAMPLE RESULTS 22
6 - MANAGING OPERATORS AND SECURITY 26
7 - OPERATOR CERTIFICATION 31
8 - CONFIGURATION 49
9 - MANAGING ORDERS 51
10 - IQM REPORTS 53
11 - ENHANCED REPORTS 55
12 - AUDIT LOGS 64
13 - ESIGNATURE 71
14 - QUALITY MANAGEMENT 76
15 - SYSTEM BACKUP 93
16 - SYSTEM RESTORE 96
17 - OPERATOR DOWNLOAD 98
18 - ADDITIONAL CONNECTIVITY OPTIONS 99

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1 - INTRODUCING GEMweb Plus500 Custom Connectivity

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Managing data efficiently, and easily, on-site or remotely

Product Intended Use

GEMweb Plus is intended to manage analytical devices and operator profiles. The user
can associate patient data with test data and displays test results. GEMweb Plus receives
data from connected devices at the point-of-care or laboratory and can send test results
to the Hospital Information System (HIS) or Laboratory Information System (LIS). The
system will also let the user send commands to selected devices. Data related to the
performance of devices is utilized by GEMweb Plus to tell users of issues which need to
be managed.

Network Organization and GEMweb Plus

GEMweb Plus500 is the new version of GEMweb Plus from SW rev. 5.0.0.
Depending on the needs of the institution, the GEM Premier analyzer may function as a
standalone analyzer or it may be networked with up to 32 other analyzers. The GEMweb
Plus server and software allow a group of analyzers to be networked so that you can
access sample data from any analyzer or remotely, via a standard web browser. This
powerful network allows data from multiple analyzers to be managed from one location.
GEMweb Plus allows the connectivity of the entire family of IL’s GEM Premier analyzers
as well as other IL analyzers (i.e. Hemochron Signature Elite) and the connectivity of 3rd
party analyzers.
Analyzers can be organized into areas, which can be configured to represent different
departments of the hospital [Intensive Care Unit (ICU), Critical Care Unit (CCU),
Emergency Department (ED), etc.]. Areas allow you to assign operators to specific groups
of GEM Premier analyzers.
Changes to sample data and patient records on one analyzer in the network are
automatically copied to a central database so that all analyzers have access to the same
information. If an analyzer is disconnected from the network, any changes will be saved
and copied to the central database when the connection is restored. If the same record is
edited on two different analyzers when the network connection is down, the most recent
change will be saved in the central database.
The GEM Premier 4000 and 5000* analyzers allow supervisors full control over their
entire blood analysis system, directly from the analyzer’s screen. On-site or at remote
locations (via a web browser), supervisors can monitor the network, gather information
about specific analyzers, search for sample information, generate reports, control operator
access and security settings, retrieve and share data, and perform system backups.

* GEM Premier 5000 system is not available in all countries.

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The GEMweb Plus main screen has a top bar and a menu bar on the left side of the

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screen. The top bar provides information about the alarms in the system, about host and
analyzers connectivity and the operator currently logged in the system.

The top bar includes:

Alarms icon – This icon is shown only if there are alarms in the
system. You can select it to review, acknowledge and clear the
alarms.
Host connectivity status icon – Green if all the host interfaces
(LIS/HIS) are connected. Yellow if one or more are connected and
one or more are disconnected. Red if all are disconnected. Can
be selected for more information.
Analyzers connectivity status icon - Green if all the configured
analyzers that are featuring continuous connectivity to the
network are connected. Yellow if one or more are disconnected.
Red if all are disconnected.
This indicator does not take into account analyzers that are not
designed to always be connected to the network.
This icon can be selected for more information.
Current user information – shows information about the current
user. Can be selected to show the Contacts, System information
and to perform the User Logout.
Filters bar – in selected screens allows to show only the
information related to a specific area, analyzer’s category or
model.
Legend – where applicable, explains the meaning of the symbols
used in the screens.

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The left menu bar includes seven components:

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Analyzers – monitors the status of all the analyzers connected to
the network.

Dashboard – provides actionable information including warnings

and alarms to facilitate the management of the POCT devices.

Samples – allows access to the GEMweb Plus patient sample’s

centralized database.

Operators – manage operators (create, modify, delete, allow area

access and modify security), operators certification, and security
settings.

Reports – allows access to iQM Reports, RiliBAEK Reports (in

specific countries), Enhanced Reports, Audit Logs and Signed
Reports.

Quality Management - Access to QC management for non-

iQM devices including Lots, Levey-Jennings and Uncertainty
Calculation. This section is visible only if non-iQM analyzers are
connected to GEMweb Plus.

Manage – access to Orders, Service and Diagnostics

functionalities

Configuration – global, area and single analyzer configuration.

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2 - ACCESSING DATA MANAGEMENT

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Accessing the data management functions

GEMweb Plus allows access to Data Management from any web browser, from the screen
of the GEM Premier 4000 and 5000*, and directly from the server. Data Management
functions are accessed from the GEM analyzers through the Menu on the Main Sampling
Screen. The user interface layout and the procedures to access GEMweb Plus may
vary depending on the analyzer’s model used to access GEMweb Plus. For the specific
information, refer to the analyzer’s operator manual.
Password protection ensures only approved operators gain access to patient information
and restricted functionality.

Access via Web Browser

1. Launch your internet browser and enter the URL for your GEMweb Plus server
2. The GEMweb Plus Sign In screen
will appear, as long as web access
is enabled for your server. Enter
your operator ID and password and
click on the Sign In button.

When you have successfully signed in,

the GEMweb Plus Analyzers screen will
appear.

* GEM Premier 5000 system is not available in all countries.

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Access via Server

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It is possible to access GEMweb Plus
directly from the server’s screen. This
functionality is useful in the initial
installation. During the first system boot
the user is guided in a step by step
procedure for completing the initial setup
and configuration of the new GEMweb
Plus server.

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Access via Networked Analyzer

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1. Choose Management / GEMweb
Plus from the drop- down Menu
located in the upper left corner of
the GEM Premier 4000 or 5000’s*
screen.

2. On the Sign In screen, enter your

operator ID and password. Then
press OK.

3. The GEMweb Plus Home Screen

will be displayed. The GEMweb Plus
available functionalities and the user
interface layout may vary.

* GEM Premier 5000 system is not available in all countries.

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Ending a Data Management Session

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Networked Server or Analyzer Sessions
To sign out of a GEMweb Plus session,
select
Sign Out from the Menu or Home from
the top bar.
ii You will be automatically logged off
the system if no activity occurs on the
analyzer for 15 minutes.

Web-based Sessions
To end your web-based GEMweb Plus
session, select Logout from the User
icon in the top right corner of the screen.
ii If there is no activity during 15 minutes,
you will be automatically logged out.

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3 - MONITORING NETWORKED ANALYZERS

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View status of all analyzers connected to a network
The GEMweb Plus Home screen allows supervisors to assess the status of all analyzers
connected to the network at a glance. Easy to understand cues indicate connection status,
number of tests and time remaining for the current cartridge, and any problems with the
analyzers. Available information depend on the analyzer model.
The default view of the GEMweb Plus
Home screen is the Analyzers tab. Within
this tab, all analyzers that are configured
in the network are represented in
Analyzer Status buttons.

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Filter

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The information in the entire section is
always shown according to the current
filter that can be applied using the bar in
the top left corner of the screen.

