lh 700 series hematology analyzer

PN A86980AA (October 2009)

LH 700 SERIES HEMATOLOGY ANALYZER

SUPPLEMENTAL TRAINING MODULES

@BeckmanCoulter

Miami Education Center

COULTER® LH 700 SERIES SUPPLEMENTAL MODULES

PN A86980AA (October 2009) Miami Education Center

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WARNINGS AND PRECAUTIONS READ ALL PRODUCT MANUALS AND CONSULT WITH BECKMAN COULTER-TRAINED PERSONNEL BEFORE ATTEMPTING TO OPERATE INSTRUMENT. DO NOT ATTEMPT TO PERFORM ANY PROCEDURE BEFORE CAREFULLY READING ALL INSTRUCTIONS. ALWAYS FOLLOW PRODUCT LABELING AND MANUFACTURER’S RECOMMENDATIONS. IF IN DOUBT AS TO HOW TO PROCEED IN ANY SITUATION, CONTACT YOUR BECKMAN COULTER REPRESENTATIVE. HAZARDS AND OPERATIONAL PRECAUTIONS AND LIMITATIONS WARNINGS, CAUTIONS and IMPORTANTS alert you as follows:

WARNING – Can cause injury. CAUTION – Can cause damage to the instrument. IMPORTANT Can cause misleading results.

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 ANALYZER.

WARNING Risk of operator injury if:

• All doors, covers and panels are not closed and secured in place prior to and during instrument operation. • The integrity of safety interlocks and sensors is compromised. • Instrument alarms and error messages are not acknowledged and acted upon. • You contact moving parts. • You mishandle broken parts. • Doors, covers and panels are not opened, closed, removed and/or replaced with care. • Improper tools are used for troubleshooting.

To avoid injury:

• Keep doors, covers and panels closed and secured in place while the instrument is in use.

• Take full advantage of the safety features of the instrument. Do not defeat safety interlocks and sensors.

• Acknowledge and act upon instrument alarms and error messages.

• Keep away from moving parts.

• Report any broken parts to your Beckman Coulter Representative.

• Open/remove and close/replace doors, covers and panels with care.

• Use the proper tools for troubleshooting.

CAUTION System integrity might be compromised and operational failures might occur if:

• This equipment is used in a manner other than specified. Operate the instrument as instructed in the Product Manuals.

• You introduce software that is not authorized by Beckman Coulter into your computer. Only operate your system’s computer with software authorized by Beckman Coulter.

• You install software that is not an original copyrighted version. Only use software that is an original copyrighted version to prevent virus contamination.

IMPORTANT

If you purchased this product from anyone other than Beckman Coulter or an authorized Beckman Coulter distributor, and, if it is not presently under a Beckman Coulter service maintenance agreement, Beckman Coulter cannot guarantee that the product is fitted with the most current mandatory engineering revisions or that you will receive the most current information bulletins concerning the product. If you purchased this product from a third party and would like further information concerning this topic, call your Beckman Coulter Representative.

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.



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TRADEMARKS 5C, COULTER, COULTER COUNTER, FACULTY, ISOTON, LIN-C, LYSE S, and S-CAL are trademarks of Beckman Coulter, Inc. All other trademarks, service marks, products or services are trademarks or registered trademarks of their respective holders. Copyright © Beckman Coulter, Inc. 2007 All Rights Reserved



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REVISION STATUS

Revision AA Initial Issue (October 2009) Software 2D1/1B1 or higher



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PN A86980AA (October 2009) Miami Education Center @Beckman

Coulter

LH 700 SERIES SUPPLEMENTAL MODULES

This booklet contains additional training modules for the LH 700 Series. A copy of this booklet is included on the Supplemental CD distributed to students during classroom training. This material may be used to continue your knowledge and skill development on the LH 700 Series. These modules may also be used as part of the Key Operator Certification Program.

The following modules are in this booklet:

• Carryover and Reproducibility This module covers running carryover and reproducibility to meet regulatory requirements and for troubleshooting.

• Decision Rules This module covers how to set up decision rules.

• Extended QC This module covers an optional quality Asssurance method that uses rules derived from the German Rili-BAEK guidelines.

• Flagging This module shows how to set up flagging limits, adjust flagging sensitivity and save/restore system configuration.

• Security Access This module covers the three levels of login access and how to set them up.

• SlideStainer This module addresses cleaning procedures, creating a new staining protocol and deleting a custom staining protocol.

• Quality Control 3 This module shows how to set up a patient control, how to run a non-bar coded control and how to edit, delete and archive a control file.

• XB This module covers the set up and use of XB analysis

• XM This module covers the set up and use of XM analysis.

PN A86980AA (October 2009) Miami Education Center C&R-1 of 8 @Beckman

Coulter

CARRYOVER & REPRODUCIBILITY

OBJECTIVES Given an operating COULTER® LH 700 Series, access to HELP, and required supplies

• Perform a Reproducibility study, verify and print results

• Perform a Carryover study, verify and print results

Why Is It Important?

Regulatory agencies require that carryover and reproducibility studies be performed periodically.

Resources

To complete this module you will need:

• LH 700 Series Analyzer

• LH Workstation with HELP

• Supplies for reproducibility: 2 EDTA tubes of blood from the same donor, and 1 additional EDTA tube of blood to use as a Prime.

• Supplies for carryover, 2 EDTA tubes of blood, 3 empty EDTA tubes

What To Learn

How to perform reproducibility and carryover procedures and verify acceptable results.

NOTE: The procedures in this module are adapted from the HELP system. To make the procedures easier to follow, various sub-procedures from hypertext have been “blended” to make a continuous procedure. Some steps may apply particularly to this exercise and not necessarily to your lab.

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COULTER® LH 700 SERIES TRAINING MODULES


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PN A86980AA (October 2009) Miami Education Center C&R-3 of 8

INFORMATION / PRACTICE SECTION

Reproducibility (Precision)

A measure of the ability of the instrument to reproduce similar results when a sample is run repeatedly. Precision of the instrument is a CV (or an SD for differential results), based on at least 31 replicate determinations of the same sample. Precision shows the closeness of test results when repeated analyses of the same material are performed.

Step Action

1

Go to

(Reproduciblity)

(from Common Toolbar) Select the Index Tab, Type Repro, Select topic “donor requirements”, Read.

2 For this exercise, use these supplies: 2 EDTA tubes of blood to use for the reproducibility and 1 EDTA tube of blood to use as a Prime.

Note The directions above apply to this exercise only. In your laboratory, you will need up to six tubes of blood from a single donor (or more, depending on the draw volume). You will need to mix all tubes together and then re-aliquot before use.

3 Ensure that the blood is well mixed.

4 Ensure pneumatics are on.

5 At the Analyzer CRT ensure the blood detector is enabled.

6 At the Command Center, ensure that Default Type is set to C. You can perform reproducibility using other operating modes, however the procedure will take longer and use more reagents.

7 At the Analyzer CRT set the number of aspirations per tube to 1.

8

Select REPRODUCIBILITY as the Process Type on the Command Center.

Note: Both the Reproducibility and Carryover procedures may be a requirement of regulatory agencies. These procedures may be used at any time to verify Diff and Retic performance, in addition to the CBC only that we will perform as part of this module. Refer to the Performance Specifications in HELP for the results criteria.



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WARNING WARNING WARNING The background color of the Reproducibility window changes to the same green background color as the Command Center when you change Process Type to REPRODUCIBILITY. Watch out for this relatively common error!

Failure to perform this step will result in data going to the database instead of to the Reproducibility screen.

9 If necessary, select on the Reproducibility window, Specific Toolbar, to clear previous old values from the results table.

10 Place the single EDTA tube into a cassette and place the cassette in the right-hand loading bay. This “prime” will automatically be omitted from the Reproducibility calculations.

11 After running the previous “prime” sample, set the number of aspirations per tube to 5. This is in preparation to run your N = 10.

12 Mix the two sample tubes and place into a cassette.

13 Place the cassette in the right-hand loading bay.

14 After the ten results are received at the Workstation review the results table and statistics.

Note 1

The procedure begins with an N=10. If all parameters pass, you may stop processing. Otherwise, see Note 2 below.

15 Verify that the %CV (Coefficient of Variation) does not exceed the established limits.

Note 2

Reproducibility Limits for CBC Parameter CV%

WBC ≤ 1.7 RBC ≤ 0.8 Hgb ≤ 0.8 MCV ≤ 0.8 Plt ≤ 3.3

MPV ≤ 2.2

Verify that the %CV does not exceed the established limits above. If limit is exceeded, repeat with two more tubes of blood, until at least 11 but not more than 31 whole blood samples have been analyzed. You may stop the analysis at any point between 11 and 31 runs if the reproducibility established limits have been met.

If any instrument results exceed these limits, repeat with another donor sample. If you still have a failure, an instrument problem may exist. Call your Beckman Coulter Representative. (Note: the above limits are also available in HELP)

16 Print your Reproducibility results for the Skill Check.


PN A86980AA (October 2009) Miami Education Center C&R-5 of 8

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 specimens” (NRSCL8-A 1998. Clinical Laboratory Standards Institute). It is conventionally expressed as a percentage of the concentration of the analyte in the first specimen which is carried into the subsequent specimen, as indicated by the specified limits listed above.

