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Advanced QC Application

Quick Reference Guide

10818243 Rev. A 2014-06


Advanced QC Application

© 2014 Siemens Healthcare Diagnostics. All rights reserved.


No part of this operator’s guide or the products it describes may be reproduced
by any means or in any form without prior consent in writing from
Siemens Healthcare Diagnostics.

www.siemens.com/diagnostics
The content was correct at the time of printing. However,
Siemens Healthcare Diagnostics continues to improve products and reserves
the right to change specifications, equipment, and maintenance procedures at
any time without notice.
If the system is used in a manner differently than specified by
Siemens Healthcare Diagnostics, the protection provided by the equipment
may be impaired. See warning and hazard statements.

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Advanced QC Application

Contents

1 Overview
Intended Use....................................................................................... 5
Application Overview ......................................................................... 5
Navigating the Advanced QC Application Windows ............................... 6

2 Using the Application


Review Window ................................................................................ 13
Analysis Window............................................................................... 15
Analyze Results................................................................................... 15
Adding Comments to Results .............................................................. 15
Using Filters ....................................................................................... 15
Reports and Printing ......................................................................... 17
Creating Reports................................................................................. 17
Setting Up Report Headers and Footers ............................................... 17
Printing a Results Reports on Your Local Printer ................................... 18

3 Maintenance
Maintaining the Database ................................................................ 19
Viewing File Capacity.......................................................................... 19
Viewing Control Files .......................................................................... 20
Maintaining Files ................................................................................ 20

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1 Overview

Overview
Intended Use
The Advanced QC application is intended for professional use in a laboratory
environment only.
This guide does not replace the Advanced QC application online help.

BIOHAZARD

All products or objects that come in contact with human or


animal body fluids should be handled, before and after
cleaning, as if capable of transmitting infectious diseases. Wear
facial protection, gloves, and protective clothing.
The operator should follow the recommendations to prevent
the transmission of infectious agents in health-care settings as
recommended by the Clinical and Laboratory Standards
Institute (formerly NCCLS) in Protection of Laboratory Workers
from Occupationally Acquired Infections; Approved Guideline -
Third Edition. 2005. CLSI Document M29-A3. This document
contains complete information on user protection and it can be
used as reference material for instructions on laboratory safety.

Application Overview
The Advanced QC application provides both real time and long term
evaluation of analyzer and method performance. Advanced QC application
features include:
• Collection of control results
• Calculation and display of statistical data
• Assessing data for errors
• Notification of QC violations
• Tools for reviewing and managing control results
• Tools for creating printed reports
• Identification and reporting of events such as lot change and calibration
date
• Patient Median feature that utilizes patient result data to help monitor
system performance and troubleshoot systemic errors

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Advanced QC Application

Navigating the Advanced QC Application Windows


The Advanced QC application windows display a status bar at the bottom of
the window and a toolbar at the top of the Advanced QC application window.
Overview

NOTE: On some systems, you can access the Advanced QC application by


selecting QC > QC Statistics.
The status bar displays the following information:
• Login identifier of the user currently logged in
• Alert color for the highest severity QC violation of open files
• Information on the latest data point received, including severity level
The toolbar enables you to navigate to other windows in the application.

Icons
The following table lists the icons and their definitions.
Status Icon Definition
Reports. Selecting the Reports button displays the
Reports window where you can set up reports such
as monthly, exception, summary, customer and
patient median.

Messages. Selecting the Messages button displays


the highest level of alert color for an unresolved
message.

Tools. Selecting the Tools button displays the Tools


window where you can set filters, backup and
restore data, and maintain the database.

Setup. Selecting the Setup button displays the


Setup window where you can configure local
settings, set auto review, and fields to display in
Review, Analysis, and Statistics.

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Status Icon Definition


Switch to … Selecting the Switch button toggles
between the Review window and the Analysis

Overview
window. (In the Review window, the button
displays as Switch to Analysis. In the Analysis
window, the button displays as Switch to Review.)
Help. Selecting the Help button displays online
help information.

Reduce. Selecting the Reduce button minimizes


the Advanced QC application to an icon on your
desktop.

Log On. Selecting the Log On button displays the


Log On window.

Exit. Selecting the Exit button closes the


Advanced QC application.

Colors and Symbols


To help you identify control data issues, the Advanced QC application uses
colors, connectors, and symbols.

