UniCel DxH 600/800 Coulter Cellular Analysis

UniCel DxH 600/800
Coulter Cellular Analysis System
Training Modules
Name_________________________
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WARNINGS AND PRECAUTIONS
READ ALL PRODUCT MANUALS AND CONSULT WITH BECKMAN COULTER-TRAINED PERSONNEL BEFORE
ATTEMPTING TO OPERATE INSTRUMENT.
BECKMAN COULTER, INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND
SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT
LIMITED TO, PROTECTIVE EYEWEAR, GLOVES AND SUITABLE LABORATORY ATTIRE WHEN OPERATING
OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY EQUIPMENT.
INTENTION FOR USE
This document is not intended to replace the information in your Instrument
Instructions for Use Manual (IFU). Information in the Instructions for Use Manual
supersedes information in any other manual.
TRADEMARKS
UniCel DxH Series with System Manager 3.2.0.0 or 1.3.0.0 Software Instruction For
Use: PN B26647AE (November 2016).
Beckman Coulter, the stylized logo, and the Beckman Coulter product and service
marks mentioned herein are trademarks or registered trademarks of Beckman Coulter,
Inc. in the United States and other countries.
All other trademarks, service marks, products or services are trademarks or registered
trademarks of their respective holders.
Copyright  Beckman Coulter, Inc. 2016
All Rights Reserved
Find us on the World Wide Web at:
www.beckmancoulter.com
Beckman Coulter Ireland, Inc.
Mervue Business Park, Mervue Galway, Ireland 353 91 774068
Made in USA
REVISION STATUS
Version 1.3
UniCel DxH Series 600/800 Training Guide
Ver 1.3 (January 2017)
(January 2017)
Software release 1.3.0.0 or Higher DxH 600
Software release 3.2.0.0 or Higher DxH 800
Presented January 2017, Miami, Florida
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COURSE GUIDE
System
Overview
Troubleshooting
Setup
UniCel DxH 600/800
System
Additional
Topics
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TRAINING TOPICS
SYSTEM OVERVIEW
SETUP
TROUBLESHOOTING
ADDITIONAL TOPICS
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GROUP DISCUSSIONS
The following discussions take place in the classroom/laboratory. Ending
times noted are approximate.
Tuesday
 General Information
 Learn about each other
 Safety: Personal Protective Equipment and Fire Evacuation
 Introduction to the course and materials
 Location of additional reference materials
 Registration Questionnaire
 Instrument Demo
Wednesday
 Pro-Service
 Data Innovation - Presentation
Thursday
 Data Innovation - Flags, Codes, & Message – Presentation
 BCI Website
Friday
 Evaluations
 Graduation
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You will see the following symbols used throughout the learning modules.
Important information you should know.
Techie-type information you may be interested in knowing.
Do these steps now!
Timely Tip
You reached the goal!
I do not understand…Questions
Resources, Help
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COURSE MAP – SYSTEM OVERVIEW
Begin Here
System Overview
Daily Checks
&
Shutdown
Quality Control
Sample Analysis
Setting Up
Supplies
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SYSTEM OVERVIEW
OBJECTIVES
Given an operating DxH 600/800 System:
 Log On and Log Off the System Manager
 Identify the main hardware of the system by labeling a diagram
 Identify the areas of the optional floor stand by labeling a diagram
 Locate and identify the areas and icons used on the screen by labeling
a diagram
 State the meaning of icon colors and how to respond to them
 Access System HELP using the Help
icon
 Find information using the Contents, Index and Search features
 Use hypertext jumps within Help
 Print Help topics
 Create Favorites in Help
Why Is It Important?
This module introduces the basics of the DxH 600/800 System. A basic
hardware overview allows identification of the general parts of the system.
A basic software introduction shows how to log on to the System Manager
and identifies the main screen areas and icons and their names using
basic Windows software conventions. The introduction to System HELP
shows you how to access the information contained in the Instructions for
Use.
These topics form the building blocks for the rest of your learning journey.
Resources
DxH 600/800 System
DxH 600/800 HELP
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INFORMATION/PRACTICE
Logoff/Logon to the System Manager
In order to access the System Manager, you must Log on. Both an
Operator ID and a Password are required. The system administrator will
assign these to you in the lab.
Step
Action
1
Select the Logoff icon
at the top right of the screen.
2
On the Logoff screen, select the logoff button.
3
On the Logon screen, type in the user name: BCI (case
sensitive), press tab.
Type in the Password: bci (case sensitive).
4
NOTE: Neither the Operator ID nor the password “bci” is present
in the system. Upon installation, Operator IDs and Passwords
must be set up.
5
Select the Log On button or Press Enter.
You will now be on the DxH Solutions “home” screen. Once you select any
button or icon to move to a different screen, the home screen disappears.
You will only see it after a Log On or if you press the F8 key.
System Manager Statistics
Your System Manager (computer) consists of the following:
 Computer with CD/DVD RW drive running Microsoft
Windows 7 Professional operating system
 LCD flat panel monitor, touch screen
 DxH Solutions Software
 Optical USB mouse
 Standard keyboard
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Access System HELP
All graphics including screens and printouts are for illustration purposes
only and must not be used for any other purpose.
Step
Action
1
Select the System HELP icon
2
Select the Index tab on the left side of Help.
3
Type the words home screen in the keyword field.
4
A list displays, double click on the words home screen in the list
or select the words and select the “Display” button at the bottom.
5
Take some time to study the Home Screen figures to learn the
names of the areas on this screen. You will label a diagram with
the correct names as part of the skill check later.
6
To place this in Favorites as a reference for you, select the
Favorites tab (to the right of the Index tab).
7
Then, select the “Add” button near the bottom.
8
You may now refer to this topic any time you select Favorites.
9
To delete a topic from Favorites, highlight it and select Remove.
10
The Help screen may be moved and resized to place it in a
better position on the screen while you are working. Try it now!
11
The font icon at the top of the Help screen allows you to
increase or decrease the size of the font used to make it easier
for you to read. Try it now!
12
The print icon at the top of Help allows you to print any
information that you want from Help. It will print in the font size
chosen. Please feel free to print any topics that you want this
week.
13
To close Help, select “x”.
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Software Overview
System Status, Worklist, Daily Checks, Quality Control, XB/XM, Supplies,
Event Log
The meaning of the alert status icon colors are:
Red = error, Yellow = warning, Neutral = OK.
To review the software areas, select the Help icon
, Contents, expand
Chapter 1, click on System Manager Indicators and scroll down to view
the different names of the areas on this within the home screen.
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Quality Control Files and Patient Data Storage
The software application provides you with the following data storage
capabilities:
Patient results
with graphics
Quality Control
Configuration
Standard Computer as
System Manager
30 files with 150 runs per file
50,000
60 files with 300 runs per file
35,000
Raw data files
12,000
Hardware Overview
The DxH 600/800 System includes a Specimen Processing Module
(SPM), a Pneumatic Supply Module (PSM) and a System Manager,
precisely integrated to provide process control, data consolidation, and
cassette or single-tube delivery of specimens.
System HELP can provide a quick overview:
Step
Action
1
Select the Help icon
2
Select the Contents tab.
3
Find Chapter 1 System Overview, and then select
the tree.
4
Find Overview, and Select
5
Select UniCel DxH 600/800.
6
Take some time to study the figure of the Stand-Alone DxH
System. You will label a diagram with the correct names as part
of the skill check at the end of this module.
7
Scroll down to the next Figured 1.3 Front View of the SPM.
8
Take some time to study the figure, Front View of SPM. You will
label a diagram with the correct names as part of the skill check
at the end of this module.
Note
.
to expand
to expand the tree.
The three Beacon colors are Red (Error), Yellow (Warning), or
Green (OK to Run).
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Floor Stand (DxH 800 Configuration Only)
The DxH 800 floor stand provides self-contained support for the SPM as
well as easy access storage for reagents and waste containers.
Additionally, the floor stand houses the Pneumatic Supply on an
integrated pull-out shelf in the left lower section on the cabinet.
Step
Action
1
Select the Index tab.
2
Type floor stand.
3
Double click Floor Stand from the list.
4
Take some time to study the DxH 800 Floor Stand figures and
their descriptions. You will label a diagram with the correct
names as part of the skill check at the end of this module.
Congratulations, you have finished Basics! Continue to the Skill Check.
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SYSTEM OVERVIEW SKILL CHECK
1. Label the sections of the Home screen:
6
5
7
1
8
2
3
4
1. ________________________
5. _________________________
2. ________________________
6. _________________________
3. ________________________
7. _________________________
4. ________________________
8. _________________________
2. Label the main areas of the
DxH System:
1
2
1. ______________
2. ______________
3. ______________
3
4. ______________
4
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3. Label the parts of the SPM:
1
2
1. ______________________
2. ______________________
3. ______________________
4. ______________________
6
3
5. ______________________
6. ______________________
5
4
4. Show facilitator your favorites tab. Demonstrate how to add and
remove a topic.
5. Show facilitator how to Log off and Log on.
6. List the Supplies used in the DxH 600/800 System:
1. ________________________
4. _________________________
2. ________________________
5. _________________________
3. ________________________
6. _________________________
7. What do the colors mean?
_____________________________________
_____________________________________
_____________________________________
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DAILY CHECKS & SHUTDOWN
OBJECTIVES
Given an operational DxH 600/800 System and using the System HELP:
 Point to the last time a Daily Checks or Shutdown was run using the
DxH 600/800 Status screen
 Access the Daily Checks Summary Screen
 Request a Daily Checks cycle
 Set up automatic Daily Checks
 Review the Daily Checks results
 Add a comment to Daily Checks results
 Set up printing options of the Daily Checks results
 Access the Export Daily Checks (optional)
 Perform the Shutdown procedure using DxH Cleaner
 State the minimum time the instrument should be in Shutdown and
how often Shutdown should be performed
 Set up Enable Automatic Shutdown to occur from Monday thru Friday
at 5:30.
Why Is It Important?
The Daily Checks screen shows you the results of running the Daily
Checks diagnostic tests. The summary screen gives a quick overview of
the results and any alerts due to failed tests.
The Shutdown procedure must be performed every day that the
instrument is used. Shutdown is used to ensure optimal cleaning of the
instrument.
Resources
DxH 600/800 System
Blank CD
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INFORMATION/PRACTICE
Daily Checks
Daily Checks ensure that your DxH 600/800 System is running correctly.
Daily Checks may be scheduled to occur automatically or manually when
initiated at the System Manager.
Run Daily Checks
Step
1
Action
Select the System Status icon
. Double click on the instrument
silhouette or click on the Details Status button on the Local
Navigation Bar (bottom of screen).
Look at the DxH 600/800 Status screen to give you an overview of
basic information about the instrument.
2
Note the date and time of the last Daily Checks, Shutdown, Last
Control (run) and Calibration.
If the date and time are a neutral color, all is OK. If they are red,
there is a problem.
Look at the sphere next to Operation.
3
A green sphere means OK. A red sphere means a problem. A
gray sphere means disabled. A black sphere means disconnected.
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Select the Daily Checks button
to display the Daily Checks
Summary screen with results of the most recent Daily Checks.
4
5
Select the Daily Checks button at the local navigation bar (bottom
of the screen). A DxH Solutions dialog box displays the following:
You have requested to perform Daily Checks.
6
Select OK to run Daily Checks, or Select Cancel.
7
While this cycle is running (approx. 4.5 minutes), refer to the Run
Daily Checks Help topic in Chapter 3.
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Viewing/Reviewing and Auto Repeat of the Daily Checks
Step
Action
Look at the Daily Checks
icon.
- When Daily Checks pass, the icon is neutral.
- If any of the Daily Checks do not pass, the;
Note



icon is red.
Problematic result is backlit in red on the Summary tab.
Tab that contains the problematic result has a red
indicator.
1
Look at each Daily Checks tab, beginning with the Summary tab.
2
Select the individual tabs to view those results. If there are any
failures, you must select Review in order to proceed with further
analysis.
3
If any Background result fails, run Daily Checks again.
4
Verify your background results when the Daily Checks cycle
finishes.
5
For classroom practice, use View Log to find a Daily Checks with
a Fail entry, select it and then select the Details button.
Select the Review button.
6
A dialogue window appears asking: Are you sure you want to
acknowledge the Daily Checks failure? Press OK to continue.
When you click “Review” for failed results, you are
acknowledging the failure and the need to repeat the Daily
checks. Be sure to document per your regulatory requirements.
Note You could add a comment in the History Log.
If Daily Checks pass, the Review button is disabled. You only
have to review results that are questionable.
7
Select OK.
If Daily Checks fail background limits, the system automatically repeats
the Daily Checks cycle one time.
Note
The automatic retry is logged in the service log and counted for
workflow recording. The initial failed run is noted in the Daily Checks
data summary log. The initial failed run is not displayed, does not turn
red, no audible alarms are activated, and no entry is placed in the
General Event log. If Daily Checks pass, the Review button is disabled.
If any of the Daily Checks do not pass (on retry or when retry is
disabled), you only need to review results that are questionable.
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Daily Checks Auto Configuration
Step
Action
From the Daily Checks screen, select Auto Configuration >
Configure Daily Checks to display the Auto Daily Checks
Configuration dialog box.
1
2
Select Enable Automatic Daily Checks to enable running daily
checks automatically on your system.
You have 2 options to choose from:
3


