Instrumentation Laboratory

ACL Coagulation Systems

Quality Control Analysis Training Guide

PN A54161AB (April, 2009) Miami Education Center

NOTICE OF INTENT
This training document is not intended to replace the information in the ACL TOP Operators Manual. Information in the ACL TOP Operators Manual supersedes information in any other document.

REVISION STATUS
Revision AA Initial Issue (April, 2008) Software Release: TOP 500 CTS 3.0.2/9.8 (April, 2009) Software Release: ACL TOP 500 CTS 3.0 ACL TOP 4.0 ACL TOP CTS 4.0 ACL TOP 700 LAS 3.5 ACL TOP Family 4.3

Revision AB

TRADEMARKS
Instrumentation Laboratory, , ACL TOP, HemosIL and AccuTrak are registered trademarks of Instrumentation Laboratory company in the Unites States and several international jurisdictions. All other trademarks, registered trademarks, service marks, products or services are trademarks or registered trademarks of their respective holders. Copyright Beckman Coulter, Inc. 2009 All Rights Reserved

ii of vi

PN A54161AB (April, 2009) Miami Education Center

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 MANUFACTURERS 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 systems 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.

PN A54161AB (April, 2009) Miami Education Center

iii of vi

iv of vi

PN A54161AB (April, 2009) Miami Education Center

ACL TOP Family Training Manual

RQC1

RUN QC 1
OBJECTIVES
Given:
The ACL TOP Family coagulation system is performing to specifications Controls are reconstituted and ready to run The instrument is setup and ready to run PT-RP and APTT-SS

Action:
Run all QC levels for PT-RP and APTT-SS from the vial Review QC Analysis

SKILL CHECK
Successfully complete all steps in the Performance Guide Correctly answer the questions in the Skill Check

MODULE RESOURCES
ACL TOP Operators Manual Contents Tab Quality Control Performing Quality Control Performance Guide Run QC 1

PN A54161AB (April, 2010) Miami Education Center

RQC1 1 of 6

RQC1 Run QC 1
Performance Guide
Perform QC from Vials

ACL TOP Family Training Manual

1. Load Normal C. Assayed and High Abn C. Assayed controls as follows: ACL TOP 500 CTS Single click or touch Reagent Area .

Place the controls in a Diluent Rack so that the barcodes are facing out. Choose track D1 by pressing the button on the front of the analyzer. Once the barcode reader is in position, load the Diluent Rack onto the analyzer. Review the Reagent Area screen to ensure that the controls were identified. ACL TOP 700 or ACL TOP 700 CTS or ACL TOP 700 LAS Single click or touch Diluent Area .

Place the controls in a Diluent Rack so that the barcodes are facing out. Choose track D1 or D2 by pressing the button on the front of the analyzer. Once the barcode reader is in position, load the Diluent Rack onto the analyzer. Review the Diluent Area screen to ensure that the controls were identified.

RQC1 2 of 6

PN A54161AB (April, 2010) Miami Education Center

ACL TOP Family Training Manual

RQC1

2. Choose QC Results List from the Menu Bar. 3. Double click on APTT-SS for the Normal C. Assayed control in the Test Code column to open the Material/Tests Definition Tree. 4. Clear the previous selection by single clicking or touching Clear Tree Selection APTT-SS PT-RP or all tests from the last run will be repeated.

5. Select the check box next to the following tests:

TIP: Selecting the check box next to the test will automatically select the check box next to each QC level for that test, so that you dont have to select each QC level separately. 6. Single click or touch Program QC 7. Single click or touch Previous Screen to start analysis. to return to the QC Results List.

8. Continue to Review QC Analysis while the QC is running.

PN A54161AB (April, 2010) Miami Education Center

RQC1 3 of 6

RQC1
Review QC Analysis

ACL TOP Family Training Manual

1. Verify that you are on the QC Results List (top left corner). If not, choose QC Results List from the Menu Bar. 2. How do you know which QC levels are running? _______________________ 3. Double click anywhere on the QC Results List to display the Material/Tests Definition Tree on the QC Statistics screen. 4. Single click on the words Normal C. Assayed under PT-RP from the Material/Tests Definition Tree to display the QC data for this level. NOTE: The checkmark before the QC level is only used to select which QC levels to run. The QC level backlit either gray or blue is the QC data displayed to the right. 5. Review the data to the right of the navigation tree. 6. Single click on the words High Abn C. Assayed for the PT-RP. 7. How did the data on the right change when you chose the different level? ______________________________________________________________ 8. Single click or touch Previous Screen to return to the QC Results List.