Each analyzer is denoted by its area, name, and type (also indicated by a graphic). Color
and icons indicate the status of the analyzer:
A green GEM Premier 4000 or GEM Premier 5000* analyzer button
means the analyzer is active, has no instrument or cartridge issues, and is
connected to the network.
For other analyzers the green color indicates that no action is required,
according to the information available in GEMweb Plus.
For analyzers featuring continuous connectivity to the network the green
color indicates the status of the connectivity.
For analyzers that are not designed to always be connected to the network
the green color indicates that during the last connection no errors or
warnings were present.
A dark gray GEM Premier 4000 or GEM Premier 5000* analyzer button
means the analyzer has an alarm associated with it.
For other devices a dark grey icon indicates an alarm associated with the
analyzer’s quality management, if configured in GEMweb Plus.
For analyzers featuring continuous connectivity to the network a light
gray analyzer button indicated that the analyzer is disconnected from the
network.
In addition, newly configured analyzers are shown in light gray color until it
is established the first connectivity with GEMweb Plus.

A red GEM Premier 4000 or GEM Premier 5000* analyzer button indicates
that the analyzer has been locked from GEMweb Plus.

iQM® quality management processes are active.

iQM2® quality management processes are active.

Analyzer is disconnected from the network.

An error exists with a particular analyzer.

A warning exists with a particular analyzer.

* GEM Premier 5000 system is not available in all countries.

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Analyzer Detail

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The Analyzer Detail screen serves as the entry point to a number of functions that allow
for remote access and control of a client analyzer. You may access this function from
either a client analyzer or from a GEMweb Plus web browser session (the layout might
differ). Once on the Analyzers Screen you select the instrument you wish to access. You
will have full remote control over the chosen instrument.
Selecting a green (active) or dark grey
(problem exists) instrument icon on the
Analyzers screen will bring you to the
Analyzer Detail screen.
The available functions change
depending on the instrument model.
For the GEM Premier 4000 and the GEM
Premier 5000* from this screen you can:
• View the Analyzer Status
• Access System Info
• View Analyzer Screen
• Send a Message to an analyzer
• Access Analyzer Configuration
• Lock Analyzer
• Access Remote Diagnostics
• Access iQM Reports
You may also lock or unlock individual
analytes by pressing the desired analyte
button.

* GEM Premier 5000 system is not available in all countries.

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Access iQM Reports

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All iQM reports can be accessed by
pressing the iQM Reports button in the
Analyzer Detail screen.
It is possible to access the iQM reports
also from the left menu bar in the Report
section.

System Info
Information about the systems level
settings on the current analyzer can
be viewed by pressing the System Info
button

* GEM Premier 5000 system is not available in all countries.

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View Analyzer Screen

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This function allows you to view the
current screen of the analyzer you chose
from the Analyzers Tab. The screen is
automatically refreshed approximately
every 15 seconds.

Send Message
The Send Message function allows you
to send a message to the analyzers.
ii When a message is received at the
instrument the message icon / envelope
will turn yellow indicating an incoming
message. Messages cannot be
responded to from an instrument.

Enter the subject of the message and

the content of the message.

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Analyzer Configuration

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The Analyzer Configuration function
allows you to access all the remote
configuration options for the GEMweb
Plus network of client analyzers.

The available functionalities vary

depending on the instrument model. You
may perform any tasks within the Global,
Area or Analyzer tabs accessible from
the Configuration button in the left menu
bar.

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Lock Analyzer

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The Lock Analyzer function provides a
means to lock an analyzer remotely.
You will be asked to confirm the Lock
(and unlock) of the unit.
Once an analyzer is locked the only
sample type that can be processed are
CVP ampoules.

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4 - DASHBOARD

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Using the Dashboard

GEMweb Plus offers a Dashboard which allows the supervision of the POC devices by
providing actionable information related to operators and analyzers.

Main Widgets Screen

The dashboard icon on the left menu
bar allows access to the Dashboard’s
section.
The Analyzers and Operators widgets
will be shown on the main screen. The
three button in the top right corner of
each widget allow to toggle between
standard and element view and to
access additional information using the
maximize button.

Filter
The information in the entire section is
always shown according to the current
filter that can be applied using the bar in
the top left corner of the screen.

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Analyzers Widget

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The Analyzers Widget provides
information regarding the alarms
associated to the analyzers and
information regarding the status of the
connections.
It is possible to expand the Analyzers
Widget by selecting one of its elements
or by selecting the maximize icon in
the top right corner of the widget.
Once an element is selected, the
corresponding Alarms will be shown at
the bottom of the screen. It is possible to
click on every line to be redirected on the
corresponding analyzer’s details screen.
The Element View shows the alarms
associated with every instrument type
connected to GWP.
The Element View is visible when the
Analyzers widget is maximized using
or selecting the corresponding icon on
the Dashboard main screen .
It is possible to select the Errors,
Warnings or the instrument icons to
show the corresponding information.
The Summary View provides
information regarding the alarms and the
status of the connections.
The Summary View is visible when
the Analyzers widget is maximized or
selecting the corresponding icon on the
Dashboard main screen.
The indicators in the first row show the
Alarms present in the system.

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Warnings:

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• Disconnections longer than 15
minutes and less than 24 hours.
• One or more of the enabled analytes
has an error.
• One or more of the enabled analytes
is in CVP Due state.
• One or more of the enabled analytes
is in iQM Fail state.
• The cartridge is about to expire.
• An analyzer alarm is posted on the
analyzer.
Total Alarms:
Shows the total number of Warnings and Errors.
Errors:

• Disconnections longer than 24 hours.

• The analyzer is waiting for a cartridge to be inserted.
• The cartridge needs to be removed.
• The analyzer is CVP due.
The indicators in the second row provide details about the status of the connections:
Connected:
Total number of analyzers that are
connected for the current filter.
Total Analyzers:
Total number of analyzers (connected
and disconnected), defined on GWP, for
the current filter.
Disconnected 15min – 24H:
Analyzers disconnected for more than 15
minutes and less than 24 hours.
Disconnected > 24H:
Analyzers disconnected for more than 24
hours.

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Operators Widget

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The Operators Widget provides
information regarding enabled and
disabled operators, accesses, operators’
certification, and password about to
expire.
It is possible to expand the Operators
Widget by selecting one of its elements
or by selecting the maximize icon in
the top right corner of the widget.
Once an element is selected, the
corresponding entries will be shown at
the bottom of the screen. It is possible to
click on every line to be redirected to the
corresponding detail page.
The Element View is visible when the
Operators widget is maximized using
or selecting the corresponding icon on
the Dashboard main screen .

Pending Certification:
Operators that have passed the certification exam and need to be manually certified,
when the automatic certification is disabled.
Not Certified:
New members of a certification group that haven’t taken the exam. The operator is still
active in the system.
Access Control Alert:
Provides a list of operators that have run a number of samples outlying, in the last 72
hours, compared to the workload distribution for all the active operators. It provides a
general indication about the proper use of the login accounts. The Enhanced reports can
then be utilized to verify the operators’ workload.
Password about to expire:
Operators with password expiring within the next 7 days.
The Summary View provides information about the status of the operators.

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The Summary View provides

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information about the status of the
operators.
The Summary View is visible when
the Operators widget is maximized or
selecting the corresponding icon on the
Dashboard main screen.

The indicators in the first row show the

Enabled operators.
Active:
Enabled operators, non-supervisors,
which have run at least a sample in the
last 6 months.
Total Enabled:
Operators non-supervisors enabled in
GEMweb Plus (active and inactive).
Inactive (6mo):
Enabled operators, non-supervisors, that
haven’t run any samples in the last 6
months.
The indicators in the second row provide
details about the disabled operators:

Password Expired:
Operators disabled because their passwords have expired.
Total Disabled:
Total number of disabled operators.
Cert. Expired:
• Certification exam not taken by the end of the grace periods.
• Failed exam with the maximum number of exam retakes fulfilled.
No Permissions:
Operators without permission to access to any area.