Perform Daily Checks After Shutdown
Perform Daily Checks at a Specified Time
For classroom purposes, select Perform Daily Checks After
Shutdown.
4
Select OK to save
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Viewing Past Results/Adding Comments
Step
1
Action
Select the View Log button from the Local Navigation Bar.
You may select one date at a time to review.
2
Note: You may view the Daily Checks entries and any areas that
failed within that Daily Checks will be backlit in red and have a
Fail.
3
Once highlighted in blue, select the Details button below to view
all tabs of those results. Select View Log to return to the log or
the back arrow on the upper left of the screen to go back one
screen. Select a date now.
4
With any date highlighted, select the Comments button below to
add a comment. Do this now!
5
Select OK to save comment.
Once saved, you will see a yellow, “page” icon appear to let you
know there is a comment associated with that entry. You may go
back to a comment to edit it as well.
6
7
Note: Comments added to the Daily Checks Data Summary Log
can be printed or exported. The comments currently do not
appear on the printout: however, the comments are contained in
the export file.
Be sure to save at least one comment for any Daily Checks result
as part of this exercise.
Print/Export Daily Checks
Step
Action
1
Select
at the top of the Daily Checks screen to manually print
Daily Checks Summary (one page) or Detail Reports (three
pages).
2
If you select View Logs from the Daily Checks screen, it will take
you to History Logs > Data Summary Logs, where you may print:
Entire Log, All Filtered, or Selected Entries.
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3
Print two selections from the log, including today’s results and
one from a week ago.
4
You may also export the Daily Checks results. The Export button
on the local navigation bar exports Daily Checks results to a raw
data file (INF/DAT) or a .csv file. The .csv file may be opened by
a spreadsheet program.
5
This is an optional exercise. Follow the steps and save a week
worth of Daily Checks onto a CD.
Auto Report Daily Checks
Step
1
Action
Select
at the top of any screen to display the Daily Checks
screen for the module selected on the System Status Screen.
Select Auto Report to display the Daily Checks Auto Report
dialog box.
2
3
You may decide to have the Daily Checks print automatically.
4
You may select to print automatically either the Summary report
or the Details report, or both.
5
For classroom practice, choose “Enable auto Summary Report
Generation” and select OK.
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SHUTDOWN
The DxH 600/800 System allows you to program the length of time the
instrument is in Shutdown. Read the Shutdown HELP topic in Chapter 8
for reference.
If the instrument exceeds 24 hours without having a shutdown performed,
the DxH 600/800 System Status (Details Status Screen) will have
Date/Time Shutdown box backlit in yellow. This serves as an alarm to the
operator. No additional system messages will appear in the History Log.
At the end of the shutdown programmed time, the system removes DxH
Cleaner and replaces it with DxH Diluent. It then awaits a Daily Checks
cycle, performed manually or automatically.
If a Shutdown cycle needs to be interrupted, just cancel and then request
a Daily Checks cycle.
Step
Action
From the Daily Checks screen, select the Shutdown button to
display the Manual Shutdown dialog box.
1
Once you select OK, no other cycles or System Manager actions
can be performed until the Shutdown cycle has completed.
Note: Once the Shutdown cycle is complete, a countdown timer
bar appears near the bottom of the Daily checks screen to let you
know how much time remains for the cleaning.
2
Select the Perform Daily Checks After Shutdown check box to
automatically begin Daily Checks after Shutdown.
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3
Enter the number in the Time in Cleaner Hours and Minutes text
boxes to determine the time in cleaner. The default time in
cleaner is 30 minutes. The maximum time in cleaner is 24 hours.
4
Select OK to begin shutdown or Cancel to exit the pop-up
window without starting shutdown.
UNLESS YOUR FACILITATOR SAYS TO DO SO, DO NOT
PUT THE INSTRUMENT INTO SHUTDOWN AS IT IS
PROGRAMMED TO GO INTO AUTO SHUTDOWN AT THE
END OF THE DAY.
Enable Automatic Shutdown
The DxH 600/800 System allows you to configure the Auto Shutdown
Cycle. Read the Daily Checks Configuration HELP topic in Chapter 9 for
reference.
Step
Action
From the Daily Checks screen, select Auto Configuration >
Configure Shutdown to display the Auto Shutdown
Configuration dialog box.
1
2
Select Enable Automatic Shutdown to enable running Shutdown
automatically on your system. Follow the steps to
enable/configure automatic Shutdown cycles.
3
Type in one hour for time in cleaner.
4
Type in 5:00 for the time the cycle should begin and select
Monday through Friday.
5
Select OK to save your selections.
Please continue to the Skill Check on the next page.
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DAILY CHECKS & SHUTDOWN SKILL CHECK
1. Show your printouts from the exercise that includes today’s result and
one from a week ago to the facilitator.
2. Go to the System Status screen and point to the time of the last Daily
Checks cycle.
3. Show facilitator that you set up automatic Daily Checks using Auto
Configuration.
4. Show facilitator the comment you added to a Daily Checks results.
5. Show facilitator that you set up automatic printing of Daily Checks.
6. Show facilitator the steps to Export Daily Checks results. (optional)
7. What is the minimum time for the DxH 600/800 System to be in
shutdown? ______
8. How often should a Shutdown cycle be performed? _______________
9. What step would you take if shutdown is programmed for one hour and
you get a STAT after only 15 minutes has elapsed?
________________________________________________________
10. If the Daily Checks fail background limits, will the DxH automatically
repeat the Daily Checks cycle?
True or False
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QUALITY CONTROL
OBJECTIVES
Given an operating DxH 600/800 System, access to the System HELP
and package inserts from control products:
 Describe proper storage and handling for COULTER LATRON CP-X
Control
 Describe proper storage and handling for COULTER 6C Cell Control
 Describe proper storage and handling for COULTER Retic-X Cell Control
 Describe proper storage and handling for COULTER Body Fluid Control
 Use the System Help for procedures to run the various controls
 Process the various controls
 Access the control data (results), select various controls
 Review control results: data and graphs
 Recognize flagged results
 Add a comment to a control run
 Exclude a control run from statistics
 Print Control Data
Why Is It Important?
Understanding how to store, handle and use the control products available
ensures reporting out the most accurate results possible to the clinician.
Resources
DxH 600/800 System
Control package inserts for Latron CP-X control, 6C, Retic-X and Body
Fluid cell controls.
Control products for processing
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INFORMATION/PRACTICE
Control Storage and Handling
Obtain the product insert sheets for each control and answer these
questions on proper storage and handling:
COULTER LATRON CP-X Control
 Latron CP-X Control may be stored at room (ambient) temperature or
refrigerated temperature. True or False
 Latron CP-X Control must be at room temperature before use. True or
False
 Gently mix a room temperature tube of Latron CP-X Control by
___________ five to eight times. Avoid foaming.
COULTER 6C Cell Control
 Store refrigerated at _______ºC
 After warming at ambient (16-30 ºC) temperature for 10-15 minutes,
mix each tube individually by hand using the 8x8x8 method, ___ times.
 Run the controls in any order using Cassette Presentation and return
to the refrigerator within _______ minutes.
COULTER Retic-X Cell Control (Optional)
 Store refrigerated at _______ºC
 After warming at ambient (16-30 ºC) temperature for 15 minutes, mix
each tube individually by hand using the 8x8x8 method, ______ time.
Only repeat if necessary after inspecting the tube for complete
resuspension.
 Run the controls in any order using Cassette Presentation and return
to the refrigerator within _______ minutes.
COULTER Body Fluid Cell Control (Optional)
 Store refrigerated at _______ºC
 After warming at ambient (16-30 ºC) temperature for 10-15 minutes,
mix each tube individually by hand using the 8x8x8 method, ___ times.
 Run the control using the Single Tube Presentation, in consecutive
order beginning with Level ___ and ending with Level ____. Return to
the refrigerator within _______ minutes.
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Analyzing Commercial Controls
Step
Action
1
Ask your facilitator to provide you with a set of package inserts
for all controls. You will also need the controls to run on your
instrument. Please run all controls, all levels.
2
Prepare the controls according to the instructions on the package
insert.
3
Select the Start button
instrument on-line.
4
Run the controls according to the instructions on the package
insert.
from the upper right to put the
Viewing/Reviewing Control Results
Step
Action
Note: Read Chapter 4 Quality Control to familiarize yourself with
the various QC screens.
1
Select the Quality Control status icon
.
Under QC out conditions, the Quality Control status icon
at
the top of the screen is red. If more then one lot is out, a dialog
box is displayed.
2
If you want to review a different control or level, use the Select
Control button
from the local navigation bar.
This opens a control tree that you may expand to choose the
various controls and levels for review.
Control files also have filters that let you select a Control State.
These filters are as follows: Accumulating, Active and Inactive.
We will go over this in the Setup > Control Files Module.
3
Highlight the control you wish to view and select OK.
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Find Summary Data (statistics) on the left of the screen.
Find the results of the most recent run to the right, the column
highlighted blue. Values that are outside of the expected range
are in red.
At the bottom of the column, you will see the word Exclude. If you
select this checkbox, the run will not be included in the statistics.
If you deselect the checkbox, it will be included again.
4
Select the View Graph button
bar.
from the local navigation
This allows review of the Levey-Jennings graphs.
The smaller graphs are thumbnails that present the most recent
ten runs. The larger (expanded) graph shows all runs for a
parameter.
As you select each parameter thumbnail, the expanded graph
changes to that parameter.
Various symbols and colors represent whether a data point is
within range, outside 2SD
, outside 3SD or excluded .
5
Return to the data screen by selecting the View Data button.
6
Note that there is another thumbnail graph on the left. This
changes when you highlight another parameter on this screen.
7
Select the Comment button
bar.
from the local navigation
This opens a window that allows you to add a comment to a
control run.
You may add to or edit comments after saving them.
8
Add a comment to one of your control runs from today.
9
Select the Click to Review at the bottom of an unreviewed control
run. The system will prompt you: Do you want to review this run?
Click OK. This will show that the control run was reviewed. Do
this for all your control runs for this exercise. In your lab, follow
your laboratory’s protocol.
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Printing Control Data
Manually print individual runs using the Print button in the utility area.
For Auto-Print, go to Menu/Setup/QC/Edit Control. You may
enable/disable Auto Print – for each control file to set up automatic
printing.
Step
Action
1
Open a QC control file.
2
Select the Print Icon
3
Under Report Type, select Summary Report.
4
Under Select Control Lot, you may choose one or multiple
controls to print.
.
For classroom practice, select one control lot.
5
6
7
Under Print, select All Runs.
Under Print Options, you may choose Full Page or Thumbnails.
For classroom practice, select Full Page.
Click Print.
Please continue to the Skill Check on the next page.
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QUALITY CONTROL SKILL CHECK
1. Show how to select different control files.
2. Show facilitator your QC runs in the System Manager. Be sure they are
all marked as “reviewed”.
3. Point out which control was run in single-tube presentation
4. Show the comment you added, on the screen and on a printout.
5. Point out a value that is out of range.
6. Show the excluded run, on the screen and on a printout.
7. Show Facilitator a printed control file.
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SAMPLE ANALYSIS
OBJECTIVES
Given an operating DxH 600/800 System, access to System HELP and
blood specimens collected in EDTA anticoagulant:
 State the aspiration volume for sampling
 Identify the five types of cassettes (A, A+,B, C, D) and the tubes to use
in each
 Process bar coded samples using cassette presentation
 Process bar coded samples using single-tube presentation
 Adding a Test Order Manually
 Process body fluid specimen (optional)
 Process a STAT
 Dispense diluent
 Process a prediluted sample
 Process a specimen in a microtainer using single-tube presentation
(optional)
 Data Review and Release Results
 Setting Up Specimen Exit Delay
Why Is It Important?
The DxH 600/800 System is a quantitative, multi-parameter, automated
hematology analyzer for in vitro diagnostic used in screening patient
populations found in clinical laboratories. Running samples is a daily task
that occupies much of your time in the lab. Learning how to process
samples efficiently on the DxH 600/800 System saves you time.
Resources
DxH 600/800 System
Blood specimens collected in EDTA
Bar code labels
Cassettes
Pipettors, tips, microtainers and clean tubes
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INFORMATION/PRACTICE
Cassette Types and Tubes
* Tube height minimum is measured from the bottom of the tube to under
the cap; the maximum is measured including the cap.
Short pierce depth tubes include:
Long false bottom tubes which fit into the Type B cassette.
Smaller length tubes such as 2 and 3 ml pediatric sizes, or tubes shorter
than a Beckman Coulter control product tube, which fit into the Type D
cassette.
Specimen Information
Notes
Whole Blood:
1
Collect whole blood in EDTA according to tube manufacturer’s
instructions and procedures in:
 CLSI publication (for capillary)
 CLSI publication (for venipuncture)
Beckman Coulter recommends using K2 or K3 EDTA.
Aspiration:
DxH System aspiration volume is 165 µL.
2
Pre-diluted blood CBC analysis requires a dilution of 50 µL of
blood and 200 µL of diluent for a x5 dilution.
Tube dead volume varies depending on the tube’s physicial
charactertistics (length, diameter), tube bottom adjustments and
the sampling presentation. The least dead volume is required by
the spring-loaded side of the Single-Tube presentation station.
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Sample Stability and Storage:
Important: Refer to CLSI, Procedures for the Handling and
Processing of Blood Specimens.
At Room Temp.
3
At Refrig. Temp.
CBC
24 hours
48 hours
NRBC
24 hours
24 hours
Retic %
24 hours
72 hours
Body Fluids
1 hour
Not Applicable
Cassette Presentation (Automatic Download from LIS)
Obtain specimens and barcode labels from your facilitator. This section
assumes bidirectional LIS download and positive identifier set to
Specimen ID.
Step
Action
1
Ensure the SPM is online.
2
Ensure your specimens have been collected, stored, and handled
properly.
Load the specimens into the cassettes.
3
Place the cassettes into the input buffer. The SPM automatically
begins cycling the cassettes.
4
5
After the SPM cycles the samples, review the sample results at
the System Manager.
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Single-Tube Presentation
The Single-Tube Station accepts many sizes of tubes. A fixed bar code
reader reads labels at or near the depression on the cover. Each side of
the cradle has a mechanical switch for tube recognition.
The right (green) position is designed for open vial aspiration from 7 to 13
mm diameter tubes. The open vial position uses a spring-drive adjustment
to allow aspiration from tubes with minimal dead volume. The minimum
tube height is 28mm.
The left (lavender) position adapts to both open and closed vial tubes from
10.5 to 13 mm in diameter. The minimum tube height is 55 mm (measured
from under the cap). The maximum tube height is 107 mm (with cap, if
present).
Obtain another bar-coded specimen.
Step
1
Action
Obtain another bar-coded specimen.
Select the Single-tube Presentation icon
.
The single-tube Presentation Dialog Box will come up.
2
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3
Place the specimen on the bar-code reader platform of the
Single-tube Presentation Station with the bar code facing the
SPM to allow the Single-Tube Presentation Bar Code Reader to
scan the specimen label.
You may also type or scan the specimen identifier. You need to
place the curser at the end of the last character of the Specimen
ID and press enter.
Note
4
Verify the Specimen Identifier and Test request. Follow the
prompts on the screen.
5
Mix the specimen according to your laboratory standards.
6
Place the specimen into the correct Single-tube position.
Note
To process a sample collected in a micro-collection device, use
single-tube presentation and place the tube on the right-hand
side of the cradle.
Predilute
Step
Action
The predilute function is a fixed x5 dilution.
Obtain diluent from the instrument, using the Diluent Dispense, to
use in making a dilution of a previously run sample. You will need
an empty tube to obtain the diluent. Follow the steps below.
1
Select the Single-tube Presentation icon
.
Select the Diluent Dispense button.
2
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3
Follow the directions on the screen, using an empty tube.
4
Prepare your x5 dilution. (Example: 50uL of sample and 200uL of
diluent).
5
If SPM timed out, select the Single-tube Presentation icon
.
Scenario for Running a Pre-diluted Sample
1. Scan, Barcode, or Type the Specimen
Identifier and press Enter.
2. The Dialog Box comes up Test Order not
Found for specimen identifier XXXX,
Default Test order assigned. Select OK.
3. Highlight the Selected Panel and click 4. Press the Submit button.
Remove. Then, select the Available
Panel PREDIx5 and click Add.
6
Place the specimen into the correct Single-tube position.
7
Once the sample is aspirated and the tube is returned select
to finish.
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Body Fluids (Optional)
To reduce body fluid sample viscosity, use hyaluronidase to treat synovial
fluids prior to analysis according to your laboratory standards. Add in the
ratio of 1 ml of synovial fluid to 5 mg of hyaluronidase. Mix for 5 minutes.
Note: Beckman Coulter recommends that a diluent be run as a Body Fluid
sample prior to analysis of Body Fluid specimens to verify acceptable
backgrounds. The Body Fluid mode provides extra cleanup after running
this type of sample.
Refer to HELP for Performance Specifications.
Step
Action
Note
Since we do not have access to body fluids in our classroom
situation, your facilitator will give you a sample to simulate a body
fluid.
1
Use the Dispense Diluent function on the instrument to dispense
diluent into a clean tube. Do this twice using the same tube.
You will use this tube for your Blank.
2
Run the sample provided using the single-tube presentation.
Choose a body fluid under Specimen Type and follow the onscreen directions.
Setting Up Specimen Exit Delay
Step
Action
Enabling Specimen Exit Delay allows orders to rerun and reflex from the
middleware or the LIS. Samples are automatically analyzed without cassettes
exiting to the Output Buffer and will not require user intervention. As the System
Manager waits for a reply, you may see up to a 45-second delay. Result
transmission is not delayed.
1
Select Menu > Setup > More > Specimen Exit Delay.
2
Enable the Specimen Exit Delay by selecting the dialog box.
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Adding a Test Order (Manual Entry)
You can add a test order by automatically downloading the order from the
LIS or by manual entry.
Note: Batching must be disabled in order to manually add a test order. If
Add Order is disabled, batching is enabled. See Batching in Chapter 9,
Setup for additional reference.
Step
Action
1
Select Menu > Worklist > Pending tab or click the Worklist icon
and then the Pending tab.
From the Worklist – Pending tab screen, select Add Order to
display the Add Order Screen.
2
Press (Tab) to move through each section and follow the steps for
Specimen Information, Available Panels, and Patient Information.
For classroom practice, get a downtime barcode label and enter
the following sample information manually.
3
Specimen ID: scan the barcode label
Specimen Type: Whole Blood
Specimen Priority: STAT
Draw Date: today’s date
Selected Panel: CD
Patient ID: Type in Today’s Date (example: 01012013)
(When you type in the Patient ID and click Enter, you will get a
box to find the patient. Click on Add Patient.)
Type in the Patient ID: Type in Today’s Date
Last Name: Johnson
First Name: Elizabeth Marie
In your lab, you may add additional Demographic information in
the active fields provided.
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4
Click OK.
5
Click Submit.
6
Place the sample on a cassette and run it in cassette presentation
or you may run it in single-tube presentation.
Data Review and Release Results
Once samples finish processing they move from the Pending tab to the
Not Processed, Review or Released tab. You can choose to release
automatically all samples to the LIS (most labs), you may choose to
partially release portions of the test panel (ie: WBC, RBC, PLT, Diff,
Retics), or you can review the results from the System Manager.

The Pending Tab displays all patient test orders with a pending or
partially complete result status (any result status that is not
complete).

The Not Processed Tab on the Worklist displays exceptions for
specimens that have been skipped such as No Read or No Match.
You may need to address the problem and reload the skipped
specimens for processing. When exceptions are posted to the Not
Processed tab, is red. This tab view is automatically displayed
when you select the worklist icon.

The Review Tab displays specimens that have been held (not
released) and require attention.