Review Window
To identify severity levels, colors indicate in-control, warning, out-of- control,
and non-numeric results:
• White (normal display) indicates results are within the test range.
• Yellow indicates results in the warning range.
• Red indicates results in the out of control range.
• Blue indicates a non-numeric result, system excluded data point.

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Analysis Window
There are 9 analysis chart colors. These indicate the number of controls in the
sample:
Overview

1st 2nd 3rd 4th 5th 6th 7th

Purple Green Sienna Maroon Navy Pink Brown

8th 9th

Teal Blue

Symbols identify a data point. These symbols represent a Usage (primary,


parallel, alternate) and Control Level (level 1 through level 6). For the control
level, the chart symbol displays the level number. Each combination must be
unique for each test.

Symbol Usage
Primary

Parallel

Alternate

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If your analyzer does not support Usage and Level, the Analysis chart displays
a . The chart also displays this symbol for closed files.

Figure 1-1 shows the use of color to indicate different control files. In this

Overview
chart, the symbols and colors of the chart indicate several levels of control
files.

1 2S error
2 Selected data point
3 Mean

Figure 1-1 Multiple Control Files

Online Help
The online help button provides access to the operating instructions and
information necessary to run the application. When you select the online help
button, the online help displays help information related to the current active
window. From there you can navigate to other sections of the online help to
find all the information you need to use the Advanced QC application.

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RiliBÄK Guidelines
The Advanced QC application supports the RiliBÄK guidelines.
The RiliBÄK are guidelines administered by the German Federal Medical
Overview

Association, which specify quality requirements for clinical laboratories.


The QC protocol specified by RiliBÄK uses a single rule QC protocol with an
assigned target and an acceptable range specified by the regulations. Results
falling outside of the prescribed range are reported as an error. Using the
RiliBÄK feature enables you to activate enforcement of the RiliBÄK QC
protocol within the Advanced QC application.

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2 Using the Application

When you review results in the Advanced QC application, you are looking for
issues with the control results. That is, at some point there is a QC rule failure or
violation of a rule. These violations are indicated by severity alerts using
symbols and colors. (Refer to Colors and Symbols‚ page 7.)
A QC rule violation refers to a result, or data point, that fails the criteria for 1 or
more QC rules. This is the highest severity level. A QC warning indicates that
the data point failed a QC rule designated as a warning rule.
The Advanced QC application lets you investigate the control results that
violate the defined rules for your system by following these processes:
• Identify any issues with the results (Review Window)
• Investigate the issues (Analyze)
• Determine what happened to cause the issues (Analysis Window)
• Follow-up on the issues (Analysis Window)
An illustration of typical review steps are in Figure 2-1 on page 12.

Using the Application

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Review Window
Identify and select QC results
with rule results.

Analyze
Show results in graphical view.

Analysis Window
Look at the results. To review
rresults in detail, select the data
point or QC Details button.
Using the Application

No Analyze Window
Filter Results? Take follow-up action on the
results by selecting: Comment,
Review, Include, or Exclude.

Yes

Filter
Display data in a specific hour,
day, week, month, or year range.

Figure 2-1 Typical Steps to Investigate QC Results

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Review Window
When you launch the Advanced QC application, the Review window displays.
Here you identify and select QC results to analyze.
The left side of the Review window displays the controls and tests (Test or
Control radio buttons). The right side shows the results. The result ranges are:
out of control, warning, and other. The default display shows all ranges.
You can select the plus sign (on the left side of the window) next to each top
level of the list to display associated data or you can select Expand All to display
the data.

Selecting Results
1. At the Show by panel (left side), select the type of data to view:
• To display the tests at the top level, select Test.
• To display the controls at the top level, select Control.
2. Select 1 or more control files:
For each control file you select, the application displays results in the results
table.
• Select or deselect individual control files.
• Select the top level of any group to select all of the associated lower

Using the Application


level files.
• Select the Select button at the bottom of the panel to select all or
deselect all of the checkboxes.
NOTE: If you select Auto-Select and then deselect a control file with issues, the
Auto-Select function no longer applies and the application clears the
Auto-Select checkbox. Any new control files with issues are listed but are not
automatically selected.
• Select Auto-Select to set the window to automatically select all control
files that contain issues, including new control files.
3. In the Results table (right side of Review window), select a review state
from the Show Results dropdown list:
• Unreviewed
• Reviewed
• All
4. Select 1 or more severity types:
• Out-of-control
• Warning
• Other
5. Review the results.