Step Action

1 Go to

(Carryover)

2 Ensure the blood detectors are Disabled at the Analyzer CRT screen. (Go to Main Menu>System Configuration>Blood Detectors).

Watch out for this relatively common error!

If blood detectors are not disabled the carryover study is invalid. The diluent values will give a partial aspiration message.

3 Ensure the Default Type is set to C. You can perform carryover check using other operating modes, however the procedure will take longer and use more reagents.

4 Ensure the number of aspirations per tube is set to 1.

5 Select CARRYOVER as the Process Type on the Command Center.

The background color of the Carryover window changes to the same green background color as the Command Center when you change the Process Type to CARRYOVER.

If necessary, select on the Carryover screen, Specific Tool bar, to clear the previous values that appear on the results table.

6 Collect your supplies: 2 EDTA tubes with blood (not necessarily from the same donor), 3 empty EDTA tubes

Tip

(In your own lab, you may wish to aliquot blood from one EDTA tube into two separate tubes.)



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7 At the Analyzer Control Keypad, press <F04> <ENTER> to dispense diluent through the Manual aspiration mode aspirator tip into each of the uncapped, empty EDTA tubes.

The Analyzer Control Keypad displays DILUENT DISPENSE while the instrument performs this function. When the function completes, the Analyzer Control Keypad displays FUNCTION = 04.

Press <ENTER> to perform this function again.

8 Press <STOP> to exit the function. The Analyzer Control Keypad displays READY.

9 Ensure that the blood samples are well mixed.

10 Place the tubes into consecutive positions in a cassette in this order:

2 blood tubes, 3 diluent tubes.

11 Place the cassette in the right loading bay. The instrument begins processing the cassette automatically.

12 Verify the carryover results.

Carryover Acceptable indicates that all results meet the High-to-Low Carryover limits.

Carryover Not Acceptable indicates that High-to-Low Carryover limits are exceeded.

High-to-Low Carryover Limits

WBC ≤ 2.0%

RBC ≤ 1.0%

Hgb ≤ 2.0%

Plt ≤ 2.0%

13 Carryover acceptable? If YES, print results. If NO, call your Beckman Coulter representative.

14 Ensure the blood detectors are Enabled at the Analyzer CRT screen.

Collect your printouts (Reproducibility and Carryover). Proceed to the Skill Check at the end of this module.

PN A86980AA (October 2009) Miami Education Center C&R-7 of 8 @Beckman

Coulter

CARRYOVER & REPRODUCIBILITY

SKILL CHECK

Attach copies of your printouts from the Reproducibility and Carryover studies for documentation towards the Key Operator Certification program.

C&R

COULTER® LH 700 SERIES SKILL CHECKS


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PN A86980AA (October 2009) Miami Education Center DR-1 of 12 @Beckman

Coulter

DECISION RULES

OBJECTIVES Given an operating COULTER® LH 700 SERIES, access to HELP, and tubes of EDTA blood

Create and apply a Reflex Manager (Decision) Rule so that the action item prints in the Comments field on a sample report.

• In Run Configuration, enable Decision Criteria.

• In Run Configuration, enable the option to print All Samples.

• [For SlideMaker] In Run Configuration, make Slides based on Decision Rules only so that slides are generated based on the rules created.

• Save Decision Rules to removable media.

Why Is It Important? Decision Rules assist laboratorians with data review by clearly showing what action(s) should be taken based on sample parameter results, flags, codes, and messages.

Resources To complete this module you will need

• LH 700 SERIES • LH Workstation with HELP • Tube of EDTA blood • CD or flash drive

What To Learn

By completing this module you will learn how to create (Reflex Manager) Decision Rules. If you also have an LH SlideMaker and LH SlideStainer, you will learn that slides can be made based solely on Decision Rules.

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IMPORTANT

• Flagging is evaluated when the sample is analyzed. • Flagging is reevaluated for a sample when the results are manually edited, or

when new results are received for a pending sample. • Flagging is not reevaluated upon a change of flagging limits for results

already in the database. Decision rules and Delta checks are not reevaluated. • Beckman Coulter suggests using all available flagging options to optimize the

sensitivity of instrument results. All flagging options include reference ranges (H/L), action limits (aH/aL), critical limits (cH/cL), definitive messages, suspect messages, parameter codes, delta checks, decision rules and system alarms. Beckman Coulter recommends avoiding the use of single messages or outputs to summarize specimen results or patient conditions.

There are Two ways in which you may be signed off for this module.

1. Work with your Applications Specialist to set up your laboratory flagging limits OR

2. Complete the following exercise.

Practice – Decision Rule (Reflex Manager)

Note: to perform this task requires Lab Administrator (Level 3) security access.

Follow these steps to set up the following Decision rule: “If WBC is ≥ 2.0 or ≤ 15.0, “Decision Rule Module Skill Check.” (This rule is created for this exercise only)

Step Action

1 From the Command Center, select .

2 Select

to display the Patient setup window.

3 Select to display any existing rules.



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4

Select from the Decision Rules and Criteria screen to set up the Rule Configuration. This is the window used to enter the text messages for the decision rule, e.g. “Review the slide” or “Call results”.

Select this to save your newmessage to the list.

a. In the “Add New Message” box, type the message you want to

appear on the report when a sample matches a rule that uses this message as an action. The message can be up to 64 characters in length.

Type in “Decision Rule Module Skill Check” now. And then select the save icon.

b. After saving your message, select to return to the Decision Rules & Criteria screen.

5 Select to create a new rule. The Define Rule screen displays.



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Use the Help Mode button for information on each selection on this screen. The basic steps to begin are to type in a Rule Name, specify the Type you are creating (Decision Rules = Reflex Manager), type a Rule Description (just use the Rule Name) and then build the rule.You may optionally attach Physician and Location information to a rule. We are not going to use this option for our practice exercise. Now let’s practice the steps.

Step Action

6 Type your name in Rule Name, choose Reflex Manager as Type and type WBC in Rule Description.

7 In Part 1 do the following steps:

a Open the drop-down box for Type and select “Parameter”.

b Next open the drop-down box for Item and select “WBC”.

Tip: Type the first letter – W.

c Open the Rel OP/Flag drop-down box and choose “> =”.

d Enter 2.0 in the Value box.

e Open the Join drop-down box and choose “OR”.

8 In Part 2 do the following:

a Open the drop-down box for Type and select “Parameter”.

b Next open the drop-down box for Item and select “WBC”.

c Open the Rel OP/Flag drop-down box and choose “< =”.

d Enter 15.0 in the Value box.

9 After entering 15.0 in the Value box, go to the Action area near the bottom of the screen. Open the drop-down box for Text Message and select “Decision Rule Module Skill Check”. This is where the entries from Rule Configuration reside.

Let’s say you have gotten this far in creating a rule and when you open the drop-down box you realize that the message you want has not been entered. All you have to do is select and enter your message, save it and finish your rule.



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10 Select the checkbox to Make Automatic Slide, if you have LH SlideMaker.

11 Select to save the rule and return to the Decision Rules & Criteria screen.

You should see your rule in the list. Notice the column “Enabled”. New rules are always enabled. By clicking the check box you may disable a rule. Let’s look at the other functions associated with rules:

Delete Highlight a rule, then delete.

Edit Use to edit an existing rule.

Copy Use to copy an existing rule. Export Rules to a File

Use to save created rules on a CD or floppy disk.

Prioritize Decision RulesUse to change the order of rules on the list.

Import Saved Rules From a File

Use to retrieve rules saved to a CD or floppy disk.

12 Be sure to do the following:

Note

In Run Configuration, make sure the Decision Criteria checkbox is enabled. Select the radio button to print All Samples. If you have an LH SlideMaker / LH SlideStainer, make sure that both checkboxes are enabled as well.

13 Process your sample.

14

After the sample is processed and results are printed, check that the statement “Decision Rule Module Skill Check” appears on the Patient Results screen in the Rule Messages field, on the Demographics tab and in the Comments field on the printout. Save the printout for the Skill Check.



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Reference Information

Now that you have been introduced to the Decision Rules area, you may want to review and print the following topics from HELP:

• Setting up rules for Flagging Sample Results

• Setting Up the Rule Environment

• Defining Reflex Manager Criteria

• Prioritizing Decision Rules

FYI: You may create an unlimited number of rules. However, the maximum number of rules that may be invoked on a single sample result is 20. This is the reason prioritizing the rules is important.

IMPORTANT If you create a rule that has more than one parameter or contains more than one item that is related to a parameter, all of the parameters included in the rule (even if an OR condition is used) must also be included in the parameters you include in your Report Profile.

Practice – Save Decision Rules to CD-R or Flash Drive

If you are using a flash drive, proceed to the next section: “Save Decision Rules” If you are using a CD, continue with this section.

Before you begin to archive or save data to a CD, you must format the CD.

Step Action

1 Place a blank CD-R in the CD writer drive. (Look at the drive to determine which one is the writer. It is usually the top drive.)

2 From the workstation desktop (Beckman Coulter main screen), double click on the "Burn CD and DVDs" icon. The Easy Creator 5 screen appears.