The Released Tab displays the released results according to the
filter that you select.
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Rerun
When you review a result from the Review tab, you may choose to rerun
the specimen. Choose the Rerun/Reflex button, and then choose Rerun. If
the specimen has just been processed recently and the cassette has not
ejected to the output buffer, the instrument will automatically rerun the
sample chosen. Otherwise, find the sample and place it back in the input
buffer.
Once you place this request, you will notice on the Details screen that a
column called Run 2 appears. You will be able to see both runs side by
side. You may then choose which result to release.
Reflex
You may use this feature to add a test to a specimen already processed. If
the original only had a CBC ordered, you may use this to add a Diff and/or
a Retic. Choose the Rerun/Reflex button, and then choose Reflex. A
screen will appear to allow you to add the additional test(s).
If the specimen has just been processed recently and the cassette has not
ejected to the output buffer, the instrument will automatically run the
sample chosen. Otherwise, find the sample and place it back in the input
buffer.
Note: When using Decision Rules (a later module), the Rerun/Reflex
functions can be automated based on the rule.
Viewing Dataplots and Histograms
The Details screen shows numeric results, histograms, dataplots and
messages.
For a larger view of the histograms, double-click on them. All three enlarge
together.
The 2-D dataplots for 5PD1 (Diff), NRBC1 and RETIC1 each have a
separate tab. For a larger view, select the View All VCSn Graphics button.
This provides larger views of the three measurements in 2-D (including
5PD2, NRBC2 and RETIC2), 3-D and Surface Plot graphics.
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Step
1
Note
Action
Now that you’ve run samples in different modes, go to the
Worklist > Released Tab.
When you open the Release Tab, all the released results will
appear in this list.
This is dependent on your Laboratory’s release criteria.
2
Select a sample from the list and click on Details.
The Patient Results screen will display the results and graphics.
You may continue reviewing other samples.
If a sample requires a rerun you can order it using the Decision
Rules to automatically rerun or reflex.
Please continue to the Skill Check on the next page.
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SAMPLE ANALYSIS SKILL CHECK
1. What is the specimen aspiration volume for the DxH 600/800 System?
_________
2. State the maximum stability time for each of the following:
At Room Temp.
At Refrig. Temp.
CBC
____________
_____________
NRBC
____________
_____________
Retic %
____________
_____________
Body Fluids
____________
_____________
3. Navigate the Worklist screen tabs with your facilitator.
4. Show how to review and release a result.
5. Where do you enable/disable the specimen exit delay option?
__________________________________________________
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SETTING UP DXH SUPPLIES
OBJECTIVES
Using an operating DxH 600/800 System and System HELP:
 Setup and replace supplies using Beckman Coulter reagents and the
bar code scanner
 Setup Reagent Configurations
 View and review the two history logs associated with Supplies
Why Is It Important?
An up-to-date supplies screen shows that your laboratory is aware of good
Quality Assurance procedures. Even if the same lot number of a reagent
replaces the previous container, the supplies setup must be updated to
show the correct open container expiration date.
Resources
DxH 600/800 System
System Help
Reagent with Barcode
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INFORMATION/PRACTICE
Entering information for DxH 600/800 System supplies is easy. You simply
scan a bar code label and you are done. Read the Set-Up Supplies HELP
topic in Chapter 9 for reference.
Step
1
Action
The Supplies screen displays the status of the supplies. The
Beckman Coulter Supplies are displayed graphically as colored
bottles. The colors on the supply screen correlate with the colors
of the consumable connection tubes. The hand-held Bar-Code
scanner lets you automatically upload DxH 600/800 Supply
information from the Setup Supplies dialog box.
Select the Supplies
icon.
Select Setup to set up supplies.
2
3
Note
4
With the Setup Supplies dialog box open, scan the bar-codes on
the Beckman Coulter reagent container and hit Enter. The
supply information is updated.
For Diluent Reagent only, select Diluent 1 or Diluent 2.
Select OK to complete the setup, or Next to configure another
supply.
When any reagent supply is getting low, a yellow Supplies icon appears.
When any reagent supply is out, a red Supplies icon appears.
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Note: With two diluents, when the first box is getting low, the field is
yellow, but the icon remains neutral. Once it switches to the second
box, the icon is yellow and the field is red. Do not change Diluent 1
until the switch to Diluent 2 occurs. Otherwise, it will never switch.
Configuring Containers
You can configure the system to run with one diluent container, or two
(dual) containers. The system will automatically switch between two
containers if so configured. This exercise shows you where to select
single or dual containers. Read the Configuring Containers HELP topic in
Chapter 9 for reference.
Step
1
Action
Select the Supplies
Icon > Configure Containers.
You may select either the Single Container or Dual Container
option from the Diluent drop-down list.
2
For Classroom purposes, make sure the Dual Container option
is selected.
3
Select the OK button to save your selection.
In the classroom, we use the dual container set up. Note on the
Supplies screen that both containers list separately. They are
also used separately, meaning one container empties and then it
switches automatically to the second container. When this
occurs, the Supplies Alert Status Icon is yellow; indicating one of
the containers needs to be replaced at your convenience.
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Configuring Low-Level Condition
Step
Action
1
The Configure Low Level option lets you to set a warning level to
alert you when a supply is running low based on the remaining
percentage of that supply. Refer to Chapter 9.
Select the Supplies
Icon > Configure Low Level.
Select a percentage from the drop-down list.
2
In the classroom, we set the low-level warning to 5%. When this
occurs, the Supplies Alert Status Icon is yellow. If both supplies
are out, the icon is red.
3
Note
Select OK.
If both supplies are out, the icon is red, and the operator will be
REQUIRED to prime the System. This scenario should be
avoided to minimize downtime.
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Supplies History Logs
There are two history logs associated with Supplies. One is located under
Event Logs and the other is located under Data Summary Logs.
Supplies Event Log
This log records any changes or alerts associated with the supplies. For
example, when the diluent switches from one container to the other, it
causes a yellow Supplies Alert Status Icon.
Supplies Data Summary Log
This log records all the information on each new container set up on the
System.
Find both of these logs and examine the entries in each one.
You reached the goal!
Please continue to the Skill Check on the next page.
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SETTING UP DXH SUPPLIES SKILL CHECK
1. Show facilitator the entry of the reagent you changed.
2. Show facilitator the Supplies screen.
3. Show facilitator both history logs associated with Supplies.
4. Show facilitator the position of Diluent 1 and Diluent 2 on the
Instrument.
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COURSE MAP - SETUP
Begin Here
Control Files
Calibration
Flagging Limits
Decision Rules
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CONTROL FILES
OBJECTIVES
Using the System HELP:
 Access the screens to set up new control files
 Set up COULTER LATRON CP-X Control
 Set up COULTER 6C Cell Control
 Set up COULTER Retic-X Cell Control (Optional)
 Set up COULTER Body Fluid Control (Optional)
 Access options for Auto Transmit, Auto Stop and Auto Print
 Change the Control State of a Control
 Configuring the Number of Control Files and Runs
Why Is It Important?
Proper and timely set up of controls is the basis of a good laboratory
Quality control program
Resources
DxH 600/800 System
System HELP
Package inserts containing 2D bar-coded information for Latron CP-X, 6C
Cell Control, Retic-X Cell Control, Body Fluid Control.
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INFORMATION/PRACTICE
Setup a New BCI Control
Read Quality Control (Commercial Controls) HELP topic in Chapter 9
for reference.
Step
Action
1
Obtain bar-coded inserts from the facilitator and follow the
procedure to setup each of the controls in the System Manager.
2
Go to Menu > Setup > Quality Control > New Control from
Barcode
Scan the control barcodes using the handheld barcode scanner.
3
You may select to:

Auto Transmit, if you want your control results to transmit
to an LIS QC package as well as to the System Manager
files.

Auto Stop, if you want the system to stop when a control
run has a parameter out of range. It is not necessary to
select this option if you run your controls separately from
your patient specimens. However, if you do run controls
and specimens together, then this option may be useful to
you.

Auto Print, if you want a hard copy of each individual
control run. Most labs no longer use this as they are trying
to go paperless.
4
If you forget to enable any of these features and decide to use
them, you can open each control file by selecting the Edit
Control button and enabling.
5
Select OK to accept.
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Auto Configuring Beckman Coulter Controls
You can set up the SPM to automatically configure the Beckman Coulter
Controls. The Auto Configure option will automatically set up a control file
for a control that is presented to the system, where a control file is NOT
present. That control file does not contain assigned values or expected
ranges; these can be configured at a later date.
Changing a Control State
Step
Action
Control files have filters that let you select a Control State.
These filters are as follows:
1

Active is the default state. Active control files are currently
in use. Active control files are evaluated and stored. Event
log messages, alarms and stop conditions are triggered as
applicable.

Accumulating controls files are used during crossover
studies. Accumulating control files will not trigger event log
messages, alarms and stop conditions. Processing is
otherwise the same as the Active State.

Inactive control lots are no longer in use. No new data will
be added to a file in an Inactive state
For classroom practice, let us change the control state of a
control file you set up.
Go to Menu > Setup > Quality Control.
2
3
4
Select one of the control files you set up in the previous
exercise.
Select More Options from the local navigation bar, then Change
State. Change the state of this control file to Accumulating.
Note: By default, the system will put all control files set up in
Active State.
Choose another control file and change the state to Inactive.
The following control files cannot have the same lot numbers:
Note



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Two accumulating files
An active and an accumulating file
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It is possible for the following to have the same lot number:
Note



An inactive and accumulating file
An inactive and active file
Different inactive files
QC History Log
When a control is out of range and/or triggers an Auto Stop, an entry goes
into the Event Log for QC.
You may add comments to the entry to catalog the actions taken. There is
an option to copy it to the maintenance log as well.
Go to the QC log, add a comment and check the option for the
maintenance log.
Configuring the Number of Control Files and Runs
Step
Action
Both the number of individual control files and the number of runs in an
individual control can be configured on your System Manager.
Control files are not individually configurable. An increase in the number
Note of control files or runs results in a decrease in patient database storage.
 30 files with 150 runs per file
 60 files with 300 runs per file
1
Log in using Temp Admin provided by Beckman Coulter.
2
Select Menu > Setup > Quality Control > More > Quality
Control Capacity.
3
Select the quality control capacity and select OK.
Note
Read the system message and select OK to confirm the quality
control capacity you have selected.
The system prunes the patient results in excess of the new
storage limit if patient result storage is being decreased.
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2
You reached the goal!
Please continue to the Skill Check on the next page.
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CONTROL FILES SKILL CHECK
1. Show the facilitator the control files that you set up.
2. Define:
Auto Transmit ____________________________________________
Auto Stop _______________________________________________
3. Define the three control states:
Active __________________________________________________
Inactive ________________________________________________
Accumulating ____________________________________________
4. Show facilitator the comment you added to a control in the QC log and
maintenance log.
5. Show facilitator the control files you changed states.
6. Complete the table below. (Hint “See Basics of the Workcell Module)
Quality Control
Configuration
50,000
Patient results
with graphics
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35,000
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CALIBRATION
OBJECTIVES
Given an operating DxH 600/800 System and using the System HELP
 Perform the calibration procedure using the COULTER® S-CAL®
Calibrator Kit
 Adjust calibration factors as required by the calibration results
 State when you should calibrate your instrument
 State when you should verify the calibration of your instrument
Why Is It Important?
Calibration fine-tunes the DxH600/800 System to give you the most
accurate results possible. Calibration is one part of verifying the accuracy
of your instrument in conjunction with your historical QC and knowing the
service history of your instrument.
Resources
DxH 600/800 System
System HELP
S-CAL Calibrator
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INFORMATION/PRACTICE
Ask your facilitator for a tube of S-CAL Calibrator and the bar-coded
insert sheet before you begin.
The calibrator should remain at room temperature for 15 minutes before
mixing and using. Please review the calibrator preparation/mixing
directions on the insert sheet before proceeding. However, please follow
the procedure Calibration in Chapter 11 of HELP.
When To Calibrate and When to Verify
When to Calibrate
You should calibrate your instrument:
 At installation
 After replacement of any component that involves dilution
characteristics (such as the BSV) or the primary
measurements (such as the apertures)
 When advised to do so by your Beckman Coulter
Representative
 If you fail verify calibration procedure.
When to Verify
You should verify the calibration of your instrument:
 As dictated by your laboratory procedures, local or national
regulations
 When controls begin to show evidence of unusual trends
 When controls exceed the manufacture’s defined acceptable
limits
 If the average ambient room temperature changes more
than 10º F or 6º C from the calibrating temperature.
If the procedure indicates you need to calibrate, continue with
the calibration procedure.
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Calibration Procedure
Step
Action
Note
Before you can start or restart the calibration process, the SPM
must be offline.
Select Menu > QA > CBC Calibration
1
Select Calibration Setup on the CBC Calibration Screen to
display the CBC Calibration Setup dialog box.
2
The screen will have the results of the last calibration run that
was performed. You will be prompted by a dialog box which
states: Existing Data will be deleted. Select OK to continue.
Select OK.
3
Type “10” in the Number of Aspirations text box.
4
Select Cassette Presentation Mode from the drop-down list.
5
Select BCI from the Calibrator Type drop-down list.
6
7
Select New Control From Bar Code and use the handheld barcode scanner to scan the 2D bar code on the product insert or
enter/select the following information:
Lot#
Expiration Date
Reference Values
Select OK and follow the screen prompts.
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8
Place the calibrator in a cassette and place it in the input buffer.
9
Select OK.
Review the calibration results.
10
If your calibration runs do not indicate the need for any
changes, please notify the facilitator before proceeding!!
11
Select the Finish button at the bottom of the screen.
12
Verify your calibration with controls.
Do not perform this in class, but do so in your lab!
You reached the goal!
Please continue to the Skill Check on the next page.
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CALIBRATION SKILL CHECK
1. When should you calibrate?
________________________________________________________
________________________________________________________
________________________________________________________
2. What parameters are calibrated on the DxH 600/800 System?
a. CBC and Diff
b. CBC
c. CBC, Diff and Retic
d. Diff and NRBC
3. Which of the following are valid reasons to run S-CAL calibrator to
verify calibration settings?
a. Controls show unusual trending.
b. On the Calibration Run Table a parameter checkbox is selected.
c. Ambient room temperature changes by more than ± 10º F or 6º C
from the calibrating temperature.
d. According to your laboratory or regulatory agency specifications.
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FLAGGING LIMITS
OBJECTIVES
Given an operating DxH 600/800 System and using the System HELP:
 Set up flagging limits for whole blood
 Process samples to show that the flagging limits entered are applied
Why Is It Important?
Setting up appropriate flagging limits for your laboratory ensures that
normal and abnormal specimen results are properly identified for further
review.
Changing flagging sensitivity can accommodate flagging seen in specific
patient populations.
Resources
DxH 600/800 System
System HELP
Several tubes of EDTA blood specimens
Bar code labels
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INFORMATION/PRACTICE
Creating a New Limit Set
Step
Action
Select:
Menu > Setup > Flagging/Rules > Flags > Flagging Limits
Tab
1
2
From the Flagging Limits Tab, select the Add Limit
button on the local navigation bar and create a limit.
Note
The Limit Ranges you will modify in the next steps for Action and
Definitive Limits are designed to “force” flagging on the normal
samples that we have in the classroom. They are not meant to
be “real life” examples!
Note
As you change each value, you may see a message about
“incorrect value”. Just select OK and continue.
 Specimen Type – Whole Blood. Use the drop-down list.
 Limit Name – Class Adult
 Location – Class Test. Use the drop-down list or select the
+ to add a Location.
3
 Age Range – From 0 Hours, To 150 years.
Note: You enter the age range, you can select the View Age
Range button to display a graphical view of the selected range.
You can also select View Age Range to view the graphical
display when you get an age range overlap violation.
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 Use the Copy Limit
set.
to copy from the original Adult
 From the Flagging Set Copy Source, select Adult Default.
 Select the Copy All Available check box. Select Copy.
 For classroom practice, make the following changes.
Reference Limits for Male/Female.

Reference tab:
Male
Female
WBC
3.0 – 3.5
3.0 – 3.5
RDW
PLT
10 - 11
50 - 100
10 - 11
50 - 100
Type in one or two Action/Critical Limits.
 Action /Critical Limits tab:
Action
WBC
2.9 – 3.6
RDW
PLT
9.9 – 11.1
49 – 101
Critical
9.7 – 11.3
Type in one or two Definitive Male/Female Limits.