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6. Change the status of reviewed results:


a. Select 1 or more results in the table.
b. Select the Reviewed button.
NOTE: Changing the state to Reviewed does not change the level of
severity displayed in the Results panel. After you mark all Warning or
Out-of-control results in a single control file as reviewed, that control
file alert color changes to green in the list of Controls/Tests.

Reviewing and Analyzing Specific Results


On the Review window results side, all unreviewed QC results display. You can
select specific results to analyze by selecting the box next to the results.
1. Select the box next to the result.
2. Select the Analysis button.
You can view results in Levey-Jennings chart, Z-score chart, or an Overlay chart
by selecting the radio button next to the chart name.

Auto Review
You can activate the Auto Review feature so that Advanced QC application
reviews all data points. Data points in the In-Control range are marked as
Using the Application

reviewed. Any results that are out of range are left as unreviewed so you may
check these tests.

Cycles Tab
The Cycles tab displays when the RiliBÄK feature is enabled and active.
The Events window enables you to view all events for the data points currently
displaying in the Cycles tab. Event information that displays includes:
• Cycle period closed or extended
• Target Mean changed
• Target %Dev changed

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Analysis Window
To analyze a specific result or results, check the box next to the result and select
the Analyze button. The Analysis window opens showing with a Levey-Jennings
chart. If the RiliBÄK is active, you can display RiliBÄK data.

Analyze Results
1. In the Review Window Results panel, select 1 or more results to review.
2. Select Analyze.
3. In the Display drop-down box, select the chart type:
• Levey-Jennings
• Z-score
• RiliBÄK
NOTE: When you select Z-score or RiliBÄK, the Overlay checkbox is available if
you select at least 2 but no more than 6 control files.

Adding Comments to Results


1. Select 1 or more results.
2. Select Comment.

Using the Application


3. Using 1 of the comment drop-down lists, select the comment.
You can assign up to 3 comments for each result. If you add a comment to a
result that is not marked as Reviewed, the Advanced QC application
changes the result to Reviewed.

Using Filters
Filters enable you to display data by a range of dates. You can specify a range in
hours, days, weeks, months, or years. Use the Filter window to:
• Remove a time filter from the control files displayed on the Analysis
window.
• Apply a time filter to control files displayed on the Analysis window.
• Select control files to display on the Analysis window.

Removing a Time Filter


When the Filter window has a time frame already set, the Current Time Filter
panel displays the starting date and time and the ending date and time of the
current filter. The Apply Time Filter button also displays a Filter icon.
To remove the current filter, select Remove Time Filter. When you exit the
Analysis window and select a new result, the Time filter automatically returns
to no time filter.

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Applying a Time Filter


1. At the Analysis window, select Filter.
2. At the Filter window, select Apply Time Filter.
This displays the Set Time Frame dialog box.
3. Set the time frame for the controls you want to see.
4. Select OK.
Verify that the time frame you set displays in the Control Time Frame panel.

Selecting Control Files


The Filter window displays all the control files, open and closed, that are
currently in the Advanced QC application database. If a time filter is currently
set, the display is limited to control files that have data points that fall within
the current time filter.
After you set the time filter to display the time frame you want to use, select
the control files you want to display:
At the Filter window, select how you want to display the control files in the list:
• To display the tests at the top level, select Show by Test.
• To display the controls at the top level, select Show by Control.
Using the Application

If the Advanced QC application database contains data from more than 1


analyzer, you must first select the analyzer from which you want to view the
control files.
1. Select Analyzer.
2. Select the control files you want to view.
3. Select OK.

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Reports and Printing


Creating Reports
Selecting Reports from either the Review window or the Analysis window
displays the control and patient median files on the Reports window. If you
applied a time filter, only the filtered QC and Patient median points display for
reporting.
1. At the Review window or Analysis window, select Reports.
2. At Report Name, select the type of report.
3. At Report Contents > Title, enter a title for the report.
4. At Report Contents > Data Points, select an option for data points.
NOTE: The Data Points options do not apply to Patient Median files.

5. At Report Contents > Sort By, select the sort order.


NOTE: The Sort by Options do not apply to Patient Median files.

6. At Report Contents > Options, select the contents of the report.


NOTE: The Patient Median feature is an optional feature that may not be
enabled on your system.
7. Use the Time Filter to apply and remove time filters.