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5 - SEARCHING SAMPLE RESULTS

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Performing database searches

GEMweb Plus allows you to search for information across the entire analyzer’s network,
making it easy to pinpoint desired patient and sample data. The database includes the
samples from all the networked analyzers and can be easily accessed from GEMweb
Plus or directly from the screen of every GEM Premier 4000 or 5000* connected to the
network.
From a networked GEM Premier 4000 or 5000* analyzers – Select Menu and Search
Results or sign in to GEMweb Plus and select the Samples button. Refer to the Operator
Manual of the analyzers for further instructions about how to perform the search. The
GEM Premier 4000/5000* will perform the search within the entire GEMweb Plus
database.
• From GEMweb Plus – Choose
Samples from the left Menu in the
center of the screen. The system will
automatically display the results from
the last eight hours.

1. Select the search icon on the top of

the screen to perform a search.
2. Select the search criteria in the
Advanced Search screen. These
function as data entry fields or drop-
down menus.
ii If no text is entered in a field, the default
value is All.
ii Date and time frame criteria (lower right-
hand corner of the screen) are required
for all searches.

* GEM Premier 5000 system is not available in all countries.

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ii For the Area/Analyzer criterion when

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searching samples from an analyzer,
if All is selected while the analyzer is
networked, the search will be performed
on all analyzers in the network (included
those that have been deleted). When
the analyzer is disconnected, only
information stored on the current
analyzer will be searched.

3. To select a date select the Date

From or Date To field, and select a
day from a specific month and year
selected clicking on the month and
year name.
4. To view the samples that meet the
selected criteria, press the Apply
button at the bottom of the screen.
All samples meeting the search
criteria will be displayed on screen.
To clear the search criteria, press
the Clear Criteria button.
ii The most recent 500 samples will be
presented.

Search Results
Search results are displayed in list
format. All samples that meet the criteria
selected by the user will be displayed.
The following actions can be performed
on the search results:
• Export – creates a Microsoft Excel-
compatible file that can be saved.
• Show PDF – creates a .pdf file
containing all patients returned in the
search.
ii The Show PDF option is available only
via a GEMweb Plus browser session.

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Sample Details

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Details of a specific sample can be
accessed by pressing one of the
patient name buttonsroaws from the
sample list; this launches the Sample
Results screen, which displays patient
demographic information as well as the
sample results.
Sample results can be reviewed in
this screen. You will have the option to
Accept or Exclude samples (if your
system is configured to manually accept
results), Send data to the LIS/HIS or
other connected data manger (if your
system is configured for this function),
Show .pdf of the record and print if
necessary, view Patient History (five
most recent samples run within a one
month time frame), Add comments, or
view the Next or Previous record.

Patient History
If a valid patient ID and sample type
are entered, the Patient History button
becomes available. Pressing this button
will launch a Patient History screen
showing the five most recent samples
run in the last month for that patient and
for the same sample type.

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Sample Information

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If you are authorized to do so, patient
temperature, patient demographic
information, and comments may be
amended by selecting the Sample
Information button, located in the upper
right corner of the Sample Details
screen.
Use the text fields and drop-down menus
to amend the sample information.

ii Patient results can never be amended. Whenever the patient’s temperature, demographic
information, or comments have been amended, a report will be generated and marked as
an Amended sample.

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6 - MANAGING OPERATORS AND SECURITY

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Controlling access to system functions

Supervisors have the ability to monitor and control operators’ level of access to system
information and functionality.
To access operator management and security functions, after signing into GEMweb Plus,
select Operators from the left menu bar.
ii Only operator groups that have been given authorization in Manage Security may access
the Management features.
The Operators menu button is dedicated
to controlling operators’ level of access
to information and functionality including
List, Certification and Security.

Manage Operators
The List function allows you to search
for operators, edit operator information,
and to delete or add an operator to the
network.
When List is selected the system will
display the list of all the operators
configured in GEMweb Plus.
The buttons in the bottom right corner of
the screen allow to:
• Renew Operators: renew all the
operators listed in the current view.
• Copy to Area: copy the listed
operators to one or more areas.
• Show PDF: creates a PDF inclusive
of all the operators listed in the current
view.

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To search for operators, select the

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search icon , fill the desired criteria
from the drop-down menus in the
Advanced Search window and press
Apply.

A table of all operators who meet the

search criteria will be displayed. This
report can be printed.

Add Operator
To add a new operator to the network, press the Add Operator button from the top right
corner of the List Operators screen. A screen with two sections will be displayed.

Step 1: Enter Information

1. Enter information for operator ID,
last name, and first name.

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2. Select level

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Training is the default. Supervisor
is the highest level of access. The
Signature Role is available only for
supervisors. Levels are defined in
the Manage Security section.

ii A default user name and password are provided for the system. This can be obtained
from the Instrumentation Laboratory Tech Support group. Defaults can be restored using a
special disc, which is provided with the system.
3. Set the password expiration date (optional); the default is one year from the current
date.
4. Enter and confirm password; it must be 1 – 16 characters in length and may be any
combination of alphanumeric characters. Passwords are not case sensitive.

Step 2: Allow Area Access

Select areas to which the operator will be granted access. Accessible areas will be shown
in gray. An operator’s access to each area can be enabled by selecting any of the area
buttons. An operator’s access can also be disabled by deselecting any available area.
ii If a new area is added on a networked analyzer, operators will have to be granted access
to the new area by selecting the newly added area icon.
To edit an operator’s information, press the line containing that operator’s ID. A screen
will be displayed to edit the operator’s name, access level, and password information. An
operator’s security profile can be edited via the Modify Security button. Operators can
also be deleted from the network in the screen by pressing the Delete Operator button.
ii Passwords for deleted operators cannot be reused however passwords and operator
identifications for active operators can be edited.

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Modify Operator Security

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This function provides a means to
edit an individual operator’s security
permissions. These permissions
are based on the Level assigned
to the operator in Manage Security.
Permissions within a level can be
disabled but permissions assigned to a
different level cannot be added.

In the example given the operator’s

permission to ‘Perform Backup and
Restore’ was revoked.

Manage Security
The Manage Security function
(accessible from the Operators Menu)
allows you to define the secure functions
accessible to each type of operator. To
enable or disable a function for a specific
type of operator, select or deselect the
corresponding checkbox. To allow all
operators to access a certain function,
select the checkbox in the Unrestricted
column.

ii For networked systems, levels of access are “global” meaning that an operator can access
authorized functions from any analyzer on the network.

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Enable Security

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For networked analyzers, the Enable
Security function allows you to control
secure functions for specific areas. If
security is enabled, operators will be
required to sign in to access secure
functions. If security is disabled, all
secure functions (with the exception of
GEMweb Plus, View Last Results and
Management) will be accessible within
that area.

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7 - OPERATOR CERTIFICATION

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Operator Certification
Operator Certification automates the certification examination process required by many
hospitals.
ii Certification examinations are taken from a browser session and are not available on a
GEM Premier client analyzer.
ii The review of Operator Certification will be in two parts. The first will review how to
configure the operator certification feature and the second will present how an operator
takes an exam.
The Operator Certification function is
accessed from the Operators menu.

The Operators Certification screen will

be presented. This screen is considered
the ‘Main Screen’ for the setup of the
certification process. The certification
process is composed of creating an
Exam(s), creating a Group to which
an operator is assigned and managing
Results. From any of these sections it’s
possible to return to the main screen by
pressing the button, in the top left
corner of the screen.

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Default Settings

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The system can be set so that an
operator that successfully takes and
passes their exam will be automatically
recertified for the term defined for the
operator’s test Group. If a Practical Exam
is required as part of the certification
process select Require Practical Exam.
This selection will automatically disable
the Automatically Certify should it have
been enabled.

ii From the ‘Main Screen’, Certification Settings and Expiration Settings will apply globally
across the certification feature unless changes are made to individual Exams and/or
Groups.