WBC
PLT
RDW
Definitive Male and Female tabs:
Male & Female Limits
2.9 – 3.6
49-101
11.1
11.3
11.5
(Aniso 1+) (Aniso 2+) (Aniso 3+)
Note: MCV, MCH and RDW have gradient ranges available.
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4
To enable this limit as the system default for this specimen type,
select the
check box.
5
Select OK to Save.
In the Flagging Limit Setup screen, you may select the H&H
Check button to enable or disable this check. You may also
Note
change the calculation from the default.
6
Obtain 3 downtime bar code labels and three blood specimens.
7
Process your specimens. Look for the three Definitive Messages
you set up. If all three messages are not present, verify your
input, make any necessary corrections and rerun your
specimens.
Flagging Sensitivity
Step
Action
Select: Menu > Setup > Flagging/Rules > Flags > Flagging
Sensitivity Tab
1
The three areas you may adjust are Variant Lymphs, Left Shift
and Immature Granulocytes. The default setting for all of these is
set to High.
Note
Before making a decision to change these settings, you should
perform a Truth Table Analysis to determine the best setting for
your particular patient populations.
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You reached the goal!
Please continue to the Skill Check on the next page.
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FLAGGING LIMITS SKILL CHECK
1. Show facilitator the limit set you created.
2. Show facilitator the flagging from the definitive message settings used.
3. Show facilitator the reports of the samples you ran.
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DECISION RULES
OBJECTIVES
Given an operating DxH 600/800 System and using System HELP:
 Create and apply a Decision Rule so that an action posts either to the
Lab Action area or to the Comments area.
 Enable and edit the ISLH (International Society for Laboratory
Hematology) Consensus rules.
Why Is It Important?
Decision Rules assist laboratorians with data review by clearly showing
what actions(s) should be taken based on sample parameter results, flags,
codes and messages.
Resources
DxH 600/800 System
System HELP
Several EDTA specimens
Bar code labels
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INFORMATION/PRACTICE
The Rules button takes you to screens where you can select Release
Rules, add or edit Decision Rules at a workbench, or view Active Decision
Rules.
Ensure that each of the following is a clear and distinct section: Release
Rules, Decision Rules Workbench, and Active Decision Rules. The
Decision Rules let you define conditions that will initiate system or
laboratory follow-up actions.
You must validate any new decision rules that you add to avoid
erroneous results.
Restoring Predefined Rules
The predefined rules are available in the system:
 Consensus rules
The Consensus rules were created by the ISLH using an international
committee of Hematology experts. If you select Restore Predefined Rules,
after acknowledging a dialog box, it will post 41 rules, named CR1 to
CR41. These Consensus rules are disabled by default.
To modify a Predefined rule for your own laboratory policies, you
must Copy the rule first in order to edit it, then activate and enable.
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Release Rules Tab
Step
Action
Select: Menu > Setup > Flagging/Rules > Rules
1
2
Select the Release all results.
The Release Rules tab lets you select from the following
options::
 Hold all Results – All processed results will be held at the
Worklist Review tab.
3
 Hold all Exceptions – All processed results with exceptions
will be held at the Worklist Review tab.
 Release all Results – All processed results will be reported
(printed or transmitted as the system is configured) including
any triggered Decision Rules actions.
 Release results based on decision rules – All results that
trigger a Decision Rule action will be held at the Worklist
Review tab.
4
Select SAVE to save your settings.
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Create a Decision Rule
(Decision Rules Work Bench)
Step
Action
Select: Menu >Setup > Flagging/Rules > Rules
Decision Rules Work Bench
1
2
Select
dialog box.
button to display the Decision Rule Setup
Enter the following information to create a rule:
o Rule Name: WBC
o Description: WBC Rule
o Specimen Type: Whole Blood
3
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Select
4
button to create the following rule:
If WBC is >2.0 or <15.0, THEN Actions, add Lab Actions:
Perform a Manual Differential.
5
Select: Test Result:
o Test Result: WBC
o > 2.0
o Select: OK
6
Click:
7
Select: Test Result:
o Test Result: WBC
o < 15.0
o Select: OK
THEN Actions:
Lab Actions (ie: Perform a Manual Diff).
8
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Step
Action
Additional Tests:
Select the checkbox for Rerun.
9
Select the Reflex button:
Make a selection according to your laboratory protocol.
10
Click OK.
11
Click OK.
Note
This rule will force the application on a normal specimen for the
purposes of the classroom exercise.
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(Activate Decision Rules)
Step
Note
Action
You must be OFFLINE in order to Activate Decision Rules!
Select: Menu > Setup > Flagging/Rules > Rules
Active Decision Rules Tab
1
Select
and select the rule/rules to be activated.
2
All the rules created in the Decision Rules Work Bench and are
not active will appear here.
You may also choose the position (priority) of this rule in the list
of active rules.
Note
The two options are:
 Insert at selected row
 Insert after selected row
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3
Select the rule you created and click OK.
The Active Decision Rules Tab lists your Active Decision Rules.
4
Created Rule
Enable Rule
Select the Decision Rule as highlighted above in blue.
Click: Enable Rule icon to enable your Decision Rule.
The Decision Rule is Enabled.
5
Enabled
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Practice/Create Your Own Rule
Now create one or two rules of your own. They could be something you
use in your own lab, or something you make up for use in the classroom.
Be creative!
Remember that to run them here, we usually have only normal specimens.
Edit and Copy Decision Rules
Step
Action
Copying Decision Rules
From the Workbench Tab
1. Select a rule or a series of rules to copy.
2. Select Copy Rule to display the Decision Rule Setup
dialog box.
3. When the system displays:
a. Are you sure you want to copy the selected rules?
Select YES to automatically copy the rule to the
end of the existing list on the Workbench tab.
b. The rule copy is named Copy of XXX. You can edit
the name and rule.
From the Active Decision Rule Tab
Note
1. Select a rule or a series of rules to copy.
2. Select Copy Rule to Workbench to display the Decision
Rule Setup dialog box.
3. When the system displays:
a. Are you sure you want to copy the selected rules?
Select YES to automatically copy the rule to the
end of the existing list on the Workbench tab.
4. When the system displays:
a. Copied 1 rule to the decision rule workbench.
Select OK to put the rule on the Decision Rule
Workbench
b. The copy has the same name as the rule on the
Active Decision Rule tab. It does not say Copy of
XXX. You can edit the name and Rule.
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Enable Consensus Rules
Select the button for Restore Predefined Rules. There are 41 Consensus
Rules. After opening the rules, if you wish to edit first, copy and rename
the rule.
For additional reference, refer to the Set-up Chapter 9 in HELP.
Try this now!
You reached the goal!
Please continue to the Skill Check on the next page.
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DECISION RULES SKILL CHECK
1. Show your sample results/printouts to the facilitator with a rule that was
applied to the results.
2. Show facilitator a consensus rule that you enabled/edited.
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COURSE MAP - TROUBLESHOOTING
Begin Here
History Logs
Troubleshooting 1
(Sample Flow)
Troubleshooting 2
(Cleaning
Procedures)
Troubleshooting 3
(Using Diagnostics)
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HISTORY LOGS
OBJECTIVES
Given an operating DxH 600/800 System
 Locate the History Logs (Event) Alert Status Icon
 State the four types of History Logs
 Show how to review (clear) a red or yellow icon
 Find the Details of an event
 Add a comment to an event
 Print a log
 Export a log
Why Is It Important?
This module introduces History (Event) Logs. These logs record every
event that occurs on the system, divided into separate categories based
on the type of error. You must review any event that causes a red icon so
that the system may continue running.
Resources
DxH 600/800 System
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INFORMATION/PRACTICE
The History (Event) Logs has four log types. You access them by
selecting the Event Status Icon
. Read Appendix C Logs in HELP for
reference.
Review
Event Logs screen displays seven unique tabbed views; however,
the options available from the local navigation bar are the same for
each tabbed view.
System Status, Supplies, QC, QA, XB/XM, Patients, General,
 Whenever the Event Status Icon
is yellow or red, select it to review
the message. This always takes you to the General tab. This log
records all entries for System problems/warnings. You must review any
or
. The
signifies information only.
entry with a
Selecting the Review button causes the Event Status Icon to return to
a neutral color. Select the Details Button to see more information about
the entry. Just as in the Daily Checks area, you may want to add a
comment to the entry to explain why you reviewed and accepted the
message.
 The System Status tab records information on reports and LIS activity.
 The Supplies tab records information associated with the reagents,
when a supply is depleted or switched.
 The QC tab records information associated with control runs.
 The QA tab records information
Repeatability and Calibration.
associated
with
Carryover,
 The XB/XM tab records information associated with the XB/XM
batches.
 The Patients tab records information about individual specimens, e.g. a
no read of a barcode.
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Data Summary Logs (two tabs)
Daily Checks, Supplies
 The Supplies tab records the details of each reagent container change.
 The Daily Checks tab records the details of each Daily Checks test run
in the past.
Audit Log (one tab)
Audit
 The Audit tab records information such as when a configuration was
changed.
Maintenance Logs (two tabs)
Maintenance, Service
 The Maintenance tab records status messages and allows the lab to
add New Entries to record cleaning or other procedures performed. It
can be thought of as an Action Log. Try adding an entry now!
 The Service tab records any diagnostic procedures performed. It may
be accessed and comments may be added by someone with a Service
access level. The lab may view and print this log.
Details
Most of the logs give you access to the Details button to find out more
about the message posted. Highlight any entry in a log and select the
Details button.
Comments
Any log allows you to attach a comment. Highlight an entry and select the
Comment button. You may enter any text you wish. You may also amend,
add to or delete previous comments. Whoever is logged in at the time is
recorded as the comment author along with the date and time.
You may also automatically add a comment to the Maintenance Log by
selecting the checkbox “Log Comment/Event in Maintenance Log” from
the Log Type>Event Logs.
Delete
Some logs allow a Delete. We do not recommend deleting any entries in
the logs.
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Print
You may print logs manually or automatically.
Manual
Open any log (e.g. QA), select a couple of entries and select the manual
print button from the utility area. A dialog box opens giving you options to
print the entire log, by filters or selected entries. You may optionally
choose Details as well.
Choose Selected Entries and OK.
Auto Print
If you want to print all or certain logs on a regular basis, choose the Auto
Print button.
This allows you to schedule printing of each category of the logs, weekly
or monthly, at a certain day and time, with or without details.
Export
Selecting the Export button gives you the option of exporting the logs you
choose to a CD or flash drive.
If you choose to save to a flash drive, you must first save temporarily to
E:\, then drag and drop to your flash drive. You may then want to delete
that temporary file.
The logs exported are converted to a .csv format that you can read on any
computer that has a spreadsheet program on it (not on the System
Manager).
You may perform this now if you think you may use this method in your
lab.
Step
Action
1
Click the Event Alert Status
icon at the top of any screen to
display the History Logs screen.
2
Select one of the logs and select a message.
3
Click on details to find the additional information pertaining to it.
4
Select another message and add a comment to the message.
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You reached the goal!
Please continue to the Skill Check on the next page.
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HISTORY LOGS SKILL CHECK
1. Point to the Event Alert Status Icon.
2. State the four types of History Logs and the tabs present in each.
________________________________________________________
________________________________________________________
________________________________________________________
________________________________________________________
3. Point to the Review button, used to clear a red or yellow Event icon.
4. Highlight an entry in a log and display the Details of an event.
5. Add a comment to a log and print it.
6. Export a log using a CD or flash drive and show the file to the
facilitator. (optional)
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TROUBLESHOOTING 1 (SAMPLE FLOW)
OBJECTIVES
Using an operating DxH 600/800 System and System HELP:
 Locate and name major components of the SAM (Sample Aspiration
Module)
 List the constituents of the WBC and RBC/PLT dilutions, using
references
 State the importance of Sweepflow and Tangential mixing, using
references
Why Is It Important?
Knowing component names and their locations as well as their functions is
important when you are troubleshooting. Recognizing and knowing what
components should be doing in a cycle helps you troubleshoot when
something is not working. Using the System Help as a primary resource
can help you solve problems.
Resources
DxH 600/800 System
System HELP
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SETUP
 Be sure to wear full-face protection (either a full-face shield OR
protective eyewear with a face mask) along with a lab coat and gloves.
 Remove the transport shield and raise the front cover.
INFORMATION/PRACTICE
Step
Action
1
Open System Help
2
Expand Chapter 1 System Overview.
3
Expand Hardware, and read the different sections to familiarize
yourself with the system functional modules.
4
Use the information in this section to locate the functional
modules and their parts.
5
Expand Chapter 2 Operation Principles.
Expand DxH 600/800 Operation Principles.
6
Expand both CBC Analysis and VCSn Analysis.
7
Use the information in these sections to learn how the dilutions
are made and measured.
Transport
STM (Specimen Transport Module)
 Input Buffer
 Single-tube station and cradle
 Pending Buffer
 Mixing Station and Drip Tray
 Output Buffer
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Aspiration
SAM (Sample Aspiration Module)
 Aspiration Syringe (Cassette and Single-tube stations)
 Blood Detectors (new type!) distinguishes between air, diluent and
blood. The tubing and sensors are coupled.
 BSV and Drip Tray
 Aspiration Probe
 Barcode Reader
You reached the goal! Please continue to the Skill Check on the next page.
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TROUBLESHOOTING 1
(SAMPLE FLOW) SKILL CHECK
Obtain the numbered tabs or show the facilitator the following components.
1. Input Buffer
14. Single-tube Station
a. Barcode Reader
b. Left Cradle
c. Right Cradle
2. Pending Barcode Reader
15. AMTC
a. NRBC Mix Chamber
b. Diff Mix Chamber
c. Retic Clearing Mix Chamber
d. Retic Stain Mix Chamber
3. Mixing Station
16. Distribution Valve (DV)
4. Aspiration Probe
17. Multi Transducer Module (MTM)
5. Tube Barcode Reader
18. Flow Cell
6. Front Blood Detector
19. 4 PSI Regulator
7. Rear Blood Detector
20. FMI Pumps (Fluid Metering Inc.)
8. Blood Sampling Valve
21. Bleach Probe
9. Aspiration Syringe
22. Output Buffer
10. RBC Aperture Bath
a. Sweep Flow Lines
b. RBC Count Chamber
23. Reagent Reservoirs
11. WBC Aperture Bath
a. WBC Count Chamber
24. Buffer/Feeder Chambers
12. Hemoglobin Analysis
a. Lamp
b. Cuvette
c. Hemoglobin Pre-amp
25. Pneumatic Supply Module (PSM)
13. Vacuum Regulator
26. Air Filter on the PSM
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Write a definition for each term below.
Tangential mixing
___________________________________________________________
___________________________________________________________
___________________________________________________________
___________________________________________________________
___________________________________________________________
Sweepflow
___________________________________________________________
___________________________________________________________
___________________________________________________________
___________________________________________________________
___________________________________________________________
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TROUBLESHOOTING 2
(CLEANING PROCEDURES)
OBJECTIVES
Use the System HELP
 Clean the BSV Externally
 Clean the STM
 Clean the AMTC Module
 Clean the Optical Sensors
 Clean the Handheld Bar Code Scanner
 Clean the Pneumatic Supply Module Fan Filter
 Clean the Vacuum Trap
 Clean the Aspiration Probe
 Add an entry to the Maintenance Log with cleaning procedures
completed.
Why Is It Important?
Knowing how to clean certain components on an as-needed basis will
keep your system running smoothly.
Resources
DxH 600/800 System
System HELP
Pliers
Screwdrivers
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INFORMATION/PRACTICE
Reminder: Please wear lab coats, gloves and full-face protection for these
procedures.
PUT THE MODULE OFFLINE TO PERFORM DIAGNOSTIC
PROCEDURES
Step
Action
1
Open System Help
2
Expand Chapter 12 Cleaning Procedures.
3
Follow the procedures for:
 Clean the BSV Externally (also wipe out its drip tray)
 Clean the STM
 Clean the AMTC
 Clean the Optical Sensors
 Clean the Handheld Barcode Scanner
 Clean the Pneumatic Supply Module Fan Filter
 Clean the Vacuum Trap
 Clean the Aspiration Probe
4
Add an entry to the Maintenance Log with the cleaning