Note: If a dialogue box to register the software appears, just close or select "Remind me later".

3 Select "Make a data CD" and then select the Direct CD option.

4 Select Format CD. You may name your volume or leave it at the default name"Volume1".

5 Select Start Format. This will take about one minute. Wait for the "CD Ready" window to appear and select OK.

6 Close the Easy CD Program.



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Save Decision Rules

Step Action

Use a formatted CD-R from the previous exercise or a flash drive.

This feature of the software allows you to save all your decision rules to removable media. The removable media can then be used to reload the rules, if there is a problem, or, if you have more than one LH 700 Series, create the rules at one and then just copy into the other(s).

1 Insert your removable media.

2 Select the Export Rules to a File button on the Decision Rules and Criteria screen.

3 When the "Please insert a disk in drive A" window appears, select Cancel.

4 When the “Save As window” opens, double click on My Computer.

5 Double click on the appropriate drive. Type in a file name and then click Save.

6 Remove your media.

7 Now test the CD. Delete only the decision rule you created for this exercise in the Workstation. Do not delete any other rules that are in use on your instrument.

8 Insert your removable media into the appropriate drive.

9 Select the Import Saved Rules From a File button on the Decision Rules and Criteria screen.

10 When the "Please insert a disk in drive A" window appears, select Cancel.

11 When the Open window appears, double click on My Computer>>double click on your drive>>double click on your file name.



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12

A warning message window appears, with the following message:

“X” number of rules could not be imported because existing rules had the same keys. “X” number of rules were imported successfully. Please check that the desired rules have been imported successfully.

Choose OK.

13 Your new rule should now appear on the screen. Remove your media.

14 Delete the decision rule you created for this exercise in your instrument’s Workstation. Do not delete any other rules that are in use on your instrument.

If you can create you own Reflex Manager Rule, collect your printout, and complete the Skill Check at the end of this module.



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PN A86980AA (October 2009) Miami Education Center DR-11 of 12 @Beckman

Coulter

DECISION RULES

SKILL CHECK

Option 1 Application Specialist Sign OFF

I _______________________ (Application Specialist) verify that (Print) _______________________ (Customer Name) has successfully (Print) set up Decision Rules for their laboratory ___________________________________ Date____________ (Signature) ____________________________________ Date___________ (Signature)

Option 2 Exercise

Decision Rule

Attach a copy of your patient sample report showing the decision rule you created for documentation for the Key Operator Certification program. Ensure no patient demograhics are visible on the printout.

Answer the following question: If you have created 40 Decision Rules and have prioritized them, how many can be applied to any given sample?

a. All of the rules

b. A maximum of 10

c. A maximum of 20

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PN A86980AA (October 2009) Miami Education Center EQC-1 0f 10 @Beckman

Coulter

EXTENDED QC

OBJECTIVES Given a working LH 700 Series Analyzer

• Enable/disable Extended QC Rules for COULTER® 5C Cell control • Define Random Error, Systematic Error and Total Error • Use Extended QC Limits (change if necessary) • Review 5C files with Extended QC, recognizing the flagging and how to

respond to the flagging • Print individual and summary reports


Extended QC is an optional quality assurance method that can be used to review COULTER® 5C Cell controls. It is used to determine if an analyzer is working as predicted within a defined range.

The Extended QC rules are derived from the German Quality Control Guidelines for the medical laboratory, known in Germany as RiLi-BÄK (or Rili-BAEK). The RiLi-BÄK (Guidelines of the Federal Chamber of Physicians), was first published in 1987. In 2003, the guidelines were extended to include hematology.

Resources

• LH 700 Series Analyzer • 5C Cell control file data • Extended QC Overview from HELP

What To Learn

• How to enable/disable Extended QC • How to change Extended QC limits • How to review 5C control runs using Extended QC • Print summary reports

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INFORMATION / PRACTICE SECTION Print the Extended QC Overview from HELP.

Using Extended QC

Enable Extended QC from the Controls Setup Screen:

Step Action

1 Select System Setup from the Command Center

2 Select Quality Assurance Setup

3 Select the Controls tab…………………

4 Select

This opens the Extended QC Settings screen as seen on the next page. Use this screen to enable or disable the Extended QC rules for 5C Cell control by clicking the checkbox in the upper left corner. The limits apply to any lot number and any level of the 5C Cell control.

The default limit settings present for Random Error, Systematic Error and Total Error are the values established by the Guidelines of the Federal Chamber of Physicians in Germany. Your laboratory may change these if you wish.



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Extended QC Limits

Note: If you use auto-stop for controls, any Random Error, Sytematic Error or Total Error applies and will trigger the auto-stop function.

Random Error

Random Error is Extended QCs measurement of imprecision (lack of reproducibility). This is expressed as the maximum allowable coefficient of variation (CV%). The method is considered out of control if the CV falls outside the Random Error Limits.

• If the control file has an N ≥ 2 and N < 20, and the CV exceeds the Random Error limit, the CV value for that parameter highlights in Yellow in the statistics section of the QC summary results screen.

• If the control has an N ≥ 20, and the CV exceeds the Random Error limit, the CV value for that parameter highlights in Red in the statistics section of the QC summary results screen. The user must acknowledge the alert. The event posts to the Control Data tab in the history log.

Enable/Disable checkbox here

Default Limits

Could use this area to enter CPT codes

Free text area for comments or information

These five parameters are the only ones used by Extended QC

CAP Proficiency Limit %

for Total Error

WBC_15 RBC__6 HGB__7 HCT__6

PLT_25

This area configures the individual parameter and summary printed reports.



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Systematic Error

Systematic Error is Extended QCs measurement of bias. A systematic error (bias) is defined as the deviation of the mean from the target value. The method is considered out of control if the deviation falls outside the Systematic Error Limits.

• If the control file has an N ≥ 2 and N < 20, and the exceeds the Systematic Error Limit, the Delta Diff for the parameter highlights in Yellow in the statistics section of the QC summary results screen.

• If the control has an N ≥ 20, and the exceeds the Systematic Error Limit, the Delta Diff for the parameter highlights in Red in the statistics section of the QC summary results screen. The user must acknowledge the alert. The event posts to the Control Data tab in the history log.

• The Delta Diff used in the formula is the absolute difference between the current lab mean and the target value.

Total Error

Total Error is Extended QCs measurement of inaccuracy, as compared to an established limit. Total error is defined as the deviation of a single measurement from the target value.

For each 5C Cell Control run, the WBC, RBC, Hgb, HCT and Plt values are evaluated using the following formula:

for that parameter.

If the result is outside of the upper or lower range, the user is notified by highlighting the result in Yellow on the parameter itself.

The laboratory may choose to evaluate target value as either the BCI Assigned Value or as the Mean-to-Lab Target value.

Troubleshooting

Basic troubleshooting remains the same as any other QC routine.

• If you have Total Error (a result is out of range), repeat the control. If the result is still out, try a new vial. Also verify the proper handling

and mixing of the control vials per the manufacturers insert sheet. • If you have Systematic (bias) Error for a parameter, you may need to verify

calibration. • If you have Random (imprecision) Error, verify reproducibility using a

patient sample. If this fails, you need to contact the manufacturer.

Other Information Sources www.westgard.com/lesson53.htm or www.ajcp.com (The Quality of Laboratory Testing Today-an assessment 2005080316.pdf)

100×⎟⎟⎠

⎞⎜⎜⎝

⎛ueTarget Val

Diff Delta absolute

100×⎟⎟⎠

⎞⎜⎜⎝

⎛ueTarget Val

Diff Delta absolute

( )100

Limit Error TotalueTarget ValueTarget Val ×±



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Printing Reports

The Extended QC Summary Report prints one parameter per page, per lot. The body of the report includes:

• Parameter name • Date and time of analysis • An indication if the Difference was outside the Target Limits, and if the

Difference was high or low • Deselected results appear with a strikethrough • A graph displays the assigned value, Extended QC Low Limit, Extended QC

High Limit and result point. Below is an example of a sample report.

This comes from the set up screen.



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You access the Extended QC Summary Report by selecting,

Step Action

1 Print a Summary Report for ONE level of 5C.

2 Open a 5C file and select a few individual runs. Print the selected runs.

3 Disable Extended QC from the Controls Setup Screen.

Once you are familiar with the information in this module, perform the Skill Check at the end of this module.

Choose either Selected Lot or All Lots to print the Summary Reports for each 5C parameter

Choose either Selected Lot or All Lots to print the Summary Reports for each 5C parameter

When you enable Extended QC, the single-run format will print (either by auto-print or manual request) with two extra columns, one for Total Error Limit % setup and Diff %, indicating the difference was outside the target limit.