Expiration Settings
The Grace Period sets how long an
operator will retain access to being
able to running samples after their
certification period has expired. The
default is 7 days. The range can be from
0 days to 365 days.
The Start Up Grace Period sets how
long a new operator will have access to
run samples before being locked out.
The default is 30 days. The range is 0
days to 120 days.

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Exams

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Creating Exams
You can create up to 50 exams. Exams can be from 1 to 100 questions in length
composed of True/False or multiple choice questions or a combination of the two.
1. Pressing the Exams button will
take you to the Certification Exam
Management screen.

2. Press the Add Exam button to

begin the exam setup process.

3. Create a name for the exam. Exam

names must be unique.

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4. Press the Add Question button

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on the right end of the Question List
blue bar to begin creating the exam
questions.

5. Add Question
Enter the text of the question.
For True/False questions select
whether the answer is True or False.
Press the green confirmation button
when done.

6. If you want to create a multiple

choice question press the Multiple
Choice button and enter the text of
the question.

7. Enter between two and four

possible answers and mark the
correct answer. When finished
with the question press the green
confirmation button.
Save to apply changes.

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Delete Exam

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1. An unneeded exam can be Deleted
selecting the corresponding
checkbox in the first column and
using the Delete button .
ii Once an exam has been taken it cannot
be deleted and the Delete button will not
be available

2. A warning box will appear to confirm

that you want to delete the exam.

Copy Exam
1. An exam can be copied to avoid
having to re-enter exam questions
when you have multiple exams. To
do so use the Copy Exam button in
the bottom left corner

2. Enter the New Exam Name. Once

you have copied an exam you can
open it and add or delete individual
questions.

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Exam Settings

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1. The Exam Settings function allows
you to set the Passing Score for an
exam, and set if the questions will
always appear in either Sequential
Order or in Random Order each
time an exam is taken.

2. You can set the passing score, as

a percentage of the total number of
questions and the order to present
the questions.
Save to apply changes.

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Show PDF

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1. The Show PDF button allows you
to create a .pdf file of the exam and
print it

2. An example of an exam print out is shown.

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Groups

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ii A maximum of fifty certification groups can be created.
1. Pressing the Groups key will allow
you to access the Groups List
screen.

2. Press the Add Group key

3. Enter a unique name for the Group.

Link a Certification Exam to the
Group

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4. Select the Certification Period for

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the Group.

5. The Group Settings function allows

you to select the Certification
Settings and the Expiration
Settings for a Group. The number
of times an operator may retake a
failed exam is also set here.
Save to apply changes.

ii The Certification and Expiration settings made for an individual group will override the
global settings made from the Defaults Settings Screen on Manage Operator Certification.

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Group Members

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1. Select the Group Members button
to begin the process of adding
operators to a Group.

2. Press the button to add an

operator.

3. When the Add Operators screen

opens the list of available operators
will be shown. It is possible to select
the desired operators clicking on
the corresponding checkbox on the
left. To restrict the list of operators
click on the icon to perform an
advanced search.
ii For operators to be available to be added
to a Group they must have first been
entered into the system via the Operator
List function, described previously.

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4. Individual operators can be selected

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and added to the group or the
Select All checkbox above the first
column can be pressed to add the
operators shown from the current
search to the Group.
Press ADD when done.

5. After the group members are added

they will be shown as associated
with a group.
ii Operators may only belong to a single
group.
ii A maximum of 2500 operators may
belong to a group.

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Delete Groups

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Groups can be deleted if desired.
1. Access to Delete Groups is from
the Group List screen. Select the
checkbox of the group you want to
delete and press the button.

2. If Delete Group is chosen a warning

screen will be presented confirming
that the group is to be deleted.
ii If a group is deleted all the members of
that group will no longer be required to
take an exam unless they are added to
another group.

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Results

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1. Managing certification exam Results
is accessed via the Main Screen
selecting Operators and then
Results.

2. Pressing the Results button

will open the Search Operators
Certification screen. The search
criteria are All Operators, by Group,
by Certification Status or Exam
Status.

3. The results of the operator search

will show the operators that met the
criteria for the search.

4. An individual operator’s record

can be viewed by selecting the
corresponding line. The Operator
Certification Results Details screen
will be presented. The screen shown
is for an operator who failed his or
her exam.

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5. The screen shown is for an operator

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that has passed his or her exam.

6. In either case of a Passed or Failed

exam the results of the exam can be
viewed via the Exam Results button.

Exam Results
The exam results show the operator
information, the results and the
questions along with the correct answers.

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Show Certificate

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If desired, a certificate documenting
that an operator successfully passed
the exam can be printed via the Show
Certificate button.

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Taking an exam

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ii Individuals with a Security Level of
Supervisor are exempt from taking an
exam.
ii Once an operator has been assigned
to a Group, when he or she logs into a
GEM Premier 4000 or 5000* instrument
or to GEMweb Plus within 30 days
of their certification period expiring
they will be automatically prompted to
take their exam. The message will be
displayed once per 24 hour period. When
an operator’s expiration date is within
five days, the prompt message will be
displayed in red.

ii An exam can be taken only from a web browser. Exams are not available on a GEM
Premier 4000 or 5000* instrument.
1. Log On to Take an Exam
The exam is accessed by entering
the IP address or URL of the
GEMweb Plus server.
The operator then signs on using
their Operator ID and password.

2. Operator ID Verification
After a successful log on a screen
is displayed requesting confirmation
of the identity of the logged on
operator.

* GEM Premier 5000 system is not available in all countries.

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3. Starting the exam

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If the operator has GEMweb Plus
privileges to start the exam select
the yellow certification icon in the
top screen’s bar. If the operator does
not have GEMweb Plus privileges
the exam will start automatically.

4. Instruction Page
The Instruction Page presents rules
surrounding the exam. When the
operator presses OK the exam will
begin.

5. Example of True/False question.

To answer the questions select
the checkbox corresponding to
the desired answer. To continue to
another question use the Previous
and Next button or select the
desired question in the left side of
the screen.
When the exam is complete select
Submit.
6. Example of a Multiple Choice

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7. Passing the Exam

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If an operator passes the exam and
Automatically Certify is enabled the
operator will be renewed with no
further actions. If a Practical exam
is required the message will instruct
the operator to see their supervisor.
8. Failing the Exam
If an operator fails the exam they will
be instructed to see their supervisor.

9. Ending Exam Session

After completing the exam
regardless of the result, the browser
session will be ended.
ii If the operator has GEMweb Plus
privileges they will be returned to a
GEMweb Plus session. If the operator
does not have GEMweb Plus privileges
the browser session will end.

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8 - CONFIGURATION

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Installation setup and configuration of the GEM Premier 4000 or 5000*

Installation setup and configuration of the GEM Premier network is described in full detail
in the Configuration Guide or Operator Manual of the Analyzer. These tasks will likely be
performed with an IL representative and/or IT specialist and will not be needed on a daily
basis, even by supervisors.
To access the configuration screens click
on Configuration and select Global, Area
or Analyzer.

1. Global – The configurations in this

section are applied to all the GEM
Premier 4000 and 5000* connected
to GEMweb Plus.

2. Area – The configurations in this

section are applied to all the GEM
Premier 4000 and 5000* connected
to the area. Select the area you
wish to configure in the top right
corner.

* GEM Premier 5000 system is not available in all countries.

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3. Analyzer – The configurations

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applicable to the single analyzer.
Select the analyzer you wish to
configure in the top right corner.