Using the Application


8. In the Show By area, select Control or Test to add the heading in the first
column of the report.
NOTE: Selecting Expand, to the right of the scrolling checklist on both the
QC tab and the Patient tab, causes this checklist to expand into a larger
separate window, thus showing a larger number of files at one time and
making file selection easier and quicker. When you select Close on this
expanded screen, your selections transfer to the original screen and the
expanded version goes away.
9. Select Print.

Setting Up Report Headers and Footers


You can add up to 3 lines of heading text, and 1 line of footer text, to each
report.
1. At the Reports window, select Setup.
2. Enter heading lines for the report in the fields labelled Line 1, Line 2 and
Line 3.
3. Enter the footer text.
4. Select OK.

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Printing a Results Reports on Your Local Printer


If a printer is connected to the Advanced QC application, you can print results
or automatically print results for samples that are being processed.
1. Select Results.
2. Select a sample ID or a range of sample IDs.
To select a range of records, press the Ctrl key as you select the records you
want to print.
3. Select Print.
From the Selection area of the Print Results screen, you can choose:
• Selected Record
• Today’s Records
• All Records
• Range (of records)
If you choose to print a range of records, you can print by one of the
following criteria:
• Sample ID
• Assay
• Date
Using the Application

• Interpretations
• Status
• RunID
4. Enter a date range indicating From: and To: to select a range of records to
print.
5. Select a report format you want to print.
6. Select OK.
The records or the predefined report prints on the default printer.

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3 Maintenance

Maintaining the Database


Use the Tools > Maintenance tab to view and maintain the control files
database. Maintenance activities are:
• Viewing database size and maximum capacity
• Viewing file information
• Adding comments
• Viewing details
• Closing files
• Deleting files

Viewing File Capacity


You can view the current file size of the Advanced QC application database.
1. Select Tools > Maintenance > Database/Backup.
2. The current file size and maximum capacities of the files display. The
databases are:
• Control Sample Results
• Patient Median Points
• Control Files
• Patient Median Files
• Unprocessed Control Sample Results
• Messages
NOTE: Some systems do not use the Advanced QC application backup and
restore function. See your system’s operator’s guide for more information.
To preserve the data in the database, backup the database before it exceeds
Maintenance

capacity. To backup the databases, refer to the Advanced QC application online


help.

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Viewing Control Files


Use the selection tables (Available Files and Selected Files) to display individual
files or groups of files:
1. Select Tools > Maintenance.
2. At the View dropdown list, select the type of control files to display in the
Available Files table:
• All
Displays all control files, open and closed, that are currently in the
Advanced QC database.
• Open
Displays only open control files that are currently in the Advanced QC
database.
• Closed
Displays only the closed control files that are currently in the Advanced QC
database.
• Not in Use
Displays only the closed control files that you have marked as not being
used.
3. In the Available Files table, select each control file you want to view.
NOTE: Hold down the Shift key to select a range of contiguous control files.
Select the first control file, hold down the Shift key, and select the last control
file in the range. To select multiple non-contiguous files, hold down the Ctrl key
while selecting each file.
• Select File Info to view detailed information about the control file.
• Select Comment to add a comment (enter a new comment, or select an
existing comment from drop-down list) to the control file.
• Select Details to view file details about the control file.

Maintaining Files
Maintenance

Siemens Healthcare Diagnostics recommends that you close the files on a


regular basis. This optimizes the response time in closing and opening the files.
For example, you might close the file at the end of each month. When the
application reaches storage capacity, you can delete the oldest month’s file,
leaving you with several months’ worth of data.
NOTE: When you close the file, new data is not added to that file. A new file is
opened. You can view and look at file information in the closed file.

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Performing Database Maintenance with QC Files


1. At the Advanced QC Tools window, select Maintenance > QC.
2. Select a QC File.
3. You can delete, close, or view file information.
a. Select Delete to delete the selected file.
b. Select Close to close the selected file.
c. Select File Info to view information about the control file.
d. Select File Info > Comments to add a comment to a file.
4. Select Archive Data before delete for the system to automatically archive
the patient median file to a saved location before the file is deleted.

Performing Database Maintenance with Patient Median Files


1. At the Advanced QC Tools window, select Maintenance > Patient.
2. Select a Patient Median file.
3. Select Archive Data before delete for the system to automatically archive
the patient median file to a saved location before the file is deleted.
4. Select Delete.
5. To delete files that are older than a specific time period, select
Delete PM Data.
NOTE: Archived data cannot be restored to the system application.

Maintenance

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