procedures completed.
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You reached the goal!
Please continue to the Skill Check on the next page
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TROUBLESHOOTING 2
(CLEANING PROCEDURES) SKILL CHECK
Have facilitator verify all cleaning procedures done properly:
 Clean the BSV Externally (also wipe out its drip tray)
 Clean the STM
 Clean the AMTC
 Clean the Optical Sensors
 Clean the Handheld Bar Code Scanner
 Clean the Pneumatic Supply Module Fan Filter
 Clean the Vacuum Trap
 Clean the Aspiration Probe
 Show Facilitator your Maintenance Log entry
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TROUBLESHOOTING 3
(USING DIAGNOSTICS)
OBJECTIVES
Use the System Diagnostics and System HELP to perform the following
troubleshooting procedures:
 Clean aspiration Probe
 Cycle the BSV
 Zap Apertures Procedure
 Clear RBC Apertures
 Clear WBC Apertures
 Clean (Bleach) Apertures
 Unlock the Distribution Valve (DV)
 Rinse Mix Chambers
 Clear Flow Cell Aperture
 Flush Flow Cell
Why Is It Important?
Using the Diagnostics available in the System will help you in any
troubleshooting efforts, especially when working with BCI
Representatives.
Resources
DxH 600/800 System
System HELP
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INFORMATION/PRACTICE
When you troubleshoot problems that may occur the Diagnostic features
available to you through the software will help you to solve the problem
and resume operation.
Step
Action
1
Open System HELP
2
Expand Chapter 10 Troubleshooting.
3
Read the Overview, General Troubleshooting.
4
Review all the following: Daily Checks, Monitoring the System,
CBC Panel, STM Panel, and Review Hardware Information.
5
Under Individual Troubleshooting Procedures, perform the
following:
 Clean the Aspiration Probe
 Cycle the BSV (Menu > Diagnostics > DxH Tools > CBC
Tab > Mechanical > Cycle BSV)
 Zap Apertures Procedure.
 Clear RBC Apertures.
 Clear WBC Apertures.
 Clean (Bleach) Apertures.
“For our classroom purposes, ask the facilitator for the
fake “bleach”.
“MUST PERFORM SHUTDOWN & DAILY CHECKS”
 Rinse Mix Chambers (Menu > Diagnostics > DxH Tools >
VCSn Tab > Fluidic > Rinse Mix Chamber)
 Unlock the Distribution Valve. (DV)
 Clear Flow Cell Aperture.
 Flush Flow Cell. (Choose Both)
 Flush Flow Cell. (Choose with Cleaner)
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You reached the goal!
Please continue to the Skill Check on the next page.
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TROUBLESHOOTING 3
(USING DIAGNOSTICS) SKILL CHECK
Have facilitator verify all diagnostic procedures:
 Clean Aspiration Probe
 Cycle the BSV
 Zap Apertures Procedure
 Clear RBC Apertures
 Clear WBC Apertures
 Clean (Bleach) Apertures
 Rinse Mix Chambers
 Unlock the Distribution Valve (DV)
 Clear Flow Cell Aperture
 Flush Flow Cell
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COURSE MAP – ADDITIONAL TOPICS
Repeatability &
Carryover
Operators & Roles
Additional QC
Review
Additional QC
Setup
Introduction
to
Truth Tables
XB Analysis
Mentor / Trainer
These modules are elective. You may perform them in any order desired. If a topic
is not applicable to your lab situation, you do not need to do it at all.
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OPERATORS AND ROLES
OBJECTIVES
Given an operating DxH 600/800 System and access to System HELP
 Create new operator logins for a Level I, Level II and Level III access
 Edit an existing operator account
 Reset an operator password
 Change your own password
 Set a Password Expiration and enable Auto–Lockout (optional)
Why Is It Important?
As a DxH 600/800 System operator with Level III (highest customer)
privileges, you will help decide the levels of security access for those
working with you, based on their laboratory responsibilities.
Resources
DxH 600/800 System
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INFORMATION/PRACTICE
The Lab Administrator can assign operator roles and access level from the
Operators and Roles screen.
During the classroom exercises, you are at a Level III access. These next
steps will show you how to manage and create the other two customer
levels. Read Operators and Roles HELP topic in Chapter 9 for
reference.
Add a New Operator
In System HELP, go to Appendix B and expand Operator Access.
There are thirteen tables that list the various operator functions by Level I,
II and III.
Step
Action
Go to Menu > Setup > Operators and Roles > New Operator to
display the New Operator dialog box.
1
Enter the appropriate information in the text boxes.
2
Follow the steps shown and create a new Level III login for
yourself as well as a Level I and a Level II login. You may be
creative with your entries!
Note that the Level III access (aka Lab Administrator) is the only
one of the levels that can set up or edit other operator levels.
TIP
1
TIP
2
Ultimately, the Operator ID and Password will be the information
entered on the login screen.
Remember that BOTH are case-sensitive.
The initial password entered at this point is considered a
“temporary” password. Simply use the word temp for now. Write
down the information you enter for each level below:
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LI
First Name _____________
Last Name _____________
Operator ID ____________
Password __temp________
Confirm Password _temp__
L II
First Name _____________
Last Name _____________
Operator ID ____________
Password __temp________
Confirm Password _temp__
L III
First Name _____________
Last Name _____________
Operator ID ____________
Password __temp________
Confirm Password _temp__
The Account Status defaults to Active.
4
5
Select OK to create the new operator.
Log on at Your New Levels
Step
Action
1
At the Log on screen, type in your new Level I Operator ID and
the Password temp.
2
A message appears telling you that the password is a temporary
one and to enter a new password. Select OK.
3
Type in temp for the old password.
4
Type in the new password you want to use. You will need to do
this for Password and Confirm Password.
5
Record your password for Level I here ___________________
6
Explore the different screen areas noting the differences (for
example, the areas to which you no longer have access).
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7
Once you complete steps 1-6 above, select Log off
.
8
Now repeat steps 1-7 for the Level II log on.
9
Record your password for Level II here ___________________
10
Now repeat steps 1-7 for the Level III log on.
11
Record your password for Level III here ___________________
Edit an Existing Operator
You must be logged in at Level III access to perform this exercise. One
reason for needing to perform this editing is to change an existing
operator’s access, e.g. from Level I to Level II. Read Edit an Existing
Operator HELP topic in Chapter 9 for reference.
Step
Action
1
Log on as a Level III (Lab Administrator user).
2
Go to Menu > Setup > Operators and Roles > Edit Operator.
You may make changes to the First Name, Last Name, Access
Level, and Account Status.
3
4
5
Follow the steps and choose the Level II account you previously
set up.
Change it to Level I and make it Inactive.
Note that you may also edit the first and last name.
Select OK to save the changes.
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Reset an Operator’s Password
The Level III Operator may reset the password of another operator. This
may be necessary if operators forget their own password. Read Reset an
Operator’s Password HELP topic in Chapter 9 for reference.
Step
Action
1
Log on as a Level III (Lab Administrator).
2
Go to Menu > Setup > Operators and Roles > Reset
Password.
3
Select the Level I Operator ID you previously set up.
4
Type the operator’s New Password and type it again in the
Confirm Password text box.
Note: Passwords must be alphanumeric and 3-9 characters in
length.
5
Select OK to save the changes.
6
Log off and Log on to try it out.
Change Your Password
Any operator may change his or her own password at any time. Select the
Change Password button from the Operators and Roles screen.
Try this now and change back to your original password for Level I.
Set Timeout Settings
A Lab Administrator (Level III)
The Password Expiration defaults to 60 days. You may change this to 30
days or 90 days or Disable it.
The Auto-Lockout feature is initially disabled. You may enable it and set
the number of minutes between 5 and 60. This is the amount of time of
non-use that requires the user to log in again.
You reached the goal!
Please continue to the Skill Check on the next page.
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OPERATOR AND ROLES SKILL CHECK
1. Show facilitator the three access levels you created.
2. Demonstrate editing an account.
3. Demonstrate resetting a password.
4. Demonstrate changing your own password.
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REPEATABILITY AND CARRYOVER
OBJECTIVES
Given an operating DxH 600/800 System and access to System HELP
 Perform a Repeatability study, verify and print results
 Perform a Carryover study, verify and print results
Why Is It Important?
Regulatory agencies may require that repeatability and carryover studies
be performed periodically. These studies may also be used for
troubleshooting instrument problems.
Resources
DxH 600/800 System
System HELP
For Repeatability: 2 EDTA specimens from the same donor
For Carryover: 1 EDTA specimen and three empty EDTA tubes
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INFORMATION/PRACTICE
Note: Both the Repeatability and Carryover procedures may be a
requirement of regulatory agencies. These procedures may be used
at any time to verify the performance of CBC, Diff and Retic
parameters.
Repeatability
Step
Action
1
Open System HELP
2
Select Chapter 11 Quality Assurance. Expand Repeatability.
3
Select Repeatability (Menu > QA > Repeatability).
Note
4
5
.
You may perform Repeatability studies in either cassette
presentation or single-tube presentation.
Select Repeatability in Cassette Presentation
Read the information and then follow the steps to perform the
study using CBC test mode.
Obtain two EDTA specimens from the same donor.
6
Print the results of your Repeatability study.
Carryover
Carryover is the discrete amount of analyte carried by the measuring
system from one specimen reaction into subsequent specimen reactions,
thereby erroneously affecting the apparent amounts in subsequent
specimen. (NRSCL8 1998, Clinical Laboratory Standards Institute)
Carryover is expressed conventionally as a percentage of the
concentration of the analyte in the first specimen that is carried into the
subsequent specimen.
Step
Action
1
Open System HELP
2
Select Chapter 11 Quality Assurance.
3
Select Carryover (Menu > QA > Carryover).
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4
Note
5
Read the information and then follow the steps to perform the
Carryover procedure.
Obtain one EDTA specimen and three empty EDTA tubes. You
may obtain diluent from the instrument for each of the empty
tubes by using the single-tube presentation icon and selecting
the Dispense Diluent button.
Print the results of your Carryover study.
You reached the goal!
Please continue to the Skill Check on the next page.
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REPEATABILITY AND CARRYOVER SKILL CHECK
1. Show facilitator the printout from the Repeatability study.
2. Show facilitator the printout from the Carryover study.
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ADDITIONAL QC SETUP
OBJECTIVES
Using the System HELP:
 Demonstrate how to set up and use lab limits
 Demonstrate how to set up a Patient Control
Why Is It Important?
Using lab limits allows your lab to more closely monitor control results and
take quick action to correct out-of-limits situations.
As part of a lab’s Quality Assurance program, a patient control may be
used in addition to a commercial control.
Resources
DxH 600/800 System
System HELP
A set of lab limits for COULTER® 6C Cell Control
An EDTA specimen
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INFORMATION/PRACTICE
Lab Limits
Step
Action
1
Open System HELP
2
Select Chapter 9 Setup.
3
Expand Quality Control (Menu > Setup > Quality Control).
4
Expand Commercial Controls.
5
Select Lab Limits.
6
Read information and then go to the Lab Limits screen.
7
Select BCI, Retic-X, Level II. Enter the following limit:
Retic % 0.9
Note
This limit is used for classroom purposes only. You will establish
your own limits for your lab.
8
Now go to the setup control tab, highlight Retic-X, Level II and
select the Edit Control button.
a. Select the Lab Limits as your Expected Limit or 2 SD
Values. (You may always Restore Original Values (Mfg.
Ranges) if you need to do so.
OR
b. Select either Use Mean as Assigned Target (the running
mean) or Restore Assigned Target Values.
9
Select OK.
10
Select Save Changes.
11
Open your Retic-X, Level II, file data. You should see the lab
limit now applied to your data, as long as there are at least five
runs in the file.
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Set Up a Patient Control File
Step
Action
Create lab limits for Patient, CBC, Normal and enter the
following:
1
WBC
0.5
MCH
1.2
PLT
25
RBC
0.15
MCHC
1.7
MPV
2.0
HGB
0.6
RDW
1.5
HCT
2.5
RDW-SD
3.5
MCV
3.0
2
Open System Help
3
Select Chapter 9 Setup.
4
Expand Quality Control.
5
Expand Commercial Controls.
6
Select New Patient Control.
7
Read information and then perform the steps required to create
a Patient Control. Be sure to enable the lab limits you just
created.
a. You may enter the Specimen ID for the patient you want to
use and have the system populate the fields (the easy method
– however, there should only be one set of results, no reruns),
OR
b. Type in the assigned values and the range.
For Classroom purposes, disable the Decision Rules.
8
9
Run the specimen. The results will appear in the control file. A
patient control requires only one run to be able to activate it.
Now go back to the control setup screen and select the Mean as
Assigned Target.
You reached the goal!
Please continue to the Skill Check on the next page.
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ADDITIONAL QC SETUP SKILL CHECK
1. Show the facilitator the Lab Limits applied to the control run.
2. Show the facilitator the Patient Control file with at least one run in it.
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ADDITIONAL QC REVIEW
OBJECTIVES
Given an operating DxH 600/800 System and using the System HELP
 Delete data from control files/delete control files
 Download control data for IQAP
 Export data from control files for electronic storage
Why Is It Important?
An understanding of the levels of deletion of control material allows you to
remove unwanted or old data.
Using the IQAP program gives your lab a means of peer review with other
users of DxH Systems and BCI controls.
Using the export feature to electronically archive control data is a
convenient means to use for long-term storage of data.
PROService was developed and customized specifically for Beckman
Coulter laboratory systems. Beckman Coulter uses the same standards of
development, maintenance and support practices that are used for
medical devices. In addition, we use robust, industry-leading development
practices to ensure that we deliver high-quality software.
Resources
DxH 600/800 System
System HELP
CD-R or flash drive
Web version of IQAP manual
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INFORMATION/PRACTICE
Delete Control Data
Delete Runs From a File
Step
Action
1
Open System Help
2
Select Chapter 4 Quality Control.
3
Expand Viewing Control File Graphics.
4
Select Delete Control File Records.
5
Read the information in this section.
6
Go to any of your control data files and select the Delete button.
Be sure you understand the differences between the three
choices given.
 Selected Run - to delete the selected run only.
7
 All Runs in Current Filter - to delete all the runs in the
current filtered view.
 All Runs in Current Control File - to delete all runs in the
current control file, regardless of the filter applied to the view,
if any.
Delete the Entire File
Step
Action
1
When you no longer need the control data information, you may
delete the entire file.
Note
Please do not delete any of the BCI Control files that are set up
in the classroom. The following two steps are for observation
only.
2
From the Control Setup Screen, highlight a control level and
then locate the Delete button. You may select more then one
control file to delete. Do not click on the button.
3
If selected, the entire file(s) would disappear. There is no way to
reverse this action.
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Export IQAP Data
When you are ready to submit your control data to IQAP:
Step
1
Action
Review your control files to be sure the runs you want to submit
are included in the statistics.
2
From the Control Setup Screen, highlight a control level or levels
and under more options, select the IQAP Export button.
3
Under Control Data to Export, choose Selected DxH Control
Lot(s).
4
Under Data Export Grouping, choose Use Multiple Shifts.
5
Under Destination, there are three choices to continue:
a. Transfer to BCI – this would be directly through the
PROService connection.
b. CD Recorder (G:\) - This process may take several minutes.
Then, use the CD to upload your data to the eIQAP website.
c. Local drive (E:\) – .This process copies the files to the E drive.
You could then open Windows Explorer and drag and drop to
a USB flash drive. (Use File, Eject before removing the flash
drive). Then, use the flash drive to upload your data to the
eIQAP website.
eIQAP Submission
 Electronic uploading of your control data files via the internet is done
using eIQAP.
 You must have an IQAP account set up first. Then you will be asked
if you want to use eIQAP. If you do, you will be given a code and
instructions to set up your internet account.
 Once you have the data from the previous exercise, you will log in to
the internet site for eIQAP. Follow screen instructions to upload your
data.
 The advantage to the internet upload is that you will have access to
the pool data in as little as 24 hours. You will access and print your
own reports via a .pdf format. The internet site provides access to
the download for Adobe® Acrobat® Reader™ if you do not have it
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 There are separate Administrator and User functions within your
account. Once you enroll all eligible hematology instruments in your
laboratory, you access your data through your eIQAP account.
Export Controls
Step
Action
Note
Before using this method, check with your regulatory
requirements to verify that this is an acceptable way to store and
retrieve data.
1
From the Control Data screen, choose More Options, then
Export.
Under Format, you will see 2 Types:
2