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9 - MANAGING ORDERS

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Managing pending blood analysis orders

The GEM Premier analyzer allows healthcare facilities to match blood analysis orders
placed by physicians with the analysis results of the patient’s blood sample so that the
order information is included with the sample results and posted to the LIS in one record.
This also allows facilities to track which orders have been filled and which are still pending.
ii Order management is available exclusively for GEMweb Plus networked analyzers.
ii To use the Manage Orders feature, your system must be configured to receive pending
orders from LIS and forward them to client analyzers. Order processing must be enabled
when your network connection is configured.
1. Select Manage and Orders buttons
in the menu bar. The number
indicates how many orders are
waiting to be processed.

2. The ending Orders List show the

orders currently pending in the
system. You can search for pending
orders by the parameters shown or
by patient, sample or date range
using the search button.

3. To view order details, select the corresponding line.

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4. You can move between individual

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orders by pressing the Previous
and Next buttons.

5. Deleting Orders
To delete an order from the
Pending Orders List, select the
corresponding check box in the left
column and press the Delete icon
. You will be prompted to confirm
that you want to delete the order.
Press Yes to proceed with deletion.

6. In addition to deleting an individual

order, you may also delete orders
by selecting multiple lines. Use the
checkbox in the column header to
select all the orders included in the
current search.

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10 - IQM REPORTS

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Monitoring iQM functions

iQM™ is Instrumentation Laboratory’s patented Intelligent Quality Management

software, which ensures the integrity of the overall analysis system. Quality testing runs
automatically in the background. By running iQM reports, supervisors can monitor the iQM
functionality.

Accessing iQM Reports

Click on the iQM button from the Reports menu.

In the iQM Reports screen you can view,

print, or export three types of reports:
CVP Reports, Delta Chart Report and
iQM Corrective Action Report.

• CVP Report – lists all CVP samples

run during the selected month for the
selected analyzer.

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• Corrective Action Report (CAR) –

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lists all significant events addressed
along with corrective action taken and
the results of that action.

• Delta Chart Report – Delta charts

show daily minimum, maximum,
and mean delta values for individual
process control solutions. Delta values
represent the expected value minus
the observed measurement.

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11 - ENHANCED REPORTS

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Management and summary reports

Enhanced Reports must be enabled via Configuration > Global > Enable Enhanced
Reports before they are available for use.
ii With the exception of the Sample Summary Counter Report access to Enhanced Reports
is via a GEMweb Plus web browser session only.

Accessing Enhanced Reports

Click on the Enhanced button from the Reports menu.

Enhanced Reports
Select Enhanced Reports from the Management screen.
Enhanced reports offer the following
choices:
• Aborted Samples Report
• Critical Values Report
• Patient Results Report
• Sample Summary Counter Report
• Device Workload
• Sample Turnaround
• Operator Workload
• Sample Handling

ii The search criteria are Area/Analyzer, Operator and by Date and Time range.

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Aborted Samples Report

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The Aborted Sample report provides a
list of patient samples that were aborted
by an analyzer due to a processing error.
An example follows.

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Critical Values Report

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The Critical Values report provides a list
of patient samples that contained results
that were outside of the critical value
ranges assigned in
Configuration>Global>Patient Ranges.
The search criteria for the Critical Values
report is by Area/Analyzer and by Date/
Time range.

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Patient Results Report

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The Patient Results report provides a
list of patient results showing patient
demographic information and analytical
results.

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Sample Counter Report

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The Sample Summary Counter report
provides a list of patient samples that
have been run on GEMweb Plus client
analyzers or standalone analyzers. The
report shows the number of Accepted
and Excluded patient samples by
Sample Type.
The search criteria is by Area/Analyzer
and Date/Time range.

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Device Workload Report

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The Device Workload Report
summarizes, in one single matrix, the
total number of samples by analyzer
(ascending or descending), sample type,
and daily shifts.
Data from this report may be utilized
to inform supervisors of how to most
efficiently deploy GEM Premier analyzers
and select correct size cartridges based
upon device workload metrics.
Select search criteria and click on Show
PDF to display report.

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Sample Turnaround Report

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The Sample Turnaround Report provides
time intervals for sample analysis, from
draw time to notification.
Select search criteria and click on Show
PDF to display report.
i. Note that sample draw time
must be entered manually
by the operator.
ii. The report requires that
two of the three timestamps
(e.g. draw, analysis,
notification) are populated
in order to generate
meaningful data.

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Operator Workload Report

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The Operator Workload Report
summarizes, in one single matrix, the
total number of samples run by operator,
analyzer, and sample type.
This report is intended to inform
Supervisors of how to most efficiently
allocate resources across departments
based upon operator workload metrics. It
may also be utilized to identify operators
running an abnormally high or low
number of samples. This type of activity
may be indicative of badge abuse or
identification of operators who should be
inactive in the system.
Select search criteria and click on Show
PDF to display report.

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Sample Handling Report

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The Sample Handling Report ties iQM
pattern recognition directly to operators
by time frame, area, analyzer, operator,
and event.
The purpose of this report is to provide
a tool to measure operator performance
related to sample handling. With this
report, operators who may be in need of
training can be identified. For example,
if this report is sorted in ascending
order by event, a supervisor will have
visibility to operators with the highest
number of sample handling events (e.g.
interference, micro clot, and absorbance
errors).
Select search criteria and click on Show
PDF to display report.

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12 - AUDIT LOGS

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Documentation of patient record and systems configuration access or change

Audit Logs
Audit logs track and document access and changes made to patient records and system
parameters.
GEMweb Plus provides the following logs:
• Patient Record Amendments
• Patient Record Access
• System Access
• System Configuration Changes
• Security and Operator Management

Accessing iQM Reports

Click on the Audit Log button from the Reports menu.

1. To access Audit Logs press

the Audit Log button on the
Management screen.

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2. Patient Record Amendments

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Searches for Patient Record
Amendments can be made using
the criteria shown. Searches can be
made by Date/Time ranges.
Pressing the Show PDF button
will display all the records returned
based upon the chosen search
criteria. The report can be printed.

The scroll bar can be used to view

all the entries.

3. Pressing the line of an individual

patient will display the details on
the patient. The ‘Show PDF’ button
allows the details to be printed.

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Patient Record Access
1. The Patient Record Access log
records each time a patient sample
result is accessed by an operator.
The search criteria are shown in the
accompanying image.

2. Information is returned based upon

the search criteria entered. ‘Show
PDF’ shows the results and allows
for printing.

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System Access

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System Access records all attempts to
access a GEM Premier 4000 or 5000*
client instrument , a GEMweb Plus
server or a GEMweb Plus web browser
session.

The System Access Log will display

records based upon the search criteria
used.

* GEM Premier 5000 system is not available in all countries.

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System Configuration Changes

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The log is accessed via a GEMweb
Plus web browser session. This log is
presented in a .pdf format only.
The System Configuration log will
document changes to the following:
• Patient Ranges
• Units of Measure
• CVP Material Setup
• Interface Setup
• Results Verification Setup
• Flag Sample Results
• Notification Setup
• Demographics Setup
• Network Setup
• Parameters Setup

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Security and Operator Management

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ii The log is accessed via a GEMweb Plus web browser session. This log is presented in a
.pdf format only.
The Security and Operator Management log will document changes to the following:
• Adding or deleting an operator
• Change to the Area access given to
an operator.
• Change of operator password (actual
password is not shown)
• Change in operator first or last name.
• Change in operator level
• Change in operator ID

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13 - eSignature

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Introduction
eSignature streamlines the signature and storage process for various regulatory reports
thus eliminating the need to print, deliver, sign off by hand and store documentation. A
benefit of eSignature is enhanced document security. Digital encryption of electronically
stored documents is more secure than physical storage of paper documents which can be
tampered with. The automated process of electronic signature also reduces the chance
of human error (e.g. signing mistakes) and ensures documents are in order. There is also
less need for items such as paper, copying, and storage with eSignature.
eSignature only available via a GEMweb Plus server or web client. This feature is not
available from a client analyzer or standalone analyzer.