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PN A86980AA (October 2009) Miami Education Center EQC-9 of 10 @Beckman

Coulter

EXTENDED QC

SKILL CHECK

1. Attach your printed individual runs and summary reports for documentation for the Key Operator Certification program.

2. List the steps to enable/disable Extended QC. Begin at the Command Center.

______________________________________________________________

______________________________________________________________

______________________________________________________________

3. Can the limits for Random Error, Systematic Error and Total Error be changed?

______________________________________________________________

4. Define the following terms:

Random Error

_______________________________________________________________

Systematic Error

_______________________________________________________________

Total Error

_______________________________________________________________

5. The Extended QC settings limits apply to a specific lot and level of 5C cell control. Circle the correct answer.

TRUE FALSE

6. List the paramaters used by Extended QC

_____________

_____________

_____________

_____________

_____________

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FL-1 of 10 @BeckmanCoulter

FLAGGING LIMITS

OBJECTIVES Given an operating COULTER® LH 700 SERIES, access to HELP

• Set up flagging limits

• Adjust flagging sensitivity (Diff Flag Preferences)

• Save/Restore System Configuration


Setting up appropriate flagging limits for your laboratory ensures that normal and abnormal samples are properly identified for further review.

Changing flagging sensitivity can accommodate flagging seen in specific patient populations.

Using the Save/Restore function can save time if the system configuration needs to be reloaded.

Resources

To complete this module you will need

• LH 700 SERIES Analyzer


• Removable media (CD-R, flash drive or floppy disk)

What To Learn

By completing this module you will learn how to set up flagging limits.

FL

COULTER LH700 SERIES TRAINING MODULES

PN A86980AA (October 2009) Miami Education Center FL-2 of 10



INFORMATION / PRACTICE SECTION There are Two ways in which you may be signed off for this module.

1. Work with your Applications Specialist to set up your laboratory flagging limits OR

2. Complete the following exercise.

Practice – Setting Up Flagging Limits (a new set)

Step Action

1 Follow these steps to create your own new flagging set:

a.) Select from the Command Center,

then , and then

b.) To create a New flagging set, click on .

c.) Enter your name (e.g. Chris) in the Limit Name box.

d.) Create the location (e.g. Mars) by choosing the Add Location(s) button and typing in the location you want to appear in the location list. Close t6he location setup window. In the Location dropdown box, select Mars.

e.) Enter the Age Range (e.g., 300 years to 500 years) in the boxes. The drop down boxes may be used to change from years to hours, days, or months.

f.) Choose to Save your new flagging limit set.

2

Highlight the new set you just created and then select the button (Modify Limit Values) to display the Laboratory Flagging Limits Setup window. On this window are tabs for each of the subsets: Male (Def.), Female, Action Limits, Critical Limits, and Definitive Messages.

a.) Enter the lower and upper limits for one or two parameters for the following new subsets: Male (Def.), Female and Action. [Def. = Default] (These are used for practice only, not for running your samples.)

3 For your Critical Limits subset, use the copy function (Copy Existing Limits). Use the HELP Mode button for an explanation of the copy feature.

a.) Choose the Critical Limits tab.

b.) Choose the Copy Existing Limits button.

c.) From the Limit Set dropdown box, choose Adult.



d.) From the Limit Category dropdown box, choose Critical.

e.) Click on . The Adult Critical Limits will copy into your Critical Limits page.

4 Choose the Definitive Messages tab, select the checkboxes for: Leukopenia, Neutrophilia%, Lymphocytosis#.

NOTE The Definitive Messages reflect the values entered for Action Limits.

5 Select the [Help Mode] button and move the cursor to any 2+ or 3+ Gradient Range field. Single-click with the left mouse button. a.) To print the procedure, click inside the pop-up window with the

right mouse button.

b.) Select Print. c.) On the Print window, click on .

Read this before continuing.

Example for Gradient Range Practice: Setup Microcytosis

Step Action

1 • On the Definitive Messages window, select the checkbox for Micro.

2 • Assume for this example that the Lower Action Limit for MCV=70.0

3 • An MCV of 65.0 is 2+ microcytosis.

4 • An MCV of 60.0 is 3+ microcytosis

5 • Therefore the value to enter in the 2+ microcytosis field is 5. (70.0-65.0=5.0)

Exam

ple

6 • The value to enter in the 3+ microcytosis field is 10. (70.0-60.0=10.0)

6 Under Definitive Messages, select the checkbox for Macro.

7 Use the following values to determine the appropriate numbers to set up 2+ and 3+ gradient ranges for Macrocytosis a.) Assume that the Upper Action Limit for MCV is 101.5

b.) 2+ Macrocytosis = MCV 108.5 c.) 3+ Macrocytosis= MCV 113.5

d.) Fill in the appropriate number for each gradient range for macrocytosis. (Remember to do the math!!)

8 Select to save your new set of Flagging Limits.

9

WHEN YOU HAVE COMPLETED ALL STEPS ABOVE, PRINT EACH SUBSET (MALE, FEMALE, ACTION, CRITICAL, DEFINITIVE) OF YOUR NEW SET to submit for your Key Operator Certification.



Diff Flagging Preferences

Step Action

1

At the Workstation, go to HELP, Search

Type flag

Click on List topics

Select Flagging Preferences

Click on

2 Print and read the Flagging Preferences procedure. Be able to describe how to change Diff Flagging Preferences for the Skill Check.

3 DO NOT change the Flagging Preferences on your instrument. Changes should only be made after a flagging study, i.e. Truth Table Analysis.

Save/Restore Configuration

Step Action

1 From HELP, select the Index tab, type saving, select the topic “Saving Configuration” Display.

2 Print the topic and review. Now let’s try it.

Note

Although the Help procedure only mentions using a floppy diskette, you may also choose to use a formatted CD-R or a flash drive. We will take you through using a CD-R or a flash drive. If using a floppy diskette use the above HELP procedure. The option is yours. Choose one or the other.

3 Obtain removable media (CD, flash drive, floppy disk).

4 In the future, once all your Workstation setups are complete in your own lab, you should save the data configurations entered as a backup for use if the need arises (e.g. if data has been deleted or erased due to software upgrade).



Formatting CD

If you are using a flash drive, proceed to the next section: “Save Configuraqtion to Removable Media”. If you are using a CD, continue with this section.

Before you begin to archive or save data to a CD, you must format the CD.

Step Action

1 Place a blank CD-R in the CD writer drive. (Look at the drive to determine which one is the writer. It is usually the top drive.)

2 From the workstation desktop (Beckman Coulter main screen), double click on the "Burn CD and DVDs" icon. The Easy Creator 5 screen appears.

Note: If a dialogue box to register the software appears, just close or select "Remind me later".

3 Select "Make a data CD" and then select the Direct CD option.

4 Select Format CD. You may name your volume or leave it at the default name"Volume1".

5 Select Start Format. This will take about one minute. Wait for the "CD Ready" window to appear and select OK.

6 Close the Easy CD Program.

Save Configuration to Removable Media

Step Action

1 Insert your removable media into the appropriate drive.

2 Open System Setup.

3 Click on

Save/Restore Configuration on the Menu Bar.

4 Select Save and then click on Next>.

5 Check both the Save Registry and Save Database Component(s) checkboxes and then click on Next>.

6 Click on Browse.

7 To use a CD or flash drive, select cancel when the "Insert disk in drive "A" window appears.

8 When the "Save as" window appears, double click on My Computer.

9 Select the appropriate drive for your removable media and choose Open.

10 Type the filename in the format as shown XXXMMDDYY (i.e. For April 12, 2010 with software version 2D1 the filename would be 2D1041210 with no extension). Click Save.

11 The filename should display with .RGS after it.



12 Click on Next and then Browse

13 To use a CD or flash drive, select cancel when the “Insert disk in drive “A” window appears.


15 Select the appropriate drive for your removable media and then choose Open.

16 Type the same filename again with no extension. Click Save.

17 The filename should display with .DBS after it. Click Next>.

18 Check all checkboxes: Patient Setup, Physician, Location and QA Setup.

19 Click on Finish. When done, the window will close automatically.

20 From the Workstation desktop, double-click My Computer.

21 Click on the appropriate removable media drive.

22 In the right pane of the window, there should be seven files. Two have the name you entered earlier with different extensions and five stain protocol files with .STP extensions.

23 Remove your media.

Restore Configuration from Removable Media

Step Action

1 Insert your removable media in the appropriate drive..

2 Open System Setup.

3 Click on

Save/Restore Configuration on the Menu Bar.

4 Select Restore and then click on Next>.

5 Check both the Restore Registry and Restore Database Component(s) checkboxes and then click on Next>.

6 Click on Browse.

7 To use CD or flash drive, select cancel when the “Insert disk in drive “A” window appears.

8 When the next window appears, double click on My Computer.

9 Select the drive for your media and choose Open.



10

Select the filename you created earlier which is in the format XXXMMDDYY (i.e. For April 12, 2010 with software version 2D1 the filename would be 2D1041210) with the extension of .RGS. Click Open.

11 The filename displays with .RGS after it. Click Next>.

12 Click on Browse…

13 To use the CD or flash drive, select cancel when the “Insert disk in drive “A” window appears.

14 When the next window appears, double click on My Computer.

15 Select the drive for your media and choose Open.

16 Select the same filename again with the extension of .DBS. Click Open.

17 The filename displays with .DBS after it. Click Next>.

18 Check all checkboxes: Patient Setup, Physician, Location and QA Setup.

19 Click on Finish.

20 A window appears with the message “The system will be restarted now to reinitialize with the new settings.”

21 Click OK.

The system shuts down Windows. Another window appears with the message, “It is now safe to turn off your computer”.