9. Did any QC from the run above fail? _________ If so, which ones? _______ ______________________________________________________________ 10. From the QC Results List screen, how did you know the QC failed? __________________________________ 11. Double click on the word FAILED to open the QC Statistics screen. 12. Which QC level is being displayed? _______________________________________ TIP: Double clicking on the word FAILED from the QC Results List to open the QC Statistics screen displays the failed QC backlit in gray or blue on the Material/Tests Definition Tree. 13. Single click on QC Alarm
.

14. What is the message? _____________________________________________

RQC1 4 of 6

PN A54161AB (April, 2010) Miami Education Center

ACL TOP Family Training Manual

RQC1

SKILL CHECK
1. What QC runs when you select the check box next to a test? ____________________ ________________________________________________________________________ 2. What QC runs when you select the check box next to the QC level? ________________________________________________________________________ 3. What does this icon do? _______________________________________________

4. What are the two ways the instrument tells you a QC failed? ________________________________________________________________________ ________________________________________________________________________ 5. What displays when you choose the QC Alarm ? ___________________________

_______________________________________________________________________

PN A54161AB (April, 2010) Miami Education Center

RQC1 5 of 6

RQC1

ACL TOP Family Training Manual

RQC1 6 of 6

PN A54161AB (April, 2010) Miami Education Center

ACL TOP Family Training Manual

RQC2

RUN QC 2
OBJECTIVES
Given:
The ACL TOP Family coagulation system is performing to specifications All controls required for this module have been reconstituted and are ready to be run PT-RP, APTT-SS, Fib-C and DDHS tests are enabled and calibrated

Action:
Run QC from Vials Run QC from sample cups Repeat FAILED QC Review QC Statistics Add a Comment to FAILED QC

SKILL CHECK
Successfully complete all steps in the Performance Guide Correctly answer the questions in the Skill Check

MODULE RESOURCES
ACL TOP Operators Manual 1. Single click or touch to open the ACL TOP Operators Manual.

2. Single click the Contents tab. 3. Single click Quality Control 4. Read the following sections: QC Overview QC Test Status List QC Results List Performing a Quality Control Test Performance Guide Run QC 2

PN A54161AB (April, 2010) Miami Education Center

RQC2 1 of 12

RQC2 Run QC 2
Performance Guide
Run QC from Vials

ACL TOP Family Training Manual

1. Load the D-Dimer Low and D-Dimer High controls on the instrument as follows: ACL TOP 500 CTS Choose Reagent Area from the Tool Bar.

Remove the Diluent Rack containing the Factor Diluent and add the controls in the rack so that the barcodes are facing out. Reload the rack in D1. Review the Reagent Area screen to ensure that the controls were identified. ACL TOP 700 or ACL TOP 700 CTS or ACL TOP 700 LAS Choose Diluent Area from the Tool Bar.

Remove the Diluent Rack containing the Factor Diluent and add the controls in the rack so that the barcodes are facing out. Reload the rack in D1. Review the Diluent Area screen to ensure that the controls were identified. 2. Choose Menu Bar QC Results List. 3. Double click anywhere on the QC Status List to open the QC Statistics screen. 4. Single click or touch Clear Tree Selection the last run. 5. Select DDHS from the Navigation Tree. 6. Single click or touch Program QC to start analysis. to clear all selections from

RQC2 2 of 12

PN A54161AB (April, 2010) Miami Education Center

ACL TOP Family Training Manual

RQC2

Run QC from a Sample Cup 1. Pour the Normal C. Assayed, High Abn C. Assayed and Low Fib. Control into labeled 2.0mL sample cups. 2. Single click or touch Sample Area from the Tool Bar.

3. Double click on the Offline Rack to open the Rack Details screen. 4. At the Sample Area screen, single click the first sample position of the Sample Rack. 5. Choose Quality Control from the drop down list in the Sample type: field. 6. Choose Normal C. Assayed from the Sample ID: drop down list. 7. Place the control in the Sample Rack in the same position it was identified. 8. Single click or touch Add/Remove Tests Programming Window. to open the Tests and Profiles

9. Choose PT-RP, APTT-SS and Fib-C (choose appropriate tests for the other controls). 10. Single click on the next available position on the Sample Rack and repeat steps 4-9 for each QC material. 11. Single click or touch Insert Rack analyzer. and load the Sample Rack onto the

NOTE: There should be NO ?s on the newly loaded Sample Rack. If there are, you forgot to choose the Insert Rack icon first. Remove the rack, double then

click on the Offline Rack to reopen it, choose the Insert Rack icon reload the rack. 12. Do you have to choose Run Test

to start analysis? ________________

13. Why? _________________________________________________________ 14. Choose Menu Bar QC Results Lists. 15. How do you know the QC is running?________________________________ NOTE: When a control is placed in a 2.0mL sample cup, material tracking features such as volume warning, on-board stability tracking and expiration date tracking will not be available.