Enablement and Configuration

1. To enable eSignature, click on
Configuration > Global > Enable
eSignature

2. Configure Reports and

Signatures -
In the Electronic Signature screen
there are a number of reports
which can be configured to require
electronic signature(s). Reports can
be configured to require up to two
levels of signature (e.g. Director and
Reviewer) required if desired.

To select reports to require eSignature, simply click on the desired box so a

checkmark appears identifying the report requiring eSignature.
Once all desired reports have been configured for eSignature click the SAVE button.

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Search and Review of eSignature Reports

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1. Access eSignature Reports -
To search and sign reports with
eSignature enabled click on
Reports>Signed.

2. Search eSignature Reports – Select

the search icon from the top bar to
open this search screen.

3. From this screen, reports can be

filtered by:
• Report Type
• Operator ID
• Reviewer Signature
• Director Signature
• Date Time Frame
• Date From
• Date To
Enter search criteria and click the
View button.

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4. Review of eSignature Reports -

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The Report List screen provides
visibility to the status of reports
that have eSignature enabled. The
“state” of the reports is represented
by an icon explained and will be one
or more of the following:
• Needs more information
• Pending – needs second signature
• Finished
• Rejected
To access the legend select the “i”
button.
There is also an indicator for if a
report has comments attached. If
a report has been signed, the time
and date stamp is visible from this
screen.
To view signatures, select a report.
To generate a printable PDF for the
list of reports, click on the Show
PDF button.

Electronically Signing Reports

eSignature enabled reports may be signed by one of two methods:
• Signed from Report List Screen (e.g. Initial and Secondary signature)
• Generation of PDF using Show PDF button (e.g. Initial signature only)
1. Signing Reports from Report
List Screen - Select a report for
signature from the Report List
screen.

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Click on the Sign button

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Signing Reports from General Search
Criteria Screens - Creating a new report
and adding a first signature can be
done from general report search criteria
screens. In this example, a report is
created for Enhanced Sample Counters
for a given period of time. An initial
signature can added to this report by
clicking on Show PDF button.

ii To add a second signature, the Director must access report from the Report List screen.
2. Signing a Report - In the Report
Signature screen the Role field is
automatically populated based upon
operator ID. The following options
may be selected to categorize the
report status:
• Yes
• Need more information
• Rejected

Once a selection has been made comments may be added if desired.

Click on the OK button and the status of the report will be changed.

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Example of eSignature Printouts

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When a report has been electronically signed a stamp will appear in the top left area of
the report with a document identification number assigned to the document.

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14 - Quality Management

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Managing traditional quality controls

This section is available only when analyzers featuring traditional quality controls are
connected to GEMweb Plus. It allows access to traditional QC management including
QC lots configuration, QC rules, Levey-Jennings graphs and automatic Uncertainty
Calculation.

QC Lots
This section allows the user to:
• Enable QC Management
• Enable ‘Active Lots’ Management
• Create and Edit QC Lots
• Setup QC Rules
When an analyzer featuring traditional quality controls performs the analysis of a QC
sample and sends the results to GEMweb Plus 500, if the results are transmitted along
with additional information regarding the QC (Lot Number, Lot Level, Description, Control
ID, Expiration Date and acceptable ranges for each analyte), and if the corresponding QC
lot is not already configured in GEMweb Plus 500, the available information is used to
automatically create a new QC Lot for the analyzer, which will be available in this section.
QC Lots can also be manually created or edited in GEMweb Plus 500. More details about
lot management are explained further ahead in this chapter.
Once a QC Lot is configured, whether it was automatically or manually created, GEMweb
Plus 500 will associate the QC samples received from the analyzer to the corresponding
lots, based on the QC lot number and level, if both are available, or on Control ID. This
allows the automatic creation of the Levey-Jennings charts and QC statistics associated
to the QC Lot.
To access the QC Lots Management Screen for an analyzer:
1. Select Quality Management and
Lots from the left menu bar.

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2. Use the filter bar in the top left

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corner of the screen to select an
analyzer. Only compatible analyzers
are shown.
3. Once an analyzer is selected, the
QC Lots Management Screen
is shown. From this screen it
is possible to Enable the QC
Management, Enable the ‘Active
Lots’ Management, and manage the
QC lots and rules.

Enable/ Disable QC Management

When an analyzer featuring traditional quality control (non-iQM) is connected to GEMweb
Plus for the first time, by default the QC Management in GEMweb Plus is not enabled for
that analyzer.
The user can enable or disable the QC Management independently for each analyzer
from the QC Lots Management Screen.
Whether the QC Management is enabled for an analyzer in GEMweb Plus 500 or not,
GEMweb Plus 500 can be used to store and review the QC lots and QC samples results,
store and review the Levey-Jennings charts for each QC lot along with the QC statistics,
and calculate the uncertainty of measurement.
If QC Management is enabled, GEMweb Plus 500 will apply the QC rules that are
configured by the user within the software to evaluete the QC received from the analyzer.
The Passed or Failed state of each QC sample will depend solely on the rules configured
in GEMweb Plus 500 and the flags associated to the QC sample received from the
analyzer will be disregarded.
Configuration of QC rules in GEMweb Plus 500, including target and ranges for each
analyte, is available only if the QC Management is active.
If QC Management is disabled, the status of each QC sample (Passed/ Failed) is
received from the analyzer.

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QC Lots

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QC lots are created automatically if both the Lot Number and Level are included in the QC
sample received from GEMweb Plus 500.
• Description
• Control ID
• Lot Number
• Lot Level
• Expiration Date
• Target and range for each analyte
QC Lots can also be created manually by the operator, but the configuration of the
analytes (including target, acceptable range and QC rules to apply) is available only if QC
Management in GEMweb Plus 500 is active for the analyzer.
New QC lots automatically received from an analyzers are created with the status
“Alternate”.
QC Lot Status Meaning
Active A QC fail for an Active lot will generate an alarm in GEMweb Plus 500.
New QC samples received for an active lot will be added to the
corresponding LJ chart and will contribute to the lot’s statistics.
Alternate Newly received QC lots are created as Alternate. New QC samples
received for an alternate lot will be added to the corresponding LJ chart
and will contribute to the lot’s statistics.
A QC fail for an Alternate lot will generate an alarm in GEMweb Plus 500
only if ‘Active lots’ Management is Disabled (explanation after the table).
If the QC Lot status is changed from Alternate to Active, the points
received while in Alternate status will be included in the QC rules
execution but will not be considered in the lots statistics.
Inactive The user can set a lot as Inactive to prevent any change in the QC data for
the lot.
New QC samples received for an inactive lot will not be added to the LJ
graph and will not alter the QC statistics of the lot. Instead, a new lot will be
created with the status “Alternate” and the new sample will be added to the
newly created lot.

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Enable ‘Active lots’ Management

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This function allows the user to decide whether a QC fail for an Alternate lot will generate
an alarm in GEMweb Plus or not. If enabled, only QC samples from Active QC lots will
be capable of generating QC alarms in GEMweb Plus 500. If disabled, the alarms can be
generated from samples correspoding to both Active and Alternate lots.
The user can enable or disable the ‘Active Lots’ Management independently for each
analyzer from the QC Lots Management Screen.
‘Active lots’ Meaning
Management
Enabled Only QC fails for Active lots will generate an alarm (warnings and errors) in
GEMweb Plus 500.
Disabled QC fails corresponding to QC samples received for Active and Alternate
lots will generate alarms in GEMweb Plus 500.