22 Remove your media. Press the Power OFF button on the computer tower.

23 Wait one minute and then Power On.

24 Log on to the Workstation. When it is completely up, reset the analyzer.

All System Configurations are restored including Decision Rules and Stain Protocols. Patient results and Control runs are not restored with this procedure.

Collect your printouts for the Skill Check. Be prepared to describe how to set up Gradient Ranges and how to change Diff Flag Preferences as part of the Skill Check.

PN A86980AA (October 2009) Miami Education Center FL-9 of 10 @Beckman

Coulter

FLAGGING LIMITS

SKILL CHECK

Option 1 Application Specialist Sign OFF I _______________________ (Application Specialist) verify that (Print) _______________________ (Customer Name) has successfully set (Print) up the Flagging Limits for their laboratory on the LH Workstation. ___________________________________ Date____________ (Signature) ____________________________________ Date___________ (Signature)

Option 2 Exercise 1. Attach printouts of all five subsets of your practice flagging set for

documentation for the Key Operator Certification program.

2. Beginning at the Command Center, list the steps needed to disable

Imm NE1 so that they are not reported.

______________________________________________________________

______________________________________________________________

______________________________________________________________

______________________________________________________________

3. The Restore procedure reloads all System Configurations including Decision Rules and Stain Protocols, but does not restore _________________________ nor __________________________________.

FL



FL-10 of 10

PN A86980AA (October 2009) Miami Education Center QC3-1 of 14 @Beckman

Coulter

QUALITY CONTROL 3 OBJECTIVES

Given an operating COULTER® LH Workstation and access to HELP Setting up a Patient Control Folder • Set up a patient control folder using bar code identification • Enter lab limits for the patient control • Run a patient control • Use button Running a Non-Bar Coded Control • Configure the Workstation to run a non-bar coded control • Run COULTER® 5C® Cell Control to simulate a non-bar coded condition Additional Extra QC • Learn how to edit control set up information • Delete data from control folders • Archive data from control folders • Describe how to print control folder data in a two-page wide format

Why Is It Important? As part of a lab’s Quality Assurance program, a patient control may be used in addition to a commercial control, or it may be used for mode-to-mode checks. Occasionally a bar code label on a commercial control will be damaged. Rather than discard the control, it can be run in the Automatic Mode if the Workstation is configured properly.

An understanding of the levels of deletion of control material allows you to remove unwanted or old data.

Archiving control data is a convenient means of long-term storage of control data for statistical analysis.

Printing a two-page wide format is easier to read.

Resources To complete this module you will need • LH Workstation with HELP • One tube of EDTA blood • Bar code label • 5C Cell Control (any level)

What To Learn Complete the patient control section to learn how to set up a patient control folder and how to use the button. Complete the exercise on non-bar coded controls to learn how to configure the Workstation to run a non-bar coded control in the Automatic Mode with the results going to the proper control folder. Use HELP and this module to learn how to edit set up information in a control folder. Also learn to delete control data and how to print a two-page format of control data.

QC3



QC3-2 of 14


PN A86980AA (October 2009) Miami Education Center QC3-3 of 14

INFORMATION / PRACTICE SECTION Setting Up A Patient Control Folder

Use one tube of bar coded EDTA blood for this exercise.

Step Action

1 Select Systen Setup QA setup

2

After you select (New Control Folder) button, choose the following:

Source: Other Type: CBC (You may choose any Type in your own lab) Level: Normal (You may choose any Level in your own lab)

3 Select (Setup Lab Limits) button.

4

If lab limits are already established by your lab, DO NOT change them. Skip this step. Enter lab limits listed below. (These lab limits are for this exercise only. You may wish to establish different lab limits in your laboratory.)

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

MCV 3.0

5 Select to save.

6 Select (Setup New Lot). Cursor is in Lot Number field.

Use the hand-held bar code scanner to scan the bar code label on the EDTA tube.

7 Set expiration date to tomorrow’s date.

8 Select Use as Default (checkbox below expiration date).

9 Select to save.

10

Select to close.

A warning appears; “One or more fields have not been completed. Do you wish to continue?” Select Yes, then select to exit Control Set Up.

11 At the Workstation Command Center

Set Default Type to “C”. Set Process type to Auto Analysis

12 At the Analyzer CRT, set # Aspirations/tube to 2.



QC3-4 of 14

Step Action

13 Place the EDTA tube in a cassette in right-hand loading bay.

At the Workstation go to Quality Assurance, Quality Control.

14

Expand the Control Tree to find the

Other / CBC folder you set up.

NOTE The Assigned Value and Expected Range lines are blank, therefore when you process your first run of the Patient Control, no results are out-of-limits.

The button becomes active as soon as one run is in the control folder.

15 After the one run is in the folder, select the button. After the second run is in the folder, you may select the button again.

The assigned value line changes to Target and is the mean value of the run(s). The Lab Limits are in the former Expected Range line.

16 When done, change # aspirations/tube back to 1.



What Do I Do On The Next Day Or Shift?

Step Action

1 On the next day or shift, select a different patient sample. Bar code the tube.

Go to , and in the Patient Control Folder, select button. 2 Select the radio button Only Table Run Data. Then select .

3

After deleting Table Run Data you can enter a new Patient Control Lot # and Expiration Date in System Set Up, Quality Assurance Set Up, Controls tab.

Highlight the folder then select (Edit Control Values) Highlight the lot number field Scan new barcode label Change the expiration date

4 Run the patient control.

5 Select . You have a new Target value for the current day or shift.



QC3-6 of 14

Running a Non-Bar Coded Control

Step Action

1

At the Workstation, from the Command Center, go to

(HELP) Click on Process Type Field

Read Step 2: NOTE

2

The two selections for running a non-bar coded control are to

Select CONTROL in the Process Type drop-down box Go to (Run Configuration)

Quality Assurance Analysis Cell Control Default (drop-down box)

Select the lot # of the control you will run without a bar code label.

3

For puposes of this exercise, a blood sample may be substituted for the control vial. Be sure to turn any barcode label toward the back of the cassette, so that it is not read by the barcode reader. After properly mixing the blood sample (control), place the blood sample (control vial) in a cassette with the bar code label toward the back of the cassette, so that it is not read by the barcode reader.

4 Place the cassette in the right-hand loading bay.

5

After the Workstation receives the control results, go to the appropriate folder to confirm that results were received by the Workstation. Print this file. Indicate the run for this module and save to submit with the skill check for Key Operator Certification. Be sure to label the printouts as documentation for this part of this module. If a blood sample was substituted for the control, delete the run from your instrument file or deselect and enter a comment.

6 Before running samples, be sure to set the Process Type field back to AUTO ANALYSIS.

IMPORTANT If you leave Process Type set to CONTROL, and you run non-bar coded patient samples, the results will go to the control folder selected as “default”.

NOTE: Do this procedure only if a 5C control bar code has damage OR if you run another type of control that is not bar coded.



Editing Control Information

This is for your information only.

DO NOT perform these steps now.

One special editing situation that you may find useful applies to the LATRON control folder. One characteristic of LATRON control is that the assigned values and expected ranges do not usually change from lot number to lot number.

When you set up a new LATRON control lot number, you do not have to type in the assigned values and expected ranges each time if you follow this procedure.

After printing old LATRON control lot number values, delete “Table Run Data”. This deletes all the runs in the file, but does not delete the Setup Table.

Step Action

1

Go to

Control Tree Open the LATRON control folder.

2 Select (Delete). Select the radio button “Only Table Run Data”.

3

Select (OK).



QC3-8 of 14

Deleting Control Folder Data

For this exercise just observe the data deletion options available. Please DO NOT delete any control data at this time.

Step Action

1 At the Workstation, access any control folder containing data from QA, QC.

2 Click on the (Delete) button on the Specific Toolbar.

3

The screen gives you three different levels of severity for deletion:

All Data for Control Lot Number(s), including Setup Table

Only Table Run Data – just the runs and statistical information not the Setup Table

Only Selected Runs Within Table

Refer to “Control Data—DELETION REQUESTED Window” in HELP, if you need further clarification of these options.

4 If you select on the above screen, you have a chance to reconsider your decision before selecting again!



Archiving Control Results

Step Action

Use one of these removable media (a CD, a 3.5-inch floppy disk or a flash drive) for this archiving exercise.

1

To archive any one control folder. Open any control file folder at your instrument workstation.

Use the Select All button on the Specific toolbar to select all runs.

Select the Archive button from the Common toolbar.

2 Choose “Selected Control Records Only” and then OK.

Note You may save the archive file to either the default a: floppy disk or to a previously formatted CD-R disk.

Note: Check your regulatory requirements to verify that this archiving method is an acceptable way to store and retrieve data.



QC3-10 of 14

3 To use a CD or flash drive, select cancel when the "Insert disk in drive "A" window appears.


5 Select the drive for your removable media. Type in a file name or use the suggested name. Select Open and then select Save.

6 Wait until the "Archive Complete" window appears, click OK.

7

Press the eject button on the CD drive, an "Eject CD" window will appear. Select "Close to Read on any computer". You may select the checkbox to "Protect" (If you do not want to add data at another time) or leave the checkbox blank (if you want to append data later).