.csv – this data can be accessed via a spreadsheet
program such as Microsoft® Excel.

INF/DAT - , this is a raw data file format that you might
send to BCI for troubleshooting purposes.
For classroom practice, choose the .csv type.
Under Data Selection, you have 3 options:
3

Select Run

All Runs in Current Filter

All Runs in Current Control Filter
For classroom practice, select one of the options.
4
Under Destination, choose CD Recorder or Local Drive to save
the data.
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PROService
PROService is a dedicated remote management and diagnostics system,
customized for Beckman Coulter instruments, that allows transfer and
analysis of instrument performance data from your instruments to
Beckman Coulter.
PROService offers a diverse suite of features and tools that can help
streamline the diagnosis, troubleshooting and resolution of instrument
issues, and proactively report potential pending instrument issues.
Benefits of PROService:
 Secure Remote Management and Diagnostic System.
 Communication is coordinated by the PROService Remote
Application Processor(RAP) box.
 Information is continuously sent through the RAP box and your
firewall to Beckman Coulter’s PROService servers via a secure
messaging protocol.
 Enables our Service and Support teams to review, diagnose and
help you resolve system issues quickly and efficiently, often without
the need for a Service visit.
 In some cases, potential future instrument issues can be identified by
PROService Triggers so they can be addressed before impacting
your lab’s efficiency.
 If a Service visit is required, the issue can be diagnosed and parts
can be prepared ahead of time to streamline the repair process and
minimize interruptions to your workflow.
You reached the goal!
Please continue to the Skill Check on the next page.
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ADDITIONAL QC REVIEW SKILL CHECK
1. Delete a control run chosen by your facilitator.
2. Show facilitator the control data exported using the spreadsheet
program provided.
3. List 3 benefits of having PROService in your lab?
_____________________________________________________
_____________________________________________________
_____________________________________________________
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XB ANALYSIS
OBJECTIVES
Given an operating DxH 600/800 System and using the System HELP:
 Demonstrate how to set up XB target values and limits
 Review XB data in your System
 Give at least three examples of results that would be excluded from an
XB batch
Why Is It Important?
XB Analysis is a cost-free quality control method that monitors instrument
performance by tracking the MCV, MCH, and MCHC parameters of all
patient samples. It is a very sensitive indicator of instrument problems.
Resources
DxH 600/800 System
System HELP
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INFORMATION/PRACTICE
What is XB Analysis?
"Weighted Moving Average" of patient sample results
 Originally created by Dr. Brian S. Bull
 Uses RBC indices (MCV, MCH, MCHC)
 Small batches of samples (20 samples)
 Compares batch results to lab "target values" automatically
 Batch results are “in control” if batch mean is within 3% of the
target value
 An on going method of monitoring automated hematology
instruments
 No additional cost (uses patient sample results)
Why Use The RBC Indices?
 MCV, MCH and MCHC are fairly stable parameters
 Stable for individual patient from day to day
 Stable for "patient population" over time
 "Target values" or mean vales can be established for your patient
population
What Is A Target Value?
 An average value, for each parameter, calculated from large
numbers of patient results
 Target values should reflect the entire patient population of the
laboratory
 Include all ages and disease states
Dr. Bull's Target Values
MCV = 89.0
MCH = 30.5
MCHC = 34.0
 Suggested starting values to use until laboratory values are
established
 Based on general population across the nation
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What Does an "Out of Control" Batch Indicate?
"Out of Control" batches may indicate:
 An instrument problem
 A reagent problem
 A sample handling problem
 A calibration problem
 A change in the patient population
Establishing Laboratory "Target Values"
Ensure the following:
 Instrument is clean
 Instrument is calibrated
 There are no instrument problems
 Sufficient data collected
How Do You Get Started?
Start with Dr. Bull's default values already in the System
 Enable XB on the XB setup screen
 Run samples to collect batches of patient samples
 Save printouts
 Collect data to reflect entire patient population (all ages and
disease states)
 Results from at least 250, but ideally 1000 blood samples should
be collected to find your laboratory's target values
 Include all types of patients (oncology, presurgical, OB, dialysis,
outpatients and so forth)
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After Data is Collected
Collect printouts of XB batches
 Calculate the mean and %CV for each of the XB parameters
 Verify the lab's means do not exceed Bull's target values by more
than 3%
 Verify the %CV is less than 1.5%
 Use the calculated means as the new target values
 Enter the new values in the XB setup screen
Non-Random Sampling
 Batch may go outside the ±3% limits, because the batch is biased
 Each subsequent batch should move closer to the target and be
back "in control" within 3 to 4 batches
 Make a note that the "batch was out due to non-random sampling"
by adding a comment in the Batch Mean Table.
Batch Results Go "Out" and Stay Out
There is a change in the patient population
 One or more new type of patient is added to the patient population
 One or more types of patient is no longer a part of the patient
population
 Seasonal changes of the patient population (hospitals or clinics
in resort areas)
Instrument problem
 Can be a gradual change that may indicate a part going bad over
time or a calibration drift
 Will go back "in control" after calibration
 Will go back "in control" after part is replaced
 Can be a sudden change that indicates an instrument problem
 Will go back "in control" after problem is fixed
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Troubleshooting When a Batch is "Out"
Know which parameter is out
 Look at the batch results
 "Out" parameters are flagged with H or L
Know where the parameter comes from
 MCV:
 MCH:
Derived from the RBC Histogram
Hgb x 10
RBC
Hgb x 100
Hct
 MCHC
where the Hct = RBC x MCV
10
 As you can see, two of the XB parameters are calculated using
other RBC results
 Troubleshoot those things that can affect the parameters used in
the calculations
What to Look for When XB Parameters are "Out"
MCV
LOW
MCV
HIGH
MCH
LOW
MCH
HIGH
MCHC
LOW
MCHC
HIGH
MCV
dec
inc
---
---
inc
dec
RBC
---
---
inc
dec
inc
dec
Hgb
---
---
dec
inc
dec
inc
Hct
dec
inc
---
---
inc
dec
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Practice
Step
Action
1
Open Help.
2
Select Chapter 9 Setup.
3
Expand Quality Control (Menu > Setup > Quality Control).
4
Select Enable/Disable XB (Menu > Setup > Quality Control > XB).
5
Read the sections on XB.
6
Review the screens associated with XB setup.
7
Review the screens associated with XB review by selecting
Status Icon
8
Be able to find the Current Batch, Previous Batches and the
Batch Means Tables and Levy-Jennngs graphs.
You reached the goal!
Please continue to the Skill Check on the next page.
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XB ANALYSIS SKILL CHECK
1. Show facilitator the XB setup screen.
2. Show facilitator the XB review screen.
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INTRODUCTION TO TRUTH TABLES
OBJECTIVES
Given the sample data and information in this module
 Determine whether a specimen is clinically normal or abnormal (in your
laboratory)
 Define review limits and review protocols (in your laboratory)
 Know criteria to follow for data collection
 Know how to interpret the Rumke Binomial Distribution Table
 Calculate the statistics necessary to determine acceptable
performance
 Perform Truth Table Analysis
 Define the four categories on a Truth Table
Why Is It Important?
A Truth Table is an effective way to evaluate an instrument’s clinical
sensitivity. Using Truth Table analysis determines the sensitivity,
specificity and efficiency of the automated differential in distinguishing
normal and abnormal specimens.
Resources
CLSI Reference Leukocyte (WBC) Differential Count (Proportional) and
Evaluation of Instrumental Methods
CLSI Method Comparison and Bias Estimation Using Patient Samples
Hand-held calculator
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INFORMATION/PRACTICE
Note: If you wish, you may work with 1-4 other colleagues on this module as a group.
However, all calculations should be your own.
Introduction
One of the most important tasks to accomplish during the Implementation
of any automated differential analyzer is to establish/verify an effective
flagging protocol. The purpose of the flagging protocol is to identify those
samples, which require a slide review so that significant morphology detail
can be added to the automated report. The extent to which an analyzer
can effectively screen "normal" vs "abnormal" is defined as the
instrument's clinical sensitivity. The Truth Table is an effective tool for
evaluation of the instruments's clinical sensitivity.
The first step in establishing an effective flagging protocol is to clearly
define those findings that are considered clinically significant. A significant
finding would be considered some detail that could add value to the report
and ultimately affect/improve patient care.
The next step is to identify ways to flag for these findings. Some flags and
codes are already built into the analyzer and are generated when the
analyzer detects an unusual or unexpected distribution of particles.
Additional flags can be set up by the operator to reflect the laboratory's
review requirements and to support the screening process.
Specimens determined to be abnormal by the automated system should
be evaluated according to the laboratory’s protocols. Specimens
determined to be normal by the automated system could be released
without further review (auto validation). The evaluation of the instrument's
clinical sensitivity is critical because over-flagging may lead to
unnecessary differential review, while under-flagging may miss abnormal
samples.
The manual differential is used as a reference method to assess whether
the instrument's flagging is appropriate. The lab determines the flagging
limits which separate normal results from abnormal results, classifying
each sample as a True Negative, True Positive, False Negative or False
Positive. Reviewing and possibly adjusting the operator definable flags
may further improve the efficiency of the automated differential system.
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IMPORTANT NOTE
Beckman Coulter, Inc. does not claim to identify every abnormality in all
samples. Beckman Coulter, Inc. suggests using all available flagging
options to optimize the sensitivity of instrument results based on your
patient population. All flagging options include reference ranges (H/L),
action and critical limits, definitive flags, suspect flags, parameter codes,
delta checks, decision rules and system alarms. Beckman Coulter, Inc.
recommends avoiding the use of single messages or outputs to
summarize specimen results or patient conditions
All Truth Tables and associated recommendations reflect the extent to
which your workflow may be managed efficiently but are limited to the
sample data submitted for evaluation. Accepting any of the suggested
recommended changes to the current review criteria would require
appropriate changes to action limits and/or lab protocol that were in place
at the time of this evaluation. Finally, all observations are
recommendations and subject to your review and discretion in the
formation of your Laboratory’s review and flagging protocols."
AUTOMATED VS MANUAL DIFF DATA COLLECTION
When comparing the automated differential to the manual differential,
ensure that the inherent variations of slide preparation are minimized by:
 Making quality smears.
 Staining with quality stain.
 Using optically clean microscopes.
 Having qualified technologists review the smear(s).
Specimens are identified by lab number on both printouts and microscopic
slides for future reference.
CLSI H20 recommends that two technologists each perform a 200 cell
manual differential on two different slides (total of 400 cells analyzed).
More cells counted results in a more precise and accurate reference
against which to judge the accuracy of the automated method. Automated
differential systems analyze thousands of cells. The following Rumke
Binomial Distribution Table4, published by C.L. Rumke in 1978, illustrates
that the statistical uncertainty of reference values is a direct function of the
number of cells counted. The imprecision of the manual differential is
especially pronounced with low numbers (e.g., monocyte, eosinophil and
basophil percent).
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TRUTH TABLE DATA COLLECTION
 The ideal truth table would include a minimum of 100 samples with 50%
having an abnormal slide review. Specimens should be collected into K2
or K3 EDTA. For optimum performance, all specimens should be
analyzed within time limits recommended by the manufacturer(s). Analyze
the same specimen within 2 hour on all instruments for accurate
comparison. Refer to CLSI Standard for Reference Leukocyte (WBC)
Differential Count (Proportional) and Evaluation of Instrumental Methods;
H20 or current revision.
 In addition, a complete manual differential should be performed. A
complete manual differential includes WBC differential, RBC and Plt
morphology and WBC and Plt estimate. Results of other test procedures,
i.e. manual Plt count, should be also noted.
 Poor statistics could be obtained because of the imprecision of the manual
differential. This will be especially pronounced in cell populations with
lower numbers.
 The statistical error of the manual differential can be reduced by
performing several 200-cell differentials. Differential counts by several
technologists are preferred. The CLSI protocol (H20) recommends two (2)
technologists each doing a 200-cell differential for each sample. If you
choose to have multiple technologists perform manual differentials,
average them and submit the average differential counts.
 Ensure a random sampling of the population. Specimens analyzed should
therefore represent your a general hospital population. Results should
span as much of the clinical range of the instrument as possible. Check
your instrument specifications.
 Random sampling should include:
 specimens with normal values.
 abnormal specimens representing various types of leukocyte
(WBC) disorders including but not limited to:
leukemias lymphocytosis lymphopenia
granulopenia granulocytosis
eosinophilia basophilia
 abnormal specimens representing various types of erythrocyte
(RBC) disorders including but not limited to:
hemoglobinopathy
polycythemia
microcytic anemias macrocytic anemias
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 abnormal specimens representing various types of platelet (Plt)
disorders, including but not limited to:
thrombocytosis thrombocytopenia
morphological platelet disorders
 If vote-outs, incomplete computation, partial aspirations or results with
System Messages are observed for any specimen, repeat the analysis of
that specimen on the evaluation instrument. Submit both the original and
repeated values.
 Printed results for all specimens analyzed on all instruments should be
obtained and labeled appropriately. For each specimen, collect the
following data:
 Printout from the Evaluation instrument(s)
 Printout from the reference instrument
 Manual differential results, note the total number of cells
counted
 Any confirmatory results
 If instrument has archive feature, archive specimen results to