Use of Active Lots Management

If ‘Active lots’ management is enabled, only samples received for Active lots will be
able to generate QC alarms in GEMweb Plus (QC fail). The user will decide from which
QC lots to receive the alarms by manually setting the desired lots to the ‘Active’ status. In
this case, a QC lot can be used as “Alternate” to allow accumulating enough QC point to
execute QC rules and calculate the statistics before manually activating it.
A QC fail will determine:
• The QC samples will be flagged as failed in GEMweb Plus 500
• The warning and/or error will be displayed in the GEMweb Plus 500 Dashboard
• The GEMweb Plus 500 analyzers screen will show the alarm by turning grey the
analyzer icon and by applying the corresponding warning or error icon
• The icon corresponding to the failed analyte will be marked as QC Fail in the GEMweb
Plus 500 analyzer detail screen
If ‘Active lots’ Management is disabled, the most recent QC sample Status (Passed/
Failed) is applied in GEMweb Plus 500 for both Active and Alternate lots, so independently
from the status of the QC lot, and without requiring the user to manually set the QC lot as
“Active”.
Since a QC sample corresponding to a new lot will trigger the automatic creation of
the QC lot with the “Alternate” status, this allows to receive QC alarms for every QC
sample received from an analyzer. Disabling ‘Active lots’ Management is a suitable
option for most POC devices.

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To enable/disable the ‘Active Lots” Management for an analyzer:

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1. Select Quality Management and
Lots from the left menu bar.

2. Use the filter bar in the top left

corner of the screen to select an
analyzer. Only compatible analyzers
are shown.
3. Once an analyzer is selected,
the corresponding QC Lots
Management Screen is shown.
To enable/disable the ‘Active
Lots’ Management select the
corresponding button in the top right
side of the screen.

QC Management enabled
Activate this feature to take control of the QC interpretation within GEMweb Plus 500 and
manually manage the QC rules and QC lots status for an analyzer.
The user can enable the QC management for an analyzer from the QC Lots
Management Screen shown in the previous example, at point 3.
When the QC Management is active for the selected analyzer, the user will be allowed to
create/ edit QC Lots and set the QC Rules for each lot and analyte.
The QC Management can be independently enabled or disabled for each analyzer. If
enabled, GEMweb Plus 500 will disregard the QC flags received with the QC samples and
will apply the rules that are configured in GEMweb Plus 500. The QC samples will be sent
to the host connection with the flags applied by GEMweb Plus 500.

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When the user turns on the QC Management, Active and Alternate QC Lots that are

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already configured for an analyzer will be set as “Inactive” to grant traceability of the
previous QC management. At the same time, new QC lots corresponding to the existing
ones will be created with the status “Alternate”. The user can then use or edit the newly
created lots to set the desired QC rules.
If QC Management is active, ‘Active Lots” Management is mandatorily active and the
QC alarms in GEMweb Plus for the selected analyzer can only be generated for lots that
have been set as “Active” by the user.
New QC lots automatically received from an analyzers are created with the status
“Alternate”.
Alternate lots can be used to evaluate the QC statistics before activating them.
The combination of Lot Number, Lot Level and Control ID must be unique among all
Active and Alternate lots. The system does not allow to create a new lot with the same Lot
Number, Level and Control ID of an existing one that has the status Active or Alternate.
To allow this operation it is necessary to deactivate the existing lot (set the status to
“Inactive”).
The user can disable a lot to:
• Stop receiving QC samples for the lot. However, if the instrument reports another QC
sample with the same Control ID and Lot Level, a new QC Lot will be created with the
“Alternate” status.
• Avoid changes to the current LJ chart and QC lot Statistics
• Allow reuse of the Contorl ID
To create/edit QC Lots and setup QC rules:
1. Access the QC Lots Management
Screen selecting Quality
Management from the left menu
bar, select Lots, and use the filter
bar in the top left side of the screen
to select an analyzer.

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2. To view or edit an existing QC Lot

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select the corresponding line. New
lots are created automatically when
QC samples are received from
compatible devices. To manually
create a new lot click the button
in the top right corner of the screen.

3. Add or edit the lot information. The

asterisks indicate mandatory fields.

4. Select the button in the QC

Parameters Config section to
configure the QC limits and rules for
an analyte. Repeat for each analyte.

To copy a lot to other analyzers:

1. Access the QC Lots Management
Screen selecting Quality
Management from the left menu
bar, select Lots, and use the filter
bar in the top left side of the screen
to select an analyzer.

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2. Select the one or more QC lots

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by clicking on the corresponding
checkbox on the left, and select the
button “Copy to Instrument” in the
bottom left corner of the screen.

3. Select the Areas and Instrument to

which to copy the selected QC lots
and press “OK”.

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Levey-Jennings Graphs

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Levey-Jennings (LJ) graphs are available for compatible devices in GEMweb Plus 500. A
LJ graph is created for each QC Lot. All the samples received for Active and Alternate lots
are automatically plotted in the graph.
LJ graphs are available for each analyte included in a QC lot only if the required
information is available in QC Lot configuration, including target value and standard
deviation or acceptable range.
To access the LJ graph:
1. Select Quality Management and
Levey Jennings from the left menu
bar.

2. Use the filter bar in the top left

corner of the screen to select an
analyzer, an analyte and a QC level.
3. Once a QC level is selected, the
corresponding Levey-Jennings chart
is shown.
The top bar shows the QC statistics,
including:
• No. of points: Shows the number
of QC points included in the graph
• No. of omitted points: Shows the
number of omitted points
• Target Mean: The target value set
in the QC lot configuration for the
parameter

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• Target Standard Deviation: The standard deviation set in the QC lot configuration

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• Observed Mean: The mean calculated from the QC sample results included in the
graph
• Observed Coefficient of Variation(%): The Coefficient of Variation (%) calculated
from the QC sample results included in the graph
• Observed Standard Deviation: The Standard Deviation calculated from the QC
sample results included in the graph
• Relative Root Mean Square Error(%): The Relative Root Mean Square Error(%)
calculated from the QC sample results included in the graph
4. Move the mouse over a point to
show more information.

5. Click on a point on the graph or on

the table below the graph to open
a popup window that allows to omit
the point and/or add a comment.
Omitted points
To omit a point it is mandatory to
add a comment. Omitted points are
not considered in the QC statistics
and are clearly marked in the graph.

Add comments
It is possible to add multiple comments to the QC points. Every comment can be
categorized as:
• General comments
• Corrective Actions
• Root Cause

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6. To print the Levey Jennings graph

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select Show PDF in the bottom right
corner of the screen.

Example of a LJ chart PDF report:

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Uncertainty reports

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The Uncertainty of Measurement for an analyzer can be calculated in GEMweb Plus 500,
for compatible analyzers featuring traditional quality controls, using a user entered bias,
commonly estimated by participation in proficiency testing schermes, along with the data
of the internal quality controls.
When a Bias is available from proficiency testing, the user can select a QC lot that has
been used for the analyzer when the proficiency sample was analyzed, and link to it the
bias of measurement. The combined information of the QC lot statistics and entered bias
is stored in GEMweb Plus 500 and can later be used to generate the uncertainty report.
The user can enter a bias for every parameter available in the QC lots that are configured
in GEMweb Plus 500.
The Uncertainty Report is generated by selecting an analyzer and a time frame. The
report will include in the calculation all the QC Lots and entered bias available in the
selected time frame. If an Uncertainty Objective has been set for the analyzer and analyte,
the Uncertainty Report will show if the calculated uncertainty is within the acceptable limit.
Values are calculated utilizing the GUM approach (Guide to the Expression of Uncertainty
in Measurement, ref G104 – Guide for Measurement Uncertainty In Testing. American
Association for Laboratory accreditation. December 2014). The following equation is used
to calculate the Uncertainty of Measurement using the Observed Standard deviation of
the QC lot and the Bias entered by the user for all the QC lots included in the selected
time frame.