8 Select OK. The CD will eject automatically. Select OK again.

9 In the future, you may repeat these steps to add more data to the same CD, if you did not write protect it.

Note

You can retrieve the archived data later on a personal computer (not the LH Workstation computer) by using a spreadsheet application, such as the Microsoft® Excel. For information about how to retrieve this data, refer to your spreadsheet application's documentation.

NOTE: The archived files are in .csv format. In a spreadsheet program you can save the files in the standard format for the program that you are using. Archive only for statistical review purposes. The Levey-Jennings graphs are not archived.

The control files in the Workstation remain unchanged after the archiving process.



When you have completed the exercises below, you are ready for the Skill Check for this module.

1. use the button to establish a mean for a Patient Control folder

2. configure the Workstation for running a non-bar coded control and run the control into the proper control file

3. edit control records, 4. delete control data at three levels of deletion 5. archive a control folder 6. print a two-page format

Printing Control Data in Two-Page (Wide) Format

Step Action

1 At the instrument Workstation go to System Set Up Quality Assurance Set Up Controls tab.

2 Select

3 Select .

4 From Command Center, select , .

5 Select any 5C control folder.

6 Select Print. Choose the Selected Lot radio button. Select Save the printout for the Skill Check.

Note You may want to print using the one-page format for comparison.



QC3-12 of 14

PN A86980AA (October 2009) Miami Education Center QC3-13 of 14 @Beckman

Coulter

QUALITY CONTROL 3

SKILL CHECK

Setting Up a Patient Control

1. Submit a printout of the lab limits you setup for the Patient Control for documentation for the Key Operator Certification program.

2. Submit a printout of your Patient Control folder to demonstrate that you can

use the button to show the mean of the patient control

runs and bring up the Lab Limits for this folder.

Running a Non-Bar Coded Control

1. List the two changes to workstation configuration for running a non-bar coded control.

______________________________________________________________

______________________________________________________________

Beginning with the Command Center, describe each step to take to make these configuration changes.

______________________________________________________________

______________________________________________________________

______________________________________________________________

______________________________________________________________

2. Submit the printout of the control file showing the run from the non-bar coded control.

3. What happens if you do not change the Process Type field back to AUTO ANALYSIS after running a non-bar coded control and before running non-bar coded patient samples?

______________________________________________________________

Continue on back>>>>>

QC3



QC3-14 of 14

Extra QC

1. To save only your control setup table, check the deletion option to use:

Only Selected Runs Within Table (meaning there are a few runs selected, but not all)

Only Table Run Data

All Data For Control Lot Number(s), Including Setup Table

2. Beginning with System Setup from the Command Center, describe each step to take to set up the option for printing a two-page wide control folder printout. ______________________________________________________

______________________________________________________________

_______________________________________________________________

What is the difference in appearance of the two-page wide printout over the one-page printout? _______________________________________________

Submit your labeled control file printout for documentation for the Key Operator Certification program.

PN A86980AA (OCTOBER 2009) Miami Education Center SA-1 of 8 @Beckman

Coulter

SECURITY ACCESS

OBJECTIVES Given an operating COULTER® LH Workstation and access to HELP

• Create new users at all Workstation access levels

• Tell which Workstation Options users at Levels 1 and 2 can and cannot access


As an LH 700 Series operator with Lab Administrator privileges, you decide security levels of access for those working with you, based on their laboratory responsibilities.

Resources


• User Privileges for Level 1, 2, and 3 Operators reference sheet on pages SA-5 of 8 and SA-6 of 8

What To Learn

How to set up users at different access (security) levels on the LH 700 Series Workstation

SA



SA-2 of 8



SA-3 0f 8


Practice

Step Action

NOTE In order to complete this exercise you must be logged on as a Level 3 user.

1

At your instrument Workstation, in HELP go to Index

type security

select

in Topics Found box, click on Setting Up User Access Levels

select

2 Print the procedure.

3 Close HELP.

4 Follow the procedure to create Level 1 and Level 2 users.

5 Select a user name and password for a Level 1 user.

User name _________________________________

Password __________________________________

6 Select a user name and password for a Level 2 user.

User name _________________________________

Password __________________________________

7 Log off the Workstation.

8 Log on to the Workstation with the Level 1 user name and password.

9

Based on what you know about Level 3 (Labadmin) security access, look at the following areas and note the differences. Refer to the next pages for information.

[NOTE: The term Labadmin is not a job but a user level].

Patient Results toolbars (all applications)

Quality Assurance toolbars (all applications)

System Set Up



SA-4 of 8

10 Repeat steps 7 through 9 using the Level 2 user name and password.

11 Log off the Workstation and log on again as a Level 3 user. Delete all users that you set up for this practice exercise.

12 Log off the Workstation and log on again at your access level for your lab.

If you can set up new users and create passwords, you are ready for the Skill check at the end of this module.



SA-5 0f 8

USER PRIVILEGES FOR LEVEL 1, 2, AND 3 OPERATORS

All Levels have access to everything on the Command Center, Run Configuration screen and to all HELP screens.

Level 1 Operators (Operator) Patient Results Screens - Results & Graphics View, DB/ToDo View

CAN:

Manually Transmit & Print, Use Database Explorer, Validate, Add Request to ToDo List, View 3-D Dataplots, Access DB/ToDo area, Use Navigation, View Save List, View History, Select/Deselect All, Access all Display modes Lock/Unlock screen, Increment slides made

CANNOT: Archive, Store Permanently, Edit, Delete,

Quality Assurance Screens – Daily Checks, QC, XB

CAN:

Manually Transmit & Print, Access QC, XB and Background Graphics, Access Daily Check Details, View History, Remove/Restore runs from statistics, Change control file status, Select/Deselect All, View by shift, Add Comments, View XB/XM Batches, Remove/Restore XB/XM runs, Add comments to XB/XM.

CANNOT: Archive, Access Reproducibility, Carryover, Calibration or Workload Recording, Delete from Daily Checks History, Archive or Delete QC, Delete runs from QC, XB or XM, Clear Tables, Download IQAP

History Logs CAN: Print, Add Comments

CANNOT: Delete Entries, Archive System Setup

CAN:

General Settings – access all QA – access reagent tab Location & Physician – access all Password – can change own password SlideMaker/Stainer - access Stainer tab only, changes state, drain and fill baths, access status, drain reagent lines, monitor sensor status

CANNOT:

Access Patient, Institution, Communications, Database Preferences, Security Access or Control Panel QA – set up controls, setup XB, set up shifts SlideMaker/Stainer – access SM tab(includes smear dispense mode, slide label definition, and automatically advance basket), create stain protocol, delete stain protocol, save stain protocol, download stain protocol



SA-6 of 8

Level 2 Operators (Advanced Operator) Patient Results Screens – Results & Graphics View, DB/ToDo

CAN: Perform all Level 1 functions plus: Store Permanently, Delete, Edit, Increment slides made

CANNOT: Archive

Quality Assurance Screens – Daily Checks, QC, XB

CAN: Perform all Level 1 functions plus: Archive, Access Reproducibilty, Carryover, Calibration and Workload Recording, Delete from Daily Checks History, Delete QC runs, Download IQAP, Clear table, Delete XB runs

History Logs

CAN: Perform all Level 1 functions plus Archive CANNOT: Delete Entries

System Setup

CAN:

General Settings – access all QA – access all Location & Physician – access all Password – can change own password Control Panel – access to basic functions

CANNOT: Access Patient, Institution, Communications, Database Preferences or Security Access SlideMaker/Stainer – same as Level 1

Level 3 Operators (Lab Administrator)

CAN:

Perform all Level 1 and 2 functions plus: Archive patient results, Delete History Log entries, Set up Patient Area, Institution, Communications, Database Preferences and Security Access, Use all features of SlideMaker / SlideStainer

PN A86980AA (October 2009) Miami Education Center SA-7 of 8 @Beckman

Coulter

SECURITY ACCESS

SKILL CHECK

1. Log on at Level 1 and list the changes in the following Workstation areas

Patient Tests [Results & Graphics] List 3 icon buttons not available to a Level 1 User

________________________________________

________________________________________

________________________________________

Quality Assurance List 3 icon buttons not available to a Level 1 User

________________________________________

________________________________________

________________________________________

System Set Up What one option is available to the Level 1 User under Quality Assurance setup?

________________________________________

2. Answer the following if you have an LH SlideMaker / LH SlideStainer.

(LH SlideMaker) List 2 operations that only a Level 3 operator can perform.

________________________________________

________________________________________

(LH SlideStainer) List 3 operations that a Level 1 or Level 2 operator cannot perform.

______________________________________

______________________________________

______________________________________

SA



SA-8 of 8

PN A86980AA (October 2009) Miami Education Center ST-1 of 8 @Beckman

Coulter

SLIDESTAINER

OBJECTIVES Given an operating COULTER® LH 700 Series with LH SlideMaker and LH SlideStainer, slide baskets and access to HELP

• Read and print an Overview of Cleaning procedures

• Create a new staining protocol

• Delete a custom staining protocol


As a lab administrator you may have to configure the LH SlideStainer at the Workstation. You may also need to create custom staining protocols and/or delete protocols that are no longer used by your laboratory.