PN A54161AB (April, 2010) Miami Education Center

RQC2 3 of 12

RQC2
Repeat FAILED QC

ACL TOP Family Training Manual

1. Verify the QC Results List is displayed or choose Menu Bar QC Results List. 2. Did any QC from the run above fail? _________ If so, which ones? _______ ______________________________________________________________ 3. Double click on the word FAILED for the level that failed to open the QC Statistics screen. 4. From the Material/Tests Definition Tree, which QC level is being displayed? _____________________________________________________ TIP: In your lab, double clicking on the word FAILED from the Results List to open the QC Statistics screen, displays the failed QC back lit in blue or gray. This will assist you in which QC to repeat. 5. Single click or touch Clear Tree Selection selection from the last run. 6. Select the check box next to the failed QC(s). 7. Repeat for all FAILED QC. 8. Single click or touch Program QC to start analysis. to clear the previous

RQC2 4 of 12

PN A54161AB (April, 2010) Miami Education Center

ACL TOP Family Training Manual

RQC2

Review QC Statistics 1. Single click on the words for any QC level on the Material/Tests Definition Tree. NOTE: The checkmark before the QC level is only used to select which QC levels to run. The QC level backlit either gray or blue is the QC level that is displayed to the right.

2. Single click or touch the Switch View icon following views:

to switch between the

Toggles from current view to Chart view (Levey-Jennings). Toggles from current view to Grid view (table of results). Toggles from current view to Chart & Grid view.

3. Choose another QC level to view by single clicking on the words.

PN A54161AB (April, 2010) Miami Education Center

RQC2 5 of 12

RQC2
Review Grid View

ACL TOP Family Training Manual

1. Single click on the words for a QC that failed on the Material/Tests Definition Tree. 2. Single click or touch Switch View is displayed. until the Grid View (table of results)

3. Looking at the picture above, how do you know D-Dimer Low Control is being displayed? ______________________________________________________________ 4. Place your mouse over the word FAILED (4 on the screen capture above) in the QC Status column. 5. What information is displayed? ______________________________________________________________ 6. Choose a QC result that has a check in the Error Status column.

7. Place your mouse over the check in the column (6 on the screen capture above). 8. What information is displayed? ______________________________________________________________
RQC2 6 of 12

PN A54161AB (April, 2010) Miami Education Center

ACL TOP Family Training Manual

RQC2

Review Chart View

1. Single click or touch Switch View Jennings) is displayed.

until the Chart View (Levey-

2. Place the tip of the mouse over a data point. 3. What information is displayed? ______________________________________________________________ 4. Place your mouse anywhere in the yellow part of the Chart. 5. What information is displayed? _____________________________________

PN A54161AB (April, 2010) Miami Education Center

RQC2 7 of 12

RQC2
Review Chart & Grid View

ACL TOP Family Training Manual

1. Single click or touch Switch View to return to the Chart/Grid View (table of result s and Levey Jennings together.

2. Use the scroll bars to view information on the table of results.

RQC2 8 of 12

PN A54161AB (April, 2010) Miami Education Center

ACL TOP Family Training Manual

RQC2

Add a Comment to a QC Result 1. Find a QC that has a failed result. Use any view you like. 2. Select the data point. Use the scroll bar at the bottom of the table of results to find the Comment column then look for a result with a check in this column. 3. Single click or touch Comment .

4. Enter Repeat same vial of control. and your initials then choose OK. 5. Repeat the same steps to review the comment.

PN A54161AB (April, 2010) Miami Education Center

RQC2 9 of 12

RQC2

ACL TOP Family Training Manual

6. Use the scroll bar to scroll over to the Comment column then run your mouse over the check in the column to view the comment. Using the Grid view (table of results) is an easy way to locate a data point with a comment.

RQC2 10 of 12

PN A54161AB (April, 2010) Miami Education Center

ACL TOP Family Training Manual

RQC2

SKILL CHECK
1. Where can QC be loaded on the instrument?__________________________________ 2. How do you view the Chart legend? _________________________________________ 3. What does this icon do 4. What does this icon ? _______________________________________________ do? _______________________________________________

5. How do you add a comment to a QC result? ____________________________________ ________________________________________________________________________

PN A54161AB (April, 2010) Miami Education Center

RQC2 11 of 12

RQC2

ACL TOP Family Training Manual

RQC2 12 of 12

PN A54161AB (April, 2010) Miami Education Center