appropriate external media, such as a floppy disk a CD, 3.5 inch
diskette or a flash drive and include with the printed result
Define Review Limits and Review Protocol
To establish review limits and a review protocol for your laboratory patient
population and specific needs:
Step
Action
1
Define and record a Test instrument review protocol on the Differential
Review Limit and Protocol Worksheet provided.
a. Record the instrument-generated flags that require further action.
b. Record the low and high results for each parameter that require
further action. Use the Definitive and/or Action limits defined in the
System Manager.
2
Define and record Reference manual differential abnormal limits for
each cell type listed on the differential Review Limit and Protocol
Worksheet provided.
Be specific, e.g. if 10 % is your limit for Eosinophils, then 9 % is
normal or negative and 11 % is abnormal or positive. Depending upon
your protocol, results falling outside these abnormal limits require
either a smear scan or a full manual differential.
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EXAMPLE ONLY – DO NOT FILL IN NOW
DIFFERENTIAL REVIEW LIMIT AND PROTOCOL WORKSHEET
1. Define Test Instrument Review Protocol (Abnormal Limits)
a. All instrument generated flags will be used. List exceptions below.
___________________________________________________________
___________________________________________________________
___________________________________________________________
b. Operator Defined Flags
Instrument
Review Limits
Low
High
WBC
RBC
Hgb
HCT
MCV
MCH
MCHC
RDW CV
RDW SD
Plt
MPV
Ne %
Ly %
Mo %
Eo %
Ba %
NRBC %
Ne #
Ly #
Mo #
Eo #
Ba #
NRBC #
2. Define Reference Manual Differential Abnormal Limits
Segmented Neutrophils
Band Neutrophils
Lymphocytes
Variant Lymphocytes
Monocytes
Eosinophils
Basophils
Other (specify)________
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Metamyelocytes
Myelocytes
Promyelocytes
Blasts
NRBCs
Other (specify)________
Other (specify)________
Other (specify)________
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How to Establish a Truth Table
The automated differential’s sensitivity, specificity and efficiency in
distinguishing normal and abnormal specimens are determined using
Truth Table analysis. The manual differential is used as a reference to
assess whether the instrument has correctly classified the specimen as
normal (released without further review-auto validation) or abnormal
(requiring review).
To perform a Truth Table Analysis:
Step
1
Action
For each specimen analyzed on the Beckman Coulter Analyzer:
a. Classify the instrument results as Normal (“negative”) if no
flags or messages are present.
b. Classify the instrument results as Abnormal (“positive”) if
flags or messages are present.
2
Perform a manual differential on all samples evaluated in Step 1.
a. Classify as Abnormal (“positive”) any morphological or
distributional abnormality observed.
b. Classify as Normal (“negative”) any manual differential
count in which all cell types are normal and within your
established limits.
3
Categorize each specimen as one of the following four categories
and record the results on the differential Truth Table Worksheet:
 True Negative (TN): Normal (negative) by both test (new
instrument) and reference (manual diff) methods.
 True Positive (TP): Abnormal (positive) by both test (new
instrument) and reference (manual diff) methods.
 False Negative (FN): Normal (negative) by test method (new
instrument) and abnormal (positive) by reference (manual
diff) method.
 False Positive (FP): Abnormal (positive) by test method (new
instrument) and normal (negative) by reference method
(manual diff).
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4
Calculate and record on the Differential Truth Table Worksheet
the following:
a. True Negative: the percentage of specimens considered
normal (negative) by both the test method (new instrument)
and the reference method (manual diff).
% TN = (# True Negatives / total number of specimens) x 100
b. True Positive: the percentage of specimens considered
abnormal (positive) by both the test method (new
instrument) and the reference method (manual diff).
% TP = (# True Positives / total number of specimens) x 100
c. False Negative: the percentage of specimens considered
normal by the test method (new instrument) and abnormal
by the reference method (manual diff).
Galen/Gambino
% FN = (# False Negatives / total number of specimens) x 100
CLSI
% FN = (#True Negative / (True Positive + False Negative)) x 100
d. False Positive: the percentage of specimens considered
abnormal by the test method (new instrument) and normal
by the reference method (manual diff).
Galen/Gambino
% FP = (# False Positives / total number of specimens) x 100
CLSI
% FP = (# False Positives / total number of specimens) x 100
e. Specificity: the percentage of manual differential normals
that were also normal on the instrument.
Specificity = #True Negatives  #(True Negative+False Positives) x 100
f. Sensitivity: the percentage of manual differential
abnormals that were also abnormal on the instrument.
Sensitivity = #True Positives  #(True Positives+False Negatives) x 100
g. Predictive Value of a Negative Test (PVN): the
percentage of specimens that were normal on both the
instrument and the manual differential.
PVN = # True Negatives  # (True Negatives + False Negatives) x 100
h. Predictive Value of a Positive Test (PVP): the percentage
of specimens that were abnormal on both the instrument
and the manual differential.
PVP = # True Positives  # (True Positives + False Positives) x 100
i. Agreement: the percentage of specimens correctly
categorized by the automated differential.
#(True Positives +True Negatives)  total number of specimens x 100
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IMPORTANT
The Truth Table format can be used for a variety of purposes. It is important to
understand that the statistics reflect the patient mix that is used during the study.
The focus of an Implementation Truth Table is to optimize Sensitivity. Focus on
the False Negative Samples. Evaluate if there is a particular flag that could be
added or modified so that these same samples would be flagged. Determine what
is an acceptable balance between False Negative (missed significant findings) and
False Positive samples (increased review rate). The responsibility to determine
acceptable performance of data lies with the evaluating laboratory.
EXAMPLE ONLY – DO NOT FILL IN NOW
DIFFERENTIAL TRUTH TABLE WORKSHEET
1. Classify differentials into one of four categories and total each column.
Reference (Manual Differential)
Test
(New Instrument)
Normal
(Negative)
Abnormal
(Positive)
Total
Normal
(Negative)
(TN)
Abnormal
(Positive)
(FP)
(FN)
(TP)
Total
2. Calculate the following parameters.
PARAMETER
CALCULATION
% TN
Number of TN/Total
% TP
Number of TP/Total
% FN
Number of FN/Total
% FP
Number of FP/Total
Specificity
[# TN/ # (TN + FP)] x 100
Sensitivity
[# TP/ # (TP + FN)] x 100
Predictive Value of a Negative
Test
Predictive Value of Positive Test
[# TN/ # (TN + FN)] x 100
[# TP/ # (TP + FP)] x 100
Agreement
[(# TP + # TN)/Total] x 100
RESULT (%)
3. Reviewed by ___________________________________ Date ____________
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Practice
Note: This practice may not be exactly the way you would perform in your
own lab. Many times a first pass using instrument generated flags only is
evaluated first. The data is reevaluated adding in laboratory-defined limits.
Step
1
Action
There are 11 examples of DxH 600/800 results on pages 184
through 194. The laboratory doing this Truth Table Study, uses
the following Review Criteria:
 Any parameter or instrument generated flag is a
positive. (i.e., suspect, definitive, action, critical, high, low,
etc).
2
3
 The example manual differential criteria are from this “lab”
are: (an abnormal condition exists if any of the values below
are found to be present)
Atypical Lymph: > 6
NRBC: > 2
Bands:  12
Meta:  1
Myelo:  1
Blast:  1
Work through the data in the eleven examples keeping this
Lab’s Criteria in mind. Decide whether each is a True Positive,
True Negative, False Positive, False Negative (using the
definitions on page AT-41). Be prepared to discuss the reasons
for your choices.
You have the right to exclude from the study any data that
you think might misrepresent or skew the conclusions.
Collate your decisions and enter the totals for each category on
the worksheet below.
DIFFERENTIAL TRUTH TABLE WORKSHEET
Reference (Manual Differential)
Test
(New
Instrument)
Normal (Negative)
Abnormal (Positive)
Normal
(Negative)
True Negative
False Positive
Abnormal
(Positive)
False Negative
True Positive
Total
Total
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Check your answers using the answer key on page 197.
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Using the data from the Truth Table Worksheet, calculate the following
parameters.
PARAMETER
CALCULATION
% TN
Number of TN/Total
% TP
Number of TP/Total
% FN
Number of FN/Total
% FP
Number of FP/Total
Specificity
[# TN / # (TN + FP)] x 100
Sensitivity
[# TP / # (TP + FN)] x 100
Predictive Value
of a Negative Test
[# TN / # (TN + FN)] x 100
Predictive Value
of a Positive Test
[# TP / # (TP + FP)] x 100
Agreement
[(# TP + # TN) / Total] x 100
RESULT (%)
Show these calculations to the facilitator as part of the Skill Check.
Thought Questions
1
If your flagging limits are set correctly, which two categories on
the Truth Table should contain most of your samples?
____________________________________________________
2
If a laboratory’s False Positive rate is around 40%, what
corrective action do you think the laboratory should take?
____________________________________________________
3
If a laboratory’s False Negative is around 35%, what corrective
action do you think the laboratory should take?
____________________________________________________
4
If agreement is around 40%, what does this mean to the
laboratory?
____________________________________________________
The above questions will be part of a discussion with the facilitator.
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You reached the goal!
Please continue to the Skill Check. Refer to the Rumke chart on the next
page to answer one of the questions.
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Rumke Binomial Distribution Table
95 % Confidence Limits for various percentages of blood cells of a given
type as determined by differential counts.
a
n = 100
n = 200
n = 500
n = 1000
0
0-2
0-2
0-1
0-1
1
0-6
0-4
0-3
0-2
2
0-8
0-6
0-4
1-4
3
0-9
1-7
1-5
2-5
4
1 - 10
1-8
2-7
2-6
5
1 - 12
2 - 10
3-8
3-7
6
2 - 13
3 - 11
4-9
4-8
7
2 - 14
3 - 12
4 - 10
5-9
8
3 - 16
4 - 13
5 - 11
6 - 10
9
4 - 17
5 - 14
6 - 12
7 - 11
10
4 - 18
6 - 16
7 - 13
8 - 13
15
8 - 24
10 - 21
11 - 19
12 - 18
20
12 - 30
14 - 27
16 - 24
17 - 23
25
16 - 35
19 - 32
21 - 30
22 - 28
30
21 - 40
23 - 37
26 - 35
27 - 33
35
25 - 46
28 - 43
30 - 40
32 - 39
40
30 - 51
33 - 48
35 - 45
36 - 44
45
35 - 56
37 - 53
40 - 50
41 - 49
50
39 - 61
42 - 58
45 - 55
60
49 - 70
52 - 67
55 - 65
46 - 54
56 - 64
70
60 - 79
63 - 77
65 - 74
67 - 73
75
65 - 84
68 - 81
70 - 79
72 - 78
80
70 - 88
73 - 86
76 - 84
77 - 83
90
82 - 96
84 - 94
87 - 93
87 - 92
100
96 - 100
98 - 100
99 - 100
99 - 100
a the observed percentage of cells of a given type
n the total number of cells counted
Rumke, CL. The statistically expected variability in differential leukocyte counting. College of American Pathologists CAP
Conference, Aspen, CO, 1977; 39-45
UniCel DxH Series 600/800 Training Guide
Ver 1.3 (January 2017)
Page 185 of 206
Beckman Coulter
Technical Training
TRUTH TABLE EXAMPLE # 001
DxH 600/800 Results:
Test
WBC:
NE%:
LY%:
MO%:
EO%:
BA%:
NRBC%:
NE#:
LY#:
MO#:
EO#:
BA#:
NRBC#:
Result Flag
23.0
87.3
5.4
6.4
0.8
0.1
0.02
20.0
1.2
1.5
0.2
0.0
0.0
aH
aH
Test
Result Flag
RBC:
HGB:
HCT:
MCV:
MCH:
MCHC:
RDW:
RDW-SD
RET%
RET#:
IRF:
MRV
2.56
8.0
22.6
88.1
31.3
35.5
15.8
42.9
1.92
.0064
0.33
100.7
Test
Result
PLT:
MPV:
854
7.3
Flag
aH
aH
DxH 600/800 Generated Messages:
Suspect/Definitive/System WBC: Suspect/Definitive/System RBC: Suspect/Definitive/System PLT:
NE Blast
1+ Anisocytosis
Thrombocytosis
Imm Grans & Left Shift
Leukocytosis
Neutrophilia
Comments / Decision Rule Generated:
[Perform a Manual diff] (due to the presence of NE Blast & LEFT SHIFT)
DxH 600/800 Outcome: (Place a ‘+’ or ‘-‘ in the boxes below.)
Any flag / message indicates an ‘instrument positive’ out-come.
WBC:
RBC:
PLT:
CBC ( + / - )
DIFF ( + / - )
Manual Differential
Neut
Lymph
Mono
Eos
Baso
NRBC
71
6
7
1
0
Atyp Lym
Bands
Meta
Myelo
ProMyelo
Blast
13
1
1
Morphology (RBC & PLT):
Slight Aniso
Increased Plts
Manual Differential Outcome: Circle below ( + / - ) with comments.
( + ):
( - ):
Truth Table
Reference:
Manual
Diff
NEG
POS
DxH 600/800 Result
NEG
POS
TN
FP
FN
TP
UniCel DxH Series 600/800 Training Guide
Ver 1.3 (January 2017)
COMMENTS:
Page 186 of 206
Beckman Coulter
Technical Training
TRUTH TABLE EXAMPLE # 002
DxH 600/800 Results:
Test
WBC:
NE%:
LY%:
MO%:
EO%:
BA%:
NRBC%:
NE#:
LY#:
MO#:
EO#:
BA#:
NRBC#:
Result Flag
12.8
76.6
12.9
8.5
1.7
0.3
0.0
9.8
1.7
1.1
0.2
0.0
0.0
Test
Result Flag
RBC:
HGB:
HCT:
MCV:
MCH:
MCHC:
RDW:
RDW-SD
RET%
RET#:
IRF:
MRV
Test
3.50
10.1
29.3
83.6
28.9
34.6
14.3
43.3
1.60
.0609
0.35
100.1
Result
PLT:
MPV:
Flag
490
7.5
DxH 600/800 Generated Messages:
Suspect/Definitive/System WBC: Suspect/Definitive/System RBC: Suspect/Definitive/System PLT:
Comments / Decision Rule Generated:
DxH 600/800 Outcome: (Place a ‘+’ or ‘-‘ in the boxes below.)
Any flag / message indicates an ‘instrument positive’ out-come.
WBC:
RBC:
PLT:
CBC ( + / - )
DIFF ( + / - )
Manual Differential
Neut
Lymph
Mono
Eos
Baso
NRBC
80
12
5
2
1
Atyp Lym
Bands
Meta
Myelo
ProMyelo
Blast
Morphology (RBC & PLT):
Manual Differential Outcome: Circle below ( + / - ) with comments.
( + ):
( - ):
Truth Table
Reference:
Manual
Diff
NEG
POS
DxH 600/800 Result
NEG
POS
TN
FP
FN
TP
UniCel DxH Series 600/800 Training Guide
Ver 1.3 (January 2017)
COMMENTS:
Page 187 of 206
Beckman Coulter
Technical Training
TRUTH TABLE EXAMPLE # 003
DxH 600/800 Results:
Test
WBC:
NE%:
LY%:
MO%:
EO%:
BA%:
NRBC%:
NE#:
LY#:
MO#:
EO#:
BA#:
NRBC#:
Result Flag
10.0
45.9
50.0
1.8
1.5
0.3
0.0
4.6
5.1
0.2
0.2
0.0
0.0
aH
aH
Test
Result Flag
RBC:
HGB:
HCT:
MCV:
MCH:
MCHC:
RDW:
RDW-SD
RET%
RET#:
IRF:
MRV
Test
3.17
10.1
30.1
91.6
31.9
34.8
12.9
42.4
1.71
.0696
0.54
105.2
Result
PLT:
MPV:
Flag
213
7.3
DxH 600/800 Generated Messages:
Suspect/Definitive/System WBC: Suspect/Definitive/System RBC: Suspect/Definitive/System PLT:
Variant LY
Comments / Decision Rule Generated:
[Perform a diff scan for variant forms]
DxH 600/800 Outcome: (Place a ‘+’ or ‘-‘ in the boxes below.)
Any flag / message indicates an ‘instrument positive’ out-come.
WBC:
RBC:
PLT:
CBC ( + / - )
DIFF ( + / - )
Manual Differential
Neut
Lymph
Mono
Eos
Baso
NRBC
Atyp Lym
Bands
Meta
Myelo
ProMyelo
Blast
17
73
5
1
0
0
4
Morphology (RBC & PLT):
Manual Differential Outcome: Circle below ( + / - ) with comments.
( + ):
( - ):
Truth Table
Reference:
Manual
Diff
NEG
POS
DxH 600/800 Result
NEG
POS
TN
FP
FN
TP
UniCel DxH Series 600/800 Training Guide
Ver 1.3 (January 2017)
COMMENTS:
Page 188 of 206
Beckman Coulter
Technical Training
TRUTH TABLE EXAMPLE # 004
DxH 600/800 Results:
Test
WBC:
NE%:
LY%:
MO%:
EO%:
BA%:
NRBC%:
NE#:
LY#:
MO#:
EO#:
BA#:
NRBC#:
Result Flag
11.3
76.6
15.1
6.4
1.5
0.3
0.09
8.7
1.7
0.7
0.2
0.0
0.01
Test
RBC:
HGB:
HCT:
MCV:
MCH:
MCHC:
RDW:
RDW-SD
RET%
RET#:
IRF:
MRV
Result Flag
3.48
10.9
32.0
92.0
31.3
34.0
14.1
47.3
0.47
.0123
0.52
114.3
Test
PLT:
MPV:
Result
223
8.6
Flag
DxH 600/800 Generated Messages:
Suspect/Definitive/System WBC: Suspect/Definitive/System RBC: Suspect/Definitive/System PLT:
Comments / Decision Rule Generated:
DxH 600/800 Outcome: (Place a ‘+’ or ‘-‘ in the boxes below.)
Any flag / message indicates an ‘instrument positive’ out-come.
WBC:
RBC:
PLT:
CBC ( + / - )
DIFF ( + / - )
Manual Differential
Neut
Lymph
Mono
Eos
Baso
NRBC
80
14
3
2
Atyp Lym
Bands
Meta
Myelo
ProMyelo