Resources

To complete this module you will need

• LH 700 Series with LH SlideMaker and LH SlideStainer


• LH SlideStainer baskets

• Slides

What To Learn

Learn how to configure the LH SlideStainer at the Workstation, create and/or delete a staining protocol

ST


PN A86980AA (October 2009) Miami Education Center ST-2 of 8


PN A86980AA (October 2009) Miami Education Center ST 3-of 8


Cleaning Procedures

Step Action

1

At the Workstation in HELP, go to Contents LH SlideStainer

Cleaning Procedures Cleaning Procedures – Overview

2 Print the procedure.

NOTE You may click on the hypertext and print any of the other cleaning procedures. Most procedures are performed on an “as-needed” basis.

Creating a New Staining Protocol

Step Action

1 At the Workstation, go to HELP, Index

2 Type keywords: staining protocol

3 Under staining protocol, click on creating

4 Select

5 Print the procedure for use later in this module.



Deleting a Selected Protocol

Step Action

1

At the Workstation in HELP, go to Contents

LH SlideStainer

Operating Procedures

Operating – Advanced

Select and print the topic: Deleting a Selected Protocol

2 Study the procedure so that you can delete the Quickie protocol for the Skill Check. Do not delete any protocol now!

NOTE To delete a protocol, it cannot be the Protocol in Use. Be sure to download whatever protocol you want the LH SlideStainer to use before you delete the protocol you do not want to keep.

3 Close HELP.

Editing a Selected Protocol

The Default protocols can not be edited. If you want to use a default with slight changes, just create a new protocol with a different name (e.g. NewWright or Wright2).

Any protocol that you create can be edited by selecting it from the list, making your changes and then saving it. You will get a message that asks if you want to change it, just answer yes.

Remember to download any new protocol or changed protocol to the SlideStainer.

Go on to the Practice part of the module.


PN A86980AA (October 2009) Miami Education Center ST 5-of 8

Get the Skill Check at the end of this module. Ask a facilitator to watch your protocol in action!

Practice

Step Action

1 Follow the procedure that you printed for “Creating a New Staining Protocol”. Name your new protocol Quickie.

2 Use the same bath contents as for Wright’s stain.

3 Set the times for baths 1 , 2, & 3 to 30 sec.

4 Set the time for bath 4 to 0 sec.

5 Set the time for bath 5 to 1 minute

6 Set the Dryer time to 1 minute

7 Save the Quickie protocol.

8 Download the Quickie protocol to the SlideStainer. Make sure you choose this icon

9 Make sure the Stainer is set to Auto Mode.

10 After completing the protocol setup, place an empty basket in the STAT input location.

The LH SlideStainer will pick up the basket and “process” it.


ST-7 of 8 @BeckmanCoulter

SLIDESTAINER

SKILL CHECK

Setting up the SlideStainer

1. Where do you enable or disable the SlideStainer?

_______________________________________________________________

2. If the SlideStainer checkbox is not selected, how does this affect how the LH SlideMaker transports baskets on its tracks? _______________________________________________________________

Creating a New Staining Protocol

• Attach a copy your Quickie staining protocol for documentation for the Key Operator Certification program.

Deleting a Staining Protocol

• What must be done prior to deleting your Quickie protocol?

_______________________________________________________________

NOTE: Review Deleting a Selected Protocol on page ST-4.

As Needed Cleaning Procedures

• List at least five of the eleven as needed cleaning procedures for SlideStainer.

_________________________________________________

_________________________________________________

_________________________________________________

_________________________________________________

_________________________________________________

ST



ST-8 of 8

PN A86980AA (October 2009) Miami Education Center XB-1 of 10 @Beckman

Coulter

BX ANALYSIS

OBJECTIVES Given an operating COULTER® LH 700 Series instrument and access to HELP

• Describe how to set up BX target values and limits

• Review BX data in your instrument Workstation

• Give at least three examples of results that would be excluded from an BX batch


BX 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.

What To Learn

Access the HELP system to learn how to set up and review BX on the LH 700 Series instrument..

Resources

To complete this module, locate and print the following HELP procedures:

• BX Analysis - Overview

• Setting Up BX Analysis

• BX Results Table

XB


PN A86980AA (October 2009)) Miami Education Center

XB-2 of 10



XB-3 of 10


What is BX 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



XB-4 of 10

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 Workstation

• Enable XB on the Run Configuration 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)



XB-5 of 10

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 Workstation setup

What Makes a Batch "Out of Control"?

• Instrument problem

• Change in patient population

One or more types of patients added or removed from mix of patient population

• Non-random patient sampling

• Batch of patients is biased by several abnormal patients of a certain type (oncology, neonatal and so forth)

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.



XB-6 of 10

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

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: Derived from the RBC Histogram

MCH: Hgb x 10 RBC

MCHC Hgb x 100 Hct

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



XB-7 of 10

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

Practice

Step Action

1

At your LH Workstation, using "Setting Up BX Analysis" HELP procedure, go to

System Set Up

Quality Assurance to review set up options.

2 Close System Set Up.

3 At the instrument Workstation, using "Reviewing BX Results" go to

Quality Assurance,

Review the BX data in the Workstation:

a) Look at the current batch as well as the previous and last batches.

b) Look at the batch mean summary table. 4

c) Examine the Levey-Jennings graphs for trending or shifts.

When you finish reviewing the BX options in the Workstation, complete the Skill check for this module.



XB-8 of 10

PN A86980AA (October 2009) Miami Education Center XB-9 of 10 @Beckman

Coulter

BX ANALYSIS

SKILL CHECK

• Describe where and how to Set up BX Analysis

_______________________________________________________________

_______________________________________________________________

_______________________________________________________________

_______________________________________________________________

• Describe where and how to Review BX Analysis

_______________________________________________________________

_______________________________________________________________

_______________________________________________________________

_______________________________________________________________

• In addition to the current batch, how many batches can you review? _________

What are the other batches called?

_______________________________________________________________

• Write down at least three causes for results to be automatically (by the instrument) excluded from an BX batch

_______________________________________________________________

_______________________________________________________________

_______________________________________________________________

XB



XB-10 of 10

PN A86980AA (October 2009) Miami Education Center XM-1 of 12 @Beckman

Coulter

XM ANALYSIS

OBJECTIVES Given an operating COULTER® LH 700 Series and access to HELP

• Describe where to enable/disable XM parameter groups

• Describe how to set up XM target values and limits for a parameter group

• Review XM data in your instrument Workstation

• Give at least five examples of results that would be excluded from an XM batch


XM Analysis is a cost-free quality control method that monitors instrument performance using an Exponentially Weighted Moving Average of CBC, Diff, and Reticulocyte parameters of all patient samples. It compares these averages with target means and limits. The use of XM is an option decided by the laboratory.

Resources

To complete this module, locate, print and read the following HELP procedures:

• XM Analysis Overview

• Setting Up XM Analysis

• Reviewing XM Results

• XM Statistics Table

What To Learn

Access the HELP system to learn how to set up and review XM on the LH 700 Series.

XM



XM-2 of 12


PN A86980AA (October 2009) Miami Education Center XM-3 of 12


What is XM Analysis?

"Exponentially Weighted Moving Average" (EWMA) of patient sample Results.

• The first form of weighted moving average statistical analysis in Hematology was XB, originally created by Dr. Brian S. Bull.

Note Although XB and XM are both ways to monitor moving averages, the EWMA used in XM and the Bull’s algorithm used in XB are different.

• Uses any of four XM Parameter Groups: CBC, DIFF, RETIC, RETIC Calc

• Batch size can be configured independently for the four parameter groups from 2-1000.

• Compares batch results to target means and limits.

• An ongoing method of monitoring automated hematology instruments

• No additional cost (uses patient sample results)

• XM provides a way to monitor calibration stability within a method or instrument. It also provides a way to monitor calibration uniformity between methods and instruments.

What Is A Target Value?

• An average value, for each parameter, calculated from large numbers of patient results

• Target values should reflect the majority of the patient population of the laboratory

• Include all ages and disease states

• The value may be static (fixed) or moving (auto-updated with each new batch mean when auto update is enabled.)

Note

If you use auto-update continually, you will never be flagged out of range. You may wish to use this feature while establishing your targets and limits, then disable.

However, auto-update works independently for both Target and Limits. You may select auto-update ON for the Target and OFF for the Limits. In this case, the batches will be evaluated.



XM-4 of 12

Where To Set up Targets

You can access the Configure Targets and Limits screen two ways:

• From System Setup, select Quality Assurance, select XM tab, select Configure Targets Limits button

OR • From Command Center QA, select XM, open any batch or the batch

mean table, select Configure Targets Limits button

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"

Before collecting data ensure the following: Instrument is clean

Instrument is calibrated

There are no instrument problems

Sufficient data collected (recommend at least six months)

Select Auto-Update Target, if you want the target recalculated for each batch. If not, deselect.

Choose between 2SD limit and 3SD limit for each parameter

This displays either the auto target values/limits or the static values/limits entered by the lab for each parameter.