Manage Bias
To link a Bias to a QC Lot:
1. Select Quality Management and
Uncertainty from the left menu bar.

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2. Select Manage Bias

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3. From this screen it is possible to
link a bias of measurement to the
analyzer on which the proficiency
sample was analyzed.
• Select the Analyzer. Only
compatible analyzers are shown.
• Select a time period. Once a time
period is selected, select a QC Lot
available in the “Select Lot” field,
that will include all the QC lots that
were active in the selected time
frame.
4. Once a QC lot is selected, click on
one of the analytes to add the Bias.
A popup window will show all the
QC levels available for the selected
QC lot. For each level the following
information is available:
• Description
• Observed Mean calculated on the
QC samples received
• Observed Standard deviation
• Number of Points (number of QC samples) received
Use the above information to select the most appropriate lot to which to link the Bias.

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5. Enter the Bias and select OK.

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6. Select Save to apply the changes.

7. The analyte icon will show ‘Bias

Set’. Repeat steps 2 to 6 to assign
the bias for each parameter.

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Uncertainty Objectives

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If the Uncertainty objectives are set the uncertainty report will show in green results within
the acceptable limit and in red results outside.
To set uncertainty objectives:
1. Select Quality Management and
Uncertainty from the left menu bar.

2. Select Uncertainty Objectives.

3. Select an analyzer model. Only

compatible analyzers are shown.
Once a model is selected, the
parameters measured by the
analyzers are shown below.

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4. Click on an analyte to assign the

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uncertainty objective. Objectives can
be set for each QC level available in
configuration for the analyte. Click
OK once complete.

5. Once the objective is saved

the analyte icon will be flagged
“Objectives Set”

Uncertainty Reports
Uncertainty reports can be generated at any time using the data stored in GEMweb Plus
500, from the QC samples received from the analyzers and from the user entered bias
obtained from proficiency samples.
To generate the Uncertainty Reports:
1. Select Quality Management and
Uncertainty from the left menu bar.

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2. Select Uncertainty Reports.

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3. Select an Analyzer and a time
frame. Only compatible analyzers
are shown. Click View to generate
the report.

4. Select Export to extract the report

in CSV format or select Show PDF
to open it in PDF format.

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15 - SYSTEM BACKUP

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Protecting data

In order to protect data stored on the GEMweb Plus, periodic backups should be
performed. These backups can be used to restore data in the event of a malfunction.
ii The Backup function is available only accessing directly from the Server screen and
is accessed from the fourth column of the Management tab. Data can be backed up to
a disc, USB or a network directory. You will have the option to Do a One Time Backup,
Schedule a Daily Backup, or Do Not Backup. Each of these options is described in detail
below.

Do Not Backup
The default selection is Do Not Backup.

Do a One Time Backup

1. Select Backup System from the GEMweb Plus Management tab. Backup System is
available only from the GEMweb Plus Server.
2. Select Do a One Time Backup.

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3. Select the backup destination: disc,

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USB device or network folder.
Backup to Disc is shown here. For
an example on backup to a network
folder, see Schedule a Daily
Backup, below.

4. Press Finish.
5. You will be prompted to insert a disc or USB device into the Server. Insert the disc or
USB device and press OK. Data will be backed up.
ii Multiple CDs or USB devices may be needed for a full backup if the facility is not backing
up to a network directory.

Schedule a Daily Backup

1. Select Backup System from the GEMweb Plus Management. Backup System is
available only from the GEMweb Plus Server.
2. Select Schedule a Daily Backup.

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3. Enter the daily backup time.

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4. Select the backup destination:
disc, USB device or network folder.
Backup to Network Folder is
shown here. For an example on
backup to a disc, see Do a One
Time Backup, above.

5. Enter the Network Folder

Information: path, username and
password (if required).

6. Press Finish. Data will be backed up to the network folder.

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16 - SYSTEM RESTORE

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Restoring backed-up data to the system
In the event of a system malfunction or loss of data from the analyzer or server, data can
be restored from a back-up disc, USB device or a network folder.
The Restore function is accessed from the fourth column of Management (Tab 3).
ii The Restore function can only be accessed from the GEMweb Plus server.
ii Data can be restored from a disc, USB device or a network directory. Each of these
options is described in detail below.

Restore from Disc or USB device

1. Select Restore System from the Management tab (Tab 3).

2. Select Restore from Disc or Restore
from USB Device. Press Next.

3. You will be prompted to insert a

disc or USB device. After inserting
the disc and closing the DVD drive
drawer, press OK.
4. Select the file to be restored. Press
Finish.

5. The system will warn you that you are about to overwrite any existing data. Press OK
to complete the restore process.

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Restore from Network Folder

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1. Select Restore System from the GEMweb Plus Management tab.
2. Select Restore from Network
Folder. Press Next.

3. Enter Network Folder Information:

path, username and password (if
required). Press Next.
4. Select the file to be restored. Press
Finish.

5. The system will warn you that you are about to overwrite any existing data. Press
OK to complete the restore process.

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17 - OPERATOR DOWNLOAD

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Downloading operator data to the system

Import Operator List

The intent of Import Operator List is to provide supervisors with a streamlined mechanism
for introducing new or modified operators to the GEMweb Plus operator list. With this
feature enabled, GEMweb Plus will be capable of receiving new and modified operators
from LIS or POCT middleware solutions where the master list of operators is managed
from.
ii An HL7 interface is required to support Import Operator List
ii To realize full functionality of Import Operator List, the LIS/POCT middleware solution
responsible for housing and maintaining the master operator list must implement an
interface protocol to communicate operator lists to GEMweb Plus.

Enabling Import Operator List

Import Operator List can be enabled for GEMweb Plus clients by either modifying or
adding a new connection through the Interface Setup Wizard. This option is also available
individually for standalone GEM Premier 5000* and 4000 analyzers
Enabling and Managing Import Operator List
1. Select Configuration (Global)>Interface Setup> and add or edit an HL7 connection. To
add a connection select the button , to edit e connection select the corresponding
line and then the button . This will open the Connection Setup Wizard.
2. On Step 6 select Receive
Operators or Restore from USB
Device. Press Next.

Management of Operator Download Alarm

There are 3 types of alarms associated with improper download of operators:
• Code 20: Operator is missing password
• Code 21: Operator password is already in use
• Code 22: Operator ID is not found
* GEM Premier 5000 system is not available in all countries.

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18 - ADDITIONAL CONNECTIVITY OPTIONS

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GEMLink
GEMLink is a “black box” software application that provides a means to connect GEM
Premier 3000 and GEM Premier 3500 instruments to a GEMweb Plus.
All patient data and iQM data from the GEM 3000 and 3500’s are transferred to the
database on the GEMweb Plus.
The direct connectivity of the GEM Premier 3000 and 3500 to GEMweb Plus is available
from software V5.2.0. The connectivity thorough GEMLink will continue to be supported.
Please contact an IL/Werfen representative for additional information.

Advanced Connectivity Module (ACM)

The Advanced Connectivity Module is a software application that when used in
conjunction with a GEMweb Plus system works in conjunction with the HIS/LIS used
by the hospital to process Admission-Discharge-Transfer data and to create orders for
samples in a point of care environment.
Please contact an IL representative for additional information.

Third Party Analyzers

GEMweb Plus allows the connectivity of analyzers from other vendors. Results and QC
samples are transferred to the database on the GEMweb Plus and to the host connection,
if enabled. Different functions can be available according to the analyzer model.
The installation and setup of third party analyzers is performed by an IL/Werfen
representative.
The direct connectivity of the GEM Premier 3000 and 3500 to GEMweb Plus is available
from software V5.2.0. The connectivity thorough GEMLink will continue to be supported.
Please contact your local IL/Werfen representative for additional information.

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