Blast
Morphology (RBC & PLT):
1
Manual Differential Outcome: Circle below ( + / - ) with comments.
( + ):
( - ):
Truth Table
Reference:
Manual
Diff
NEG
POS
DxH 600/800 Result
NEG
POS
TN
FP
FN
TP
UniCel DxH Series 600/800 Training Guide
Ver 1.3 (January 2017)
COMMENTS:
Page 189 of 206
Beckman Coulter
Technical Training
TRUTH TABLE EXAMPLE # 005
DxH 600/800 Results:
Test
WBC:
NE%:
LY%:
MO%:
EO%:
BA%:
NRBC%:
NE#:
LY#:
MO#:
EO#:
BA#:
NRBC#:
Result Flag
0.4
15.8
60.5
5.3
18.4
0.0
0.0
0.1
0.2
0.0
0.1
0.0
0.0
cL
R
RaH
R
R
R
R
R
R
R
R
R
R
Test
Result Flag
RBC:
HGB:
HCT:
MCV:
MCH:
MCHC:
RDW:
RDW-SD
RET%
RET#:
IRF:
MRV
2.99
9.3
26.2
87.3
31.0
35.5
16.3
45.1
3.38
.1058
0.42
105.4
Test
Result
PLT:
MPV:
4
6.0
Flag
cL
aH
DxH 600/800 Generated Messages:
Suspect/Definitive/System WBC: Suspect/Definitive/System RBC: Suspect/Definitive/System PLT:
Low Events:D
1+ Anisocytosis
Thrombocytopenia
Leukopenia
Lymphocytosis
Eosinophilia
Comments / Decision Rule Generated:
[Perform a manual diff] (due to the presence of the Low Events:D and ‘R’ flag on diff count)
DxH 600/800 Outcome: (Place a ‘+’ or ‘-‘ in the boxes below.)
Any flag / message indicates an ‘instrument positive’ out-come.
WBC:
RBC:
PLT:
CBC ( + / - )
DIFF ( + / - )
Manual Differential
Neut
Lymph
Mono
Eos
Baso
NRBC
Atyp Lym
Bands
Meta
Myelo
ProMyelo
Blast
10
60
10
20
10
Morphology (RBC & PLT):
NOTE: Only 10 cells were
counted on the manual diff.
Manual Differential Outcome: Circle below ( + / - ) with comments.
( + ):
( - ):
Truth Table
Reference:
Manual
Diff
NEG
POS
DxH 600/800 Result
NEG
POS
TN
FP
FN
TP
UniCel DxH Series 600/800 Training Guide
Ver 1.3 (January 2017)
COMMENTS:
Page 190 of 206
Beckman Coulter
Technical Training
TRUTH TABLE EXAMPLE # 006
DxH 600/800 Results:
Test
WBC:
NE%:
LY%:
MO%:
EO%:
BA%:
NRBC%:
NE#:
LY#:
MO#:
EO#:
BA#:
NRBC#:
Result Flag
9.3
66.5
24.1
6.8
2.5
0.1
2.3
6.2
2.2
0.6
0.2
0.0
0.2
Test
Result Flag
RBC:
HGB:
HCT:
MCV:
MCH:
MCHC:
RDW:
RDW-SD
RET%
RET#:
IRF:
MRV
Test
5.17
13.8
40.3
78.0
26.6
34.1
14.3
43.3
0.82
.0376
0.26
113.5
Result
PLT:
MPV:
Flag
257
9.2
DxH 600/800 Generated Messages:
Suspect/Definitive/System WBC: Suspect/Definitive/System RBC: Suspect/Definitive/System PLT:
Comments / Decision Rule Generated:
DxH 600/800 Outcome: (Place a ‘+’ or ‘-‘ in the boxes below.)
Any flag / message indicates an ‘instrument positive’ out-come.
WBC:
RBC:
PLT:
CBC ( + / - )
DIFF ( + / - )
Manual Differential
Neut
Lymph
Mono
Eos
Baso
NRBC
62
24
7
2
0
2
Atyp Lym
Bands
Meta
Myelo
ProMyelo
Blast
Morphology (RBC & PLT):
5
Slight Aniso
Manual Differential Outcome: Circle below ( + / - ) with comments.
( + ):
( - ):
Truth Table
Reference:
Manual
Diff
NEG
POS
DxH 600/800 Result
NEG
POS
TN
FP
FN
TP
UniCel DxH Series 600/800 Training Guide
Ver 1.3 (January 2017)
COMMENTS:
Page 191 of 206
Beckman Coulter
Technical Training
TRUTH TABLE EXAMPLE # 007
DxH 600/800 Results:
Test
WBC:
NE%:
LY%:
MO%:
EO%:
BA%:
NRBC%:
NE#:
LY#:
MO#:
EO#:
BA#:
NRBC#:
Result Flag
6.8
65.7
26.0
7.5
0.5
0.3
0.02
4.5
1.8
0.5
0.0
0.0
0.0
Test
Result Flag
RBC:
HGB:
HCT:
MCV:
MCH:
MCHC:
RDW:
RDW-SD
RET%
RET#:
IRF:
MRV
Test
4.06
12.1
35.4
87.1
29.9
34.3
13.6
42.9
1.11
.0449
0.35
112.9
Result
PLT:
MPV:
Flag
322
9.5
DxH 600/800 Generated Messages:
Suspect/Definitive/System WBC: Suspect/Definitive/System RBC: Suspect/Definitive/System PLT:
Comments / Decision Rule Generated:
DxH 600/800 Outcome: (Place a ‘+’ or ‘-‘ in the boxes below.)
Any flag / message indicates an ‘instrument positive’ out-come.
WBC:
RBC:
PLT:
CBC ( + / - )
DIFF ( + / - )
Manual Differential
Neut
Lymph
Mono
Eos
Baso
NRBC
65
21
7
3
1
Atyp Lym
Bands
Meta
Myelo
ProMyelo
Blast
3
Morphology (RBC & PLT):
Manual Differential Outcome: Circle below ( + / - ) with comments.
( + ):
( - ):
Truth Table
Reference:
Manual
Diff
NEG
POS
DxH 600/800 Result
NEG
POS
TN
FP
FN
TP
UniCel DxH Series 600/800 Training Guide
Ver 1.3 (January 2017)
COMMENTS:
Page 192 of 206
Beckman Coulter
Technical Training
TRUTH TABLE EXAMPLE # 008
DxH 600/800 Results:
Test
WBC:
NE%:
LY%:
MO%:
EO%:
BA%:
NRBC%:
NE#:
LY#:
MO#:
EO#:
BA#:
NRBC#:
Result Flag
6.7
75.0
13.3
6.7
4.9
0.1
0.02
5.0
0.9
0.4
0.3
0.0
0.0
Test
Result Flag
RBC:
HGB:
HCT:
MCV:
MCH:
MCHC:
RDW:
RDW-SD
RET%
RET#:
IRF:
MRV
Test
2.97
10.1
27.8
93.6
33.9
36.2
14.4
44.2
2.63
.0906
0.40
113.5
Result
PLT:
MPV:
Flag
129
11.0
DxH 600/800 Generated Messages:
Suspect/Definitive/System WBC: Suspect/Definitive/System RBC: Suspect/Definitive/System PLT:
Left Shift
Comments / Decision Rule Generated:
[Perform a diff scan] (Scan for the presence of Bands)
DxH 600/800 Outcome: (Place a ‘+’ or ‘-‘ in the boxes below.)
Any flag / message indicates an ‘instrument positive’ out-come.
WBC:
RBC:
PLT:
CBC ( + / - )
DIFF ( + / - )
Manual Differential
Neut
Lymph
Mono
Eos
Baso
NRBC
72
13
4
2
0
0
Atyp Lym
Bands
Meta
Myelo
ProMyelo
Blast
Morphology (RBC & PLT):
9
Manual Differential Outcome: Circle below ( + / - ) with comments.
( + ):
( - ):
Truth Table
Reference:
Manual
Diff
NEG
POS
DxH 600/800 Result
NEG
POS
TN
FP
FN
TP
UniCel DxH Series 600/800 Training Guide
Ver 1.3 (January 2017)
COMMENTS:
Page 193 of 206
Beckman Coulter
Technical Training
TRUTH TABLE EXAMPLE # 009
DxH 600/800 Results:
Test
WBC:
NE%:
LY%:
MO%:
EO%:
BA%:
NRBC%:
NE#:
LY#:
MO#:
EO#:
BA#:
NRBC#:
Result Flag
5.5
83.3
6.4
8.6
1.4
0.3
0.03
4.6
0.4
0.5
0.1
0.0
0.0
Test
Result Flag
RBC:
HGB:
HCT:
MCV:
MCH:
MCHC:
RDW:
RDW-SD
RET%
RET#:
IRF:
MRV
Test
2.73
8.3
24.1
88.2
30.4
34.4
14.8
44.2
1.98
.0754
.036
108.4
Result
PLT:
MPV:
Flag
300
6.8
DxH 600/800 Generated Messages:
Suspect/Definitive/System WBC: Suspect/Definitive/System RBC: Suspect/Definitive/System PLT:
Left Shift
Imm Grans
Comments / Decision Rule Generated:
[Perform a manual diff ] (review slide for immature cells)
DxH 600/800 Outcome: (Place a ‘+’ or ‘-‘ in the boxes below.)
Any flag / message indicates an ‘instrument positive’ out-come.
WBC:
RBC:
PLT:
CBC ( + / - )
DIFF ( + / - )
Manual Differential
Neut
Lymph
Mono
Eos
Baso
NRBC
76
4
9
Atyp Lym
Bands
Meta
Myelo
ProMyelo
Blast
Morphology (RBC & PLT):
15
Manual Differential Outcome: Circle below ( + / - ) with comments.
( + ):
( - ):
Truth Table
Reference:
Manual
Diff
NEG
POS
DxH 600/800 Result
NEG
POS
TN
FP
FN
TP
UniCel DxH Series 600/800 Training Guide
Ver 1.3 (January 2017)
COMMENTS:
Page 194 of 206
Beckman Coulter
Technical Training
TRUTH TABLE EXAMPLE # 010
DxH 600/800 Results:
Test
WBC:
NE%:
LY%:
MO%:
EO%:
BA%:
NRBC%:
NE#:
LY#:
MO#:
EO#:
BA#:
NRBC#:
Result Flag
5.9
40.3
48.7
6.2
4.1
0.7
0.0
2.4
2.9
0.4
0.2
0.0
0.0
aH
Test
Result Flag
RBC:
HGB:
HCT:
MCV:
MCH:
MCHC:
RDW:
RDW-SD
RET%
RET#:
IRF:
MRV
Test
4.60
12.8
37.4
81.3
27.9
34.3
12.6
43.8
1.16
.0533
0.25
105.1
Result
PLT:
MPV:
Flag
222
9.0
DxH 600/800 Generated Messages:
Suspect/Definitive/System WBC: Suspect/Definitive/System RBC: Suspect/Definitive/System PLT:
Variant LY
Comments / Decision Rule Generated:
[Perform a manual diff] (review slide for the presence of atypical cells)
DxH 600/800 Outcome: (Place a ‘+’ or ‘-‘ in the boxes below.)
Any flag / message indicates an ‘instrument positive’ out-come.
WBC:
RBC:
PLT:
CBC ( + / - )
DIFF ( + / - )
Manual Differential
Neut
Lymph
Mono
Eos
Baso
NRBC
46
37
3
4
1
0
Atyp Lym
Bands
Meta
Myelo
ProMyelo
Blast
9
Morphology (RBC & PLT):
Manual Differential Outcome: Circle below ( + / - ) with comments.
( + ):
( - ):
Truth Table
Reference:
Manual
Diff
NEG
POS
DxH 600/800 Result
NEG
POS
TN
FP
FN
TP
UniCel DxH Series 600/800 Training Guide
Ver 1.3 (January 2017)
COMMENTS:
Page 195 of 206
Beckman Coulter
Technical Training
TRUTH TABLE EXAMPLE # 011
DxH 600/800 Results:
Test
WBC:
NE%:
LY%:
MO%:
EO%:
BA%:
NRBC%:
NE#:
LY#:
MO#:
EO#:
BA#:
NRBC#:
Result Flag
14.4
79.1
14.7
5.8
0.2
0.2
0.0
11.4
2.1
0.8
0.0
0.0
0.0
Test
Result Flag
RBC:
HGB:
HCT:
MCV:
MCH:
MCHC:
RDW:
RDW-SD
RET%
RET#:
IRF:
MRV
Test
3.77
11.1
32.2
85.6
29.4
34.3
14.9
49.4
1.64
.0767
0.33
120.3
Result
PLT:
MPV:
Flag
190
7.8
DxH 600/800 Generated Messages:
Suspect/Definitive/System WBC: Suspect/Definitive/System RBC: Suspect/Definitive/System PLT:
Comments / Decision Rule Generated:
DxH 600/800 Outcome: (Place a ‘+’ or ‘-‘ in the boxes below.)
Any flag / message indicates an ‘instrument positive’ out-come.
WBC:
RBC:
PLT:
CBC ( + / - )
DIFF ( + / - )
Manual Differential
Neut
Lymph
Mono
Eos
Baso
NRBC
76
15
8
1
0
0
Atyp Lym
Bands
Meta
Myelo
ProMyelo
Blast
Morphology (RBC & PLT):
Manual Differential Outcome: Circle below ( + / - ) with comments.
( + ):
( - ):
Truth Table
Reference:
Manual
Diff
NEG
POS
DxH 600/800 Result
NEG
POS
TN
FP
FN
TP
UniCel DxH Series 600/800 Training Guide
Ver 1.3 (January 2017)
COMMENTS:
Page 196 of 206
Beckman Coulter
Technical Training
Answer Key for Examples
Category
Number in
Category
Example #
True Pos
3
1, 9, 10
True Neg
4
2, 6, 7, 11
False Pos
2
3, 8
False Neg
1
4
#5 was discarded due to low diff cells counted, but would be a FP.
If you used an n=10, then your calculations should be:
%TN
%TP
%FN
%FP
Pass Rate
Review Rate
Specificity
Sensitivity
Predictive Value of
Neg. Test
Predictive Value of
Pos. Test
Agreement
UniCel DxH Series 600/800 Training Guide
Ver 1.3 (January 2017)
4/10
3/10
1/10
2/10
40+10
30+20
4/(4+2)
3/(3+1)
40%
30%
10%
20%
50%
50%
66.6%
75%
4/(4+1)
80%
3/(3+2)
60%
(3+4)/10
70%
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INTRODUCTION TO TRUTH TABLES SKILL CHECK
Using the RUMKE BINOMIAL DISTRIBUTION TABLE as a reference:
1. If you count a 100-cell diff where the Monocyte % on a smear is found
to be 10%, according to Rumke the actual % could be between______
If you now count a 200-cell diff on the same smear, according to
Rumke, the actual % could be between ________________________
2. According to the CLSI EP standard, the minimum number of
specimens to analyze for method comparison is __________________
3. According to the CLSI standard, the minimum number of specimens to
perform manual diff for truth tables is _______________
4. Why should the collection time for specimens for comparative studies
span a period of several days?
________________________________________________________
5. Based on the DxH 600/800 Differential as the TEST and the Manual
Differential as the REFERENCE define each of the following terms:
 True Negative:
_____________________________________________________
 True Positive:
_____________________________________________________
 False Negative:
_____________________________________________________
 False Positive:
_____________________________________________________
6. Show your facilitator the Truth Table and calculations that you did in
the Practice portion of the module.
7. Discuss the “thought questions” from the Practice portion of the
module with your facilitator.
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MENTOR / TRAINER
OBJECTIVES
Given an operating DxH 600/800 System, training modules, and
appropriate supplies for administering modules:
 Format a training plan for your laboratory
 Verify skill performance for each trainee
 Have a course Facilitator and/or Applications Specialist verify your
performance as a mentor/trainer
Why Is It Important?
In order to have competent DxH 600/800 System operators in your
laboratory, it is important that they be grounded in the basics of instrument
operation. As the mentor/trainer for your laboratory, it is your responsibility
not only to train, but also to mentor your colleagues as they progress
through the skills required to become a competent, DxH System operator.
Resources
DxH 600/800 Training Modules with Skill Checks
Training Checklist
UniCel DxH Series 600/800 Training Guide
Ver 1.3 (January 2017)
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UniCel DxH Series 600/800 Training Guide
Ver 1.3 (January 2017)
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INFORMATION / PRACTICE SECTION
Hints Before You Start
Step
Action
1
Have a plan!
2
Let trainees know that you expect them to become competent
DxH System operators
3
Have supplies ready: copies of modules, Skill Checks, etc.
4
Provide practice, practice, and more practice for trainees!
5
Watch trainees, but let them do the “hands-on” stuff!
6
It’s OK for trainees to make a mistake! Don’t jump in too
quickly, unless there is a real danger involved!
7
Offer encouragement and positive reinforcement!
8
Have trainees tell you what they learned about the topics.
9
Training is an ongoing process, not a one-time event!
10
Encourage pride in a job well done.
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Create a Training Plan
Step
Action
1
Create a written training plan outline for your facility. Include
basic training topics (for all) as well as more advanced training
topics (selected individuals).
Note
Note
 Basic topics should include: Daily Checks, Running
Controls, Reviewing Controls, Running Patient Samples,
Reagent Setup and Replacement, Shutdown.
 You may also want to consider including Workstation
Basics and Using Help as part of basic topics. Any
other topics to include are up to you.
 More advanced topics for selected individuals are up to
you but you may want to consider: Setting up Control files,
History Logs, Calibration, etc.
2
List the topics you plan to cover in each section.
3
Describe how you will do the training for each topic. List the
resources you will need and the techniques (verbal, module,
practice, demo, summaries, etc.) you plan to use.
4
List the important points that need to be covered in each topic.
5
Describe how you will verify that a trainee learned the topics
listed (observation, skill check, etc.)
6
Describe the documentation you will use to show completed
training for an individual (checklist provided or your own sign
off sheet).
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Train a Person in the Basics
Step
1
Note
Action
Choose a person to train in all the basic topics listed.
You may or may not be able to complete this part of the
practice while at the Education Center. In that case, an
Applications Specialist will observe you and sign your
Skill Check.
A facilitator will observe as you do the training:
2
 Following your training plan, provide the trainee with any
supplies and materials needed.
3
 Using the technique(s) you outlined, have the trainee
learn all the topics on your list.
4
 Verify each topic learned according to your outline.
5
 Document your training on a checklist.
You reached the goal!
Please continue to the Skill Check.
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MENTOR / TRAINER SKILL CHECK
Facilitator (or Applications Specialist) Review of Training Plan
 Training plan contains a list of the basic topics to teach to everyone.
_______________________________________________________
 Training plan includes a list of more advanced topics to teach to
selected individuals.
_______________________________________________________
 Training plan contains a list of the important points to cover in each
topic.
_______________________________________________________
 Training plan describes how a trainee will be verified.
_______________________________________________________
 There is a checklist and sign off sheet to document each individual’s
training.
_______________________________________________________
Continued on back >>>>>
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Facilitator (or Applications Specialist) Observation of Training
 Trainer followed their training plan.
________________________________________________________
 Trainer used the techniques outlined in their plan.
________________________________________________________
 Trainer had all supplies on hand
________________________________________________________
 Trainer coached the trainee offering corrective action, as needed
________________________________________________________
 Trainer offered encouragement and positive reinforcement
________________________________________________________
 Trainer verified each topic learned according to their plan.
________________________________________________________
 Trainer documented the training using their checklist.
_______________________________________________________
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