Select Auto-Update Limits, if you want the limits recalculated for each batch. If not, deselect.



How Do You Get Started?

• Enable XM on the Run Configuration screen for each data set required

• Configure your requirements in System Setup, QA, XM tab

You might want to use the auto-update feature during the data collection phase, then switch to static values for some or all of your parameters when you are satisfied with your mean and limit value.

For example, you could leave auto-update on for the target and turn auto-update off for the limits.

Another consideration for those who want to use both XB and XM: if you leave a target blank and turn auto-update off for a parameter, you will not get a value or graph for that parameter. In other words, you can use this to disable parameters within a parameter group that you do not want to monitor. So, if you are using XB, you can turn off MCV, MCH and MCHC in XM.

• You may want to use historically established means and limits to begin or run samples to collect batches of patient samples

You might want to set to a large batch (250-1000+) for the data collection.

• Collect data to reflect entire patient population (all ages and disease states).

• Consider that you need an adequate N in a reasonable time frame, a relatively homogenous population over time (or else your mean may drift) and no excessive biological variation within the time frames (you might see a difference in means between in-hospital tertiary care patients in the AM vs. normal patients from doctor’s offices/external clinics in the PM.

After Data is Collected

• Compare means and limits calculated using auto update to establish static values or to make adjustments to previously entered historic values.



XM-6 of 12

What Makes a Batch "Out of Control"? • Instrument problem

• One large outlier in a small batch size (e.g. you get a WBC of 380 in a batch size of 40, but your WBC usually runs 8.0 as a mean.)

• Seasonal changes (change in patient population)

One or more types of patients added or removed from mix of patient population

• Batch of patients is biased by several abnormal patients of a certain type (oncology, neonatal and so forth)

• 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"

• Consider adjusting limits to more adequately reflect your population

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 are 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

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 (see table next page) Is it a directly measured parameter? Is it a derived parameter (derived from a histogram)? Is it a calculated parameter? Refer to table on next pages…



Parameter Method Description WBC Coulter

Principle White Blood Cell Count or Leukocyte Count • Measured directly, multiplied by the calibration factor.

It is corrected for interference, if necessary. Both the WBC and uncorrected WBC (UWBC) are reported. If no correction is required, then WBC = UWBC.

• WBC = N X 103 cells/µL

RBC Coulter Principle

Red Blood Cell Count or Erythrocyte Count • Measured directly, multiplied by the calibration factor

• RBC = N X 106 cells/µL

Hgb Photometric Measurement

Hemoglobin or Hemoglobin Concentration • Transmittance of light at 525 nm through a lysed WBC solution

in the Hgb cuvette, compared to the transmittance of the same light through a reagent blank. The system converts this ratio to the Hgb value using a calibration factor.

• Weight (mass) of Hgb determined from the degree of absorbance found through photo current transmittance expressed in g/dL

•

Hct Calculated Hematocrit • The relative volume of packed erythrocytes to whole blood

•

MCV Derived from RBC Histogram

Mean Corpuscular Volume • The average volume of individual erythrocytes derived from the

RBC histogram

• The system multiplies the number of RBC in each channel by the size of the RBC in that channel. The products of each channel between 36 and 360 femtoliters (fL) are added. This sum is divided by the total number of RBC between 36 and 360 fL. The analyzer then multiplies by a calibration constant

• Expressed in fL

MCH Calculated Mean Corpuscular Hemoglobin • The weight of Hgb in the average erythrocyte

•

MCHC Calculated Mean Corpuscular Hemoglobin Concentration • The average weight of Hgb in a measure dilution

•

RDW Derived from RBC Histogram

Red Cell Distribution Width • The size distribution spread of the erythrocyte population

derived from the RBC histogram

( ) 100×⎟⎠⎞

⎜⎝⎛=

HctHgbg/dLMCHC

( ) 10×⎟⎠⎞

⎜⎝⎛=RBCHgbpgMCH

( ) ( )10

MCVRBC%Hct ×=

( ) ⎥⎦

⎤⎢⎣

⎡⎟⎟⎠

⎞⎜⎜⎝

⎛×=

TT

%%log10 Sample

Referenceconstantg/dLHgb



XM-8 of 12

• Expressed as coefficient of variation (%)

Parameter Method Description PLT Derived from Plt

Histogram Platelet Count or Thrombocyte Count • The number of platelets derived from the Plt histogram,

multiplied by a calibration factor

Plt = n X 103 cell/µL

MPV Derived from Plt Histogram

Mean Platelet Volume • The average volume of individual platelets derived from the Plt

histogram, multiple by a calibration factor

• Expressed in fL

NE% VCS Technology

Neutrophil Percent •

Expressed as a percentage (%)

LY% VCS Technology

Lymphocyte Percent •

• Expressed as a percentage (%)

MO% VCS Technology

Monocyte Percent •


EO% VCS Technology

Eosinophil Percent •


BA% VCS Technology

Basophil Percent •


NRBC% VCS Technology and WBC Histogram

Nucleated Red Blood Cell Count • The number of nucleated red blood cells (NRBC) per 100 WBC


( ) 100×⎥⎦

⎤⎢⎣

⎡++++

=events BAEOMOLYNE

eventsBA BA%

( ) 100×⎥⎦

⎤⎢⎣

⎡++++

=events BAEOMOLYNE

events EOEO%

( ) 100×⎥⎦

⎤⎢⎣

⎡++++

=events BAEOMOLYNE

events MOMO%

( ) 100×⎥⎦

⎤⎢⎣

⎡++++

=events BAEOMOLYNE

events LYLY%

( ) 100×⎥⎦

⎤⎢⎣

⎡++++

=events BAEOMOLYNE

events NENE%



Parameter Method Description NE# Calculated Neutrophil Absolute Count

LY# Calculated Lymphocyte Absolute Count

MO# Calculated Monocyte Absolute Count

EO# Calculated Eosinophil Absolute Count

BA# Calculated Basophil Absolute Count

NRBC# Calculated Nucleated Red Blood Cell Absolute Count • Represents the total number of nucleated red blood cells

•

RET% VCS Technology

Reticulocyte Percent • The number of reticulocytes per 100 RBC

• Ratio of retics to the total number of red cells

•

RET# Calculated Reticulocyte Absolute Number

IRF Calculated Immature Reticulocyte Fraction • A percentage of the count of the highest light scatter retics (the

most immature retics) relative to the total retic count • Expressed as a decimal ratio

•

MRV Calculated Mean Reticulocyte Volume • The average volume of all retic events

•

( )( )100 Regions Events Retic

100 Regions VolumeReticMRV−−

=)( fl

( )( )100 Regions Retics

103 Regions Events ReticIRF−

−=

RBCL ×⎟⎠⎞

⎜⎝⎛=

100Retic%cellsx10Retic# 6 μ/

100×⎟⎠⎞

⎜⎝⎛=

Events Cell RedEvents ReticRet%

WBC100

NRBC%cellsx10NRBC# 3 ×⎟⎠⎞

⎜⎝⎛=Lμ/

WBC100

BA%cellsx10BA# 3 ×⎟⎠⎞

⎜⎝⎛=Lμ/

WBC100

EO%cellsx10EO# 3 ×⎟⎠⎞

⎜⎝⎛=Lμ/

WBC100

MO%cellsx10MO# 3 ×⎟⎠⎞

⎜⎝⎛=Lμ/

WBC100LY%cellsx10LY# 3 ×⎟

⎠⎞

⎜⎝⎛=L/μ

WBCNE%cells/x10NE# 3 ×⎟⎠⎞

⎜⎝⎛=

100μL



XM-10 of 12

Practice

Step Action

1

At your LH Workstation, using the "Setting Up XM Analysis" HELP procedure, go to

System Set Up Quality Assurance

to review set up options.

2 Close System Set Up.

3 At the instrument Workstation, using "Reviewing XM Results" from HELP, go to Quality Assurance,

4

Review the XM data in the Workstation for each of the four parameter groups. Look at the current batch as well as the previous and last batches. Look at the batch mean summary table and graphs. Examine the Levey-Jennings graphs for trending or shifts.

When you finish reviewing the XM options in the Workstation, complete the Skill check at the end of this module.

PN A86980AA (October 2009) Miami Education Center XM-11 of 12 @Beckman

Coulter

XM ANALYSIS

SKILL CHECK

• Describe where and how to set up XM analysis.

_____________________________________________________

_____________________________________________________

_____________________________________________________

_____________________________________________________

• Describe where and how to Review XM Analysis. _____________________________________________________

_____________________________________________________

_____________________________________________________

_____________________________________________________

• In addtion to the current batch, how many other batches can you review?_________

What are these other batches called? _____________________________

• Name the four XM sets:

_______________________________________________________________

_______________________________________________________________

_______________________________________________________________

_______________________________________________________________

• A batch size can range from __________ to ___________.

• Which of the following would not be excluded from an XM batch?

_____ Partial Aspiration

_____ RBC values < 1.0 x 106 cells/µL

_____ Plt values < 30 x 103 cells/µL

_____ over linearity “+”

XM


PN A86980AA (July 2009) Miami Education Center

XM-12 of 12

lh 700 series hematology analyzer

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